Latest news with #monomethylauristatinE
Business Wire
07-08-2025
- Business
- Business Wire
ProteinQure Receives Regulatory Clearance to Initiate Phase I Trial for PQ203 in the U.S. and Canada; Granted FDA Fast Track Designation
TORONTO--(BUSINESS WIRE)--ProteinQure, a leader in computational protein drug discovery, today announced it has received regulatory clearance from both the U.S. Food and Drug Administration (FDA) and Health Canada to initiate a Phase I clinical trial evaluating the safety, pharmacokinetics, pharmacodynamics and anti-cancer activity of its lead candidate, PQ203. The FDA has also granted PQ203 Fast Track designation for patients with triple negative breast cancer, recognizing the therapy's potential to address a serious unmet medical need. The upcoming Phase I trial, which will be conducted in both the United States and Canada, will use an accelerated titration design to more efficiently identify the optimal dosing regimen while quickly arriving at therapeutic dose levels. 'This is a major step forward for ProteinQure and for the field of rationally designed peptide therapeutics,' said Dave Garman, VP Translation and Development at ProteinQure. 'The Fast Track designation reflects the FDA's recognition of the promise PQ203 holds for cancer patients, and we are thrilled to move swiftly into the clinic across North America.' PQ203 is a first-in-class therapeutic developed using ProteinQure's proprietary platform that integrates physics-based modeling with generative machine learning. The company believes PQ203 could unlock new frontiers in oncology by combining high specificity with novel mechanisms of action. The Phase I study is expected to begin at Princess Margaret Cancer Centre in Toronto, with expansion to U.S. clinical sites later this year. About PQ203 PQ203 is the company's first internally owned AI designed peptide therapeutic entering the clinic. PQ203 is a novel Peptide Drug Conjugate composed of a peptide targeting the Sortilin receptor conjugated to the cytotoxic agent monomethyl auristatin E. The Sortilin receptor is expressed in a high percentage of diseased tissue from Triple Negative Breast Cancer (TNBC) patients and as such represents a novel target for this challenging sub-type of breast cancer. ProteinQure has generated data that PQ203 exhibits potent efficacy in multiple patient-derived xenograft (PDX) models including those resistant to Sacituzumab Govitecan (Trodelvy™), an antibody drug conjugate that is the emerging standard of care for metastatic TNBC.
Yahoo
28-03-2025
- Health
- Yahoo
Genmab's Tivdak approved in Japan for advanced cervical cancer
Genmab has received approval from the Japan's Ministry of Health, Labour and Welfare for Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that progressed on or following chemotherapy. This is the first approval of an antibody-drug conjugate (ADC) for cervical cancer patients in the country. The approval is grounded on the open-label Phase III innovaTV 301 clinical trial data that assessed the safety and efficacy of the therapy against chemotherapy. The trial comprised 502 participants, 101 of whom were Japanese. It met the overall survival (OS) goal, which was its primary endpoint, showing a 30% decrease in the mortality risk against chemotherapy. Genmab chief development officer and executive vice-president Judith Klimovsky stated: 'As a company, we understand the urgent need of patients with advanced cervical cancer whose disease has progressed. 'This approval marks an important step forward in transforming the treatment paradigm in Japan, ultimately bringing new hope and possibility to patients and their loved ones.' The trial was conducted by Seagen in partnership with Genmab, the Gynecologic Oncology Group (GOG) Foundation and the European Network of Gynaecological Oncological Trial Groups, along with other international gynaecological oncology co-operative groups. Pfizer acquired Seagen in December 2023. Tivdak comprises Genmab's human monoclonal antibody directed to tissue factor (TF) with the ADC technology of Pfizer, which leverages a protease-cleavable linker covalently attaching the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Genmab and Pfizer jointly developed and commercialised the antibody worldwide, sharing profits and expenses under their agreement. In Japan and global regions other than China and the US, Genmab spearheads commercialisation for previously treated recurrent or metastatic cervical cancer. "Genmab's Tivdak approved in Japan for advanced cervical cancer" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
