The stock of ImmunityBio, Inc. (NASDAQ: IBRX) is experiencing a notable surge, exhibiting a substantial uptick of 7.94% during the current trading session, reaching $5.33. This significant rise in IBRX stock price closely follows the regulatory clearance of one of its pharmaceutical products.
The FDA has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) in conjunction with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) accompanied by carcinoma in situ (CIS), with or without papillary tumors, ImmunityBio (IBRX) shared yesterday.
The approval of ANKTIVA by the FDA signals the arrival of a next-generation immunotherapy that will outperform checkpoint drugs. ANKTIVA not only stimulates the proliferation and activation of the patient’s innate NK cells and CD8+ cytotoxic T cells but also triggers CD4+ T helper cells, thereby amplifying the expansion of memory cytotoxic T cells.
This innovative mode of action, akin to dendritic cell biology, initiates the progression of immunotherapy beyond solely targeting T cells. The amalgamation of enhanced proliferation of crucial anti-cancer immune cells, alongside the activation of memory T cells, culminates in enduring complete responses.
The ‘triangle offense’ of immune system-mediated tumor cell eradication coupled with sustained memory underscores the cornerstone of endeavors to craft a therapeutic cancer vaccine spanning various tumor types, irrespective of their origin. The complete response rate for the 77 assessable patients stood at 62%, with the upper limit of the confidence interval reaching 73%.
The persistence of complete response surpassing 47 months as of the November 2023 assessment, and ongoing to date, surpasses the threshold for clinically meaningful outcomes suggested by an expert panel at the IBCG.
The protracted duration of complete response, exceeding 24 months with ANKTIVA and BCG, heralds a paradigm shift for NMIBC patients, offering compelling clinical evidence of ANKTIVA’s efficacy for individuals historically confronted with high recurrence rates and substantial decline in quality of life due to radical surgical interventions.
With this endorsement, ANKTIVA may potentially establish a new treatment standard for NMIBC patients, potentially revolutionizing the management of bladder cancer. ANKTIVA is slated to be accessible in the U.S. by mid-May 2024.
