FDA accepted for review a BLA from ImmunityBio for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.
ImmunityBio filed the BLA based on positive results from a series of studies of the investigational treatment, including the ongoing QUILT 3.032 trial. The PDUFA target action date is May 23, 2023.
This combination of N-803 with BCG is ImmunityBio’s first BLA to reach this stage of FDA acceptance for review. This marks an important milestone in the pursuit of ImmunityBio’s vision of transforming how cancer patients are treated without high-dose chemotherapy, but instead by activating the patient’s innate immune system. If approved, N-803 plus BCG would be the first immunotherapy combination for this indication in 23 years that can be delivered directly to the bladder (intravesically) to induce natural killer cells and T cells.
Medicenna Therapeutics announced new clinical data on safety, pharmacodynamics and anti-tumor activity from the Phase 1/2 ABILITY study of MDNA11, the company’s long-acting IL-2 super agonist. The data, which provide preliminary evidence of MDNA11’s single agent anti-cancer activity in patients with advanced solid tumors who have been unresponsive to other treatments, are being featured in an oral presentation taking place at 1:00 PM ET today at the Cytokine Based Drug Development Summit. MDNA11 treatment in Cohort 4 (comprised of two step-up doses of 30 µg/kg followed by fixed doses of 60 µg/kg every 2 weeks) was not associated with any dose-limiting toxicities. Four of ten evaluable patients have achieved tumor control as defined in the study with MDNA11 monotherapy, including two patients at the 10 µg/kg dose (sarcoma and metastatic melanoma), one sarcoma patient at the 30 µg/kg dose and one pancreatic cancer patient in Cohort 4 receiving the 60 µg/kg dose.
