Quanta Begins Phase 1/1b Trial with First Patient Dosed for QTX3046 and Provides Program Updates

Quanta Therapeutics, a clinical-stage biopharmaceutical company specializing in the development of innovative oral therapies for cancers driven by RAS mutations, has announced significant advancements in its pipeline of KRAS-directed drug candidates. The company has initiated two clinical trials aiming to treat patients with advanced solid tumors harboring KRASG12D mutations.

The first clinical trial is a Phase 1 study focusing on QTX3046, a novel, orally bioavailable, brain-penetrant, non-covalent allosteric inhibitor specifically targeting the KRASG12D mutation. This trial has successfully dosed its first patient and is currently enrolling additional participants. The goal is to assess the safety, tolerability, and pharmacokinetic properties of QTX3046.

Simultaneously, Quanta Therapeutics has commenced the combination portion of another Phase 1 clinical trial evaluating QTX3034. This drug is a G12D-preferring multi-KRAS inhibitor being tested in conjunction with cetuximab, an EGFR inhibitor. This combination aims to treat patients with KRASG12D-mutated colorectal cancer. The trial is now in the dose escalation phase, enrolling patients to determine the maximum tolerated dose and recommended Phase 2 dosage.

Quanta has also launched GLP toxicology studies for QTX3544, a multi-KRAS inhibitor with a preference for the G12V mutation. These studies are essential steps toward an investigational new drug (IND) submission, anticipated in the fourth quarter of 2024.

Chief Medical Officer Leonardo Faoro highlighted that the company's dual approach with KRAS inhibitors aims to address the challenges presented by G12D-mutated cancers. Faoro noted that combining KRAS and EGFR inhibitors has shown promising efficacy in multiple KRASG12C-mutated tumor types, and similar breakthroughs are anticipated for the more prevalent G12D mutation with Quanta's oral small molecules.

Perry Nisen, Chief Executive Officer, emphasized that Quanta's chemically distinct KRAS inhibitors are well-positioned to address the significant unmet needs of patients with KRAS-mutated cancers beyond the G12C mutation. He noted that the company's proprietary research and translational platform has enabled the development of potentially best-in-class profiles for RAS-driven cancers.

The Phase 1 trials for QTX3034 and QTX3046 are enrolling patients with KRASG12D mutations in various advanced solid tumors such as pancreatic, colorectal, lung, and endometrial cancers. The trials aim to evaluate safety, tolerability, pharmacokinetic properties, antitumor activity, and molecular markers. Clinical sites across the United States are participating in these studies.

Quanta Therapeutics is a private biopharmaceutical company based in South San Francisco, CA, with a site in Radnor, PA. The company focuses on targeting RAS, the most frequently mutated oncogene in cancers, by developing novel small molecule cancer medicines. Quanta's unique platform utilizes Second Harmonic Generation (SHG) optical technology to identify allosteric modulators of protein complexes, a key to oncogenic RAS activity.

The company has extensive expertise in drug development and research within the RAS space. Its KRAS inhibitor pipeline includes three main programs: QTX3034, a multi-KRAS inhibitor with G12D-preferring activity; QTX3046, a G12D-selective KRAS inhibitor; and QTX3544, a multi-KRAS inhibitor with G12V-preferring activity, which is expected to file for IND in late 2024.

These advancements underscore Quanta's commitment to addressing the challenges of RAS-driven cancers and providing new therapeutic options for patients with these difficult-to-treat malignancies.