Marengo Therapeutics Completes Enrollment in Phase 1/2 STARt-001 Monotherapy Cohorts for Invikafusp Alfa in PD-1–Resistant Solid Tumors
核心洞察
Marengo Therapeutics (搜索) has completed enrollment in the monotherapy cohorts of its Phase 1/2 STARt-001 trial evaluating invikafusp alfa in PD-1 (搜索)–resistant, antigen-rich solid tumors.
Updated STARt-001 results have been selected for an oral presentation at the ESMO 2026 Congress, taking place October 23–27 in Madrid, Spain.
The company appointed Amy Otto as SVP of Program Leadership and Zhenming Shun, Ph.D., as SVP of Data Science to support late-stage development.
Marengo Therapeutics (搜索), Inc. announced the completion of enrollment in the monotherapy cohorts of STARt-001, its global Phase 1/2 clinical trial evaluating invikafusp alfa in patients with PD-1 (搜索)–resistant, antigen-rich solid tumors. Enrollment continues in the trial's standard of care combination cohorts. The Cambridge, Massachusetts-based clinical-stage biotechnology company also disclosed that updated results from the study have been selected for an oral presentation at the European Society for Medical Oncology (ESMO) 2026 Congress, scheduled for October 23–27 in Madrid, Spain.
The monotherapy cohorts evaluated invikafusp alfa as a single agent across eight distinct PD-1 (搜索)–resistant tumor types, including MSS colorectal cancer (搜索), PD-L1–negative non-small cell lung cancer and triple-negative breast cancer (搜索).
"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 (搜索)–resistant tumor types," said Zhen Su, M.D., MBA, President and Chief Executive Officer of Marengo Therapeutics (搜索). "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."
Following the ESMO presentation, Marengo expects to complete planned interactions with the U.S. Food and Drug Administration (搜索) (FDA) to align on the development plan for invikafusp alfa, with the next stage of development expected to begin in 2027.
Trial Design and Candidate Profile
STARt-001 is a global Phase 1/2 trial evaluating the safety, tolerability and preliminary efficacy of invikafusp alfa as a monotherapy in biomarker-selected patients with advanced, antigen-rich solid tumors that are refractory or resistant to PD-1 (搜索)–directed therapy, including rare tumor types. The Phase 2 portion uses biomarker-enriched cohorts, including TMB-H and MSI-H, to assess activity across multiple tumor types and to help identify patients most likely to benefit. The study is registered on ClinicalTrials.gov under NCT05592626.
Invikafusp alfa (STAR0602) is the lead candidate from Marengo's STAR platform and is described as 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. According to the company, this approach promotes the expansion of clonally diverse, effector memory Vβ T cells (搜索), enhancing antitumor immunity and enabling durable tumor clearance. The agent was designed to restore and amplify antitumor immunity in patients who have progressed on, or are insensitive to, prior immune checkpoint blockade.
Leadership Additions to Support Late-Stage Development
Marengo announced two senior appointments intended to strengthen its integrated development, execution and data capabilities as it prepares invikafusp alfa for its next stage of clinical development.
Amy Otto joins as Senior Vice President, Program Leadership, where she will lead integrated development strategy and cross-functional execution for invikafusp alfa, partnering with Marengo's leadership and functional teams on the program's clinical, regulatory and operational priorities. She brings more than 20 years of oncology development leadership experience across Amgen, Seagen and Gilead, with 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, she 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 Otto. "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."
Zhenming Shun, Ph.D., joins as Senior Vice President, Data Science, leading biostatistics and data management across Marengo's clinical portfolio, a role the company says will be central to shaping trial design, statistical strategy and evidence generation. Shun brings more than 30 years of experience across the pharmaceutical industry and academia. He previously served as Vice President, Global Head of Biostatistics and Data Management at Daiichi Sankyo and earlier as Global Head of Biostatistics in Oncology at Sanofi. In these roles, he 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 Shun. "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.
Platform Context
Marengo Therapeutics (搜索) is a clinical-stage biotechnology company developing novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire, with the stated goal of providing lifelong protection against cancer and autoimmune diseases. The company's portfolio includes three proprietary platforms: Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (Tri-STAR) and T cell Depletor (MSTAR).