Drugs / agenT-797
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07869368 | Oct 2026 → Feb 2029 expected | B-cell acute lymphoblastic leukemia | UNC Lineberger Comprehensive Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05108623 | Jan 2022 → Jan 2024 | — | MiNK Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04754100 | Mar 2021 → Jan 2023 | refractory plasma cell neoplasm | MiNK Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04582201 | Sep 2020 → Apr 2023 | adult acute respiratory distress syndrome | MiNK Therapeutics | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07550088 | Jun 2026 → Sep 2028 expected | colorectal cancer | Scripps Health | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07615010 | May 2026 → Jun 2027 expected | pneumonia | MiNK Therapeutics | Recruiting | No outcome recorded |
| Phase 2 | NCT07492888 | Apr → Nov 2026 | adult acute respiratory distress syndrome, infectious disease with sepsis, lymphopenia, pneumonia | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT06251973 | Feb 2024 → Aug 2027 expected | esophageal adenocarcinoma, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT07492875 Comparator | Apr 2026 → Apr 2029 | acute respiratory distress syndrome, immunodeficiency disease, infectious disease with sepsis, lymphopenia +1 | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2026-10-02 | MiNK Therapeutics | Results MiNK Therapeutics to Present Data on Treatment-Resistant Colorectal Cancer and Clearance of Senescent Tumor Cells and Fibroblasts at SITC 2026 minktherapeutics.com ↗
agenT-797 enables tumor-cell killing in a human relevant model of checkpoint inhibitor–resistant colorectal cancer liver metastases |
| 2026-08-13 | MiNK Therapeutics | Results MiNK Therapeutics Reports Second Quarter 2026 Financial Results and Reports Observations from Randomized Phase 2 Trial of agenT-797 in Acute Lung Injury minktherapeutics.com ↗
First patients treated in randomized Phase 2 trial C-1300-02 were alive at Day 28, with improved oxygenation, resolution of ARDS with return to spontaneous breathing and liberation from vasopressor support |
| 2026-08-06 | MiNK Therapeutics | Results MiNK Therapeutics Presents Early Observations from Ongoing Phase 2 Trial at the 2026 Military Health System Research Symposium minktherapeutics.com ↗
First patients treated with agenT-797 were alive and afebrile at endpoint Day 28 with improved oxygenation, infection control and removal from ventilator and vasopressor support |
| 2026-05-20 | MiNK Therapeutics | Results MiNK Therapeutics Reports New Data on agenT-797, an allo-iNKT Cell Therapy at ATS 2026; Simultaneously Published in Clinical Immunology Communications minktherapeutics.com ↗
agenT-797 demonstrates pathogen suppression, lung immune restoration and tissue repair activation, supporting Ongoing Phase 2 trial |
| 2026-05-12 | MiNK Therapeutics | Results MiNK Therapeutics Presents Clinical Evidence That a Single, Off-the-Shelf, iNKT Cell Product Drives Context-Dependent Immune Responses at ASGCT 2026 minktherapeutics.com ↗
MiNK Therapeutics Presents Clinical Evidence That a Single, Off-the-Shelf, iNKT Cell Product Drives Context-Dependent Immune Responses at ASGCT 2026 |
| 2026-04-17 | MiNK Therapeutics | Results MiNK Therapeutics Reports Phase II Data on Immune Reprogramming and Durable Survival in PD-1 Refractory Gastroesophageal Cancer minktherapeutics.com ↗
First study of agenT-797, botensilimab (BOT) and balstilimab (BAL) in gastroesophageal cancer shows disease control rate (DCR) in 77% of patients and long-term survival beyond 20 months in a subset of patients |
| 2026-04-17 | Agenus Inc. | Results Agenus Reports Phase II Data Demonstrating Immune Reprogramming and Durable Survival with Botensilimab, Balstilimab and agenT-797 in PD-1 Refractory Gastroesophageal Cancer agenusbio.com ↗ |
| 2025-11-07 | MiNK Therapeutics | Results MiNK Therapeutics Reports Durable Responses and Immune Reactivation with Allo-iNKT Cell Therapy agenT-797 in PD-1–Refractory Solid Tumors at SITC 2025 minktherapeutics.com ↗
The results demonstrate durable survival, deep and lasting responses, and broad immune restoration in patients with solid tumors that had progressed on checkpoint inhibitors and multiple prior therapies. |
| 2025-07-11 | MiNK Therapeutics | Results MiNK Therapeutics Announces Publication of Complete Remission Following Allogeneic iNKT Cell Therapy in Metastatic Testicular Cancer minktherapeutics.com ↗
The patient achieved a complete clinical, radiologic, and biochemical remission, with no evidence of disease over two years later. |
| 2025-02-24 | MiNK Therapeutics | Results MiNK Therapeutics Presents First-in-Kind Allo-iNKTs Combination Data in 2L Gastric Cancer at AACR IO Annual Meeting minktherapeutics.com ↗ |
| 2025-02-24 | Agenus Inc. | Results Agenus Presents New Botensilimab/Balstilimab Data in Gastric Cancer at AACR IO Annual Meeting agenusbio.com ↗
The addition of MiNK’s allogeneic iNKT therapy, agenT-797, to BOT/BAL drove robust immune activation, including elevated interferon-gamma (IFNγ) levels, indicating potent systemic engagement and overcoming immunosuppressive pathways in PD-1–refractory gastric tumors. |
| 2025-01-22 | Agenus Inc. | Results Agenus Presents Data at ASCO GI Demonstrating Impact of BOT/BAL in Colorectal Cancer Across Neoadjuvant and Advanced Disease agenusbio.com ↗
The novel approach demonstrated early signals of activity and tolerability in the second-line treatment setting |
| 2024-11-07 | MiNK Therapeutics | Results MiNK’s iNKT Cell Therapy Shows Potential for Optimal Multi-Combination for Resistant Solid Cancers at SITC 2024 minktherapeutics.com ↗
The presentations showcased new data from MiNK’s iNKT cell therapy programs, agenT-797 and PRAME-TCR. |
| 2024-05-22 | MiNK Therapeutics | Results MiNK Presents AgenT-797 Clinical Activity in Immune-Compromised Transplant Patient with Severe ARDS at ATS Annual Meeting minktherapeutics.com ↗ |
| 2024-02-06 | MiNK Therapeutics | Results MiNK Therapeutics' AgenT-797 Shows Promising Results in the Treatment of Severe Acute Respiratory Distress, Published in Nature Communications minktherapeutics.com ↗
These findings show that agenT-797 holds significant promise in improving patient survival and reducing secondary infections, all while maintaining a favorable safety profile. |
| 2024-01-30 | MiNK Therapeutics | Results MiNK’s AgenT-797 Offers New Hope in Overcoming ICI Resistance in PD-1 Refractory Gastric Cancer - Published in Oncogene minktherapeutics.com ↗
one infusion of agenT-797 in gastric cancer refractory to anti-PD1 led to a durable confirmed partial response |
| 2023-11-09 | MiNK Therapeutics | Results MiNK Therapeutics Reports Third Quarter 2023 Results minktherapeutics.com ↗
MiNK presents first-of-a-kind data with allogeneic iNKTs, agenT-797, showing durable clinical benefit in solid tumor cancers and persistence >6 months without toxic pre-conditioning. |
| 2023-11-03 | MiNK Therapeutics | Results MiNK Therapeutics Presents Clinical Activity and Long-Term Persistence of Allogeneic iNKT Cells in Solid Tumors at SITC 2023 minktherapeutics.com ↗
Single administration of agenT-797 alone or in combination with anti-PD-1 delivered clinical benefit in heavily pre-treated patients with solid tumors. |
| 2023-05-22 | MiNK Therapeutics | Results MiNK Presents Clinical Data on Allogeneic iNKT Cells (agenT-797) in Severe Respiratory Distress at the American Thoracic Society International Conference minktherapeutics.com ↗
75% survival in patients with severe respiratory distress treated with agenT-797 |
| 2023-04-18 | MiNK Therapeutics | Results MiNK Therapeutics Announces Clinical Data of Allogeneic iNKT Cells (agenT-797) in Solid Tumor Cancers at the AACR Annual Meeting minktherapeutics.com ↗
MiNK Therapeutics Announces Clinical Data of Allogeneic iNKT Cells (agenT-797) in Solid Tumor Cancers at the AACR Annual Meeting |
| 2022-11-10 | MiNK Therapeutics | Results MiNK Presents Clinical Data at SITC 2022 Showcasing iNKT Cell Therapy Pipeline minktherapeutics.com ↗
Allogeneic off-the-shelf iNKT cell therapy, agenT-797, alone and in combination with pembro/nivo reports early clinical activity in solid tumors, with 27% and 66% of patients, respectively, had a reduction of target and non-target lesions or disease stabilization |
| 2021-11-12 | MiNK Therapeutics | Results MiNK Therapeutics Announces 77% Survival Rate in Intubated Patients with COVID-19 Respiratory Failure Treated with AgenT-797 minktherapeutics.com ↗
AgenT-797 in COVID-19 respiratory failure showed a 77% survival rate in older, ventilated patients compared to the national average approximating 20-30%. |
| 2020-11-09 | Agenus Inc. | Results Agenus Presents Additional Clinical Responses and Novel Biomarker Data at SITC2020 agenusbio.com ↗
iNKTs can also be engineered with CAR technology |
| 2020-06-02 | Agenus Inc. | Regulatory FDA Clears IND for iNKT Cells to Treat COVID-19 Patients agenusbio.com ↗
announced today the FDA's clearance of AgenTus' IND application for an allogeneic iNKT therapy. |
| 2020-05-13 | Agenus Inc. | Regulatory FDA Clears AgenTus IND for Allogeneic iNKT Cell Therapy agenusbio.com ↗
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers and infectious diseases, announced today the FDA acceptance of the IND application for an allogeneic iNKT therapy, agenT-797, submitted by its subsidiary, AgenTus Therapeutics. |
All press releases naming this drug 35 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | agenT-797 | “AgenT-797 is an investigational invariant natural killer T (iNKT) cell therapy administered as a single intravenous infusion in combination with blinatumomab.” NCT07869368 ↗ |
| Modality | Cell therapy | “agenT-797 is an off-the-shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT cells isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex vivo.” NCT04582201 ↗ |
| Route | Intravenous | “agenT-797 will be administered to hospitalized participants as a single intravenous infusion.” NCT04582201 ↗ |