Marengo Therapeutics to Reveal New Invikafusp Alfa Data at AACR 2025 Conference

Marengo Therapeutics to Present Clinical Trial Results



Marengo Therapeutics, Inc., a leader in precision immunotherapy, is excited to announce its upcoming presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025. The company will showcase the updated clinical results from its Phase 1/2 clinical trial, STARt-001, that evaluates the efficacy of invikafusp alfa (STAR0602) in patients with tumors resistant to anti-PD(L)1 therapies. This innovative treatment targets solid tumors rich in antigens, focusing on those that have previously shown resistance to immunotherapies.

Key Findings Highlighted in the Presentation


The trial results are promising, revealing a 67% disease control rate, a 44% tumor regression rate, and a preliminary objective response rate of 22% in patients with high tumor mutational burden (TMB-H) when dosed with invikafusp alfa. This dual T cell agonist compounds the potency of traditional therapies by selectively activating specific T cell populations even in challenging cases.

Dr. Ke Liu, Chief Development Officer at Marengo, explained, "These findings are the first clinical proof of our precision T cell agonist strategy aimed at overcoming anti-PD(L)1 resistance. The unique ability of invikafusp monotherapy to engage and expand T cell functions in such heavily pretreated cancers demonstrates a significant breakthrough."

Implications for the Future of Cancer Therapy


As the field of cancer immunotherapy continually evolves, these findings may pave the way for a new class of treatments specifically designed for patients who have run out of options with standard checkpoint inhibitors. Invikafusp’s unique mechanism - selectively activating T cell subsets - showcases notable potential, which could redefine therapeutic approaches against resistant malignancies.

The STARt-001 trial's data elucidates that invikafusp not only shows enhanced immune response but also reinvigorates anti-tumor activities among the cancerous cells in patients where previous treatments failed. This trial involves an ongoing Phase 2 section that is focused on expanding applications to include additional antigen-rich tumor types.

Highlights of the STARt-001 Study


Among the chief outcomes of the study presented at the conference, the following were prominent:
  • - Initial Clinical Activity: In a subgroup of nine efficacy-evaluable patients with TMB-H, six achieved disease control, with two achieving confirmed partial responses (cPRs) and four exhibiting stable disease.
  • - Recommended Phase 2 Dose (RP2D): The optimal dosing was established at 0.08 mg/kg every two weeks, based on collected pharmacokinetics and efficacy data, showcasing a significant peak expansion of relevant T cell populations around 600%.
  • - T Cell Activation: Following dosing, researchers observed increased levels of soluble markers indicating T cell activation, implying a bolstered immune response without excessive inflammation.

Expectations from AACR 2025


The plans for the presentation, scheduled for April 29, 2025, will delve deeper into not only the clinical findings but also the translational study results that support the overall viability of invikafusp as a breakthrough in oncology. Attendees can expect to learn more about the complexities of its action in the immune landscape, alongside testimonials from patients exhibiting strong responses to the therapy.

Conclusion


As Marengo Therapeutics prepares for its pivotal AACR 2025 presentation, the expanded data from the STARt-001 trial could significantly impact future cancer treatment paradigms, especially for those patients who have not responded to traditional therapies. The commitment to advancing novel therapeutic strategies encapsulates the essence of innovation that Marengo embodies in the realm of cancer treatment. For continuous updates and insights, visit Marengo Therapeutics.

Topics Health)

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