Alentis Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its antibody ALE.C04 to treat patients with recurrent or metastatic, CLDN1-positive head and neck squamous cell carcinoma (HNSCC).
The first-in-class, investigational monoclonal antibody ALE.C04 has been developed for targeting exposed CLDN1 in specific on cancer cells.
It is designed to treat cancer by remodelling of the extracellular matrix, leading to improved NK and T-cell trafficking and killing of direct tumour cells through the effector function.
With its unique mechanism of action, ALE.C04 is expected to have therapeutic potential as a single agent and in combination.
Alentis Therapeutics CEO Dr Roberto Iacone said: “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.
“We continue to advance our pipeline of antibodies against Claudin-1, an extraordinary target with therapeutic potential across indications in oncology and organ fibrosis.”
With this designation, the company will now be able to accelerate the review of new therapies that intend to treat life-threatening or serious conditions with unmet medical needs.
Alentis Therapeutics chief medical officer Dr Luigi Manenti said: “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.”