Science News Roundup: Stem cells give hope for revival of Malaysia’s extinct rhinos; Human versus disease showcased and more – Devdiscourse

Following is a summary of current science news briefs.

Back from the dead? Stem cells give hope for revival of Malaysia's extinct rhinos

Some skin, eggs and tissue samples are all that remain of Malaysia's last rhino, Iman, who died last November after years of failed breeding attempts. Now scientists are pinning their hopes on experimental stem cell technology to bring back the Malaysian variant of the Sumatran rhinoceros, making use of cells from Iman and two other dead rhinos.

Humanity versus disease showcased as London's Science Museum reopens doors

Exhibits showcasing humanity's battle with infectious disease will greet visitors recently emerged from coronavirus lockdowns when London's Science Museum re-opens its doors next week after its longest closure since World War II. "Medicine: The Wellcome Galleries" tracks medical advances through history, and its timely displays include an iron lung used for polio patients in the 1950s, an isolation trolley from the 1970s, PPE from the Ebola epidemic and statistics on the effectiveness of vaccinations.

British fossil hunters find bones of new dinosaur species, cousin to T.Rex

Four bones found on a beach on the Isle of Wight, off England's south coast, belong to a new species of theropod dinosaur, the group that includes Tyrannosaurus rex, researchers at the University of Southampton said on Wednesday. The new dinosaur, which has been named Vectaerovenator inopinatus, lived in the Cretaceous period 115 million years ago and was estimated to have been up to four metres long, the palaeontologists said.

Here is the original post:
Science News Roundup: Stem cells give hope for revival of Malaysia's extinct rhinos; Human versus disease showcased and more - Devdiscourse

Cellect Biotechnology Reports Second Quarter Financial and Operating Results; First Half 2020 Strategic Developments Create Long-Term Revenue…

TEL AVIV, Israel, Aug. 12, 2020 /PRNewswire/ -- Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative technology which enables the functional selection of stem cells, today reported financial and operating results for the second quarter ended June 30, 2020. The Company's six-month progress includes the development of several strategic initiatives, including growth-oriented opportunities in pain management and COVID-19 related therapeutics.

"Despite the COVID-19 pandemic business disruptions and the near-term delays to completing and commencing our clinical programs in Israel and the U.S., respectively, we acted swiftly over the past few months to leverage our sought-after technology to create several long-term business initiatives to enhance our value," commented Dr. Shai Yarkoni, Chief Executive Officer. "In addition to pursuing a potential merger with a global leader in the high growth medical-grade cannabis market, which is being delayed due to COVID-19, we have either initiated or are contemplating other business development activities that will greatly benefit from our innovation, technology and know-how. I believe each of these opportunities represents meaningful catalysts for Cellect in multi-billion-dollar markets, subject to resolution of the COVID-19 pandemic and return to normal course of business."

Notwithstanding the continued delays due to COVID-19, the Company remains focused on the following operational and clinical objectives:

The Company's cash and cash equivalents totaled $7 million as of June 30, 2020, which includes the approximately $1.5 million (gross before expenses)resulting from several investors exercising certain warrants that were issued in February 2019.

SecondQuarter 2020 Financial Results:

*For the convenience of the reader, the amounts above have been translated from NIS into U.S. dollars, at the representative rate of exchange on June 30, 2020 (U.S. $1 = NIS 3.466).

About Cellect Biotechnology Ltd.

Cellect Biotechnology (APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that aims to improve a variety of stem cell-based therapies.

The Company's technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.

Forward Looking Statements

This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellect's expectations regarding timing of the commencement of its planned U.S. clinical trial and its plan to reduce operating costs. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products; and the Company's ability to pursue any strategic transaction or that any transaction, if pursued, will be completed. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC.

Cellect Biotechnology Ltd.

Consolidated Statement of Operation

Convenience

translation

Six months

ended

Six months ended

Three months ended

June 30,

June 30,

June 30,

2020

2020

2019

2020

2019

Unaudited

Unaudited

U.S. dollars

NIS

(In thousands, except share and per

share data)

Research and development expenses

837

2,901

7,086

1,364

3,564

General and administrative expenses

1,356

4,703

5,064

2,116

2,709

Operating loss

2,193

7,604

12,150

3,480

6,273

Financial expenses (income) due to warrants exercisable into shares

1,098

3,807

(7,111)

4,697

(5,919)

Other financial expenses (income), net

(15)

(55)

880

627

462

Total comprehensive loss

3,276

11,356

5,919

8,804

816

Loss per share:

Basic and diluted loss per share

0.010

0.034

0.029

0.024

0.004

Weighted average number of shares outstanding used to compute basic and diluted loss per share

338,182,275

338,182,275

200,942,871

365,428,101

224,087,799

Cellect Biotechnology Ltd.

Consolidated Balance Sheet Data

Convenience

translation

June 30,

June 30,

December 31,

2020

2020

2019

Unaudited

Unaudited

Go here to read the rest:
Cellect Biotechnology Reports Second Quarter Financial and Operating Results; First Half 2020 Strategic Developments Create Long-Term Revenue...

California Propositions on the 2020 Ballot – Fullerton Observer

Local News

In addition to voting for candidates, California voters will be asked to vote on several ballot measures this November. Heres a breakdown of each Proposition on the ballot.

Prop. 14: Stem Cell Research Funding

Would issue $5.5 billion in bonds for the California Institute for Regenerative Medicine (CIRM), which was created to fund stem cell research.

Support has raised $6.58 million, with $4.63 million from Robert N. Klein II, a real estate investor and stem-cell research advocate.

There were no committees registered to oppose the ballot initiative.

For more information about the measure, click HERE. For the latest financial contributions, click HERE.

Prop. 15: Property Tax Increase on Commercial and Industrial Properties for Education and Local Government Funding

Would allow commercial and industrial properties (with some exceptions) to be taxed based on their market value, as opposed to their assessed value. Residential properties would not be affected. The State fiscal analyst estimated that the ballot initiative would generate between $8 billion and $12.5 billion in revenue per year. Revenue would be distributed mostly to local governments, school districts, and community colleges.

Support has raised $21 million, including $6 million from the California Teachers Association Issues PAC.

Opposition has raised $5.5 million, including $266,490 from the California Business Roundtable Issues PAC.

For more information about the measure, click HERE. For the latest financial contributions, click HERE.

Prop. 16: Ending the Ban on Affirmative Action

Would remove the ban on affirmative action involving race-based or sex-based preferences from the California Constitution by repealing Proposition 209 (1996). State and local governments, public universities, and other public entities wouldwithin the limits of federal lawbe allowed to develop and use affirmative action programs that grant preferences based on race, sex, color, ethnicity, and national origin in public employment, public education, and public contracting.

Support has raised $3.14 million. M. Quinn Delaney is the largest donor, contributing $1,500,000.

Opposition has raised $105,678, including $50,000 from Students for Fair Admissions, Inc.

For more information about the measure, click HERE. For the latest financial contributions, click HERE.

Prop. 17: Restoring the Right to Vote to People on Parole

Would allow people on parole for felony convictions to vote in California. Currently, the California Constitution disqualifies people with felonies from voting until their imprisonment and parole are completed.

Campaign finance data has not been reported.

For more information about the measure, click HERE. For the latest financial contributions, click HERE.

Prop. 18: Letting (some) 17-year-olds Vote

Would allow 17-year-olds who will be 18 at the time of the next general election to vote in primary elections and special elections.

Campaign finance data has not been reported.

For more information about the measure, click HERE. For the latest financial contributions, click HERE.

Prop. 19: Property Tax Breaks

Would allow homeowners who are over 55, disabled, or victims of natural disaster to take a portion of their property tax base with them when they sell their home and buy a new one. It would also limit the ability of new homeowners who inherit properties to keep their parents or grandparents low property tax payments. Most of the additional money raised would go into a State fire response fund.

Support has raised $19.15 million with $15.70 million from The California Association of Realtors Issues Mobilization PAC.

For more information about the measure, click HERE. For the latest financial contributions, click HERE.

Prop. 20: Criminal Sentencing, Parole, and DNA Collection Initiative

Would amend several criminal sentencing and supervision laws that were passed between 2011 and 2016.

Would allow prosecutors to charge repeat or organized petty theft as a felony, require probation officers to seek tougher penalties for those who violate the term of their parole 3 times, and exclude those who have been convicted of domestic violence and certain nonviolent crimes from early parole consideration.

Support has raised $1.6 million with $50,000 from San Bernadino County Sheriffs Employees Benefit Association Committee.

Opposition has raised $2.1 million with major funding from the Schusterman Foundation, the Heising-Simons Action Fund, and Patty Quillin.

For more information about the measure, click HERE. For the latest financial contributions, click HERE.

Prop. 21: Local Rent Control Initiative

Would allow cities to introduce new rent control laws, or expand existing ones.

Support has raised $16.68 million, with 99.8% from the AIDS Healthcare Foundation.

Opposition has raised $16.25 million, including $4.70 million from Essex Property Trust, $117,000 from California Rental Housing Association, and other property owner groups.

For more information about the measure, click HERE. For the latest financial contributions, click HERE.

Prop. 22: Self-employment for ride-hail and other app-drivers

Would consider app-based drivers to be independent contractors and not employees or agents. Therefore, the ballot measure would override Assembly Bill 5 (AB 5), signed in September 2019, on the question of whether app-based drivers are employees or independent contractors.

Support has raised $111 million, including $30 million from Lyft, $30 million from Uber, and $30 million from DoorDash.

Opposition has raised $866,591, with the Transport Workers Union of America providing $500,000.

For more information about the measure, click HERE. For the latest financial contributions, click HERE.

Prop. 23: Dialysis Clinic Requirements

Would require chronic dialysis clinics to have a minimum of one licensed physician present at the clinic and to report data on dialysis-related infections to the State and federal health officials.

The ballot measure would also state that a chronic dialysis clinic cannot discriminate with respect to offering or providing care nor refuse to offer or to provide care, on the basis of who is responsible for paying for a patients treatment.

Support has raised $6 million from a healthcare workers union.

Opposition has raised $2 million, with $1 million from DaVita, Inc. and $1 million from Fresenius Medical Care (dialysis clinics).

For more information about the measure, click HERE. For the latest financial contributions, click HERE.

Prop. 24: Consumer Privacy Protections

Would strengthen Californias consumer privacy law and establish a California Privacy Protection Agency.

Support has raised $4.76 million with most funding from developer Alastair Mactaggart.

No opposition funding has been reported.

For more information about the measure, click HERE. For the latest financial contributions, click HERE.

Prop. 25: Replace Cash Bail with Risk Assessments

Would end the States cash bail system and give judges the right to determine whether someone who is arrested should be kept behind bars based on the risk they are deemed to pose to themselves or others.

Support has raised $1.36 million. Action Now Initiative was the largest donor, contributing $500,000.

Opposition has raised $4.24 million, including $921,633. from Triton Management Services, LLC and the bail bond industry.

For more information about the measure, click HERE. For the latest financial contributions, click HERE.

Visit the California Secretary of State ballot measures page HERE.

Orange County voters will have three options for returning their ballots.

Protect local journalism please subscribe to the print edition of the Fullerton Observer. Our online edition is free, but we depend on print subscriptions from readers. Annual subscription is only $35/year.It only takes a minute Click Here To Subscribe. Thank you for your support for the Fullerton Observer. Click here to view a copy of the print edition.

Continued here:
California Propositions on the 2020 Ballot - Fullerton Observer

Gore partners with San Diego company on cell delivery system with potential to treat Type 1 diabetes – delawarebusinessnow.com

ViaCyte, Inc. and Newark-based W. L. Gore & Associates, Inc. announced the two companies have signed an agreement covering the next phase of their collaboration focused on the development of ViaCytes Encaptra Cell Delivery System that uses Gore material technologies.

The technology is designed to produce insulin for patients with Type I diabetes, formerly known as juvenile diabetes.

The Encaptra System could be a transformative therapy for patients with type 1 diabetes, the companies noted.

Tapping into Gores world-class materials science and medical device expertise, new membrane technology was developed that appears to allow successful engraftment and beta cell proliferation while minimizing the host foreign body response, said Paul Laikind, CEO of ViaCyte. This agreement is an important next step on our path towards a commercial product as well as a template for future agreements for additional work ViaCyte and Gore may do together on cell delivery technology.

Our collaboration with ViaCyte has been very productive in enabling the clinical advancement of the PEC-Encap product candidate with proprietary Gore materials technology, said Erin Hutchinson, business leader, Gore PharmBIO Cell Encapsulation Products. We are delighted to further strengthen our collaboration on the path to the delivery of a potentially functional curative product for those currently suffering with type 1 diabetes and help pioneer the new field of cell replacement therapy.

ViaCyte is the only company with stem cell-derived islet replacement candidates undergoing clinical testing and the only group to show that the implanted cells are capable of producing insulin in people with type 1 diabetes.

The Companys promising candidates have the potential to deliver a functional cure for people with type 1 diabetes and could be an advancement for people with insulin-requiring type 2 diabetes.

Under the terms of the agreement, Gore will manufacture and supply a proprietary membrane and the device component for use with ViaCytes PEC-Encap product candidate.

The novel Gore membrane has been evaluated in preclinical studies. Gore will continue to collaborate with ViaCyte to optimize the device design and implant techniques in support of human clinical trials.

Early human clinical trials of PEC-Encap with the new membrane are underway and preliminary histological results are encouraging. Should the membrane prove successful in the ongoing trial, Gore will assume the responsibility for manufacturing the Encaptra System incorporating the novel membrane technology for late stage clinical development and commercial use.

ViaCyte has shown that once implanted and successfully engrafted PEC-01 cells mature into beta cells that secrete insulin in a regulated manner to control blood glucose levels. The Encaptra System serves to protect the PEC-01 cells from the host immune system thus eliminating the need for immune suppression drugs commonly used with other transplants.

A critical enabling component of the Encaptra System that contains and protects the cells is a specifically designed semi-permeable membrane that encapsulates the cells but allows for diffusion of oxygen and nutrients into the device and insulin and other hormones out of the device and into the circulation.

The Encaptra System membrane is composed of an expanded PTFE composite, similar to materials that are used in Gores implantable medical products..

Gore and ViaCyte began a collaboration in 2017.

ViaCyte is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. ViaCyte is headquartered in San Diego.

Continue reading here:
Gore partners with San Diego company on cell delivery system with potential to treat Type 1 diabetes - delawarebusinessnow.com

FibroGenesis Reports Breakthrough in Prevention of COVID-19 Blood Clotting Laboratory Studies Suggest PneumoBlast COVID-19 Cell Therapy Reduces…

HOUSTON, Aug. 12, 2020 (GLOBE NEWSWIRE) FibroGenesis, a clinical stage company developing fibroblast based therapeutic solutions for unmet medical needs, announced today new data supporting utilization of its PneumoBlast product in treatment of COVID-19. Laboratory experiments comprised of admixing PneumoBlast with activated monocyte or endothelial cells demonstrated significant inhibition of tissue factor expression. Tissue factor is the key molecule inducing blood clotting in COVID-19 patients. Monocytes are cells which normally protect the body against pathogens. In the case of COVID-19, monocytes enter the lungs and cause coagulation. Endothelial cells are cells which make up the inside of the blood vessel and regulate substance flow between the bloodstream and surrounding tissues.

It was observed that treatment of activated monocytes with PneumoBlast resulted in a 77% reduction of tissue factor expression as compared to untreated monocytes (p,lt; 0.001). Mixture of mesenchymal stem cells with activated monocytes resulted in a 13% inhibition of tissue factor expression (p= 0.01). Furthermore, in activated endothelial cells, PneumoBlast decreased expression of tissue factor by 80% (p,lt; 0.001), whereas mesenchymal stem cells resulted in a 30% (p= 0.01) reduction.

It is believed that a significant cause of morbidity and mortality in COVID-19 occurs because of unrestrained blood clotting. Studies have shown the high propensity for clotting in COVID-19 patients is associated with inflammation. The Company previously demonstrated PneumoBlast reduces proteins necessary for inflammation, such as TNF-alpha. The current study shows PneumoBlast can also work downstream of inflammation and directly suppress the clotting cascade.

This data is truly stunning, said Tom Ichim, Ph.D., Chief Scientific Officer of FibroGenesis. Currently one of the major obstacles to successful treatment of COVID-19 is the unusually high level of unregulated coagulation, which in many cases is not resolved by standard anticoagulants. The ability of PneumoBlast cells to reduce blood clotting potential in both monocytic and endothelial cells speaks volumes about the multifactorial mechanisms by which we believe our product will work on COVID-19.

We are thankful for our team of clinical collaborators and scientists who are exploring and identifying novel mechanisms by which PneumoBlast appears to be effective against COVID-19, commented Pete OHeeron, President and CEO of FibroGenesis. We are the first cell therapy company to address the issue of coagulation in COVID-19. We see this, as another indication of the superiority of fibroblasts compared to stem cells.

About FibroGenesis

Based in Houston, Texas, FibroGenesis, is a regenerative medicine company developing an innovative solution for chronic disease treatment using human dermal fibroblasts. Currently, FibroGenesis holds 235+ U.S. and international issued patents/patents pending across a variety of clinical pathways, including Disc Degeneration, Multiple Sclerosis, Parkinsons, Chronic Traumatic Encephalopathy, Cancer, Diabetes, Liver Failure, Colitis and Heart Failure. Funded entirely by angel investors, FibroGenesis represents the next generation of medical advancement in cell therapy.

Visit http://www.Fibro-Genesis.com.

Read this article:
FibroGenesis Reports Breakthrough in Prevention of COVID-19 Blood Clotting Laboratory Studies Suggest PneumoBlast COVID-19 Cell Therapy Reduces...

The Proteus Effect: Stem Cells and Their Promise for Medicine

The views expressed in this book are solely those of the author(s) and do not necessarily reflect the views of the National Academies.

Ann B. Parson is a science journalist who has covered a range of topics in the areas of medicine, technology, and the environment. She is co-author of Decoding Darkness; The Search for the Genetic Causes of Alzheimer's Disease. Published in 2000, Decoding Darkness was hailed by Publisher's Weekly as a "fascinating story" and "not just another sterile account of scientific discovery." Parson is co-author as well of Menopause. She has written dozens of articles for a range of publications, among them The Boston Globe, The New York Times, McCalls, The San Diego Union-Tribune, and Harvard Health Letter. From 1990 to 1998, she taught in Boston University's graduate program in science journalism. She currently resides in South Dartmouth, Massachusetts.

The Proteus Effect; Stem Cells and Their Promise for Medicine was nominated for a LA Times Book Prize and named to Library Journals annual list of best Science-Technology books. Anns earlier books include Decoding Darkness; The Search for the Genetic Causes of Alzheimer's Disease, which she co-authored with neuroscientist Rudolph Tanzi, Harvard Medical School, and a book on womens health co-authored with Dr. Isaac Schiff, Chief of Obstetrics, Mass General Hospital. Each book was considered a leader among comparable titles.

Between 2008 & 2012 Ann wrote five commissioned family histories/biographies, each privately printed. First came three New England families: the Lymans, the Wigglesworths, and the Pickerings. Biographies of two outstanding engineers followed: Mortimer Rogoff, a pioneer of GPS and cell-phone technology; and Antonio Ferri, the unparalleled father of supersonic and hypersonic flight.

Stem cells could be the key that unlocks cures to scores of diseases and illnesses. Their story is at once compelling, controversial, and remarkable. Part detective story, part medical history, The Proteus Effect recounts the events leading up to the discovery of stem cells and their incredible potential for the future of medicine.

What exactly are these biological wonders these things called stem cells? They may be tiny, but their impact is earth shaking, generating excitement among medical researchers and outright turmoil in political circles. They are reported to be nothing short of miraculous. But they have also incited fear and mistrust in many. Indeed, recent research on stem cells raises important questions as rapidly as it generates new discoveries.

The power of stem cells rests in their unspecialized but marvelously flexible nature. They are the clay of life waiting for the cellular signal that will coax them into taking on the shape of the beating cells of the heart muscle or the insulin-producing cells of the pancreas. With a wave of our medical magic wand, its possible that stem cells could be used to effectively treat (even cure) diseases such as Parkinson's disease, diabetes, heart disease, autoimmune disorders, and even baldness.

But should scientists be allowed to pick apart four-day-old embryos in order to retrieve stem cells? And when stem cells whisper to us of immortality they can divide and perpetuate new cells indefinitely how do we respond? Stem cells are forcing us to not only reexamine how we define the beginning of life but how we come to terms with the end of life as well.

Meticulously researched, artfully balanced, and engagingly told, Ann Parson chronicles a scientific discovery in progress, exploring the ethical debates, describing the current research, and hinting of a spectacular new era in medicine. The Proteus Effect is as timely as it is riveting.

Ann B. Parson. 2004. The Proteus Effect: Stem Cells and Their Promise for Medicine. Washington, DC: Joseph Henry Press. https://doi.org/10.17226/11003.

Go here to read the rest:
The Proteus Effect: Stem Cells and Their Promise for Medicine

Marker Therapeutics Reports Second Quarter 2020 Operating and Financial Results – PRNewswire

HOUSTON, Aug. 10, 2020 /PRNewswire/ -- Marker Therapeutics, Inc.(Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today provided a corporate update and reported financial results for the second quarter ended June 30, 2020.

"We continue to make progress toward advancing our planned Phase 2 trial with our novel MultiTAA-specific T cell therapy in patients with acute myeloid leukemia, or AML," said Peter L. Hoang, President & CEO of Marker Therapeutics. "While the COVID-19 pandemic has impacted hospital systems globally, we have augmented our process development for our MT-401 product, continued the buildout of our manufacturing facility and added further clinical sites for our Phase 2 AML trial. With a novel cell therapy product candidate that has demonstrated the ability to induce broad and durable immune responses in earlier clinical studies, Marker remains well-positioned to provide a potential treatment option for patients suffering from this devastating disease."

PROGRAM UPDATES

Multi-Antigen Targeted (MultiTAA) T Cell Therapies

Phase 2 AML Trial Update The Company continues to identify and add clinical trial sites in preparation for the Phase 2 AML trial initiation. The study is currently subject to a partial clinical hold on the use of a new reagent in the manufacturing processuntil the FDA reviews and accepts the final data and certificates of analysis for the new reagent. The alternate supplier has been delayed in providing the reagent but expects to ship the reagent to Marker in Q3. Once Marker receives the reagent and completes the required analyses for FDA, the Company will provide additional clarification around the timing of the AML trial enrollment.

USAN Council Approval of "Zelenoleucel" for MT-401Marker recently announced that the United States Adopted Names (USAN) Council approved "zelenoleucel" as the nonproprietary (generic) name for MT-401, a MultiTAA-specific T cell product candidate for the treatment of patients with AML following allogeneic stem cell transplant in both adjuvant and active disease settings.

Pancreatic Cancer Data Presented During ASCO Updated clinical results from an ongoing investigator-sponsored Phase 1 trial led by the Baylor College of Medicine, evaluating the Company's MultiTAA-specific T cell therapy in patients with advanced or metastatic pancreatic adenocarcinoma, were presented during the 2020 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting. Data from a cohort of patients receiving MultiTAA-specific T cell therapy in combination with standard-of-care chemotherapy in the first-line setting (Arm A) were presented.

BUSINESS UPDATES

On June 30, 2020, Marker announced that the Company executed a lease agreement to establish an in-house cGMP manufacturing facility in Houston, TX. The facility is expected to be completed by year-end and operational in 2021. Marker will continue to manufacture its MultiTAA-specific T cell therapy at the Baylor College of Medicine to support the Company-sponsored AML trial until the in-house cGMP manufacturing facility is operational.

SECOND QUARTER 2020 FINANCIAL RESULTS

Cash Position and Guidance:At June 30, 2020, Marker had cash and cash equivalents of $32.1 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into Q2 2021.

R&D Expenses:Research and development expenses were$4.3 million for the quarter endedJune 30, 2020, compared to$3.2 million for the quarter ended June 30, 2019.

G&A Expenses:General and administrative expenses were$2.5 million for the quarter endedJune 30, 2020, compared to $2.7 million for the quarter ended June 30, 2019.

Net Loss:Marker reported a net loss of$6.3 millionfor the quarter endedJune 30, 2020, compared to a net loss of$5.6 million for the quarter ended June 30, 2019.

About Marker Therapeutics, Inc. Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker's cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient's immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

To receive future press releases via email, please visit:https://www.markertherapeutics.com/email-alerts

Forward-Looking Statement Disclaimer This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements." Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; the impact of the COVID-19 pandemic; and the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at http://www.sec.gov. Such risks and uncertainties may be amplified by the COVID-19 pandemic and its impact on our business and the global economy. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Marker Therapeutics, Inc. Condensed Consolidated Balance Sheets

June 30,

December 31,

2020

2019

(Unaudited)

(Audited)

ASSETS

Current assets:

Cash and cash equivalents

$ 32,124,187

$ 43,903,949

Prepaid expenses and deposits

2,632,514

1,526,442

Interest receivable

3,440

56,189

Total current assets

34,760,141

45,486,580

Non-current assets:

Property, plant and equipment, net

1,592,094

417,528

Construction in progress

2,629,141

-

Right-of-use assets, net

9,542,228

455,174

Total non-current assets

13,763,463

872,702

Total assets

$ 48,523,604

$ 46,359,282

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable and accrued liabilities

$ 4,528,021

$ 1,757,680

Lease liability

456,065

204,132

Warrant liability

-

31,000

Total current liabilities

4,984,086

1,992,812

Non-current liabilities:

Lease liability, net of current portion

9,025,273

280,247

Total non-current liabilities

9,025,273

280,247

Total liabilities

14,009,359

2,273,059

Commitments and contingencies

-

-

Stockholders' equity:

Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively

-

-

Common stock, $0.001 par value, 150 million shares authorized, 46.6 million and 45.7 million shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively

46,617

45,728

Additional paid-in capital

374,828,385

371,573,909

Accumulated deficit

(340,360,757)

(327,533,414)

Total stockholders' equity

34,514,245

44,086,223

Total liabilities and stockholders' equity

$ 48,523,604

$ 46,359,282

Continued here:
Marker Therapeutics Reports Second Quarter 2020 Operating and Financial Results - PRNewswire

New Report: Regenerative Medicine & Advanced Therapies Sector Thriving Despite COVID-19 – PharmiWeb.com

Cell, Gene & Tissue-Based Therapy Developers Poised to Break Year-Over-Year Global Financing Records

WASHINGTON, D.C. August 6, 2020 The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies, today announces the publication of its H1 2020 Global Sector Report, Innovation in the Time of COVID-19. The report provides an in-depth look at trends and metrics in the gene, cell, and tissue-based therapeutic sector in the midst of the pandemic.

As the voice of the sector globally, ARM regularly publishes sector data reports to showcase clinical and scientific progress, as well as advancements and remaining challenges in the policy environment surrounding cell, gene and tissue-based therapies. The report also includes updated metrics on fundraising and clinical trials from more than 1,000 therapeutic developers worldwide.

Highlights from the H1 2020 Global Sector Report include:

Janet Lambert, CEO of ARM, commented: The regenerative medicine and advanced therapy sector has shown remarkable resilience in the face of many new challenges posed by COVID-19. Most importantly, were continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinical development. ARM will continue to work with our membership and with policymakers in the second half of 2020 to further advance these transformative technologies. We are committed to bringing these life-changing therapies to patients in need.

This report is the latest in ARMs series of global regenerative medicine sector reports, providing up-to-date metrics on financings and the clinical landscape, as well as expert commentary on key trends and progress in the field. The full report is available online here, with key sector metrics and infographics available here. For more information, please visit http://www.alliancerm.org or contact Kaitlyn (Donaldson) Dupont at kdonaldson@alliancerm.org.

About the Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory and reimbursement initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 11-year history, ARM has become the voice of the sector, representing the interests of 360+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

See the original post here:
New Report: Regenerative Medicine & Advanced Therapies Sector Thriving Despite COVID-19 - PharmiWeb.com

Regenerative Medicine & Stem Cell Practice in Medical Spas …

In todays video, we talk about how medical spas and medical practices handle some of the legal issues with regenerative medicine, and stem cell therapies.

Im Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. Weve advised hundreds of healthcare industry clients on healthcare and FDA legal issues. Our clients include medical spas and healthcare companies that work with stem cell therapies and regenerative medicine.

Weve also gotten a lot of client questions about use of stem cell therapies, whether by medical doctors, naturopathic physicians, or midlevel practitioners such as RNs. As healthcare and FDA attorneys working in regulatory territory, we receive many deep-in-the-weeds questions.

For example, what about injecting stem cells for beauty and cosmetic treatments?

Using stem cells in IV infusions?

Are stem cell therapies covered within state law on nonsurgical medical cosmetic procedures?

Do stem cell therapies require an initial, in-person exam by an MD or under MD supervision by a PA or in collaboration by an NP?

What about procedures such as micro-needling, do these require medical supervision and a good faith exam?

Let me give you three tips to help you keep you in mind when youre looking to get a healthcare lawyer to address these kinds of legal questions.

First, a lot of the law simply says no. It doesnt tell you what you can do, only in broad terms what you cant do. So, when youre looking for legal advice, youre really asking for a professional read by an attorney, between the yes and the no. Obviously, either extreme is unsatisfying and doesnt give you any real guidance.

What you want in a healthcare lawyer is knowledge, skill and experience. A good healthcare lawyer can tell you, this particular scenario is more likely to get you in regulatory trouble, that scenario is more likely not going to be the biggest enforcement priority.

This week, one of our clients, a medical doctor who also runs a medical spa, told me that his biggest competitors were marketing and advertising their services, using advertising copy that he considered deceptive and misleading. He was at wits end trying to compete with these industry players who just dont follow the rules. Its not fair.

We talked through some of the strategies they were using and the legal risks that they were undertaking. Finally, he listened, and concluded: dont poke the bear. In a way, the process of mapping out the regulatory landscape helped him clarify his own business decision.

Second, a lot of these questions come under state law and they have to do with what licensing statutes, regulations, and Board policy statements say.

The federal government doesnt regulate the practice of medicine, or the healthcare practice of other licensed professionals. Rather, the United States Constitution leaves the regulation of health, safety and welfare up to the States.

And so, each State will have different laws and rules about what medical spas can do; about who can do what kinds of therapies; about whether you need a doctor to perform therapy X or Y or whether this can be done by an RN under MDs supervision; or, whether some services can and cant be performed by a licensed esthetician, because for example, they might constitute the practice of medicine.

Depending on your legal budget, it often doesnt make sense to research the law in all states, or even a lot of states. If youre a medical spa in one location, then obviously, your state law matters; and if your business is multi-state, sometimes we focus on key states or we get a small sampling of the ones with the toughest rules.

My third tip is, dont rely on advice which you got from someone else, because it is often incorrect, and based on facts and circumstances that dont necessarily apply to your situation.

As an example, recently, one medical spa came to our Firm with all of these questions swirling around in their minds. They were worried, because a medical spa in the same neighborhood had been visited by a very, very, super friendly medical board investigator, who was asking too many questions, in too friendly a way; and across town, medical spas had been raided by enforcement officials in a very heavy-handed way.

Up till then, the medical spa had thought it was legally safe, because, after all, it had a HIPAA-compliant software platform, and had its doctor making remote Skype calls with patients, before the RN would initiate a whole host of regenerative medicine therapies.

This kind of scenario in fact created much regulatory jeopardy.

The medical spa client basically told us: we use stem cells we get here from Company X, we mix them up in the back of our office with formula Y, then we inject them here and there as the doctor emails us, were only doing it for beauty, we think its ok, we just want some clarification on the laws.

OK, so if the speed limit is 55 and Im going 90, but Im telling you its ok because Im driving an old Chevy, my seat belt if fastened, I have a radar detector, and Ive also surrounded myself with white light and asked the angels to protect me which by the way is not a bad idea, but dont rely on it when you go 90 because if I drive too fast and I have a long way to go and I want to get there quickly all I want to know is, i just want to know if am I legally ok I mean, my cousins lawyers half-sisters friend, who swears by this and also asked a lawyer, said it was ok, as long as I dont go over 90 miles an hour .

I know it sounds really silly, but its the sort of thing we hear, in one form or another all the time.

And thats why you cant take excuses, and your healthcare lawyers experience and professional lens can help you interpret the law.

Thanks for watching. Heres to the success of your healthcare venture, we look forward to speaking with you soon.

See the original post here:
Regenerative Medicine & Stem Cell Practice in Medical Spas ...

Global Stem Cell Therapy Market Research Analysis Including Growth Factors, Types And Application By Regions From 2020 To 2024 – Owned

Global Stem Cell Therapy Market Analysis to 2024 is a focused and comprehensive study of the Stem Cell Therapy industry with a focus on the global market trend. The information mentioned in the Global Stem Cell Therapy Market research report presents an overview of the latest trends observed in the global market. Besides, this report emphases on the latest events such as the technological developments and the product launches and their consequences on the Market. The research report delivers the global market revenue, parent market trends along with market attractiveness per market segment.

Get Free Pdf Sample Copy of this [emailprotected]:

https://www.globalmarketers.biz/report/medicine/global-stem-cell-therapy-market-2019-by-company,-regions,-type-and-application,-forecast-to-2024/130793#request_sample

Top Players of Stem Cell Therapy Market are:

Osiris Therapeutics NuVasive Chiesi Pharmaceuticals JCRPharmaceutical Pharmicell Medi-post Anterogen Molmed Takeda (TiGenix) Regional Stem Cell Therapy Market (regional production, demand and forecast by country):

The main goals of the research report elegant the overall market overview on Stem Cell Therapy market dynamics, historic volume and value, robust market methodology, Latest and future trends, Porters Five Forces Analysis, new technological development, cost structure, government policies and regulations, etc. Major companies, company overview, financial data, products and services, strategy analysis, key developments market competition, industry competition structure analysis, SWOT Analysis, etc.

Get Discount On This Comprehensive Report: https://www.globalmarketers.biz/discount_inquiry/discount/130793

KEY MARKET SEGMENTS

On the basis of types, the Stem Cell Therapy Market is primarily split into:

Autologous Allogeneic On the basis of applications, the Stem Cell Therapy Market covers:

Musculoskeletal Disorder Wounds & Injuries Cornea Cardiovascular Diseases Others

Which market factors are explained in the report?

Study Coverage:Covers significant companies, vital market segments, the scope of the products offered in the global Stem Cell Therapy market, the years considered and the study objectives.

Executive Summary:It contains a summary of the most important studies, the Stem Cell Therapy market growing rate, modest conditions, market drivers, trends and problems as well as macroscopic indicators.

Production by region:This Stem Cell Therapy report provides information on imports and exports, production, sales and key players in all examined regional markets.

Manufacturer Profile:Each Company defined in this section is screened based on a SWOT analysis, products, value, their capacity and other important factors.

Do Inquiry Before Purchase @ https://www.globalmarketers.biz/report/medicine/global-stem-cell-therapy-market-2019-by-company,-regions,-type-and-application,-forecast-to-2024/130793#inquiry_before_buying

Table of Contents

1 Stem Cell Therapy Market Overview

2 Global Stem Cell Therapy Competition by Manufacturers

3 Global Stem Cell Therapy Capacity, Revenue (Value) by Region)

4 Global Stem Cell Therapy Supply (Production), Export, Import by Region

5 Global Stem Cell Therapy Market Revenue (Value), Price Trend by Type

6 Global Stem Cell Therapy Market by Application

7 Global Stem Cell Therapy Company Profiles

8 Industrial Chain, Sourcing Strategy and Downstream Buyers

9 Stem Cell Therapy Market Effect Factors Analysis

10 Global Stem Cell Therapy Market Forecast

11 Research Findings and Conclusion

12 Appendix

Get Full [emailprotected] https://www.globalmarketers.biz/report/medicine/global-stem-cell-therapy-market-2019-by-company,-regions,-type-and-application,-forecast-to-2024/130793#table_of_contents

Why Globalmarketers Reports:

Explore extensive library of market reports

Focus on Key Trends and Market Movements

24/7 Online and Offline Support

Most-detailed market segmentation

Latest Details, Current and future trends provides in this research report

Go here to see the original:
Global Stem Cell Therapy Market Research Analysis Including Growth Factors, Types And Application By Regions From 2020 To 2024 - Owned