Accurate Diagnostic Solutions Remain Vital to Overcoming the Pandemic - Agenus (NASDAQ:AGEN)

NEW YORK, May 4, 2021 /PRNewswire/ -- While the U.S and the rest of the Western world is slowly recovering from the worst phases of the pandemic, India is going through its worst wave yet. In 24 hours, the country reported more than 368,000 news cases, bringing the total number of cases to more than 19 million, while the total number of deaths is more than 219,000, according to ABC. However, private businesses have been responding to the crisis. Dr. Albert Bourla, the Chief Executive Officer of Pfizer, announced on Sunday that the company would donate medicines valued at about more than USD 70 Million to the country. "Right now, Pfizer colleagues at distribution centers in the U.S., Europe and Asia are hard at work rushing shipments of Pfizer medicines that the Government of India has identified as part of its COVID treatment protocol," Bourla said in a letter posted to LinkedIn. "We are donating these medicines to help make sure that every COVID19 patient in every public hospital across the country can have access to the Pfizer medicines they need free of charge." Todos Medical Ltd. TOMDF, Atossa Therapeutics, Inc. ATOS, Agenus Inc. AGEN, VBI Vaccines Inc. VBIV, AIkido Pharma Inc. AIKI

Now that vaccines are available and are being rolled out, the worries of the pandemic are slightly receding. Yet, testing remains a crucial factor. Experts say that people who exhibit symptoms consistent with the infection, such as cough, fever, congestion, fatigue, headache or loss of sense of smell should get tested even if they have been vaccinated or previously had been diagnosed with the virus. Ahmad Gaber, Chief Executive Officer of Wellhealth and founder of GoGetTested, explained according to Healthline that "testing is important for two reasons. It warns the individual person, and it provides surveillance that allows us to find out what we can do about the disease from a public health perspective."

Todos Medical Ltd. TOMDF just announced breaking news this morning that, "the US Food & Drug Administration granted the Company a new Certificate of Free Sale for a second dosing regimen for Tollovid™ as a dietary supplement. Under the new Certificate of Free Sale, the Company is authorized to market Tollovid with a dosing regimen of 60 pills over a five-day period, equivalent to 12 pills per day. Tollovid, a potent 3CL protease inhibitor botanical product, is a dietary supplement that helps to support and maintain healthy immune function. The 3CL protease is an important part of certain coronavirus' reproductive mechanism and inhibiting this protease may help to support and maintain healthy immune function in the face of circulating coronaviruses. The Company sees this dosing regimen for Tollovid as optimal for supporting healthy immune function.

"We were very pleased with the speed with which this dosing regimen for Tollovid was granted a new Certificate of Free by the US FDA," said Gerald E. Commissiong, President & CEO of Todos Medical. "After a successful initial launch at The Alchemist's Kitchen in New York City, where we gained significant feedback from customers on what worked best for them with Tollovid, we developed an upgraded dosing regimen based on the first-hand experience of customers that had a successful experience with the product. With that critical information and this new Certificate of Free Sale in hand, we are now preparing to launch Todos Medical's branded Tollovid product into the US market via a soon to be launched website www.MyTollovid.com in a direct-to-consumer model with overnight shipping. We also intend to explore opportunities to distribute Tollovid in other areas of the world that are eagerly seeking new products that can potentially inhibit 3CL protease, and are in active discussions with distributors to bring this product forward in those markets.

The Company intends to utilize a portion of the proceeds from a recently completed $3.3 million fixed price crossover investmentwith Yozma Group, a venture capital firm from South Korea to help with the Tollovid launch. With Yozma's recent investment, Todos has raised $9.7 million in this crossover round since January 2021. In addition to the Tollovid launch, the Company is utilizing the proceeds from these investments to retire certain outstanding debts, further advance the ongoing Phase 2 clinical trial of the Company's oral 3CL protease targeting drug candidate Tollovir™ for hospitalized COVID-19 patients, the completion of initial clinical studies for the Company's 3CL protease targeting COVID-19 diagnostic assay Tollotest™ and general corporate purposes.

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

For COVID-19 testing inquiries, please email sales@todosmedical.com

About Todos Medical Ltd.

Founded in Rehovot, Israel with offices in New York City, Todos Medical Ltd. TOMDF, engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company's state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos' two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe. Todos recently entered into an exclusive option agreement to acquire U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the third quarter of 2020.

Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.

Todos has entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The agreements cover multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory in the United States. Todos has formed a strategic partnership with Integrated Health LLC to deploy mobile COVID-19 testing in the United States. Additionally, Todos has entered into a joint venture with NLC Pharma to pursue the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target the reproductive mechanism of coronaviruses.

For more information, please visit https://www.todosmedical.com/ "

Atossa Therapeutics, Inc. ATOS announced on February 23rd, final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa's proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered to be safe and well tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19. There are currently no FDA-approved therapies to treat COVID-19 at home. "The results from this study are very encouraging and we look forward to quickly commencing the next study of AT-301," commented Steven Quay, M.D., Ph.D., Atossa's President and CEO. "We recently received input from the FDA on this program and based in part on that input, we are now preparing to conduct an additional pre-clinical study, which we expect to start this quarter. Following that, we expect to apply to the FDA to commence a Phase 2 study here in the United States."

Agenus Inc. AGEN announced on February 4th, positive preliminary results from its Phase 1 trial of iNKT cell therapy in patients with moderate to severe symptoms of COVID-19 through its subsidiary, AgenTus Therapeutics. "We are heartened by these early results, which suggest that very sick patients who were admitted to intensive care units and intubated may benefit from a single administration of our iNKT cell therapy," said Dr. Garo Armen, Chairman and CEO of Agenus. "iNKT cells can be manufactured at scale and so far patients in this trial have tolerated the treatment well."

VBI Vaccines Inc. VBIV and CEPI, the Coalition for Epidemic Preparedness Innovations announced on March 10th, a partnership to develop VBI's enveloped virus like particle (eVLP) vaccine candidates against SARS-CoV-2 variants, including the B.1.351 variant, also known as 501Y.V2, first identified in South Africa. "Remarkable progress has been made to develop safe and effective vaccines against COVID-19, but in parallel to the global roll out of vaccines we must now redouble our R&D efforts so we have the tools we need to tackle emerging variants of the virus. I am delighted that CEPI will support the development of VBI's promising vaccine candidates against variants of concern, which crucially can be made globally accessible through COVAX if proven to be safe and effective.

AIkido Pharma Inc. AIKI announced on February 22nd, an update on its broad spectrum anti-viral platform compounds with the potential to treat influenza, COVID-19, Ebola and other viral infections. The initial two lead compounds, which target the SKI complex in humans, have been optimized through the use of computer assisted learning, through two rounds of chemical modifications to achieve drug-like properties required to move the compounds into animal testing. In addition, a third lead compound has been identified and will be subjected to optimization. These new compounds are currently being tested against Influenza virus with testing on SARS-CoV-2 in the near future. Subsequently, the top analogs from each series of lead compounds will be selected for tests of their anti-viral effects in a SARS-CoV-2 mouse model. Anthony Hayes , CEO of AIkido Pharma, stated, "We are excited to be using Artificial Intelligence technology to advance the development of these compounds and proud to announce these advancements in the research."

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