- Notice of Publication received for treatment of CMML with lenzilumab

- Additional data in AML, non-RAS CMML and other conditions adjacent to CMML, may lead to development of treatment for multiple myeloid conditions and a significant scale revenue franchise approach, if approved and commercialized

BURLINGAME, CA / ACCESS Newswire / August 11, 2025 / Taran Therapeutics ("Taran") a privately held company focused on hematology/oncology, and with an almost completely enrolled Phase 2/3 trial with lenzilumab, a monoclonal antibody which neutralizes human granulocyte-macrophage colony-stimulating factor ("GM-CSF") showing benefit in this study in treatment-naïve participants with CMML and RAS-pathway mutations, announced the recent publication of a U.S. Non-Provisional Patent Application. The publication number is US-2025-0154243-A1. Under applicable US law, once an application has been published, it is eligible for Provisional Rights. This means that damages may be available for any infringement occurring after the date of publication. The Notice of Publication confirms this patent application has been published by the United States Patent and Trademark Office and covers the treatment of chronic myelomonocytic leukemia with RAS-pathway mutations using Lenzilumab in combination with current standard of care agents.

CMML is a rare, aggressive cancer in which levels of monocytes, blast cells, and pro-monocytes are significantly elevated from normal levels. These pathologic changes are accompanied by significantly elevated pro-inflammatory markers, including C-reactive protein. Current treatment options for CMML patients are limited to blood transfusions, hydroxyurea, and supportive care alongside the current standard of care, which includes hypomethylating agents such as azacitidine and decitabine, which have limited response rates of 7% to 18%^{1, 2, 3} with no proven increase in overall survival.

In the last 30 years, no new medicines with a novel mechanism of action have been approved for CMML patients who are at high risk of death or disease progression.⁴ About 80% of patients diagnosed with CMML do not survive beyond three years.⁵

"The publication of this patent application adds further strength to the intellectual property and potential exclusivity for lenzilumab," said Taran Therapeutics Founder Cameron Durrant, MD, MBA. "Our strategy would be to utilize this intellectual property to bolster the 12-year exclusivity provision in the US. The timeline of the biologics exclusivity commences from the launch date of the approved biologic, such as lenzilumab. In addition, we would expect to submit for and receive orphan drug designation, which, if granted would convey seven years market exclusivity in the US and differing levels of exclusivity under similar regulatory provisions in other territories. Further, Lenzilumab may be eligible for BreakThrough Designation and/or Accelerated Approval in the US."

"Treating patients with lenzilumab appears to be improving clinical parameters, quality of life and systemic inflammation in the patients studied so far, and patients appear to be tolerating lenzilumab well," continued Dr. Durrant. "Critically, clinical responses appear to occur early, prior to the fourth monthly treatment cycle. The encouraging results to date in the PREACH-M study, and separate data in secondary AML, may create the possibility for lenzilumab development in a range of myelodysplastic leukemias. We are also seeing encouraging data in RAS MDS and various other conditions, suggesting the possibility that lenzilumab may play a valuable role across the spectrum of myeloid disorders and offer a revenue franchise opportunity if approved and commercialized. In addition, we now are seeing data in non-RAS CMML, which could expand the market even further."

About Taran Therapeutics
Taran Therapeutics ("Taran"), is a clinical-stage biopharmaceutical company focused on developing lenzilumab, a first-in-class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor. Taran is developing lenzilumab as a treatment for multiple myeloid disorders and also exploring the use of lenzilumab 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 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
Cameron Durrant
Founder
cdurrant@tarantherapeutics.com

References

1. Costa, R., et. al. (2010). Activity of azacitidine in chronic myelomonocytic leukemia. Cancer, 117(12), 2690-2696. https://doi.org/10.1002/cncr.25759.

2. South Australian Registry data, South Australian Health and Medical Research Institute, April 14, 2021

3. Pleyer, L., et. al. (2014). Azacitidine in CMML: Matched-pair analyses of daily-life patients reveal modest effects on clinical course and survival. Leukemia Research, 38(4), 475-483. https://doi.org/10.1016/j.leukres.2014.01.006

4. Aim of first-ever CMML study - to improve survival. Leukaemia Foundation. (2023, January 3). Retrieved January 3, 2023, from https://www.leukaemia.org.au/stories/aim-of-first-ever-cmml-study-to-improve-survival/

5. Ma, L., Jiang, L., Yang, W., Luo, Y., Mei, C., Zhou, X., Xu, G., Xu, W., Ye, L., Ren, Y., Lu, C., Lin, P., Jin, J., & Tong, H. (2021). Real-world data of chronic myelomonocytic leukemia: A chinese single-center retrospective study. Cancer medicine, 10(5), 1715-1725. https://doi.org/10.1002/cam4.3774

SOURCE: Taran Therapeutics