Flow Pharma Announces Strategic Partnership with Oakwood Labs for GMP Manufacturing of FlowVax COVID-19 Vaccine
Wednesday, April 15, 2020 2:11 AM
Oakwood Laboratories in the Cleveland, Ohio area is a leader in microsphere-based pharmaceutical development and manufacturing. Oakwood will operate Flow Pharma's production volume vaccine manufacturing system at their Solon, Ohio manufacturing plant, using Oakwood's state-of-the-art microsphere-based processing, quality testing, and packaging systems to make GMP FlowVax COVID-19 vaccine doses for clinical testing.
PLEASANT HILL, CA / ACCESSWIRE / April 15, 2020 / Flow Pharma, Inc., a San Francisco Bay Area biotechnology company developing the FlowVax(TM) peptide vaccine platform technology, today announced that Oakwood Laboratories, headquartered in Oakwood Village Ohio (a suburb of Cleveland) will begin working with Flow Pharma to interface Oakwood's microsphere based, GMP pharmaceutical manufacturing operations to the FlowVax vaccine platform manufacturing system. FlowVax vaccines 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.
"Oakwood Laboratories has for many years been a leader in controlled release, injectable microsphere-based pharmaceutical development and manufacturing. We are currently manufacturing multiple FDA approved sterile products in our GMP facility, designed specifically to manufacture microsphere-based products" said Mark Smith, President of Oakwood Labs. "We also have the analytical, Quality Control, and other quality systems and infrastructure in place to test this type of product. Since the vaccine does not make use of either live or attenuated virus, there is no risk of infection from processing it."
"Flow Pharma's FlowVax platform has many applications from immuno-oncology to infectious diseases, and we are partnering with Oakwood to accelerate all of our products under development into clinical testing." Said Reid Rubsamen, M.D., CEO, Flow Pharma. "Our work with FlowVax Ebola demonstrated protection in a mouse model and we have used the same approach for SARS-CoV-2, the virus that causes COVID-19. We are proud to have developed a vaccine prototype which, based on our prior research, we believe will protect against COVID-19, and are doing everything we can to get FlowVax COVID-19 into clinical testing as soon as possible."
"There are many companies developing antibody vaccines to protect against infection with SARS-CoV-2, the virus that causes COVID-19." Said Charles Herst, Ph.D., Chief Science Officer, Flow Pharma. "We are taking a different approach. We believe that vaccination with FlowVax COVID-19 will cause killer T-cells specific to SARS-CoV-2 to increase in number, rather than produce the antibody response created by most COVID-19 vaccines currently under development. Relying on killer T-cells rather than antibodies 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 vaccine. We plan to test FlowVax COVID-19 for both pre-exposure and post-exposure prophylaxis because killer T-cells can kill infected cells."
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 US 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.
About Oakwood Laboratories
Oakwood Laboratories, LLC is a Cleveland-based specialty pharmaceutical company focused on the development, scale-up, and manufacture of sustained and controlled release injectable microsphere-based pharmaceuticals. Oakwood's technology enables one injection to last from two weeks to one year. This enables patients to receive fewer injections, and is also useful for targeted therapies, and in situations where patient compliance is an issue.
The manufacturing process developed by Oakwood is readily scalable and is used to manufacture commercial scale products under GMP. Oakwood partners with pharmaceutical and biotech companies to bring their products from conception through commercialization.
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.
Flow Pharma, Inc.
3451 Vincent Road
Pleasant Hill, California 94523
SOURCE: Flow Pharma, Inc.