{"id":45880,"date":"2022-07-06T19:02:20","date_gmt":"2022-07-06T17:02:20","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/global-coalition-for-adaptive-research-biohaven-and-vigeo-announce-commencement-of-biohavens-troriluzole-and-vigeos-vt1021-in-gbm-agile-trial\/"},"modified":"2022-07-06T19:02:20","modified_gmt":"2022-07-06T17:02:20","slug":"global-coalition-for-adaptive-research-biohaven-and-vigeo-announce-commencement-of-biohavens-troriluzole-and-vigeos-vt1021-in-gbm-agile-trial","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/global-coalition-for-adaptive-research-biohaven-and-vigeo-announce-commencement-of-biohavens-troriluzole-and-vigeos-vt1021-in-gbm-agile-trial\/","title":{"rendered":"Global Coalition for Adaptive Research, Biohaven, and Vigeo Announce Commencement of Biohaven\u2019s Troriluzole and Vigeo\u2019S VT1021 in GBM AGILE Trial"},"content":{"rendered":"
\n

\nBiohaven and Vigeo Now Enrolling in GBM AGILE, Registrational Phase 2-3 Adaptive Platform Trial to Evaluate Interventions for Patients With Glioblastoma<\/b>\n<\/p>\n

LARKSPUR, Calif.–(BUSINESS WIRE)–#GBMAGILE<\/a>–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<\/i> and Vigeo’s VT1021<\/i> in GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment). GBM AGILE is a revolutionary patient-centered, adaptive platform trial for registration that tests multiple therapies for patients with newly-diagnosed and recurrent glioblastoma (GBM) \u2013 the deadliest form of brain cancer.\n<\/p>\n

<\/a><\/p>\n

\nBiohaven’s troriluzole<\/i> and Vigeo’s VT1021<\/i> are entering the GBM AGILE trial, which initially opened in July 2019 and has screened over 1200 patients to date. Troriluzole<\/i> and VT1021<\/i> will enroll patients with newly-diagnosed and recurrent glioblastoma.\n<\/p>\n

\nDr. Michael Lim, Chair of the Department of Neurosurgery at Stanford University and Dr. Michael Weller, Director Department of Neurology, University Hospital Zurich, Switzerland will serve as arm Principal Investigators for troriluzole\u2019s<\/i> evaluation in GBM AGILE. VT1021 <\/i>will be led by arm 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 & Clinical Trials Office, Henry Ford Health.\n<\/p>\n

\n\u201cGBM AGILE is a ground-breaking trial that enables us to simultaneously and dynamically study the effects of multiple new drug candidates in an optimized learning environment. The trial\u2019s nimble model allows us to more efficiently and rapidly identify effective therapies for GBM patients,\u201d said Dr. Michael Lim, who also serves as a member of the GBM AGILE Arm Identification and Selection Committee. \u201cWe are excited to include troriluzole<\/i> and VT1021 <\/i>in GBM AGILE. These investigational drugs have the potential to support improved outcomes for GBM patients, who desperately need more effective treatment options.\u201d\n<\/p>\n

\nGBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless phase 2\/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE can be used as the foundation for a new drug application (NDA) and biologics license application (BLA) submissions and registrations to the FDA and other health authorities.\n<\/p>\n

\nThe new interventions are opening first at Henry Ford Health Cancer in Detroit under Henry Ford site Principal Investigator Dr. Tom Mikkelsen and will subsequently open at more than 40 trial sites across the United States with additional global sites to follow.\n<\/p>\n

\n\u201cGlioblastoma is a devasting disease with few effective treatment options and no cure. Currently the average survival rate is estimated to be only eight months,\u201d noted Dr. Mikkelsen. \u201cWe are enthusiastic to be the first site to activate troriluzole<\/i> and VT1021 <\/i>in the GBM AGILE study. We are committed to finding our patients the best possible treatments.\u201d\n<\/p>\n

\nBiohaven\u2019s troriluzole<\/i> is a novel, orally administered small molecule that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. Troriluzole <\/i>is thought to restore glutamate homeostasis by enhancing glutamate cycling, decreasing presynaptic glutamate release, and augmenting the expression and function of excitatory amino acid transporters (i.e., EAAT2) located on glial cells that play a key role in clearing excess glutamate from the synapse. Troriluzole<\/i> was selected for inclusion in GBM AGILE, based on compelling evidence showing deregulation of glutamate in glioblastoma. The therapeutic potential of troriluzole<\/i> in glioblastoma and other oncology indications is supported by several recent clinical and translational research studies conducted with troriluzole<\/i> and its active moiety.\n<\/p>\n

\n\u201cThe initiation of this pivotal trial of troriluzole for glioblastoma is an exciting milestone,\u201d commented Dr. Vlad Coric, Chairman and Chief Executive Officer of Biohaven. \u201cWe are extremely proud to be joining the highly 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 in order to rapidly advance the development of troriluzole in combination with standard of care therapies as a novel treatment for people suffering from glioblastoma, which is amongst the most recalcitrant and lethal of all cancers.\u201d\n<\/p>\n

\nVigeo\u2019s VT1021<\/i>, is a first-in-class dual modulating 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 both CTL:Treg and M1:M2 macrophage ratio. The biological\/therapeutic activity of VT1021<\/i> is mediated by the stimulation of thrombospondin-1 (Tsp-1). Through these dual-modulating effects VT1021<\/i> reprograms the tumor microenvironment from one that is immune suppressive, or \u201ccold,\u201d to immune enhanced (or sensitized), or \u201chot,\u201d that are more susceptible to attack from the immune system. With its novel mechanism of action and clinical data from a Phase 2 expansion study in recurrent GBM patients, VT1021 is undergoing further studies to determine its effect in treating the disease, given that CD36 and CD47 are found to be highly expressed in tumor cells compared to normal brain tissue. Vigeo is developing VT1021<\/i> as a therapeutic agent across a range of cancers, with a current focus on solid tumors.\n<\/p>\n

\n\u201cVT1021 has seen remarkable patient response, with a great safety profile, in our earlier clinical trials. We are excited that VT1021 is included as part of this global, multi-site effort to treat such a devastating disease,\u201d said Jim Mahoney, Chief Executive Officer, Vigeo Therapeutics. \u201cThe opportunity to work with these distinguished Principal Investigators and to test our drug in both newly diagnosed and recurrent GBM patient populations are key factors in our decision to join AGILE.\u201d\n<\/p>\n

\nAbout Global Coalition for Adaptive Research (GCAR)<\/b>\n<\/p>\n

\nThe Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) nonprofit organization uniting physicians, clinical researchers, advocacy and philanthropic organizations, biopharma, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases by serving as Sponsor of innovative and complex trials including master protocols and platform trials. GCAR is the sponsor of GBM AGILE, an adaptive platform trial for patients with GBM \u2013 the most common and deadliest of malignant primary brain tumors. Key strategic partners for the GBM AGILE trial effort include the National Brain Tumor Society<\/a>, National Foundation for Cancer Research<\/a>, Asian Fund for Cancer Research<\/a>, and Cure Brain Cancer Foundation<\/a>, four nonprofit organizations that are working together to provide philanthropic support as well as assistance in communicating with patients and families and inviting all others to join in supporting this innovating approach to brain tumor treatment development. <\/b>To learn more about GCAR, visit gcaresearch.org<\/a>\n<\/p>\n

\nAbout Biohaven<\/b>\n<\/p>\n

\nBiohaven is a global commercial-stage 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\u2122 portfolio includes FDA-approved NURTEC\u00ae<\/sup> ODT (rimegepant) for the acute and preventive treatment of migraine (EMA-approved as VYDURA\u00ae<\/sup> for the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month) and a broad pipeline of late-stage product candidates across five distinct mechanistic platforms: CGRP receptor antagonism for the acute 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<\/a>.\n<\/p>\n

\nNURTEC, NURTEC ODT and VYDURA are registered trademarks of Biohaven Pharmaceutical Ireland DAC. Neuroinnovation and NOJECTION are trademarks of Biohaven Pharmaceutical Holding Company Ltd.\n<\/p>\n

\nAbout Vigeo Therapeutics<\/b>\n<\/p>\n

\nBased 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 being led by VT1021, its dual-modulating compound that blocks the CD47 immune checkpoint and reprograms CD36 mediated activities. Single-agent VT1021 has been investigated in a Phase 1\/2 clinical trial in patients with glioblastoma, pancreatic cancer and other solid tumors, and is currently progressing to late-stage clinical development. For more information visit vigeotherapeutics.com or follow us on LinkedIn and Twitter.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nGlobal Coalition for Adaptive Research<\/b>
Rachel Rosenstein-Sisson
\n
Rrosenstein.sisson@gcaresearch.org<\/a>\n<\/p>\n

\nBiohaven<\/b>
Investors:
\n
Jennifer Porcelli
\n
VP, Investor Relations
\n
Jennifer.porcelli@biohavenpharma.com<\/a>\n<\/p>\n

\nMedia:
\n
Mike Beyer
\n
Sam Brown Inc.
\n
mikebeyer@sambrown.com<\/a>
312-961-2502\n<\/p>\n

\nVigeo Therapeutics<\/b>
Investors:
\n
Sam Martin
\n
212.600.1902
\n
sam@argotpartners.com<\/a>\n<\/p>\n

\nMedia:
\n
Liza Sullivan
\n
617-340-6073
\n
liza@argotpartners.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Biohaven and Vigeo Now Enrolling in GBM AGILE, Registrational Phase 2-3 Adaptive Platform Trial to Evaluate Interventions for Patients With Glioblastoma LARKSPUR, Calif.–(BUSINESS WIRE)–#GBMAGILE–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, … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-45880","6":"format-standard","7":"category-industry"},"yoast_head":"\nGlobal Coalition for Adaptive Research, Biohaven, and Vigeo Announce Commencement of Biohaven\u2019s Troriluzole and Vigeo\u2019S VT1021 in GBM AGILE Trial - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/global-coalition-for-adaptive-research-biohaven-and-vigeo-announce-commencement-of-biohavens-troriluzole-and-vigeos-vt1021-in-gbm-agile-trial\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Global Coalition for Adaptive Research, Biohaven, and Vigeo Announce Commencement of Biohaven\u2019s Troriluzole and Vigeo\u2019S VT1021 in GBM AGILE Trial - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Biohaven and Vigeo Now Enrolling in GBM AGILE, Registrational Phase 2-3 Adaptive Platform Trial to Evaluate Interventions for Patients With Glioblastoma LARKSPUR, Calif.–(BUSINESS WIRE)–#GBMAGILE–Global Coalition for Adaptive Research (LARKSPUR, CA), Biohaven Pharmaceutical Holding Company Ltd. 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