ImmunityBio Celebrates US Approval of Anktiva for Bladder Cancer
ImmunityBio, a San Diego-based biotech company led by renowned entrepreneur Dr. Patrick Soon-Shiong, is celebrating the US Food and Drug Administration (FDA) approval of its lead drug candidate, Anktiva, for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
Strong Clinical Results Back Approval
A multicenter clinical trial involving 77 patients demonstrated a 62% complete response rate with Anktiva, exceeding the benchmark suggested by experts. The duration of complete response was over 47 months and is ongoing. These results highlight the potential of Anktiva in improving outcomes for patients with BCG-unresponsive NMIBC.
Addressing a Significant Unmet Need
NMIBC is a type of bladder cancer that can be treated with BCG injections. However, 30-40% of patients do not respond to BCG, and 50% of those who initially respond will relapse. Anktiva offers a new treatment option for these patients who have limited therapeutic choices.
Pipeline and Market Potential
ImmunityBio has a robust pipeline of drug candidates, including BCG, PD-L1 t-haNK, hAd5 and yeast TAAs, and aldoxorubicin, which are being evaluated in combination with Anktiva. The company is also pursuing approvals for Anktiva in other indications, such as BCG-unresponsive bladder cancer papillary and BCG naive bladder cancer CIS and papillary.
Financial Considerations
ImmunityBio has accumulated a deficit of $3 billion, largely funded by Dr. Soon-Shiong. The company has also received financing from Oberland Capital and has filed for a mixed shelf to raise additional capital.
Investment Outlook
The approval of Anktiva is a significant milestone for ImmunityBio. However, the company’s future prospects depend on the successful execution of its clinical trials, reimbursement coverage for Anktiva, and competition from other therapies. Investors should carefully consider the company’s financial situation and the potential risks and rewards before making investment decisions.
