ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, announced on Monday that ITM's subsidiary, ITG Isotope Technologies Garching GmbH (ITG), and Nordic Nanovector ASA (OSE: NANO) have signed long-term global supply agreements for the medical radioisotope no-carrier-added Lutetium-177 (n.c.a. 177Lu) EndolucinBeta to support R&D, clinical and commercial supply of Betalutin (177Lu-Lilotomab-Satetraxetan).

Under the terms of the agreement for the study phase, ITM has partnered with Nordic Nanovector to support its clinical development. Concurrently, both parties have signed a commercial agreement for the supply of EndolucinBeta post marketing approval of Betalutin. Additional terms of the agreement were not disclosed.

EndolucinBeta, radiolabeled to anti-CD37 murine antibody lilotomab, is an active component of Betalutin, a next generation radioimmuno conjugate (RIC) currently under clinical development in patients who suffer from Non-Hodgkin Lymphoma (NHL). Betalutin is a drug candidate with an excellent profile. As well as leveraging an alternative therapeutic target (anti-CD37 antigen) in recurrent lymphoma patients who have relapsed following anti-CD20-based therapy, it has shown durable responses in heavily pre-treated NHL patients after a one-time administration, combined with a predictable and manageable toxicity, an important feature for elderly NHL patients who may not be suited to chemotherapy.

Also, EndolucinBeta, a radiopharmaceutical precursor, is used in Targeted Radionuclide Therapy in the field of Precision Oncology and has marketing authorisation in the EU. Radiolabeled to disease-specific targeting molecules like antibodies or peptides, the tumour tissue is precisely destroyed by cytotoxic doses of ionising radiation.

Reportedly, ITM has developed a unique methodology to produce a particularly highly pure form of Lutetium-177. No-carrier-added Lutetium-177 contains no metastable Lutetium-177m, therefore there is no need for cost intensive clinical waste management. This is especially important in countries with a release limit of Lutetium-177m into public sewage systems.

This global supply agreement is a key milestone in the implementation of Nordic Nanovectors's CMC (Chemistry, Manufacturing and Controls) strategy for gaining regulatory approval for Betalutin and its subsequent commercial rollout, as it provides certainty of continued supply of n.c.a. Lutetium-177 throughout clinical development as well as after launch.