This section highlights FDA-related milestones and regulatory updates for drugs developed by MiNK Therapeutics (INKT).
Over the past two years, MiNK Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AgenT-797 and MiNK-215. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
AgenT-797 FDA Regulatory Timeline and Events
AgenT-797 is a drug developed by MiNK Therapeutics for the following indication: Multiple myeloma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AgenT-797
- Announced Date:
- May 12, 2026
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, Inc. announced data being presented at the American Society of Gene and Cell Therapy Annual Meeting (ASGCT 2026) in Boston, Massachusetts.
AI Summary
MiNK Therapeutics said it will present new data at the American Society of Gene and Cell Therapy Annual Meeting in Boston. The poster, scheduled for May 14, 2026, shows that its agenT-797 cell therapy can trigger different immune responses depending on the disease being treated. In 34 patients with solid tumors, the treatment activated a TH1 pro-inflammatory response, which is linked to stronger cancer-fighting activity. In 20 patients with ARDS, the same product led to a TH2 anti-inflammatory response, which may help calm harmful immune activity.
The company said the results were seen across multiple manufacturing batches and donors, suggesting the platform works consistently at scale. MiNK said this supports its goal of using allogeneic invariant natural killer T cell therapies to restore immune balance and produce lasting immune effects in serious diseases.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- April 17, 2026
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, announced data from an investigator-initiated Phase II trial at Memorial Sloan Kettering Cancer Center, evaluating agenT-797, MiNK's allo-iNKT cell therapy, in combination with botensilimab (BOT) and balstilimab (BAL), ramucirumab and paclitaxel in patients with advanced PD-1 refractory gastroesophageal adenocarcinoma.
AI Summary
MiNK Therapeutics reported results from an investigator-initiated Phase II trial (n=17) at Memorial Sloan Kettering Cancer Center testing agenT-797, an allogeneic iNKT cell therapy, given with botensilimab and balstilimab plus ramucirumab and paclitaxel in patients with advanced, PD‑1–refractory gastroesophageal adenocarcinoma.
Correlative analyses indicated the combination drove significant intratumoral T cell and dendritic cell infiltration and, in one patient with prolonged benefit, the formation of organized tertiary lymphoid structures in on‑treatment biopsies. Peripheral immune activation was also seen, with increased CD4 and CD8 T cell activity. These findings suggest the regimen can stimulate local and systemic anti‑tumor immune responses.
The safety profile matched expectations for the component agents. Common treatment‑emergent adverse events included fatigue, fever, diarrhea, anorexia, nausea and mucositis. Immune‑related events reported included dermatitis, colitis, gastritis, enteritis, hepatitis and hypothyroidism. Further analysis of the full biospecimen set is ongoing to clarify mechanisms, optimal sequencing and biomarkers to identify likely responders.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- April 3, 2026
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, announced that data from an investigator-initiated Phase II trial at Memorial Sloan Kettering Cancer Center, evaluating agent-797, MiNK's allo-iNKT cell therapy, in combination with botensilimab (BOT) and balstilimab (BAL), will be presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA.
AI Summary
MiNK Therapeutics said data from an investigator‑initiated Phase II trial at Memorial Sloan Kettering Cancer Center, evaluating agenT‑797, MiNK’s allo‑iNKT cell therapy in combination with botensilimab (BOT) and balstilimab (BAL), will be presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, April 17–22, 2026. The study tests this multi‑mechanistic immunotherapy in patients with PD‑1‑refractory gastroesophageal cancer (GEC), an area of high unmet need where checkpoint inhibitors have failed.
MiNK expects the results to shed light on immune modulation, treatment sequencing, and the durability of response when re‑engaging immunity after prior checkpoint therapy. Jennifer Buell, Ph.D., MiNK’s President and CEO, said the trial is one of the first to combine an iNKT cell therapy with dual checkpoint modulation in GEC.
Presentation details: Abstract titled “A phase II study of agenT‑797, botensilimab (BOT) and balstilimab (BAL) in PD‑1 refractory gastroesophageal cancer (GEC),” presenter Samuel L. Cytyrn, MD; Session “Phase II and Phase III Clinical Trials”; April 20, 2026, 2:00–5:00 PM PT (5:00–8:00 PM EDT); Poster Section 52; Abstract No. CT166.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- January 8, 2026
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, Inc announced the upcoming initiation of a Phase 1, investigator-sponsored clinical trial evaluating its lead therapy, agenT-797, in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
AI Summary
MiNK Therapeutics announced the upcoming start of a Phase 1 investigator‑sponsored trial testing agenT‑797 in patients receiving allogeneic hematopoietic stem cell transplantation (allo‑HSCT). The study, led by Hongtao Liu, MD, PhD, with co‑investigator Kalyan V. G. Nadiminti at the University of Wisconsin, will assess safety, tolerability, and early signs of benefit in reducing graft‑versus‑host disease (GvHD), relapse, and other post‑transplant complications in people with high‑risk leukemias and blood cancers.
AgenT‑797 is an off‑the‑shelf, donor‑derived invariant natural killer T (iNKT) cell therapy designed to be HLA‑independent and used without lymphodepleting conditioning. iNKT cells may suppress harmful allo‑immune inflammation while preserving anti‑leukemia activity and helping immune recovery, offering a potential way to lower GvHD and relapse risk after transplant.
The trial is funded by two non‑dilutive awards: an NIAID STTR grant supporting preclinical development with UW–Madison and the Mary Gooze Clinical Trial and Translation Award funding enrollment, immune monitoring, and trial operations, enabling parallel translational and clinical research.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- October 30, 2025
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, Inc announced that late-breaking data demonstrating durable clinical activity of AgenT-797, allo-INKTs, in advanced solid tumors will be presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place November 7–9, 2025, in National Harbor, Maryland..
AI Summary
MiNK Therapeutics announced that late-breaking data on AgenT-797, its off-the-shelf allogeneic invariant natural killer T (iNKT) cell therapy, will be presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Maryland, November 7–9, 2025. The data highlight durable clinical activity and safety in patients with advanced solid tumors from the ongoing Phase 1 study.
The presentation, titled “AgenT-797, an Allogeneic iNKT Cell Therapy, Demonstrates Durable Clinical Activity in Solid Tumors: Updated Phase 1 Findings” (Abstract #1344), will be delivered by Dr. Benjamin Garmezy. Attendees can view the poster on Saturday, November 8, from 12:15–1:45 p.m. ET and 5:10–6:35 p.m. ET in the Prince George ABC Exhibit Halls at the Gaylord National Resort & Convention Center.
AgenT-797 is designed to reprogram the immune system and overcome resistance to standard immunotherapies. These updated findings will inform the therapy’s potential to offer durable responses in hard-to-treat solid tumors.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- July 15, 2025
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, Inc. announced the publication of a peer-reviewed article titled "CAR-iNKT Cells: Redefining the Frontiers of Cellular Immunotherapy" in Frontiers in Immunology.
AI Summary
MiNK Therapeutics, Inc. announced the publication of a peer-reviewed article titled "CAR-iNKT Cells: Redefining the Frontiers of Cellular Immunotherapy" in Frontiers in Immunology. The article focuses on the innovative use of allogeneic invariant natural killer T (iNKT) cells, showing how they can overcome challenges seen with traditional cell therapies for solid tumors. Researchers explain that when iNKT cells are engineered with chimeric antigen receptors (CARs), they offer dual targeting—leveraging both the natural invariant T-cell receptor and the added CAR mechanism. This dual action not only directly kills tumor cells but also helps remodel the tumor microenvironment, which is crucial for overcoming fibrotic barriers. The study highlights MiNK’s unique approach with therapies like MiNK-215, an IL-15–armored, FAP-targeting CAR-iNKT treatment, demonstrating the potential of these cells to provide potent and durable responses without the need for complex conditioning processes.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- July 11, 2025
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, Inc. announced the publication of another landmark case in Nature's Oncogene describing a complete and durable remission in a patient with metastatic, treatment-refractory testicular cancer, following treatment with agenT-797, MiNK's allogeneic iNKT cell therapy.
AI Summary
MiNK Therapeutics, Inc. recently announced a major breakthrough in the treatment of metastatic, treatment-refractory testicular cancer. The company published a landmark case in Nature’s Oncogene showing that a patient who had exhausted several therapies, including platinum-based chemotherapy, autologous stem cell transplant, and multiple immune checkpoint inhibitors, achieved a complete and durable remission. This success came after the patient received a single infusion of MiNK’s allogeneic iNKT cell therapy, agenT-797, along with nivolumab. The case demonstrated that the donor iNKT cells remained detectable for up to six months post-infusion, and the treatment was well-tolerated without severe side effects such as cytokine release syndrome or graft-versus-host disease. These promising findings underscore the potential of agenT-797 to offer new hope for patients with difficult-to-treat cancers and support further clinical studies in this area.
Read Announcement
MiNK-215 FDA Regulatory Events
MiNK-215 is a drug developed by MiNK Therapeutics for the following indication: Treatment-resistant Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MiNK-215
- Announced Date:
- November 20, 2025
- Indication:
- Treatment-resistant Solid Tumors
Announcement
MiNK Therapeutics, Inc. announced the publication of new preclinical data for MiNK-215, a novel, next-generation FAP-targeting, IL-15–enhanced CAR-iNKT therapy.
AI Summary
MiNK Therapeutics published preclinical data for MiNK-215, a next-generation, IL-15–armored FAP-targeting CAR-iNKT therapy. The manuscript reports that MiNK-215 is engineered to recognize and eliminate FAP-positive cancer-associated fibroblasts (CAFs), the cells that form the dense, immunosuppressive tumor stroma that often blocks immune cell entry and limits immunotherapy success.
In lung and microsatellite-stable (MSS) colorectal cancer liver metastasis models, MiNK-215 remodeled the tumor microenvironment, cleared the protective stromal barrier, and enabled strong immune cell infiltration. The therapy activated dendritic cells and antigen-presentation pathways, repolarized macrophages toward a pro-inflammatory, tumor-killing state, and supported deep infiltration of tumor-specific T cells. Secretion of IL-15 enhanced persistence and immune activation, improving durability of response in preclinical studies.
As an allogeneic, off-the-shelf cell therapy, MiNK-215 is designed for scalable manufacture and rapid delivery, offering a potential new approach for solid tumors that resist current immunotherapies.Read Announcement
