- Phase 1 clinical trial of CDX-005 expected to initiate prior to year-end 2020 - Serum Institute to ramp-up manufacturing for large-scale safety and efficacy studies and to meet global vaccine supply requirements [22-September-2020] FARMINGDALE, N.Y. , Sept. 22, 2020 /PRNewswire/ -- Codagenix, Inc., a clinical-stage biotechnology company developing pr
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FARMINGDALE, N.Y., Sept. 22, 2020 /PRNewswire/ -- Codagenix, Inc.., a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies, today announced that the Serum Institute of India, Ltd. has begun manufacturing CDX-005, the company’s intranasal, live-attenuated vaccine candidate for SARS-CoV-2, the virus that causes COVID-19. Codagenix, backed by investors Adjuvant Capital and TopSpin Partners, is collaborating with the Serum Institute of India, the world’s largest vaccine maker by number of doses produced, to develop CDX-005. Preclinical animal studies have been successfully completed, and Codagenix expects to initiate a Phase 1 first-in-human clinical trial in the UK by the end of 2020. “Today marks an important step in our efforts to advance the development of CDX-005,” said J. Robert Coleman, Ph.D., CEO of Codagenix. “Currently, there are no licensed vaccines for COVID-19. Given the scale of the pandemic – more than 28 million confirmed cases worldwide and more than 900,000 deaths -- the normal development process of waiting until after a vaccine has been proven effective to begin manufacturing wastes precious time. Preclinical testing of a single, intranasal dose of CDX-005 in animals has yielded encouraging safety and efficacy signals, and with Serum Institute’s financial and technical support, we expect to rapidly propel the vaccine into the clinic before the end of 2020.” Dr. Coleman continued, “CDX-005 was engineered using our proprietary codon deoptimization software platform, which allowed us to recode the genome of the SARS-CoV-2 virus by inserting hundreds of mutations. These mutations result in a live-attenuated vaccine that is non-pathogenic yet has the potential to stimulate a robust T cell and antibody immune response that mimics that of the wild-type virus. Our live-attenuated vaccine approach is in sharp contrast to many of the more common COVID-19 immunization strategies currently undergoing human testing, such as mRNA or virus-like-particle candidates, which only target the spike protein, or the adenovirus vectored approaches that could cause off-target effects. Moreover, CDX-005 is delivered intranasally rather than via an injection, which allows for more efficient, patient-friendly administration.” Having received the necessary regulatory approval from the Review Committee on Genetic Manipulation (RCGM) of India’s Department of Biotechnology (DBT), Serum Institute will initiate manufacturing for large-scale safety and efficacy studies, in addition to preparing to meet global vaccine supply requirements. Glenn Rockman, Managing Partner at Adjuvant Capital, added: “The COVID-19 pandemic has highlighted the need for a paradigm shift in the development of vaccines. The software-driven virus recoding approach used by Codagenix holds the potential to not only develop optimized, more affordable versions of existing vaccines, but also rapidly respond to future outbreaks. We believe, now more than ever, that Codagenix has an important role to play in the fight against COVID-19, as well as other infectious diseases, both existing and those yet to emerge.” About Serum Institute of India Serum Institute of India Pvt. Ltd. is the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses), which includes polio vaccine as well as diphtheria, tetanus, pertussis, Hib, BCG, r-hepatitis B, measles, mumps, and rubella vaccines. It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute. Serum Institute of India was founded in 1966 by Dr. Cyrus Poonawalla with the aim of manufacturing life-saving immuno-biologicals, which were in shortage in the country and imported at high prices. Thereafter, several life-saving biologicals were manufactured at prices affordable to the common man and in abundance, with the result that the country was made self-sufficient for tetanus anti-toxin and anti-snake venom serum, followed by DTP (diphtheria, tetanus and pertussis) group of vaccines and then later on MMR (measles, mumps and rubella) group of vaccines. The philanthropic philosophy of the company has proliferated to bring down the prices of newer vaccines such as hepatitis-B vaccine, combination vaccine etc., so that not only India’s, but all under-privileged children of the world are protected from birth onwards. About Codagenix, Inc. Codagenix is a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies. The company’s breakthrough codon deoptimization software platform utilizes a computer algorithm to recode the genomes of viruses and construct live-attenuated vaccines to prevent viral infections or treat solid tumors. Codagenix has demonstrated its live-attenuated viruses stimulate a robust T cell and antibody immune response but are safe and non-pathogenic. Codagenix possesses a deep pipeline of clinical and pre-clinical programs including vaccine candidates for SARS-CoV-2, the virus that causes COVID-19 (CDX-005); respiratory syncytial virus (CodaVax™-RSV) in Phase I testing; influenza (CodaVax™-H1N1); dengue virus; and triple negative breast cancer (using a rationally designed virus). Codagenix was spun out of the laboratory of National Academy of Science Member Eckard Wimmer, Ph.D., at Stony Brook University, and the company’s programs are supported by Adjuvant Capital, TopSpin Partners, Euclidean Capital, and government agencies including the USDA, NIH/NIAID and the Department of Defense. Media Contacts:
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