On March 25, 2024 Edgewood Oncology, a clinical-stage biotechnology company focused on delivering BTX-A51 to patients with hematologic malignancies and genetically-defined solid tumors, reported to have emerged from stealth with $20 million in Series A financing backed by Alta Partners to advance the clinical development of BTX-A51 in acute myeloid leukemia (AML) and a precision medicine approach to breast cancer (Press release, Edgewood Oncology, MAR 25, 2024, View Source [SID1234641424]). BTX-A51 is a first-in-class, small molecule, multi-kinase inhibitor of casein kinase 1 alpha (CK1), cyclin-dependent kinase 7 (CDK7) and CDK9 that synergistically co-targets master regulators of cancer to promote programmed cell death, or apoptosis.

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Edgewood acquired the rights to BTX-A51 from Yissum, the technology transfer company of The Hebrew University of Jerusalem, in 2023 and will use the Series A funding to advance efficacy studies in AML and breast cancer.

"We formed Edgewood Oncology because of the synergistic mechanism of action and promising safety and anti-tumor data that was observed with BTX-A51 in Phase 1 in AML and solid tumor patients. We look forward to further developing this compound using a precision medicine approach in patient populations who lack effective treatment options," said David N. Cook, Ph.D., chief executive officer, Edgewood Oncology. "Furthermore, we have taken a virtual approach to drug development, which allows us to remain highly-focused, agile and efficient as we advance this investigational compound in the clinic."

Testing the Use of Combination Therapy in AML

There exists a significant unmet need for improved first-line regimens in AML as well as for patients with relapsed or refractory (R/R) disease. In a Phase 1 study in heavily pre-treated R/R AML patients, monotherapy BTX-A51 demonstrated a favorable safety profile and encouraging antileukemic activity. As a next step, Edgewood initiated a study of BTX-A51 in combination with azacitidine in R/R AML patients in December 2023. The aim of this Phase 2, multicenter, open-

label study is to evaluate the response rate (CR, CRh and CRi) as well as the safety, toxicity and pharmacokinetics of BTX-A51 in combination with azacitidine in patients with R/R AML.

"We’re incredibly excited about the potential of BTX-A51in this patient population, and we also have good reason to believe that BTX-A51 could be complementary to standard of care in first-line unfit AML," said Zung Thai, M.D., Ph.D., chief medical officer, Edgewood Oncology. "In Phase 1 monotherapy, we observed several complete responses and a wide therapeutic window and our preclinical data also suggest that BTX-A51 acts synergistically with both azacitidine and venetoclax in human leukemia cells and animal models."

Edgewood is expecting to initiate a Phase 2 study in breast cancer in patients with a genetically-defined profile in Q2 2024.

Leadership Team Comprised of Seasoned Biotech Veterans

"Edgewood’s leadership team not only has a strong track record in company formation and drug development, but Dr. Thai brings an in-depth understanding of BTX-A51, having led all clinical and regulatory efforts for this program during his tenure at BiotheryX," said Dan Janney, managing partner, Alta Partners. "Moreover, we believe Edgewood’s virtual approach to drug development is the best strategy to get innovative new medicines to patients as quickly and efficiently as possible."

The executive team includes Dr. Cook as chief executive officer, and Dr. Thai as chief medical officer. BTX-A51’s scientific founder is Yinon Ben-Neriah, M.D., Ph.D., professor of Immunology and Cancer Research, The Hebrew University of Jerusalem. The company’s board of directors includes Dr. Cook, Dan Janney, and Isan Chen, M.D., a noted clinical oncologist and co-founder, president and chief executive officer, MBrace Therapeutics, Inc.