Marengo Therapeutics

Cambridge, Mass. – October 15, 2026 -- The U.S. Food and Drug Administration has granted a second Fast Track Designation to Marengo Therapeutics' invikafusp alfa, extending the drug's expedited status from one tumor type to all tumor mutational burden high (TMB-H) solid tumors regardless of tissue of origin.

The new designation covers unresectable, locally advanced or metastatic TMB-H solid tumors that have progressed after prior treatment, including immune checkpoint inhibition, and for which no satisfactory treatment options exist. Marengo believes invikafusp alfa is the first immuno-oncology T-cell agonist to receive Fast Track Designation in a biomarker-defined, tissue-agnostic indication.

Cambridge, Mass. – October 02, 2026 -- Marengo Therapeutics will present interim results from its STARt-002 trial combining invikafusp alfa with Gilead's TRODELVY (sacituzumab govitecan-hziy) at the Society for Immunotherapy of Cancer's 41st Annual Meeting in Phoenix, Arizona, November 4-8, 2026.

STARt-002 pairs a T-cell agonist with an antibody-drug conjugate for the first time in clinical testing

The Phase 1b/2 study tests invikafusp alfa, a Vβ6-selective dual T-cell agonist, alongside TRODELVY's TROP2-directed cytotoxic payload delivery. Marengo's Chief Medical Officer Kevin Chin said the ADC is designed to release tumor antigens and inflame the tumor microenvironment, priming less immunogenic tumors for T-cell-mediated responses that invikafusp alfa can then amplify.

Cambridge, Mass. – September 13, 2026 -- Marengo Therapeutics has completed enrollment in the monotherapy cohorts of its Phase 1/2 STARt-001 trial evaluating invikafusp alfa across eight distinct PD-1-resistant tumor types, with updated results selected for an oral presentation at the ESMO 2026 Congress in Madrid, October 23-27.

Trial enrollment closes across eight PD-1-resistant tumor types

The monotherapy cohorts covered patients with MSS colorectal cancer, PD-L1-negative non-small cell lung cancer and triple-negative breast cancer, among others resistant to checkpoint blockade. Enrollment continues in standard-of-care combination cohorts, while the company plans to name lead indications for focused development alongside the ESMO data release.