ALE-P02

BASEL, Switzerland--( BUSINESS WIRE )--Alentis Therapeutics (“Alentis”), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced today that it has raised $181.4 million in Series D financing, supported by a syndicate of top-tier biotech investors. The financing will support Alentis to develop a deep pipeline of CLDN1 targeted medicines for solid tumors. 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. About Alentis Therapeutics Alentis Therapeutics, the CLDN1 company, is a clinical-stage biotech developing breakthrough treatments for CLDN1+ tumors. CLDN1 is a previously unexploited target that plays a key role in the pathology of cancer and fibrotic disease. Alentis is the leading company pioneering anti-CLDN1 ADCs and antibodies to modify and reverse the course of select diseases. Alentis was founded 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 and Medical Research (Inserm). Alentis is headquartered at the pharma-biotech hub in Basel, Switzerland with an R&D subsidiary in Strasbourg, France and clinical operations in the US. Visit www.alentis.ch About OrbiMed OrbiMed is a healthcare investment firm, with approximately $17 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, through a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and extensive global team resources to help build world-class healthcare companies. OrbiMed’s team of over 130 professionals is based in New York City, San Francisco, London, Shanghai, Hong Kong, Mumbai, Herzliya, and other key global markets. More info: www.orbimed.com About Novo Holdings A/S Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation. Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S (Novozymes A/S) and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Asia, Planetary Health and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2023, Novo Holdings had total assets of EUR 149 billion. www.novoholdings.dk About Jeito Capital Jeito Capital is a global leading Private Equity fund with a patient benefit driven approach that finances and accelerates the development and growth of ground-breaking medical innovation. Jeito empowers and supports managers through its expert, integrated, multi-talented team and through the investment of significant capital to ensure the growth of companies, building market leaders in their respective therapeutic areas with accelerated patients’ access globally, especially in Europe and the United States. Jeito Capital has €534 million under management and a rapidly growing portfolio of investments. Jeito Capital is based in Paris with a presence in Europe and the United States. For more information, please visit www.jeito.life or follow us on Twitter or LinkedIn.

Alentis Therapeutics already has two antibodies against CLDN1 in clinical testing, but the biotech is looking to build out its pipeline by turning one of the hottest modalities against the target — antibody-drug conjugates (ADCs). The company raised a $181.4-million D round on Tuesday to fund Phase I/II studies for a pair of CLDN1-targeting ADCs.The financing was led by OrbiMed and featured Novo Holdings — the controlling shareholder of Novo Nordisk — and Jeito Capital as co-leads. Since launching in 2019 with a $12.5-million A round, Alentis has raised more than $365 million, including a $67-million series B in 2021 and $105 million in series C funding.New investors Frazier Life Sciences, Longitude Capital, Catalio Capital, Piper Heartland Healthcare Capital and Avego Bioscience Capital also participated in the round, as did existing backers RA Capital Management, Morningside Venture Investments, BB Pureos, and Bpifrance through its InnoBio 2 fund.The capital injection comes less than a month after the FDA approved the first Claudin-targeting drug in the US: Astellas' anti-CLDN18.2 antibody Vyloy (zolbetuximab-clzb) for first-line gastric cancer. The Claudin family has quickly become the source of some of the most popular targets for solid tumour drug development, though efforts have mostly focussed on CLDN18.2 or CLDN6 with more than 30 assets in the clinic against the two targets, collectively. For further analysis on the Claudin landscape, see Spotlight On: New players emerge in anti-Claudin arena and Spotlight On: What’s next in the anti-Claudin pipeline?All in on ClaudinTuesday's financing will propel ALE.P02 and ALE.P03, both CLDN1-targeting ADCs, into Phase I/II testing for CLDN1-positive cancers. The most advanced, ALE.P02, carries a tubulin inhibitor and is expected to start its trial in patients with advanced or metastatic squamous solid tumours in the first quarter of 2025. ALE.P03, which has a topoisomerase I payload, is wrapping up GLP toxicity studies and is slated to enter the clinic next year.Alentis also has lixudebart (formerly ALE.F02), a monoclonal antibody (mAb) that targets exposed CLDN1 in fibrotic tissue, in a Phase II trial for kidney fibrosis and a Phase Ib study for liver fibrosis.The firm's other clinical-stage asset is ALE.C04, a CLDN1-targeting mAb in a Phase I/II study of patients with head and neck squamous cell carcinoma.