ImmunityBio, Serum Institute of India Partner for Global BCG Cancer Supply

ImmunityBio, Inc. has entered into an exclusive global agreement with the Serum Institute of India (SII), known for being the largest vaccine producer by volume, to supply Bacillus Calmette-Guerin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC). This collaboration involves the production of both traditional BCG (sBCG) and a newer recombinant version (iBCG), which is undergoing clinical trials.

The partnership aims to tackle the chronic shortage of BCG, a critical issue for bladder cancer patients globally. ImmunityBio, led by Executive Chairman Dr. Patrick Soon-Shiong, expressed pride in partnering with SII, emphasizing that this collaboration leverages SII's vast manufacturing capabilities to address BCG shortages effectively.

This agreement will ensure immediate availability of sBCG for clinical trials. Simultaneously, both companies will expedite ongoing Phase 2 clinical trials of iBCG in Europe. These trials have shown iBCG to be safer and more immunogenic than standard BCG, particularly in activating CD8+ and CD4 T cells. This advancement follows the FDA's approval of ImmunityBio’s ANKTIVA for NMIBC, aiming to improve BCG availability for combined therapy with ANKTIVA.

Adar C. Poonawalla, CEO of Serum Institute of India, highlighted the transformative potential of this collaboration in cancer treatment, focusing on enhancing global BCG access and improving patient outcomes.

Originally developed as a tuberculosis vaccine, BCG has been the standard NMIBC treatment since 1977 when administered directly into the bladder. BCG's immune response helps clear cancer cells in many patients. Despite its wide use and safety record, BCG production remains complex due to its biological nature. The collaboration with SII is expected to address these production challenges efficiently.

Richard Adcock, President and CEO of ImmunityBio, praised the scale and quality of SII’s vaccine production. He emphasized that the collaboration would provide more treatment options for NMIBC patients, both as monotherapy and in combination with ANKTIVA.

ImmunityBio plans to conduct global clinical trials combining sBCG and iBCG produced by SII with ANKTIVA for treating various cancers. The BCG supply will commence once the trial protocols are approved by the FDA and other regulatory bodies. These protocols are expected to be submitted within the next 30 days.

Dr. Soon-Shiong noted the excitement surrounding the trial of iBCG, which has shown enhanced safety profiles compared to standard BCG in Phase 1/2 studies. He anticipates that combining ANKTIVA with BCG could significantly advance cancer treatment by overcoming immune evasion and enhancing the immune response.

The Serum Institute of India, a leader in vaccine production, manufactures a vast array of vaccines, including those for diphtheria, tetanus, and hepatitis B. SII has been pivotal in making essential vaccines affordable globally, notably producing 'Pneumosil,' the world's most affordable PCV, and 'Cervavac,' the first indigenous qHPV vaccine in India. During the COVID-19 pandemic, SII delivered over 2 billion vaccine doses worldwide, demonstrating its critical role in global health.

Recombinant BCG (iBCG) has been developed through gene modifications to enhance its immunogenicity and safety. It has undergone several clinical trials demonstrating its tolerance and improved safety profile compared to standard BCG. These trials included studies in healthy adults, newborns, and in the context of TB and respiratory diseases, including during the COVID-19 pandemic.

ImmunityBio focuses on developing next-generation immunotherapies and vaccines to fight cancers and infectious diseases by activating the body's natural immune responses. The company’s ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer, aiming to provide durable and safe protection against the disease. ImmunityBio is committed to advancing cancer treatment through innovative therapies that are more effective and accessible than current standards.