ImmunityBio, Inc. reports developments as a commercial-stage biotechnology company focused on immunotherapies designed to activate innate and adaptive immune responses for cancer and infectious disease. Its news centers on ANKTIVA® (nogapendekin alfa inbakicept-pmln), an IL-15 superagonist used with BCG for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary tumors.
Recurring updates cover ANKTIVA product revenue and unit demand, global regulatory authorizations and commercial availability, distribution partnerships, and scientific presentations involving bladder cancer, lung cancer, and broader IL-15 oncology programs. Company announcements also address BCG-naïve NMIBC clinical development, FDA promotional-compliance correspondence, and financing arrangements tied to revenue interests and convertible debt.
ImmunityBio (NASDAQ: IBRX) announced three podcasts with UroToday discussing the FDA approval of ANKTIVA® (N-803) plus BCG for non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS). Dr. Patrick Soon-Shiong and Dr. Ashish Kamat highlighted ANKTIVA’s unique mechanism, which activates NK cells, killer T cells, and memory T cells to fight tumors. They emphasized the collaboration with Serum Institute of India to address BCG shortages. ANKTIVA, an IL-15 receptor agonist, offers a new treatment option for BCG-unresponsive NMIBC patients, promoting durable complete responses by converting MHC-negative tumors to MHC-positive. The podcasts are available on UroToday's website.
ImmunityBio, Inc. (NASDAQ: IBRX) has completed the drug substance manufacturing for ANKTIVA, providing 170,000 doses, with two-year storage stability data. The company's GMP fill-finish facility in New York is on track for completion in 12-18 months, capable of producing a million vials annually. The recent partnership with the Serum Institute of India for BCG availability enhances the company's inventory and capacity.
ImmunityBio, Inc. (NASDAQ: IBRX) has entered into an exclusive global agreement with the Serum Institute of India to supply Bacillus Calmette-Guerin (BCG) for use in combination with ImmunityBio's ANKTIVA.
This collaboration will address the chronic BCG supply shortage issue, providing both standard BCG (sBCG) and next-generation recombinant BCG (iBCG) for approved indications benefiting from ANKTIVA's therapeutic effects.
The agreement aims to enhance immunogenicity and safety compared to standard BCG, improving outcomes for bladder cancer patients globally.
ImmunityBio's Executive Chairman, Dr. Patrick Soon-Shiong, will discuss the recent FDA approval of ANKTIVA® for use in combination with BCG for non-muscle invasive bladder cancer at the AUA 2024 conference. ANKTIVA's Breakthrough Therapy designation and novel mechanism will be highlighted, offering an alternative therapy to radical surgery for advanced bladder cancer cases. The discussion will focus on transforming cold bladder cancer cells to hot tumors via ANKTIVA's activation of NK and T cells, resulting in durable responses.
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