FDA Clears Phase 1 Trial of MRANK-106 in Advanced Solid Tumors

US FDA

• The FDA has cleared the investigational new drug (IND) application for MRANK-106, a first-in-class dual WEE1/YES1 kinase inhibitor for advanced solid tumors.
• Preclinical data show superior efficacy, reduced hematotoxicity, and broad activity in pancreatic, lung, ovarian, breast, and colorectal cancers.
• Phase 1 trials of the agent will launch in 2025 to evaluate its safety, tolerability, and antitumor activity.

The FDA has cleared the IND application for MRANK-106, allowing for the initiation of phase 1 clinical trials in 2025 to target advanced or metastatic solid tumors, including pancreatic cancer, small cell lung cancer, ovarian cancer, breast cancer, and colorectal cancer.¹

MRANK-106 is a first-in-class, orally available dual inhibitor of WEE1 and YES1 kinases. The agent is set apart from other WEE1 inhibitors in development through its unique dual-targeting mechanism.

The upcoming phase I trial will evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MRANK-106 for the treatment of patients with advanced or metastatic solid tumors.

"The FDA IND clearance of MRANK-106 is a significant milestone for MindRank and validates the potential of our AI-driven approach to drug discovery. As the company's second clinical-stage pipeline following our GLP-1 program, MRANK-106 demonstrates the versatility and reproducibility of our Molecule Pro platform in designing innovative therapies for undruggable targets," said Zhangming Niu, PhD, founder and chief executive officer of MindRank, in a press release.

MRANK-106 works by simultaneously inhibiting WEE1 and YES1 kinases; the compound leverages synergistic antitumor effects. Preclinical studies of the agent have demonstrated that MRANK-106 exhibits superior efficacy both as a single agent and in combination therapies across a range of cancer models.

In addition, MRANK-106 has preferential distribution in tissues and tumors over plasma, with a selectivity range of 10- to 120-fold, which is expected to reduce the hematotoxicity that is commonly associated with WEE1 inhibition.

Preclinically, MRANK-106 has shown potent antitumor activity, a favorable pharmacokinetic profile, and strong safety characteristics. Specifically, the compound has shown robust efficacy in models of pancreatic cancer, small cell lung cancer, ovarian cancer, breast cancer, and colorectal cancer.

"By simultaneously targeting WEE1 and YES1 kinases, MRANK-106 has demonstrated remarkable preclinical efficacy in multiple hard-to-treat cancers with limited treatment options. We look forward to evaluating its potential in patients,” added Niu in the press release.

REFERENCE:

1. Dual WEE1/YES1 kinase inhibitor MRANK-106 secures FDA IND clearance, positioning MindRank in first-in-class oncology pipeline. News release. March 7, 2025. Accessed March 7, 2025. https://tinyurl.com/566au32b