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Surging Ahead: ImmunityBio’s (IBRX) Momentum Persists

ImmunityBio, Inc. (NASDAQ: IBRX) appears to be sustaining the momentum from yesterday’s surge as it enters today’s trading session. As of the last check, INRX shares were observed trading 5.69% higher at $9.48, following a 5.09% increase in the previous session, closing at $8.97. This notable uptick follows an exclusive agreement for global supply.

ImmunityBio (IBRX) has entered into an exclusive global agreement with the Serum Institute of India (SII), recognized as the largest producer of vaccines worldwide in terms of doses manufactured. This agreement entails the provision of Bacillus Calmette-Guerin (BCG) to ImmunityBio.

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The scope of the agreement encompasses the production of standard BCG (sBCG), currently sanctioned for use beyond the U.S. borders, alongside a next-generation recombinant BCG (iBCG) currently undergoing evaluation. The latter is intended for utilization in conjunction with ImmunityBio’s ANKTIVA for both existing and prospective indications, contingent upon regulatory endorsements.

By forging this partnership with SII, ImmunityBio aims to harness the substantial, top-tier GMP manufacturing capabilities at the institute to alleviate the scarcity of BCG, which adversely impacts numerous bladder cancer patients annually.

This collaboration will result in supplementary provisions of the prevailing standard sBCG for ongoing trials. Concurrently, efforts will be directed towards expediting the Phase 2 clinical trials of iBCG underway in Europe, demonstrating thus far superior safety attributes compared to standard BCG, along with augmented immunogenicity in fostering both CD8+ and CD4 T cells.

The synergistic endeavor between SII and ImmunityBio follows the recent FDA approval of ANKTIVA for treating non-muscle invasive bladder cancer with carcinoma in situ (CIS). Augmenting the available BCG supply aims to mitigate shortages for combination therapy involving ANKTIVA.

ImmunityBio intends to initiate clinical trials to evaluate recombinant iBCG and sBCG, manufactured by SII, in conjunction with ANKTIVA for treating various bladder and other cancers. Availability of BCG is contingent upon FDA authorization of the trial protocol. Within the following thirty days, ImmunityBio intends to submit its protocol to the FDA and other international regulatory bodies.

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