Latest news with #ProteinQure
National Post
07-08-2025
- Business
- National Post
ProteinQure Receives Regulatory Clearance to Initiate Phase I Trial for PQ203 in the U.S. and Canada; Granted FDA Fast Track Designation
Article content Article content TORONTO — 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. Article content 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. Article content 'This is a major step forward for ProteinQure and for the field of rationally designed peptide therapeutics,' Article content said Dave Garman, VP Translation and Development at ProteinQure. Article content '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.' Article content 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. Article content 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. Article content About PQ203 Article content 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. Article content Article content Article content
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.
National Post
28-05-2025
- Business
- National Post
ProteinQure Raises Series A Financing to Advance First AI-Designed Peptide Therapeutic into Clinical Trials
Article content TORONTO — ProteinQure Inc., a biotechnology company pioneering computational peptide therapeutics, announced today the close of an $11 million Series A financing round. The proceeds will support the initiation of the company's first clinical trial for PQ203, a first-in-class peptide-drug conjugate for triple-negative breast cancer (TNBC), and the advancement of additional pipeline programs in neurology and nephrology. The financing round was led by Tom Williams of Heron Rock Fund, with participation from Golden Ventures, Kensington Capital, and select returning investors. This brings ProteinQure's total funding to $16 million across seed and Series A rounds. Article content Article content 'With this financing, we're advancing what we believe to be the first AI-designed peptide therapeutic into the clinic. It's a defining moment for ProteinQure and for the field,' said Lucas Siow, CEO and co-founder of ProteinQure. 'The support from new and returning investors allows ProteinQure to advance a new class of medicines that underscores the strength of our platform. With this foundation in place, we're ready to generate clinical validation of how our next-generation peptide design platform can unlock previously unreachable targets and tissues.' Article content ProteinQure's lead candidate, PQ203, is a first-in-class peptide-drug conjugate designed to target the sortilin receptor, which is overexpressed in many solid tumors, including TNBC. The drug is being developed for tumors resistant to topoisomerase I inhibitors (e.g., antibody-drug conjugates like Trodelvy ®), based on robust preclinical evaluation in patient-derived xenograft models. Article content The upcoming multicenter phase 1 clinical trial is anticipated to open in the third quarter of 2025 with planned enrollment of 70-100 patients across Canada and the United States at world-renowned cancer centers, including Princess Margaret Cancer Centre, MD Anderson Cancer Center, and Yale Cancer Center. Article content 'We're witnessing the birth of a new drug class – AI-engineered peptide therapeutics – and ProteinQure is at the forefront,' said Mr. Williams. 'Ever since leading the pre-seed round of ProteinQure, I believed that ProteinQure's approach to building both proprietary data libraries and learning models would advantage the Company in a world where AI played a significant role in the drug discovery process. Heron Rock's decision to lead the Series A was an easy one: ProteinQure has demonstrated true platform capabilities for designing non-canonical peptide therapeutics with exceptional specificity and drug-like properties and they've gone from concept-to-clinic with remarkable capital efficiency.' Article content About ProteinQure Article content ProteinQure is redefining peptide therapeutics with a drug discovery platform that goes beyond the limits of traditional drug design. At the core is ProteinStudio™, a proprietary platform that integrates machine learning, structural biology, and atomic-level simulations to design therapeutic peptides using thousands of non-natural amino acids, enabling tissue-specific delivery and access to novel target classes. From cytotoxic payloads to RNA delivery, our precision-designed peptides deliver diverse payloads and unlock previously inaccessible targets with broad potential across oncology, neurology, nephrology, and rare disease. Headquartered in Toronto, ProteinQure is advancing a robust internal pipeline and partnering with global biopharma to accelerate the future of programmable peptide medicines. For more information, visit Article content Article content Article content Article content Article content
