On November 12, 2024 Alentis Therapeutics ("Alentis"), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, reported that it has raised $181.4 million in Series D financing, supported by a syndicate of top-tier biotech investors (Press release, Alentis Therapeutics, NOV 12, 2024, View Source [SID1234648155]). The financing will support Alentis to develop a deep pipeline of CLDN1 targeted medicines for solid tumors.

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The funding round was led by OrbiMed with co-leads Novo Holdings and Jeito Capital. New investors Frazier Life Sciences, Longitude Capital, Catalio Capital, Piper Heartland Healthcare Capital and Avego Bioscience Capital participated in the round. Significant backing was also received from existing investor RA Capital Management, along with support from Morningside Venture Investments, BB Pureos, Bpifrance through its InnoBio 2 fund, as well as other early institutional investors, all of whom have been instrumental to Alentis’ development path.

"This financing is a testament to the transformational potential of CLDN1 antibody-drug conjugates (ADCs) for the treatment of solid tumors," said Roberto Iacone, Chief Executive Officer of Alentis. "Let me take this opportunity to extend a warm welcome to our new investors." Dr. Iacone added, "We’re excited to execute our development strategy and deliver clinical data for our programs over the next 12-18 months."

The proceeds of the financing will be used to conduct Phase 1/2 clinical trials of two first-in-class ADCs targeting CLDN1, ALE.P02 and ALE.P03, further development of the pipeline, and general corporate purposes.

The FDA recently cleared an IND application for a Phase 1/2 clinical trial of ALE.P02 (with a tubulin inhibitor) in advanced or metastatic CLDN1+ squamous solid tumors. The clinical trial is expected to commence Q1 2025. For ALE.P03 (with a topoisomerase I inhibitor), a first-in-human trial in patients with CLDN1+ tumors is planned to start in 2025.

Luca Santarelli, Chairman of Alentis said, "I am excited about the future of Alentis, especially after this very significant financing, and would like to welcome the new Board Members that will join after the closing of the transaction."

OrbiMed Partner, Dina Chaya said, "With this financing, Alentis is now well positioned to advance its CLDN1 antibody-drug conjugates, which have the potential to be first and best-in-class therapies for the treatment of cancer."

"ADCs have shown their potential to be highly effective cancer treatments," said Naveed Siddiqi, Senior Partner at Novo Holdings, Venture Investments. "Alentis has an exciting pipeline of first-in-class ADCs and we are proud to have co-led this round. We are looking forward to seeing the data generated from the first clinical trials of ALE.P02 and ALE.P03."

Dr. Rafaèle Tordjman, Founder and CEO of Jeito Capital said, "We are excited to co-lead this major new financing round for Alentis that further validates the strength of its pipeline. We look forward to continuing to bring our expertise to support their development."

New Board of Directors Appointments
As part of the financing, three new Board Members will join the Alentis Board of Directors, further strengthening the business, science and drug development expertise at the Board level.

Dina Chaya, Partner at OrbiMed, has over 20 years of experience in healthcare investments, specializing in biopharma and medical technology.
Anna Chen, Principal at Frazier Life Sciences, where she has been involved with investing in and building many of Frazier Life Sciences’ biopharmaceutical portfolio companies over the past 7 years.
Brian Liu, Managing Director at Longitude Capital, brings more than 10 years of biopharma consulting and investing experience, focusing on transformative healthcare innovation.
About ALE.P02 and ALE.P03
ALE.P02 and ALE.P03 are first-in-class ADCs designed by linking a potent cancer drug (a tubulin and topoisomerase I inhibitor, respectively) to our antibody that specifically targets a unique CLDN1 epitope exposed on cancer cells. This combination creates a powerful new tool to fight cancer with less toxicity than traditional cancer drugs. The IND application for ALE.P02 to commence a Phase 1/2 clinical trial in advanced or metastatic CLDN1+ squamous solid tumors was recently cleared by the FDA.