Marengo Therapeutics Receives Second U.S. FDA Fast Track Designation for Invikafusp Alfa
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The FDA granted Marengo Therapeutics a second Fast Track Designation for invikafusp alfa, targeting unresectable or metastatic TMB-H solid tumors.
CAMBRIDGE, Mass., Oct. 15 -- Marengo Therapeutics Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation and immunology (I&I), today announced that the U.S. Food and Drug Administration (FDA) has granted a second Fast Track Designation (FTD) to invikafusp alfa for the treatment of unresectable, locally advanced, or metastatic, tumor mutational burden high (TMB-H) solid tumors that have progressed following prior treatment including immune checkpoint inhibition and who have no satisfactory treatment options.
The new designation expands invikafusp alfa's Fast Track status from a single tumor type, TMB-H colorectal cancer (granted January 2025), to TMB-H solid tumors regardless of their tissue of origin. It is supported by objective responses across multiple tumor types, including colorectal, gastric, breast, urothelial, endometrial, gastroesophageal, head and neck, and lung cancers, in the ongoing Phase 1/2 STARt-001 study, with initial data presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting. Updated Phase 2 results will be presented in an oral session at ESMO 2026 in Madrid on October 23.
Invikafusp alfa received its first FDA Fast Track Designation for the treatment of unresectable, locally advanced or metastatic colorectal cancers with TMB-H in January 2025. Invikafusp alfa is investigational and has not been approved by the FDA or any other regulatory authority.
About Fast Track Designation
Fast Track Designation is an FDA process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. It provides more frequent communication with the FDA and, for drugs that meet the relevant criteria, eligibility for rolling review, Accelerated Approval, and Priority Review.
About TMB-High Solid Tumors
Tumor mutational burden measures the number of somatic mutations in a tumor's genome. Tumors with high TMB (≥10 mutations/megabase) occur across many cancer types. Patients whose TMB-H tumors progress on or after checkpoint inhibitor therapy, or who are not candidates for it, have limited treatment options.
About Invikafusp alfa (STAR0602)
Invikafusp alfa (STAR0602), the lead candidate from Marengo's STAR™ platform, is a first-in-class, bispecific dual T-cell agonist. It is designed to selectively activate a common Vβ T-cell subset found in all cancers by combining a non-clonal mode of TCR activation with a T-cell co-stimulatory signal in a single molecule. This approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing antitumor immunity and enabling durable tumor clearance. Invikafusp alfa was designed to restore and amplify antitumor immunity in patients who have progressed on, or are insensitive to, prior immune checkpoint blockade.
About Marengo Therapeutics
Marengo Therapeutics, Inc., a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and autoimmune diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, and three proprietary platforms: Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (Tri-STAR) and T cell Depletor (MSTAR), Marengo is working to selectively target the right T cells in the right patients to create a world in which everyone's immune system can defeat cancer and autoimmune diseases.
