On May 11, 2023 ImmunityBio, Inc. (the "Company") reported that it has received a complete response letter from the U.S. Food and Drug Administration ("FDA") on May 9, 2023 regarding its Biologics License Application ("BLA") for its product candidate, Anktiva (N-803) in combination with Bacillus Calmette-Guérin ("BCG") for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") with carcinoma in situ ("CIS") with or without Ta or T1 disease (Press release, ImmunityBio, MAY 11, 2023, View Source [SID1234631510]). The letter indicates that the FDA has determined that it cannot approve the BLA in its present form, and the FDA has made recommendations to address the issues raised.
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The deficiencies relate to the FDA’s pre-license inspection of the Company’s third-party contract manufacturing organizations. Satisfactory resolution of the observations noted at the pre-license inspection is required before the BLA may be approved. The FDA further provided recommendations specific to additional Chemistry, Manufacturing and Controls ("CMC") issues and assays to be resolved.
No new preclinical studies or Phase 3 clinical trials to evaluate safety or efficacy were requested by the FDA. The FDA requested that the Company provide updated duration of response data of the efficacy population as identified by the FDA in the Company’s resubmission, as well as a safety update.
The Company plans to request a meeting with the FDA as soon as possible to address the subject matter of the letter and a response timeline, and plans to diligently address and resolve the issues identified and seek approval as expeditiously as possible.
Business Development Updates
On May 9, 2023, the Company’s Executive Chairman and Global Chief Scientific and Medical Officer agreed to provide immediate non-convertible debt financing to the Company in an amount of $30.0 million on substantially similar terms as prior financings, including an interest rate of Term Secured Overnight Financing Rate ("SOFR") plus 8% per annum and a maturity date of December 31, 2023.
As previously disclosed, the Company has been exploring partnering with a large biopharmaceutical company for commercialization of N-803 for intravesical administration. The Company has confirmed with the potential partner that these negotiations will continue notwithstanding the letter referenced above, with the view of completing such a transaction during 2023, though there can be no assurance that the Company will complete a transaction on acceptable terms in accordance with this timeline or at all.