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
Access Advance Announces New Effective Discount Rates for Its Multi-Codec Bridging Agreement, Starting on January 1, 202711.11.2026 20:18:00 CET | Press release
Access Advance LLC today announced that the Licensors of the HEVC Advance and VVC Advance Patent Pools have independently approved a two-step, phased reduction in the effective royalty discount available under the Multi-Codec Bridging Agreement (MCBA) for Licensees of both pools who sign the MCBA on or after January 1, 2027. Licensees that join both the HEVC Advance and VVC Advance Patent Pools and execute the MCBA on or before December 31, 2026, will secure the current MCBA rates, resulting in an effective discount of up to 50%. Licensees that sign on or after January 1, 2027 will receive a reduced discount as further described below. The MCBA is an administrative agreement, not a separate license, that lets Licensees of both HEVC Advance and VVC Advance Patent Pools pay a single, reduced royalty rate for products that include both HEVC and VVC codecs. Today the MCBA rate for a dual-codec product is the same as the VVC Advance single codec product rate; up to 50% of what a Licensee wo
Angel Aligner Unveils Six Innovations for 202711.11.2026 17:23:00 CET | Press release
Angel Elevates the Orthodontic Specialty by Focusing on Complex-Case Solutions Angelalign Technology Inc. (6699.HK) (“Angel”), a global clear aligner leader, has unveiled six new clinical innovations, including SuperElastic (MC-SE)* aligner material, a Deepbite Solution for significantly expanded indications, and the Adapt-MATMsystem for next generation growth guidance for young patients. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261110338654/en/ Unveiling Angel's 2027 Innovations. Orthodontists and opinion leaders have long remarked about Angel’s clinical excellence. Orthodontics educator and thought leader Dr. David Sarver said: “In over 4 decades, I’ve never had a parent say I’d be happy if you ensure that my child’s treatment results are average.” Angel is committed to elevating the orthodontic specialty well above the average, especially as more competition and harder referral cases demand outstanding results. Bind
Abu Dhabi Future Health Summit Concludes with Research Partnerships and New Programmes to Advance Prevention and Health Innovation11.11.2026 15:58:00 CET | Press release
Partnerships span drug discovery, clinical research, preventive and reproductive health Launch of an AI Clinician Framework and a Trusted Research Environment for health and genomic data Four whitepapers address genomics, therapeutics, fertility and wearable technologies New programmes support health innovators and entrepreneurs More than 17,300 visitors from 85 countries, with 130 speakers across 45 sessions Held under the patronage of His Highness Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Chairman of the Abu Dhabi Executive Council, Abu Dhabi Future Health Summit 2026 concluded with agreements and initiatives spanning drug discovery, clinical research, preventive and reproductive health, alongside research and entrepreneurship programmes that will sustain collaboration beyond the Summit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261111545964/en/ The Summit is the annual flagship gath
De' Longhi Group: Record Results for the Quarter, With Revenue Growing by 7.7% and Net Profit Pertaining to the Group Progressing Significantly by 19%11.11.2026 15:58:00 CET | Press release
The Board of Directors of De' Longhi S.p.A. approved the consolidated results1 for the nine months of 2026. In the nine months the Group achieved: revenues for € 2,621.3 million, up by 6.5% with respect to 2025 (+7.7% at constant currency); an adjusted2 Ebitda of € 455.2 million, equal to 17.4% on revenues (vs. 15.8% with respect to last year); a net income pertaining to the Group equal to € 225.8 million (+20.4% with respect to last year); a positive net financial position equal to € 606.0 million. CEO Fabio de' Longhi commented: “The Group delivered its thirteenth consecutive quarter of organic revenue growth, underscoring our proven ability to capitalize on industry opportunities and respond promptly to market evolution, while ensuring consistent performance across both divisions. The professional business recorded a strong acceleration, spanning all geographies and brands, with revenues growth exceeding 35% for both the quarter and the nine-month period, this against an already par
Starr Chile Assigned A Rating from AM Best11.11.2026 14:30:00 CET | Press release
Starr, a global insurance and investment organization, today announced that the global credit rating agency AM Best has assigned Starr International Seguros Generales S.A. (Starr Chile) a Financial Strength Rating of A (Excellent) and a Long-Term Issuer Credit Rating of a+ (Excellent). The outlook for both credit ratings is positive. The rating reflects Starr’s strong balance sheet and Starr Chile’s successful implementation of Starr’s business model. AM Best also cited Starr’s operating performance, a favorable business profile and enterprise risk management as key factors supporting the positive rating. “This strong rating is another important endorsement of Starr’s business model as we continue to build our presence in Latin America,” said Jeff Greenberg, chairman and co-CEO of Starr. “It reflects the financial strength, underwriting discipline and experienced teams that underpin our business around the world, reinforcing the confidence brokers and clients can place in Starr.” Starr
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