Pharma Focus Europe

Immunitas Therapeutics Receives FDA Clearance of IND Application for IMT-009 in Solid Tumors and Hematological Malignancies

Thursday, September 22, 2022

The FDA has accepted ImmunityBio, Inc.'s Biologics License Application (BLA) for review. The BLA focuses on their antibody cytokine fusion protein as a potential treatment for BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS). ImmunityBio submitted the BLA based on positive results from various studies, including the ongoing QUILT 3.032 trial. The target action date under the Prescription Drug User Fee Act (PDUFA) is set for May 23, 2023.

If approved, this combination therapy of N-803 with BCG would be the first immunotherapy option for this indication in 23 years that can be directly administered to the bladder (intravesically). It aims to activate natural killer cells and T cells, leveraging the patient's innate immune system. This milestone represents an essential step in demonstrating the clinical application of the Nant Cancer Vaccine hypothesis proposed by ImmunityBio's founder, Patrick Soon-Shiong, M.D.

N-803 functions by stimulating the proliferation of NK and T cells, which are crucial components of the adaptive and innate immune system. By doing so, it provides an additional boost to the immunological response triggered by BCG for bladder cancer or checkpoint inhibitors for other conditions. The QUILT 3.032 study demonstrated a response rate of over 50% and increased median duration compared to FDA-approved alternatives such as Valrubicin and Pembrolizumab.

ImmunityBio's leadership expressed enthusiasm about the BLA acceptance, as it brings them closer to offering this promising combination therapy to more patients with non-muscle-invasive bladder cancer and potentially reducing the need for cystectomies. The company is prepared to swiftly move forward with manufacturing and marketing if the therapeutic receives approval from the FDA.

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