Under the terms of the agreement, ITM will receive $140 million upon closing and can exercise additional tranches. Further details of the agreement have not been disclosed.
In a statement, ITM said that it would use the funds for the commercial development and potential market launch of the company’s lead candidate, no carrier added (n.c.a.) lutetium-177 edotreotide (also known as ITM-11 or Lu-177 edotreotide).
ITM-11 is a radiolabeled peptide conjugate designed to deliver beta radiation to SSTR-positive tumor cells while sparing healthy organs and tissue. ITM said that it plans to submit a New Drug Application (NDA) for ITM-11 to the U.S. Food and Drug Administration (FDA) this year. The company shared positive phase III results from the COMPETE phase III study in March for ITM-11 as a potential treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
ITM-11 was previously granted orphan drug status in both the EU and the U.S., as well as fast-track designation in the U.S., for the treatment of GEP-NETs, based on positive results from a retrospective phase II study.
Additionally, the funding will be used to accelerate the development of other therapies in ITM’s pipeline, the Munich-based firm said. This includes scaling up the manufacturing for actinium-225 through its joint venture, Actineer.
