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ImmunityBio and Serum Institute of India Reach Exclusive Agreement for Global BCG Supply in Treating All Cancer Types

Friday, May 03, 2024

ImmunityBio, Inc. (NASDAQ: IBRX) recently announced an exclusive global collaboration with the Serum Institute of India, the world's largest vaccine manufacturer in terms of doses produced. This partnership aims to provide ImmunityBio with a sustainable supply of Bacillus Calmette-Guerin (BCG), a critical component in cancer treatment.

Under this agreement, the Serum Institute of India will manufacture both standard BCG (sBCG), approved for use outside the U.S., and a next-generation recombinant BCG (iBCG), currently undergoing testing. The latter is intended for use alongside ImmunityBio's ANKTIVA for various approved and potential future indications, pending regulatory approvals.

ImmunityBio, expressed satisfaction with the partnership, emphasizing the capacity of the Serum Institute to address the shortage of BCG, particularly impacting bladder cancer patients. He highlighted the significance of partnering with Dr. Cyrus Poonawalla, Chairman and founder of the Serum Institute, known for his substantial contributions to global health.

This collaboration will immediately increase the supply of standard sBCG for ongoing trials while expediting Phase 2 clinical trials of iBCG in Europe. Initial results indicate iBCG's safety advantages over standard BCG, coupled with enhanced immunogenicity, stimulating both CD8+ and CD4 T cells.

The timing of this partnership coincides with the FDA's recent approval of ANKTIVA for treating non-muscle invasive bladder cancer with carcinoma in situ (CIS). The aim is to mitigate BCG shortages for combination therapy with ANKTIVA.

Serum Institute of India, expressed excitement about the transformative potential of the collaboration in cancer treatment. He anticipated significant improvements in patient outcomes and emphasized the critical role of this partnership in enhancing global BCG access.

BCG, originally a tuberculosis vaccine, has been pivotal in treating non-muscle invasive bladder cancer since 1977. However, its production complexity has led to shortages. The Serum Institute, a key BCG manufacturer globally, will address this issue through this collaboration.

ImmunityBio, underscored the significance of providing an alternative BCG option, anticipating broader benefits for bladder cancer patients.

ImmunityBio plans extensive clinical trials to evaluate iBCG and sBCG in combination with ANKTIVA for various cancer types. Regulatory approvals are expected soon, paving the way for trial commencement.

Dr. Soon-Shiong highlighted iBCG's promising safety and efficacy profile, emphasizing its potential to enhance cancer vaccine therapy. He outlined plans to explore ANKTIVA in combination with BCG across different tumor types, anticipating significant advancements in cancer treatment.

In summary, the partnership between ImmunityBio and the Serum Institute of India holds immense promise in revolutionizing cancer treatment through enhanced BCG access and innovative therapeutic combinations.



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