New corporate identity to better reflect the company’s advanced stage
IND approval allows initiation of Phase I/II clinical trial with lead compound CAM-H2 in advanced/metastatic HER2-positive cancer
Brussels, Belgium, 21 September 2020 – Camel-IDS, a private, clinical-stage biotechnology company developing novel radiopharmaceuticals in oncology, today announces the launch of a new corporate identity and company name change to PRECIRIX®, effective immediately. Further, the company announces it has received Investigational New Drug (IND) approval to initiate a Phase I/II clinical trial with CAM-H2 in patients with advanced/metastatic HER2-positive breast and gastric cancer.
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)
About CAM-H2
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.
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 (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.
Your browser is not supported. Update your browser for more security, speed and to make the most of this site.