STX-0712 / Solu Therap - LARVOL DELTA

A first-in-human study of stx-0712, a CCR2+ cytotoxicity targeting chimera (CyTAC™) in patients with chronic myelomonocytic leukemia (CMML) and Acute Myeloid Leukemia (AML) (ASH 2025) - P1 | "Expansion of CCR2+ monocytic progenitorsdrives acute transformation in CMML and contributes to venetoclax resistance in AML. Key exploratory endpoints include: (1) assessment of changes in CCR2+ tumorcells following STX-0712 dosing, (2) evaluation of candidate biomarkers, (3) characterization of T cells, Bcells and NK cells at baseline and over the course of treatment, and (4) to explore the effects of STX-0712on patient-reported outcomes using the CMML Symptoms Assessment Tool (MPN-SAF-TSS scoringsystem) and the EuroQoL 5 Dimension 5 level (EQ-5D-5L) for AML. Enrollment for Cohort 1 (CMML) beganin March 2025, and the study is ongoing.Clinical Trial Information: NCT06950034"

Clinical • First-in-human • P1 data • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • CCR2

Solu Therapeutics Announces Presentation of Trial in Progress on STX-0712 for Treatment of Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia at ASH Annual Meeting (PRNewswire) - "The poster will highlight the design of the ongoing Phase 1, open-label, multicenter study, which is evaluating STX-0712 as monotherapy in patients with refractory or resistant CMML and relapsed or refractory monocytic or monocytic-predominant AML."

Clinical protocol • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia

Ex-Vivo Evaluation of Stx-0712, a CCR2 Cytotoxicity Targeting Chimera (CCR2-CyTAC) for the Treatment of Acute Myeloid Leukemia (ASH 2024) - "We present here the characterization of CCR2 expression in AML patient samples, ex vivo depletion of AML malignant monocytes via treatment with STX-0712, and combination efficacy data with Venetoclax (Ven) and Azacitidine (Aza), supporting AML as a promising indication for STX-0712. STX-0712 outperforms Aza+Ven in targeting differentiated monocytic cells, while Ven-Aza outperformed STX-0712 in targeting undifferentiated blasts. Therefore, the improved therapeutic outcome of the combination of STX-0712 and Aza+Ven could be attributed to the differential targeting of subpopulations of pathological cells rather than to additive/synergic effects against individual cells Conclusion : These results demonstrate high and homogenous CCR2 expression on malignant populations, ex vivo human target engagement and pharmacodynamic activity of STX-0712 and support single agent efficacy of STX-0712 in myelomonocytic/monocytic AML and the potential value of combining STX-0712 with Aza+Ven..."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CCR2 • CD34 • ITGAM

Preclinical Evaluation of Stx-0712, a CCR2 Cytotoxicity Targeting Chimera (CCR2-CyTAC) for the Treatment of Chronic Myelomonocytic Leukemia (ASH 2024) - "Conclusion : These results demonstrate high and homogenous CCR2 expression on malignant monocytes, ex vivo human target engagement and pharmacodynamics, and in vivo depletion of CCR2 MO1 monocytes in a potent and dose dependent manner. Based on this data we plan a First in Human, phase 1 clinical trial for patients with relapsed/refractory CMML."

Preclinical • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • CCR2 • CD14 • CD34

New Therapies and Targeted Treatments: MDS/ MPN Overlap Syndromes (SOHO 2025) - "This has led to the use of parenteral azanucleosides — decitabine and azacitidine — and, perhaps most successfully in the United States, the oral agent decitabine/ cedazuridine (Dec-C)...While decitabine led to improved response rates, it failed to show benefit in event-free survival (EFS) or overall survival (OS) over the hydroxyurea arm, 5 raising questions about the role of azanucleosides — at least in MP-CMML — and underscoring the urgent need for disease-specific therapies for patients with MPCMML and other MDS/MPNs...This yielded promising responses, 8 but the arm was closed, as itacitinib was discontinued by the manufacturer...9 Given these findings, in the phase 2 PREACH study in Australia comparing lenzilumab plus azacitidine in untreated, high-risk RAS- mutated CMML, investigators reported a 55% complete response (CR) rate, found to be durable at 18 months...STX-0712 is a cytotoxicity targeting antibody (CyTAC) that links an antibody designed to induce..."

IO biomarker • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • ABL1 • BCR • CCL2 • CCR2 • CSF2 • LILRB4 • SF3B1

Applications of Cytotoxicity Targeting Chimera (CyTACTM) and Therapeutic Index Control Targeting Chimera (TicTACTM) platforms to unlock cellular surface targets to antibody pharmacology (ACS-Fall 2025) - "To illustrate the CyTAC platform, we will share data from our lead compound STX-0712, a CCR2-CyTAC, that uses an ADCC enhanced antibody for the treatment of chronic myelomonocytic leukemia (CMML). To demonstrate the TicTAC platform, we will share pre-clinical validation of our long-acting Nav ion channel antagonists for chronic pain that utilizes an Fc-disabled antibody."

Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • CCR2

CCR2-DIRECTED TARGETING OF MONOCYTIC-BIASED PROGENITOR AND MONOCYTIC POPULATIONS IN CHRONIC MYELOMONOCYTIC LEUKEMIA AND ACUTE MONOCYTIC LEUKEMIA (EHA 2025) - "CCR2 represents an actionable target in CMML and venetoclax-resistant AMoL. STX-0712 can selectively deplete CCR2+ monocyte, progenitor and monoblast populations through direct cytotoxicity and NK-cell mediated cell killing."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • ANXA5 • CCR2 • CD14 • CD34 • NCAM1 • PTPRC

A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML) (clinicaltrials.gov) - P1 | N=105 | Recruiting | Sponsor: Solu Therapeutics, Inc

New P1 trial • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

Solu Therapeutics Closes $41M Series A Financing and Announces First Patient Dosed in Phase 1 Clinical Trial of STX-0712 in Patients with CMML and Other Advanced Hematologic Malignancies (PRNewswire) - "Solu Therapeutics...announced the successful completion of a $41 million Series A financing that included participation from five new investors – Eli Lilly and Company, Biovision Ventures, Pappas Capital, Hengdian Group Capital (HgC), and The Leukemia & Lymphoma Society Therapy Acceleration Program – as well as continued support from existing Solu investors Longwood Fund, DCVC Bio, Santé Ventures, Astellas Venture Management, and Alexandria Venture Investments. The company also announced initiation of treatment of the first patient in its first-in-human Phase 1 clinical trial evaluating STX-0712 in patients with resistant/refractory chronic myelomonocytic leukemia (CMML) and other hematologic malignancies....Proceeds from the Series A financing will be used to complete dose escalation and expansion of the company's lead CCR2-CyTAC program, STX-0712, for the treatment of CMML."

Financing • New P1 trial • Chronic Myelomonocytic Leukemia

Solu Therapeutics Presents Positive Preclinical Data on STX-0712 for…Acute Myeloid Leukemia at ASH Annual Meeting (PRNewswire) - "Preclinical Results for STX-0712 in AML - Key Findings: CCR2 was highly expressed on malignant monocytes from AML patient samples, with cases of acute monocytic leukemia (M5) and acute myelomonocytic leukemia (M4), showing the highest levels of expression. STX-0712 successfully eliminated CCR2-positive malignant monocytes in 80% of patient samples, with up to 74% of cancer cells depleted and an average potency of 3nM. When combined with venetoclax and azacitidine (standard-of-care treatments for AML), STX-0712 improved therapeutic efficacy in 60% of patient samples by differential targeting both CCR2-positive monocytes and undifferentiated blasts."

Preclinical • Acute Myelogenous Leukemia

Solu Therapeutics Presents Positive Preclinical Data on STX-0712 for Chronic Myelomonocytic Leukemia…at ASH Annual Meeting (PRNewswire) - "Preclinical Results for STX-0712 in CMML - Key Findings: CCR2 was highly expressed in >98% of malignant monocytes in peripheral blood and in a subset of CD34+ progenitors in the bone marrow of CMML patients, while minimal or no CCR2 expression was observed in CD34+ progenitor healthy controls. In all patient samples tested, STX-0712 effectively depleted CD14+CCR2+ monocytes, achieving 66–91% cancer cell elimination with an average potency of 3nM."

Preclinical • Chronic Myelomonocytic Leukemia

Solu Therapeutics to Present First Preclinical Data of STX-0712 for the Treatment of Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia at ASH Annual Meeting (PRNewswire) - "Solu Therapeutics...announced that it will present the first preclinical data on STX-0712, its novel CCR2-CyTAC (Chemokine Receptor Type 2 Cytotoxicity Targeting Chimera) for the treatment of chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML). The data will be featured in two poster presentations at the American Society of Hematology (ASH) Annual Meeting, being held December 7-10, 2024, in San Diego, California."

Preclinical • Chronic Myelomonocytic Leukemia