ABM Announces First Patient Dosed in Phase I Clinical Trial of MEK Inhibitor for Solid Tumor

SAN DIEGO and SHANGHAI, May 4, 2023 /PRNewswire/ -- ABM Therapeutics, an innovative clinical-stage biopharmaceutical company, with an emphasis on developing drugs with high blood–brain barrier (BBB) penetration for CNS diseases including brain metastases, today announced that the first patient was successfully dosed with ABM-168 in the United States.

MEK (mitogen-activated protein kinase kinase), a key kinase of the MAPK pathway, is frequently activated in various cancers, including those with RAS mutations. These mutations are present in 20% of human cancers and 20-30% of NSCLC. ABM-168, a novel small molecule MEK inhibitor developed by ABM, exhibits good water solubility, high cell permeability and brain penetration. Preclinical studies have clearly demonstrated its anti-cancer properties, particularly in intracranial animal models.

"The dosing of the first patient with ABM-168 in the USA represents another important milestone for ABM. ABM-168 is a strategically important program for ABM's development of combination therapies," Dr. Chen Chen, founder and CEO of ABM Therapeutics said. "Selective MEK inhibitors have the ability to inhibit tumor growth and induce cell death in RAF- and RAS-mutant cell lines. A MEK inhibitor in combination with a BRAF inhibitor has been demonstrated to be more effective and less toxic than a single BRAF inhibitor, which has become the standard of care for patients with BRAF-mutated melanoma. The combination of a MEK inhibitor with other anti-cancer drugs such as KRAS inhibitors and PD-1/PD-L1 antibodies is also explored. We look forward to the early clinical data which will help us to figure out the most effective combination for treating cancers, particularly those with high brain metastasis rates."

This phase I clinical trial in the US is a first-in-human multicenter, open-label, dose escalation and cohort expansion study, which is intended to assess the safety, tolerability, and pharmacokinetics of ABM-168 monotherapy in adult patients with advanced/metastatic solid tumors.

"We are very pleased to reach our study's first patient dosed milestone at NEXT Oncology - Dallas, one of the clinical trial centers for this novel MEK inhibitor and collaborate with all study sites and investigators," said Dr. Zane Yang, CMO of ABM, "ABM will strive for ABM-168 clinical development to fulfill unmet medical needs and offer more therapeutic options. This makes a major step for our mission, passionate about developing drugs and improving patients' quality of life."

As a clinical-stage biotechnology company, ABM Therapeutics has built a broad pipeline to construct a robust proprietary Brain-Penetrant Kinase Drug Discovery Platform (BPKdd^TM). Its first drug candidate ABM-1310, the next generation of BRAF inhibitor, is under clinical studies in both the US and China and has shown good safety profile including tolerability. ABM Therapeutics is in the process of Series B+ round financing, and looks forward to cooperating with international pharmaceutical companies, domestic and foreign biopharmaceutical companies, and securities and funds.

About ABM-168

ABM-168 is a novel small molecule MEK inhibitor with high water solubility, cell and brain permeability. It has demonstrated anti-cancer efficacy in vitro in multiple cancer cell lines and in vivo in multiple xenograft animal models. It was granted clearance of the Investigational New Drug (IND) application to proceed with the first-in-human clinical trial in October 2022 by the US FDA. More information about ABM's ongoing ABM-168 trial is available at https://www.clinicaltrials.gov/ct2/show/NCT05831995 (NCT 05831995) and on the company website at www.abmtx.com.

About ABM Therapeutics

ABM Therapeutics, a clinical-stage biopharmaceutical company with a mission to focus on small molecule research and development of novel drugs for the treatment of cancer, and on brain cancer and cancer metastases. ABM has been building a broad and robust proprietary pipeline to construct a brain medicine R&D platform. ABM's pipeline includes several programs in various stages of discovery and development, most of which have improved brain permeability to address the unmet needs of treating cancers and metastases in the brain.

SOURCE ABM Therapeutics