MiNK Therapeutics, a clinical-stage biopharmaceutical company, is at the forefront of a transformative approach to harnessing the power of invariant natural killer T (iNKT) cells. With its proprietary platform and manufacturing capabilities, MiNK is pioneering the development of allogeneic, off-the-shelf iNKT cell therapies to treat a wide range of cancers and immune-mediated diseases.
Company Background
Founded in 2017, MiNK has rapidly established itself as a leader in the field of iNKT cell therapy. The company’s origin can be traced back to its exclusive licensing agreement with Agenus, a prominent biopharmaceutical company, which granted MiNK access to Agenus’ extensive portfolio of iNKT cell-related intellectual property and know-how. In its early years, MiNK relied heavily on Agenus for its working capital requirements, with many of its operations fully integrated with Agenus, including corporate functions such as finance, human resources, IT, and legal.
A significant milestone in MiNK’s development came in 2021 when the company entered into an Intellectual Property Assignment and License Agreement with Agenus. This agreement assigned certain patent rights and know-how related to the iNKT cell platform to MiNK, while also providing the company with an exclusive, royalty-free license to research, develop, manufacture, and commercialize the licensed technology. Later that year, in October 2021, MiNK completed its initial public offering, raising approximately $39.8 million in net proceeds after underwriting discounts and commissions. This influx of capital allowed MiNK to further develop its pipeline and invest in its manufacturing capabilities.
However, the company faced a setback in 2022 when it learned that the Walloon Region had obtained a default judgment against it for repayment of a grant and advance that MiNK had received in 2018 for one of its research programs. MiNK had discontinued the research efforts related to this program in 2020.
Lead Candidate and Clinical Trials
MiNK’s lead candidate, agenT-797, is an off-the-shelf, allogeneic iNKT cell therapy that has demonstrated promising results in clinical trials. In a Phase 1 trial, agenT-797 achieved durable disease control in heavily pre-treated patients with various solid tumors, including non-small cell lung cancer, testicular cancer, and gastric cancer. Additionally, the therapy showed the potential to enhance the efficacy of immune checkpoint inhibitors and bispecific engagers in these challenging disease settings.
The company has completed a Phase 1 clinical trial evaluating agenT-797 as both a monotherapy and in combination with anti-PD-1 checkpoint inhibitors in solid tumor cancers. The trial demonstrated durable clinical benefits with a tolerable safety profile across various heavily pre-treated solid tumors. Notably, the median progression-free survival exceeded six months, with approximately 30% of patients experiencing durable disease stabilization.
Building on these results, MiNK is actively enrolling a randomized, Phase 2 investigator-sponsored trial led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center. This trial aims to evaluate the clinical safety and efficacy of the combination of agenT-797, botensilimab (a novel Fc-enhanced CTLA-4 inhibitor), balstilimab (anti-PD-1), ramucirumab, and paclitaxel in patients with previously treated, advanced esophageal, gastric, or gastroesophageal junction adenocarcinoma.
Recognizing the versatility of iNKT cells, MiNK has also advanced its pipeline to explore the use of these unique immune cells in tackling immune-mediated diseases. The company is currently conducting a Phase 1 trial evaluating agenT-797 in the prevention and treatment of acute graft-versus-host disease (GvHD), a significant complication following allogeneic hematopoietic stem cell transplantation. Preclinical data has shown that iNKT cells can effectively modulate immune responses without triggering graft-versus-host reactions, making them a promising therapeutic option for this high-unmet-need indication.
MiNK has also completed a Phase 1 study of agenT-797 in viral Acute Respiratory Distress Syndrome (ARDS), leveraging the unique anti-inflammatory properties of iNKT cells. The study results, published in Nature Communications, reported an encouraging 75% survival benefit compared to approximately 10-22% in an in-hospital control group and time-matched data from the Centers for Disease Control and Prevention. In a cohort of 21 patients on mechanical ventilation, survival rates exceeded 70%, with an 80% survival rate among those on venovenous extracorporeal membrane oxygenation. In addition to the survival benefit, agenT-797 improved lung function and significantly reduced inflammation and secondary infections.
Pipeline and Research Programs
In addition to its clinical programs, MiNK is leveraging its proprietary platform to develop next-generation engineered iNKT cell therapies. The company’s MiNK-215 and MiNK-413 programs are advancing in preclinical development, with the former targeting tumor-associated fibroblasts in solid tumors and the latter focusing on B-cell maturation antigen (BCMA) for the treatment of multiple myeloma.
MiNK-215 is an IL-15 armored tumor stromal targeting FAP-CAR-iNKT program that has demonstrated efficacy in preclinical models of non-small cell lung cancer and melanoma, promoting curative responses, eliminating tumor burden in the lungs, and enhancing tumor-specific CD8 T cell infiltration through tumor stroma.
MiNK-413 is an IL-15 armored CAR-iNKT program targeting BCMA that has shown tumor clearance and improved persistence in preclinical models, as well as manufacturing and logistical improvements over current BCMA cell therapies.
Financials
MiNK’s financial position reflects its commitment to strategic cost management and operational efficiency. As of September 30, 2024, the company reported a cash balance of $6.3 million, a significant reduction in cash used in operations compared to the same period in 2023. This financial discipline, coupled with its progress in clinical trials and pipeline advancement, positions MiNK to continue its mission of transforming the treatment landscape for cancer and immune-mediated diseases.
The company’s most recent quarter’s financial results show no revenue, a net income of -$1,806,597,000, operating cash flow (OCF) of -$7,822,976,113, and free cash flow (FCF) of -$7,822,976,113. The decrease in revenue, net income, OCF, and FCF is primarily due to increased R&D and G&A expenses as the company continues to advance its pipeline of iNKT cell therapies.
As of September 30, 2024, MiNK had an accumulated deficit of $141.7 million. The company believes that its current cash and cash equivalents, plus anticipated funding from partnerships, will be sufficient to satisfy its liquidity requirements for more than one year from the filing of its Quarterly Report on Form 10-Q. However, MiNK has disclosed that substantial doubt exists about its ability to continue as a going concern for a period of one year after the date of filing due to the uncertainty around the completion of anticipated funding, which is not entirely within the company’s control.
Liquidity
The company’s cash management strategy and reduced operational expenses have contributed to an improved liquidity position. MiNK’s focus on efficient resource allocation and strategic partnerships has helped extend its cash runway, allowing for continued investment in key research and development programs.
MiNK’s liquidity metrics as of the most recent reporting period include:
To support its liquidity requirements, MiNK is exploring various funding sources, including seeking strategic partnerships and collaborations, securing non-dilutive financing such as grants and fee-based services, and potential equity or debt financing options.
The company has been able to achieve further operating efficiencies and reductions in operating burn by nearly an additional 60% compared to the same period last year. This cost reduction was partly driven by external funding of their clinical programs as well as continued development of manufacturing efficiencies that reduced their cost of goods and increased scale and production capacity.
Leadership and Expertise
The company’s unwavering focus on iNKT cell therapy has attracted the attention of industry experts, including the recent appointment of Dr. Robert Kadlec to its Board of Directors. Dr. Kadlec’s extensive experience in public health, biodefense, and pandemic preparedness is expected to provide valuable strategic guidance as MiNK explores the broader applications of its iNKT cell platform, including in the context of infectious diseases and high-impact health challenges.
Future Outlook
Despite the challenges faced by the biopharmaceutical industry, MiNK has demonstrated its resilience and ability to navigate the complex landscape. With a robust pipeline, strong manufacturing capabilities, and a experienced leadership team, the company is poised to continue its transformative work in the field of iNKT cell therapy.
The company remains focused on financial discipline and exploring strategic initiatives to strengthen their financial position to support the growth and development of their iNKT T-cell therapy platform. While MiNK has not provided specific quantitative guidance for future periods, the management team has expressed confidence in the company’s strategic direction and operational progress.
As MiNK Therapeutics progresses, investors and the broader medical community will eagerly await the company’s upcoming milestones, including data readouts from its ongoing clinical trials and the potential advancement of its novel engineered iNKT cell programs. The future looks promising for this innovative biopharmaceutical company as it pioneers a new frontier in the treatment of cancer and immune-mediated diseases.
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