MUNICH & GARCHING, Germany--(BUSINESS WIRE)--ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, announced today 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. At the same time, both parties signed a commercial agreement for the supply of EndolucinBeta® post Marketing Approval of Betalutin®. Additional terms of the agreement are 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.
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EndolucinBeta®, a radiopharmaceutical precursor, is used in Targeted Radionuclide Therapy in the field of Precision Oncology and has marketing authorization in the EU. Radiolabeled to disease-specific targeting molecules like antibodies or peptides, the tumor tissue is precisely destroyed by cytotoxic doses of ionizing radiation. 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.
Marco Renoldi, Chief Operating Officer at Nordic Nanovector, said: “We are pleased to extend our collaboration with a long-standing and reliable partner such as ITM. This global supply agreement is a key milestone in the implementation of our 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. The agreement with ITM, alongside other manufacturing supply and development agreements in place with specialist manufacturers at all stages of the manufacturing and supply chain for Betalutin® strengthens our confidence in the ability to deliver a reliable and sustainable supply chain in support of the launch of our lead asset.”
Steffen Schuster, CEO of ITM, added: “Nordic Nanovector is one of our longstanding partners, as ITM has been supplying n.c.a. Lutetium-177 to Nordic Nanovector since 2010. We are delighted that Nordic Nanovector has reaffirmed their confidence through this long term supply agreement for EndolucinBeta®. In addition to the development of our own pipeline, we have once again been able to gain a strategic partner for the development of targeted radiopharmaceuticals in Precision Oncology, thereby making a significant contribution to advancing a promising treatment option for difficult-to-treat cancers. With our manufacturing facilities around the world and our unrivaled logistics network, we feel well equipped to reliably meet our partners’ needs and to enter into further strategic relationships.”