MiNK Therapeutics Announces Clinical Data of Allogeneic iNKT Cells (agenT-797) in Solid Tumor Cancers at the AACR Annual Meeting

Rhea-AI Summary

MiNK Therapeutics (Nasdaq: INKT) presented promising results at the AACR annual meeting for its iNKT cell therapy, agenT-797, showing effectiveness against refractory solid tumors. In a phase 1/2 trial involving heavily pretreated patients, significant tumor shrinkage of over 42% was observed in a patient with gastric cancer, maintaining response for over 9 months. The therapy, administered without toxic lymphodepletion, remained detectable for about 8 weeks, promoting immune cell infiltration into tumors. Following these results, MiNK plans to expand trials, combining agenT-797 with established therapies in additional cancer types, furthering its commitment to advancing cancer treatment options.

Positive

• AgenT-797 demonstrated significant tumor shrinkage (42%) in a gastric cancer patient, with effects persisting for over 9 months.
• The therapy shows a favorable safety profile, with no severe toxicities reported.
• Plans for expansion trials in multiple cancer types, indicating a strategic path for further development.

Negative

• None.

• Allogeneic iNKTs, agenT-797, administered alone or in combination with anti-PD-1 therapy, shows activity in patients with refractory solid tumor cancers.
• In a patient with metastatic gastric cancer who had no response to treatment with pembrolizumab and nivolumab/FOLFOX, agenT-797 induced a partial response with 42% tumor shrinkage, which continues beyond 9 months.
• AgenT-797 was administered without toxic lymphodepletion, persists for ~8 weeks, and appears to generate and drive immune cells into the tumor for destruction of cancer cells.
• HC Wainwright to host KOL webcast with MiNK Therapeutics on Thursday, April 20^th at 10:00am ET with Investigators Dr. Benedito Carneiro and Dr. Yelena Janjigian.

NEW YORK, April 18, 2023 (GLOBE NEWSWIRE) -- MiNK Therapeutics (Nasdaq: INKT), a clinical-stage biopharmaceutical company specializing in 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, presented data at the American Association of Cancer Research (AACR) annual meeting, demonstrating the clinical benefit of allo-iNKTs, agenT-797, alone and in combination with anti-PD-1 in patients with refractory non-small cell lung cancer (NSCLC), testicular, and gastric cancers. 

“MiNK's groundbreaking research presented at AACR showcases a new era in cancer treatment with the potential to transform the lives of patients who have failed traditional therapies, including anti-PD-1 treatment," said Dr. Jennifer Buell, President and CEO at MiNK. "Our pioneering off-the-shelf iNKT cell therapy, agenT-797, has demonstrated clinical benefit in solid tumor cancers, and we are committed to expediting its development. With a scalable manufacturing process and a favorable safety profile, we look forward to collaborating with world-leading experts to expand our trials and bring new hope to patients with anti-PD-1 refractory NSCLC, testicular, and gastric cancers."

In a phase 1/2 trial, patients received a single infusion of agenT-797, alone or in combination with pembro or nivo, without lymphodepletion. Patients were heavily pretreated with a median of 4 prior lines of therapy and were unresponsive to prior anti-PD-1 therapy. The results showed that agenT-797 promoted durable responses, including a partial response and tumor reduction of >42% which was ongoing at 9 months in a patient with metastatic gastric cancer who had no response to prior treatment with pembro or nivo plus FOLFOX. Additionally, durable disease stabilization and biomarker responses were observed in NSCLC and testicular cancers refractory to anti-PD-1.

AgenT-797 was persistent and detectable in the periphery for > ~8 weeks and tolerable up to 1000x10⁶ cells, with no neurotoxicity, dose-limiting toxicities, or severe cytokine release syndrome (> grade 3). Administration of agenT-797 induced a systemic and local anti-tumor response, driving immune cell infiltration into tumors and promoting immune cell activation.

MiNK Therapeutics will further evaluate agenT-797 through phase 1/2 expansion trials in combination with standard of care agents (pembro/nivo) with or without botensilimab (a multifunctional CTLA-4) in relapsed/refractory NSCLC, testicular cancer, and in 2L gastric cancer through a phase 1/2 investigator sponsored trial led by Dr. Yelena Janjigian, Chief Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center.

Webcast Details
HC Wainwright to host KOL webcast on Thursday, April 20^th, at 10:00am ET, with Dr. Jennifer Buell, MiNK President & CEO, Dr. Benedito Carneiro, Director of Clinical Research at the Lifespan Cancer Institute, and Dr. Yelena Janjigian, Chief, Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center.

Registration is available at: https://my.ct.events/register.aspx?meid=4ea7d1f0-186b-41ae-833a-8f60df147d45&rpid=daae579e-ee18-4405-8ad9-a9fa6af17523

About AgenT-797 
Invariant natural killer T (iNKT) cell therapies are a unique innate cell type that serve as master regulators of immune response, combining killing power of NK cells and the memory of T-cells. iNKTs can elicit a range of immune responses depending on the disease context, whether created by virus, bacteria, or cancer. AgenT-797 is an allogeneic unmodified iNKT cell product, designed for scalable “off-the-shelf” use. MiNK has established and launched house manufacturing and product release capacity to supply more than 5000 doses per year through an FDA-approved scalable, fully closed, and automatic iNKT manufacturing process.  

Presentation Details 
The poster is available on the Publications page of MiNK Therapeutic’s Website.  
Title: Phase 1 clinical update of allogeneic invariant natural killer T cells (iNKTs), agenT-797, alone or in combination with pembrolizumab or nivolumab in patients with advanced solid tumors 
Presenting Author: Dr. Benedito Carneiro 
Abstract Number: CT275 
Session Title: Phase I Clinical Trials 2 
Session Date and Time: Tuesday April 18, 2023, 1:30 PM - 5:00 PM ET 

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.

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/. Follow us on Twitter @MiNK_iNKT. 

Contact 
Alexa Buffa 
781-674-4428 
communications@minktherapeutics.com  

Investor relations: 
Zack Armen 
917-362-1370 
investor@minktherapeutics.com  

FAQ

What are the results of the latest clinical trial for INKT?

AgenT-797 showed a partial response with over 42% tumor shrinkage in a gastric cancer patient, sustained for more than 9 months.

How does agenT-797 perform without lymphodepletion?

The therapy was administered without toxic lymphodepletion, maintaining effectiveness and safety, and remained detectable for approximately 8 weeks.

What are MiNK Therapeutics' future plans for agenT-797?

MiNK plans to expand trials of agenT-797 in combination with standard therapies for relapsed/refractory NSCLC, testicular cancer, and gastric cancer.

What is the significance of the AACR presentation for MiNK Therapeutics?

The presentation highlighted the potential of agenT-797 in transforming treatment for patients unresponsive to traditional therapies, showcasing its clinical benefits.