Lutetium (177Lu) edotreotide

As radiopharmaceuticals continue their hot streak, one of the few players with a marketed product, ITM Isotope Technologies Munich, has pulled in additional funding to help advance its lead pipeline candidate. The firm has secured a new investment of €188 million ($204 million), led by previous backer Temasek, with participation from BlackRock, Qatar Investment Authority and ATHOS.ITM currently markets EndolucinBeta, which uses lutetium-177 (177Lu) for radiolabelling of other medicines, and TOCscan/Sogacin, which uses gallium (68Ga) edotreotide for diagnosing neuroendocrine tumours (NETs). While the two products are sold in a handful of European countries, ITM's pipeline has loftier ambitions and is stacked with a number of targeted radionuclide therapies based not only on 177Lu and 68Ga, but also on actinium-225 (225Ac), fluorine-18 and terbium-161.Phase III nearing completionIts lead asset, ITM-11 (177Lu-edotreotide), is nearing the end of Phase III testing in gastroenteropancreatic NETs (GEP-NETs). The late-stage COMPETE study is evaluating ITM-11 in patients with Grade 1 - 2 GEP-NETs, while the COMPOSE trial is for patients with well-differentiated high Grade 2 - 3 GEP-NETs. With this in mind, ITM will use some of the proceeds from the latest financing to “prepare commercial readiness” of ITM-11.“We have reached key milestones since our last financing round including advancing our pipeline with novel targets in multiple oncology indications,” remarked CEO Steffen Schuster. Almost exactly a year ago to the day, ITM announced a haul of €255 million – again led by Temasek – building on the €58 million it raised in 2022 and €114 million it secured in the prior year. Key supplier to NovartisAside from its internal pipeline, ITM recently launched a joint venture to produce 225Ac, while it has several supply agreements in place for 177Lu, including with Telix Pharmaceuticals and Endocyte, the latter now part of Novartis. In fact, the Swiss drugmaker is one of the key players in the radiopharmaceutical space, with its marketed products including Lutathera (177Lu dotatate) for GEP-NETs and the prostate cancer therapy Pluvicto (177Lu vipivotide tetraxetan). However, Novartis itself has faced production issues for Pluvicto, and only recently gained clearance for a new US radioligand manufacturing facility to help it keep up with demand.ITM plans to put some of the new funding toward ramping up its in-house manufacturing capacities for 177Lu and expand these to new radioisotopes including 225Ac. ITM said it will use the radioisotopes not only for its own pipeline, but also provide them to its global supply network. For related analysis, see Vital Signs: Mapping the slim pickings in radiopharmaceuticals.

Dive Brief:Radiopharmaceutical drug developer ITM has raised 188 million euros, or about $205 million, to fund its development of the targeted radiation therapies for cancer.Announced by ITM Thursday, the financing is the latest evidence of the substantial investment flowing into the field of radiopharmaceuticals, which are designed to deliver a cancer-killing radioisotope directly into tumors while sparing nearby healthy tissue.ITM, short for Isotope Technologies Munich, has advanced a radiopharmaceutical drug for a type of gastrointestinal cancer into two Phase 3 studies that are estimated to complete this year and in 2027. Uniquely, ITM is also a supplier of radioisotopes, including the commonly used lutetium-177.Dive Insight:Thursdays funding comes almost exactly one year after ITM raised 255 million euros from the same group of investors, a syndicate that includes Temasek, BlackRock and the Qatar Investment Authority.In the 12 months since that June 2023 funding, four of ITMs radiopharma peers have been acquired in deals worth a combined $8.5 billion. Several others have struck research collaborations with large drugmakers like Eli Lilly and Roche. And hundreds of millions of dollars in investment have flown into new startups.Steffen Schuster, the longtime CEO of ITM, hasnt been surprised by the frenzy of activity. Hes expected as much since Novartis acquired the radiopharma company Endocyte five years ago, gaining a prostate cancer treatment it now sells as Pluvicto.We said as soon as Pluvicto is a blockbuster, big pharma will wake up and say, Hey, wait a minute, I missed the train, Schuster said in an interview.Pluvicto sales last year totaled $980 million and Novartis expects theyll eventually reach triple that sum each year. The success of Pluvicto and another radiopharma Novartis sells called Lutathera have helped convince other large companies that the drug class is an essential building block for their oncology pipelines. Bristol Myers spent $4.1 billion to buy RayzeBio; AstraZeneca paid $2 billion for Fusion Pharmaceuticals; and Eli Lilly bought Point Biopharma for $1.4 billion.The whole market has changed completely, Schuster said.The executive declined to comment on whether ITM has had discussions with larger firms, but said that its position supplying isotopes and developing drugs both gives it control and builds value.The bulk of the new funding will go toward ITMs pipeline, which is led by its gastrointestinal cancer drug ITM-11. Other treatments are in much earlier phases of testing, but involve a range of tumor types as well as radioisotopes.ITM-11 is aimed at the same target as Novartis Lutathera and uses the same isotope: lutetium-177. Schuster noted differences in its dosing intervals as well as in some of the treatments components, however.[The goal] is not just taking market share from Novartis, said Schuster. Its creating a larger market. There are so many patients who could get this treatment who dont get treatment.In addition to development, ITM currently manufactures and supplies lutetium-177 as well as an imaging radioisotope known as gallium-68. In January, the company said a new production site in Germany was ready for business and, several months prior, launched a joint venture with Canadian Nuclear Laboratories to produce actinium-225, another radioisotope that drugmakers are using.There are so many synergies between these two parts of the businesses, said Schuster.Along with Temasek, BlackRock and Qatar Investment Authority, investors Athos and Carbyne were involved in ITMs fundraising. Nextech, which participated in the June 2023 funding, was not among the named investors in Thursdays announcement. '