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Amid a broader industry renaissance in innate immunity highlighted by surging investment and clinical activity in NK, T, and iNKT-based therapies iNKT cells represent a distinct T cell ( T ) population that uniquely bridges innate and adaptive immunity.
They combine durable memory responses characteristic of adaptive T cells with rapid, MHC-independent rapid cytolytic capabilities of natural killer ("NK") cells.
This dual functionality enables direct tumor killing via CD1d and stress ligands, potent orchestration of the tumor microenvironment through activation of dendritic cells and NK cells, elimination of immunosuppressive myeloid populations, and restoration of exhausted T-cell function all while naturally suppressing graft-versus-host disease ("GvHD").
These indications include but are not limited critical pulmonary immune failure (including severe hypoxemic respiratory failure / pneumonia), GvHD, solid tumor cancers, and other severe immune-related diseases.
Our discovery efforts are focused applying our proprietary technologies to build a broad pipeline of engineered iNKT cells, including CRs, CAR-iNKTs (such as MiNK-215 (FAP-CAR-iNKT) and MiNK-413 (BCMA-CAR-iNKT)), and INKT cell engager technology.
Having treated nearly 100 patients with agenT-797 across oncology and critical pulmonary immune failure, we have generated mechanistic and clinical insights that support continued development of our iNKT platform beyond oncology into pulmonary diseases and auto-immune diseases, including in graft-versus-host disease prevention.
Hammond, our Head of Inflammatory and Pulmonary Diseases, we are advancing a differentiated franchise in critical pulmonary immune failure with agenT-797, our off-the-shelf, allogeneic iNKT cell therapy.
Building on the foundational Phase 1/2 data published in Nature Communications in February 2024 which demonstrated 70% 30-day survival (80% in the veno-venous extracorporeal membrane oxygenation ( VV-ECMO ) subgroup) in mechanically ventilated patients with severe viral ARDS versus ~10% in contemporaneous controls we are now advancing agenT-797 in a randomized Phase 2 adaptive, placebo-controlled trial in patients with severe pneumonia and moderate-to-severe hypoxemic acute respiratory failure ("AHRF").
Our published results highlighted rapid inflammation resolution, rescue of exhausted T cells, and reduced secondary infections, supporting the broad therapeutic potential of iNKT cells in life-threatening respiratory conditions, including interstitial lung disease ("ILD").
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Exhibits, Financial Statement Schedules 87 Item 16 Form 10-K Summary 89 i Note Regarding Forward Looking Statements This Annual Report on Form 10-K and other written and oral statements we make from time to time contain forward-looking statements.
You can identify these forward-looking statements by the fact they use words such as could, expect, anticipate, estimate, target, may, project, guidance, intend, plan, believe, will, potential, opportunity, future and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance.
Certain forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts.
These statements relate to, among other things, our business strategy, our research and development, our product development efforts, our ability to commercialize our product candidates, our prospects for initiating partnerships or collaborations, the timing of the introduction of products, the effect of new accounting pronouncements, uncertainty regarding our future operating results and our profitability, anticipated sources of funds as well as our plans, objectives, expectations, and intentions.
iNKT cells represent a distinct T cell population, combining durable memory responses with the rapid cytolytic capabilities of natural killer ("NK") cells.
These indications include but are not limited to solid tumor cancers, acute respiratory distress ( ARDS ) and other severe immune-related diseases, such as 2L gastric cancer, and graft-versus-host disease ("GvHD").
Our discovery efforts are focused applying our proprietary technologies to build a broad pipeline of engineered iNKT cells, including TCRs, CAR-INKTS (such as, MiNK-215, FAP-CAR-iNKT and MiNK-413.
Encouraging early activity was seen with agenT-797 monotherapy and combination, with reductions in target and non-target lesions and disease stabilization, which included a durable partial response in a PD-1 refractory gastric cancer patient.
AgenT-797 also showed long-term persistence (detected in the periphery for up to 6 months), which was independent of human leukocyte antigen ("HLA") matching and in absence of lymphodepletion.
These data were presented at Society of Immunotherapy for Cancer ( SITC ) in 2024.