ImmunityBio partners with Serum Institute for new combo as Merck dominates BCG supply

ImmunityBio and the Serum Institute of India have announced a collaborative effort to address the global shortage of Bacillus Calmette-Guérin (BCG), a critical treatment for bladder cancer. This initiative follows ImmunityBio’s recent FDA approval for its drug Anktiva to be used in conjunction with BCG for certain bladder cancer patients. The shortage of BCG has been a persistent issue, impacting treatment availability worldwide.

ImmunityBio, based in California, has entered into an exclusive agreement with the Serum Institute of India to manufacture BCG on a global scale. This partnership aims to provide a sustainable solution to the ongoing BCG supply crisis and ensure large-scale production for use alongside Anktiva in treating non-muscle invasive bladder cancer (NMIBC). According to ImmunityBio, NMIBC accounts for approximately 80% of the 80,000 new bladder cancer cases diagnosed annually in the United States.

The FDA has approved the combined use of Anktiva and BCG for patients with BCG-unresponsive NMIBC with carcinoma in situ. ImmunityBio is also exploring the combination’s efficacy in patients with BCG-unresponsive NMIBC with papillary tumors and BCG-naïve NMIBC.

Currently, ImmunityBio faces competition from Merck & Co.’s Keytruda and Ferring Pharmaceuticals’ Adstiladrin, both of which are administered without BCG. Ironically, Merck is the only BCG supplier in the U.S., distributing its TICE BCG since 2012 after other manufacturers, including Sanofi, exited the market due to production issues. Merck plans to expand its manufacturing capacity with a new facility in North Carolina by 2026, which it claims will triple its current BCG output to meet future demand. However, since 2019, Merck has been rationing its BCG supply, allocating based on historical purchasing patterns.

The Serum Institute of India, the largest global manufacturer of BCG vaccines, already supplies a traditional BCG product called Onco-BCG for oncology use outside the U.S. Under the new deal, the Serum Institute will provide this standard BCG for ImmunityBio’s clinical trials as soon as the FDA approves the trial protocols, which ImmunityBio plans to submit within 30 days. Additionally, the Serum Institute is developing a recombinant BCG, which is undergoing midstage testing in Europe. This new version has shown enhanced immunogenicity and safety compared to standard BCG and includes two gene modifications. The partners are working to accelerate the recombinant BCG’s phase 2 program.

Despite these developments, the timeline for the commercial availability of these BCG products remains uncertain. ImmunityBio expects more clarity once the trial protocols are submitted to the FDA.

A notable advantage for ImmunityBio is that Anktiva’s current U.S. label does not specify the type of BCG it must be used with. This flexibility allows ImmunityBio to consider alternatives to Merck’s TICE BCG, explained Patrick Soon-Shiong, M.D., Executive Chairman of ImmunityBio, during a recent investor call.

In a statement, Soon-Shiong expressed satisfaction with the partnership, highlighting the Serum Institute’s large-scale, GMP-certified manufacturing capacity as a key factor in addressing the BCG shortage that affects numerous bladder cancer patients annually.

The financial terms and specific conditions of the deal between ImmunityBio and the Serum Institute of India were not disclosed.