FDA fast-tracks monoclonal antibody for head and neck cancer

Monoclonal antibody

Fast Track designation from the Food and Drug Administration (FDA) will accelerate the path to US submission for Alentis Therapeutics’ investigational monoclonal antibody.

ALE.C04 is indicated to treat patients with recurrent or metastatic CLDN1-positive head and neck squamous cell carcinoma (HNSCC).

Fast Track designation aims to facilitate the development and expedite the review of new medicines that intend to treat serious or life-threatening conditions with unmet medical needs.

“The FDA’s decision to grant Fast Track designation underscores ALE.C04’s potential to address a serious unmet medical need in cancer, specifically HNSCC,” said Dr Roberto Iacone, Chief Executive Officer of Alentis. “We continue to advance our pipeline of antibodies against Claudin-1, an extraordinary target with therapeutic potential across indications in oncology and organ fibrosis.”

ALE.C04 is a first-in-class monoclonal antibody developed to specifically target exposed CLDN1 on cancer cells. The investigational antibody is designed to treat cancer in two ways: remodelling of the extracellular matrix, leading to improved NK and T cell trafficking, and direct tumour cell killing through the effector function.

Dr Luigi Manenti, Chief Medical Officer of Alentis added: “We are excited with this opportunity to expedite the development of ALE.C04 in patients with recurrent or metastatic, CLDN1-positive HNSCC. The ongoing Phase I/II clinical trial in HNSCC will give us important information on ALE.C04’s safety and pharmacodynamic profile as well as its anti-tumour efficacy as monotherapy and in combination with pembrolizumab.”

Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World

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