Novavax, Inc, a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and SK bioscience, a vaccine business subsidiary of SK Group, today announced a development and supply agreement for the antigen component of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate, for supply to global markets including the COVAX Facility. In addition, the companies have signed a letter of intent with the Republic of Korea’s Ministry of Health and Welfare to work toward broad and equitable access to NVX-CoV2373 for the global market as well as to make the vaccine available in South Korea.
Under the terms of the agreement, SK bioscience will manufacture the vaccine antigen component for use in the final drug product globally during the pandemic period.
NVX-CoV2373 was developed using Novavax' recombinant nanoparticle technology to generate a stable, prefusion antigen derived from the coronavirus spike (S) protein. It contains Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Phase 1 data from the Company’s Phase 1/2 randomized, observer-blinded, placebo-controlled trial shows that NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.
SK bioscience, using its cell culture and recombinant protein capability, will initiate the production of the NVX-CoV2373 antigen at its vaccine facility in Andong L-house, South Korea beginning in August 2020.
This contract development and manufacturing organization agreement leverages the capacity reservation agreement between SK bioscience and the Coalition for Epidemic Preparedness Innovations (CEPI). Novavax' NVX-CoV2373 will be manufactured using a part of the reserved capacity at SK Bioscience’s “L-House” facility.
This agreement further boosts the potential global supply of the NVX-CoV2373 vaccine and is an important component of Novavax’ collaboration with CEPI. Through that partnership with CEPI, Novavax has committed to develop and manufacture significant amounts of NVX-CoV2373, including vaccine derived from antigen coming from SK bioscience, if proved safe and effective, to be procured and distributed by the COVAX Facility through a globally fair allocation framework.
"We are proud to partner with SK bioscience to fulfill our commitment to ensure global supply of NVX-CoV2373 in alignment with our partnership with CEPI,” said Stanley C. Erck, President and CEO of Novavax. “SK bioscience shares our sense of urgency to ensure broad and equitable access for our COVID-19 vaccine candidate around the world.”
Jaeyong Ahn, CEO of SK bioscience said, "SK's accumulated vaccine R&D and production capability has been spotlighted by the world's most advanced global pharmaceutical companies as well as the global initiatives for the COVID-19 vaccine manufacturing and supply such as CEPI." He added, "We will cooperate with the government supporting its two-track strategy, developing vaccine in Korea and securing COVID-19 vaccine from a global manufacturer in a short period of time."
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NVXâ€‘CoV2373 is a vaccine candidate engineered from the genetic sequence of SARSâ€‘CoVâ€‘2, the virus that causes COVID-19 disease. NVXâ€‘CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVXâ€‘CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVXâ€‘CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).