Codagenix Appoints Linda Maldonado as VP, Biologics Chemistry and Manufacturing Controls

 

FARMINGDALE, N.Y., April 14, 2021 /PRNewswire/ -- Codagenix, Inc., a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies, today announced the appointment of biotech industry veteran Linda Maldonado as Vice President, Biologics Chemistry and Manufacturing Controls (CMC).

"We are pleased to welcome Linda to Codagenix's growing management team in anticipation of multiple significant growth opportunities this year, including the advancement COVI-VAC, our single-dose, intranasal, live-attenuated COVID-19 vaccine, to late-stage clinical trials," said J. Robert Coleman, Ph.D., CEO of Codagenix. "Linda has a proven track record with clinical process development, scale-up and technology transfer to GMP production that will be critical to ensuring the productivity, consistency and high quality of all Codagenix vaccines."

Codagenix utilizes its proprietary Synthetic Attenuated Virus Engineering (SAVE) platform to re-code the genome of a virus – turning the virus from dangerous pathogen into safe vaccine or solid-tumor therapeutic. Unlike other vaccine platforms that require the development and construction of supportive manufacturing in parallel, all Codagenix vaccine candidates leverage existing live-attenuated vaccine manufacturing systems to scale-up.  

Ms. Maldonado has more than 25 years of experience in biologics manufacturing from early clinical phase to commercial operations, spanning development to commercial launch for vaccine, antibody and gene therapy processes and products. Prior to joining Codagenix, she served as Senior Director of GMP Manufacturing, Downstream and Fill Finish for Catalent Cell and Gene Therapy, where she led early-phase production for a wide variety of biologics. Before Catalent, she held positions of increasing responsibility at vaccine and therapeutic manufacturers including PharmAthene, Human Genome Sciences,  Baxter Bioscience, Progenics and Sanofi Pasteur. Ms. Maldonado earned a M.S. in Biology from East Stroudsburg University and a B.S. in Biology from Bloomsburg University. 

"This is an exciting time for Codagenix, which has seen substantial growth over the past year in concert with the rapid advance of COVI-VAC, which went from concept-to-clinic in less than nine months," Ms. Maldonado said. "As VP, Biologics CMC, I look forward to working with the management team to optimize all vaccines in development, and in particular COVI-VAC, which has the potential to address several key logistical challenges to immunization against SARS-CoV-2 at a global scale including ease of administration and scalable manufacturing."

About Codagenix Inc.
Codagenix is a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies. The company's breakthrough Synthetic Attenuated Virus Engineering (SAVE) 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 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 (COVI-VAC); respiratory syncytial virus (CodaVax™-RSV) in Phase I testing; influenza (CodaVax™-H1N1); dengue virus; and triple negative breast cancer (using a rationally designed virus). To date, as part of Phase 1 clinical studies, 194 healthy volunteers ranging in age from 18 to 75 years old have received Codagenix vaccines. Codagenix was founded based on technology developed in the laboratory of National Academy of Science member Dr. Eckard Wimmer at Stony Brook University, and is supported by Adjuvant Capital, TopSpin Partners, and Euclidean Capital. The company has ongoing research and license programs with various federal agencies.

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SOURCE Codagenix Inc.

 

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