On September 9, 2026 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapy approaches for cancer and autoimmune diseases, reported the completion of enrollment in the monotherapy cohorts of STARt-001, its Phase 1/2 clinical trial evaluating invikafusp alfa in patients with PD1–resistant, antigen-rich solid tumors. Enrollment continues in standard of care combination cohorts. In addition, updated results from the study have been selected for an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2026 Congress, taking place October 23– 27 in Madrid, Spain.
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The company also announced the appointments of Amy Otto as Senior Vice President, Program Leadership, and Zhenming Shun, Ph.D., as Senior Vice President, Data Science. Together, they will strengthen Marengo’s integrated development, execution and data capabilities as the company prepares invikafusp alfa for its next stage of clinical development.
"Completing enrollment in the STARt-001 monotherapy cohorts represents an important step in establishing invikafusp alfa’s single-agent activity across eight distinct PD-1–resistant tumor types, including MSS colorectal cancer, PD-L1–negative non-small cell lung cancer and triplenegative breast cancer," said Zhen Su, M.D., MBA, President and Chief Executive Officer of Marengo Therapeutics. "The signals observed across these diverse tumor types highlight invikafusp’s long-term potential as a pan-tumor immuno-oncology backbone. Our near-term priority is a focused development path in lead indications selected from these monotherapy cohorts, in areas of high unmet need for patients whose tumors are unresponsive to PD-1– directed therapies, which we expect to announce alongside the updated data at ESMO (Free ESMO Whitepaper)."
Following the ESMO (Free ESMO Whitepaper) presentation, the company expects to complete planned interactions with the U.S. Food and Drug Administration (FDA) to align on the development plan for invikafusp alfa, with the next stage of development expected to begin in 2027.
Appointment of Amy Otto, Senior Vice President, Program Leadership
Amy joins Marengo as Senior Vice President, Program Leadership. In this role, she will lead integrated development strategy and cross-functional execution for invikafusp alfa, partnering closely with Marengo’s leadership and functional teams to advance the program’s clinical, regulatory and operational priorities. Amy brings more than 20 years of oncology development leadership experience across Amgen, Seagen and Gilead, with deep expertise guiding programs from early development through regulatory approval, global launch and lifecycle expansion. Most recently, she served as Vice President and Head of Oncology Program Strategy Leadership at Gilead, where she grew the oncology program strategy function and shaped portfolio and program decisions across the pipeline of oncology investigational assets, including TRODELVY. Previously, Amy served as Product Team Leader for PADCEV at Seagen, leading the program through late-stage development, FDA approval, global launch and lifecycle expansion.
"Invikafusp alfa has generated compelling clinical momentum and has the potential to become an important new immuno-oncology backbone," said Amy. "I am excited to join Marengo at this important stage and work with its highly experienced team to integrate the evidence, strategy and execution required to realize the program’s full potential for patients."
Appointment of Zhenming Shun, Ph.D., to Senior Vice President, Data Science
Zhenming has been appointed Senior Vice President, Data Science, to lead biostatistics and data management across Marengo’s clinical portfolio, which will play a central role in shaping trial design, statistical strategy and evidence generation.
Zhenming brings more than 30 years of experience across the pharmaceutical industry and academia. Before joining Marengo, he served as Vice President, Global Head of Biostatistics and Data Management at Daiichi Sankyo and previously as Global Head of Biostatistics in Oncology at Sanofi. Across these roles, Zhenming led global teams responsible for clinical trial design, statistical analysis and regulatory submissions and contributed to multiple successful drug approvals in oncology and cardiovascular medicine.
"The breadth and maturity of the emerging invikafusp dataset create an important opportunity to apply rigorous statistical and data science approaches to its next stage of development," said Zhenming. "I look forward to working with our clinical, regulatory and program teams to translate these findings into an efficient, evidence-driven late-stage development strategy."
"As invikafusp advances toward its next critical inflection point, Amy’s extensive experience guiding oncology programs from early development through approval and commercialization and Zhenming’s deep statistical and data science expertise significantly strengthen our ability to translate emerging clinical evidence into a focused, integrated late-stage development strategy," said Dr. Su.
(Press release, Marengo Therapeutics, SEP 9, 2026, View Source [SID1234670669])