Welcome to Flow Pharma Inc.

Page Loading...

Menu
blob-1
blob-2

Flow Pharma Announces Publication of Pre-Clinical Efficacy Study for FlowVax COVID-19 Vaccine

The Peer Reviewed Journal Vaccines Has Published the Results of a Primate Study Showing Efficacy of the Flow Pharma’s COVID-19 Vaccine

PLEASANT HILL, CA / ACCESSWIRE / May 19, 2021 / Flow Pharma, Inc., a San Francisco Bay Area biotechnology company developing the FlowVax™ peptide vaccine platform technology, today announced the publication of an article describing research performed at the University of Texas Medical Branch at Galveston (UTMB). The article, entitled, “A synthetic peptide CTL vaccine targeting nucleocapsid confers protection from SARS-CoV-2 challenge in rhesus macaques,” was published May,18 2021 in the peer-reviewed journal Vaccines. Dr. Paul Harris and Dr. Trevor Brasel were equally contributing first authors on the paper.

“Several spike antibody evoking vaccines are being deployed in mass vaccination programs. Recent data suggest that as spike mutations increase, these vaccines may lose efficacy” said Paul Harris, Ph.D., Department of Medicine, Columbia University. “We are pleased with the positive results of this COVID-19 study, which were achieved by using a T-cell vaccine that does not target the mutating spike protein.

Trevor Brasel, Ph.D., M(ASCP)CM, assistant professor, Department of Microbiology & Immunology, UTMB said, “We are happy to be working with Flow Pharma on the pre-clinical testing phase of vaccines based on the FlowVax platform. Our team has extensive experience working with viruses in pre-clinical models and has been focusing on animal models for COVID-19 since the beginning of the pandemic. This study demonstrated that animals vaccinated with FlowVax COVID-19, and later challenged with SARS-CoV-2, were free of pneumonia-like infiltrates characteristic of COVID-19 infection, and presented with lower viral loads relative to controls.”

Dr. Brasel is author/co-author of over 80 peer-reviewed articles, editorials, book chapters, and presentations on topics including bioaerosol science and vaccine efficacy testing. Dr. Brasel’s ultimate goal is the development of high-profile FDA-compliant medical countermeasures specific to biodefense-related and emerging infectious diseases.

“We designed FlowVax COVID-19 to fight SARS-CoV-2 infections with killer T-cells rather than antibodies,” said Charles Herst, Ph.D., chief science officer, Flow Pharma. “This allows us to target the portions of the virus least likely to mutate, mitigating the risk of viral escape from vaccines that lead to a primarily antibody-driven response. In this study, we showed that a room-temperature-stable peptide vaccine targeting the SARS-CoV-2 nucleocapsid protein can provide protection against COVID-19 infection in nonhuman primates.”

“We are currently manufacturing clinical trial test doses of FLOVID-20, a version of FlowVax COVID-19 optimized for mass production,” stated Reid Rubsamen, M.D., M.S., CEO Flow Pharma, Inc. “The next step will be to conduct clinical trials of FLOVID-20 as a therapeutic for patients with acute and chronic COVID infections.”

About Flow Pharma

Flow Pharma, Inc. engineers and manufactures next generation T-cell stimulating biomedicines to treat and prevent viral diseases and cancers. Current products under development include FLOVID-20, to treat and prevent COVID-19, Ebola and Marburg virus vaccines and cancer vaccines to treat patients with breast cancer and cancers caused by human papilloma virus, including cervical cancer and throat cancer. Flow Pharma uses a proprietary mix of artificial intelligence, bioinformatics, and synthetic biochemistry to design and manufacture its expanding product portfolio.

About the University of Texas Medical Branch and the Galveston National Laboratory

The Galveston National Laboratory (GNL) is a sophisticated high containment research facility that serves as a critically important resource in the global fight against infectious diseases. The GNL is located on the campus of the University of Texas Medical Branch and operates under the umbrella of UTMB’s Institute for Human Infections and Immunity. The GNL is an anchor lab of the NIAID Biodefense Laboratory Network and is one of only two National Laboratories with Biosafety Level 4 (BSL-4) capabilities located on a U.S. university campus.

Forward Looking Statements

This press release may contain forward-looking statements, including information about management’s view of Flow Pharma, Inc. (“the Company”), future expectations, plans and prospects. In particular, when used in the preceding discussion, the words “believes,” “expects,” “intends,” “plans,” “anticipates,” or “may,” and similar conditional expressions are intended to identify forward-looking statements. Any statements made in this presentation other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of the Company, its subsidiaries and concepts to be materially different than those expressed or implied in such statements. Unknown or unpredictable factors also could have material adverse effects on the Company’s future results. The forward-looking statements included in this presentation are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these statements after the date of this release, except as required by law, and also takes no obligation to update or correct information prepared by third parties that are not paid for by Flow Pharma, Inc.

CONTACT:
Investor Relations
Flow Pharma, Inc.
3451 Vincent Road
Pleasant Hill, California 94523
925-708-8000
www.flowpharma.com
[email protected]

Published on Accesswire

The alarming trend in the number of observed mutations on SARS-COV-2, the virus causing COVID-19, continues apace. We continue to see mutations on these variants that could change the stability of the spike protein and its binding potential to antibodies, thus allowing for more infectivity and immune evasion respectively.

The number of mutated sequences and overall mutation count continues to increase as expected. This is cause for concern as sequence variants may not have the same efficacy as the previously characterized sequences against vaccines and therapeutics:

FLOVID-20 targets a subset of the nucleocapsid protein that has not been shown to mutate at a high degree. This region is conserved through evolution of coronaviruses due to its roles in replication of the viral genome. FLOVID-20 is able to accomplish this by specifically stimulating T-cells that can target these highly expressed and immunogenic conserved internal proteins. This is in stark contrast to current antibody vaccines and therapeutics that are restricted to targeting a region of the spike protein shown to mutate and evade antibodies in recent research.

The last few months have seen an alarming number of observed  mutations on SARS-COV-2, the virus causing COVID-19. These mutations may not be random, but increasing evidence points to viral variants avoiding protection given by vaccines, therapeutics, or previous infection:

“Some of the data I’ve seen in the last 48 hours have really scared me,” says Daniel Altmann, an immunologist at Imperial College London, who worries that some of results could portend a reduction in the effectiveness of COVID-19 vaccines.

“Fast-spreading COVID variant can elude immune responses”, Nature, Janurary 21, 2021

Mutations on these variants could change the stability of the spike protein and its binding potential to antibodies, thus allowing for more infectivity and immune evasion respectively.

The plot shown above illustrates the increasing mutations of spike protein around the time variants of the virus were discovered, specifically with origins in the United Kingdom, South Africa, and California. In January 2021, nearly 50% of viral samples sequenced from infected individuals around the world have been found to have 6 to 12 amino acid substitutions on the spike protein. The number of mutated sequences and overall mutation count is expected to continue to increase. This is cause for concern as sequence variants may not have the same efficacy as the previously characterized sequences against vaccines and therapeutics.

FLOVID-20 targets a subset of the nucleocapsid protein that has not been shown to mutate at a high degree. This region is conserved through evolution of coronaviruses due to its roles in replication of the viral genome. FLOVID-20 is able to accomplish this by specifically stimulating T-cells that can target these highly expressed and immunogenic conserved internal proteins. This is in stark contrast to current antibody vaccines and therapeutics that are restricted to targeting a region of the spike protein shown to mutate and evade antibodies in recent research.

Galveston National Laboratory
The Galveston National Laboratory (GNL) is a sophisticated high containment research facility that serves as a critically important resource in the global fight against infectious diseases.

Flow Pharma today announced that researchers at the University of Texas Medical Branch at Galveston (UTMB) will begin testing Flow Pharma’s FlowVax-based COVID-19 treatment candidate by challenging nonhuman primates with SARS-CoV-2, the virus that causes COVID-19 in humans, after the animals are vaccinated this month with FLOVID-20. FlowVax biomedicines utilize Flow Pharma’s patented Size Exclusion Antigen Presentation Control (SEAPAC(TM)) technology based on the benefits of making vaccine microspheres the same size as human white blood cells.

“We are happy to be working with Flow Pharma on the pre-clinical testing phase of their FlowVax COVID-19 development program. Our team has extensive experience working with a variety of viruses in various pre-clinical models and is currently focusing on animal models for COVID-19. We are very fortunate at UTMB in that we have access to the Galveston National Laboratory that allow us to conduct studies like these safely and at a high level of quality to ensure data integrity for sponsors like Flow Pharma,” said Trevor Brasel, Ph.D., M(ASCP)CM, Assistant Professor, Department of Microbiology and Immunology, UTMB.

Dr. Brasel is author/co-author of over 70 peer-reviewed articles, editorials, book chapters, and poster/podium presentations on a broad range of topics including bioaerosol science and vaccine efficacy testing against select agents. To date, no vaccines or therapeutics have been approved for human use against SARS-CoV-2, the virus that causes COVID-19. Dr. Brasel’s ultimate goal is FDA approval of high-profile medical countermeasures specific for biodefense-related and emerging infectious diseases.

“We designed FlowVax COVID-19 to rely on killer T-cells rather than antibodies to fight virus infections,” said Charles Herst, Ph.D., Chief Science Officer, Flow Pharma “This allows us to more easily target the portions of the virus least likely to mutate, because mutations can allow a virus to hide from the antibody vaccine. We took the same approach to the design of FlowVax Ebola which successfully protected mice from Ebolavirus infection in studies also performed at UTMB under Dr. Brasel’s team. The nonhuman primates at UTMB will be challenged with the same virus that causes COVID-19 in humans providing a realistic test of FlowVax COVID-19 before we begin testing in human subjects.”

“We have successfully completed many pre-clinical studies with the team at UTMB” said Reid Rubsamen, M.D., CEO, Flow Pharma. “We are very fortunate to have access to one of the first animal models in the world being developed to test vaccines designed to prevent COVID-19.”

About the University of Texas Medical Branch and the Galveston National Laboratory

The Galveston National Laboratory (GNL) is a sophisticated high containment research facility that serves as a critically important resource in the global fight against infectious diseases. The GNL is located on the campus of the University of Texas Medical Branch and operates under the umbrella of UTMB’s Institute for Human Infections and Immunity. The GNL is an anchor lab of the NIAID Biodefense Laboratory Network and is one of only two National Laboratories with Biosafety Level 4 (BSL-4) capabilities located on a U.S. university campus.

About Flow Pharma

Flow Pharma, Inc. is a San Francisco Bay Area based, biotechnology company using artificial intelligence to guide selection of neoantigen peptide targets on cancer cells or virus-infected cells for attack by the patient’s own, native immune system. These peptides can then be loaded into the FlowVax(TM) platform for administration by injection.

Flow Pharma, Inc. is conducting gene sequencing studies with neoantigen identification on breast cancer patients in the U.S. and cervical cancer patients in China, in preparation for conducting Phase I/II clinical trials planned for later this year. Neoantigens are small peptide markers expressed on cancer cells as a result of a cancer-causing viral infection or mutation of the DNA in normal cells, agents that cause transformation into cancer cells.

Forward Looking Statements

This press release may contain forward-looking statements, including information about management’s view of Flow Pharma, Inc. (“the Company”), future expectations, plans and prospects. In particular, when used in the preceding discussion, the words “believes,” “expects,” “intends,” “plans,” “anticipates,” or “may,” and similar conditional expressions are intended to identify forward-looking statements. Any statements made in this presentation other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of the Company, its subsidiaries and concepts to be materially different than those expressed or implied in such statements. Unknown or unpredictable factors also could have material adverse effects on the Company’s future results. The forward-looking statements included in this presentation are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these statements after the date of this release, except as required by law, and also takes no obligation to update or correct information prepared by third parties that are not paid for by Flow Pharma, Inc.