Friday, August 25, 2023
Alentis Therapeutics, a clinical-stage biotechnology company, has been granted Fast Track development status by the US Food and Drug Administration (FDA) for their drug candidate ALE.C04. This drug is being developed to treat patients with recurrent or metastatic, CLDN1-positive Head and Neck Squamous Cell Carcinoma (HNSCC), a condition with limited treatment options.
The Fast Track designation from the FDA is designed to accelerate the development and review process for new drugs targeting serious or life-threatening diseases with unmet medical needs.
Dr. Roberto Iacone, CEO of Alentis, highlighted the importance of the Fast Track status as recognition of ALE.C04's potential to address the urgent medical needs of HNSCC patients. He also emphasized Alentis' commitment to advancing their range of antibodies targeting Claudin-1, a promising therapeutic target for various applications including cancer treatment and organ fibrosis.
Dr. Luigi Manenti, Chief Medical Officer of Alentis, expressed excitement about the opportunity to expedite the development of ALE.C04 for patients dealing with recurrent or metastatic, CLDN1-positive HNSCC. The ongoing Phase 1/2 clinical trial will provide valuable information about the safety, pharmacodynamics, and anti-tumor efficacy of ALE.C04 as both a standalone treatment and in combination with pembrolizumab, another therapeutic approach.
ALE.C04 is a monoclonal antibody designed to specifically target exposed CLDN1 on cancer cells. Its unique mechanism of action involves remodeling the extracellular matrix, which enhances the movement of natural killer (NK) and T-cells, and directly destroying tumor cells. This dual mechanism of action positions ALE.C04 as a promising candidate for monotherapy as well as combination treatments.
