FDA Rejects ImmunityBio's Bladder Cancer Therapy, Sends Stock Tumbling

Pictured: Blue sign outside FDA building/JHVEPhoto/Adobe Stock

Pictured: Blue sign outside FDA building/JHVEPhoto/Adobe Stock

ImmunityBio took a hit on Thursday as the FDA rejected its bladder cancer treatment due to deficiencies with the company’s third-party contract manufacturer. The company’s stock was down nearly 60% in premarket trading.

After announcing the acceptance of its Biologics License Application (BLA) in July 2022, the California-based company received a Complete Response Letter (CRL) on Tuesday indicating the FDA “cannot approve the BLA in its present form” due to deficiencies observed during the regulator’s pre-license inspection of ImmunityBio’s third-party contract manufacturer, according to an SEC filing.

BioSpace reached out to ImmunityBio regarding the FDA’s CRL but did not receive an immediate response.

ImmunityBio said in its SEC filing that the FDA provided recommendations to resolving specific “Chemistry, Manufacturing and Controls issues and assays” but the regulator did not request new preclinical or Phase III studies for safety or efficacy.

However, the FDA did request that the company provide updated “duration of response data of the efficacy population” as identified by the FDA in ImmunityBio’s resubmission, as well as a safety update. ImmunityBio has requested a meeting with the regulator to address the CRL and timeline to resolve issues and “seek approval as expeditiously as possible.”

The investigational treatment under consideration is ImmunityBio’s Anktiva (N-803). The antibody cytokine infusion protein is being tested in combination with Bacillus Calmette-Guerin (BCG), a common immunotherapy used in early-stage bladder cancer, for patients with carcinoma in situ.

Up to 40% of patients with non-muscle-invasive bladder cancer (NMIBC) will fail BCG therapy, according to the NIH. A vast majority of NMIBC are prone to recurrence. A Phase II/III open-label trial of Anktiva in combination with BCG showed a complete response rate of 71%, 58 of 82 patients, with a median duration of 26.6 months.

ImmunityBio has been courting big pharma companies, seeking a partner for the commercialization of Anktiva. Despite the CRL, the company has a potential partner lined up and is in negotiations that will continue, according to its SEC filing.

Sesen Bio took a hit on its bladder cancer drug in 2021 when the FDA slapped its candidate, Vicineum, with a CRL. In addition to manufacturing, concerns around the drug’s substance, trial methods and more flagged the FDA’s concern. Controversy roiled on from there, including a bombshell report from STAT News.

Sesen paused the development of Vicineum and started seeking a partner. The biotech has now joined forces with Carisma Therapeutics in a reverse merger.

It’s not clear if the new company will restart the development of Vicineum, but the merger deal included a contingent value right, entitling Sesen’s shareholders to “receive cash payment related to any proceeds from potential proceeds from the sale of Sesen Bio's legacy assets, including Vicineum,” according to the press release.

Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.  

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