On January 9, 2023 Alentis Therapeutics ("Alentis"), the biotechnology company developing breakthrough treatments for organ fibrosis and CLDN1+ tumors, reported 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 (Press release, Alentis Therapeutics, JAN 9, 2023, View Source [SID1234626025]). 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.
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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."