After receiving a significant regulatory approval, ImmunityBio, Inc. (NASDAQ: IBRX) saw a sharp rise in the value of its shares. IBRX shares rose 18.25% to $3.96 as of the most recent market check. In reaction to the FDA’s approval of an Expanded Access Program (EAP) that will enable a different source of Bacillus Calmette-Guérin (BCG), a vital therapy for bladder cancer, the spike has occurred.
Resolving Serious Deficits in the Treatment of Bladder Cancer
TICE BCG is the standard-of-care treatment for non-muscle invasive bladder cancer (NMIBC), and the United States has been struggling with ongoing shortages. According to a recent Sermo poll of 100 urologists nationwide, 57% of participants reported having trouble treating patients in the last 12 months as a result of a lack of BCG supplies.
The treatment efficiently targets malignant cells by inducing an immunological response in the bladder. Supply chain vulnerabilities have been exacerbated by the U.S.’s exclusive reliance on Merck & Co. for domestic manufacture of TICE BCG, despite its extensive use.
Partnership with the Indian Serum Institute
ImmunityBio has teamed up with the Serum Institute of India, the biggest vaccine producer in the world by volume, to help alleviate the supply shortage. The goal of this partnership is to present a different source of BCG that has shown encouraging outcomes in clinical studies conducted in Europe.
Compared to earlier formulations, the recombinant BCG vaccination has demonstrated improved safety and increased immunogenicity, activating both CD8+ and CD4+ T cells.
Maintaining Constant Access to Essential Medical Care
The continuous scarcity of necessary medications emphasizes how the biopharmaceutical sector needs to innovate. The move by ImmunityBio, in collaboration with the FDA and the Serum Institute of India, is a big step in ensuring that patients with bladder cancer have a steady supply of BCG.
Further demonstrating its dedication to developing treatments for bladder cancer, ImmunityBio (IBRX) has also obtained many patents for the combination of BCG and ANKTIVA.