Tasquinimod is a once-daily, oral immunomodulatory compound that reduces a tumor’s ability to grow and spread. Tasquinimod is in development for treatment of multiple myeloma, a rare form of blood cancer with a high medical need. Patents in key markets have been granted, providing protection for the use of tasquinimod in malignant blood disorders, specifically acute forms of leukemia and multiple myeloma, until 2035. Furthermore, the FDA has granted orphan drug designation for tasquinimod for the treatment of multiple myeloma, which provides for seven years of market exclusivity in the event of future registration.
Tasquinimod shows potent antitumor effects, both as monotherapy and in combination with immunomodulatory drugs and proteasome inhibitors, in experimental models of multiple myeloma. Currently, a phase Ib/IIa study in relapsed or refractory multiple myeloma patients is ongoing. The study is a dose finding study and will include up to 54 patients. The primary endpoint is optimal dose and schedule of tasquinimod as single agent and in combination with a standard oral myeloma regimen of ixazomib, lenalidomide, and dexamethasone (IRd). Key secondary endpoints include preliminary antimyeloma activity with single agent tasquinimod and during therapy with tasquinimod in combination with IRd. The study was initiated in July 2020 and the principal investigator is Dr Dan Vogl, Abramson Cancer Center, Philadelphia, University of Pennsylvania.More information about the study is available at clinicaltrials.gov (NCT04405167).
Tasquinimod targets the tumor microenvironment in multiple myeloma
The immunosuppressed tumor microenvironment is essential for development of multiple myeloma in the bone marrow. Tasquinimod targets suppressive immune cells in the tumor microenvironment, specifically immunosuppressive myeloid cells, and thereby unlocks the body’s immune system to attack the cancer cells. With this novel mode of action tasquinimod has the potential, as a single therapy and in combination with other medicines, to overcome resistance and increase survival in patients that have progressed on standard therapy.
Tasquinimod has previously been in development for the treatment of prostate cancer with completed phase I – III clinical trials. The results from the phase III trial in prostate cancer showed that tasquinimod prolonged progression free survival compared to placebo. However, this benefit did not translate into an improved overall survival in this patient population and development for prostate cancer was discontinued. The clinical development of tasquinimod is today focused on the blood cancer multiple myeloma.
Tasquinimod has been studied in both healthy subjects and cancer patients. Clinical effects and an overall good tolerability have been demonstrated through more than 650 person-years of exposure to tasquinimod.