PQ-203 / ProteinQure - LARVOL DELTA

PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: ProteinQure Inc.

New P1 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

ProteinQure Announces First Patient Dosed in Phase I Clinical Trial of PQ203 in Advanced Metastatic Cancer (Businesswire) - "The Phase 1 trial is a first-in-human trial with three parts: dose escalation, dose expansion (in multiple tumor types), and dose optimization. The study will evaluate the safety, tolerability, pharmacokinetics, preliminary activity, and pharmacodynamics of PQ203."

Trial status • Solid Tumor

ProteinQure Receives Regulatory Clearance to Initiate Phase I Trial for PQ203 in the U.S. and Canada; Granted FDA Fast Track Designation (Businesswire) - "ProteinQure...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....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."

Fast track • IND • New P1 trial • Triple Negative Breast Cancer

ProteinQure to Present Data on PQ203, a Novel Peptide-Drug Conjugate for Triple Negative Breast Cancer, at 2024 San Antonio Breast Cancer Symposium (ACCESSWIRE) - "ProteinQure...will be presenting compelling new data on the progress of their lead triple negative breast cancer (TNBC) drug PQ203 (December 12, 2024 presentation ID: P4-12-17) at the 2024 San Antonio Breast Cancer Symposium....ProteinQure has recently generated data that PQ203 exhibits potent efficacy in a patient-derived xenograft (PDX) model resistant to Sacituzumab Govitecan (Trodelvy), an antibody drug conjugate that is the emerging standard of care for metastatic TNBC. Additionally, PQ203 has shown an encouraging safety profile. Based on these findings as well as earlier in vivo efficacy studies, ProteinQure has initiated GLP-toxicology studies for PQ203 in support of an anticipated investigational new drug application filing in Q2 of 2025....Phase 1a/b trial initiation for PQ203 is planned for the second half of 2025 and will be coordinated at the Princess Margaret Cancer Center in Toronto and other leading hospitals in North America."

IND • New P1 trial • Preclinical • Triple Negative Breast Cancer

ProteinQure Announces A Breakthrough Therapeutic with Remarkable Efficacy in Heterogenous Patient-Derived Xenograft Models of Triple-Negative Breast Cancer to be presented at AACR (ACCESSWIRE) - "ProteinQure...announces a significant breakthrough in the fight against triple-negative breast cancer (TNBC). The novel Peptide Drug Conjugate (PDC) designed by ProteinQure demonstrated exceptional efficacy in a comprehensive suite of Patient-Derived Xenograft (PDX) models....The drug candidate was tested across a broad range of breast cancer models. The results demonstrated remarkable antitumor efficacy, including cancers resistant to standard chemotherapies and antibody-drug conjugates."

Preclinical • Triple Negative Breast Cancer