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.
FDA alignment expected before 2027 development phase
Marengo said it expects to complete planned interactions with the U.S. Food and Drug Administration following the ESMO presentation to align on invikafusp alfa's development plan, with the next clinical stage targeted to begin in 2027. Invikafusp alfa (STAR0602), the lead candidate from Marengo's STAR platform, is a bispecific dual T-cell agonist designed to activate a common Vβ T-cell subset present across cancer types by combining non-clonal TCR activation with a co-stimulatory signal in one molecule.
Two pharma veterans join to steer late-stage strategy
Amy Otto joins as Senior Vice President, Program Leadership, bringing more than 20 years of oncology development experience from Amgen, Seagen and Gilead. At Gilead, she led oncology program strategy across the pipeline, including TRODELVY; at Seagen, she served as Product Team Leader for PADCEV through late-stage development, FDA approval and global launch.
Zhenming Shun, Ph.D., joins as Senior Vice President, Data Science, to lead biostatistics and data management across Marengo's clinical portfolio. He brings more than 30 years of experience, most recently as Vice President, Global Head of Biostatistics and Data Management at Daiichi Sankyo, and previously as Global Head of Biostatistics in Oncology at Sanofi, where he contributed to multiple oncology and cardiovascular drug approvals.
"Completing enrollment in the STARt-001 monotherapy cohorts represents an important step in establishing invikafusp alfa's single-agent activity,