Palm Beach, FL – July 22, 2021 – According to WebMD, this week the nation’s top health officials said Tuesday that the Delta variant of the coronavirus is racing through North America and other parts of the world and now is responsible for 83% of all U.S. cases alone. That’s a massive increase from a week ago, when Delta was seen as responsible for just more than half of new cases, CDC Director Rochelle Walensky, MD, told a Senate committee. “The best way to prevent the spread of COVID-19 variants is to prevent the spread of disease, and vaccination is the most powerful tool we have,” she said. Meanwhile, several states in the South are reporting a large increase in COVID-19 cases, particularly in areas with low vaccination rates, according to The Atlanta Journal-Constitution. Arkansas, Florida, and Missouri are reporting full-fledged outbreaks, and neighboring states such as Alabama, Georgia, Louisiana, Mississippi, Tennessee, and Texas are following behind. According to the National Institutes of Health (NIH): “When variants of SARS-CoV-2 (the virus that causes COVID-19) emerged in late 2020, concern arose that they might elude protective immune responses generated by prior infection or vaccination, potentially making re-infection more likely or vaccination less effective. To investigate this possibility, researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and colleagues analyzed blood cell samples from 30 people who had contracted and recovered from COVID-19 prior to the emergence of virus variants. They found that one key player in the immune response to SARS-CoV-2—the CD8+ T cell—remained active against the virus.” Active biotech companies in the market this week include BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV), Pfizer Inc. (NYSE: PFE), Johnson & Johnson (NYSE: JNJ), Moderna, Inc. (NASDAQ: MRNA), Sorrento Therapeutics, Inc. (NASDAQ: SRNE).
NIH continued with: “The investigators asked whether CD8+ T cells in the blood of recovered COVID-19 patients, infected with the initial virus, could still recognize three SARS-CoV-2 variants: B.1.1.7, which was first detected in the United Kingdom; B.1.351, originally found in the Republic of South Africa; and B.1.1.248, first seen in Brazil. Each variant has mutations throughout the virus, and, in particular, in the region of the virus’ spike protein that it uses to attach to and enter cells. Mutations in this spike protein region could make it less recognizable to T cells and neutralizing antibodies, which are made by the immune system’s B cells following infection or vaccination. Optimal immunity to SARS-Cov-2 likely requires strong multivalent T-cell responses in addition to neutralizing antibodies and other responses to protect against current SARS-CoV-2 strains and emerging variants, the authors indicate. They stress the importance of monitoring the breadth, magnitude and durability of the anti-SARS-CoV-2 T-cell responses in recovered and vaccinated individuals as part of any assessment to determine if booster vaccinations are needed.”
BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV.CNQ) BREAKING NEWS: FDA PROVIDES NECESSARY GUIDANCE FOR BIOVAXYS TO BEGIN PREPARATION OF IND FOR PHASE I/II CLINICAL TRIALS OF COVIDTH – BioVaxys Technology Corp. (“BioVaxys”), is pleased to announce today that the US Food and Drug Administration (“FDA”) has provided its official Written Response to the Company’s request for a Pre-IND Type B review of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.
The FDA found the Chemistry, Manufacturing and Controls, and other elements of the clinical development program proposed by BioVaxys to be acceptable and provided guidance and feedback supportive of BioVaxys’ clinical development plans for CoviDTH. In addition, the FDA indicated that animal toxicity studies for CoviDTH were not required and that the Company could start its clinical development program with a combined Phase I/II study. Based on this feedback, BioVaxys will begin preparation of an IND application to support a Phase I/II safety, dosing, and efficacy study.
BioVaxys submitted a Pre-Investigational New Drug (“IND”) meeting request and briefing package with the FDA’s Center for Biologics Evaluation and Research (CBER) for CoviDTH earlier this year. The Pre-IND review is a critical step in the US regulatory approval process, as it affords an opportunity for study sponsor companies to seek clarification from the FDA on clinical trials design, clinical materials manufacturing, quality controls, etc.
“With the guidance we received from this FDA review, BioVaxys is now able to begin preparing its IND,” stated BioVaxys President and Chief Operating Officer Ken Kovan. He adds “Although the FDA has indicated that our planned animal tox study is discretionary, we will likely continue with the animal tox study of CoviDTH as it does not interfere with the development time frame and may in fact provide useful data.”
James Passin, BioVaxys CEO, stated, “We are pleased to advance CoviDTH towards clinical trials, as we believe that mass screening for T cell immunity to Covid-19 will represent a critical tool for public health authorities to address the continued pandemic, as Covid variants continue to circulate and major governments in the southern hemisphere enact new lockdown policies.” CONTINUED... Read this full release and more news for BioVaxys Technology at: https://www.financialnewsmedia.com/news-biov/
Other recent developments in the biotech industry include:
Johnson & Johnson (NYSE: JNJ) this week announced results for second-quarter. “Our second-quarter results showcase Johnson & Johnson’s diversified portfolio, driven by strong sales and earnings growth across our Medical Device, Consumer Health and Pharmaceutical businesses,” said Alex Gorsky, Chairman and Chief Executive Officer. “I’m so proud of our 136,000 colleagues who remain focused on delivering our medicines and products to patients and consumers around the world, in addition to advancing our pipeline with new product launches and regulatory submissions. These accomplishments exemplify our commitment to advancing transformational innovations that improve the health of people and communities everywhere while continuing to deliver long-term value to all of our stakeholders.” Read the full report at https://finance.yahoo.com/news/johnson-johnson-reports-q2-2021-102500914.html
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) recently announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union.
Biovac will perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span three continents and include more than 20 manufacturing facilities. To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately.
Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, this week announced that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE: TAK) have agreed to purchase and distribute an additional 50 million doses of Moderna’s COVID-19 vaccine and its updated variant booster vaccine candidate, if authorized, to begin delivery in 2022.
This new supply agreement is in addition to the prior agreement for 50 million doses in 2021 resulting in a total of 100 million doses for Japan. Moderna is responsible for the manufacture and supply of Moderna’s vaccine candidate, and Takeda, with the support of the MHLW and Moderna, is responsible for all import, local regulatory, development and distribution activities in Japan for these additional 50 million doses beginning in 2022.
Sorrento Therapeutics, Inc. (NASDAQ: SRNE) this week announced that COVID-19 patients have been dosed in its Phase 2 efficacy trial. Approximately 350 outpatients with COVID-19 who are asymptomatic or have mild symptoms will be enrolled in this large double-blind, randomized clinical trial evaluating COVIDROPS doses of 10 mg or 20 mg against placebo (details can be found on www.ClinicalTrials.gov using the identifier NCT04900428). This study uses a novel decentralized design where subjects are assessed and treated in their homes and received a rapid review and clearance from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
A previously completed safety study conducted in the US at doses up to 60 mg in healthy subjects showed a comparable safety profile to placebo with all reported adverse effects being mild in severity. The UK study will complement Phase 2 trials currently being started in the US and should the results of these studies demonstrate that COVIDROPS is both safe and effective against SARS-CoV-2, Sorrento will apply for Emergency Use Authorization in the US, UK, Canada, India, Mexico and European Union as well as other territories.
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