OKLAHOMA CITY, April 23, 2020 (GLOBE NEWSWIRE) -- Cytovance® Biologics, a USA-based contract development and manufacturing organization (CDMO) and a subsidiary of the Shenzhen Hepalink Pharmaceutical Group Co., Ltd. ("Hepalink") announced today that it has entered into a collaboration agreement with Akshaya Bio, Inc., a Canadian development stage biotechnology company (“Akshaya”) to provide rapid access to clinical materials using Akshaya’s proprietary Chimigen® Platform Technology for vaccine development for COVID-19 and HBV.
“Cytovance is driven to leverage innovative solutions and superior technologies to help advance vaccine development efforts for infectious diseases including COVID-19,” said Jesse McCool, Chief Executive Officer of Cytovance Biologics. “Our scientists are deeply passionate about helping drug companies succeed in the highly complex clinical development arena. I am excited to report that tech transfer activities have begun between Cytovance and Akshaya Bio in order to install their cutting-edge production technologies right here in our Oklahoma City facilities.”
“Our Open Innovation program has a primary focus of bringing new and state-of-the-art technology into our company. This collaboration with Akshaya is a great example of our commitment to innovation,” stated April Stanley, Associate Director of Open Innovation at Cytovance. “Our team of scientists are excited for this opportunity that has the potential to help people all over the world. We, too, are worried about the COVID-19 pandemic and with our mix of manufacturing capabilities and scientific community, this is our unique way to contribute to solving the problem.”
Under the terms of the collaboration agreement, the companies will focus on using Akshaya’s proprietary Chimigen® Platform Technology to execute bulk drug products of both COVID-19 and HBV vaccines to be used in Phase I clinical trials. Akshaya utilizes the Chimigen® Platform to develop therapeutic vaccines for patients with chronic viral infections as well as prophylactic vaccines to prevent infections. Cytovance will scale-up production using its GMP insect cell microbial manufacturing platform for evaluation of the Chimigen® technology in humans for SARS CoV-2 coronavirus and chronic hepatitis B.
“We are very excited to be working with Cytovance Biologics,” stated Dr. Eric Shi of Akshaya Bio. “We truly believe our unique vaccine technology and vaccine products for HBV and COVID-19 will benefit from this partnership as our platform models align beautifully with Cytovance. They not only provide excellent CDMO services, but also simplify co-development with a deep understanding of our innovative vaccine technology.”
About Cytovance® Biologics
Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule active pharmaceutical ingredients (APIs) from both mammalian cell culture and microbial fermentation such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines and other biological products including plasmid DNA and cell-based therapeutics. In addition to our clinical and commercial cGMP API manufacturing services, Cytovance offers well-integrated development services supporting the entire product lifecycle including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. A centralized, responsive program management team coordinates all critical chemistry manufacturing and controls (CMC) activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support. Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.
Cytovance offers deep industry expertise and unique customized services for the scale-up and CGMP manufacture of protein-based therapeutics; from early-stage pre-clinical development to commercial production, for both mammalian and microbial. Further information can be found at www.cytovance.com.
About Akshaya
Akshaya Bio, Inc., a Canadian development stage biotechnology company (“Akshaya”), and its wholly owned subsidiary Chimigen Inc., a US-based company (“Chimigen”), develop innovative therapeutics for infectious diseases and cancer-based vaccines using its proprietary Chimigen® Platform Technology. The Chimigen® Platform’s unique competitive advantage lies in its design, consisting of a chimeric protein made up of the antigen and antibody mimicking the normal and effective biological process of inducing an immune response initiated through antigen-antibody complexes. Furthermore, the proprietary design also mimics the natural process of targeting receptors on antigen presenting cells such as dendritic cells to elicit broad immune responses.
Additionally, manufacture of the chimeric antigen in insect cells provides for additional immunogenicity to Chimigen® Technology-derived product candidates. Akshaya’s intellectual property-protected Chimigen® Platform has been used to develop a portfolio of dendritic cell receptor-targeted chimeric molecules which have therapeutic as well as prophylactic applications (immunotherapies and vaccines) that address several major current medical needs. Akshaya’s business strategy is to develop and commercialize immunotherapeutic products in infectious diseases and cancer, and currently focusing on Chimigen® HBV Immunotherapy Vaccine and Chimigen® SARS-CoV-2 (COVID-19) for prophylactic use to prevent infection by SARS-CoV-2.
Akshaya is currently in discussions with NIH-NIAID for support with HBV clinical studies and other US and Canadian Government Agencies for support with COVID-19 vaccine development. Akshaya is also seeking to attract venture financing to advance development of the product. Learn more about Akshaya at www.akshayabio.com/.
Media Contact:
Jodie Gutkowski
Tel: 405-319-8309
E-mail: jgutkowski@cytovance.com