Cambridge, Massachusetts, September 9, 2026
Marengo Therapeutics has completed enrollment in the monotherapy cohorts of its Phase 1/2 STARt-001 clinical trial, evaluating invikafusp alfa (STAR0602) in patients with PD-1-resistant, antigen-rich solid tumors. The biotechnology company also announced the appointment of Amy Otto as Senior Vice President, Program Leadership, and Zhenming Shun, Ph.D., as Senior Vice President, Data Science, as it prepares the investigational immunotherapy for its next stage of clinical development. Updated STARt-001 results have been selected for an oral presentation at the ESMO 2026 Congress in Madrid in October.
STARt-001 Completes Monotherapy Enrollment
The STARt-001 Phase 1/2 study is evaluating invikafusp alfa as a monotherapy in patients whose advanced solid tumors are refractory or resistant to prior PD-1-directed therapy. Enrollment has now been completed in the monotherapy cohorts, while enrollment continues in cohorts evaluating invikafusp alfa in combination with standard-of-care treatments. The completed monotherapy cohorts cover eight distinct PD-1-resistant tumor types, including microsatellite-stable colorectal cancer, PD-L1-negative non-small cell lung cancer and triple-negative breast cancer. The Phase 2 portion of the study uses biomarker-enriched cohorts, including tumors characterized by high tumor mutational burden (TMB-H) and microsatellite instability-high (MSI-H) status, to investigate activity across multiple tumor types and identify patients who may be more likely to respond. According to Marengo, the study has generated clinical signals across diverse tumor types. However, the company has not yet disclosed the updated dataset associated with the upcoming ESMO presentation. Therefore, the enrollment milestone should not be interpreted as confirmation of clinical efficacy. The forthcoming presentation is expected to provide additional information on the emerging clinical profile of invikafusp alfa.
Invikafusp Alfa Targets T-Cell Activation
Invikafusp alfa, also known as STAR0602, is the lead candidate from Marengo’s proprietary STAR platform. The investigational therapy is described as a first-in-class bispecific dual T-cell agonist designed to selectively activate a common Vβ T-cell subset found across cancers. The molecule combines a non-clonal T-cell receptor activation mechanism with a T-cell co-stimulatory signal in a single therapeutic construct. The company’s scientific rationale is based on selectively expanding clonally diverse effector-memory Vβ T cells and enhancing antitumor immune responses. Marengo is developing invikafusp alfa specifically for patients who have progressed following, or whose tumors are insensitive to, previous immune checkpoint blockade. This approach is intended to address an important challenge in oncology, where some patients develop resistance to therapies targeting the PD-1 pathway. The ongoing clinical investigation will assess safety, tolerability and preliminary efficacy, while biomarker-selected cohorts may help identify tumor characteristics associated with treatment response. The study therefore represents an important component of Marengo’s strategy to determine where invikafusp alfa could have the greatest therapeutic potential.
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Leadership Additions Support Late-Stage Planning
Marengo’s leadership changes come as the company prepares for the next stage of invikafusp alfa development. Amy Otto, appointed Senior Vice President of Program Leadership, brings more than 20 years of oncology development experience across Amgen, Seagen and Gilead. Her responsibilities will include integrated development strategy and cross-functional execution covering clinical, regulatory and operational priorities. Zhenming Shun, Ph.D., appointed Senior Vice President of Data Science, will lead biostatistics and data management across Marengo’s clinical portfolio. He brings more than 30 years of pharmaceutical and academic experience, including leadership roles at Daiichi Sankyo and Sanofi. His responsibilities will include clinical-trial design, statistical strategy and evidence generation as Marengo advances its programs. Following the ESMO 2026 presentation, Marengo expects to complete planned interactions with the U.S. Food and Drug Administration regarding the development strategy for invikafusp alfa. The company expects the next stage of development to begin in 2027. The combination of completed monotherapy enrollment, upcoming clinical data and expanded development leadership represents a significant milestone for Marengo. Further clinical results and regulatory discussions will determine how invikafusp alfa progresses into later-stage testing and whether its T-cell activation approach can provide a meaningful treatment option for patients with PD-1-resistant cancers.
Source: Marengo Therapeutics press release
