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MiNK Presents AgenT-797 Clinical Activity in Immune-Compromised Transplant Patient with Severe ARDS at ATS Annual Meeting

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MiNK Therapeutics has unveiled clinical data on their allogeneic invariant natural killer T (iNKT) cell therapy, agenT-797, in a severe ARDS case at the ATS Annual Meeting. The subject, a 26-year-old post-renal transplant immunocompromised individual who developed severe hypoxemic respiratory failure due to COVID-19, was treated with a single dose of agenT-797. Significant clinical improvements included reduced inflammatory cytokines and successful extubation by day 37. The patient was discharged by day 60 and resumed normal activities within six months. These findings align with Phase 1 trial data, supporting the potential of agenT-797 in treating severe respiratory conditions in immune-compromised patients.

Positive
  • Observed rapid decrease in inflammatory cytokines post-treatment.
  • Successful extubation of the patient by day 37.
  • Patient discharged from the hospital by day 60.
  • Patient weaned off hemodialysis and returned to normal activities within six months.
  • Data aligns with prior Phase 1 trial results, indicating consistency and reliability.
  • Potential of agenT-797 to address critical unmet needs in immune-compromised patients with respiratory distress.
Negative
  • Single case study limits the generalizability of results.
  • No long-term data provided on the durability of treatment effects.
  • High costs and complex logistics associated with cell therapies.
  • Potential risks and side effects of allogeneic iNKT cells were not discussed.

Insights

MiNK Therapeutics has presented clinical data on the usage of agenT-797, an allogeneic invariant natural killer T (iNKT) cell therapy, in a severely immune-compromised patient with ARDS. The case study indicated that a single dose of the therapy significantly reduced inflammatory cytokines and improved the patient's clinical condition, allowing for eventual discharge and resumption of normal activities.

From a medical research perspective, this data is promising because it demonstrates that agenT-797 can potentially offer therapeutic benefits in critical care scenarios. The rapid decrease in inflammatory cytokines such as IL-18 suggests that agenT-797 may effectively modulate the immune response, a key factor in managing ARDS. These findings align with earlier Phase 1 trial results, suggesting consistency and reproducibility. Given the critical unmet need for effective treatments for immune-compromised patients, this study provides a compelling case for further investigation and larger-scale clinical trials to validate these preliminary findings.

The potential for iNKT cell therapies to treat not only cancer but also other immune-mediated diseases opens up a broad spectrum of clinical applications, which is highly significant in the field of translational medicine.

The data presented by MiNK Therapeutics could have notable financial implications. Successfully demonstrating the efficacy of agenT-797 in severe ARDS cases provides a strong catalyst for investor confidence. If further studies confirm these results, it could lead to faster regulatory approvals and market entry, translating into significant revenue streams.

Investors should note that MiNK's focus on treating critical unmet needs in immune-compromised patients could capture a niche but essential market segment. The potential for this therapy to reduce hospital stays and intensive care requirements also adds economic value, which can be appealing for healthcare providers and payers.

However, it’s important to remain cautious as the data is still in its early stages. Larger clinical trials will be required to confirm these findings and any setbacks in these trials could impact the stock negatively. Therefore, while the preliminary results are promising, investors should monitor upcoming clinical milestones closely.

The presentation of agenT-797 at the ATS Annual Meeting highlights MiNK Therapeutics' strategic approach to positioning itself in the competitive landscape of ARDS treatment. This niche market is currently underserved, particularly for immune-compromised patients, making MiNK's developments particularly impactful.

From a market research perspective, the successful application of iNKT cell therapy in ARDS could disrupt existing treatment protocols, offering a new modality that leverages the body’s immune system. This is consistent with broader market trends favoring immunotherapies, which have shown substantial growth and investment interest. If agenT-797 gains regulatory approval, it could set a precedent for similar therapies, potentially increasing MiNK's market share and influencing competitor strategies.

The strategic dissemination of these findings at a high-profile medical conference also aids in building MiNK's brand reputation and scientific credibility, which are essential for future collaborations and partnerships.

NEW YORK, May 22, 2024 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced presentation of clinical data on agenT-797 in a complex case of severe acute respiratory distress (ARDS) at the American Thoracic Society (ATS) Annual Meeting. These translational and mechanistic insights build on an expanding dataset of clinical activity for patients with severe ARDS.

“Consistent with our prior publication of the survival benefit of agenT-797 in severe respiratory distress, the observed improvement in this case further demonstrates the potential of allogeneic iNKT cells in this setting,” said Dr. Terese Hammond, University of California Los Angeles. “New therapeutic options, like allogeneic cell therapies, are urgently needed to address the critical unmet need in immune-compromised individuals with respiratory distress. I believe this growing body of data illuminates how iNKTs may have an impactful role in treating acute critical illness and merits further investigation.”

Clinical Findings

  • Patient: A 26-year-old chronically immunosuppressed patient post-renal transplant contracted COVID-19 and progressed to severe hypoxemic respiratory failure, requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO).
  • Treatment: A single dose of 1x10^9 allogeneic iNKT cells (agenT-797) on hospital day 13.
  • Outcomes: Clinical changes showed a rapid decrease in inflammatory cytokines, including IL-18 following agenT-797 administration, consistent with the data observed in the Phase 1 trial of agenT-797 in COVID-19 ARDS (Hammond, T.C., Nat Commun 2024). The patient was extubated on day 37 and discharged home from the hospital on day 60, weaned off hemodialysis and returned to normal activities of daily living (ADLs) within 6 months of dosing.

The full poster presentation can be found on the Publications page of the MiNK website at https://minktherapeutics.com/publications/.

About MiNK Therapeutics

MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit https://minktherapeutics.com/ or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels.

Forward Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic and curative potential of agenT-797 and iNKT cells the mechanism of action, potency and safety, interim or top-line data, including statements regarding clinical data of agenT-797, the anticipated benefits of agenT-797 and clinical development plans and timelines. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Investor Contact

917-362-1370

investor@minktherapeutics.com

Media Contact

781-674-4428

communications@minktherapeutics.com


FAQ

What is agenT-797 and its significance in treating ARDS?

AgenT-797 is an allogeneic invariant natural killer T (iNKT) cell therapy developed by MiNK Therapeutics. It shows potential in treating severe acute respiratory distress syndrome (ARDS) by reducing inflammatory cytokines and improving clinical outcomes in immune-compromised patients.

What were the key outcomes of the agenT-797 treatment in the severe ARDS case?

The key outcomes included a rapid decrease in inflammatory cytokines, successful extubation by day 37, discharge from the hospital by day 60, and the patient resuming normal activities within six months.

How does agenT-797 align with MiNK Therapeutics' previous clinical data?

The clinical improvements observed in this ARDS case are consistent with data from MiNK Therapeutics' Phase 1 trial of agenT-797 in COVID-19 ARDS, supporting its potential efficacy.

What are the limitations of the agenT-797 clinical data presented?

The data is based on a single case study, limiting its generalizability. Additionally, long-term effects and potential risks or side effects were not discussed.

What are the next steps for the development of agenT-797?

Further investigation and larger clinical trials are needed to confirm the efficacy and safety of agenT-797 in treating severe respiratory conditions in immune-compromised patients.

MiNK Therapeutics, Inc.

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