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ImmunityBio, Inc. has signed an exclusive US agreement with Japan BCG Laboratory to develop and supply the Tokyo strain of BCG for the American market. The move is part of ImmunityBio’s bigger push to deal with the BCG shortage that has been dragging on in the US bladder cancer space for more than a decade.
The agreement gives ImmunityBio exclusive rights in the US for the Tokyo-172 BCG strain, including development, import, regulatory filings, and commercialization. The company also plans to work directly with the FDA on the approval pathway.
What makes this important is the latest Phase III data from the SWOG S1602 trial backed by the National Cancer Institute. The study compared the Tokyo strain against TICE BCG in patients with BCG-naïve high-grade non-muscle invasive bladder cancer. So it looks like the Tokyo strain did pretty much the same, in a non-inferior sense, when it was lined up against TICE BCG, basically.
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In the trial they kinda enrolled about 1,000 eligible patients, starting 2017 through 2020, with no big twist or anything. After that the team followed the patients for a median span of 4.6 years. By the time they estimated the five-year high grade recurrence free survival, the Tokyo group landed at 64%, while the TICE group was at 58%. Complete response rates in carcinoma in situ cases at six months were also close between both groups.
The Tokyo strain has already been used in Japan for nearly 30 years in high-risk bladder cancer treatment, but it still remains investigational in the US and has not received FDA approval yet.
This deal also gives ImmunityBio a second possible BCG supply source. The company already works with Serum Institute of India on recombinant BCG through its FDA Expanded Access Program for eligible patients. Both partnerships are basically aimed at one thing right now. Making sure bladder cancer patients and urologists in the US are not stuck dealing with unstable BCG supply every few months.
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