2022-07-06 | NYSE:BHVN | Press release

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Biohaven and Vigeo Now Enroll in GBM AGILE, Phase 2-3 Adaptive Platform Registration Trial to Evaluate Interventions for Glioblastoma Patients

Global Coalition for Adaptive Research (LARKSPUR, CA), Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Vigeo Therapeutics — The Global Coalition for Adaptive Research (GCAR), in collaboration with Biohaven and Vigeo Therapeutics, today announced the activation of Biohaven’s troriluzole and Vigeo VT1021 in GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment). GBM AGILE is a revolutionary patient-centric adaptive trial platform for registration that tests multiple therapies for patients with newly diagnosed and recurrent glioblastoma (GBM) – the deadliest form of brain cancer.

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Biohaven’s troriluzole and Vigeo VT1021 are entering the GBM AGILE trial, which began in July 2019 and has screened more than 1,200 patients to date. Troriluzole and VT1021 will recruit patients with newly diagnosed and recurrent glioblastoma.

Dr. Michael Lim, director of the department of neurosurgery at Stanford University and Dr. Michael Weller, director of the department of neurology at the University Hospital of Zurich, Switzerland, will act as principal investigators for troriluzole’s evaluation in GBM AGILE. VT1021 will be led by the arm’s principal investigators, Dr. Howard Colman, professor, Huntsman Cancer Institute and Department of Neurosurgery, University of Utah, and Dr. Tom Mikkelsen, medical director, precision medicine program and office of clinical trials, Henry Ford Health.

“GBM AGILE is a ground-breaking assay that allows us to simultaneously and dynamically study the effects of multiple new drug candidates in an optimized learning environment. The trial’s agile model allows us to more efficiently and quickly identify effective therapies for patients with GBM,” said Dr. Michael Lim, who is also a member of the GBM Arm Identification and Selection Committee. AGILE. “We are delighted to include troriluzole and VT1021 in GBM AGILE. These investigational drugs have the potential to improve outcomes for patients with GBM, who desperately need more effective treatment options.”

GBM AGILE is an innovative international trial platform designed to more quickly identify and confirm effective therapies for patients with glioblastoma through adaptive response randomization and a transparent phase 2/3 design. The trial, designed by more than 130 key opinion leaders, is conducted according to a master protocol, allowing several therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. Thanks to its innovative design and efficient operational infrastructure, GBM AGILE data can be used as the basis for the submission and registration of a New Drug Application (NDA) and a Biologics License Application ( BLA) with the FDA and other health authorities.

The new interventions are opening first at Henry Ford Health Cancer in Detroit under the leadership of the Henry Ford site’s principal investigator, Dr. Tom Mikkelsen, and will later open at more than 40 trial sites across the United States. United with other global sites to follow.

“Glioblastoma is a devastating disease with few effective treatment options and no cure. Currently, the average survival rate is estimated at only eight months,” Dr. Mikkelsen noted. to activate troriluzole and VT1021 in the GBM AGILE study. We are committed to finding the best possible treatments for our patients.”

Biohaven’s troriluzole is a new orally administered small molecule that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. Troriluzole is believed to restore glutamate homeostasis by enhancing glutamate cycling, decreasing presynaptic glutamate release, and increasing the expression and function of excitatory amino acid transporters (i.e., EAAT2) located on glial cells which play a key role in removing excess glutamate from the synapse. Troriluzole was selected for inclusion in GBM AGILE, based on compelling evidence showing dysregulation of glutamate in glioblastoma. The therapeutic potential of troriluzole in glioblastoma and other oncology indications is supported by several recent clinical and translational research studies conducted with troriluzole and its active moiety.

“The initiation of this pivotal trial of troriluzole for glioblastoma is an exciting milestone,” commented Dr. Vlad Coric, Chief Executive Officer of Biohaven. “We are extremely proud to join the very innovative GBM AGILE trial. We look forward to collaborating with the principal investigators, Drs. Lim and Weller, the team at GCAR and the GBM AGILE trial sites to rapidly advance the development of troriluzole in combination with standard of care therapies as a new treatment for people with glioblastoma, which is the one of the most recalcitrant and deadly of all cancers.”

Vigeo’s VT1021, is a first-in-class dual modulator compound that blocks the CD47 immune checkpoint and activates the apoptotic and macrophage reprogramming activity of CD36. The result of the dual modulating activity is the induction of apoptosis in tumor and endothelial cells, as well as an increase in the ratio of CTL:Treg and M1:M2 macrophages. The biological/therapeutic activity of VT1021 is mediated by stimulation of thrombospondin-1 (Tsp-1). Thanks to these double modulation effects VT1021 reprograms the tumor microenvironment from an immunosuppressive, or “cold,” to immune-enhanced (or sensitized), or “warm,” microenvironments that are more susceptible to attack by the immune system. With its novel mechanism of action and clinical data from a Phase 2 expansion study in patients with recurrent GBM, VT1021 is undergoing further studies to determine its effect in treating the disease, as CD36 and CD47 appear to be be highly expressed in tumor cells compared to normal brain tissue Vigeo grows VT1021 as a therapeutic agent in a range of cancers, with particular emphasis on solid tumors.

“VT1021 has had outstanding patient response, with an excellent safety profile, in our early clinical trials. We are thrilled to have VT1021 included as part of this global, multi-site effort to treat such a devastating disease,” said Jim Mahoney, CEO of Vigeo Therapeutics. “The opportunity to work with these distinguished principal investigators and to test our drug in newly diagnosed and recurrent GBM patient populations are key factors in our decision to join AGILE.”

About the Global Coalition for Adaptive Research (GCAR)

The Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) nonprofit organization bringing together physicians, clinical researchers, advocacy and philanthropic organizations, biopharmaceuticals, health authorities, and other stakeholders keys in the health sector to accelerate the discovery and development of treatments. for patients with rare and life-threatening diseases by serving as a sponsor of innovative and complex trials, including master protocols and platform trials. GCAR is the sponsor of GBM AGILE, an adaptive testing platform for patients with GBM – the most common and deadliest malignant primary brain tumour. Key strategic partners for the GBM AGILE testing effort include the National Brain Tumor Society, National Cancer Research Foundation, Asian Cancer Research Fundand Cure Brain Cancer Foundationfour non-profit organizations working together to provide philanthropic support as well as communication assistance with patients and families and inviting all others to join in this innovative approach to brain tumor treatment development.To learn more about GCAR, visit gcaresearch.org

About Biohaven

Biohaven is a commercial-stage global biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven’s Neuroinnovation™ portfolio includes FDA-approved NURTEC® ODT (rimegepant) for the acute and preventive treatment of migraine (approved by the EMA as VYDURA® for the acute treatment of migraine with or without aura and the prophylaxis of episodic migraine in adults who have at least four migraine attacks per month) and a wide range of late-stage product candidates on five distinct mechanistic platforms: antagonism of CGRP receptors for and preventive treatment of migraine and other CGRP-mediated diseases; glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia; myeloperoxidase (MPO) inhibition for amyotrophic lateral sclerosis; Kv7 ion channel activators for focal epilepsy and neuronal hyperexcitability, and myostatin inhibition for neuromuscular diseases. More information about Biohaven is available at www.biohavenpharma.com.

NURTEC, NURTEC ODT and VYDURA are registered trademarks of Biohaven Pharmaceutical Ireland DAC. Neuroinnovation and NOJECTION are registered trademarks of Biohaven Pharmaceutical Holding Company Ltd.

About Vigeo Therapeutics

Based in Cambridge, MA, Vigeo Therapeutics is a clinical-stage immuno-oncology company pioneering novel cancer therapies. The company is building a first-in-class drug development pipeline led by VT1021, its dual-modulated compound that blocks the CD47 immune checkpoint and reprograms CD36-mediated activities. Single-agent VT1021 has been studied in a Phase 1/2 clinical trial in patients with glioblastoma, pancreatic cancer and other solid tumors, and is currently progressing into late-stage clinical development. For more information, visit vigeotherapeutics.com or follow us on LinkedIn and Twitter.

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