First Refractory Gastric Cancer Patient Dosed in Phase 2 Trial with Novel Combination of MiNK’s Allogeneic INKT Cell Therapy and Agenus’ Botensilimab and Balstilimab
MiNK Therapeutics, Inc. (INKT) announces the initiation of a Phase 2 investigator sponsored study for agenT-797 in second line gastroesophageal cancer at Memorial Sloan Kettering Cancer Center. The study aims to address the treatment challenges faced by ~70% of Gastroesophageal Cancer (GEC) patients. The trial involves a novel combination of Allogeneic Cell Therapy with BOT/BAL and aims to evaluate the safety and efficacy of agenT-797 in combination with botensilimab, balstilimab, ramucirumab, and paclitaxel for patients with advanced esophageal, gastric, or gastro-esophageal junction adenocarcinoma.
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MiNK Therapeutics, Inc. (NASDAQ: INKT) initiates a Phase 2 study for agenT-797 in second line gastroesophageal cancer at Memorial Sloan Kettering Cancer Center.
The study targets patients with refractory gastric cancers and aims to evaluate a novel combination therapy involving Allogeneic Cell Therapy with BOT/BAL.
The trial will assess the safety and efficacy of agenT-797 in combination with botensilimab, balstilimab, ramucirumab, and paclitaxel for advanced esophageal, gastric, or gastro-esophageal junction adenocarcinoma.
Dr. Yelena Janjigian leads the investigator sponsored study, focusing on improving outcomes for patients with challenging GI cancers through innovative treatment approaches.
The collaboration between MiNK and Agenus aims to leverage the immune-enhancing potential of agenT-797 to address unmet needs in cancer care.
The study aims to enroll around 38 patients with advanced, unresectable, or metastatic forms of esophageal, gastric, or GEJ adenocarcinoma who have experienced disease progression after initial treatment.
The initiation of a Phase 2 clinical trial for agenT-797 in the treatment of gastroesophageal cancer represents a significant advancement in the field of oncology. The study's focus on patients for whom current treatments are ineffective addresses a critical unmet need within this patient population. As an off-the-shelf iNKT cell-based therapy, agenT-797's compatibility with immune checkpoint inhibitors could potentially lead to improved patient outcomes. It's noteworthy that this therapy has already shown promise in overcoming resistance to existing treatments, which is a common and challenging issue in cancer therapy.
Understanding the combination of agenT-797 with botensilimab, an fc-enhanced CTLA-4 inhibitor and balstilimab, alongside standard treatments like ramucirumab and paclitaxel, could provide insights into new, more effective treatment protocols. The potential for durable disease stabilization and confirmed response rates in refractory gastric cancer is particularly encouraging, as it suggests a possibility of extending survival and improving the quality of life for patients with advanced disease stages.
The strategic collaboration between MiNK Therapeutics and Agenus is a key factor in the development of innovative cancer treatments. The incorporation of novel agents like botensilimab and balstilimab in combination with iNKT cell therapy could redefine the therapeutic landscape for refractory gastric cancers . From a research perspective, the trial's design to assess clinical safety and efficacy provides essential data that could influence future drug development and approval processes.
Furthermore, the study's enrollment criteria, targeting advanced, unresectable, or metastatic forms of gastroesophageal cancer, ensures that the trial addresses the needs of a patient group with limited options. The trial's outcomes have the potential to not only extend the therapeutic arsenal for clinicians but also to impact regulatory and reimbursement policies, given the high cost and complexity of cancer treatments.
From a market perspective, the launch of this Phase 2 study by MiNK Therapeutics could signal a positive trajectory for the company's stock, contingent on the trial's outcomes. The fact that this study is supported by Stand Up To Cancer enhances its visibility and could potentially attract investor interest. The successful development of agenT-797, especially if it shows a significant improvement over existing therapies, could lead to substantial market growth for MiNK Therapeutics.
Investors will be closely monitoring the progress of this trial, as positive results could lead to increased confidence in the company's pipeline and potentially drive up its stock value. However, it is also important to acknowledge the inherent risks of clinical trials, as unexpected safety concerns or efficacy shortcomings could adversely affect investor sentiment and the company's financial health.
02/14/2024 - 08:00 AM
Dr. Yelena Janjigian, Chief of GI Cancers, Leads Investigator Sponsored Study at Memorial Sloan Kettering Cancer Center Trial is Supported by Stand Up To Cancer as Part of an Initiative to Find Treatments for the ~70% of Gastroesophageal Cancer (GEC) Patients for Whom Current Treatments Don't Work Randomized Phase 2 Represents First Novel Combination of Allogeneic Cell Therapy with BOT/BAL Through Collaboration of Agenus and MiNK NEW YORK, Feb. 14, 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 first patient dosed in a Phase 2 investigator sponsored study for agenT-797 in second line gastroesophageal cancer, led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center. The trial builds upon findings from MiNK’s recently published clinical trial (Carneiro et al . 2024 Oncogene ) demonstrating that agenT-797 appears to overcome resistance to immune checkpoint inhibitors, with durable disease stabilization and a confirmed response in chemotherapy and anti-PD-1 refractory gastric cancer.
“This study is an important step in new treatment combinations to improve outcomes for patients with refractory gastric cancers, an incurable disease with limited response to available therapies,” said Dr. Yelena Janjigian, Chief Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center. "AgenT-797, an off-the-shelf iNKT cell-based therapy, has shown the capacity to target cancerous cells in diseased tissues and is compatible with immune checkpoint inhibitors. This study builds upon the promising outcomes observed with iNKTs in gastric cancer and with botensilimab/balstilimab in GI cancers. By harnessing the immune-enhancing potential of agenT-797, we aspire to improve outcomes for a greater number of patients facing challenging GI cancers."
This Phase 2 Study will evaluate the clinical safety and efficacy of the combination of agenT-797 (iNKT cells), botensilimab, a novel fc-enhanced CTLA-4 inhibitor, plus balstilimab (anti-PD-1) with ramucirumab and paclitaxel for patients with previously treated, advanced esophageal, gastric, or gastro-esophageal junction (GEJ) adenocarcinoma. The study aims to enroll around 38 patients with advanced, unresectable, or metastatic forms of these cancers who have experienced disease progression after initial treatment.
"We are thrilled to collaborate with GI cancer expert Dr. Yelena Janjigian on this Phase 2 study, furthering the development of agenT-797 in refractory gastric cancer," stated Dr. Jennifer Buell, President and Chief Executive Officer at MiNK. "This study is designed to provide crucial insights into the clinical efficacy of agenT-797, while also assessing its potential synergies with chemotherapy and next-generation immune checkpoint inhibitors, botensilimab and balstilimab. This milestone underscores our unwavering commitment to advancing iNKT cell therapies to address the pressing unmet needs in cancer care and highlights the strength of our collaboration with Agenus to access these novel and exciting combinations to deliver meaningful benefits to our patients."
About Botensilimab
Botensilimab is Agenus’ investigational multifunctional anti-CTLA-4 immune activator (antibody) designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 750 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.
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 other therapeutic candidates, for instance, anti-CTLA-4 and 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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What is the purpose of the Phase 2 investigator sponsored study for agenT-797 (INKT)?
The study aims to evaluate the safety and efficacy of agenT-797 in combination with botensilimab, balstilimab, ramucirumab, and paclitaxel for patients with advanced esophageal, gastric, or gastro-esophageal junction adenocarcinoma.
Who is leading the Phase 2 study for agenT-797 (INKT)?
Dr. Yelena Janjigian is leading the investigator sponsored study at Memorial Sloan Kettering Cancer Center.
How many patients are expected to be enrolled in the Phase 2 study for agenT-797 (INKT)?
The study aims to enroll around 38 patients with advanced, unresectable, or metastatic forms of esophageal, gastric, or gastro-esophageal junction adenocarcinoma.
What is the unique aspect of the combination therapy in the Phase 2 study for agenT-797 (INKT)?
The trial involves a novel combination of Allogeneic Cell Therapy with BOT/BAL, aiming to address the treatment challenges faced by ~70% of Gastroesophageal Cancer (GEC) patients.
What is the goal of the collaboration between MiNK and Agenus in the Phase 2 study for agenT-797 (INKT)?
The collaboration aims to leverage the immune-enhancing potential of agenT-797 to address unmet needs in cancer care and deliver meaningful benefits to patients.
