PRECIRIX
Precirix NV, a clinical-stage biotechnology company developing precision radiopharmaceuticals in oncology, announces that it has dosed the first patients in its Phase I/II clinical study of CAM-H2 for the treatment of HER2-positive metastatic cancer. This is a major milestone in the company’s development of its lead therapeutic asset.
The Phase I/II trial (NCT04467515 ) evaluates safety, tumor uptake, tumor retention and early signs of antitumor activity of single-agent CAM-H2 in HER2-positive metastatic breast and gastric/gastro-esophageal cancer patients that have relapsed or are refractory to available anti-HER2 therapies. The trial is a continuous study composed of two parts: a Phase I dose-escalation phase to establish the recommended dose for Phase II in 3+3 dose-ascending cohorts of patients, followed by a Phase II dose-expansion phase. The Phase I/II clinical study will allow inclusion of patients with brain metastases, a population in dire need of effective therapies, and will enroll a total of appr. 70 patients.
Ruth Devenyns, CEO commented: “We are very excited to have dosed the first patients in this clinical study, the result of years of thorough scientific research, collaboration and operational excellence of our entire team and partners. Special thanks to our former CMO Ruggero Della Bitta, for his contribution to our global clinical development strategy and securing regulatory clearance for the Phase I/II trial. We look forward to recruiting additional patients and generating efficacy data to confirm the strong results from our preclinical and first-in-human studies, with the goal of bringing new treatment options to cancer patients.”
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.
About HER2-positive cancer
Worldwide, >1.6 m cases of breast cancer and >1.2m cases of gastric cancer are diagnosed annually, of which >20% are HER2-positive. In breast cancer, some 60% of the patient population develops metastatic disease, with brain metastases occurring in up to 50% of metastatic patients1,2 . HER2 is also overexpressed in subsets of patients with other solid tumors including biliary tract, colorectal, non-small-cell lung and bladder cancer3 .
HER2 is an established therapeutic target and a variety of agents targeting HER2 have been approved, however none of these cure metastatic disease. Specifically in brain metastases there are limited treatment options. There are no approved HER2 targeting radiopharmaceuticals and CAM-H2 is the lead candidate in therapeutic development, leveraging the advantages of using a single-domain antibody to deliver targeted radiation to the tumor and bringing a new mechanism of action in the current HER2 treatment landscape to address important unmet medical needs, including brain metastases and low HER2 expression.
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.
1
‘From diagnosis to treatment: Understanding breast cancer’, Roche website
2
‘Real-world characteristics metastatic breast cancer’ (ASCO 2018)
3
Oh et al. Nature Reviews Clinical Oncology
2019
View source version on businesswire.com: https://www.businesswire.com/news/home/20211006005529/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Lattice Wins 2025 Global Semiconductor Alliance Award6.12.2025 00:49:00 CET | Press release
‒ Named Most Respected Public Semiconductor Company Achieving $100 Million to $500 Million in Annual Sales ‒ Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, today announced that it was selected as ‘Most Respected Public Semiconductor Company’ at the 2025 Global Semiconductor Alliance (GSA) Awards. The GSA awards recognize companies that have demonstrated excellence through their success, vision, strategy, and future opportunities in the industry as determined by votes from GSA members. “We are honored to be recognized by the Global Semiconductor Alliance and our peers as one of 2025’s most respected public semiconductor companies. This recognition reflects the dedication of the Lattice team and the trust of our customers, partners, suppliers, and investors. Looking ahead, we remain laser-focused on driving innovation and strengthening our role as the trusted low power programmable leader for semiconductor and system solutions,” said Ford Tamer, Chief Executive
Andersen Consulting udvider sine kapaciteter inden for digital transformation5.12.2025 16:53:00 CET | Pressemeddelelse
Andersen Consulting indgår en samarbejdsaftale med Neit Consulting, et firma med fokus på at skabe mere effektiv drift, integrere intelligente teknologier og accelerere den digitale modenhed for kunder. Neit Consulting er et konsulentfirma med base i Tjekkiet og mere end 20 års erfaring med at levere ISO-certificerede it- og forretningsrådgivningsydelser inden for dataanalyse, performance management og procesoptimering. Med mere end 200 konsulenter hjælper firmaet kunder – herunder globale banker, forsikringsselskaber, produktionsvirksomheder og offentlige instanser –gennem virksomhedsrådgivning, implementering af it-systemer og langsigtet systemsupport. Neit Consulting betjener kunder internationalt med fokus på at afstemme digital kapacitet med komplekse driftsmæssige behov. "Dette samarbejde afspejler et markant fremskridt i omfanget af de ydelser, vi tilbyder vores kunder," udtaler Tomáš Niederle, salgsdirektør for Neit Consulting. "Andersens globale rækkevidde og tværfaglige tilga
Fitch Learning Completes Acquisition of Moody’s Analytics Learning Solutions and the Canadian Securities Institute5.12.2025 16:48:00 CET | Press release
Combined entity to accelerate financial services skills development and drive measurable business outcomes across 148 countries Fitch Learning, the global leader in financial learning and professional certifications, today announced the completion of its acquisition of Moody’s Analytics Learning Solutions (MALS) and the Canadian Securities Institute (CSI). MALS is a global provider of credit and digital learning, and CSI is a leading provider of certifications for the Canadian financial services industry. Fitch Learning, recognized globally as the premier financial education provider, delivers specialized training for the financial services industry through accredited qualifications, flexible corporate solutions programs, managed services and digital learning solutions trusted by leading institutions worldwide. The combined business will serve over 92,000 finance professionals across 148 countries, at every stage of their careers. “This acquisition is about creating more opportunities
Arthur D. Little and Vega IT Unveil Joint Venture for Digital Innovation5.12.2025 16:00:00 CET | Press release
Arthur D. Little (ADL) and Vega IT today announced the formation of Axceler8 Solutions, a 50/50 joint venture created to design, develop, and operate a portfolio of digital and AI solutions aimed at improving efficiency and automating complex business processes. The launch of this new company is the direct outcome of a year of successful collaboration between the two firms and marks a new phase in their shared ambition to bring scalable, high-performance digital solutions to market, aiming to further augment their clients’ capacity to compress time to impact in a variety of domains. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251205465303/en/ Arthur D. Little and Vega IT have announced the formation of Axceler8 Solutions, a 50/50 joint venture created to design, develop, and operate a portfolio of digital and AI solutions. Axceler8 Solutions’ first product, Axceler8 Rx, is now live as a newly developed platform, and is a
Lone Star Announces Sale of SPX FLOW to ITT Inc.5.12.2025 13:30:00 CET | Press release
Lone Star Funds (“Lone Star”) today announced the signing by an affiliate of Lone Star Fund XI, LP of a definitive agreement to sell SPX FLOW, Inc. (“SPX FLOW”), a leading provider of highly engineered equipment and process technologies for attractive end markets including industrial, health and nutrition, to ITT Inc. (NYSE: ITT) for $4.775 billion in cash and shares of common stock. Based in Charlotte, N.C., SPX FLOW focuses on process technologies delivering mixing, blending, fluid handling, separation, thermal heat transfer and other solutions integral to industrial, health and nutrition markets. The company has operations in more than 25 countries and sales in more than 140 countries. In partnership with Lone Star, SPX FLOW has focused on improving its sales execution and operating platform, while ensuring high quality and innovative product development. The management team has improved the company’s commercial organization and executed growth initiatives to build its presence in e
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom