MiNK Therapeutics presented encouraging translational data from its Phase 2 study of allo-iNKTs, agenT-797, in combination with botensilimab and balstilimab for patients with refractory gastroesophageal cancer, at the AACR IO Annual Meeting. The study (NCT06251973) aims to evaluate the safety and efficacy of this novel combination in patients who have failed prior lines of therapy.
The data indicated a synergistic effect between MiNK’s allo-iNKT cells, checkpoint inhibitors, and chemotherapy, leading to immune reactivation and clinical activity in previously unresponsive tumors. According to Dr. Jennifer Buell, President and Chief Executive Officer at MiNK, this combination has the potential to deliver durable clinical benefits by intensifying immunologic activity and driving anti-tumor immune cells into the tumor microenvironment.
Enhanced Anti-Tumor Immunity
Early induction with agenT-797 resulted in broad immune activation, a key indicator of potential durable responses. The study reported a significant increase in interferon-gamma (IFNγ) levels, along with enhanced tumor infiltration by T cells and antigen-presenting cells (APCs), signaling robust systemic immune engagement. These biomarkers are typically associated with improved clinical outcomes and a sustained anti-tumor immune response, reinforcing the potential of this combination in solid cancers.
Importance of Treatment Sequencing
The study also highlighted the importance of treatment sequencing. The most pronounced immune expansion and strong peripheral memory T-cell activation were observed when agenT-797 was administered concurrently with checkpoint inhibitors and before standard chemotherapy. This suggests that early allo-iNKT induction is a critical driver of therapeutic benefit.
Strategic Advantages of Allo-iNKT Platform
MiNK Therapeutics' allogeneic, off-the-shelf platform offers several strategic advantages. The scalable manufacturing process generates billions of donor-derived iNKT cells in a single run, yielding thousands of doses for rapid global distribution. This approach reduces logistical hurdles and lowers costs, potentially enabling greater patient access worldwide. Furthermore, MiNK’s iNKT platform supports expansion into additional hard-to-treat cancers, creating opportunities for pipeline breadth and partnerships.
About the Phase 2 Trial
The ongoing Phase 2 trial is evaluating the combination of agenT-797, botensilimab, and balstilimab in patients with PD-1 refractory gastroesophageal cancer. The primary endpoint is to assess the safety and efficacy of the combination therapy. The study is being conducted at multiple centers, with Dr. Samuel Cytryn from Memorial Sloan Kettering Cancer Center as a lead investigator.
Prior Phase 1 Data
Previous data from a Phase 1 trial (NCT05108623) demonstrated long-term, durable responses and tolerability in PD-1 refractory relapsed/refractory cancers, including testicular, appendiceal, lung, and gastric cancers. Notably, gastric cancer patients exhibited significant clinical and immunologic responses, including robust T cell infiltration and expansion compared to non-responders.
