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
Niagen Bioscience Receives Exclusive U.S. FDA Rare Pediatric Disease (RPD) Designation and European Medicines Agency Orphan Medicinal Product Designation (OMPD) for NB4168 for the Treatment of Ataxia Telangiectasia (A-T)13.7.2026 14:32:00 CEST | Press release
Regulatory recognition in the United States and Europe supports the development of NB4168, a novel small molecule candidate for a rare pediatric disease with no approved treatments Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announced that the U.S. Food & Drug Administration (FDA) granted Rare Pediatric Disease (RPD) Designation for its proprietary lead small molecule drug candidate NB4168 for the treatment of Ataxia Telangiectasia (A-T). NB4168 is an oral small molecule therapy engineered to deliver substantially greater nicotinamide riboside (NR) exposure than conventional NR while maintaining a differentiated pharmacokinetic and safety profile. In addition, the European Medicines Agency (EMA) has granted Orphan Medicinal Product Designation (OMPD) to NB4168 for the treatment of A-T, providing regulatory recognition in the European Union and further supporting the Company'
SLB OneSubsea Awarded EPC Contract for Eni’s Baleine Phase 3 Project Offshore Côte d'Ivoire13.7.2026 14:00:00 CEST | Press release
Integrated subsea production system and local capabilities enable accelerated deepwater development Global energy technology company SLB (NYSE: SLB) announced today that its OneSubsea™ joint venture has been awarded a major multi-well engineering, procurement, and construction (EPC) contract by Eni for Phase 3 of the deepwater Baleine project offshore Côte d’Ivoire. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260712734539/en/ SLB OneSubsea™ joint venture has been awarded a major multi-well engineering, procurement, and construction (EPC) contract by Eni for Phase 3 of the deepwater Baleine project offshore Côte d’Ivoire. Under the contract, SLB OneSubsea will deliver complete subsea production systems (SPS) for 13 wells, reinforcing its role as a core technology and execution partner on one of the most strategically significant offshore developments currently underway in the region. The EPC scope includes subsea trees, um
HistoSonics Receives CE Mark, Unlocking Access Across Europe and Accelerating Global Commercialization of the Edison® Histotripsy Platform13.7.2026 14:00:00 CEST | Press release
HistoSonics, today announced that the company has received CE Mark approval in Europe for its Edison® System, enabling commercialization of the company’s non-invasive histotripsy technology in Europe and other markets that recognize the CE Mark. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260713505048/en/ HistoSonics Edison® Histotripsy System The Edison System is a novel, non-invasive, image guided platform that is intended for the destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors. It uses the mechanical properties of focused ultrasound, called histotripsy, to liquefy and destroy unwanted tissue and tumors in a single procedure without the need for invasive procedures or radiation, and with potentially fewer side effects than traditional therapies. CE Mark approval follows an increasing number of regulatory clearances and was supported by a growing body of clinical ev
Esri Introduces ArcGIS Velocity for ArcGIS Enterprise to Power Real-Time GIS Operations13.7.2026 14:00:00 CEST | Press release
ArcGIS Velocity Brings Real-Time Data Ingestion, Analysis, and Automated Alerting to ArcGIS Enterprise Deployments Esri announces that ArcGIS Velocity is now available for ArcGIS Enterprise, enabling real-time data analytics and automated actions in self-hosted environments. This capability’s new deployment unifies real-time workflows across ArcGIS Online and ArcGIS Enterprise. This update benefits organizations across industries: public safety, transportation, logistics, and more. Esri, the global leader in location intelligence, has released for general availability ArcGIS Velocity for ArcGIS Enterprise for self-hosted deployments on Windows and Linux. This enables organizations to leverage Velocity from secure on-premises and private cloud environments. Available as software as a service (SaaS) for ArcGIS Online and now for self-hosted environments in ArcGIS Enterprise, Esri’s next-generation geospatial capability delivers real-time analytics on streaming, Internet of Things (IoT),
Agenus Announces Oversubscribed Private Placement of Up to $340 Million to Advance Registrational ROBBIN Trial of Neoadjuvant BOT+BAL in MSS Colon Cancer13.7.2026 12:00:00 CEST | Press release
$85M upfront financing, along with up to $255 million upon exercise of purchase warrants, is expected to fund ROBBIN1, Agenus' registrational Phase 3 trial of neoadjuvant botensilimab and balstilimab (BOT+BAL) in microsatellite-stable (MSS) colon cancer Transaction is structured to fund Agenus through key value-inflection points, including interim topline pathologic response data and interim and final event-free survival (EFS) analyses, with proceeds to fund Agenus operations through year-end 2031, assuming full warrant exercise ROBBIN target population in MSS colon cancer represents a >$7 billion addressable annual sales opportunity in the US for which no new therapies have been approved in over 20 years2,3 To focus resources on the neoadjuvant opportunity, Agenus is discontinuing financial support for the ongoing BATTMAN Phase 3 study in late-line metastatic MSS colorectal cancer Company to host conference call and webcast today at 8:30 a.m. ET Agenus Inc. (Nasdaq: AGEN), a leader in
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