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BioVaxys Announces Bioproduction of BVX-1021 for its Pan-Sarbecovirus Program in Collaboration with The Ohio State University

On March 17, 2022 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company"), reported that it has entered into an agreement with Millipore-Sigma ("Millipore") a global Contract Development and Manufacturing Research Organization ("CDMO"), to manufacture a supply of GLP-grade BVX-1021, the Company’s newly developed vaccine ("BVX-1021") for the strain of coronavirus that causes Severe Acute Respiratory Syndrome ("SARS1"), the respiratory illness responsible for the deadly 2002–2004 pandemic. There are no vaccines approved for SARS1 (Press release, BioVaxys Technology, MAR 17, 2022, View Source [SID1234610291]).

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BVX-1021 is the subject of an ongoing research collaboration between The Ohio State University ("Ohio State") and BioVaxys, announced in December 2021, that is evaluating the Company’s novel approach for a "universal vaccine" that can treat a broad range of sarbecoviruses ("pan-sarbecovirus vaccine"). Sarbecoviruses are a family of viruses that include SARS-CoV-2 and all current ‘Variants of Concern’ such as Delta and Omicron (as well as at least ten additional variants that are currently being monitored), SARS1, and a broad range of other potentially dangerous zoonotic viruses.

The collaboration between BioVaxys and Ohio State, which has been underway since early January 2022, is evaluating the combination of BVX-0320 and BVX-1021 in a guinea pig model. The major endpoints of the study are the development of virus-neutralizing antibodies to live virus SARS-CoV-2 and other sarbecoviruses, including bat and pangolin SARS-related coronaviruses. Bats are a major reservoir of many strains of SARS, with several strains have been identified in palm civets, which were likely ancestors of SARS-CoV-1. (Journal of Virology. 84 (6): 2808–19, 2010). The presence of neutralizing antibodies in the animal model would strongly suggest that BVX-1021 would confer an additional immune response across all sarbecoviruses in those people fully vaccinated for Covid-19 as well as those with natural immunity.

Dr. David Berd, Chief Medical Officer of Biovaxys, explained, "Scientists have observed that people who survived the 2002-03 SARS pandemic and then were administered a Covid-19 vaccine developed antibodies that cross-reacted with all of the sarbecoviruses that they tested. That observation suggested to us that a similar pan-sarbecovirus immune response could be generated by immunizing with haptenized spike protein from SARS1 and SARS-Cov-2, i.e., our BVX-0320 and BVX-1021 products."

BVX-1021 is a hapten-modified recombinant S-protein from SARS-CoV-1, whereas BVX-0320, BioVaxys’ Covid-19 vaccine, is a hapten-modified recombinant S-spike protein from SARS-CoV-2, the virus which causes Covid-19. A hapten is a small molecule that stimulates an immune response when conjugated with a protein such as a virus surface antigen, but lacks antigenicity of its own. Previous studies conducted by BioVaxys in mice have shown that haptenized SARS-CoV-2 spike protein elicits both, robust T cell and antibody response.

BioVaxys recently announced results of a study that demonstrated that BVX-0320, its haptenized SARS-CoV-2 s-spike protein vaccine, does not bind to the Angiotensin Converting Enzyme-2 (ACE2) receptor. The finding suggests that Company’s haptenized SARS-CoV-2 spike protein vaccine may not lead to the unusual but serious myocarditis observed with mRNA vaccines.

Kenneth Kovan, President & Chief Operating Officer of BioVaxys stated, "The Covid-19 market is shifting to vaccines that will not only protect against emerging variants of SARS-CoV-2, but also for any related coronaviruses that likely may arise in the future. BVX-1021 demonstrates that we can leverage our technology platform to create novel hapten-viral antigen vaccines to target additional markets."

BioVaxys intends to develop BVX-1021 as a standalone "booster" targeting anyone who has been immunized with a World Health Organization-recognized Covid-19 vaccine or convalesced from a Covid-19 infection. To date, approximately 389 million people worldwide have recovered from Covid-19 (Worldometer, March 11, 2022), and 57% of the global population (Our World in Data, March 2022), or 4.4 billion people, have received a full course of SARS-CoV-2 vaccine.

Millipore is a subsidiary of Merck KGaA (Deutsche Bourse: MRCG), one of the largest pharmaceutical companies in the world, with a market capitalization of US$81 billion.

For greater certainty, BioVaxys is not making any express or implied claims that the Company can currently treat COVID-19.

TC BioPharm Announces FDA Orphan Drug Status Granted for OmnImmune

On March 17 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, reported orphan drug status has been granted for lead product OmnImmune for use in Acute Myeloid Leukemia ("AML") (Press release, TC Biopharm, MAR 17, 2022, View Source [SID1234610290]). After reviewing the Phase 1b/2a trial results in relapse/refractory AML patients the FDA approved the Company’s application for Orphan Drug Status.

"This is another milestone achieved by TC BioPharm, further strengthening our leadership position in Gamma Delta therapies for oncology," stated CEO Bryan Kobel. "The granting of orphan drug status provides us a seven-year window post approval of exclusive marketing rights for allogeneic gamma delta use in AML, another added layer of protection around our lead product in a commercial setting beyond our existing strong IP. We look forward to the advancement of OmnImmune in the Phase 2b/3 trial and to helping patients with AML in the near future."

Orphan drug status is a designation granted by the Federal Drug Administration for therapies targeting rare diseases. The status allows for a seven-year exclusive marketing window post approval of the drug, certain lowered application fees and tax incentives, broadly.

About OmnImmune
OmnImmune an allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells. The trial, for treatment of patients suffering from relapse/refractory Acute Myeloid Leukemia (AML), OmnImmune comprises GDT cells sourced from healthy donors, expanded and activated in large numbers before being purified and formulated for infusion into patients. OmnImmune is a frozen and thawed product, now "banked" from donor derived cells. Phase 2/3 trials will begin enrollment in the first quarter of 2022 in the UK with expansion into the US in 2022.

Manhattan Scientifics Announces Early Results from Cancer Company

On March 17, 2022 Manhattan Scientifics Inc. (OTCQB: MHTX ), reported that positive early results from Imagion Biosystems Cancer Diagnostic human study (Press release, Manhattan Scientifics, MAR 17, 2022, View Source [SID1234610289]).

Imagion Biosystems Ltd. (IBX.AX) shares were up 46% trading 71 million shares.

Manhattan Scientifics Inc., initially funded and is the current owner of more that 50 million shares of Imagion Biosystems Ltd.

China CDE Approved First Universal CAR-T IND !

On March 17, 2022 Nanjing Bioheng Biotech Co., Ltd reported that China National Drug Administration Drug Review Center (CDE) approved first Universal Chemeric Antigen Receptor T (UCAR-T) cell drug (Acceptance No. : CXSL2101509). CTA101 is independently developed by targeting CD19 and CD22, for the indication of adult recurrent or refractory B-cell acute lymphoblastic leukemia ( r / r B-ALL ) (Press release, Bioheng Biotech, MAR 17, 2022, View Source;301505078.html [SID1234610288]).

"The approval of CTA101 product IND is an important milestone for Bioheng in developing innovative immuno-cell therapies", said Xiaohong He, CEO of Bioheng."It will further accelerate the development and commercialization of "off-the-shelf" allogeneic CAR-T, which potentially offers greater benefits to patients over autologous CAR-T. We look forward to pushing more such disruptive products to clinical and providing more choices to solve the unmet medical needs and treatment accessibility".

Biological Dynamics Study Demonstrates Detection of Early-Stage Cancers

On March 17, 2022 Biological Dynamics, Inc. reported the publication of its study, Early-Stage Multi-Cancer Detection Using an Extracellular Vesicle Protein-Based Blood Test, published in Nature Communications Medicine (Press release, Biological Dynamics, MAR 17, 2022, View Source [SID1234610287]). The test correctly identified 71 percent of stage 1 cancers in a combined cohort of pancreatic, ovarian, and bladder cancers with pancreatic stage 1 cancer detection at 96%.

"The results are remarkable and highlight exosomal protein markers as a viable candidate for early-stage cancer detection," said Scott Lippman, M.D., co-senior author of this report and Director of UC San Diego Moores Cancer Center. "Specifically, pancreatic cancer is notoriously difficult to detect at an early stage, when surgery, the only curative therapy, is possible. Biological Dynamics’ assay is demonstrating the potential for early-stage cancer detection to be included in the standard of care."

The case-controlled pilot study explored a cohort of 139 pathologically staged patients with stage 1 and stage 2 pancreatic, ovarian, and bladder cancers. While other liquid biopsy approaches have shown high sensitivity in the later stages of cancer progression, they have been relatively unsuccessful in detecting cancers in earlier stages. Results from the study demonstrate that the company’s unique proprietary Verita platform can rapidly isolate extracellular vesicles (EVs) from 250 microliters of plasma and provide a multi-marker, protein-based analysis that clearly discriminates early-stage cancer cases from healthy controls. The method enables a unique, rapid, multiomic assessment from a single small blood draw.

"Our study shows effective use of EVs isolated by the Verita platform for early cancer detection," said Dr. Paul R. Billings, Biological Dynamic’s CEO and Director. "In addition to delivering the current exo-protein analysis, the platform can provide data on other exo-proteins, exosomal nucleic acids, and circulating DNA biomarkers. With our own development and in partnership, we intend to rapidly improve cancer detection and management."

Publication of this study follows Breakthrough Device Designation granted by the U.S. Food and Drug Administration (FDA) in October 2021. It reviewed Biological Dynamic’s liquid biopsy assay, Exo-PDAC, which delivers early-stage detection of pancreatic ductal adenocarcinoma (PDAC), an aggressive and lethal form of cancer growing in incidence worldwide.