ALE.P02 / Alentis Therap - LARVOL DELTA

A Study to Investigate ALE.P02 As Monotherapy in Adult Patients with Selected CLDN1+ Solid Tumors (clinicaltrials.gov) - P1/2 | N=170 | Recruiting | Sponsor: Alentis Therapeutics AG

Monotherapy • New P1/2 trial • Cervical Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Alentis Receives FDA Fast Track Designation for ALE.P02 for the Treatment of CLDN1+ Squamous Solid Tumors (Businesswire) - "Alentis Therapeutics...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALE.P02 for the treatment of advanced or metastatic CLDN1+ squamous cancers irrespective of the organ of origin. ALE.P02 is an investigational antibody-drug conjugate (ADC) targeting CLDN1, developed for CLDN1+ squamous cancers including but not limited to lung, head and neck, cervical and esophageal cancers."

Evidence highlight • Fast track • Cervical Cancer • Esophageal Cancer • Head and Neck Cancer • Lung Cancer • CLDN1

FDA Fast Tracks ALE.P02 for CLDN1-Poisitive Solid Cancers (Oncology Nursing News) - "'Squamous cancers of various origin have been shown to overexpress CLDN1, making ALE.P02 a promising ADC to address the unmet medical needs of these patients,' Tony S. K. Mok, MD...stated in a news release. 'CLDN1 is an exciting new target for ADCs, and Alentis [Therapeutics] has been the frontrunner in developing anti-CLDN1 therapeutics.'"

Media quote

Novo Holdings co-leads $181.4 million Series D financing in Alentis Therapeutics to advance groundbreaking antibody-drug conjugates (ADCs) for solid tumours (PRNewswire) - "This financing will enable Alentis to begin Phase 1/2 trials for two first-in-class ADCs: ALE.P02, which targets advanced or metastatic CLDN1+ squamous solid tumours with a tubulin inhibitor payload, and ALE.P03, which targets CLDN1+ tumours with a distinct topoisomerase I inhibitor payload. FDA clearance is already obtained for ALE.P02, with clinical trials expected to commence in Q1 2025. For ALE.P03, a first-in-human trial in patients with CLDN1+ tumours is subsequently planned to start in 2025."

Financing • New P1/2 trial • Oncology • Solid Tumor