BOULDER, Colo. & MUNICH– Clovis Oncology, Inc. (NASDAQ: CLVS) and ITM Isotope Technologies Munich SE, a leading radiopharmaceutical biotech company, today announced the signing of a clinical supply agreement that provides Clovis Oncology with ITM’s therapeutic radioisotope no-carrier-added Lutetium-177 (n.c.a. 177Lu), EndolucinBeta®, for use in the clinical development of FAP-2286, Clovis’ fibroblast activation protein (FAP)-targeting therapeutic candidate. FAP-2286 is the first peptide-targeted radionuclide therapeutic (PTRT) candidate directed against fibroblast activation protein undergoing clinical testing and is currently being investigated in the Phase 1/2 LuMIERE study for patients with advanced solid tumors. The agreement covers an initial period of five years. Further details of the agreement were not disclosed.
“Clovis Oncology is committed to advancing FAP-2286’s clinical development program and emerging as a leader in targeted radionuclide therapy. A critical element to advance this program is ensuring long-term supply of radioisotopes, and this agreement allows us to achieve that goal,” said Patrick Mahaffy, President and CEO of Clovis Oncology. “In particular, we value ITM’s radiopharmaceutical expertise and global reach as we advance our targeted radionuclide therapy program into the clinic.”
“This agreement underscores the potential of our n.c.a. Lutetium-177 to provide therapeutic value to patients with hard-to-treat tumors. Through our proprietary pipeline of Targeted Radionuclide Therapies and our agreements with other oncology leaders, we are establishing a new era of precision oncology treatments and we are happy to contribute to this exciting Clovis program,” commented Steffen Schuster, CEO of ITM.
FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting FAP. FAP is highly expressed by cancer-associated fibroblasts (CAFs) which are found in the majority of cancer types, but with limited expression in healthy fibroblasts, potentially making it a suitable target across a wide range of tumors. FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach medical radioisotopes, such as Lutetium-177 for therapeutic use, or Gallium-68 for imaging use.
ITM’s n.c.a. 177Lu (EndolucinBeta®) is a high-purity version of the beta-emitting radioisotope Lutetium-177, that can be linked to a variety of tumor-specific targeting molecules for Targeted Radionuclide Therapy and has demonstrated significant anti-tumor effects in clinical and commercial use. ITM has developed a unique methodology to produce the highly pure form of Lutetium-177, without metastable Lutetium-177m, and manufactures n.c.a. 177Lu for development partnerships, distribution to clinics worldwide, and its own growing precision oncology pipeline.
In June 2021, Clovis initiated the Phase 1/2 LuMIERE clinical study of FAP-2286 in advanced solid tumors. The Phase 1 portion of the LuMIERE study (NCT 04939610) will evaluate the safety of the FAP-targeting investigational therapeutic agent and identify the recommended Phase 2 dose and schedule of Lutetium-177 labeled FAP-2286 (177Lu-FAP-2286), for which ITM will provide its n.c.a. 177Lu. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.
