QTX3034 / 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

A phase 1 trial evaluating the safety, tolerability, PK, and preliminary efficacy of QTX3034, an oral G12D-preferring multi-KRAS inhibitor, in patients with solid tumors with KRAS G12D mutation. (ASCO 2024) - P1 | "To further optimize the recommended dose, patients will be randomized between two dose levels in the pancreatic cancer cohort. QTX3034 plus cetuximab will be explored following identification of a recommended combination dose in patients with CRC."

Clinical • P1 data • Endometrial Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

QTX3034-001: QTX3034 in Patients With KRAS G12D Mutation (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: Quanta Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • KRAS

QTX3034-001: Evaluate QTX3034 in Patients With KRAS G12D Mutation (clinicaltrials.gov) - P1 | N=250 | 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 Announces IND Clearance by U.S. FDA for QTX3034, G12D-Preferring Multi-KRAS Inhibitor, and Other Pipeline Updates (GlobeNewswire) - "The QTX3034 Phase 1 clinical trial will initially enroll patients with KRASG12D mutations in dose escalation cohorts as monotherapy and in combination with cetuximab. Dose expansion cohorts consist of patients with KRASG12D-mutant pancreatic, colorectal, lung, and endometrial cancers. Endpoints include safety and tolerability, determination of the maximum tolerated dose/ recommended Phase 2 dose, pharmacokinetic properties, antitumor activity, and molecular markers. The study will be conducted at clinical sites in the US."

Clinical protocol • Colorectal Cancer • Endometrial Cancer • Lung Cancer • Oncology • Pancreatic Cancer

Quanta Therapeutics Presents Late-Breaking Data for QTX3034, a multi-KRAS inhibitor, at AACR-NCI-EORTC Conference (GlobeNewswire) - "Quanta Therapeutics...announced data from a late-breaking presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 11-15, 2023, in Boston, Massachusetts....The combination of QTX3034 and EGFR (epidermal growth factor receptor) inhibitors, a class of drugs used to treat many commonly occurring cancers, demonstrated potent, synergistic anti-tumor activity in preclinical studies....'These compelling data validate the potential of QTX3034 in combination with EGFR-targeted therapy across multiple cancer types and support the planned evaluation of this combination as part of our Phase 1 clinical development program, which is on track to begin in early 2024'."

Late-breaking abstract • New P1 trial • Preclinical • Oncology

QTX3034, a potent and selective multi-KRAS inhibitor, synergizes with EGFR inhibitors and enhances anti-tumor activity (AACR-NCI-EORTC 2023) - No abstract available

Late-breaking abstract • Oncology • KRAS

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 QTX3034, a potent, selective, and orally bioavailable allosteric KRAS inhibitor (AACR 2023) - "QTX3034 exhibited weak CYP inhibition (direct and time-dependent) with a favorable in vitro off-target selectivity/safety profile. Taken together, this preclinical characterization supports the advancement of QTX3034 into IND-enabling studies for KRAS mutant cancers."

Late-breaking abstract • Oncology • BRAF • KRAS • NRAS

Quanta Therapeutics Presents Data from KRAS Inhibitor Pipeline at Annual AACR Meeting in Late-Breaking Research Session (GlobeNewswire) - "QTX3034...Demonstrated binding affinity to GDP-bound KRAS G12D/V mutant and wild-type proteins; binding prevents GTP exchange and locks KRAS in the GDP-bound inactive state, thereby disrupting the KRAS: RAF1 effector interaction....Exhibited potent, durable, and dose-responsive inhibition of MAPK/KRAS signaling in cells expressing human KRAS variants....Preclinical data support the advancement of QTX3034 into IND-enabling studies for clinical investigation in mutant KRAS-driven solid tumors."

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