ImmunityBio joins Serum Institute for BCG vaccines

ImmunityBio has formed a global partnership with the Serum Institute of India to ensure a steady supply of Bacillus Calmette-Guerin (BCG) vaccine for various cancer treatments. This collaboration focuses on two types of BCG vaccines: the standard BCG (sBCG), which is approved for use outside the United States, and a next-generation recombinant BCG (iBCG) that is currently undergoing clinical trials.

The iBCG vaccine is designed to be used with ImmunityBio’s ANKTIVA (nogapendekin alfa inbakicept-pmln), contingent upon regulatory approvals, for both current and future medical indications. The primary goal of this partnership is to enhance the availability of sBCG immediately for ongoing research, while simultaneously accelerating the Phase II clinical trials of iBCG in Europe.

The iBCG has demonstrated superior safety and increased immunogenicity compared to the standard BCG, particularly in its ability to stimulate CD8+ and CD4 T cells. This makes it a promising candidate for further investigation and potential use in various cancer therapies.

This strategic collaboration comes on the heels of the US Food and Drug Administration’s (FDA) approval of ImmunityBio’s ANKTIVA for treating non-muscle invasive bladder cancer with carcinoma in situ. The increased supply of BCG through this partnership aims to address the current shortages in the combination therapy involving ANKTIVA.

ImmunityBio plans to conduct additional trials to assess the efficacy of both iBCG and sBCG produced by the Serum Institute in conjunction with ANKTIVA. These trials will focus on treating bladder cancer and potentially other types of cancer. The availability of BCG for these trials is pending FDA approval of the trial protocols, which ImmunityBio intends to submit to the FDA and other global regulatory bodies by early June 2024.

Patrick Soon-Shiong, the executive chairman and global chief scientific and medical officer of ImmunityBio, expressed his enthusiasm for the new partnership. He highlighted the significance of initiating trials with the recombinant BCG, which has already shown enhanced safety in Phase I/II studies compared to the standard BCG. Soon-Shiong is optimistic about the potential of combining ANKTIVA with BCG to treat non-muscle invasive bladder cancer and other tumor types. He emphasized that this combination therapy could overcome the immune evasion seen in tumors treated with BCG alone and could convert MHC-negative cold tumors to MHC-positive hot tumors, thereby expanding the therapeutic potential of their cancer vaccine development.

Overall, this partnership represents a significant step forward in improving cancer treatment options by ensuring a reliable supply of BCG vaccines and advancing the development of next-generation therapies.