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
Incyte’s Pivotal frontMIND Trial Showed Tafasitamab (Monjuvi®/Minjuvi®) Combination Significantly Prolonged Progression-free Survival, Reducing the Risk of Disease Progression or Death by 25% in Patients with Previously Untreated, High-risk DLBCL30.5.2026 14:00:00 CEST | Press release
The Phase 3 frontMIND study evaluated tafasitamab (Monjuvi®/Minjuvi®) and lenalidomide in addition to R-CHOP, the current standard of care, compared with R-CHOP alone in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL)Positive trends toward progression-free survival (PFS) benefit with tafasitamab and lenalidomide plus R-CHOP (Tafa-Len-R-CHOP) were observed acrossprespecified subgroups, including in patients with centrally confirmed lymphoma subtypes and both cell-of-origin (COO) molecular subtypesThe frontMIND data support the submission of global regulatory applications for tafasitamab and lenalidomide added to R-CHOP for previously untreated DLBCLThe data are being presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The Lancet* Incyte (Nasdaq:INCY) today announced positive results from the pivotal Phase 3 frontMIND trial evaluating t
Fortegra Completes Acquisition by DB Insurance29.5.2026 22:30:00 CEST | Press release
The Fortegra Group, Inc. ("Fortegra"), a global specialty insurance company, today announced the completion of its acquisition by DB Insurance Co., Ltd. ("DB"), one of Korea's leading property and casualty insurers. The transaction, announced on September 26, 2025, received all required regulatory and stockholder approvals. Fortegra will operate independently, maintaining its existing leadership team, distribution relationships, and underwriting discipline. Agents, distribution partners, and customers will continue to experience the service excellence that has defined the Fortegra experience. Richard Kahlbaugh, Chairman and CEO of Fortegra, said: "Every company eventually changes ownership. That is the nature of business. The closing of this acquisition is a starting point. As part of DB Insurance, Fortegra is positioned to expand our business geographically, enhance our capabilities and deepen our market presence in the US, Europe, the United Kingdom and Asia. Together, DB Insurance a
SINOVAC Receives Nasdaq Notification Regarding Late Filing of 2025 Annual Report29.5.2026 22:01:00 CEST | Press release
Sinovac Biotech Ltd. (Nasdaq: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that it received a notification letter dated May 20, 2026 (the “Notification Letter”), from Nasdaq Listing Qualifications (“Nasdaq”) stating that as of May 8, 2026, the Company had regained compliance with the periodic filing and interim financial requirements in Nasdaq Listing Rules 5250(c)(1) (the “Periodic Filing Rule”) and 5250(c)(2), as required by the Panel’s decision dated January 21, 2026. As previously disclosed on January 22, 2026, under the Panel’s decision, SINOVAC was required to, on or before May 11, 2026, demonstrate compliance with such Nasdaq Listing Rules by completing filings of its annual report for the year ended December 31, 2024, on Form 20-F and an interim balance sheet and income statement as of the end of its second quarter of 2025 on Form 6-K. The Company timely completed such filings as required by the Panel’s decision.
From Network Automation to Agentic NetOps: NetBrain Sets the Standard for Deploying AI in Network Operations29.5.2026 15:00:00 CEST | Press release
Newest expansion of the NetBrain platform delivers Agent Skills, AI Path Doctor, MCP Server, and expanded cross-domain integrations, extending the agentic capabilities already running in production at hundreds of enterprises. NetBrain Technologies, Inc. today announced major new platform features that advance Agentic NetOps from an emerging category to operational reality. NetBrain's clients are already deploying agents that are diagnosing and remediating issues across complex multi-vendor enterprise networks. These new features further extend the platform with new agent tooling, cross-domain context, and open interfaces for the broader agentic enterprise. Early customer outcomes show the magnitude of the shift: A leading health insurer used NetBrain's Deep Diagnosis agent to diagnose and resolve a weeks old VPN connectivity issue in under five minutes. A large manufacturer resolved a critical device issue with a single prompt, isolating the root cause across the network path in under
Adtran resolves long-running patent litigation, reinforcing commitment to defend innovation29.5.2026 14:00:00 CEST | Press release
News summary: Non-practicing entity litigation continues to create costly, time-consuming pressure across the technology industry Adtran has reached a full settlement following counterclaims, with payment made to Adtran and all claims dismissed with prejudice Outcome reflects Adtran’s commitment to defend its innovations, customers and business against meritless patent assertions Adtran today announced it has resolved a patent litigation matter, resulting in a full settlement and dismissal of all claims with prejudice. The case, initiated in 2020 by a non-practicing entity asserting five patents, was transferred to the US District Court for the Northern District of Alabama in 2021 following a successful motion by Adtran. Adtran subsequently filed counterclaims, including bad-faith patent assertion under Alabama statutory law. The settlement includes payment to Adtran to resolve its counterclaims. Terms of the agreement remain confidential. “This outcome reflects a disciplined and consi
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