Business
ImmunityBio, Serum Institute of India Agree on an Exclusive Arrangement for Global Supply of Bacillus Calmette-Guerin (BCG) Across All Cancer Types
Collaboration will result in BCG manufacture at large scale for use in combination with ANKTIVA®, ImmunityBio’s recently approved treatment for non-muscle
About this update from Immunitybio, Inc.
[{"type":"text","content":"\n\nCollaboration will result in BCG manufacture at large scale for use in combination with ANKTIVA®, ImmunityBio’s recently approved treatment for non-muscle invasive bladder cancer (NMIBC)\n\n\n\nSerum Institute of India (SII) will manufacture both standard BCG (“sBCG”) and next-generation recombinant BCG (“iBCG”), creating a long-term solution to chronic BCG supply shortage issues\n\n\n\nStandard BCG (sBCG) from the Serum Institute is currently administered in number of countries worldwide for treatment of NMIBC\n\n\n\nRecombinant BCG (iBCG) has demonstrated potent immunogenicity with CD8+ and CD4+ stimulation and improved safety compared to standard BCG in clinical trials across Europe.\n\n\n\nCollaboration will help to ensure availability of BCG for all approved indications that benefit from ANKTIVA’s triangle offense of natural killer cells, T cells, and memory T cells\n\n\n\nGlobal clinical trials planned to study standard of care ANKTIVA plus BCG with globally available sBCG and iBCG from Serum Institute, the QUILT BCG randomized clinical trial\n\n\n\n CULVER CITY, Calif.--(BUSINESS WIRE)--\nImmunityBio, Inc. (NASDAQ: IBRX), has signed an exclusive global arrangement with the Serum Institute of India, the world’s largest manufacturer of vaccines by number of doses produced, to supply ImmunityBio with Bacillus Calmette-Guerin (BCG). The agreement covers the manufacturing of standard BCG (sBCG) that is currently approved for use outside the U.S., as well as a next-generation recombinant BCG (iBCG) undergoing testing, intended for use in combination with ImmunityBio’s ANKTIVA (nogapendekin alfa inbakicept-pmln) for currently approved and potential future indications, subject to regulatory approvals.\n\n\n“We are pleased to partner with the Serum Institute of India so that the power of its large-scale, world-class, GMP manufacturing capacity can be used to address the issue of BCG shortage, which affects thousands of bladder cancer patients annually,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “We are especially proud to be partnering with Dr. Cyrus Poonawalla, the Institute’s Chairman and founder and someone who has made such a positive impact on global health.”\n\n\nThe arrangement will result in additional supplies of the current standard sBCG immedia...