FDA approval has been granted for ALE.C04. Credit: Orawan Pattarawimonchai / Shutterstock.com.

Alentis Therapeutics has received US Food and Drug Administration (FDA) clearance for its investigational new drug (IND) application for ALE.C04 to treat Claudin-1 positive (CLDN1+) tumours.

ALE.C04 is an investigational antibody designed to target exposed CLDN1 in cancer cells.

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This approval has been granted for ALE.C04 both as a monotherapy and in combination with pembrolizumab in a first-in-human clinical study in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

The planned Phase I/II clinical trial in HNSCC will begin in the second half of 2023.

Alentis chief medical officer Dr Luigi Manenti stated: “With ALE.C04, we aim to treat solid tumours in a unique way. By targeting exposed CLDN1 on cancer cells, our antibody remodels the extracellular matrix favouring T and NK-cell [natural killer cells] trafficking, which in turn directly kills CLDN1+ tumour cells and breaks the checkpoint inhibitor resistance in immune-excluded tumours.

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“The high unmet medical need, strong scientific rationale and our compelling preclinical and translational data make HNSCC an ideal first indication for ALE.C04 as a monotherapy and in combination with anti-PD-1 [a protein found on T cells] treatment.”

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Claudin will help treat cancer in two ways: by remodelling the extracellular matrix to enhance NK and T-cell trafficking, and by direct tumour cell killing via the effector function.

Alentis CEO Dr Roberto Iacone stated: “The IND clearance for ALE.C04 is an important step for Alentis as it marks our entry into the oncology space.

“The planned Phase 1/2 study will tell us a lot about the anti-tumour efficacy of our antibody to treat CLDN1+ tumours.”

This content was updated on 25 January 2024