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MiNK-215, an IL-15 armored FAP-targeting CAR iNKT cell therapy, effectively treats human organoid models of treatment-refractory MSS colorectal cancer (CRC) liver metastases (Section 2) - Mar 5, 2024 - Abstract #AACR2024AACR_4205; Here we describe MiNK-215, an IL-15 armored FAP-targeting CAR iNKT cell therapy, derived from the AgenT-797 allogeneic iNKT platform, as a potential novel therapeutic approach for patients with CRC liver metastases.To better model ICB refractory human MSS CRC liver metastases, we developed an ex vivo human organoid model that recapitulates the histological and immunological features of human disease...Models were treated with Fc-enhanced anti-CTLA-4 (botensilimab) and anti-PD-1 (balstilimab) antibodies, or MiNK-215 to assess tumor killing and immune activation.Botensilimab and balstilimab enhanced T cell activation and cytotoxicity of CRC tumor cells in the absence of "normal" liver cells and in lung organoids...Tumor killing in CRC liver organoid models by MiNK-215 was associated with depletion of immune suppressive FAP-expressing stellate cells and increased CD8+ T cell infiltration.Our findings demonstrate that in treatment-refractory CRC-liver metastatic organoid models, MiNK-215 overcomes the limitations of ICB therapy to home to sites of disease, reprogram the TME, recruit tumor-reactive T cells and enhance tumor killing. Ex-vivo human CRC liver and lung metastatic organoid models are a novel platform that can be leveraged to rapidly identify new therapeutic approaches for potential clinical evaluation.
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Journal: Overcoming resistance to programmed cell death protein 1 (PD-1) blockade with allogeneic invariant natural killer T-cells (iNKT). (Pubmed Central) - Mar 4, 2024 Activation of iNKT cells by tumor lipid antigens can trigger direct cytotoxicity and promote indirect anti-tumor immune responses such as recruitment and activation of T cells, NK cells, and dendritic cells through secretion of cytokines and IFN?. We describe immune modulation leading to durable tumor response in a patient with microsatellite instability-high (MSI-H) advanced gastric adenocarcinoma treated with agent-797 after progression on standard chemotherapy and anti-PD-1 therapy.
- |||||||||| New P2 trial, Combination therapy, Metastases: A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer (clinicaltrials.gov) - Feb 15, 2024
P2, N=38, Recruiting,
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Peripheral and tissue persistence of agenT-797, an allogeneic iNKT cell-based cell therapy for the treatment of cancer (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1066; P1 Such persistence and clinical activity were observed in the absence of traditional lymphodepletion regimens employed in nearly all other forms of immune cell therapy. The observed persistence of agenT-797 in the absence of lymphodepletion, therefore, uniquely allows it to unfold its maximal potential though directing integral endogenous immune responses, which otherwise would be severely compromised by lymphodepleting agents.
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Enrollment closed, Trial completion date, Trial primary completion date: Evaluate the Safety of agenT-797 in Participants With Moderate to Severe Difficulty Breathing Secondary to SARS-CoV-2 (clinicaltrials.gov) - Jul 3, 2023 P1/2, N=20, Active, not recruiting, The observed persistence of agenT-797 in the absence of lymphodepletion, therefore, uniquely allows it to unfold its maximal potential though directing integral endogenous immune responses, which otherwise would be severely compromised by lymphodepleting agents. Completed --> Active, not recruiting | Trial completion date: Jun 2022 --> Sep 2023 | Trial primary completion date: Jun 2022 --> Aug 2023
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Trial primary completion date, Combination therapy, Checkpoint inhibition: A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors (clinicaltrials.gov) - Jun 6, 2023 P1, N=30, Recruiting, Completed --> Active, not recruiting | Trial completion date: Jun 2022 --> Sep 2023 | Trial primary completion date: Jun 2022 --> Aug 2023 Trial primary completion date: Dec 2022 --> Dec 2023
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Trial completion, Enrollment change, Trial primary completion date: agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Jun 6, 2023 P1, N=13, Completed, Trial primary completion date: Dec 2022 --> Dec 2023 Active, not recruiting --> Completed | N=20 --> 13 | Trial primary completion date: Sep 2022 --> Jan 2023
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Enrollment closed: agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Oct 24, 2022 P1, N=20, Active, not recruiting, Results support the potential of a novel therapeutic strategy employed by agenT-797 to enhance antitumor immunity in PD-1 refractory tumors. Recruiting --> Active, not recruiting
- |||||||||| MiNK-413 / Agenus
MiNK-413: a Next generation armored allogenic BCMA CAR iNKT product (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_659; MiNK-413 is eligible to target a broader rrMM patient population due to intrinsic iNKT cell properties such as effective bone-marrow homing, high BCMA specific activity augmented by natural CD1d and NK receptor-ligand mediated activity. We believe MiNK-413 will provide additional benefits to rrMM patients beyond currently available treatments.
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