Marker Therapeutics, Inc., a clinical-stage immunotherapeutic company, announced that the FDA has granted orphan drug designation to its product candidate, MT-601, for the treatment of patients with advanced pancreatic cancer. The company noted that the orphan drug treatment has a 5-year survival rate of less than 10%. Results from a study presented at the 2020 American Society of Medical Oncology’s Virtual Annual meeting indicated that the therapy could provide durable responses.
The study revealed that the spread of epitopes to multi-specific T cells was consistent with the response rate observed among patients with advanced pancreatic cancer. Marker Therapeutics noted that the results of the study reinforced the potential of its multi-antigen targeting approach against solid tumors and blood cancers. This therapy is the second multi-antigen product that has received orphan drug designation. MT-601 is a multi-antigen product that targets six tumor-associated antigens. The company plans to initiate a Phase 1 study in combination with standard chemotherapy in patients with locally advanced or metastatic pancreatic cancer.