- CR or mCR in 86% of patients within the first 12 months

- Venetoclax-resistant secondary AML transformed from CMML responds to lenzilumab

BURLINGAME, CA / ACCESS Newswire / November 4, 2025 / Taran Therapeutics ("Taran") a privately held company focused on hematology/oncology, announced American Society of Hematology ("ASH") accepted abstracts for lenzilumab ("LENZ") at the 67th. ASH medical conference to be held December 4-7, 2025, in Orlando, FL.

Abstract number abs25-9821, titled ‘Durable efficacy of lenzilumab plus azacitidine in newly diagnosed proliferative CMML patients: Interim analysis after four years of study commencement', authored by Devendra Hiwase et al, will be available to view and discuss at the ASH conference on Sunday, December 7, 5.30-7.30 pm EST in West Halls B3-B4. The authors concluded that LENZ/AZA resulted in durable CRs beyond 12 months, with 86% of subjects achieving a CR or mCR without significant LENZ related toxicity.

The abstract describes updates from the PREACH-M Phase 2/3 study in 54 treatment-naive CMML adults, stratified according to mutation status. Subjects exhibiting RAS-pathway mutations (NRAS, KRAS, CBL, PTPN11, NF1, BRAF) receive 24 cycles of LENZ and azacitidine ("AZA") therapy, while those with TET2 mutations and no RAS-pathway mutations receive the same AZA regimen and sodium ascorbate. The primary endpoint is the frequency of complete response (CR) or marrow complete remission (mCR) at any point during the first 12 cycles determined by the Savona Criteria.

As of May 30, 2025, 40 subjects were enrolled overall, with 19 receiving >12 months of treatment. 32 subjects were enrolled in the LENZ/AZA arm (11 females, 21 males; mean age 73; mean white cell count 20x10^9/L; mean Hb 108 g/L; mean platelet count, 74x10^9/L; mean blast count, 8%). Mutations included CBL (50% of subjects), ASXL1 (50%), NRAS (31%), KRAS (47%), PTPN11 (6%), BRAF (1%) and TET2 (72%). The LENZ/AZA arm will be fully enrolled with 36 subjects.

The majority of the 32 LENZ/AZA subjects exhibited high-risk CPSS-MOL scores (n=21), with seven (7) subjects exhibiting intermediate risk 2 and four (4) intermediate risk 1. Overall, subjects had completed a median number of 17 cycles of LENZ/AZA at the time of reporting.

81% (26) of subjects had not progressed, two (2) went to allogeneic transplant (of which one had progressive disease), 9% (three subjects) had progressive disease (of which one was transplanted), one discontinued and one deceased. 22 subjects had evaluable responses within the first 12 months.

Regardless of whether results were assessed according to IWG 2006 or Savona Criteria, 86% of patients attained a CR or mCR or optimal marrow response within the first 12 months on treatment, with the majority attaining such responses by month 3. Bone marrow blast counts decreased from a mean of 8% at baseline to 3% at 3 months (P=0.0001), 3% at 6 months (P=0.0005) and 4% at 12 months (P=0.008). Hemoglobin improved from 111 g/L to 124 g/L at 12 months.

The second abstract, number abs25-10365, titled ‘Secondary Acute Myeloid Leukemia transformed from chronic myelomonocytic leukemia is strongly resistant to venetoclax but demonstrates sensitivity to anti-GM-CSF lenzilumab immunotherapy' authored by Kelly Lim et al, will be available to view and discuss at the ASH conference on Saturday, December 6, 6-8pm EST in West Halls B3-B4.

Secondary acute myeloid leukemia ("sAML") arising from prior myelodysplastic syndrome or chronic myelomonocytic leukemia accounts for 20-30% of AML cases. Published reports from the South Australian Registry show a dismal median overall survival of sAML of 3.5-3.7 months. Decreased sensitivity to venetoclax ("VEN") in monocytic phenotypes has been reported. The authors observed a durable response to LENZ in combination with AZA in patients with high blast count CMML and increased risk of AML transformation in the PREACH-M trial (ACTRN 1262100022383).

In vitro testing of 6 of 7 sAML showed VEN IC50 greater than 500 nM (P=0.04) confirming strong resistance to VEN inhibition. 4 of 6 were able to form colonies in the absence of exogenously supplied cytokines. Crucially, 4 of 4 sAML that were able to form spontaneous colonies were inhibitable by 20µg/mL LENZ (P=0.003) suggestive of an autocrine source of GM-CSF driving sAML proliferation targetable by LENZ. The authors developed a short-term liquid culture assay for in vitro LENZ sensitivity testing and found that the viability of CD45+ mononuclear cells was significantly reduced following 5 days treatment with LENZ (P=0.006) consistent with the colony-forming assay (P=0.0001) of the same patient sample.

Colony suppression by LENZ was significantly greater than VEN or AZA alone or in combination (vs. VEN, P=0.0004; vs. AZA, P=0.0002; vs. VEN+AZA, P=0.007) but comparable to VEN/AZA/LENZ triple therapy.

Based on these data, the authors treated an end-stage patient with sAML transformed from CMML and resistant to VEN/AZA (after 8 cycles) with VEN/AZA/LENZ triple therapy (100 mg PO VEN D1-D28, AZA 75 mg/m2 D1-D7, LENZ 552 mg D1 and D15 given as a 35-day cycle). The subject showed durable response following 10 cycles of triple therapy and remains on treatment with clinical improvement in weight (73 to 76 kg) and quality of life with no acute admissions over 11 months. Triple therapy was well tolerated. The subject remained transfusion independent throughout all 10 cycles. Bone marrow blast percentage decreased from 20% at baseline to 7% after cycle 3 and 13% after cycle 6, with improvements in platelet count and hemoglobin and normal lactate dehydrogenase levels.

The authors demonstrated for the first time that VEN-resistant sAML transformed from CMML showed sensitivity and clinical improvement with LENZ treatment, representing a possible advancement in the management of VEN-resistant AML.

About the PREACH-M Trial

PREACH-M (PREcision Approach to CHronic Myelomonocytic Leukemia) is a Phase 2/3, non-randomized, open-label clinical trial investigating precision medicine for treatment-naïve adults with CMML, assessing treatment response rates after administration of lenzilumab alongside azacitidine in patients with RAS pathway mutations. The study also measures the patients' quality of life, using the MPN Symptoms Assessment Form: Total Symptom Score.

During the active treatment phase of the study, participants are required to attend clinic visits on Days 1 & 15 of the first cycle, and then on Day 1 of each subsequent 28-day cycle to assess safety and tolerability. Participants' disease response assessments are scheduled after 3, 6, 12 and 24 cycles of therapy to measure disease response. Assessments include regular blood tests, bone marrow aspirate and trephine, ultrasound of the spleen, physical exam and assessment of transfusion requirements and clinical symptoms.

Participants who complete 24 cycles of active treatment enter the follow-up phase of the study where they are followed up every 6 months for 24 months for survival, disease status and further CMML-related treatment. For patients with confirmed progressive disease or relapse during the active treatment phase of the study, further study treatment will cease. Patients remain on study and are followed up for disease status, survival, and further CMML-related treatment until 48 months from Cycle 1, Day 1. During the follow-up period, participants no longer receive any investigational drugs but are permitted to receive any CMML treatment at the discretion of the treating clinician under compassionate use.

As part of the screening process, participants are required to have a bone marrow aspirate and trephine to test for certain acquired mutations that can be present in CMML. The study has enrolled participants with TET2 and/or RAS pathway mutations. Participants with RAS pathway mutations or both TET2 and RAS mutations, receive azacitidine (administered subcutaneously at a dose of 75mg/m2 on Days 1-5, 8-9 or Days 1-7 for a total of 7 doses per 28-day cycle) in combination with lenzilumab (administered intravenously at a dose of 552mg on Days 1 & 15 of Cycle 1. Day 1 only for all subsequent cycles).

The trial is sponsored by the South Australian Health and Medical Research Institute ("SAHMRI") and funded by a Medical Research Future Fund grant from the National Health and Medical Research Council of the Australian government to the University of Adelaide. Taran provides lenzilumab for use in the study through its Australian subsidiary.

Additional information is available on the Australian New Zealand Clinical Trials Registry (www.anzctr.org.au).

About Taran Therapeutics

Taran Therapeutics ("Taran"), is a clinical-stage biopharmaceutical company focused on developing lenzilumab ("LENZ") a first-in-class humanized monoclonal antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor, which may be described as a myeloid inflammatory factor. GM-CS has bene demonstrated to be a key growth factor in the development of CMML and potentially other myeloid conditions. LENZ is being developed as a treatment for CMML, AML and other adjacent myeloid disorders, as well as to prevent toxicities associated with CAR-T therapy through investigator-initiated trials. Taran is also developing several antibody drug conjugates (ADCs) utilizing its EphA-3 targeted humanized monoclonal antibody ifabotuzumab ("IFAB") for solid tumors. For more information, visit www.tarantherapeutics.com.

Forward-Looking Statements about Taran Therapeutics

All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to continue as a going concern; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation or arbitration; and the various risks and uncertainties described in the "Risk Factors" sections of our latest annual and quarterly reports and other filings with the SEC.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

Taran Therapeutics Contact
[email protected]

SOURCE: Taran Therapeutics



View the original
on ACCESS Newswire


Information contained on this page is provided by an independent third-party content provider. XPRMedia and this Site make no warranties or representations in connection therewith. If you are affiliated with this page and would like it removed please contact [email protected]