MiNK’s AgenT-797 Offers New Hope in Overcoming ICI Resistance in PD-1 Refractory Gastric Cancer - Published in Oncogene
- Case report published in Oncogene from phase 1/2 study in patients with advanced solid tumors
- One infusion of agenT-797 in gastric cancer refractory to anti-PD1 led to a durable confirmed partial response
- iNKT cells have unique potential to overcome resistance to immune checkpoint inhibitors
- Randomized phase 2 trial underway led by Chief of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center
- None.
The case report from MiNK Therapeutics regarding their phase 1/2 study of agenT-797, an iNKT cell therapy, is a significant development in the field of oncology, particularly for gastric cancer treatment. The reported durable partial response in a patient with advanced solid tumors who was refractory to anti-PD1 therapy represents a potential breakthrough. Gastric cancer, characterized by low responsiveness to immune checkpoint inhibitors (ICIs), presents a substantial treatment challenge. The reported outcome suggests that iNKT cell therapy could offer a new avenue for patients who have exhausted other treatment options.
Furthermore, the observed increase in immune cell infiltration and proliferation post-treatment provides evidence of the therapy's mechanism of action. This aligns with the known role of iNKT cells in modulating the immune system and may explain the partial response in a patient profile that typically has a poor prognosis. It is also noteworthy that agenT-797 was administered without the need for lymphodepletion, which is often required with other cell therapies and can be associated with significant side effects. The implications of these findings could extend to other refractory solid tumors, potentially broadening the impact of this therapeutic approach.
From a research perspective, the case report published by MiNK Therapeutics offers compelling data that warrants further investigation. The durability of the response to agenT-797, especially in a patient with a high mutational burden and PD-L1 positivity, suggests that iNKT cell therapies may have a unique capacity to overcome the limitations of current treatments. The absence of lymphodepletion prior to administering agenT-797 is particularly notable, as it suggests a reduced toxicity profile compared to other cell therapies that require such conditioning.
Additionally, the scalability and 'off-the-shelf' nature of allogeneic iNKT cell therapies could represent a significant advantage over autologous treatments, which are more personalized and time-consuming to produce. This could lead to increased accessibility and reduced costs for patients. However, it is important to consider that these findings are preliminary and derived from a single case report within a phase 1/2 study. The ongoing randomized phase 2 trial will be critical in validating the efficacy and safety of agenT-797 in a larger patient population.
The positive outcome from MiNK Therapeutics' phase 1/2 study of agenT-797 could have notable implications for the company's market position. The potential of iNKT cell therapies to fill a gap in the treatment of refractory solid tumors, such as gastric cancer, may attract the attention of investors and larger pharmaceutical companies interested in novel cancer therapies. The market for cancer immunotherapies is highly competitive and the introduction of an effective off-the-shelf iNKT cell therapy could disrupt the current treatment landscape.
Moreover, the scalability and ease of administration associated with agenT-797 could lead to a favorable cost structure and ease of distribution, factors that are critical in the adoption of new therapies. The anticipation of further updates on MiNK's solid tumor programs throughout the year could maintain investor interest and potentially impact the company's stock performance. However, investors will likely await results from the ongoing phase 2 trial before making significant financial commitments.
NEW YORK, Jan. 30, 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 the publication of a case report in Oncogene from its phase 1/2 study in patients with advanced solid tumors where one infusion of agenT-797 in gastric cancer refractory to anti-PD1 led to a durable confirmed partial response, highlighting the unique potential of iNKT cells to overcome resistance to immune checkpoint inhibitors (ICIs).
“Gastric cancer remains an area of high unmet need, where the majority of patients develop disease progression related to tumor resistance,” said Dr. Benedito A. Carneiro, Director of Clinical Research, Director of Cancer Drug Development (Phase I), Associate Director of the Division of Hematology/Oncology, Legorreta Cancer Center at Brown University. “Novel therapeutic approaches, like allogeneic iNKT cells, are urgently needed to overcome resistance to immune checkpoint inhibitors in gastric cancers and other refractory solid tumors. The activity, tolerability, and ease of off-the-shelf administration of iNKT-based cell therapies position them as an attractive approach for overcoming cancer resistance.”
Gastric cancer, the fifth most common malignancy globally, is incurable with only
This case report describes a durable response (by RECIST 1.1 criteria) in a patient with a challenging clinical profile—a PD-L1 positive, HER-2 negative, MSI-H adenocarcinoma with a high mutational burden (84 mut/MB). Prior treatments, including single-agent anti-PD-1 pembrolizumab, had failed to elicit a response, prompting a combination therapy approach involving chemotherapy (FOLFOX) and nivolumab. However, even this combined regimen proved ineffective before the patient's enrollment in MiNK’s clinical trial. Following treatment with agenT-797, increased immune cell infiltration and proliferation were observed, which correlated with the radiographic partial response.
“These findings reinforce the distinct potential of iNKTs as a novel therapeutic approach to address refractory solid tumor cancers,” said Dr. Jennifer Buell, Chief Executive Officer of MiNK. “Allogeneic iNKTs are an ideal approach for addressing refractory solid tumor cancers because of their unique ability to modulate the immune system, long-term persistence, scalability, and off-the-shelf administration without toxic pre-conditioning. We are continuing to advance iNKT cells in this setting and look forward to further updates on our solid tumor programs this year.”
A randomized phase 2 trial, led by Dr. Yelena Janjigian, Chief of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center, is underway.
References:
- Rawla P, Barsouk A. Epidemiology of gastric cancer: global trends, risk factors and prevention. Prz Gastroenterol 2019; 14: 26-38.
- Kono K, Nakajima S, Mimura K. Current status of immune checkpoint inhibitors for gastric cancer. Gastric Cancer 2020; 23: 565-578.
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 alone and in combination with anti-PD-1, 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, Form 10-Q and the S-1 Registration Statement 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.
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