CAM-H2 production at Evergreen marks the expansion of Precirix’ clinical trial to the US
Brussels, Belgium and New Jersey, US - 08 June 2023 – Precirix, a clinical-stage biotechnology company developing precision radiopharmaceuticals in oncology, today announced the production of a first clinical trial batch of CAM-H2 at Evergreen Theragnostics’ state-of-the-art facility in Springfield, NJ (US).
Precirix is currently running a Phase I/II clinical trial in Canada to evaluate the safety, tolerability and efficacy of CAM-H2 in HER2-positive metastatic breast, gastric and gastroesophageal cancer, including patients with brain metastases. With Evergreen ready for the production of clinical trial batches, Precirix is significantly increasing its manufacturing capacity in anticipation of patient recruitment in the US.
Evergreen will produce CAM-H2 in therapeutic as well as imaging doses. Patients will receive a first imaging dose to evaluate HER2 expression in the lesions followed by therapeutic doses in case the patient qualifies for CAM-H2 treatment.
Dimitrios Mantzilas, Chief Technology Officer of Precirix, comments: “We are proud to announce the first clinical batch production at Evergreen. The combination of Precirix’ innovative technology and know-how with Evergreen’s technical capabilities have resulted in a smooth technology transfer. We look forward to continuing our collaboration and to evaluate CAM-H2 in patients throughout North America”.
James Cook, Chief Executive Officer of Evergreen Theragnostics, said: “We are very excited to play a role in the development of CAM-H2 by making this important product broadly available for clinical trials. We have a great collaboration with Precirix and are committed to ensuring high quality and high reliability supply from our factory in Springfield, New Jersey.”
About neuroendocrine tumors
Neuroendocrine tumors (NETs) are a diverse set of cancers that originate in neuroendocrine cells, which are cells that carry messages from the nervous system to the endocrine system. Because neuroendocrine cells are located in many organs, NETs are often heterogeneous in their symptoms and therefore difficult to diagnose. The incidence of NETs are low, but are increasing, likely in part due to increased diagnosis of the disease. Once a patient has been identified as having a NET, they will often undergo a PET scan to localize and stage the cancer, which will help the care team identify the best course of treatment.
About Precirix
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 therapeutic dose for treatment.
About CAM-H2
CAM-H2 comprises a single-domain antibody targeting HER2, covalently linked to iodine-131. Single-domain antibodies are ideally suited for targeted delivery of radiation to tumors given their size, specificity and pharmacokinetic characteristics. Imaging studies conducted with the HER2 targeting single-domain antibody labelled with gallium-68 have demonstrated specific uptake and retention in primary, metastatic and brain lesions in HER2-positive breast cancer patients. CAM-H2 is currently being evaluated in a Phase I/II clinical study including HER2-positive metastatic breast, gastric and gastroesophageal cancer patients.
About Evergreen Theragnostics, Inc.
Evergreen Theragnostics, headquartered in Springfield, NJ in a state-of-the-art GMP radiopharmaceutical facility, is focused on improving the available options for cancer patients using radiopharmaceuticals. Founded in 2019, the company is engaged in three core areas: CDMO, Products, and Drug Discovery. The CDMO business unit offers research and commercial scale, centralized production capacity for therapeutic and long-lived diagnostic products. The Products business unit develops and commercializes Evergreen-owned assets. Evergreen Discovery is focused on developing novel radiopharmaceuticals for cancer therapy, focusing on unprecedented and first-in-class radiopharmaceuticals.
For further information, please contact:
Precirix NV
Ruth Devenyns, CEO
+32 2 479 93 60
info@precirix.comwww.precirix.com
Evergreen Theragnostics, Inc.
James Cook, CEO