FDA Clears IND for Dual Kinase Inhibitor MRANK-106, Advancing MindRank in Oncology

HANGZHOU, China and LONDON, UK I March 07, 2025 I MindRank, a company specializing in AI-driven drug discovery, has achieved a significant milestone with the U.S. Food and Drug Administration's approval of its Investigational New Drug (IND) application for MRANK-106. This novel orally administered drug acts as a dual inhibitor targeting WEE1 and YES1 kinases, and is intended to treat several challenging cancers, including pancreatic, small cell lung, ovarian, breast, and colorectal cancers.

MRANK-106 stands out from existing WEE1 inhibitors due to its unique mechanism targeting two critical proteins involved in DNA damage response and cancer cell proliferation. This dual inhibition approach offers a promising alternative to single-target therapies, potentially overcoming limitations faced by conventional DNA damage repair inhibitors. Extensive preclinical studies have demonstrated impressive anti-tumor efficacy, a robust pharmacokinetic profile, and favorable safety characteristics for MRANK-106, suggesting its potential as a leading treatment option for cancers with significant unmet needs.

The forthcoming Phase I clinical trial, scheduled for 2025, aims to assess the safety, tolerability, pharmacokinetics, and initial anti-tumor effects of MRANK-106 in patients with advanced or metastatic solid tumors. This trial represents a critical step in evaluating the clinical viability of this innovative therapy.

MindRank's success in advancing MRANK-106 from a preclinical candidate to the IND approval stage is largely attributed to its advanced AI-driven platforms, specifically Molecule Pro™ and PharmKG™. These proprietary technologies have enabled the company to expedite the drug discovery process, facilitating the rapid development of MRANK-106 as its first officially nominated First-in-Class candidate. This achievement underscores MindRank's commitment to pioneering breakthrough therapies for challenging and previously undruggable targets.

Dr. Zhangming Niu, MindRank’s Founder and CEO, expressed confidence in the company’s AI-driven approach, highlighting that the FDA’s IND clearance of MRANK-106 validates their strategy for drug discovery. He emphasized the versatility of the Molecule Pro™ platform, noting its success in creating innovative therapies like MRANK-106 and its role in advancing the company's GLP-1 program to clinical stages. Dr. Niu looks forward to further evaluating MRANK-106’s potential in clinical settings, particularly for patients with limited treatment options.

MindRank leverages its proprietary AI platforms to significantly accelerate the drug discovery process, aiming to deliver differentiated small molecule medicines with clear clinical benefits. The company’s leading asset, MDR-001, an AI-designed oral GLP-1RA small molecule, has already progressed to a phase 2b clinical study, showcasing the effectiveness and potential of MindRank’s AI-driven approach in developing impactful therapies.

In summary, MindRank’s MRANK-106 represents a promising advancement in cancer treatment, with its novel dual-inhibition approach and AI-driven development process. The upcoming clinical trials will be pivotal in determining its effectiveness and safety in real-world applications, potentially offering new hope for patients with difficult-to-treat cancers.