Meet Marker Therapeutics: Fly exclusive interview with CEO Juan Vera

In an exclusive interview with The Fly, Marker Therapeutics (MRKR) CEO Juan Vera talked about the company, its pipeline, ongoing trials, upcoming milestones and much more.

BROAD SPECTRUM: Marker Therapeutics is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. The cell therapy technology Marker has in place is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient’s immune system to produce broad spectrum anti-tumor activity.

“We manufacture our therapy by basically training the immune cells, by training the T cells to recognize multiple elements, multiple antigens. And it is that broad spectrum of targets that makes this therapy unique,” Marker Therapeutics’ CEO Juan Vera explained to The Fly.

DIFFERENTIATED PLATFORM: Marker sees its multi-antigen targeted technology differing significantly from today’s leading cell therapies, which are genetically engineered to recognize a single portion of a single tumor-associated antigen. Because Marker does not genetically engineer the T cells, the company believes its product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit.

“We see it as a technology platform as you can basically use the same manufacturing process to derive multiple different products. That feature allows to extend this very quickly from one indication to another,” Vera tells The Fly. “This technology is capable of recognizing multiple antigens within a tumor and that’s a very important component that makes this different from other types of immunological strategies. I think it’s that restrictive target recognition that you see with traditional immuno-oncology strategies that leads to the resistance of the cancer cells to the therapy.”

OFF-THE-SHELF CELL THERAPIES: Marker is expanding its technology to off-the-shelf cell therapies. “There is a huge bottleneck when you look at cellular therapies. One of the biggest bottlenecks is basically the manufacturing complexity of a lot of these therapies. It takes a lot of time to create them and is very costly. And that has a lot to do with the 1-1 ratio: one product manufactured and one patient being treated. Off-the-shelf will break that association. You will manufacture one product for multiple patients and given the fact that it will be manufactured ahead of time, when the patient decides to get the product, it will be readily available. You now bring the limitation of time. You’re basically extending the benefit of one product,” the executive explained.

MT-401 CANDIDATE: Marker Therapeutics has recently announced that zedenoleucel/MT-401 was granted Orphan Drug Designation by the Committee for Orphan Medicinal Products of the European Medicines Agency for the treatment of patients with acute myeloid leukemia. MT-401 is currently being studied in a Phase 2 clinical trial for the treatment of relapsed AML following allogeneic HSCT.

“MT-401 was the first study we launched at Marker Therapeutics. This product is now being tested in patients who have AML post-transplant and in different arms. The first arm regards adjuvant administration and is a double-blind randomized study. It’s still too early; still enrolling. The second arm is the MRD positive group. This is an unmet medical need. And we’ve been able to describe some positive early clinical readouts that we already made public. We continue to enroll in this group. The last group involves patients with frank relapse. So far, we have yet to see any objective responses. However, we recently obtained a $2M grant from NIH to investigate our therapy in combination with hypomethylating agents and now we have data that demonstrates synergistic anti-tumor activity. The study is progressing well in all three arms and hope to update the investors very soon on how it is progressing,” the CEO added.

MT-601 CANDIDATE: Aside from the MT-401 trial, Marker has another studying the efficacy of MT-601 in patients with relapsed/refractory lymphoma. “We recently announced the treatment of our first patient in this particular group. This is going to be a very difficult population to treat because we’re now treating patients who failed several lines of treatment. However, we believe our therapy has developed to effectively treat even those patients. The enrollment is going as expected. We hope to be reading some patient data closer to the end of the year,” Vera explained.

UPCOMING MILESTONES: Looking out over the remainder of the year and early next year, Marker’s CEO sees three main milestones. “The next set of news releases will be the readout on the AML patients, update on how we’re collecting data on the lymphoma group and how these patients are responding to the therapy, and lastly, update and progression on the off-the-shelf program,” he adds.

“Meet the Company” is The Fly’s recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.