Solu Therapeutics Initiates Dosing in Acute Myeloid Leukemia Cohort of the Ongoing Phase 1 Study of STX-0712

BOSTON, MA, October 8, 2026 - Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, today announced that it has initiated dosing in an acute myeloid leukemia (AML) cohort of the ongoing Phase 1 study of STX-0712, the Company's investigational therapeutic designed to deplete disease-driving CCR2-positive malignant monocytes and CCR2-positive bone marrow progenitors. The cohort will enroll patients with relapsed/refractory monocytic or monocytic-predominant AML.

"Initiating dosing in the AML cohort marks an important milestone for STX-0712 and represents the next step in the development of our Phase 1 study in hematologic malignancies," said Philip Vickers, President and CEO of Solu Therapeutics. "Given the emerging data we have seen in chronic myelomonocytic leukemia and that a significant subset of AML is also driven by CCR2-positive monocytes and progenitors, we're excited to evaluate STX-0712 as a monotherapy in this setting. With limited treatment options for patients with relapsed or refractory disease, we look forward to building a broader clinical dataset and further defining the therapeutic potential of STX-0712."

The Phase 1 study (NCT06950034) is an open-label, multicenter study evaluating the safety, tolerability, recommended Phase 2 dose and preliminary antitumor activity of STX0712 as monotherapy in patients with relapsed/refractory chronic myelomonocytic leukemia (CMML) and AML.