Precirix NV, a clinical-stage biotechnology company developing novel radiopharmaceuticals in oncology, and Evergreen Theragnostics, Inc., a radiopharmaceutical contract manufacturer, announced that the companies have entered into an agreement whereby Evergreen will provide US-based manufacturing for Precirix’s lead product candidate, CAM-H2.
CAM-H2 is being evaluated in a Phase I/II clinical trial targeting HER2-positive metastatic breast and gastric cancer. The novel precision therapy aims to effectively irradiate cancer lesions while sparing healthy tissue, based on its unique technology platform that leverages the favorable characteristics of single-domain antibodies.
“Establishing a strong manufacturing footprint in North America is an important step for Precirix to ensure reliable clinical trial supply. We are very pleased to be working with Evergreen, a team with solid expertise and a proven track record in radiopharmaceutical manufacturing,” said Ruth Devenyns, Chief Executive Officer of Precirix.
Evergreen will manufacture CAM-H2, an I-131 based radiopharmaceutical, at its new state-of-the-art facility in Springfield, New Jersey, USA. Opening in 2021, the facility is located near Newark Liberty International Airport and within driving distance of John F. Kennedy International Airport. The location is ideal for receiving isotope shipments from Europe and distributing finished product to hospitals across North America.
“CAM-H2 is a very promising product with potential to significantly improve outcomes for patients with HER2-positive cancer. We are pleased to be working together with an outstanding team at Precirix. Evergreen is committed to ensuring reliable supply throughout these important clinical studies,” said James Cook, Chief Executive Officer of Evergreen.
About Precirix NV
Precirix is a private, clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing precision radiopharmaceuticals, using camelid single-domain antibodies labeled with radioisotopes. The company has a broad pipeline with one product candidate in a Phase I/II clinical trial and two in advanced preclinical stage. Research on multiple isotopes, linker technology and combination therapies further expand the platform. Precirix’ technology also allows for a theranostic approach, where patients can be selected using a low dose/imaging version of the product, followed by a higher therapeutic dose for treatment.
About Evergreen Theragnostics, Inc.
Evergreen Theragnostics was established in 2019 to be a leading US-based radiopharmaceutical Contract Development and Manufacturing Organization (CDMO). With a state-of-the-art global GMP facility opening in 2021, Evergreen will provide highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals, from early development through commercialization. The company was founded by a team that brings a strong track record in theragnostic radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management.