The approval allows for the investigation of ALE.C04 both as a standalone treatment and in combination with pembrolizumab in a pioneering clinical trial
The trial will target patients with recurrent or metastatic HNSCC. (Credit: PublicDomainPictures from Pixabay)
Alentis Therapeutics, a biotechnology company in the clinical stage of development, focusing on therapies for tumours and organ fibrosis associated with Claudin-1 positive (CLDN1+) conditions, recently shared news of the FDA’s approval of an IND application for ALE.C04.
This approval allows for the investigation of ALE.C04 both as a standalone treatment and in combination with pembrolizumab in a pioneering clinical trial. The trial will target patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) and is scheduled to commence in the latter half of 2023.
Alentis chief medical officer Dr Luigi Manenti said: “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 trafficking, which in turn directly kills CLDN1+ tumour cells and breaks the check-point inhibitor resistance in immune-excluded tumours.”
“The high unmet medical need, strong scientific rationale and our compelling preclinical and translational data makes HNSCC an ideal first indication for ALE.C04 as a monotherapy and in combination with anti-PD-1 treatment.”
Alentis CEO Dr Roberto Iacone said: “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. We are the leading company targeting CLDN1 across organ fibrosis and cancer.”
ALE.C04 represents a groundbreaking monoclonal antibody that has been meticulously developed to specifically target cancer cells displaying exposed CLDN1. As a first-in-class investigational antibody, its primary objective is to combat cancer through two distinct mechanisms.
Firstly, it aims to remodel the extracellular matrix, thereby enhancing the trafficking of NK and T-cells, which are crucial for effective immune responses against tumours. Secondly, ALE.C04 directly eliminates tumour cells through its effector function, contributing to their destruction.
This unique mode of action endows ALE.C04 with significant therapeutic potential as a standalone treatment as well as in combination with checkpoint inhibitors, amplifying its efficacy and widening its range of applications.
Head and Neck Squamous Cell Carcinoma (HNSCC) stands as the sixth most prevalent cancer type on a global scale, and its occurrence continues to escalate. While surgical intervention, chemotherapy, and radiation therapy are commonly employed treatment approaches, approved therapies such as cetuximab and pembrolizumab have also proven effective. Notably, pembrolizumab has demonstrated advancements in overall survival when administered as a monotherapy in the first-line setting. Nonetheless, the demand for novel treatment alternatives remains substantial, emphasizing the necessity for further therapeutic options.