AgenT-797

近日，国内企业基因启明研发的新型异体即用型iNKT细胞注射液（GKL-006RTU注射液）获得国家药品监督管理局（NMPA）的新药临床试验批准，用于治疗感染引起的中、重度急性呼吸窘迫综合征。这是该公司获得的第五个IND批件，也是其在非肿瘤疾病领域的首个获批项目，标志着我国首款异体即用型iNKT细胞治疗产品步入注册性临床阶段，填补了国内该疗法在非肿瘤领域的空白，为重症救治提供了新的技术选择。 近年来，CAR-T细胞疗法在血液肿瘤治疗中成效显著，但在实体瘤治疗中仍面临挑战，主要受限于实体瘤微环境（TME）的免疫抑制作用。因此，科研人员正积极探索新的治疗策略。其中，基于iNKT细胞的新一代细胞免疫疗法展现出对抗实体瘤的潜力，逐渐成为研究热点。 目前，全球多家生物医药公司正积极布局iNKT细胞疗法。例如，Mink Therapeutics、Arovella Therapeutics、Kite & Appia Bio等公司均有相关产品处于不同研发阶段。近期，MiNK Therapeutics公司公布其异体iNKT细胞疗法agenT-797在治疗转移性睾丸癌和胃癌方面取得积极进展，相关成果发表于《Oncogene》杂志，并推动其股价单日大涨730%。 临床研究显示，一名曾接受多线治疗无效的转移性睾丸癌患者，在接受单次agenT-797与nivolumab联合治疗后，症状、影像及生化指标均恢复正常，且在两年多的随访中未见复发。治疗后在体内仍可检测到供体来源的iNKT细胞，且未出现细胞因子释放综合征或移植物抗宿主病，显示出良好的安全性与耐受性。另一例胃癌患者联合用药后肿瘤缩小42%，无进展生存期超过9个月。 iNKT细胞（恒定自然杀伤T细胞）是一类兼具T细胞与NK细胞特性的免疫细胞，能够早期快速释放大量细胞因子，在固有免疫与适应性免疫间发挥桥梁作用。其识别由CD1d分子递呈的脂质抗原，具备抗肿瘤活性，且不依赖多态性HLA，有助于降低移植物抗宿主病风险，因此被视为异基因CAR疗法的理想平台。 iNKT细胞疗法的制备通常包括从供体分离细胞、体外激活与扩增等步骤，以获得足够数量且功能活跃的细胞用于治疗。尽管该领域进展积极，但仍面临细胞在肿瘤组织内迁移能力有限、肿瘤微环境抑制、细胞存活与增殖能力不足及CAR设计优化等挑战。 为应对上述问题，研究人员正在探索多种策略，如利用IL-15和IL-21等细胞因子增强iNKT细胞的增殖与功能，或通过工程化手段在CAR结构中整合相关信号元件，以提升其抗肿瘤效果。此外，对不同iNKT细胞亚群功能与分化状态的深入研究，也有助于优化治疗策略，提升疗效与安全性。 综上所述，iNKT细胞疗法结合了T细胞与NK细胞的优势，有望突破传统CAR-T疗法在实体瘤治疗中的瓶颈，未来或将成为多种癌症治疗的重要新方向。

New clinical data show durable remissions and long-tail survivors including >2-year complete remissions in chemotherapy- and checkpoint-refractory cancersGVHD trial launching through non-dilutive funding from NIH- and philanthropic grantsLaunching Phase 2+ trial in severe pulmonary disease in US population with FDA-validated endpointsAdded national leaders in pulmonary medicine, trauma, and biodefense join MiNK management (Dr. Hammond) and Board (Dr. Holcomb) to drive pivotal developmentCash runway extended through 2026, enabling multiple inflection points NEW YORK, Nov. 14, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (allo-iNKT) cell therapies to reconstitute immunity to treat cancer and immune disorders, today reported financial results for the third quarter ended September 30, 2025, and provided a corporate update highlighting durable clinical responses with agenT-797, expansion of its iNKT platform across oncology, inflammation and transplantation, and strengthening of its leadership team as the company advances toward pivotal development. Q3 2025 Highlights Durable clinical responses in refractory solid tumors with agenT-797At SITC 2025, MiNK reported updated clinical data showing sustained tumor regression and immune reprogramming with its lead asset agenT-797 across checkpoint-refractory cancers, including complete remissions lasting more than two years and survival exceeding two and three years in late stage, refractory cancers. Safety profile was favorable with no ≥ Grade 3 CRS or neurotoxicity.Ongoing publication and translational momentumPeer-reviewed publications in Oncogene and Frontiers in Immunology further validated agenT-797’s ability to reinvigorate immune-exhausted T cells and reduce pulmonary inflammation without lymphodepletion, providing mechanistic and clinical rationale for pivotal-enabling trials across oncology and inflammatory diseases.Launch of federally and philanthropically funded collaboration with the University of Wisconsin Carbone Cancer Center (UWCCC) in GvHD with agent-797In collaboration with the University of Wisconsin Carbone Cancer Center–Madison, MiNK initiated a preclinical and Phase 1 study of agenT-797 with the goal of preventing GvHD and reduce relapse in stem-cell transplant patients. The study, led by Dr. Hongtao Liu and Dr. Jenny Gumperz, is supported by the Mary Gooze Clinical Trial and Translation Award and an NIH STTR grant from NIAID. “This trial reflects the broader momentum of our iNKT platform as we expand into diseases marked by profound immune dysregulation,” said Dr. Terese Hammond, Head of Inflammatory and Pulmonary Diseases at MiNK Therapeutics. “Whether in transplantation, severe pulmonary inflammation, or systemic immune collapse, the ability of iNKT cells to rebalance immunity creates a compelling opportunity to change outcomes across multiple high-need conditions. With strong support from NIH and our philanthropic partners, we are advancing a development program with meaningful potential across several disease areas.” Strengthened leadership Dr. Terese C. Hammond, a nationally recognized expert in pulmonary and critical care medicine, joined MiNK as Head of Inflammatory and Pulmonary Diseases to lead the Company’s late-stage ARDS and GvHD programs.Colonel (Ret.) John B. Holcomb, MD, FACS joined MiNK’s Board of Directors, bringing global expertise in trauma and critical care to advance iNKT therapies in immune-mediated and pulmonary diseases. “This quarter, MiNK achieved meaningful clinical and organizational milestones as we continue our disciplined path toward pivotal development,” said Jennifer Buell, PhD, President and Chief Executive Officer of MiNK Therapeutics. “The durability and mechanistic depth of our off-the-shelf iNKT cell therapy, agenT-797 results, paired with the launch of our grant supported GvHD study and new leadership in critical care, underscore the breadth of our platform and the momentum driving MiNK forward. We believe our iNKT therapies can restore immune balance across settings where current treatments have failed — in cancer, transplant, and severe inflammation, where we prepare for the next phase of clinical expansion.” Financial Highlights Cash Position: MiNK ended Q3 2025 with approximately $14.3 million in cash and cash equivalents and subsequently raised $1.2 million through equity sales, providing expected runway through 2026. Net Loss: Net loss for Q3 2025 was $2.9 million, or $0.65 per share, compared to $1.8 million, or $0.46 per share for Q3 2024. For the nine-months ended Q3 2025, net loss was $9.9 million, or $2.39 per share compared to $8.3 million or $2.24 per share for the same period in 2024. Current period results reflect ongoing activity supporting our agent-797 programs. Summary Consolidated Financial Information Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) September 30, 2025 December 31, 2024 Cash and cash equivalents$14,281 $4,577 Other Financial Information(in thousands)(unaudited) Three months ended September 30, Nine months ended September 30, 2025 2024 2025 2024 Net loss$2,888 $1,807 $9,892 $8,322Net loss per share 0.65 0.46 2.39 2.24 Cash used in operations$941 $2,995 $3,851 $7,828 Future Catalysts Q1 2026: Initiation of the NIH- and philanthropy-supported Phase 1 GvHD study with UW–Madison2026: Early data from our randomized Phase 2 trial in severe pulmonary inflammatory disease2026: Clinical and translational updates from agenT-797 oncology and inflammatory cohorts, including early signals from transplant, GVHD, and pulmonary programs2026: Continued progress on strategic partnerships and manufacturing optimization to support multi-program clinical execution Taken together, these milestones position MiNK to have multiple studies enrolling, early clinical readouts emerging, and increasing clarity on pivotal-enabling paths across our oncology, inflammatory, and critical-illness portfolio over the next 12 months. Conference Call and Webcast Information MiNK executives will host a conference call and webcast at 8:30 a.m. ET on Friday, November 14, 2025 to discuss results and corporate updates. Conference Participant Dial InformationUnited States - New York (646) 307-1963USA & Canada - Toll-Free (800) 715-9871Conference ID: 3474114 Webcast & Replay InformationA live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website following the event. Live event link: https://edge.media-server.com/mmc/p/4bufw45xWebcast Replay: https://investor.minktherapeutics.com/events-and-presentations About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the development of allogeneic invariant natural killer T (iNKT) cell therapies and precision immune modulators designed to restore immune balance and drive durable cytotoxic responses. MiNK’s proprietary iNKT platform bridges innate and adaptive immunity to address cancer, autoimmune disease, and immune collapse. Its lead candidate, agenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical trials for solid tumors, graft-versus-host disease (GvHD), and critical pulmonary immune failure. MiNK’s pipeline also includes TCR-based and neoantigen-targeted iNKT programs that enable tissue-specific immune activation. With a scalable manufacturing process and broad therapeutic potential, MiNK is advancing a new class of immune reconstitution therapies designed to deliver durable, accessible, and globally deployable treatments. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential, safety, clinical benefit, and development plans for agenT-797 and other iNKT-based therapies. These statements involve risks and uncertainties, including those described under “Risk Factors” in MiNK’s most recent SEC filings. MiNK undertakes no obligation to update these statements except as required by law. Contacts Investor Contact: 917-362-1370 | investor@minktherapeutics.comMedia Contact: 781-674-4428 | communications@minktherapeutics.com Source: MiNK Therapeutics