Positive Results from Single Ascending Dose Phase 1 Study of ALE.F02 Targeting Claudin-1

– Alentis is the only company developing potential treatments for solid cancers and fibrosis targeting Claudin-1 (CLDN1)

– ALE.F02 found to be well tolerated at all doses with a good safety profile and demonstrated initial evidence of on-target biological activity

– Planned initiation of first-in-human clinical study for lead oncology asset ALE.C04 in H2 2023

BASEL, Switzerland–(BUSINESS WIRE)–Alentis Therapeutics (“Alentis”), the biotechnology company developing breakthrough treatments for organ fibrosis and CLDN1+ tumors, today announces positive results from a single ascending dose Phase 1 study of its lead program, ALE.F02, currently in development for the treatment of advanced kidney, lung and liver fibrosis. The study found ALE.F02 to be well tolerated in healthy volunteers at all doses with a good safety profile and demonstrated initial evidence of on-target biological activity.

CLDN1, one of the claudin family of transmembrane proteins like Claudin-18.2, is a previously unexploited target that plays a key role in the pathology of tumors with immune evasive properties and fibrotic diseases across multiple organs. Alentis is the only company developing potential treatments for solid cancers and fibrosis targeting CLDN1.

ALE.F02 is a highly selective anti-CLDN1 mAb that recognizes pathological overexpressed and conformation-dependent CLDN1 epitopes on transformed epithelial cells and is being investigated for the treatment of fibrotic disease in the kidney, lung and liver.

The Phase 1 clinical study was initiated in January 2022 to look at the safety and tolerability of ALE.F02 in 40 individuals comprising of five dose cohorts with eight individuals in each cohort. Dosing ranged from a minimum of 0.3mg/kg to a maximum of 20 mg/kg. Pharmacokinetic results predict an optimal dose for full receptor occupancy in humans within the range. No serious or severe adverse events were recorded. A multiple ascending dose Phase 1 study is ongoing, the results of which will be reported in Q1 2023.

Dr. Roberto Iacone, CEO at Alentis Therapeutics, commented: “These important clinical data for our lead program ALE.F02 are very encouraging, have enabled us to identify an optimal dose for further Phase 1 testing, and demonstrated encouraging on-target biological activity.

“As we continue to develop breakthrough treatments for solid cancers and fibrosis targeting CLDN1, we look forward to reporting the full Phase 1 results for ALE.F02 in Q1 2023. In addition, we expect to initiate a first-in-human clinical study of our lead oncology asset ALE.C04 in cancer patients in H2 2023.”

Dr. Markus Meyer, VP R&D Operations at Alentis Therapeutics, added: “There are currently limited treatment options available for patients with fibrotic associated cancers and kidney, lung and liver fibrosis. CLDN1 is a novel, previously unexplored target with a unique mechanism of action in the pathology of CLDN1+ solid tumors and fibrosis. We continue to gather further clinical data as we develop a potential new treatment option for patients in the future.”

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About Alentis Therapeutics

Alentis Therapeutics, the Claudin-1 (CLDN1) company, is a clinical stage biotechnology company that focuses on developing breakthrough treatments for CLDN1+ tumors and organ fibrosis.

Alentis is pioneering a novel approach to modify and reverse the course of disease progression targeting CLDN1, a previously unexploited target that plays a key role in the pathology of tumors with immune evasive properties and fibrotic disease across multiple organs. Alentis is the only company developing potential treatments for solid cancers and fibrosis targeting CLDN1.

Alentis’ portfolio of anti-CLDN1 monoclonal antibodies includes a novel class of anti-cancer therapies designed to reprogram the tumor microenvironment (TME). The interplay between cancer cells and their surrounding microenvironment is highly promising for drug development as many cancers use the TME to build barriers that shield against immune system attack. Alentis’ lead oncology asset, ALE.C04, is the first potential treatment to target CLDN1 to open up the mechanical barrier that characterizes immune-excluded CLDN1+ tumors, thus making the tumors vulnerable to treatment.

In addition, Alentis’ pipeline includes a first-in-class therapy designed to modify and reverse the course of advanced organ fibrosis. ALE.F02, which is currently in Phase 1 clinical trials, is designed to target pathological overexpression of CLDN1 outside of the tight junction to resolve and reverse organ fibrosis and is being investigated for the treatment of fibrotic disease in the kidney, lung and liver.

The company was founded in 2019 based on ground-breaking research in the laboratory of Prof. Thomas Baumert MD at the University of Strasbourg and the French National Institute of Health (Inserm). Alentis is headquartered in Basel’s pharma-biotech hub in Switzerland with a subsidiary for R&D in Strasbourg, France.

For more information, visit https://alentis.ch

Contacts

For more information, please contact

Alentis Therapeutics
Nathalie Graf-Tschupp

[email protected]

Consilium Strategic Communications (International)
Mary-Jane Elliott / Matthew Cole / Ashley Tapp

[email protected]
Tel: +44 (0) 20 3709 5700