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ImmunityBio & Serum Institute of India Enter Global BCG Supply Agreement for Cancer Treatment

Written by : Aishwarya Sarthe

May 8, 2024

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Under the agreement, Serum Institute of India will manufacture sBCG, approved for use outside the US and iBCG and undergoing testing for potential future indications. 

ImmunityBio and the Serum Institute of India have forged an exclusive global arrangement to supply Bacillus Calmette-Guerin (BCG) to address shortages and enhance cancer treatment worldwide. 

The collaboration targets the production of both standard BCG (sBCG) and next-generation recombinant BCG (iBCG), focusing on bolstering the efficacy of ANKTIVA in treating bladder cancer.

Under the agreement, Serum Institute of India will manufacture sBCG, approved for use outside the US and iBCG and undergoing testing for potential future indications. 

Sharing insights, Adar C Poonawalla, CEO of Serum Institute of India, said, "The collaboration between Serum Institute of India and ImmunityBio will undoubtedly transform how we approach cancer treatment. It will improve global access to BCG, and at the same time—the unique therapy is the key to achieving a complete solution for bladder cancer."

Bolstering Cancer Treatment Through Collaboration

The partnership follows the FDA's approval of ANKTIVA for the treatment of non-muscle invasive bladder cancer with carcinoma in situ (CIS). Increasing the supply of BCG is intended to address shortages for combination therapy with ANKTIVA. 

Sharing thoughts on the same, Richard Adcock, president and CEO of ImmunityBio, said, "By providing another option for BCG, we believe more NMIBC patients will benefit from this proven treatment as both a monotherapy and a combination therapy with ANKTIVA."

Expanding Clinical Trials & Global Access

ImmunityBio plans to conduct clinical trials to study iBCG and sBCG manufactured by Serum Institute in combination with ANKTIVA to treat various cancers. Supply of BCG is expected once regulatory bodies authorize trial protocols. 

Adding insights, Patrick Soon-Shiong, MD, executive chairman and global chief scientific and medical officer at ImmunityBio, said, "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."

Other Relevant Developments

In addition to the ImmunityBio-Serum Institute collaboration, Serum Institute India partnered with Belgian biotech innovator Univercells to offer affordable personalized cancer care globally. The collaboration planned to democratize access to advanced cancer treatments, potentially benefiting millions worldwide.

Furthermore, the Serum Institute of India recently joined the Coalition for Epidemic Preparedness Innovations (CEPI) network, focusing on accelerating the development of vaccines and biological countermeasures against epidemic and pandemic threats.

Last year, Serum-Mylab's Cy-TB Test, a rapid and precise diagnostic tool for latent TB infections, was incorporated into the National Tuberculosis Elimination Programme (NTEP). This development aims to enhance TB diagnosis in India, addressing a significant healthcare concern.

The Cy-TB Test, developed by Serum-Mylab, combines cost-effectiveness with the precision of traditional lab-based tests, bringing a new level of accuracy and accessibility to latent TB diagnosis.


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