Today MiNK Therapeutics announced that a patient from its phase 1 trial with testicular cancer, who had received its off-the-shelf iNKT cell therapy, had achieved a complete remission over a 2-year period. This data was said to be published in Nature’s Oncogene medial publication, whereby the patient was able to achieve no detectable disease over 2 years after having received agenT-797 in combination with PD-1 inhibitor OPDIVO (nivolumab). The company’s stock closed higher by 730% to $64.17 per share on the back of this positive publication of data. What makes this ideal is that this was a very hard-to-treat patient. By that, I mean that the patient had progressed on the disease beforehand when taking many different lines of treatments.
For instance, they failed on multiple types of checkpoint inhibitors, had a stem cell transplant done, and didn’t do well when given platinum-based chemotherapy. That is, the phase 1 study in question is recruiting patients with relapsed/refractory solid tumors. Besides the fact that this iNKT cell therapy is efficacious, it is quite safe as well. The reason why is because it is able to be given to the patient without the need for prior lymphodepletion (wiping out a certain amount of immune cells to make way for new ones implanted). Plus, no need for HLA donor matching. The end result is that this cell therapy is ideal because not only did it help this testicular cancer patient, but it did so without a major problem found in immune cell therapies, which is cytokine release syndrome (CRS).
In addition, no graft-versus-host disease was said to be a problem either. If this was just a one-off type of a thing, then I would say maybe some skepticism is in order. However, this iNKT cell therapy has not only thus far been tested in one type of solid tumor. The goal of the phase 1 study is to test a multitude of relapsed/refractory tumors; thus it is quite possible that it could end up working for many other solid tumors. Additional evidence of this cell therapy working well, especially when given in combination with OPDIVO, could be noted from another publication in Oncogene, where one patient with metastatic gastric cancer achieved tumor reduction of 42% alongside progression-free survival (PFS) of 9 months.
MiNK is even in the process of evaluating agenT-797 in combination with many other drugs in targeting 2nd-line gastric cancer patients in an ongoing phase 2 study. Most notably combining this iNKT cell therapy with the Fc-enhanced CTLA-4 Inhibitor botensilimab, the anti-PD-1 Balstilimab, the vascular endothelial growth factor receptor 2 (VEGFR2) ramucirumab and paclitaxel. One item to immediately point out is that it is nice to see that this biotech’s cell therapy can be combined with so many other therapies and still be tolerable for advanced solid tumor patients to take. Speaking of which, these are gastric cancer patients who have been previously treated with other therapies.
Despite this fact, the combination of iNKT with all of these other therapies allowed the company to see extended survival beyond 12 months, which is interesting considering this is rarely seen in this specific setting. Whether or not the company continues to achieve success in using agenT-797 remains to be seen, but investors won’t have to wait too long to get a glimpse of new data for this specific program targeting gastric cancer patients. The reason why is because it expects to release additional results from the phase 2 study targeting these patients in the next several months. Not only could this mean further upside for the stock price, but it could also be additional proof of mechanism of action (MOA).
By that I mean this therapy appears to do what it is intended to do, which is to alter the tumor microenvironment (TME) and still be able to help patients who are resistant to other cancer immunotherapies. Plus, the fact that agenT-797 incorporates a dual mechanism of action, which is to launch both an innate and adaptive immune response against cancer. All the mean while, having greater persistence and ability for therapy to be re-dosed in light of no lymphodepletion being necessary. All of these key factors are what brought fortune to this biotech today in showing the true power of iNKT cells. Everything I have described is only with respect to targeting cancer or solid tumors. However, the company has even shown the ability to use this cell therapy to reduce inflammation in respiratory disorders. Lastly, its pipeline extends beyond only iNKT cell therapies; it is in the process of advancing preclinical chimeric antigen receptor (CAR) and T-cell receptors (TCRs) as part of its oncology effort.