On March 11, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported that it has entered into a Material Transfer Agreement (MTA) with MD Anderson Cancer Center (Press release, Aprea, MAR 11, 2025, View Source [SID1234651064]). Under the agreement, Aprea will supply its proprietary WEE1 kinase inhibitor, APR-1051, to support preclinical research aimed at exploring its potential in treating HPV+ and HPV- head and neck squamous cell carcinoma (HNSCC) expressing genomic markers of replication stress.

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The agreement will enable the research group at MD Anderson to conduct a series of pre-clinical experiments designed to generate preliminary efficacy and mechanistic data to support future clinical trials and treatment regimens. The goal of this research is to further characterize the therapeutic potential of APR-1051 in HNSCC and generate insights that could support future clinical development strategies. The studies will include combining APR-1051 with immune checkpoint inhibitors (ICIs) to treat both HPV+ and HPV- HNSCC tumors harboring genomic markers of replication stress. The project is being overseen by Professors Jeffrey N. Myers, M.D., Ph.D., F.A.C.S., and Abdullah A. Osman, Ph.D., both from the Department of Head and Neck Surgery, MD Anderson Cancer Center. Prof. Myers is the leading expert on head and neck cancers.

"This agreement with MD Anderson Cancer Center underscores our commitment to leveraging strong academic partnerships to advance our pipeline of DDR inhibitors" said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "HNSCC represents a major global health burden, and prior work conducted at MD Anderson, and published by Professors Myers, Osman and their colleagues, suggests that WEE1 kinase may present a promising therapeutic target. We look forward to the insights that will emerge from this important research."

Head and neck cancers, particularly those associated with HPV infection, present significant clinical challenges. WEE1 kinase inhibition represents a novel therapeutic strategy by targeting the effectiveness of DNA damage response, potentially enhancing the sensitivity of cancer cells to existing treatments.

A high proportion of HNSCC cases are attributable to HPV. An estimated 70% of the 20,000 cases of OPSCC (HNSCC that occurs in the oropharynx) seen annually in the US are attributable to HPV. Although these HPV+ tumors generally have a better prognosis than their HPV- counterparts, standard of care chemotherapy and radiation is very toxic and surviving patients often face a lifetime of difficulties. The group at MD Anderson was the first to observe that HPV+ HNSCC tumor lines are very sensitive to WEE1 kinase inhibition both in vitro and in vivo. Their findings were published in a paper in Clinical Cancer Research in 2015. The researchers also showed in their previous experiments that a subset of HPV- HNSCC tumors may also be susceptible to this mechanism.

Under the terms of the agreement, Aprea will retain all rights, title, and interest in APR-1051.

APR-1051 is a potent and selective small molecule that has been designed to potentially solve tolerability challenges of the WEE1 class and may achieve greater clinical activity than other programs currently in development. The candidate is currently being tested in the ongoing ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051) clinical trial. This Phase 1 clinical trial is evaluating single-agent APR-1051 in patients advanced solid tumors harboring cancer-associated gene alterations.