Alentis Therapeutics recently announced that the Fast Track development program for ALE.C04 has been approved by the US Food and Drug Administration (FDA). This program is intended to use ALE.C04 as a treatment for individuals dealing with recurrent or metastatic CLDN1-positive HNSCC.
ALE.C04, a first-in-class monoclonal antibody, has been created to specifically target exposed CLDN1 on cancer cells. This antibody has a dual purpose in cancer treatment: it modifies the extracellular matrix, enhancing the movement of NK and T-cells. It directly eradicates tumor cells by activating its effector function. This unique operational approach positions ALE.C04 with significant therapeutic potential as a monotherapy and when used with other therapies.
Dr. Roberto Iacone, the Chief Executive Officer of Alentis, commented that granting the Fast Track designation by the FDA highlights the capacity of ALE.C04 to address a significant and unmet medical requirement within the realm of cancer, specifically focusing on HNSCC.
Source: Alentis Therapeutics receives FDA fast track designation for ALE.C04 for the treatment of Claudin-1 positive HNSCC.
https://alentis.ch/alentis-therapeutics-receives-fda-fast-track-designation-for-ale-c04-for-the-treatment-of-claudin-1-positive-hnscc/
