ITM Signs Clinical Supply Agreement with Y-mAbs for n.c.a. Lutetium-177

ITM to supply its medical radioisotope, no-carrier-added Lutetium-177, for the clinical development of Y-mAbs’ Targeted Radionuclide Therapy candidate GD2-SADA: ¹⁷⁷Lu-DOTA Complex for GD2-positive solid tumors

Garching / Munich, Germany, July 21, 2022 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the signing of a clinical supply agreement for its medical radioisotope no-carrier-added lutetium-177 (n.c.a. ¹⁷⁷Lu / EndolucinBeta®) with Y-mAbs Therapeutics, Inc. (Y-mAbs), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. Under the terms of the agreement, ITM will provide its n.c.a. ¹⁷⁷Lu for the clinical development of Y-mAbs’ radiopharmaceutical candidate GD2-SADA: ¹⁷⁷Lu-DOTA Complex.

GD2-SADA is currently in the preclinical development for the treatment of GD2-positive solid tumors, with a phase I study planned for 2022. GD2 (Disialoganglioside 2) is a tumor-associated antigen overexpressed by various tumor types, such as malignant melanoma, sarcoma, and small cell lung cancer, and used as a target for Targeted Radionuclide Therapy, potentially a precise approach being developed to directly destroy tumor tissue with minimal impact to surrounding healthy tissue.

The radiopharmaceutical candidate GD2-SADA: ¹⁷⁷Lu-DOTA Complex, is a two-step radioimmunotherapy, administered as an IV infusion. The ¹⁷⁷Lu-DOTA Complex consists of a chelator (DOTA) and ITM’s medical radioisotope n.c.a. ¹⁷⁷Lu and targets the previously administered tumor-binding antibody construct GD2-SADA enabling the delivery of the therapeutic radiation of n.c.a. ¹⁷⁷Lu to the tumor-site in order to destroy the malignant cells.

“GD2-positive solid tumors include a wide range of tumor types, and we believe the Y-mAbs approach can potentially offer a promising treatment option for patients who are affected by these cancers. We are proud to contribute to the company’s candidate development with our highly pure n.c.a. ¹⁷⁷Lu,” comments Steffen Schuster, CEO of ITM. “We are committed to providing high-quality radioisotopes not only to our own radiopharmaceutical pipeline, but also to our partners to offer improved precision oncology treatments to healthcare professionals and their patients to the greatest extend possible.”

N.c.a. ¹⁷⁷Lu is a market-approved, highly pure form of the beta-emitting radioisotope lutetium-177 that can be linked to a variety of tumor-specific targeting molecules for the treatment of various cancers and has been successfully used in numerous clinical and commercial radiopharmaceutical cancer treatments.

The agreement was executed between Y-mAbs and ITM’s wholly owned subsidiary ITM Pharma Solutions GmbH.

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About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, like receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, thereby destroying tumor tissue. The highly precise localization enables targeted treatment with minimal impact to healthy surrounding tissue.

About ITM Isotope Technologies Munich SE

ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com

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About ITM Isotope Technologies Munich SE
Executive Board: Steffen Schuster (CEO), Dr. Klaus Maleck (CFO) – Supervisory Board: Udo J Vetter (Chairman) – Registered Office: Garching/Munich
District Court of Munich – Commercial Register 269592  –  Phone: +49 (0)89 329 8986 6000  –  Fax: +49 (0)89 329 8986 6061  –  Email: info@itm-radiopharma.com
Tax Number: 143/100/82466  –  VAT Number: DE813228901  –  Deutsche Bank Freiburg  –  IBAN: DE52680700300022816300  –  BIC: DEUTDE6F

Attachment

• PR_ITM-YMABS_Clinical-Supply-Agreement-Lutetium