New Haven, Connecticut October 30, 2017 – Biohaven Pharmaceutical Holding Company Ltd. (Biohaven, NYSE: BHVN), a clinical-stage biopharmaceutical company, announced a clinical collaboration today 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.”
More information about the clinical trial can be found at: https://clinicaltrials.gov/ct2/show/NCT03229278?cond=trigriluzole&rank=1
Trigriluzole is a novel tripeptide prodrug being developed by Biohaven for the treatment of diseases mediated by glutamate disruption. Trigriluzole represents more than six years of chemistry development and research involving more than 300 drug candidates. Trigriluzole has been observed in clinical trials to have a favorable safety and tolerability profile and excellent absorption and distribution when compared to other glutamate modulating agents.
Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders such as. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions – including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, Rutgers, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven’s lead development programs include multiple compounds across its CGRP receptor antagonist and glutamate modulation platforms. The company’s common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. More information about Biohaven is available at www.biohavenpharma.com.
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company’s management. All statements, other than statements of historical facts, included in this press release, including statements regarding the potential utility of glutamate modulating agents in the treatment of cancer, the potential efficacy and safety of trigriluzole, both alone and in combination with other therapies and the Company’s expectations for timing and results of its planned and ongoing clinical trials, are forward-looking statements. The use of certain words, including the words “believe,” “continue” and “will” and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans and objectives disclosed in the forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements, including the significant risks and uncertainties regarding the development of biopharmaceutical product candidates and the potential limitations of intellectual property protection that may be afforded by any patents that are issued with respect to the Company’s technology. Additional important factors to be considered in connection with forward-looking statements are described in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2017. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
For further information, contact Dr. Vlad Coric, Chief Executive Officer of Biohaven at Vlad.Coric@biohavenpharma.com.