NEW YORK, July 2, 2021 /PRNewswire/ -- While the economy is slowly coming back to normal, concerns over the hyper-transmissible delta variant are rising. According to the CDC, the number of new cases in the United States rose 10% this week. CDC Director Dr. Rochelle Walensky explained during a White House briefing that the country's lagging vaccination rate, coupled with the highly contagious delta variant, could account for the increase. "As the delta variant continues to spread across the country, we expect to see increased transmission in these communities unless we can vaccinate more people now," Walensky said, according to NBC News. Todos Medical Ltd. (OTC: TOMDF), Pfizer Inc. (NYSE: PFE), Dynavax Technologies Corporation (NASDAQ: DVAX), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), Agenus Inc. (NASDAQ: AGEN)
Since the pandemic spread throughout the United States and the world, the need for alternative healthcare options has become clear. As a result, new technologies and innovation will play a major role in drug and therapeutic developments in the coming years. For instance, the telehealth sector includes a wide range of technological segments under its umbrella. Specifically, technologies such as telemedicine, robots, and chatbots are being deployed to help gather information, reassure the population, treat patients, make diagnoses, and even prepare future vaccines.
'The first half of 2021 has seen a dramatic shift in the COVID-19 marketplace in the United States,' said Gerald E. Commissiong, President & CEO of Todos Medical. 'In light of the emerging Delta variant circulating widely in the US, there is now a clear need for novel COVID-19 antiviral therapies to protect the unvaccinated and those for whom authorized vaccines do not confer immunity, which includes a large portion of the elderly and those taking immune suppressants, against COVID-19 infection. The Biden administration recently underscored this need by pledging to invest $3.2 billion into research for COVID-19 antiviral therapies, similar to the US government's investments into COVID-19 vaccines in 2020 at the beginning of the pandemic. We believe this government recognition of the need for antivirals will provide a significant tailwind for the development of our Tollovir™ antiviral that is currently undergoing a Phase 2 clinical trial in Israel with plans progressing rapidly to expand the clinical development program to India. We are also optimistic about the interest we have seen from several potential international distribution partners for our dietary supplement Tollovid that provides immune support as a protease inhibitor. We expect to build a significant international distribution footprint in the second half of 2021 as we begin our initial roll-out of this important product.
'As the COVID-19 pandemic remains very fluid, the US has focused its efforts on vaccination in the first half of 2021, which has largely been successful in bringing down daily COVID-19 case numbers and has given confidence to state governments to re-open economies with limited COVID-19 restrictions. We see this vaccination focus creating a significant new opportunity for our recently acquired CLIA/CAP certified lab, Provista Diagnostics. Through Provista we are focusing our COVID-19 diagnostic testing strategy to prioritize delivering diagnostic services, including PCR and neutralizing antibody testing, thereby expanding beyond simply distributing testing supplies. This expansion into testing services serves to diversify our business into higher margin revenue in the COVID-19 space, as well as help us to expand our business development opportunities with the labs we work with by providing reference lab testing services as we increase Provista's automated testing capabilities. We are especially excited to begin our expansion into COVID-19 neutralizing antibody testing that receives nearly double the reimbursement vs. traditional COVID antibody testing (~$79 vs. ~42). We believe neutralizing antibody testing will become more critical to help determine robust COVID-19 immunity.'
Mr. Commissiong continued, 'Going forward, the Company is concentrating its extensive investment in automated lab equipment to the benefit of Provista. We have begun working to substantially expand Provista's lab sales team to build relationships with healthcare providers prescribing tests to patients, as well as provide reference lab testing services to CLIA labs who are looking to deprioritize internal COVID-19 testing. Due to our lab automation infrastructure and distributor pricing for our reagents, we believe that we can compete for large volume COVID-19 testing business, and we expect to see a resurgence in this testing in the fall as schools seek to re-open in classroom learning for K-12 and college-aged students who are the least likely groups to have been vaccinated, as well as among employers. We believe that the significant strides we have made at Provista will position the Company to accelerate growth into 2022 and build significant long-term value for the benefit of our stockholders.'
Tollovir™ Phase 2 Scientific and Clinical Development Programs
We are continuing to make progress with enrollment of our Phase 2 clinical trial to treat hospitalized COVID-19 patients in Israel, with our TolloTest™ biomarker being used for the first time as a surrogate biomarker to monitor patient response to treatment. The recent resurgence of COVID-19 in Israel, driven by the Delta variant, has increased hospitalizations in both the vaccinated and unvaccinated, and has led to a reimposition of indoor mask mandates to help curb the spread. While the total number of hospitalized patients remains relatively low, we see the Israel program as critical to our overall clinical development strategy because the clinical investigators we are working with in Israel have tremendous international collaborators who think quite highly of the science emerging from Israel, making them willing to collaborate on broader international clinical development programs that will likely be needed for the ultimate regulatory approval of Tollovir.
As part of the ongoing scientific effort to further elucidate the mechanisms that have enabled Tollovir to achieve its very positive early clinical results, our partners at NLC Pharma identified an anti-inflammatory mechanism of action of Tollovir to complement its 3CL protease inhibiting mechanism. This dual mechanism of action helps more readily explain the significant reduction in symptoms and the biomarker C Reactive Protein (CRP) that was documented in the earliest clinical COVID-19 data sets produced in Israel, which could not be explained by a reduction in viral load alone likely caused by Tollovir's 3CL protease inhibiting mechanism. As a result of these quite complementary 3CL protease inhibiting and anti-inflammatory mechanisms, given that we are in a race with Pfizer to get to market with the first 3CL protease inhibiting COVID-19 antiviral for which therapeutic claims could be made, we believe it is critical to rapidly expand our clinical development programs to gather additional data in multiple clinical settings to demonstrate Tollovir's ability to help patients suffering from COVID-19…"
Pfizer Inc. (NYSE: PFE) announced back in June plans to provide the U.S. government at a not-for-profit price 500 million doses of the companies' COVID-19 vaccine, 200 million doses in 2021 and 300 million doses in the first half of 2022, to further support the multilateral efforts to address the surge of infection in many parts of the world and to help end the pandemic. The government will, in turn, donate the Pfizer-BioNTech vaccine doses to low- and lower middle-income countries and organizations that support them. "Our partnership with the U.S. government will help bring hundreds of millions of doses of our vaccine to the poorest countries around the world as quickly as possible. COVID-19 has impacted everyone, everywhere, and to win the battle against this pandemic, we must ensure expedited access to vaccines for all. I want to thank President Biden for his leadership in protecting the least advantaged of our global neighbors," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Fair and equitable distribution has been our North Star since Day One and we are proud to do our part to help vaccinate the world, a massive but an achievable undertaking."
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Dynavax Technologies Corporation (NASDAQ: DVAX) with Clover Biopharmaceuticals, announced this week the execution of a commercial supply agreement of Dynavax's CpG 1018™ advanced adjuvant, for use in Clover's protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum). The commercial supply agreement extends to the end of 2022.The agreement includes doses for delivery in 2021, which were manufactured under the previously announced funding agreement between Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax. "Throughout the development of our COVID-19 vaccine candidate, Dynavax has been an invaluable partner with a shared goal of maximizing our collective impacts in fighting the unprecedented COVID-19 pandemic. We look forward to the continued partnership as we accelerate large-scale production of SCB-2019 (CpG 1018/Alum) for potential commercial supply to communities in need around the globe," stated Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals.
Sorrento Therapeutics, Inc. (NASDAQ: SRNE) reported last week that following its receipt of EUA approval from COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) under registration number "OFICIO: CAS/10720/2021", it is establishing a local "Sorrento Mexico Ltd" subsidiary to manage commercial operations in Mexico. COVI-STIX is a sensitive and rapid (approximately 15-minute) diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal or nasopharyngeal samples of patients ("Inmunoensayo de flujo lateral para la detección cualitativa de la proteína nucleocápside del SARS-CoV-2"). COFEPRIS issued Emergency Use Authorization (EUA) approval and an importation permit for COVI-STIX on June 14, 2021. Sorrento will commercially launch the COVI-STIX test in Mexico with the first shipments expected to be delivered in July.
Agenus Inc. (NASDAQ: 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."
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