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
TOURISE and Oxford Economics Release New Global Report on Tourism Resilience in an Era of Permanent Disruption17.8.2026 16:33:00 CEST | Press release
New analysis shows destinations that assume risk will recover up to 1.5 times faster with global rehabilitation times dropping from 24 months to as little as 10 TOURISE, in collaboration with Oxford Economics, today released a new report, “Resilience in a World that Doesn’t Reset: Redesigning Tourism for an Era of Permanent Disruption.” The analysis of 85 major crises over two decades shows a clear pattern: in a world defined by continuous shocks, destinations that act before disruption hits recover up to 1.5 times faster than those that wait. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260817880835/en/ “In a world that does not reset between crises, disruption is a constant feature of the global tourism landscape,” said His Excellency Ahmed Al-Khateeb, Minister of Tourism of Saudi Arabia and Chairman of TOURISE. “The real test for destinations measures how they prepare for volatility, protect traveler confidence, and mai
The Expensify Visa® Commercial Card Brings New Proactive Spend Controls to 14 Countries17.8.2026 15:00:00 CEST | Press release
New admin-defined spend rules let businesses control how, where, and when every card is used, stopping the wrong spend before it happens instead of cleaning it up after. Expensify, Inc. (Nasdaq: EXFY), the easiest way to manage expenses, travel, and corporate cards, today expanded the reach of Expensify Card spend rules, the market-leading way for businesses to control corporate card spend before it happens. Available to businesses in 14 countries, spend rules let admins decide exactly how, where, and when each Expensify Card can be used, so only compliant transactions go through. Unlike traditional corporate cards that rely on after-the-fact expense review, the Expensify Card enforces policy at the point of purchase. Admins set the rules once, and the card handles the rest. With Expensify Card spend rules, admins can: Lock a card to a subscription. Give each recurring SaaS tool its own virtual card, so a vendor can only ever charge what it should. If the card owner changes teams or le
Riskified Analysis Finds Travel Fraudsters Are Adapting Faster Than Traditional Signals Can Keep Up, With May Flight Risk Up 32%17.8.2026 14:30:00 CEST | Press release
New Travel Industry report reveals sophisticated fraud rings are exploiting trusted customer behaviors across flights, hotels, and travel platforms Riskified (NYSE: RSKD), a global leader in ecommerce fraud and risk intelligence, today released new findings from its Travel Industry Insights report, revealing how sophisticated fraud rings and AI-enabled fraudsters are evolving their tactics across airlines, hotels, and online travel platforms. Riskified’s analysis shows that fraudsters are increasingly adapting their behavior to resemble legitimate travelers, making traditional fraud indicators less reliable and creating new challenges for travel merchants. Riskified’s analysis of hundreds of millions of travel transactions across flights, hotels, and land transportation found that flight fraud risk increased through the first five months of 2026, with May 2026 marking the sharpest year-over-year increase at 32% compared to May 2025. The findings show that sophisticated fraud activity i
PIF Delivers Strong Revenue and Profit Growth in 202517.8.2026 13:54:00 CEST | Press release
Revenue rose 9% to $120 billion while net profit more than doubled to $17 billionCumulative domestic investments reached more than $199 billion since 2021PIF has contributed more than $342 billion to Saudi Arabia’s real non-oil GDP between 2021 and 2025Assets under management exceed $900 billion, up from around $530 in 2021 and $150 billion in 2015 PIF today published its 2025 Annual Report demonstrating strong financial performance and continued progress against its long-term objectives. As a long-term investor with a unique mandate to drive the economic transformation of Saudi Arabia and deliver sustainable financial returns, PIF maintained a diversified portfolio in 2025, balancing returns with national impact and long-term resilience. Maintaining Financial Discipline In 2025, revenue rose 9% year on year to $120 billion, while net profit more than doubled to $17 billion, supported by stronger contributions from maturing portfolio companies. PIF retained over $900 billion in assets
Foundever Successfully Closes a Holistic Recapitalization, Reducing its Debt by Nearly $900 Million and Strengthening its Financial Position for Long-Term Growth17.8.2026 13:30:00 CEST | Press release
Secures $225 Million Equity Infusion; Revolving Credit Facility and Term Loan Maturities ExtendedBenoit Leclercq Appointed Interim Chief Executive Officer to Lead Foundever Through its Next Phase of Growth; Company Begins Formal Search Process for Permanent CEO Foundever Group S.A.® (“Foundever” or the “Company”) – a global leader in integrated customer experience, digital operations and analytics services, today announced that it has successfully closed a holistic recapitalization (the “Transaction”) in coordination with 95.4% of the lenders under its term loan facility (“Term Loan Lenders”), 100% of its revolving credit facility lenders (“RCF Lenders”), and the Company’s existing majority shareholders. The Transaction meaningfully strengthens Foundever’s financial foundation and positions the Company to invest in its growth strategy. Key terms of the Transaction include: Company's existing majority shareholders invest $225 million into common equity. Term loan facility exchange reduc
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