Therapy Harnesses Immune System to Slow Progression of DIPG Brain Tumors – University of Michigan Health System News

Researchers are learning more about how to harness the immune system to find new treatment options for a deadly brain cancer that strikes young children.

Diffuse intrinsic pontine glioma, or DIPG, tumors cant be surgically removed due to their location on a critical structure of the brain called the brain stem. In addition, because of the presence of the blood-brain barrier, these tumors do not respond well to chemotherapy. Radiation is the most common treatment but its temporary, because the tumor grows back, and it isnt the ideal option for the young, developing brains of small children.

Some adult brain cancers, though, have responded to efforts to invigorate the immune system against the tumor, and a new study shows similar effects in animal models with one of the mutations that is present in human DIPG.

Immune-mediated gene therapy may lead us to a safe and effectivetherapeutic approach for DIPG in the future, says first author Flor Mendez, Ph.D.

MORE FROM MICHIGAN: Turning the Tables on Glioblastoma

The researchers treated mouse models with DIPG-like tumors in the brain stem, using an immunostimulatory gene therapy called TK/Flt3L to assess whether it would have a positive outcome on survival compared to regular care.

Together, these therapeutic genes sparked the immune system to recognize and kill the tumor cells, says Maria G. Castro, Ph.D., co-senior author.

We found anti-tumor immunity and an increase in anti-tumor specific T cells, says co-senior author Pedro Lowenstein, M.D., Ph.D. In this type of brain tumor, there are low numbers of immune cells in the tumor microenvironment, and this approach addresses that shortcoming.

Additionally the team found that the immune-mediated gene therapy was well tolerated and did not cause any adverse side effects. They say these results will pave the way for future clinical implementation of this immune-stimulatory gene therapy in DIPG patients at the University of Michigan and beyond.

The work was funded by the National Institutes of Healths National Institute of Neurological Disorders and Stroke, the ChadTough Foundation and the Leahs Happy Hearts Foundation.

Paper cited: Therapeutic efficacy of immune stimulatory thymidine kinase and fms-like tyrosine kinase 3 ligand (TK/Flt3L) gene therapy in a mouse model of high grade brainstem glioma, Clin Cancer Res. DOI: 10.1158/1078-0432.CCR-19-3714

MORE FROM MICHIGAN: Tackling Tumors That Always Come Back: New Brain Cancer Research Could Improve Outcomes

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Therapy Harnesses Immune System to Slow Progression of DIPG Brain Tumors - University of Michigan Health System News

Stemline Slated for Acquisition by Menarini in Deal Worth Up to $677M – Xconomy

XconomyNew York

Stemline Therapeutics, whose drug for a rare, aggressive type of acute leukemia was approved by the FDA about 18 months ago, has signed an acquisition deal with Italian biopharma Menarini Group.

Stemline (NASDAQ: STML), a New York-based company, developed the first FDA-approved drug for blastic plasmacytoid dendritic cell neoplasm, or BPDCN. The drug, tagraxofusp (Elzonris) targets CD123, a cell surface protein associated with the blood cancer.

The Menarini transaction is worth up to $677 million, according to the companies, which announced the agreement Monday. Under the deal terms Menarini, which is headquartered in Florence, plans to acquire Stemline shares at $12.50 apiece, split into $11.50 up front and another $1 upon the first sale of its drug in France, Germany, Italy, Spain or the United Kingdom following approval by the European Commissionas long as it occurs on or before the end of 2021.

Stemline requested European regulators review the drug as a treatment for adult BPDCN patients in January 2019, according to its latest annual report.

US sales of the drug brought in $43.2 million in 2019, its first year on the market. That year the company reported a net loss of $76.8 million.

Menarini CEO Elcin Barker Ergun, in a statement, said the acquisition would expand the Italian companys presence in the US and strengthen its oncology portfolio. The privately held biopharma says its annual sales top $4.2 billion.

As part of the Italian drug maker, Stemline plans to continue its efforts to launch the BPDCN drug outside of the US and to advance it as a potential treatment for other diseases. Stemline is also evaluating the drug in Phase 1/2 trials as a treatment for patients with chronic myelomonocytic leukemia, myelofibrosis, and acute myeloid leukemia.

Stemline saw its stock price soar on the acquisition announcement, rising to $12.10 in a jump of more than 150 percent compared to its close at $4.75 per share Friday. When Stemline went public in 2013, it priced its shares at $10 apiece.

Founded in 2003 by current CEO Ivan Bergstein, the companys approach to drug development is based on research into what are known as cancer stem cells, or cancerous cells that act like stem cells in that they reproduce themselves and sustain the cancer, showing outsize ability to resist chemotherapy and other standard cancer treatments. Read more about Stemlines origins in this Xconomy piece from 2011.

Both companies boards of directors have OKd the tie-up. If shareholders agree, the firms anticipate the deal will close this quarter.

Image: iStock/ChiccoDodiFC

Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.

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Stemline Slated for Acquisition by Menarini in Deal Worth Up to $677M - Xconomy

Teva and Celltrion Healthcare Announce the Launch of TRUXIMA (rituximab-abbs) Injection for Rheumatoid Arthritis, the Only Biosimilar to Rituxan…

TEL AVIV, Israel & PARSIPPANY, N.J. & INCHEON, South Korea--(BUSINESS WIRE)-- Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Celltrion Healthcare, Co., Ltd. (KRX KOSDAQ:091990), today announced that TRUXIMA (rituximab-abbs) injection is now available in the United States for the treatment of:

TRUXIMA is the only biosimilar to the reference product Rituxan1 (rituximab) available to treat rheumatoid arthritis in the United States. See important safety information below including Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.

We are proud to make TRUXIMA available to patients and providers as a treatment option for these indications, especially as this is the only rituximab biosimilar indicated for rheumatoid arthritis, said Brendan OGrady, Executive Vice President, North America Commercial, Teva. Following the launch of our other biosimilar earlier this year, we remain focused on our commitment to lower healthcare costs and increase price competition through the availability of biosimilars.

Celltrion Healthcare and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 for Teva to commercialize TRUXIMA in the U.S. and Canada. In May 2019, TRUXIMA was approved by the U.S. Food and Drug Administration (FDA) to match all of the reference products oncology indications described below.

We are pleased that patients in the United States can now have access to TRUXIMA for these new indications, said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. We believe that the continued use of biosimilars in the U.S. market will contribute to addressing unmet needs for patients and providers.

Earlier this year, the Centers for Medicare and Medicaid Services (CMS) granted pass-through status for TRUXIMA in the hospital outpatient setting. The Wholesale Acquisition Cost (WAC or list price) for TRUXIMA will be 10 percent lower than the reference product. TRUXIMA is expected to be available through primary wholesalers at a WAC of $845.55 per 100mg vial and $4,227.75 per 500mg vial. Actual costs to individual patients and providers for TRUXIMA are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patients insurance payer and eligibility for participation in the assistance program.

Teva also offers dedicated patient support services through the CORE program. CORE is available to help eligible patients, caregivers and healthcare professionals navigate the reimbursement process. CORE offers a range of services, including benefits verification and coverage determination, support for precertification and prior authorization, assistance with coverage guidelines and claims investigation, and support through the claims and appeals process. A savings program is also available for eligible commercially insured patients. To learn more, please visit TevaCORE.com.

Please see the Important Safety Information below including the Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. For more information, please see the full prescribing information.

Indications TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with:

Non-Hodgkins Lymphoma (NHL)

Chronic Lymphocytic Leukemia (CLL)

Rheumatoid Arthritis (RA)

Granulomatosis with Polyangiitis (GPA) (Wegeners Granulomatosis) and Microscopic Polyangiitis (MPA)

Important Safety Information

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Infusion-Related Reactions: Administration of rituximab products, including TRUXIMA, can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue TRUXIMA infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products

Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with TRUXIMA. Discontinue TRUXIMA and concomitant medications in the event of HBV reactivation

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions - Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes. Rituximab product-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death

Premedicate patients with an antihistamine and acetaminophen prior to dosing. For RA, GPA, and MPA patients, methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion. Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Depending on the severity of the infusion-related reaction and the required interventions, temporarily or permanently discontinue TRUXIMA. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved. Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (25,000/mm3)

Severe Mucocutaneous Reactions - Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab products. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these reactions has been variable and includes reports with onset on the first day of rituximab exposure. Discontinue TRUXIMA in patients who experience a severe mucocutaneous reaction. The safety of re-administration of rituximab products to patients with severe mucocutaneous reactions has not been determined

Hepatitis B Virus Reactivation - Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs] positive)

HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases increase in bilirubin levels, liver failure, and death can occur

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with TRUXIMA. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during TRUXIMA treatment

Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following TRUXIMA therapy. HBV reactivation has been reported up to 24 months following completion of rituximab therapy

In patients who develop reactivation of HBV while on TRUXIMA, immediately discontinue TRUXIMA and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming TRUXIMA treatment in patients who develop HBV reactivation. Resumption of TRUXIMA treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV

Progressive Multifocal Leukoencephalopathy (PML) - JC virus infection resulting in PML and death can occur in rituximab product-treated patients with hematologic malignancies. The majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. Most cases of PML were diagnosed within 12 months of their last infusion of rituximab

Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture

Discontinue TRUXIMA and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML

Tumor Lysis Syndrome (TLS) - Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 12-24 hours after the first infusion of rituximab products in patients with NHL. A high number of circulating malignant cells ( 25,000/mm3) or high tumor burden, confers a greater risk of TLS

Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated

Infections - Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab product-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure). New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue TRUXIMA for serious infections and institute appropriate anti-infective therapy. TRUXIMA is not recommended for use in patients with severe, active infections

Cardiovascular Adverse Reactions - Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of TRUXIMA for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina

Renal Toxicity - Severe, including fatal, renal toxicity can occur after rituximab product administration in patients with NHL. Renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and TRUXIMA is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue TRUXIMA in patients with a rising serum creatinine or oliguria

Bowel Obstruction and Perforation - Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1-77) days in patients with NHL. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur

Immunization - The safety of immunization with live viral vaccines following rituximab product therapy has not been studied and vaccination with live virus vaccines is not recommended before or during treatment

Prior to initiating TRUXIMA physicians should ensure patients vaccinations and immunizations are up-to-date with guidelines. Administration of any non-live vaccines should occur at least 4 weeks prior to a course of TRUXIMA

Embryo-Fetal Toxicity - Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. Advise pregnant women of the risk to a fetus. Females of childbearing potential should use effective contraception while receiving TRUXIMA and for 12 months following the last dose of TRUXIMA

Concomitant Use With Other Biologic Agents and DMARDS Other Than Methotrexate

Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly as limited safety data is available.

Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with rituximab products

Use in RA Patients Who Have Not Had Prior Inadequate Response to TNF Antagonists

TRUXIMA should only be used in patients who have had a prior inadequate response to one or more TNF antagonist

Most common adverse reactions in clinical trials of NHL (25%) were: infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia

Most common adverse reactions in clinical trials of CLL (25%) were: infusion-related reactions and neutropenia

Most common adverse reactions in clinical trials of RA (10%) were: upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis (other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events)

Most common adverse reactions in clinical trials of GPA and MPA (15%) were: infections, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema, and infusion-related reactions

Nursing Mothers - There are no data on the presence of rituximab in human milk, the effect on the breastfed child, or the effect on milk production. Since many drugs including antibodies are present in human milk, advise a lactating woman not to breastfeed during treatment and for at least 6 months after the last dose of TRUXIMA due to the potential for serious adverse reactions in breastfed infants

About TRUXIMA TRUXIMA (rituximab-abbs) is a U.S. Food and Drug Administration (FDA)-approved biosimilar to RITUXAN (rituximab) for the treatment of: adult patients with CD20-positive, B-cell NHL to be used as a single agent or in combination with chemotherapy or CLL in combination with fludarabine and cyclophosphamide (FC); for rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies; and granulomatosis with polyangiitis (GPA) (Wegeners Granulomatosis) and microscopic polyangiitis (MPA) in adult patients in combination with glucocorticoids

TRUXIMA has the same mechanism of action as Rituxan and has demonstrated biosimilarity to Rituxan through a totality of evidence.

About Celltrion Healthcare, Co. Ltd. Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcares products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines.

About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve peoples lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at http://www.tevapharm.com.

Teva's Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of TRUXIMA Injection for Rheumatoid Arthritis in the United States, which are based on managements current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors and Forward Looking Statements. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

1 RITUXAN is a registered trademark of Genentech and Biogen.

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Teva and Celltrion Healthcare Announce the Launch of TRUXIMA (rituximab-abbs) Injection for Rheumatoid Arthritis, the Only Biosimilar to Rituxan...

Genmab Announces U.S. FDA Approval of Subcutaneous Formulation of Daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), for the Treatment…

Company Announcement

Copenhagen, Denmark; May 01, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of the subcutaneous formulation of daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj). The Biologics License Application (BLA) for this formulation was submitted by Genmabs licensing partner, Janssen Biotech, Inc. (Janssen) in July 2019. DARZALEX FASPRO is approved for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX FASPRO is a fixed-dose formulation that can be administered over approximately three to five minutes, significantly less time than intravenous DARZALEX, which is given over several hours. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the subcutaneous formulation of daratumumab to the intravenous formulation in patients with relapsed or refractory multiple myeloma and data from the Phase II PLEIADES (MMY2040) study, which is evaluating subcutaneous daratumumab in combination with different standard multiple myeloma treatment regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and the 24th European Hematology Association (EHA) Annual Congress. An update of the COLUMBA data as well as data from the PLEIADES study were presented during poster sessions at the 61st American Society of Hematology (ASH) Annual Meeting in December 2019.

The approval of the subcutaneous formulation of daratumumab, DARZALEX FASPRO, is a landmark event in the development of daratumumab. Not only is it now the first and only subcutaneous CD38 antibody approved for the treatment of multiple myeloma, the subcutaneous administration of DARZALEX FASPRO considerably reduces treatment burden, as the fixed-dose injection is administered in approximately three to five minutes, offering patients a more convenient treatment experience. As seen in the pivotal study supporting the approval, this reduction in infusion time from hours to minutes led to higher satisfaction levels for patients and in addition, infusion-related reactions were both mild and significantly reduced with this formulation of daratumumab. We are very much looking forward to the launch of DARZALEX FASPRO in the U.S. and the potential for positive impact it will have on the lives of the patients receiving the drug, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the COLUMBA (MMY3012) studyThe Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that included 522 adults diagnosed with relapsed and refractory multiple myeloma. Patients were randomized to receive either: subcutaneous (SC) daratumumab, as 1,800 mg daratumumab with rHuPH20 2,000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study; or 16 mg/kg IV daratumumab once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The co-primary endpoints of the study are overall response rate and Maximum trough concentration of daratumumab (Ctrough; defined as the serum pre-dose concentration of daratumumab on Cycle 3 Day 1).

About the PLEIADES (MMY2040) studyThe Phase II trial (NCT03412565) is a non-randomized, open-label, parallel assignment study that includes 265 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma are being treated with 1,800 mg SC daratumumab in combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan and prednisone (D-VMP). Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg SC daratumumab plus lenalidomide and dexamethasone (D-Rd). An additional cohort of patients with relapsed and refractory multiple myeloma treated with daratumumab plus carfilzomib and dexamethasone (D-Kd) was subsequently added to the study. The primary endpoint for the D-VMP, D-Kd and D-Rd cohorts is overall response rate. The primary endpoint for the D-VRd cohort is very good partial response or better rate.

About DARZALEX (daratumumab) DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for ASCT; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for ASCT; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resul cvfting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5,6

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of three approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Arzerra (ofatumumab, under agreement with Novartis AG), for the treatment of certain chronic lymphocytic leukemia indications in the U.S., Japan and certain other territories and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development by Novartis for the treatment of relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra is a trademark of Novartis AG or its affiliates. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV. TEPEZZA is a trademark of Horizon Therapeutics plc.

1 DARZALEX Prescribing information, April 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s027lbl.pdf Last accessed April 20202 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed October 20193 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.4 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.5 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.6 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974

Company Announcement no. 19CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces U.S. FDA Approval of Subcutaneous Formulation of Daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), for the Treatment...

Stem cell therapy shows 83% survival of Coronavirus patients on ventilators – International Business Times, Singapore Edition

Top US vaccine expert was fired

Patients with acute respiratory distress syndrome (ARDS), a symptom of COVID-19, received a stem cell therapy which resulted in an 83 percent survival rate in ventilator-dependent coronavirus patients with moderate to severe ARDS

The drugs given were two intravenous infusions of the experimental 'allogeneic mesenchymal stem cell' candidate Ryoncil (remestemcel-L) by Mesoblast Limited based in Australia and the United States. Ryoncil, under a priority review by the FDA, is also under development for other rare diseases and inflammatory conditions, according to the company's release.

The company had previously announced that the drug received clearance from the US Food and Drug Administration (FDA) earlier this month as an Investigational New Drug (IND) to treat those with ARDS caused by novel coronavirus infection under expanded access compassionate use and also in a planned randomized controlled trial.

Among the 12 patients, nine were off ventilators within 10 days. There was 83 percent survival rate. Seven patients were already discharged. However, all the patients also received other experimental therapies before receiving the stem cell one, at New York City's Mt Sinai hospital.

Once ventilated after facing acute respiratory distress syndrome, the likelihood of coming off the ventilator is nine percent, while the survival rate is 12 percent, said Mesoblast CEO Silviu Itescu to BioWorld. The company would complete the phase II/III trials which are randomized placebo-controlled ones to confirm the efficiency of remestemcel-L

The drug focuses on rare adult stem cells called MLC's that responds to signals that are linked to tissue damage, and secrete molecules promoting tissue repair and also modulates immune responses. The drug is believed to counter the inflammatory processes by decreasing the production of pro-inflammatory cytokines while increasing the production of anti-inflammatory cytokines that stops the inflammations caused by the coronavirus.

This comes at a time when hydroxychloroquine, the most hopefully talked about drug failed in tests. Even Gilead's remdesivir, which even the WHO upheld, failed in the first randomized controlled trial. It is to be seen how stem cell therapy works out.

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Stem cell therapy shows 83% survival of Coronavirus patients on ventilators - International Business Times, Singapore Edition

There’s no treatment for COVID-19, but Virginia researchers are ramping up clinical trials to try to find one – Richmond.com

For the doctors treating the hundreds of patients who are hospitalized for COVID-19 in Virginia, there's no playbook. The disease that has spread rapidly across the world - killing hundreds in the state and more than 200,00 worldwide - has no known treatment, so COVID-19 has presented a unique challenge to the doctors faced with saving lives against a mostly-unknown enemy.

But, in an effort to discover treatments, medical researchers in the state have dropped everything to ramp up experimental clinical trials that many be the patients' best hope of recovery.

When Dr. Antonio Abbate, speaks with patients about the possibility of joining a clinical trial, hes used to standing next to the patients, holding their hands and looking into their eyes.

Joining a clinical trial means he or she is volunteering to receive an experimental treatment that has not been proven to be effective. Abbate,the medical director of the clinical research unit at VCU Medical Center, has to tell them about the possible benefits and risks.

But in the new reality where physical proximity means greater danger for health care workers and patients alike, hes had to get accustomed to having those conversations by video chat.

As of Friday, VCU had enrolled 38 people in trials to test two drugs,remdesivir andsarilumab.

Everybody stopped what they were doing and really focused on [COVID-19], said Dr. F. Gerard Moeller, who chairs the committee at VCU that reviews new clinical trials.

Studies on two experimental drugs were approved in days rather than the usual weeks or months it would usually take, he said.Currently, the trials are only for people whose COVID-19 is serious enough for them to be hospitalized and doctors determine which trial to enroll a patient based on the specifics of the case.

Were not jumping steps, were just working nights and weekends to make things happen, Abbate said, emphasizing the importance of not disregarding safety. I am optimistic that we will have treatments within months. Im just not sure which one it will be.

Remdesivir is an antiviral drug that has not been approved, but has been used experimentally to treat Ebola and tested in animals with other diseases caused by different kinds of coronaviruses. The company that manufactures the drug, Gilead Sciences Inc., announced hopeful results on April 10 that the drug had shown improvement in 68% of a small group of 53 patients with severe complications of COVID-19 treated through a clinical trial.

But the World Health Organization accidentally published findings from a trial that took place in China that found no benefit from the drug, but the findings were inconclusive because the study was ended early, Stat News reported Thursday. Remdesivir is also being tested at clinical trials at HCA Henrico Doctors Hospital and the University of Virginia Medical Center.

Sarilumab is approved for treating rheumatoid arthritis and is focused not on fighting the novel coronavirus directly, but on calming an overactive inflammatory response to the virus that damages the body.

At UVA Medical Center, doctors specializing in infectious disease and critical care began looking at evidence for different potential therapies for COVID-19 before treating their first patient.

We wanted to hit the ground running, said Dr. Patrick Jackson, an infectious disease specialist leading the remdesivir trial at UVA.

Jackson said that many of his patients have been enthusiastic about participating in the clinical trial because they want to be part of the effort to find a treatment for COVID-19 that will help more people down the road. Hes hoping to have some initial results from the trial, which is being run at hospitals across the country lead by the National Institutes of Health.

On Monday, his team will begin the second phase of the trial that will include adding a different drug, baricitinib, which is an anti-inflammatory used to treat rheumatoid arthritis.

They also plan to start enrolling patients in additional studies soon, including another effort to reduce the bodys inflammatory response by using adult stem cells.

Another experimental treatment that is taking hold across the world is the use of convalescent plasma, which is taken from the blood of people who have recovered from COVID-19. The plasma contains antibodies that can help the immune system fight of the virus.

Theres been a history of using the plasma of patients who have successfully recovered from a disease, said Dr. Dennis Szurkus, Chief Medical Officer at HCA Henrico Doctors Hospital, which is participating in a study run by the Mayo clinic. Were hoping it will be highly effective.

VCU Medical Center, Bon Secours hospitals and UVA Medical Center are also using the plasma treatment.

But in order for the hospitals to administer this treatment, they need blood donations from people who have recovered from COVID-19 and meet the criteria, which currently include having a positive test for the disease and being symptom free for at least 28 days, or symptom free for at least 14 days and have a negative COVID-19 test.

But as testing shortages have plagued the country, only 10% of the thousands of people who have reached out to the Red Cross hoping to donate over the last month met the eligibility criteria, according to a press release from the American Red Cross Friday.

To help streamline the process, last week, the Food and Drug Administration approved an antibody test that the Red Cross will roll out to screen donated plasma for COVID-19 antibodies. The Red Cross wont be doing antibody testing for the general public. Those wanting to donate can learn more at redcrossblood.org/plasma4covid.

But even as researchers talk about the promise of quickly moving toward potential treatments, theyre careful to warn against disregarding scientific protocol.

You want to do the best thing you can for that patient, said Moeller from VCUs clinical trial committee, explaining a physicians temptation to try out multiple treatments on a patient. At the same time, if you just throw everything at the patient without any evidence, you dont know if what you did helped the patient whether medications can be helpful or harmful without controlled studies, we dont know that.

The FDA has issued a warning against using hydroxychloroquine, an antimalarial drug that President Donald Trump has promoted as a possible treatment for COVID-19, outside of hospital and clinical trial settings because of possible side effects that could impact the heart.

Theres a pressure to get treatments out there -- as there should be, said Jackson, from UVA. But we also risk doing the wrong thing for patients We take very seriously the principal of, first, do no harm. Thats why clinical trials like this are so important.

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There's no treatment for COVID-19, but Virginia researchers are ramping up clinical trials to try to find one - Richmond.com

Newest American Academy of Arts and Sciences members | Stanford News – Stanford University News

Fifteen Stanford faculty members are among the 276 new members elected to the American Academy of Arts and Sciences, which honors exceptional scholars, leaders, artists and innovators engaged in advancing the public good.

From left to right starting from the top: Howard Y. Chang, Arogyaswami J. Paulraj, Michele Barry, Dan Jurafsky, Eva Silverstein, Caroline M. Hoxby, Jenny S. Martinez, Guadalupe Valdes, Anne Joseph OConnell, Kenneth F. Scheve, Thomas A. Rando, Paul V. Kiparsky, Thomas R. Clandinin, James Ferguson and Florencia Torche. (Image credit: Andrew Brodhead)

The new Stanford members to join the Class of 2020 are as follows:

Michele Barry, the Drs. Ben & A. Jess Shenson Professor, is the senior associate dean for global health and director of the Center for Innovation in Global Health in the Stanford School of Medicine. She is also a professor of medicine, a senior fellow at the Woods Institute and at the Freeman Spogli Institute. As the co-founder and co-director of the Yale/Stanford Johnson and Johnson Global Health Scholar Award, she has sent more than 1,000 physicians overseas to underserved areas to help strengthen health infrastructure in low-resource settings.

Howard Y. Chang, the Virginia and D.K. Ludwig Professor of Cancer Genomics and of Genetics, is a professor of dermatology and of genetics. He is also a Howard Hughes Medical Institute investigator. Changs research focuses on the role of epigenomics in the control of large groups of genes involved in cell cycle control, and on the study of long noncoding RNAs in biological development, cancer and aging.

Thomas R. Clandinin, the Shooter Family Professor, is a professor and chair of neurobiology. Clandinins research focuses on three central questions in neurobiology: how neuronal circuits assemble during development, how the functions of these circuits are maintained during adult life and how these circuits mediate the complex computations essential to animal behavior.

James Ferguson, the Susan S. and William H. Hindle Professor in the School of Humanities and Sciences, is a professor of anthropology. His research has focused on southern Africa. His recent work has explored the surprising creation and/or expansion both in southern Africa and across the global South of social welfare programs that target the poor and are anchored in schemes that directly transfer small amounts of cash to large numbers of low-income people.

Caroline M. Hoxby, the Scott and Donya Bommer Professor in the School of Humanities and Sciences, is a professor of economics and a senior fellow at the Hoover Institution and at the Stanford Institute for Economic Policy Research (SIEPR). Hoxby specializes in public economics, the economics of education and labor economics.

Dan Jurafsky, the Jackson Eli Reynolds Professor in Humanities, is a professor of linguistics and computer science. His research ranges across computational linguistics, including natural language understanding, human conversation, the relationship between human and machine processing and the application of natural language processing to the social and behavioral sciences. He also works on the linguistics of food and the linguistics of Chinese.

Paul V. Kiparsky, the Robert M. and Anne T. Bass Professor in the School of Humanities and Sciences, is interested in how words are structured, how the vocabulary of a language is organized, how word meaning relates to syntax, how languages change, and what all this tells us about the human mind. His current work focuses on the interface between phonology and morphology.

Jenny S. Martinez, the Richard E. Lang Professor of Law, is dean of Stanford Law School. Martinez is an expert on international law and constitutional law, including comparative constitutional law. She is the author of The Slave Trade and the Origins of International Human Rights Law (Oxford University Press, 2012). An experienced litigator, she has worked on cases involving international law and constitutional law issues.

Anne Joseph OConnell, the Adelbert H. Sweet Professor of Law, is a lawyer and political scientist whose research and teaching focuses on administrative law and the federal bureaucracy. OConnell has written on such topics as agency and judicial nominations, political appointees, bureaucratic organization (and reorganization), political changes in agency rulemaking, quasi-agencies and congressional oversight of agencies.

Arogyaswami J. Paulraj is a professor (research) of electrical engineering, emeritus, and is the inventor of MIMO wireless communications, a technology that enables improved wireless performance. MIMO is now incorporated into all new wireless systems. He also pioneered MIMO-OFDMA technology, which has become the core of 4G mobile systems.

Thomas A. Rando, professor of neurology and neurological sciences, is the director of the Glenn Center for the Biology of Aging at Stanford and of the Rehabilitation Research and Development Center of Excellence at the Veterans Affairs Palo Alto Health Care System. His research focuses on understanding the biological signals that activate stem cells in response to injury or other environmental cues, particularly in the context of aging.

Kenneth F. Scheve is a professor of political science and a senior fellow at FSI. His research interests are in the fields of international and comparative political economy and comparative political behavior, with particular interest in the behavioral foundations of the politics of economic policymaking. He is currently examining the role of social preferences in opinion formation about tax policy, trade policy and international environmental cooperation. His work also focuses on the political origins of changes in wealth inequality in the 19th and 20th centuries.

Eva Silverstein, professor of physics, explores basic problems in several areas of theoretical physics, including mechanisms for cosmic inflation, supersymmetry breaking, the stabilization of extra dimensions in string theory and the physics of black holes. She is also a principal investigator on the Simons Foundation Origins of the Universe program.

Florencia Torche is a professor of sociology. Her research interests are in social demography, stratification and education. A longer-term area of her research examines inequality dynamics, with a particular focus on educational attainment, assortative mating and the intergenerational transmission of wealth.

Guadalupe Valdes, the Bonnie Katz Tenenbaum Professor of Education at Stanford Graduate School of Education, is a founding partner of Understanding Language, an initiative at Stanford that focuses attention on the role of language in subject-area learning. Her research explores many of the issues of bilingualism relevant to teachers in training and the role of education in national policies on immigration.

The American Academy of Arts and Sciences serves the nation as a champion of scholarship, civil dialogue and useful knowledge. The academy is committed to interdisciplinary, nonpartisan research that provides pragmatic solutions for complex challenges.

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Newest American Academy of Arts and Sciences members | Stanford News - Stanford University News

‘I Will Not Kill Children to Live’ – Church Militant

TYLER, Texas (ChurchMilitant.com) - The bishop of Tyler, Texas has issued a pastoral letterrousing Catholics to understandthe mortal dangerof any coronavirusvaccine developed using stem cells from aborted babiesand is urgingthemto fight.

Announcing his April 23 letter, Bp. Joseph Strickland encouraged "all who believe in the Sanctity of Life in the womb" to reflect on his message, as "it is critical for the whole human family."

In the letter, Strickland explainedthat the pandemichas opened his eyes to the dangerousreality ofthe "use of in line stem cells from aborted babies in developing vaccines."

"I urge you to join me, NOW, in passionately but prayerfully speaking out against this practice," he urged.

"We must insist that legislators create legislation which establishes the illegal and immoral nature of any use of the remains of aborted babies for research," said Strickland. "Further, we must insist that pharmaceutical companies comply with such legislation." he said.

"I believe this can be a significant building block in a culture of life which eliminates the taint of economic gain that too easily infects the abortion industry," the bishop added.

Strickland stressed that there are ethical ways to develop vaccines. "Scientists I've spoken with assure me that there is no medical necessity for using aborted children in order to develop the much-needed vaccine to protect us from this particular strain of Coronavirus," he noted. "Thankfully, ethical means are available and can prove to be just as effective in developing vaccines; umbilical cells, placental cells, adult stem cells and other sources of cells, including even those of insects, provide completely viable paths to an effective vaccine.""We all know the sad saga of abortion in our nation and throughout the world which continues to grow more diabolical even as we energetically proclaim, with ever deeper clarity, the precious gift of every unborn child," he lamented.

Strickland declaredthatthis new threat a coronavirus vaccine fashioned from the cells of murdered childrenmust be countered.

"Just because the crime of abortion is considered legal in our nation does not mean it is morally permissible to use the dead bodies of these children to cure a global pandemic," he warned. "Emphatically, this practice is evil."

The bishop recalled how recent popes have raised their voices in defense of life from conception to natural death and to warn about the dangers of scientific research unchecked by moral truth.

Pope St. John Paul II's 1995 encyclical "The Gospel of Life" (Evangelium Vitae) warned of the growingclash between the "culture of death" and the "culture of life," reiterating,"The killing of innocent human creatures, even if carried out to help others, constitutes an absolutely unacceptable act."

Bishop Strickland also pointed to Pope Emeritus Benedict XVI's 1987 "Respect for Human Life" (Donum Vitae), whichgave clear warning that"what is technically possible is not for that very reason morally admissible."

He noted these historic pontificalpleas have gone largely unheeded.

Twice in theletterin both his opening and his conclusion Stricklandpromisedto help those who join their voices with his, vowing to helpthem"navigate the storm" of the current troubled times"as best he can."

The bishop also pledged that in the upcoming week he will provide a guide to assist the faithful "in speaking the truth to your elected officials, the pharmaceutical industry, and your local community."The guidewillbe posted on theSt. Philip Institute of Catechesis and Evangelizationwebsite,a resource center dedicated to teaching the Faith.

Speaking with Church Militant, Dr. Stacy Trasancos, Executive Director of the St. Philip Institute,summed up the significance of the bishop'shistoric call:

If we stand with Bp. Strickland and let it be known that we will refuse a vaccine made from the exploitation of aborted children, then we can influence the research, development, and market. I don't want to find myself a year from now being required to accept an immorally produced vaccine knowing that I did not speak up when I had the chance. I won't leave that legacy to my children and grandchildren.

Trasancos added, "Bishop Strickland is asking us all, the entire human race, to stand up with him and say, 'I will not kill children to live.'"

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'I Will Not Kill Children to Live' - Church Militant

Morning Update: Canadas data gaps are hurting our ability to fight the pandemic – The Globe and Mail

Good morning,

Crucial data gaps are hurting Canadas ability to fight the COVID-19 pandemic, leaving Canadians in the dark about who is being infected or struggling with the devastated economy.

Canada has a long-standing problem of information gaps, The Globe and Mail found in a year-long series, and that has left us vulnerable during public health crises before. But now, these blind spots could blunt the federal economic rescue effort, hide inequities in deaths from the disease and slow our emergence from self-isolation in the months ahead.

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Father Victor Fernandes puts on personal protection equipment prior to visiting with a patient in the COVID-19 intensive care unit at St. Paul's hospital in downtown Vancouver on April 21, 2020.

JONATHAN HAYWARD/The Canadian Press

This is the daily Morning Update newsletter. If youre reading this on the web, or it was forwarded to you from someone else, you can sign up for Morning Update and more than 20 more Globe newsletters on our newsletter signup page.

Nova Scotia shooting: Premier Stephen McNeil is urging his mourning province to help investigators unravel questions around a gunmans weekend rampage. A new tip line was created specifically for the killings. He acknowledged there is anger over the RCMPs decision not to use the provincial emergency alert system during the 12-hour manhunt, but he asked people to be patient, and wait for answers.

New details are emerging about the chaos that ensued as police tried to capture the killer disguised as an RCMP officer. Audio recordings of first responders communicating on two-way radios provide a glimpse of frantic attempts to help the first victims in the village of Portapique.

A couple pays their respects at a memorial in Portapique, N.S., on April 22, 2020.

Andrew Vaughan/The Canadian Press

Economy: Saskatchewan has laid out a detailed, comprehensive plan to reopen its economy, and is the first province in the country to do so. On May 4, the five phases will begin, opening non-essential medical procedures, and the reopening of provincial parks, campgrounds and golf courses.

In Quebec, Premier Franois Legault is preparing to lay the groundwork next week for a plan to gradually restart the provinces economy and get children back to school.

Rent: Ottawa is proposing to offer commercial rent relief, in the form of loans for landlords of small and medium-sized businesses, that would cover up to 75 per cent of tenants payments for three months, according to sources familiar with the negotiations.

When it comes to investment properties, small landlords across Canada might not qualify for government assistance and are scrambling to figure out how to accommodate rent reductions while making their mortgage payments.

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World news:

Researchers at the University of Oxford are racing to develop a vaccine for COVID-19 and plan to make a million doses of it this summer. The team has been working since January, and clinical trials involving more than 500 volunteers began yesterday. The testing is expected to take several months, but the researchers have already teamed up with manufacturers globally to produce the doses September and millions more by the end of the year. The Globes Paul Waldie reports.

An aerial view of people queuing outside a bank in downtown Quito, Ecuador, on April 22, 2020.

RODRIGO BUENDIA/AFP/Getty Images

Got a news tip that youd like us to look into? E-mail us at tips@globeandmail.com Need to share documents securely? Reach out via SecureDrop

Scheer, Tories refrain from criticizing MP accused of racist comments: People of Asian descent have faced a spike in hate crimes and slurs since the COVID-19 pandemic began in China last year and experts say the comments from an elected official give licence for the attacks to continue.

Child protection organizations seeing significant uptick in predators: In dark-web forums, sexual predators are increasingly discussing the COVID-19 pandemic as an opportunity to exploit children online as they spend more time out of school and on the internet.

Ontarios Serious Fraud Office investigates Bondfield: A special unit of Ontario police officers and prosecutors launched the investigation in 2019, looking into allegations of wrongdoing by a major builder of hospitals, transit stations and other public infrastructure across the province.

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Parents of teen girls killed by Paul Bernardo seek to obtain his file with the parole board: The two families filed for judicial review this month after their requests for the documents under access to information legislation were denied.

MPs seek to overcome hurdle in getting WHO adviser to testify: A parliamentary committee scrutinizing the response to the pandemic is working to get key World Health Organization adviser Bruce Aylward to testify. The WHOs legal counsel has said that Dr. Aylward cannot testify unless he receives authorization from WHO Director-General Tedros Adhanom Ghebreyesus.

World stocks fall on worries over EU stimulus details, coronavirus drug: Global shares fell on Friday, spurred by delays to an agreement on divisive details of the European Unions stimulus package and doubts about progress in the development of drugs to treat COVID-19. In Europe, Britains FTSE 100 was down 0.93 per cent around 6 a.m. ET. Germanys DAX and Frances CAC 40 fell 1.07 per cent and 1.03 per cent, respectively. In Asia, Japans Nikkei fell 0.86 per cent. Hong Kongs Hang Seng fell 0.61 per cent. New York futures were flat. The Canadian dollar was trading at 71.05 U.S. cents.

Canada must protect itself from Americas response to COVID-19

Robyn Urback: It is not implausible that Mr. Trump would retaliate in some sort of petty but potentially grave economic way on supply lines for essential goods, for example if Canada refuses to lift restrictions on non-essential travel if and when the President decides that time is up.

This Ramadan, in solitude, will be more meaningful than ever

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Fatima Al Fahim: But the pandemic need not dampen Ramadan spirits. Physical distancing gives us a reminder of the true meaning of the holy month.

The world has a big China problem now

Campbell Clark: We dont know precisely what happened in China in the early days of COVID-19, but we know some whistle-blowers were stifled and, for whatever reason, officials waited for days to tell the world after learning they faced a serious epidemic.

By Brian Gable

Brian Gable/The Globe and Mail

What you really need is a room edit, not a reno

Especially while in isolation, you may be looking for curatorial guidance, but are keen to avoid the expense of a full interiors overhaul. Some people would rather rip out a wall or buy a bigger house, when all it often takes is reimaging and reworking what you already have, says Joanna Teplin, the Nashville co-founder of the Home Edit. If you want to remodel, read about how you might be able to make the change with what you already have.

Snuppy, right, the first male dog cloned from adult cells by somatic nuclear cell transfer, and the male Afghan hound from which an adult skin cell was taken to clone Snuppy, are seen in this handout photo released in Seoul on Aug. 3, 2005.

Seoul National University via Reuters

Snuppy worlds first cloned dog is born

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If he were born today, Snuppy would be dubbed, in internet lingo, a very good pupper or an excellent doggo. Instead, Snuppy, the first successful clone of a dog, had to settle for merely being hailed as a breakthrough in biotechnology. A team of 45 South Korean researchers, led by stem-cell researcher Hwang Woo-suk, produced the pup using a process called somatic cell nuclear transfer with a cell from the ear of a male Afghan dog, Tai. Snuppy was named for Seoul National University (SNU) and puppy. While other mammals had been cloned successfully starting with Dolly the sheep in 1996 cloning mans best friend proved more challenging. The achievement suggested that, given time and expertise, almost any mammal could be reproduced. Defying concerns that clones would be rife with ailments, Snuppy was generally healthy. He fathered 10 pups by artificial insemination and produced, by stem-cell clone, a litter with three surviving pups. Snuppy died of cancer, a common fate in dogs, just days after his 10th birthday in 2015. Jessie Willms

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Morning Update: Canadas data gaps are hurting our ability to fight the pandemic - The Globe and Mail

Adult Stem Cell – an overview | ScienceDirect Topics

Adult Stem Cells

Adult stem cells are those cells found in tissues after birth that are able to self-renew and yield differentiated cell types. Initially it was thought that adult stem cells were only located in a limited selection of organs and could differentiate into just those phenotypes found in the originating tissue. The field is still developing, however, and recent studies have identified stem cells in more tissues and indicate a greater range of potential than that originally believed. Already stem cells have been derived from human bone marrow (Edwards, 2004), blood (Ogawa, 1993; Asahara et al., 1997), brain (Steindler and Pincus, 2002), fat (Zuk et al., 2002), liver (Tosh and Strain, 2005), muscle (Alessandri et al., 2004), pancreas (Zulewski et al., 2001), and umbilical cord blood (Erices et al., 2000; Benito et al., 2004).

As with many rapidly expanding fields, the use of non-standardized methods makes interpreting results from different investigators difficult, and this thus has led to controversy. Since adult stem cells are often a very small percentage of the total cells isolated from a given tissue, generating a pure population is difficult. In many cases different investigators use different means of isolating the stem cells from a given tissue. The question then arises whether the stem cells generated from the various techniques are identical or distinct stem cell populations. This difficulty is further exacerbated as these cells are commonly identified using a range of criteria, such as isolation procedure, morphology, protein expression, etc., leaving some question as to the defining characteristics of these stem cell populations.

The potential to yield mature phenotypes is typically shown through either differentiation in vitro using biochemical cues or implantation in vivo in immunosuppressed mice. The lack of lineage tracing and clonal expansion in some studies has called into question whether observed phenotypes are due to the differentiation potential of a stem cell or to a heterogeneous initial population. As standardized protocols develop for adult stem cells, more rigorous criteria will develop for determining stem cell populations and their differentiation potential.

There is a growing argument that all adult stem cells may have a signature expression profile. It is possible that self-renewing capabilities combined with multipotency, regardless of the cell origin, are associated with a set of characteristic properties. While such properties have not yet been determined, one candidate may be dye exclusion. When stained with Hoechst, some adult stem cells have been found to actively exclude the dye using transmembrane pumps. These cells have been coined side population cells, as they appear in a peripheral area when analyzed by flow cytometry using a UV laser. Originally identified in murine bone marrow (Goodell et al., 1996), the commonality of this functional property across adult stem cells has best been shown in the mouse model, where side population cells have been found in muscle, liver, lung, brain, kidney, heart, intestine, mammary tissue, and spleen (Asakura and Rudnicki, 2002). Expression of the ABCG2 protein, which plays a role in the transmembrane pump (Scharenberg et al., 2002), may be a convenient expression marker of this functional property. It is still unclear, however, which signature expressions, if any, are inherently associated with all adult stem cells.

While adult stem cells may ultimately be derived from practically every tissue in the body, there is a subset, based on ease of isolation, availability, or potency, that is most likely to contribute to regenerative medicine. These stem cells, and the phenotypic lineages they have been shown to generate, are indicated in Table 3.2. Bone marrow- and blood-derived stem cells are fairly easy to isolate and have been the most thoroughly investigated. Both contain hematopoietic stem cells (HSCs) (Ogawa, 1993; Tao and Ma, 2003), which give rise to blood cells, and endothelial progenitor cells (EPCs) (Asahara et al., 1997; Kocher et al., 2001). Bone marrow additionally contains mesenchymal stem cells (MSCs) (Pittenger et al., 1999; Jiang et al., 2002), which have been shown to differentiate into mesodermal phenotypes, including orthopedic and vascular. The low yield of stem cells from marrow and blood motivates efforts to find alternative adult stem cell sources. HSCs and MSCs can also be derived from umbilical cord blood (Broxmeyer et al., 1989; Erices et al., 2000). As a widely available source of stem cells with extensive expansion capabilities in vitro, stored umbilical cord blood is considered an exciting resource for regenerative medicine applications (Chiu et al., 2005). One plentiful autologous adult stem cell source is fat. Lipoaspirate-derived stem cells have yet to be thoroughly investigated, but have already been shown to differentiate into multiple phenotypes (Zuk et al., 2002; Ashjian et al., 2003; Huang, J.I., et al., 2004). Overall, the proven differentiation potential of human adult stem cells is limited. Research in stem cell plasticity and animal adult stem cells, however, implies that the full potential of human adult stem cells is likely to be more extensive than has been currently shown.

Table 3.2. Differentiated cells derived from human adult stem cells

PLA: processed lipoaspirate

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