Government Efforts to Mitigate Fallout Accentuate the Need for Expanded Testing Capabilities

NEW YORK, July 28, 2020 /PRNewswire/ --  The pandemic continues to devastate the economy as well as healthcare systems around the world. In response to the outbreak, governments have focused their resources on treatment and prevention. Besides the research necessary to develop a vaccine, accelerated R&D also focuses on diagnostic techniques, specifically on the scope of blood testing services throughout the industry. The World Health Organization (WHO) has also published a list of medical devices needed at this time, breaking down into several categories including personal protective equipment (PPE), medical equipment, medical consumables, single use devices, laboratory and test-related devices. When it comes to testing, there has been a lot of progress in how the virus can be detected. For example, researchers around the world 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. Todos Medical Ltd. (OTC: TOMDF), Aytu BioScience, Inc. (NASDAQ: AYTU), iBio, Inc. (NYSE: IBIO), Heat Biologics, Inc. (NASDAQ: HTBX), Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP).

As the viral pandemic continues to ravage countries, so too does the world's collective uncertainty regarding when and how quickly society will return to normal. In the meantime, the importance and adoption of PPEs by the public has helped prevent even higher numbers of infected. Some PPEs are reviewed by the FDA before they can be legally sold in the United States. The manufacturers have to show they meet specific criteria for performance, labeling, and intended use to demonstrate substantial equivalence. As for testing, labs and healthcare facilities are facing supply shortages, a lack of instrument access, as well as increased staffing needs. In response, the FDA opened the emergency use authorization (EUA) process to high-complexity CLIA labs on Feb. 28th, creating a new pathway for regulated assay development. 

Todos Medical Ltd. (OTCQB: TOMDF) announced yesterday breaking news that, "the Company has entered into a contract to supply NJ-based laboratory Best Supply, Inc. with COVID equipment and reagents to enter the COVID testing field. The total value of the contract is initially $1,400,000. Best Supply is a NJ-based laboratory seeking CLIA/CAP certification to initiate COVID-19 testing.  Concurrent with this announcement, Todos appointed Mr. Andrew Blumenthal, RN as Vice President of Business Development for COVID Testing.

Best Supply Agreement

Under the terms of the contract with Best Supply, Todos Medical will supply the equipment, training and software necessary to run an optimized automated PCR laboratory with capacity to run 300 tests per day, with the priority right to supply equipment and supply to scale up to 75,000 tests per day for SARS-CoV-2, the virus that causes COVID-19.

'This agreement will allow additional capacity to come online in the New York / New Jersey Area to bring additional options for the local community seeking greater access to COVID testing,' said Mr. Gerald Commissiong, President & CEO of Todos Medical. 'This is a great example of how we can get involved with young labs who are eager to grow rapidly in the COVID-19 testing space.'

Earlier this month Todos Medical licensed exclusive rights from 3D Medicines Corporation (3D Med) to seek U.S. Food & Drug Administration (FDA) Emergency Use Authorization (EUA) for 3D Med's SARS-CoV-19 testing products, as well as exclusive branding and distribution rights to 3D Med's qPCR test kits in the U.S. 3D Med recently completed an expansion of its extraction reagent manufacturing capacity, adding 1 million extraction reagent production per week (~140,000 per day). 3D Med has validated SARS-CoV-2 pool testing at a ratio of 10:1 and Todos intends to complete pool testing validation in the U.S. in the coming weeks, with plans to seek U.S. FDA EUA over the summer of 2020.  Todos intends to be ready to deploy pool testing broadly for back-to-school and return-to-work testing, which Todos expects to ramp up significantly in the second half of the 2020 third quarter.

Appointment of Mr. Andrew Blumenthal, RN as VP Business Development COVID Testing

Mr. Andrew Blumenthal, RN, comes to Todos with over 20 years in the healthcare industry.

Mr. Blumenthal is a seasoned health care professional with an extensive and eclectic background in medical project financing, product technology development and implementation with emphasis on both corporate development and product implementation. Performing hundreds of technical lectures and in-services internationally, Mr. Blumenthal has proven results in healthcare product and systems sales, team building and team management. Mr. Blumenthal leverages his deep industry knowledge of the medical service industry and long-term relationships to create joint ventures between physicians and healthcare organizations to optimize economies of scale and productivity.

Prior to joining Todos Medical, Mr. Blumenthal served in executive management positions, including DDU Advisory Service, where Mr. Blumenthal secured offerings for projects including the ground up construction of a 200-physician state-of-the-art hospital and wellness facility. Mr. Blumenthal is a C-suite officer in the California-based Global Diabetes Network, the Managing Director of Frontier Medical Ventures, President of business development and DON for Cross River Medical and a partner in Goodlight Capital Group Latin America. 

'We are very pleased to announce Mr. Blumenthal's appointment as our Vice President of Business Development for our COVID-19 business,' said Gerald E. Commissiong, President & CEO of Todos. 'Andrew is a seasoned executive who understands the intricacies of the healthcare services space in the United States and internationally. Given the need to bring different groups together that previously did not interact regularly with the healthcare system in order to administer COVID-19 testing, we believe Andrew's role as a registered nurse will be invaluable as we work to bring additional national COVID-19 testing capacity online.'

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

Aytu BioScience, Inc. (NASDAQ: AYTU) reported earlier this month that the Company has signed a distribution agreement with Apollo Med Innovations, Inc. ("Apollo") to distribute the COVID-19 IgG/IgM Rapid Test Cassette to Apollo's network of over 1,000 practices across the United States. This distribution relationship expands the Company's coverage of clinician and professional customers to a large network of medical clinics, clinical laboratories, and wellness centers. Apollo is also engaged with a growing number of employers and municipalities in offering their COVID-19 testing services. Through Apollo's introduction of innovative research-based COVID-19 testing protocols and their offering of comprehensive laboratory support services, this distribution relationship significantly expands the Company's COVID-19 potential user base. Through this relationship between the Company and Apollo, Apollo has begun to introduce the COVID-19 IgG/IgM Rapid Test Cassette as part of a comprehensive support program for professional medical organizations, integrated wellness centers, employers, and municipalities.

iBio, Inc. (NYSE: IBIO) announced back in April this month the signing of two Master Services Agreements and a Memorandum of Understanding with the Infectious Disease Research Institute ("IDRI") in support of iBio's SARS-CoV-2 Virus-Like Particle ("VLP") vaccine development. Under the MSAs, IDRI will support pre-clinical development and provide clinical trial oversight, while iBio will provide process development and manufacturing services to IDRI, as needed. Additionally, the MoU calls for iBio and IDRI to establish a separate, additional agreement within the next 60 days if the Company opts to include one of IDRI's novel adjuvants in the vaccine development program ("IBIO-200"). The MSAs and the MoU integrate IDRI into iBio's collaboration with the Texas A&M University System to create a strong partnership that brings deep experience and advanced technologies and capabilities to the task of moving IBIO-200 into the clinic.

Heat Biologics, Inc. (NASDAQ: HTBX) reported back in June further progress on its COVID-19 vaccine program. Jeff Hutchins, Chief Scientific and Operating Officer of Heat, stated, "I am pleased to report important advancements related to our COVID-19 vaccine program. Specifically, we have achieved stable co-expression of gp96/nCoV-S protein, as measured by both immunofluorescence and ELISA, in our clinically validated human cell line, enabling selection of our COVID-19 vaccine. These steps are important milestones and necessary precursors to completion of our vaccine in preparation for its manufacture and use in clinical trials." Jeff Wolf, CEO of Heat, commented, "We remain on track to complete design and development of our COVID-19 vaccine in July, and expect that our gp96/nCoV-2 expressing cell line will be available for clinical-grade manufacturing with our partner, Waisman Biomanufacturing, in early August. Given our progress to date, we remain encouraged by the potential of our unique vaccine to provide broad cellular T-cell and humoral protection against COVID-19, as well as possible future mutations or other coronaviruses."

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced earlier this month that it has entered into a research collaboration and option agreement with Columbia University focused on studying the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. The research collaboration will focus on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19 at the cellular level including human monoclonal antibodies and anti-idiotypes. The research is designed to fill in important gaps in understanding the detailed immune responses to COVID-19, and to provide a foundation upon which to target vaccines and therapeutics to appropriate individuals by precision medicine.

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