The Food and Drug Administration (FDA) has accepted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease. 

A decision from the regulatory agency on approval for the treatment is anticipated on 23 May next year. 

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The N-803 plus BCG combination is the first BLA of the company to be accepted by the regulatory agency for review.  

On obtaining approval, it would be the first immunotherapy combination to be used for this indication in 23 years.

It can be intravesically delivered to the bladder to induce T cells and natural killer cells. 

The company submitted the BLA based on positive data from various studies of the investigational therapy, including the Phase II/III QUILT 3.032 clinical trial underway. 

The open-label, three-cohort, multicentre trial analysed intravesical BCG, N-803 combination in BCG-unresponsive high-grade NMIBC patients.

According to the trial findings, 71% of trial subjects who had failed prior treatments demonstrated a complete response with a median duration of 26.6 months.

Furthermore, a 91% and 100% cystectomy avoidance rate and bladder cancer overall survival, respectively, were observed at 24 months without any serious adverse events (SAE).

An antibody cytokine fusion protein, N-803 is a new interleukin-15 (IL-15) superagonist complex. 

ImmunityBio executive chairman and global chief scientific and medical officer Patrick Soon-Shiong said: “This BLA acceptance brings us a very important step closer to being able to offer this promising combination therapeutic to more people living with NMIBC and, ultimately, reduce the incidence of cystectomies. 

“This is a compelling example of the power of inducing trained innate immune memory to potentially provide long-term, durable effects against serious, life-threatening diseases.”

In January, ImmunityBio and Amyris have concluded a joint venture (JV) agreement announced previously to accelerate the marketing of a Covid-19 vaccine.