The agreement aims to supply ImmunityBio with Bacillus Calmette-Guerin (BCG), a critical component in cancer treatment. Under the collaboration, the Serum Institute will manufacture both standard BCG (sBCG) and next-generation recombinant BCG (iBCG), intending to address the chronic BCG supply shortage issues prevalent across the globe.

"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.

The arrangement will result in additional supplies of the current standard sBCG immediately for trials. At the same time, the two companies will work to accelerate the ongoing Phase 2 clinical trials of iBCG currently being conducted in Europe, which has so far demonstrated safety advantageous over standard BCG as well as enhanced immunogenicity in driving both CD8+ and CD4 T cells.

The collaboration between Serum Institute of India and ImmunityBio comes on the heels of the FDA’s approval of ANKTIVA for the treatment of non-muscle invasive bladder cancer with carcinoma in situ (CIS). Increasing the available supply of BCG is intended to address shortages for the combination therapy with ANKTIVA.

“The collaboration between Serum Institute of India and ImmunityBio will undoubtedly transform the way we approach cancer treatment. It will improve global access to BCG and at the same time—the unique therapy is the key to achieve a complete solution for bladder cancer. We are truly excited to witness the incredible impact this collaboration will have on improving patient outcomes and saving countless lives," said Mr. Adar C. Poonawalla, CEO, Serum Institute of India.

ImmunityBio plans to conduct clinical trials to study recombinant BCG (iBCG) and sBCG manufactured by Serum Institute in combination with ANKTIVA for the treatment of different types of bladder and other cancers. Supply of BCG is expected to be available once the protocol for the trial has been authorized by the FDA. ImmunityBio plans to submit the protocol to the FDA and to global regulatory bodies in the next 30 days.