ImmunityBio Receives FDA Approval for ANKTIVA in BCG-Unresponsive Bladder Cancer
FDA Approval and Commercialization
ImmunityBio has received FDA approval for ANKTIVA, a treatment for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) who have not responded to BCG therapy. This approval marks a significant milestone for ImmunityBio, transitioning the company into a commercial biotech with the potential to generate revenue. Additionally, the FDA approval triggers a $100 million payment from the total $320 million royalty financing and equity investment contingent upon this approval.
Potential Expansion Opportunities
Beyond the current indication, ImmunityBio is exploring the potential of ANKTIVA in treating two other large market target indications: acute myeloid leukemia (AML) and platinum-resistant ovarian cancer (PROC). The drug’s successful application in NMIBC provides optimism for its effectiveness in these additional cancer indications.
Understanding ANKTIVA for Bladder Cancer Treatment
ANKTIVA, also known as N-803, is a cytokine fusion protein that selectively activates NK cells and T effector cells, enhancing the immune response against cancer cells. Combined with BCG, a common treatment for bladder cancer, ANKTIVA has shown promising results in clinical trials.
Clinical Trial Results
In a Phase 2/3 open-label trial, 84 patients with BCG-unresponsive NMIBC received ANKTIVA plus BCG for 6 consecutive weeks, followed by maintenance treatments for up to 18 months. The primary endpoint of a complete response (CR) rate of at least 30% was exceeded, with 58 out of 82 patients achieving a CR (71%). The duration of CR was also significant, with an average of 26.6 months. Additionally, 91.4% of patients avoided cystectomy (surgical removal of the bladder) at 24 months, and disease-specific survival was 100%.
Challenges and CRL
ImmunityBio initially faced a setback when the FDA issued a Complete Response Letter (CRL) for ANKTIVA’s Biologics Licensing Application (BLA) due to concerns regarding pre-license inspection and Chemistry, Manufacturing, and Controls (CMC) issues. However, the company addressed these issues and ultimately received FDA approval.
Financial Implications
As of December 31, 2023, ImmunityBio had cash, cash equivalents, and marketable securities of $267.4 million, including $850 million raised in 2023. The company believes its cash runway is sufficient for at least the next 12 months, but the recent FDA approval brings an additional $100 million into its coffers. However, ImmunityBio may need to raise additional capital before the end of 2024 through its shelf financing or Open Market Sale Agreement. Its cash burn in the year ending December 31, 2023, was $362.87 million.
Risks to Consider
Investors should be aware of several risks associated with investing in ImmunityBio. ANKTIVA’s revenue potential in the bladder cancer market is uncertain, given the presence of competitors such as Merck’s Keytruda and Ferring Pharmaceuticals’ Adstiladrin. Additionally, the expansion opportunities in AML and PROC require further clinical validation. The company’s financial position also requires monitoring, as it may need to raise additional capital in the future.
Conclusion
ImmunityBio’s FDA approval for ANKTIVA in BCG-unresponsive bladder cancer is a significant achievement. The drug’s potential to generate revenue and its expansion opportunities in AML and PROC provide promising investment opportunities. However, investors should be mindful of the risks associated with competition, clinical uncertainties, and the company’s financial position.