ITM secures $262.5M for GEP-NET radiotherapy funding

ITM Isotope Technologies, a German radiopharmaceutical company, recently announced it has secured up to $262.5 million in debt financing from Blue Owl Capital. This funding is intended to advance the company's main cancer treatment, ITM-11 (177Lu-edotreotide), toward potential commercialization in the United States. The financial support will specifically aid the preparation for the market launch of ITM-11 following promising outcomes from the Phase III COMPETE trial.

The COMPETE trial revealed that ITM-11 significantly surpassed Novartis' treatment, Afinitor (everolimus), in managing patients with Grade 1 or 2 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 extended the median progression-free survival to 23.9 months, in contrast to 14.1 months for the established therapy, translating to a 33% decrease in the risk of disease progression or death. Moreover, ITM-11 exhibited a more favorable safety profile, according to results shared in March.

ITM Isotope Technologies plans to submit its dossier to the FDA in 2025. ITM-11 combines the therapeutic β-emitting radioisotope lutetium-177 with the synthetic somatostatin receptor agonist edotreotide, and it's currently being examined in the Phase III COMPOSE trial. This study involves patients with well-differentiated, aggressive Grade 2 or 3 somatostatin receptor-positive GEP-NETs.

Under the agreement with Blue Owl Capital, ITM will receive $140 million immediately upon closure, with additional funds accessible when necessary. CEO Andrew Cavey expressed that this strategic funding arrangement allows the company to swiftly progress toward potential US commercialization of ITM-11, conditional on FDA approval. The agreement also provides flexibility for development and expansion of ITM's innovative pipeline of targeted radiopharmaceuticals across diverse indications.

Radiopharmaceuticals have gained traction following successful launches by companies like Novartis, which markets Lutathera (lutetium Lu 177 dotatate) for GEP-NETs that test positive for the somatostatin receptor. Novartis reported sales of $724 million for Lutathera last year. However, ITM differentiates itself in the radiopharmaceutical industry through a combination of longstanding expertise and in-house manufacturing capabilities.

Having operated in the radiopharmaceutical sector for over two decades, ITM not only focuses on drug development but also maintains in-house manufacturing. This unique combination has attracted substantial investment from prior funders like Temasek and BlackRock, contributing around €615 million ($700 million) since 2022 in earlier financing rounds.

Overall, the debt financing from Blue Owl Capital represents a significant step for ITM Isotope Technologies as it moves closer to introducing ITM-11 to the US market. With a successful Phase III trial behind it, ITM-11 has shown promise in extending patient survival and demonstrating a better safety profile than existing treatments. As the company gears up for FDA submission, ITM remains committed to expanding its radiopharmaceutical offerings and advancing cancer treatment options for patients worldwide.