HELP ME HAYLEY: Spokane father of six receiving life-saving cells from Poland donor – KHQ Right Now

UPDATE:

SPOKANE, Wash. -- Life-saving cells for alocal father of six are on their way to him from Poland. His family has been panicked after a travel ban was put in place by the Polish Government. They say they were told the status of the transport was stalled, and with time slipping away, they needed immediate action.

Jared Weeks was diagnosed withAcute Myeloid Leukemia back in October. His wife Janet contacted 'Help Me Hayley' on Saturday. On Sunday morning, Janet got word that the cells were on their way. She reached out to many government officials and is still trying to sort how and who helped make this happen for her husband.

"I heard that relief in (my husband's) voice and that's all I needed," she said. "I'm so thankful to everyone who shared the story, sent us prayers. I felt it. I really did. People are so overwhelmingly beautiful."

Janet says her husband will have the stem-cell transplant on Tuesday.

"I will be traveling over to Seattle on Monday evening to be there for his 're-birthday,'" she said of the procedure. "I'm so grateful."

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SPOKANE, Wash. -- A local father of six desperately needs help receiving life-saving cells provided by an overseas donor. His family says his life depends on it.

His wife Janet sent our Hayley Guenthner this 'Help Me Hayley' request:

"Dear Help Me Hayley,

My children and I are desperate to save my husband. He was diagnosed with Acute Myeloid Leukemia on 10/15/2019 (on his 42nd birthday of all days) since then he has been in the hospital. At the beginning of February we started our journey to the west side of the state to be under the care of Seattle Cancer Care Alliance and to make a long story short, we are now in the transplant stage of his disease.

My husband, Jared Weeks, went inpatient to the University of Washington Medical Center (UWMC) on behalf of the Seattle Cancer Care Alliance. He started his myeloablative chemo regimen on March 10th with the expectation of receiving an Unrelated Allogeneic Peripheral Blood Stem Cell transplant. He had the highest dose of chemotherapy to eliminate his disease and replace his immune system with a 38-year-old female peripheral blood stem cell donation from Poland. Because of the travel ban put in place by the Polish Government in response to the outbreak of the Novel COVID-19 virus, it is becoming impossible to transport these LIFE-SAVING cells that have been extracted from my husband's donor and brought back to the United States. I have left messages for Senator Cathy McMorris-Rodgers, Governor Jay Inslee, Mayor Woodward and Senator Maria Cantwell. I was able to speak personally with State Senator Shelly Short who is passing on this to some of her contacts in the cabinet. I reached out to the Polish Government agency handling the travel ban restrictions and have spoken with an Overseas Citizen Services Safety Officer out of Krakow Poland at the US Embassy-State Department. The travel ban has been put in place but I have been told that roads are still open as well as trains and planes, but as of midnight tonight (not sure if our time or their time) the borders will be closed until March 25th, and maybe extended depending on the COVID-19 outbreak. The cells have been collected from the donor and we are desperate to get them here. Please help us!! God help us.

My husband, Jared Weeks, was diagnosed with Acute Myeloid Leukemia on October 15, 2019 and is in DIRE need of these stem cells to survive.

We need some assistance from the "powers that be" to get these life-saving stem cells to my husband in Washington State ASAP.

His life depnds on it."

There have many people offering to test to see if they are a local match for Jared. Unfortunately, the family doesn't have the kind of time required to find a new donor.

"They would need to go to bethematch.org , however, it is too late in the game to be a donor for Jared but there are hundreds of others that need this life-saving donation as well," Janet said. "The HLA TYPING that is done can take weeks to complete and for Jared, we don't have that kind of time."

Janet is currently in Spokane with their children. She said she is doing everything she can to stay strong for her husband.

"(Jared) is one heck of a dad," Janet said. "He is hardworking, loves the outdoors, fishing, boating and taking his kids on adventures. He is amazing to us and is the center of gravity for our rather large family. He has been through hell and back with this cancer, and is still trusting God completely."

Seattle Cancer Cancer Care Alliance sent KHQ a statement on Jared and other cancer patients relying on life-saving bone marrow transplants during the COVID-19 outbreak.

"The COVID-19 outbreak is an evolving and fluid situation, and the global medical community is collaborating to address the needs of people who are relying on bone marrow transplants for their treatment and survival.

"Seattle Cancer Care Alliance is evaluating every patient who is currently connected with an international or USA-based donor to ensure we have an alternative solution for their treatment should the need arise.

"We are committed to continuing to coordinate with the National Marrow Donor Program and the World Marrow Donor Association, along with donor representatives in various countries, to prevent potential disruptions of critical medical transport so that every cancer patient has access to the life-saving treatment they need.

"SCCA is dedicated to providing the highest-quality cancer care, and we take that responsibility very seriously. We continue to work very closely with our alliance partners -Fred Hutch, UW Medicine and Seattle Childrens- and sharing our approach and best practices with other transplant centers around the country who may face similar unprecedented challenges."

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HELP ME HAYLEY: Spokane father of six receiving life-saving cells from Poland donor - KHQ Right Now

Gene Therapy Reverses Heart Failure in Mouse Model – Technology Networks

Barth syndromeis a rare metabolic disease caused by mutation of a gene calledtafazzinorTAZ. It can cause life-threatening heart failure and also weakens the skeletal muscles, undercuts the immune response, and impairs overall growth. Because Barth syndrome is X-linked, it almost always occurs in boys. There is no cure or specific treatment.

In 2014, to get a better understanding of the disease,William Pu, MD, and colleagues at Boston Childrens Hospital collaborated with the Wyss Institute to create a beatingheart on a chip model of Barth syndrome. The model used heart-muscle cells with theTAZmutation, derived from patients own skin cells.It showedthatTAZis truly at the heart of cardiac dysfunction: the heart muscle cells did not assemble normally, mitochondria inside the cells were disorganized, and heart tissue contracted weakly. Adding a healthyTAZgene normalized these features, suggesting that gene replacement therapy could be a viable treatment.

But to fully capture Barth syndrome and its whole-body effects, Pu and colleagues needed an animal model. The animal model was a hurdle in the field for a long time, says Pu, director of Basic and Translational Cardiovascular Research at Boston Childrens and a member of the Harvard Stem Cell Institute. Efforts to make a mouse model using traditional methods had been unsuccessful.

As described in the journalCirculation Research, most mice with the whole-bodyTAZdeletion died before birth, apparently because of skeletal muscle weakness. But some survived, and these mice developed progressive cardiomyopathy, in which the heart muscle enlarges and loses pumping capacity. Their hearts also showed scarring, and, similar to human patients with dilatedcardiomyopathy, the hearts left ventricle was dilated and thin-walled.

Mice lackingTAZjust in their cardiac tissue, which all survived to birth, showed the same features. Electron microscopy showed heart muscle tissue to be poorly organized, as were the mitochondria within the cells.

Pu, Wang, and colleagues then used gene therapy to replaceTAZ, injecting an engineered virus under the skin (in newborn mice) or intravenously (in older mice). Treated mice with whole-bodyTAZdeletions were able to survive to adulthood.TAZgene therapy also prevented cardiac dysfunction and scarring when given to newborn mice, and reversed established cardiac dysfunction in older mice whether the mice had whole-body or heart-onlyTAZdeletions.

Thats where the challenge will lie in translating the results to humans. Simply scaling up the dose of gene therapy wont work: In large animals like us, large doses risk a dangerous inflammatory immune response. Giving multiple doses of gene therapy wont work either.

The problem is that neutralizing antibodies to the virus develop after the first dose, says Pu. Getting enough of the muscle cells corrected in humans may be a challenge.

Another challenge is maintaining populations of gene-corrected cells. While levels of the correctedTAZgene remained fairly stable in the hearts of the treated mice, they gradually declined in skeletal muscles.

The biggest takeaway was that the gene therapy was highly effective, says Pu. We have some things to think about to maximize the percentage of muscle cell transduction, and to make sure the gene therapy is durable, particularly in skeletal muscle."

Reference: Wang et al. (2020).AAV Gene Therapy Prevents and Reverses Heart Failure in A Murine Knockout Model of Barth Syndrome.Circulation Research.https://www.ahajournals.org/doi/abs/10.1161/CIRCRESAHA.119.315956.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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CytoDyn Files Modified IND and Protocol for Phase 2 Clinical Trial for Treatment of Patients with Coronavirus with Leronlimab (PRO 140) and Advises…

VANCOUVER, Washington, March 16, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the Company filed a modified IND and protocol for its Phase 2 clinical trial with leronlimab (PRO 140) as a therapy for patients who experience respiratory complications as a result of contracting Coronavirus Disease 2019 (COVID-19). The modification came at the behest of the U.S. Food and Drug Administration (FDA) in response to the Companys filing of its IND and protocol for its Phase 2 clinical trial on March 9, 2020.

The modified protocol is a Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab in Patients with Coronavirus Disease 2019 (COVID-19) and calls for 75 planned patients in up to 10 centers in the United States. Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks.

Jacob Lalezari, M.D., CytoDyns Interim Chief Medical Officer commented: We appreciate the FDAs timely input on protocol design and hope to start the treatment study in the very near future.

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn said: We are pleased with the new trial design and are rapidly sending supplies of leronlimab to the clinics to begin patient treatment.

With respect to the Companys press release issued on March 12, 2020, management announces the following correction: Patient #1 had missed one treatment of carboplatin and will continue to be treated with carboplatin and leronlimab. Additional updates about this patient will be included in the next Company update on all cancer patients.

About Leronlimab (PRO 140) The U.S. Food and Drug Administration (FDA) have granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including NASH. Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use. In the setting of cancer, research has shown that CCR5 plays an important role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is therefore conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additionalclinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn Files Modified IND and Protocol for Phase 2 Clinical Trial for Treatment of Patients with Coronavirus with Leronlimab (PRO 140) and Advises...

Heartbreaking coronavirus reality as isolated mum’s daughter waves at her from street – Mirror Online

A mum has laid bare the devastating reality of coronavirus by sharing a picture of her young daughter waving at her from the street as she self-isolates.

Dr Laura Noonan has a rare blood disease and needs a type of chemotherapy and stem cell treatment unavailable in Ireland.

TheGP, who travels to Russia every three to four months, is now in a Dublin hospital and fears the coronavirus could kill her.

Dr Noonan, who had just left out of an Intensive Care Unit for her prior health difficulties, said: Im back to the normal ward now, but I dont feel safe at all here.

I think Ill be be exposed to coronavirus through staff even [though there are] no visitors allowed.

I wanted to share with you what I think is the most powerful and impactful image I have seen that represents lockdown Ireland through the eyes of a child."

Mrs Noonan, who said she misses her daughter terribly, added to the Irish Mirror : "Thats my little girl [Freya] and mother waving up to me in isolation on the second floor of the hospital from the footpath below."

The patient, who has been travelling to Russia since January 2018, continued: "She is only seven. We cant see each other because of Covid-19 visiting restrictions.

Mrs Noonan said: "Thisis the face and bravery of one child in the midst of the coronavirus pandemic.

This is possibly one of the saddest photos I have ever taken.

My mother and Freya, two of the strongest women I know, standing outside the hospital waving up at me, talking on the phone and even trying to take a family selfie from a two-storey height difference.

This is not the first time we have had visits through the glass of a hospital window.

We grew very accustomed to that but it was very different that time.

There was a defined period it would last for and I knew when my numbers picked up enough I would be reunited with them albeit with each of us gowned and masked.

This is so different. This time there is no defined period."

Thousands of patients in Irish hospitals by the visiting bans that have been imposed since the coronavirus outbreak.

And Dr Noonan added: "My family have been called to say their goodbyes a few times.

"My brother and sister-in-law had to take an emergency visa to get out to me when I was really sick abroad.

Two weekends ago my husband [Archie] thought I wasnt going to wake from the coma and I did.

I was almost angry at first as I thought I was only living to die another day and I had already put up with so much I couldnt face anymore, but perspective changed over the next few days and Im ready to fight for my daughter again.

"But coronavirus has me terrified again."

Ironically, Mrs Noonan was on a flight from Russia to Ireland on February 2 when officials in hazmat suits removed a suspected coronavirus victim from the plane.

She said: We were all given a leaflet stating that we had possibly been exposed and a list of symptoms to watch out for over the following days.

It also advised we go straight to our onward destinations with as little contact with other people as possible and wait to hear from a doctor the next day.

A public health doctor and some paramedics came onto the plane and distributed contact forms for us to fill in.

It was about two hours after we landed before we got that much info.

But we all knew what the possible problem was within 10 minutes of landing as a paramedic in a hazmat suit removed a Chinese passenger from the plane."

That passenger subsequently tested negative for coronavirus, but if Mrs Noonan does contract the virus it could potentially be fatal for her.

Mrs Noonan said she has no idea when she will see her family.

She added: "I don't know how long I will be looking at my family through a pane of glass or on a video call of some type.

"Im lucky Im able to have my phone and use it.

"Many times, even during this admission, I didnt have my phone as I was too sick to manage it.

"I am always in isolation in hospital due to my lack of a functioning immune system from the chemo and other medications.

"But I could see my close family once they strictly adhere to the hygiene rules and wear masks, gloves and aprons/gowns as directed.

This time I cant see anyone.

Nobody [is allowed] in or out of the hospital without security clearance.

This time it was sprung on us with no real warning. I was told along the grapevine on Friday that no more visitors were allowed.

That was it. There was no time to gather up stuff to bring in to me.

Simple things like toiletries and clean pyjamas and family have since dropped things to the reception, which have been passed on after being sanitised, but its very hard to know they are in the building and I still cant see them even for a minute."

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Heartbreaking coronavirus reality as isolated mum's daughter waves at her from street - Mirror Online

Week In Review: Nanjing Legend Files To Stage IPO In The U.S. – Seeking Alpha

Deals and Financings

Nanjing Legend Biotech, a subsidiary of GenScript (HK: 1548) (OTC:GNNSF), has filed for an IPO on a US exchange. In 2017, Legend surprised the world when its CAR-T therapy produced a 94% response rate in pretreated multiple myeloma patients. Six months later, Johnson & Johnson (NYSE:JNJ) partnered the treatment in a deal that paid Legend $350 million upfront, plus unspecified milestones and royalties. The CAR-T candidate, JNJ-4528, is now in Phase II trials in the US.

Harbour BioMed (HBM) raised $75 million in a Series B+ round to advance its clinical-stage compounds and portfolio of next-gen biotherapies for cancer and immunological diseases. The company builds its portfolio by in-licensings and via its proprietary Harbour Mice program. Harbour develops drugs for China and US markets, while it has entered partnerships to discover candidates for China companies Innovent (OTCPK:IVBIY) and BeiGene (NASDAQ:BGNE), along with other prominent global biopharmas. The company previously completed an $85 million Series B financing in August 2018. HBM is headquartered in Cambridge, MA, and it conducts R&D in Suzhou and Shanghai.

GenFleet Therapeutics (Shanghai) closed a $57 million Series B financing, co-led by CDH Investments and Shenzhen Capital Group. Founded in 2017, GenFleet is developing novel large and small therapeutic molecules for oncology and immunology targets. The company says its projects are potential first-in-class therapeutics with technical advantages and large markets. It will use the capital for ex-China development and clinical trials of its existing pipelines, plus expanding its immunology platform, working on new projects and building an industrial base.

Arctic Vision of Shanghai in-licensed greater China rights to Xipere, a treatment for macular edema associated with uveitis, from Clearside Bio (NASDAQ:CLSD) in a $35.5 million agreement. Founded last year, Arctic in-licenses breakthrough ophthalmology products for China. Xipere is its first deal. Arctic plans to acquire China rights to 3-5 products and then expand to a combination of global rights and internal discovery for additional drugs. Clearside, which is located in Alpharetta, Georgia, said Xipere is a proprietary suspension of the corticosteroid triamcinolone acetonide.

Exuma Biotech (formerly F1 Oncology), a Florida-Shanghai company developing CAR-T products for solid tumors, closed a $19 million Series B round. The financing included investments from MSD Partners and F1 BioVentures, plus conversion of notes held by individual investors. Exuma's Logic Gated CAR-T products become activated only when the target antigen and the tumor microenvironment are both present, reducing off-tumor side effects. The company has started clinical trials of two candidates. Exuma's Shanghai subsidiary oversees the company's development, manufacturing, and commercial units in Shanghai and Shenzhen.

OBiO Technology (Shanghai) completed a B+ Round of more than $15 million for its viral-based gene therapy CRO services and genetic drug CDMO/CMO services. Founded in 2013, OBiO collaborated with GE Healthcare (NYSE:GE) to establish the first domestic GMP viral production workshop in China and supply CRO/CDMO/CMO services for viral drugs. At the same time, OBiO is incubating gene therapy drugs for cancer therapy with three ADC candidates for oncotherapy that have proprietary IP. The B+ Round investors included GP Capital, Sinowisdom and Efung Capital.

Shanghai OPM Biosciences raised $14 million from China Life Medical Fund to support its CDMO service platform. The company offers serum-free media for cell cultures based on animal cells, as well as a full-range of cell culture development services. It customizes high-quality personalized animal cell culture media to optimize the cell culture process and reduce production costs. OPM has developed a variety of chemically defined CHO/HEK293 cell culture media and nutritional products. The company claims its media improve cell growth and expression.

China Immunotech Biotech of Beijing completed a $6.5 million Series A financing, led by Jianxin Capital with Grower Venture Capital and Huacheng Group participating. Founded in March 2018, China Immunotech is developing TCR-T and CAR-T products that target hematological tumors, solid tumors and virus-related diseases. It has two unique technology platforms, STAR-T and TCR-T. The STAR-T platform uses a proprietary structure of antigen receptor complexes. The company believes the platform provides multi-targeted molecules with better efficacy, fewer side effects and easier development than traditional CAR-T products.

Chengdu's HitGen has signed a licensing agreement to develop a novel class of drugs for Kaken, a Japanese (TK: 4521) specialty pharma. HitGen has already used its large library of small molecule and macrocyclic compounds to identify potential candidates. Few details were released, but Kaken is known to be concentrating its R&D on inflammation/immunology (dermatitis, rheumatoid arthritis and osteoarthritis), pain relief and fungal infections. One year ago, the two companies formed a similar collaboration, presumably for other targets. HitGen will receive an upfront payment and be eligible to receive preclinical and clinical milestones.

Suzhou Ascentage Pharma (HK: 6855) announced approvals for three clinical studies of APG-2575, a novel Bcl-2 inhibitor, two in the US and one in China. APG-2575 is an oral drug designed to treat several hematologic malignancies by blocking Bcl-2 to restore the normal apoptosis process in cancer cells. According to Ascentage, the candidate is the first China-made Bcl-2 inhibitor to start clinical trials. In its Phase I clinical studies, APG-2575 did not exhibit any dose-limiting toxicity or tumor lysis syndrome (which is commonly associated with other Bcl-2 inhibitors).

Denovo Biopharma, a San Diego-Beijing precision medicine company, has discovered a novel genetic biomarker for depression that it intends to use with DB104, a triple dopamine, serotonin and norepinephrine reuptake inhibitor. The company made the discovery using its proprietary biomarker discovery platform. Denovo licensed DB104 from Albany Molecular Research. Bristol-Myers Squibb (NYSE:BMY) returned the candidate to Albany after two Phase IIb clinical trials in treatment-resistant depression. The biomarker is one of four DeNovo biomarkers aimed at psychiatric use.

I-Mab (NASDAQ:IMAB), a Shanghai clinical-stage biopharma, has started to develop TJM2 (TJ003234) to treat cytokine release syndrome in severe cases of COVID-19. TJM2 is an I-Mab-discovered neutralizing antibody that binds human granulocyte-macrophage colony stimulating factor (GM-CSF), an important cytokine that plays a critical role in acute and chronic inflammation. By binding GM-CSF, TJM2 prevents downstream signaling and target cell activation, inhibiting other inflammatory responses. I-Mab intends to start clinical trials in the US and expand to countries especially hard-hit by COVID-19.

Mesoblast (NSDQ: MESO; ASX: MSB), an Australia-based regenerative medicine company, announced plans to start trials of remestemcel-L, its allogeneic mesenchymal stem cell (MSC) product candidate, in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19. The trial will be conducted in the US, Australia, China and Europe. ARDS is the principal cause of death in COVID-19 patients. In a small China trial, allogeneic MSCs cured or significantly improved all seven patients with severe COVID-19 pneumonia.

Ascletis (HK: 1672), a Hangzhou biopharma, reported that an initial group of 11 COVID-19 patients all recovered after being treated with a combination Ganovo and Ritonavir therapy. Ascletis's Ganovo, the first approved direct-acting anti-viral agent developed by a China company, was launched in 2018 to treat hepatitis C. Ritonavir is a generic anti-retroviral that is used in AIDS/HIV combination therapies. The small clinical trial was led by Dr. Hongyi Chen, the director of the Ninth Hospital of Nanchang.

Disclosure: None

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Editor's Note: The summary bullets for this article were chosen by Seeking Alpha editors.

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Week In Review: Nanjing Legend Files To Stage IPO In The U.S. - Seeking Alpha