QTX3046 / Quanta Therap - LARVOL DELTA

Quanta Announces IND Clearance by U.S. FDA for QTX3544, an Oral G12V-Preferring Multi-KRAS Inhibitor, and Other Pipeline Updates (GlobeNewswire) - "Quanta Therapeutics...announced progress across its pipeline of KRAS-directed drug candidates, including U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application clearance for QTX3544, an oral G12V-preferring, dual ON/OFF state, multi-KRAS inhibitor, enabling initiation of a Phase 1 clinical trial...The Company has also initiated the combination portion of the ongoing Phase 1 clinical trial evaluating QTX3046, an oral KRASG12D-selective dual ON/OFF state allosteric inhibitor, with cetuximab...Additionally, the Phase 1 clinical trial evaluating QTX3034, an oral G12D-preferring multi-KRAS inhibitor, as a monotherapy and in combination with cetuximab, continues to enroll patients, and data is anticipated from this program in 2025."

IND • New P1 trial • P1 data • Colorectal Cancer • Pancreatic Adenocarcinoma • Solid Tumor

Quanta Announces Dosing of First Patient in Phase 1/1b Clinical Trial of QTX3046, an Oral KRASᴳ¹²ᴰ-Selective Dual-State Allosteric Inhibitor, and Other Program Updates (GlobeNewswire) - "Quanta Therapeutics...announced the advancement of two clinical trials from its pipeline of KRAS-directed drug candidates. The first patient has been dosed in the monotherapy portion of a Phase 1 clinical trial evaluating QTX3046, a KRAS^G12D-selective inhibitor, and patient dosing has begun in the combination portion of the ongoing Phase 1 clinical trial assessing QTX3034, G12D-preferring multi-KRAS inhibitor, and cetuximab. Both clinical trials are enrolling patients with KRASG12D-mutated advanced solid tumors. Quanta has also initiated GLP toxicology studies for QTX3544, its G12V-preferring KRAS inhibitor, that will support an investigational new drug (IND) submission anticipated in the fourth quarter of 2024."

IND • Trial status • Oncology • Solid Tumor

QTX3046 in Patients With KRAS G12D Mutations (clinicaltrials.gov) - P1 | N=240 | Recruiting | Sponsor: Quanta Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor • KRAS

QTX3046 in Patients With KRAS G12D Mutations (clinicaltrials.gov) - P1 | N=240 | Not yet recruiting | Sponsor: Quanta Therapeutics

New P1 trial • Oncology • Solid Tumor • KRAS

Quanta Announces IND Clearance by U.S. FDA for QTX3034, G12D-Preferring Multi-KRAS Inhibitor, and Other Pipeline Updates (GlobeNewswire) - "Quanta Therapeutics...announced progress across its pipeline of KRAS-directed drug candidates, including U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application clearance for QTX3034, a multi-KRAS inhibitor with G12D-preferring activity (G12D+ multi-KRAS), enabling the initiation of a Phase 1 clinical trial in the first quarter of 2024. Additionally, QTX3046, a KRASG12D-selective inhibitor continues its advancement through IND-enabling activities positioning the company to file an IND in the first half of 2024. Further, the company has recently selected QTX3544, a multi-KRAS inhibitor with G12V-preferring activity (G12V+ multi-KRAS), as a development candidate, representing Quanta’s third KRAS inhibitor program."

IND • New P1 trial • Oncology • Solid Tumor

Quanta Therapeutics Raises Over $50 Million in Series D Financing to Advance its Pipeline of KRAS Inhibitors (GlobeNewswire) - "The proceeds from the financing will be used to advance Quanta’s pipeline including: Two chemically distinct allosteric KRAS inhibitors, QTX3034, a multi-KRAS inhibitor, and QTX3046, a G12D-selective KRAS inhibitor....These programs are currently in Investigational New Drug Application (IND)-enabling studies to support anticipated clinical trial initiation in KRAS-driven solid tumor indications in 2024."

Financing • New trial • Oncology

Discovery and characterization of QTX3046, a potent, selective, and orally bioavailable non-covalent KRASG12D inhibitor (AACR 2023) - "The systemic clearance in rats and dogs was high to moderate, respectively and despite low apparent permeability, demonstrated good oral bioavailability in each species. The current PK profile and preclinical proof-of-concept data support advancement of QTX3046 into IND enabling studies to support potential clinical investigation in KRASG12D-driven solid tumor indications."

Late-breaking abstract • Colorectal Cancer • Embryonal Tumor • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Quanta Therapeutics Presents Data from KRAS Inhibitor Pipeline at Annual AACR Meeting in Late-Breaking Research Session (GlobeNewswire) - "QTX3046...Exhibited potent, durable, and dose-responsive inhibition of KRASG12D-mediated MAPK signaling and induced apoptotic markers....Demonstrated selective inhibition of KRASG12D-driven cell signaling and proliferation in isogenic cell panels....Preclinical data support the advancement of QTX3046 into IND-enabling studies for clinical investigation in KRASG12D-driven solid tumor indications."

Preclinical • Oncology • Solid Tumor

Quanta Therapeutics Announces Two Late-Breaking Preclinical Presentations from KRAS Inhibitor Pipeline at Annual AACR Meeting (GlobeNewswire) - "Quanta Therapeutics...announced the acceptance of two late-breaking abstracts for presentation at the American Association for Cancer Research (AACR) Annual Meeting being held April 14-19, 2023, in Orlando, Florida....AACR abstracts highlight the Company’s allosteric approach to developing novel, oral small-molecule medicines to treat RAS-driven cancer indications."

Late-breaking abstract • Preclinical • Oncology