Ruth Devenyns, CEO of Precirix, commented: “The significant progress in the development of our company, such as the IND approval for CAM-H2, has lead us to adopt a new corporate identity. Precirix reflects our mission to become a leader in precision radiopharmaceuticals as we aim to improve and extend the lives of patients with hard-to-treat cancers.”
Precirix received IND approval from the US FDA and Clinical Trial Approval (CTA) from the Canadian authorities, which allows the initiation of a Phase I/II trial with lead product candidate, CAM-H2 (NCT04467515). Recruitment is expected to commence in 4Q20. The international, multicenter, Phase I/II trial will evaluate CAM-H2 in patients with advanced/metastatic HER2-positive breast and gastric cancer. In the dose-escalation phase, cohorts of three patients will be treated with increasing doses of CAM-H2. In the dose-expansion phase, over 50 patients will be treated with the selected dose.
Research demonstrated the potential of CAM-H2 to target brain lesions. This life-threatening complication still represents a significant unmet need as over 30% of HER2-positive metastatic breast cancer patients will be affected and limited treatment options are available1. Therefore, the trial will include and enrich for patients with HER2-positive brain metastases. In addition to safety, tolerability and dosimetry, the study will report on objective response rates, progression-free survival, overall survival, and duration of responses.
With its name change, the company also launches a new website, logo and corporate presentation (www.precirix.com)
CAM-H2 is a HER2-targeting single-domain antibody radiolabeled with Iodine-131. The product candidate is being evaluated in a Phase I/II trial. Cancer patients with tumors that overexpress HER2, a growth-promoting protein, can benefit from effective targeted treatments today, yet have a poor prognosis when the cancer spreads. CAM-H2 aims to effectively irradiate cancer lesions while sparing healthy tissue, based on its unique technology platform that leverages the favorable tissue distribution of camelid-derived, single-domain antibodies linked to radionuclides.
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 (sdAb) 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.
Precirix was incorporated in 2014 as a spin-off from the Vrije Universiteit Brussel. The Company secured EUR 37m (USD 42m) in a Series A investment round in November 2018, led by V-Bio Ventures (Belgium) and Gimv (Belgium), joined by the co-lead investors HealthCap (Sweden), Novo Holdings (Denmark), Pontifax (Israel), BioMedPartners (Switzerland) and existing investors.
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