Core Insights - MiNK Therapeutics presented new data on the role of invariant natural killer T (iNKT) cells in idiopathic pulmonary fibrosis (IPF) at the Emerging Cell Therapies Meeting, indicating a significant depletion of iNKT cells in patients with end-stage IPF [1][2][3] Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing allogeneic iNKT cell therapies and precision-targeted immune technologies [6] - The company's lead candidate, agenT-797, is designed to restore immune balance and is currently in clinical development for conditions such as GvHD, solid tumors, and severe pulmonary inflammation [6][7] Research Findings - The data presented by Dr. Terese Hammond showed that iNKT cells are significantly depleted in lung-associated lymph nodes of patients with advanced IPF, suggesting a loss of natural immunoregulatory mechanisms that may contribute to persistent inflammation and fibrotic remodeling [2][5] - The findings support the potential of iNKT cell replenishment strategies to restore immune balance and aid tissue repair in fibrotic lung diseases, expanding MiNK's platform relevance into chronic fibrotic and senescence-associated indications [3][8] Disease Context - IPF is a progressive and fatal lung disease characterized by irreversible lung scarring and a median survival of 3–5 years, affecting approximately 100,000 patients in the U.S. with 30,000–40,000 new diagnoses annually [4] - There are currently no approved treatments that can reverse fibrosis or restore immune balance in IPF, highlighting a significant unmet medical need [4]

Core Insights - MiNK Therapeutics reported significant clinical advancements and financial results for Q3 2025, highlighting durable clinical responses with its lead asset, agenT-797, and the expansion of its iNKT platform across various therapeutic areas [1][4][6] Q3 2025 Highlights - Durable clinical responses were observed in refractory solid tumors with agenT-797, including complete remissions lasting over two years and survival rates exceeding two to three years in late-stage cancers [2] - The safety profile of agenT-797 was favorable, with no reported cases of Grade 3 cytokine release syndrome (CRS) or neurotoxicity [2] - MiNK initiated a collaboration with the University of Wisconsin Carbone Cancer Center for a preclinical and Phase 1 study of agenT-797 aimed at preventing graft-versus-host disease (GvHD) in stem-cell transplant patients [2][4] Leadership Strengthening - Dr. Terese C. Hammond joined as Head of Inflammatory and Pulmonary Diseases, focusing on late-stage programs for acute respiratory distress syndrome (ARDS) and GvHD [5] - Colonel (Ret.) John B. Holcomb was appointed to the Board of Directors, bringing expertise in trauma and critical care [5] Financial Highlights - As of September 30, 2025, MiNK had approximately $14.3 million in cash and cash equivalents, an increase from $4.6 million at the end of 2024 [9][14] - The net loss for Q3 2025 was $2.9 million, or $0.65 per share, compared to a net loss of $1.8 million, or $0.46 per share for Q3 2024 [11][14] - Cash used in operations for Q3 2025 was $941,000, a decrease from $2.995 million in Q3 2024 [11] Future Catalysts - MiNK plans to initiate multiple studies and expects early clinical readouts over the next 12 months, focusing on oncology, inflammatory diseases, and critical illness [12][13] - Key upcoming milestones include the initiation of the NIH-supported Phase 1 GvHD study and early data from a Phase 2 trial in severe pulmonary inflammatory disease [15]

Core Insights - MiNK Therapeutics has appointed Dr. Terese C. Hammond as Head of Inflammatory and Pulmonary Diseases, which is expected to enhance the company's focus on innovative therapies for severe pulmonary and inflammatory diseases [1][3]. Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company specializing in invariant natural killer T (iNKT) cell therapies and precision-targeted immune technologies [6]. - The company's lead asset, AgenT-797, is an allogeneic iNKT cell therapy currently in clinical development for graft-versus-host disease (GvHD), solid tumors, and critical pulmonary immune collapse [6][9]. Leadership and Expertise - Dr. Hammond is a recognized leader in pulmonary and critical care medicine, with over two decades of experience and a history of advancing registration-stage programs in severe diseases [2][5]. - She has served as principal investigator on pivotal studies for major pharmaceutical companies and is the lead author of significant publications related to MiNK's iNKT cell therapy [2][3]. Clinical Programs - Dr. Hammond will lead MiNK's inflammatory and pulmonary disease portfolio, which includes a grant-supported clinical trial in GvHD and a planned late-stage trial in severe pulmonary disease [3][7]. - These programs are positioned as substantial, low-risk opportunities supported by strong biological rationale and peer-reviewed data [3]. Research and Development - iNKT therapies have shown promising results in acute respiratory distress syndrome (ARDS) and other severe pulmonary diseases, indicating a substantial opportunity for near-term pivotal advancement [4][9]. - The unique biology of iNKTs allows for a robust immune response against difficult-to-treat tumors, enhancing the potential for transformative treatment options [9].

Core Insights - MiNK Therapeutics is pioneering allogeneic invariant natural killer T (iNKT) cell therapies, with a focus on treating solid tumors where conventional therapies have struggled [1][2] - The company’s lead product, agenT-797, has shown durable responses in patients with treatment-refractory solid tumors, demonstrating its potential as a next-generation therapy [3][4] Company Overview - MiNK Therapeutics is a clinical-stage biopharmaceutical company focused on developing iNKT cell therapies and precision-targeted immune technologies [7] - The company’s proprietary platform aims to restore immune balance and drive cytotoxic immune responses across various diseases, including cancer and immune-mediated disorders [7][9] Clinical Data - In a recent case, a patient with metastatic testicular cancer achieved complete remission after treatment with agenT-797 combined with anti–PD-1 therapy, remaining disease-free for over two years [3] - Ongoing Phase 2 trials in gastric cancer have shown that agenT-797 can activate the immune system, enhance tumor infiltration, and provide durable disease control in patients who previously failed immunotherapy [4] Unique Mechanism of Action - iNKT cells, when engineered with CARs, maintain their innate tumor-homing and immunomodulatory features while gaining antigen-specific precision, allowing for both direct tumor killing and broad immune reprogramming [5] - MiNK-215, an IL-15–armored, FAP-targeting CAR-iNKT therapy, is designed to penetrate fibrotic tumors and has shown promise in preclinical studies by enhancing T cell infiltration and depleting stromal barriers [6][8] Manufacturing and Scalability - The iNKT platform allows for scalable and cost-effective manufacturing, with the potential for off-the-shelf therapies that do not require complex conditioning or lymphodepletion [8][9]

Core Insights - MiNK Therapeutics has published a significant case study demonstrating the efficacy of its allogeneic iNKT cell therapy, agenT-797, in achieving complete and durable remission in a patient with metastatic testicular cancer who had previously failed multiple treatments [1][2][3] Group 1: Clinical Evidence - The case study published in Nature's Oncogene details a patient who achieved complete clinical, radiologic, and biochemical remission after receiving a single infusion of agenT-797 alongside nivolumab, with no evidence of disease over two years later [2] - The patient had previously undergone multiple lines of therapy, including platinum-based chemotherapy and various immune checkpoint inhibitors, highlighting the potential of iNKT cell therapy in heavily pre-treated patients [2][3] - MiNK presented additional data at the 2025 AACR Immuno-Oncology meeting, showing immune activation and early signals of tumor control in patients with gastric cancer who were previously refractory to checkpoint inhibitors [3][4] Group 2: Mechanism and Development - AgenT-797 is designed to harness both innate and adaptive immunity, functioning as a "master regulator" that combines the cytotoxic capabilities of NK cells with T-cell-like antigen recognition [7] - The therapy is scalable and off-the-shelf, aimed at providing accessible treatment options for patients with solid tumors and severe pulmonary inflammation [8] - MiNK is actively enrolling patients in an ongoing Phase 2 trial for gastric cancer, with further readouts expected in the coming months [4]