In just one year, Alentis Therapeutics has completed the first phase of its first-in-human trial for 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.
Alentis is the only company developing potential treatments for solid cancers and fibrosis targeting Claudin-1 (CLDN1), a previously unexploited target that plays a key role in the pathology of tumors with immune evasive properties and fibrotic diseases across multiple organs.
The company’s lead and most advanced candidate 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. “There are currently limited treatment options available for patients with fibrotic-associated cancers and kidney, lung and liver fibrosis”, commented Markus Meyer, VP of R&D Operations at Alentis.
In January 2022, Alentis initiated the Phase 1 clinical study to look at the safety and tolerability of ALE.F02 in 40 individuals comprising 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.
“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”, said Roberto Iacone, CEO at Alentis Therapeutics.
Pipeline of first-in-class anti-CLDN1 monoclonal antibodies
In addition to ALE.F02, 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.
Alentis 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). The company is headquartered in Basel’s pharma-biotech hub in Switzerland, with a subsidiary for R&D in Strasbourg, France.
(Press release/RAN)
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