Biohaven Pharmaceutical Holding Company, a clinical-stage biopharmaceutical company, announced a clinical collaboration with Drs. Ann Silk and James Goydos at the Rutgers Cancer Institute of New Jersey. Biohaven’s glutamate modulating compound, trigriluzole, is being evaluated for safety in a phase 1 trial in combination with PD-1 blocking antibodies in patients with inoperable, advanced or refractory cancers.
The study began enrollment in October 2017 and the first patient has begun treatment.
Biohaven previously acquired the patent rights to develop and commercialize certain glutamate modulating agents for the treatment of cancer from Rutgers, The State University of New Jersey. Glutamate receptors, in particular the metabotropic glutamate receptor 1 (GRM1), are expressed on a large number of tumors, including melanomas, breast cancers and lymphomas, and are believed to play a critical role in tumor metabolism. Research at Rutgers Cancer Institute and elsewhere has established a role of glutamate receptor signaling in the growth and spread of multiple tumor types, similar to other known oncogenes. Targeting glutamate and inhibiting its signaling in tumors could, therefore, have a therapeutic effect in cancer patients.
Vlad Coric, M.D., chief executive officer at Biohaven, commented, “The team at Rutgers has translated its preclinical findings into this proof of concept study to explore the combination of our glutamate modulating agent, trigriluzole, with immunotherapies for hard-to-treat cancers. We are excited to see the initiation of this Phase 1 trial at Rutgers to pursue better treatments for patients suffering from advanced cancers.”
In this phase 1 trial, patients with inoperable or metastatic advanced solid tumors or lymphomas will be treated with increasing doses of trigriluzole in combination with nivolumab (marketed as Opdivo) and other PD-1 blocking immunotherapies. Once the maximum tolerated dose of trigriluzole has been identified, it will be used in combination with PD-1 blocking antibodies for a further cohort of patients. A total of 12 to 27 patients will be enrolled in the trial and blood samples and biopsies will be collected regularly.
Robert Berman, M.D., chief medical officer at Biohaven, commented, “The line of investigation from Rutgers University researchers has presented a compelling mechanistic rationale to assess Biohaven’s portfolio of glutamate modulators in the treatment of cancer. We are excited to build on their work and advance our compounds for clinical testing in the treatment of cancer.”