Dosing of patients has begun in a Phase 1 clinical trial evaluating the safety and tolerability of Karus Therapeutics‘ lead anti-cancer candidate, KA2237, as a treatment for B-cell lymphoma, the company announced.
The open-label, dose-ascending study (NCT02679196), which is currently recruiting patients with relapsed, treatment-resistant B-cell lymphoma, is part of a collaboration between Karus and MD Anderson Cancer Center at the University of Texas.
KA2237 is a first-in-class dual inhibitor of the PI3K molecular pathway, meaning that it inhibits two forms of the PI3K protein, p110beta and p110delta. By inhibiting these two forms, KA2237 has both a direct effect on tumor growth and works to induce an immunotherapeutic response.
According to Karus, KA2237 has the potential to treat both hematological and solid tumors, either as a single agent or in combination with other compounds. It is the first treatment developed by Karus to enter a clinical trial.
The trial will be composed of two parts. In the first, researchers will determine the optimal dose of KA2237 tolerated by relapsed, treatment-resistant B-cell lymphoma patients. The second part, scheduled to start next year, will evaluate the safety and efficacy of the dose, found to be optimal, in treating these patients. The company expects up to 40 patients will be enrolled and treated during the study, which is taking place at MD Anderson in Houston. (More information, including contact information, is available on the study’s clinical trials.gov webpage.)
“Our first clinical trial is a major milestone for the company,” Simon Kerry, Karus’ CEO, said in a news release. “Karus has made exceptional progress and our collaboration with MD Anderson will help us to accelerate this clinical program. We believe that as an orally-active dual p110beta/delta inhibitor, KA2237 has significant potential in the treatment of hematological and solid tumors in areas of high, unmet medical need.”
The collaboration between Karus and MD Anderson also covers a number of preclinical studies for two other investigative cancer drugs, KA2237 and KA2507. These studies aim to identify optimal drug combinations and appropriate patient populations for further clinical development.
KA2507, in particular, is believed to provide targeted therapy and immunotherapeutic action by inhibiting the HDAC6 protein, and is a potential treatment for multiple myeloma, B- and T-cell lymphomas, and PD-L1 expressing hematological and solid tumors.