Changing Approach to Testing Could Ease Burden on Healthcare Systems

-FinancialBuzz.com News Commentary

NEW YORK, Aug. 4, 2020 /PRNewswire/ -- The pandemic has drastically changed the world's social and economic landscape. Countries have shut down schools and businesses, restricted travel, postponed entertainment and sporting events, and are still encouraging the public to stay at home as much as possible. Earlier last week, the World Health Organization (WHO) indicated that although our world has changed, the fundamental pillars of the response have not: political leadership, and informing, engaging and listening to communities. "Keep your distance from others, clean your hands, avoid crowded and enclosed areas, and wear a mask where recommended. Where these measures are followed, cases go down. Where they're not, cases go up," WHO explains. Responses from businesses were plenty as well. Several biotechs, as well as medical device companies, have made announcements that vaccines are being developed or testing kits are in production. Todos Medical Ltd. (OTC: TOMDF), Dynavax Technologies Corporation (NASDAQ: DVAX), BioNTech SE (NASDAQ: BNTX), Eli Lilly and Company (NYSE: LLY), Vir Biotechnology, Inc. (NASDAQ: VIR).

While biotech companies work on vaccines and possible treatments and medical device companies progress on patient monitoring, many others have been working on improving testing options. For example, various companies are racing to develop antibody tests, also called serological tests, that can confirm whether someone was infected even after their immune system has cleared the virus. In addition, back in April, Rutgers University researchers had received U.S. government clearance for the first saliva test to help diagnose the virus, which is a new approach that could help expand testing options and reduce the risks of infection for healthcare workers. According to a report by the Associated Press, Andrew Brooks, who directs the Rutgers lab that developed the test, explained that the test "prevents health care professionals from having to actually be in the face of somebody that is symptomatic."

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news today that, "it has appointed Jorge Leon, Ph.D. as consulting Chief Medical and Scientific Officer (CMSO) for Infectious Disease and Oncology. Dr. Leon has served as Todos' medical advisor since July 2019.

'As medical advisor I have been able to follow Todos' progress over the last year as they've continued to build their exciting pipeline of diagnostics for cancer and Alzheimer's disease,' said Dr. Leon. 'The approach Todos has taken to enter COVID-19 testing has been spot on, by focusing on an accurate, scalable and diverse product portfolio, coupled with reliable access to the key instrumentation needed to equip a large number of labs and supply them with the reagents and consumables needed to make a meaningful increase to PCR testing capacity in the United States.

'As we now have a clear framework from the U.S. Food and Drug Administration (FDA) to gain Emergency Use Authorization (EUA) for COVID+influenza A/B and COVID pool testing, we believe we are entering the fall with the right portfolio to become a significant player in the space,' he added. 'We intend to begin to establish combined screening and reflex testing strategies using antigen, antibody and PCR pooling testing to screen patients and ultimately confirm the suspected COVID-19 cases with PCR testing. Todos is also developing an innovative saliva-based molecular test that could deliver point-of-care results in under five minutes, using a smartphone camera and software, which would represent a major advancement for the field. We expect to initiate clinical validation of that test in August in Israel with the hopes of gathering sufficient data to submit an EUA.'

Dr. Leon is internationally recognized for his pioneering work in molecular diagnostics. He holds a Ph.D. in cellular and molecular biology from New York University, and completed his postdoctoral studies at the German Cancer Research Center in Heidelberg and Columbia University in New York. Dr. Leon's subsequent academic research at Columbia University focused on developing monoclonal antibody-based tumor marker assays and radio-immuno imaging devices, which are currently in wide use.

In the early 1990s, Dr. Leon played an integral role in establishing and leading the molecular diagnostics laboratories at Quest Diagnostics. As Director of Molecular Diagnostics, Senior Director of Biotechnology Development and Vice President of Applied Genomics, Dr. Leon spent 12 years developing Quest's molecular diagnostics strategy, which is now the world's largest molecular diagnostics service laboratory. In 2003, Dr. Leon founded Leomics Associates, Inc., a consulting firm committed to helping prestigious, successful companies and academic institutions develop molecular diagnostics and personalized medicine in the United States and globally. Dr. Leon specializes in identifying breakthrough opportunities and industry trends, and helps start-up businesses, academic centers and established companies successfully build and commercialize innovative business strategies, product pipelines and test menus.

'Dr. Leon becoming more active with Todos' management team adds significant intellectual capacity to develop the protocols to use available testing tools in combination to solve the testing challenges in the United States,' said Gerald E. Commissiong, President & CEO of Todos Medical. 'We look forward to bringing Jorge into key discussions with our partners to deploy COVID-19 testing nationwide.'

For information related to Todos Medical's COVID-19 testing capabilities, please visit www.todoscovid19.com"

Dynavax Technologies Corporation (NASDAQ: DVAX) and commercializing novel vaccines, and Medigen Vaccine Biologics Corporation (MVC) reported last month, their collaboration to develop an adjuvanted vaccine candidate to protect against COVID-19. The collaboration is evaluating the combination of MVC's stable prefusion form of the SARS-CoV2 recombinant spike protein with Dynavax's advanced adjuvant CpG 1018™, the adjuvant contained in Dynavax's U.S. FDA-approved adult hepatitis B vaccine. "The COVID-19 pandemic is straining healthcare systems across the globe, making a safe, effective and affordable vaccine an important tool in combatting the disease and protecting patients, especially for low and middle-income countries (LMICs)," said Charles Chen, Chief Executive Officer of Medigen. "In preclinical testing, the combination of Dynavax's proven adjuvant with our recombinant spike protein vaccine candidate generated strong virus neutralizing antibody responses and cellular immunity. These results support advancing evaluation of the combination into Phase 1 human testing, which we expect to begin in September of this year."

BioNTech SE (NASDAQ: BNTX) and Pfizer Inc. announced last month an agreement with the United Kingdom to supply 30 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, currently in development, subject to clinical success and regulatory approval. Financial details of the agreement were not disclosed, but the terms were based on the timing of delivery and the volume of doses. "In the face of this global health crisis, Pfizer's purpose – breakthroughs that change patients' lives – has taken on an even greater urgency. Consequently, we're harnessing our scientific expertise, and we're marshaling our manufacturing resources to ensure that the vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted," said Albert Bourla, Chairman and Chief Executive Office, Pfizer.  "This agreement is a testament to our shared goal to have millions of doses of a vaccine against COVID-19 available before the end of the year.  We would like to thank the U.K. government for its commitment and support in helping to protect the people of the United Kingdom from this deadly virus."

Eli Lilly and Company (NYSE: LLY) announced yesterday the initiation of BLAZE-2, a Phase 3 trial studying LY-CoV555 for the prevention of SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the U.S. (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities). LY-CoV555, the lead antibody from Lilly's collaboration with AbCellera, is a neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19. The rapid spread of SARS-CoV-2 among residents of long-term care facilities combined with the higher mortality rate for the elderly creates the urgent need for therapies to prevent COVID-19 in this vulnerable population. "COVID-19 has had a devastating impact on nursing home residents. We're working as fast as we can to create medicines that might stop the spread of the virus to these vulnerable individuals. While it's not easy to conduct clinical trials in this setting, we're taking on the challenge in an effort to help those who need us the most," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "We are grateful to the NIAID team for their exceptional partnership on this innovative trial and we are deeply appreciative of the care facilities, their staff and the many residents who will be participating in this important study." 

Vir Biotechnology, Inc. (NASDAQ: VIR) reported back in May that is has finalized a process development and manufacturing agreement with Biogen Inc. based on the letter of intent that the companies announced in March. Under the agreement Biogen will perform process development activities and specified manufacturing and process transfer services to enable commercial supply of Vir's SARS-CoV-2 monoclonal antibodies. "Biogen's world-class cell line and process development expertise is a tremendous asset as we work with great urgency to develop our antibody candidates, including employing technology that is designed to maximize the yield of each manufacturing batch produced," said Michael Kamarck, Ph.D., Chief Technology Officer of Vir. "The willingness of both Vir and Biogen to begin work before the definitive agreement was in place exemplifies our shared commitment to working in unconventional ways in the interest of the public good, and mutual recognition that bringing these therapies to people at the speed and scale that is needed requires the combined resources of multiple collaboration partners and significant manufacturing capacity."

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