ImmunityBio has entered an exclusive worldwide agreement with the Serum Institute of India to secure a supply of Bacillus Calmette-Guerin (BCG) vaccine for all cancer types.

The partnership focuses on producing the standard BCG (sBCG) approved for use outside the US, and a next-generation recombinant BCG (iBCG) currently undergoing tests.

iBCG is intended for use with ImmunityBio’s ANKTIVA (nogapendekin alfa inbakicept-pmln) for approved and additional future indications, contingent on regulatory approvals.

The collaboration aims to increase the availability of sBCG immediately for ongoing trials, while also accelerating the Phase II clinical trials of iBCG in Europe.

The iBCG has shown safety advantages over the standard BCG and enhanced immunogenicity in stimulating CD8+ and CD4 T cells.

The strategic partnership follows the US Food and Drug Administration’s approval of ImmunityBio’s ANKTIVA for non-muscle invasive bladder cancer with carcinoma in situ.

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The increased supply of BCG is intended to mitigate shortages of the combination therapy with ANKTIVA.

ImmunityBio plans further trials to evaluate both iBCG and sBCG produced by the Serum Institute, in combination with ANKTIVA for treating bladder and other cancer types.

The supply of BCG for these trials will become available on receipt of FDA authorisation of the trial protocol.

ImmunityBio will submit the trial protocol to the FDA and other global regulatory authorities by the beginning of June 2024.

ImmunityBio executive chairman and global chief scientific and medical officer Patrick Soon-Shiong stated: “The opportunity to initiate a trial of an immunogenic recombinant BCG, which has already demonstrated enhanced safety compared to standard BCG in Phase I/II studies, is exciting.

“We look forward to exploring ANKTIVA in combination with BCG in non-muscle invasive bladder cancer and across other tumour types. With our ability to overcome immune evasion of the tumour to BCG when BCG is given alone, and by converting an MHC- negative cold tumour to a MHC+ positive hot tumour with the combination of ANKTIVA with BCG, we will now further expand the development of our therapeutic cancer vaccine with BCG.”