ALE.C04 for Claudin-1 positive tumors

Lead program in oncology

With ALE.C04 we aim to treat Claudin-1 positive solid tumors including head and neck squamous cell carcinoma (HNSCC). The FDA granted ALE.C04 Fast Track designation for the treatment of Claudin-1 positive HNSCC.

The role of Claudin-1 in solid tumors

In healthy cells, Claudin-1 is hidden within tight junctions where its normal function is to bind cells together. In many solid tumors, Claudin-1 is overexpressed and exposed outside tight junctions. Exposed Claudin-1 drives the buildup of extracellular matrix, forming a physical collagen barrier around the tumor. This barrier shields the tumor from immune cell attacks and protects it from cancer immunotherapies such as anti-PD-1 treatment.

What is ALE.C04

ALE.C04 is an investigational first-in-class monoclonal antibody designed to treat cancer by targeting exposed Claudin-1 on solid tumors.

ALE.C04 – a novel mechanism of action for cancer treatment

ALE.C04 selectively binds tumor cells that have exposed Claudin-1 (Claudin-1 positive tumors). Upon binding ALE.C04 mediates tumor cell killing through its effector function (ADCC). The antibody also disrupts the physical interactions between exposed Claudin-1 and collagen-binding receptors, breaking down the collagen barrier around the tumor. When the barrier is opened, the immune system can attack and kill tumor cells. Restoring immune cell trafficking may also restore the activity of other immunotherapies.

Urgent need for new cancer drugs

Solid tumors account for about 90% of adult cancers. Despite earlier detection and better treatment, survival rates have only increased modestly. Exposed Claudin-1 helps tumors evade the immune system and resist immunotherapy drugs, leading to poorer outcomes for patients.

What is head and neck squamous cell carcinoma (HNSCC)

HNSCC is the 6th most common cancer worldwide, and exposed Claudin-1 is often found on this type of tumor. It most often occurs in the oral cavity (mouth), pharynx (throat) and larynx (voice box). Because mortality remains high and the number of cases of HNSCC is quickly rising, safer and more effective treatments are urgently needed.

Phase 1/2 clinical trial of ALE.C04 in HNSCC - recruiting

We are currently testing ALE.C04 in a Phase 1/2 study in people with HNSCC (NCT06054477). This first-in-human study is an open-label, multi-center, clinical trial investigating ALE.C04 as a single agent and in combination with pembrolizumab (anti-PD-1 antibody). Around 220 adults with recurrent or metastatic HNSCC will participate. Endpoints include safety, tolerability, pharmacokinetics and anti-tumor efficacy.