MiNK Therapeutics Announces Lasting Responses and Immune Activation from Allo-iNKT Cell Therapy agenT-797 in PD-1–Refractory Solid Tumors at SITC 2025
Clinical Results of agenT-797: MiNK Therapeutics reported promising clinical results for agenT-797, showing durable survival and deep remissions in patients with advanced solid tumors resistant to checkpoint inhibitors, with a median overall survival of approximately 23 months.
Immune Activation and Tumor Remodeling: The therapy demonstrated immune reprogramming within the tumor microenvironment, enhancing immune responses and restoring the immune system's ability to recognize and attack tumors, even in cases of profound treatment resistance.
Safety and Efficacy Profile: agenT-797 exhibited a favorable safety profile with manageable side effects, supporting its potential for combination therapies and repeat-dose regimens in future studies.
Potential Impact on Cancer Treatment: The findings position agenT-797 as a first-in-class iNKT cell therapy that could transform treatment for patients with refractory solid tumors, bridging innate and adaptive immunity to extend the benefits of immunotherapy.
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- iNKT Cell Depletion Discovery: MiNK Therapeutics presented evidence at the Keystone Symposium showing significant depletion of iNKT cells in lung-associated lymph nodes from end-stage idiopathic pulmonary fibrosis (IPF) patients, suggesting that iNKT insufficiency may be a mechanistic feature of disease progression, thus providing new directions for therapeutic strategies.
- Clinical Application Potential: The findings support iNKT cell replenishment strategies as a potential approach to restore immune balance and promote tissue repair in fibrotic lung disease, particularly in the absence of effective treatments, highlighting the broad applicability of MiNK's iNKT platform in chronic immune-mediated lung diseases.
- Significant Market Need: Idiopathic pulmonary fibrosis is a fatal, progressive lung disease affecting approximately 100,000 patients in the U.S., with 30,000 to 40,000 new diagnoses annually, indicating a substantial unmet medical need in this area, and MiNK's research may offer new hope for patients.
- Platform Expansion: This research not only strengthens the relevance of MiNK's development programs in oncology, GVHD, and severe pulmonary inflammation but also indicates the potential applications of its iNKT cell therapy in chronic fibrotic and senescence-associated diseases, further solidifying the company's market position.
- Clinical Trial Launch: MiNK Therapeutics announces the upcoming initiation of a Phase 1 clinical trial to evaluate the safety and preliminary efficacy of its lead therapy, agenT-797, in high-risk leukemia patients, aiming to reduce graft-versus-host disease (GvHD) and relapse risk.
- Funding Support: The trial is backed by NIH STTR funding from NIAID and the Mary Gooze Clinical Trial Award, ensuring the simultaneous advancement of clinical and translational research, highlighting the focus on GvHD as a serious complication.
- Innovative Therapy: agenT-797 is an off-the-shelf iNKT cell therapy that requires no HLA matching, designed to improve survival and quality of life for transplant patients by suppressing inflammatory responses without the cytotoxic burden.
- Research Collaboration: The trial is led by Dr. Hongtao Liu at the University of Wisconsin, integrating efforts from multiple researchers to leverage the immune-regulating properties of iNKT cells to potentially transform post-transplant treatment outcomes.
- Reverse Split Announcement: Ryvyl Inc's announcement of a 1-for-35 reverse stock split to regain Nasdaq's $1 minimum bid compliance led to a pre-market plunge of 14.4% in share price to $0.13, indicating a significant loss of investor confidence and potential liquidity issues.
- Market Reaction: Following the reverse split news, Ryvyl's shares fell sharply, reflecting market concerns about the company's future prospects, which could hinder its ability to raise capital and maintain competitive positioning.
- Other Stock Movements: Shares of Mink Therapeutics and SMX dropped 13.4% and 8.2% respectively, illustrating a broader market sentiment decline that may negatively impact investor confidence across related sectors.
- Industry Impact: Despite NeoGenomics' 7.1% decline in share price, the appointment of industry veteran John P. Kenny to its Board may provide a strategic turning point for the company, potentially enhancing its competitive edge in the diagnostics and lab services market.

- Take-Private Agreement Signed: Fonar Corp announced the signing of a definitive agreement for a take-private sale, resulting in a 24.5% surge in pre-market shares to $18.25, indicating strong market confidence that could provide financial backing for future growth.
- Strong Market Reaction: The stock's robust performance in pre-market trading reflects optimistic investor sentiment regarding the privatization deal, potentially attracting more investor interest and enhancing the company's overall market capitalization.
- Significant Industry Impact: Fonar's privatization move may trigger similar actions among other medical device companies, prompting more firms in the sector to consider privatization to enhance operational efficiency and shareholder value.
- Future Strategic Direction: By going private, Fonar is expected to concentrate resources on its core business and optimize its operational model, thereby strengthening its market position and profitability in a highly competitive healthcare market.

Overview of MiNK-215: MiNK-215 is a novel CAR-iNKT therapy designed to target and eliminate FAP-positive cancer-associated fibroblasts, which create an immunosuppressive environment in solid tumors, thereby enhancing immune cell infiltration and anti-tumor activity.
Mechanism of Action: The therapy dismantles the protective stromal barrier and reprograms the immune landscape by activating dendritic cells, repolarizing macrophages, and enabling deep infiltration of tumor-specific T cells, particularly in models of lung and colorectal cancer.
Scalability and Accessibility: As an "off-the-shelf" therapy, MiNK-215 can be manufactured at scale and delivered on demand, providing a new treatment option for patients with solid tumors that have been resistant to traditional immunotherapies.
Company Background: MiNK Therapeutics is focused on developing allogeneic iNKT cell therapies and precision immune modulators, with a pipeline that includes various therapies aimed at restoring immune balance and addressing cancer and immune disorders.

Earnings Reports Overview: Several companies, including Spire Inc., Scholar Rock Holding Corporation, and Twist Bioscience Corporation, are set to report their earnings for the quarter ending September 30, 2025, with varying forecasts for earnings per share (EPS) and growth compared to the previous year.
Spire Inc. Performance: Spire Inc. is expected to report an EPS of $-0.46, reflecting a 14.81% increase year-over-year, with a Price to Earnings (P/E) ratio of 20.08, indicating stronger growth potential than its industry peers.
Scholar Rock Holding Corporation and Twist Bioscience: Scholar Rock is forecasted to have an EPS of $-0.88, a 33.33% decrease from last year, while Twist Bioscience anticipates an EPS of $-0.40, a 32.20% increase, despite missing previous earnings expectations.
Other Notable Companies: Companies like Bit Digital, Sigma Lithium, and SBC Medical Group are also reporting, with SBC Medical expected to show significant growth with a 333.33% increase in EPS, while others like MiNK Therapeutics and Mersana Therapeutics are facing declines in their EPS forecasts.





