Mumbai, April 11, 2022: Epygen Biotech, an Indian Biopharmaceutical company engaged in research and manufacturing therapeutic proteins, has received funding from the Department of Biotechnology, Government of India to initiate the Phase I and Phase II trials of an indigenous affordable Receptor Binding Domain (RBD based vaccine) against present and future SARS-CoV–2 variants. With an anticipated price point of less than INR 150 per dose, an Indian company for the first time will be able to adopt the highly productive C1-cell protein production platform, which has been demonstrated by scientists at the European Union Zoonotic Anticipation and Preparedness Initiative (ZAPI) program.
The COVID-19 vaccine will be made available to the government as well as for private consumption and it is expected to hit the Indian market by the end of 2022 or early 2023. The company plans to initially produce a minimum of 100 million doses of this vaccine, to help address health disparity in the subcontinent.
Epygen has licensed the C1-cell protein production platform from Dyadic International of USA (Nasdaq DYAI), to develop the hyper-productive C1 SARS-CoV-2 RBD cell line which was developed together with the Israeli Institute of Biological Research (IIBR), an Israeli government biotech lab and VTT, a government-owned lab in Finland. Epygen is developing & expects to produce large quantities of the vaccine at a much lower cost at its Patalganga (near Mumbai, India) based state of the art Biologics facility. Combining the powers of the C1 platform in its world class biologics facility, Epygen’s goal is delivering to the masses the inalienable right of healthcare.
The immunogenicity response has produced very high titers (level of antibodies) in preclinical trials and demonstrated excellent protection against lethal challenges of the SARS-CoV-2 virus. The group has more than 20 years of experience with the C1 platform, churning out recombinant proteins at a much higher level compared to most current commercial vaccine cell lines.
Mr. Debayan Ghosh, Founder and CMD of Epygen Biotech, explains, “There exists a natural process of continuous mutation of Coronavirus. Vaccines have to evolve against new variants to stay ahead in the game. The team has already developed antigens against the Wuhan (the original Covid-19 virus), Alpha, Beta, Gamma, Delta, and Omicron variants. The Department of Biotechnology of India has thoroughly evaluated our extremely encouraging data from Europe, Israel and India, facilitating the
funding for Phase I and Phase II clinical trials. We are further planning to raise INR 200 Crores for Phase III, which will help us augment our production capacity and roll out the vaccine as soon as possible. I personally have more than two decades of experience with the C1 platform, which gives me tremendous confidence on this technology. The vaccine will serve as the primary dose as well as a booster to fight the newer variants amongst the masses of this country.”
It is not only the unprecedented high expression levels of the vaccine manufacturing process that makes it exciting. The ‘smart single loci gene manipulation’ enables rapid tweaking to switch variant antigens, without altering the cell’s genetic profile. The platform is capable to quickly churn out variant of concern vaccine candidates on emergence of the mutating Covid-19 viruses. The high productivity of the Dyadic C1 technology platform can potentially be used to produce several other therapeutics as well. Substantial progress has been achieved in developing this protein production platform for producing low-cost monoclonal antibodies against infectious disease and cancer.