ITM Secures Exclusive Global License for Debiopharm’s CA IX-Targeted Theranostic Pair

Exclusive License Agreement:
ITM Isotope Technologies Munich SE (ITM) has obtained an exclusive worldwide license from Debiopharm for the clinical and commercial development of a peptide-based theranostic pair, ITM-91/ITM-94D (formerly Debio 0228/0328), targeting the Carbonic Anhydrase IX (CA IX) surface protein.

Theranostic Pair:
The pair consists of a therapeutic compound, ITM-91 (Debio 0228) ([177Lu]Lu-DPI-4452), and a diagnostic imaging agent, ITM-94D (Debio 0328) ([68Ga]Ga-DPI-4452).

Clinical Trial:
The theranostic pair is currently being evaluated in the phase 1/2 GaLuCi™ clinical trial for patients with locally advanced Clear Cell Renal Cell Carcinoma (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC), and Colorectal Cancer (CRC).

Financial Terms:
Debiopharm will receive upfront, development, and regulatory milestone payments of approximately €300 million, as well as commercial milestones and low double-digit royalties on potential future sales.

Strategic Alignment:
The acquisition aligns with ITM's mission to expand access to innovative radiopharmaceuticals on a global scale and reinforces its commitment to delivering life-changing diagnostic and therapeutic agents to patients.

Expertise and Production:
ITM will utilize its production capabilities and clinical expertise to advance the theranostic pair, leveraging its position as the globally leading manufacturer of n.c.a. Lutetium-177 and its broad pipeline of radiopharmaceutical diagnostic and therapeutic candidates.