What's Happening?
Akamis Bio, a clinical-stage oncology company based in Cambridge, Massachusetts, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its drug NG-350A. This drug is intended for the treatment of mismatch
repair-proficient locally advanced rectal cancer (LARC). NG-350A is an intravenously delivered oncolytic immunotherapy designed to drive intratumoral expression of a CD40 agonist monoclonal antibody, which activates antigen-presenting cells in solid tumors and their draining lymph nodes. The Phase 1b FORTRESS study is currently recruiting patients to evaluate NG-350A in combination with chemoradiotherapy. The Fast Track designation is aimed at expediting the development and review of drugs that address unmet medical needs for serious conditions.
Why It's Important?
The Fast Track designation by the FDA is significant as it acknowledges the urgent need for new therapies to treat locally advanced rectal cancer, particularly among younger populations where incidence rates are rising. Patients with mismatch repair-proficient tumors represent approximately 90% of LARC cases, highlighting the need for improved treatment options that could potentially reduce the necessity for surgical interventions. The designation allows for more frequent interactions with the FDA, potentially leading to faster approval and access to the drug for patients. This development could significantly impact the standard of care for LARC, offering new hope for patients and potentially improving survival rates.
What's Next?
The Phase 1b FORTRESS study is actively recruiting patients to further evaluate the efficacy and safety of NG-350A in combination with chemoradiotherapy. The study aims to enroll approximately 30 patients and will focus on achieving a clinical complete response at week 12 as its primary endpoint. Secondary endpoints will include the incidence and severity of adverse events and MRI-based tumor regression grades. The results of this study could pave the way for subsequent trials and potentially lead to broader clinical use of NG-350A in treating LARC.
