PRECIRIX
6.10.2021 13:02:09 CEST | Business Wire | Press release
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
GenBio AI Builds First World Model of the Human Cell18.8.2026 15:00:00 CEST | Press release
First-of-its-kind system simulates human cell behavior across the full biological hierarchy, from DNA and RNA through protein to the whole-cell level GenBio AI ('GenBio') is an AI for Science company co-founded by Nobel Laureate David Baker, leading AI scientist Eric Xing, and other prominent life science and artificial intelligence researchers from Stanford, Carnegie Mellon University, Mohamed Bin Zayed University of Artificial Intelligence, Harvard, Weizmann Institute, and other research institutions. Today, the company introduced AIDO Cell, its virtual cell world model — the first system capable of simulating a human cell, both in its natural state and in response to drugs and other interventions, across its full biological hierarchy, from DNA and RNA through protein to the whole-cell level. A Key First in Biological and Medical Sciences: Full-hierarchy virtual cell simulation has been widely identified as a key milestone in computational biology. Compared to the previous efforts by
Xsolla Partner Network Expands Verified Creator Partnerships and Unifies Campaign Management Ahead of gamescom 202618.8.2026 15:00:00 CEST | Press release
Developers Gain Vetted Creator Partnerships And A Single Campaign Workflow, Managed From The Publisher Account They Already Use Xsolla, a global video game commerce company, today announced an expansion of the Xsolla Partner Network ahead of gamescom 2026 in Cologne, giving game developers a simpler, more reliable way to grow their games through creators. The creator platform now lives within Xsolla Publisher Account, where developers already run their business, with verified creator onboarding and a redesigned and unified campaign workflow. Flat-fee campaigns, a new guaranteed payment option alongside revenue share, and data-driven creator recommendations are coming soon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260818140062/en/ Graphic: Xsolla Xsolla Partner Network gives developers one place to launch, manage, track, and report on creator campaigns while Xsolla handles payments, payouts, taxes, and compliance.Verifi
KOCCA to Showcase 13 Korean Game Companies at ‘Gamescom 2026’ with PC, Mobile, and VR Lineups18.8.2026 14:48:00 CEST | Press release
- Featuring a diverse lineup of roguelike deckbuilders, AI-powered rhythm education, and cooperative horror games - Ranging from new titles based on the popular animated IP ‘LARVA’ to real-time K-POP dance coaching content - Hands-on experience available August 26–28 at the Korea Joint Pavilion B2B Hall, Koelnmesse, Booth Hall 3.2 C-050g–D051g The Korea Creative Content Agency (KOCCA) announced that 13 Korean game companies will gather under one roof at Gamescom 2026, Europe’s largest game show, held in Cologne, Germany, from August 26 to 28 (B2B, 09:00~20:00). Located in Booth Hall 3.2 C-050g–D051g, the Korea Joint Pavilion offers visitors hands-on experiences with an expansive lineup of titles, ranging from PC and mobile games to VR-powered titles across diverse genres. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260818271881/en/ KOCCA will bring 13 Korean game companies to Gamescom 2026 in Cologne, Germany (Image: KOCC
SLB to Support Offshore Production Restoration for Brunei Shell Petroleum18.8.2026 14:06:00 CEST | Press release
Integrated execution model combines multiple disciplines to improve recovery from mature offshore assets Global energy technology company SLB (NYSE: SLB) today announced it has been awarded a contract by Brunei Shell Petroleum (BSP) to support production restoration from shut-in wells across multiple offshore fields. The contract scope spans subsurface evaluation, well candidate selection, engineering and offshore execution. Project management, intervention services, monitoring, metering and marine logistics are integrated within a single coordinated execution model designed to support efficient production restoration. “Building on our long collaboration in the region, this contract reflects a shared commitment to maximizing value from existing offshore resources,” said Gokhan Yarim, senior vice president of Integration, SLB. “Together with BSP, we are combining SLB’s production expertise and integrated execution capabilities to help restore production from shut-in wells, increase reco
BeOne Medicines, BeOne Care Foundation, and The Max Foundation Renew Partnership to Expand Access to BRUKINSA® for the Treatment of Chronic Lymphocytic Leukemia in Low- and Middle-Income Countries18.8.2026 12:00:00 CEST | Press release
Renewed collaboration builds on access provided to more than 300 patients with CLL to date and plans to support approximately 1,000 patients through 2028 BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, together with the BeOne Care Foundation, a nonprofit charitable foundation, and The Max Foundation, a leading global health nonprofit organization, today announced the renewal of their partnership through 2028 to expand access to BRUKINSA® (zanubrutinib) for the treatment of chronic lymphocytic leukemia (CLL) in low- and middle-income countries, with the program projected to support approximately 1,000 patients cumulatively. Building on a collaboration launched in 2023, the renewed partnership reflects the organizations’ shared commitment to improving access to innovative cancer treatments in underserved communities. To date, the partnership has enabled access to BRUKINSA for more than 300 patients with CLL across Armenia, Ethiopia, and
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