CULVER CITY, Calif. - ImmunityBio, Inc. (NASDAQ: IBRX) announced today that ANKTIVA, in combination with Bacillus Calmette-Guérin (BCG), has received U.S. Food and Drug Administration (FDA) approval for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
ANKTIVA, a novel immunotherapy agent, has been designated as a Breakthrough Therapy by the FDA. It is designed to stimulate the body's natural killer (NK) and killer T-cell immune system to attack tumor cells. The 77 patients evaluated in a single-arm, multicenter trial achieved a complete response (CR) rate of 62%, with the upper end of the confidence interval at 73%. Impressively, the duration of complete response has exceeded 47 months and is ongoing, surpassing the benchmarks for clinically meaningful results set by the International Bladder Cancer Group (IBCG).
The treatment has been approved for maintenance therapy for up to 37 months and has shown tolerable side effects, with Grade 3/4 adverse events ranging from 0% to 3%. ANKTIVA is expected to be available in the U.S. market by mid-May 2024.
Bladder cancer represents the 10th most commonly diagnosed cancer globally, with a significant number of cases being NMIBC. The standard therapy has been intravesical instillation of BCG, but for many patients, this treatment fails or cancer recurs. The approval of ANKTIVA offers a new therapeutic option that could potentially reduce the need for cystectomy, a highly invasive surgery, for many patients.
ANKTIVA's mechanism of action involves the enhancement of NK cell recruitment and T cell stimulation, which, along with stimulating the innate immune memory response, improves the ability to kill tumor cells. The therapy has been well-tolerated, with adverse events consistent with those of BCG alone.
ImmunityBio has pledged to assist patients in accessing ANKTIVA through a Patient Assistance Program that will be operational in mid-May. The program aims to ensure that those in need can access this innovative treatment.
Further updates on the ongoing analysis of ANKTIVA will be presented at the American Urological Association's annual conference on May 3, 2024. This approval marks a significant milestone for ImmunityBio in its quest to develop cancer vaccines and preventative vaccines for patients with a genetic predisposition to developing cancer.
InvestingPro Insights
ImmunityBio's recent FDA approval of ANKTIVA marks a pivotal moment in the company's trajectory, reflecting its commitment to innovation in cancer treatment. As investors and stakeholders evaluate the company's performance and potential, real-time data from InvestingPro offers valuable insights.
According to InvestingPro data, ImmunityBio, Inc. (NASDAQ: IBRX) currently holds a market capitalization of $3.34 billion. Despite the company's significant progress in developing cancer treatments, analysts have expressed concerns regarding profitability, as the company is not expected to be profitable this year. This is reflected in the company's negative P/E ratio of -4.37, adjusted to -5.76 for the last twelve months as of Q4 2023.
However, the company's stock has demonstrated a strong return over the last three months, with a 47.02% price total return, and an even more impressive six-month price total return of 245.45%. This suggests a robust investor confidence following key developments such as the FDA approval of ANKTIVA.
InvestingPro Tips also highlight that ImmunityBio's liquid assets exceed its short-term obligations, which is an encouraging sign of financial stability. Nonetheless, the company's revenue valuation multiple is considered high, and it does not pay a dividend to shareholders, which could be a consideration for income-focused investors.
For those interested in a more in-depth analysis, InvestingPro offers additional tips on ImmunityBio, which can be accessed at https://www.investing.com/pro/IBRX. Readers looking to explore these insights further can benefit from an additional 10% off a yearly or biyearly Pro and Pro+ subscription by using the coupon code PRONEWS24. InvestingPro lists a total of 9 additional tips that can provide a comprehensive understanding of ImmunityBio’s financial health and market potential.
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