What's Happening?
ImmunityBio, Inc. has announced an exclusive U.S. Development and Supply Agreement with Japan BCG Laboratory for the Tokyo strain of BCG (Tokyo-172 BCG). This agreement grants ImmunityBio the rights to develop, import, and commercialize this strain in the United
States. The Tokyo strain has shown non-inferior efficacy compared to TICE BCG in treating BCG-naïve high-grade non-muscle invasive bladder cancer (NMIBC), according to a Phase III study sponsored by the National Cancer Institute. ImmunityBio plans to engage with the FDA to address the longstanding BCG shortage in the U.S. and will be the sole Biologics License Application applicant for this strain. The Tokyo strain has been used in Japan for nearly 30 years for high-risk NMIBC treatment.
Why It's Important?
The agreement is significant as it aims to alleviate the chronic BCG shortage in the U.S., which has affected bladder cancer treatment for over a decade. By securing a second potential BCG source, ImmunityBio enhances the availability of treatment options for U.S. patients. This development could lead to improved patient outcomes and provide a more reliable supply of BCG, which is crucial for treating high-risk NMIBC. The partnership with Japan BCG Laboratory and ongoing collaboration with the Serum Institute of India positions ImmunityBio to potentially transform the landscape of bladder cancer treatment in the U.S.
What's Next?
ImmunityBio plans to work closely with the FDA to pursue approval for the Tokyo strain of BCG. The company will lead all regulatory submissions and commercialization efforts in the U.S. Additionally, ImmunityBio will continue its FDA Expanded Access Program for recombinant BCG, ensuring eligible patients have access to treatment. The company is also in discussions to incorporate data from the SWOG S1602 trial into its planned BLA submission, which could further support the regulatory process.
