Edgewood Oncology (a clinical-stage biotechnology company focused on delivering BTX-A51 to patients with hematologic malignancies and genetically defined solid tumors) has emerged from stealth mode with $20 million in Series A funding 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.
BTX-A51 is a first-in-class, small molecule, and multi-kinase inhibitor of casein kinase 1 alpha (CK1α), cyclin-dependent kinase 7 (CDK7) and CDK9 that co-targets master regulators of cancer to promote programmed cell death (apoptosis).
Edgewood bought 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 for advancing efficacy studies in AML and breast cancer.
There is an unmet need for improved first-line regimens in AML as well as for patients with relapsed or refractory (R/R) disease. And 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 combined with azacitidine in R/R AML patients in December 2023. And the aim of this Phase 2, multicenter, open-label study is to evaluate the response rate (CR, CRh and CRi) and the safety, toxicity and pharmacokinetics of BTX-A51 in combination with azacitidine in patients with R/R AML.
Edgewood plans to initiate a Phase 2 study in breast cancer patients with a genetically defined profile in the second quarter of this year.
The executive team includes Dr. Cook as CEO and Dr. Thai as chief medical officer. And 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 board of directors at the company 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.
KEY QUOTES:
“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. 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.”
– David N. Cook, Ph.D., chief executive officer, Edgewood Oncology
“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. 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.”
– Zung Thai, M.D., Ph.D., chief medical officer, Edgewood Oncology
“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. 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.”
– Dan Janney, managing partner, Alta Partners
