The US Food and Drug Administration (FDA) has accepted ImmunityBio’s biologics licence application (BLA) resubmission for its bladder cancer candidate N-803.

The resubmission followed the FDA’s decision to not approve Immunity Bio’s immunotherapy in May 2023. The agency sent ImmunityBio a complete response letter at the time, citing deficiencies found during an inspection of third-party contract manufacturing organisations.

The FDA has accepted the BLA resubmission and will now review the therapy. It has set a Prescription Drug User Fee Act (PDUFA) date of 23 April 2024.

The therapy involves ImmunityBio’s candidate N-803 in combination with Bacillus Calmette-Guérin (BCG), a vaccine used mainly against tuberculosis. As per the BLA, the therapy indicated for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.

Also known as anktiva, n-803 is a cytokine interleukin-15 (IL-15) superagonist. The candidate is a complex of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor immunoglobulin G1 Fc fusion protein. ImmunityBio hypothesises that the drug works by stimulating cytotoxic T cells and natural killer cells, while also generating memory T cells.

The BLA was resubmitted with data from a Phase II/III trial (NCT03022825). The results were published in NEJM Evidence in November 2022. As per an FDA request in the complete response letter, the company updated the duration of the response in subjects. Based on the updated duration, the probability of maintaining a complete response longer than two years was 60% while the cystectomy-free rate was over 90% in the same time frame.

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ImmunityBio’s global chief scientific and medical officer Patrick Soon-Shiong said in a statement: “We are pleased that the FDA has accepted ImmunityBio’s resubmission of the BLA as a complete response, following our productive interactions leading up to the resubmission.”

The candidate is also being investigated in a Phase Ib trial (NCT02138734) – a long-term follow-up of patients who first took the treatment in 2014. Out of the six patients available for follow-up, 100% demonstrated complete remission, with none requiring a cystectomy.

Soon-Shiong added: “We look forward to working closely with the agency to finalise the review and to bringing this important immune-enhancing therapeutic to patients suffering from bladder cancer.”