C101248

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Boston, MA – May 16, 2023 – Cerevance, a private, clinical-stage drug discovery and development company focused on developing novel therapeutics for central nervous system (CNS) diseases using the company’s proprietary Nuclear Enriched Transcript Sort sequencing (NETSseq) platform, today announced plans to present an oral presentation at the upcoming American Society of Clinical Psychopharmacology (ASCP) conference, taking place in Miami, Florida, May 30 – June 2, 2023. “We are very excited to present the Phase 1 CVN766 data for the first time at a medical conference,” said Craig Thompson, chief executive officer of Cerevance.“The favorable safety and tolerability profile coupled with lack of somnolence supports the potential of CVN766 to become an impactful treatment to address the unmet need of negative and cognitive symptoms in patients with schizophrenia.” ‍ Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Doses of CVN766, an OX1R Highly Selective Antagonist in Healthy Subjects Presenter: Ottavio Vitolo, MD Session Date and Time: Tuesday, May 30th, 2:00pm – 4:00pm Session Title: Pharmaceutical Pipeline CVN766 is a potent and highly selective antagonist of the Ox1R compared to Ox2R (>1000 fold). Ox1R has genetic links to domains of psychiatric disorders and is expressed in areas of the brain important for regulating emotions, fear, anxiety and motivation. To date, Cerevance’s Nuclear Enriched Transcript Sort sequencing(NETSseq) technology platform has confirmed Ox1R expression in cell types relevant to schizophrenia in humans. Orexin A, the endogenous ligand for Ox1R, is dysregulated in patients with various psychiatric conditions including schizophrenia. CVN766 has demonstrated efficacy in multiple preclinical models of cognition and negative symptoms of schizophrenia and in models of dependency type behaviors and anxiety. These include efficacy in executive function/attentional set shifting paradigms of cognition, reversal of phencyclidine (PCP) induced social interaction deficits, reduction in amphetamine induced dopamine release, efficacy in binge eating, alcohol and nicotine-dependency models and efficacy in the marmoset human threat test of anxiety. Schizophrenia is a severe neurodevelopmental disorder that interferes with a person’s ability to think clearly, manage emotions, make decisions and relate to others. Approximately 1% of the population is affected by schizophrenia with a similar global prevalence. Patients with schizophrenia experience a variety of symptoms which are broadly clustered into three primary symptom domains, positive symptoms, negative symptoms and cognitive deficits. While positive symptoms can be largely managed with existing medication, negative symptoms and cognitive deficits are not well treated and can be predictors of patient outcome. Negative symptoms include social withdrawal, anhedonia, blunted effect, alogia and avolition, while cognitive deficits include problems in speed of processing, attention and vigilance, working memory, verbal and visual learning and social cognition. Cerevance is focused on the development of treatments for central nervous system (CNS) disorders, with a focus on chronic neurodegenerative conditions such as Alzheimer's disease, Parkinson's disease, and Amyotrophic Lateral Sclerosis (ALS). Utilizing a large and growing collection of over 13,000 human brain tissue samples, Cerevance is generating an unprecedented level of expression and epigenetic data thereby enabling the company to identify the most promising targets for the next generation of treatments for CNS disorders. The company utilizes its proprietary NETSseq platform and advanced machine learning techniques to uncover the gene expression profiles of select cell types to identify novel targets that are uniquely expressed in relevant circuits affected by diseases or are altered in disease states. With the information obtained from its research, combined with the expertise of its team of scientists and drug developers, Cerevance is advancing multiple therapeutics that selectively modulate the discovered targets. These treatments are progressing through clinical development, with CVN424, CVN766, and CVN293 being the furthest along in the pipeline. CVN424 is a first-in-class non-dopamine therapy that shows promise in improving both motor and non-motor symptoms of Parkinson's disease and may also have disease-delaying effects.CVN766 is a potent antagonist of the orexin 1 receptor with high selectivity over the orexin 2 receptor and is in development for the treatment of negative and cognitive symptoms of schizophrenia. CVN293 is a novel blocker of potassium efflux in glia, regulating the inflammasome in individuals living with ALS and Alzheimer's disease. By leveraging its extensive collection of brain tissue samples, employing advanced technologies, and generating actionable data, Cerevance aims to transform the lives of patients affected by CNS diseases. For additional information, please visit www.cerevance.com. Cerevance: Johnna Simoes, ir@cerevance.com Media: Andrew Mielach, amielach@lifescicomms.com, +1-646-876-5868 Solengepras is a potentially first-in-class, oral, non-dopaminergic investigational therapy in development for Parkinson’s disease ARISE will evaluate the efficacy of solengepras as an adjunctive therapy to levodopa and other background Parkinson’s disease medications Company expects to report topline data in the first half of 2026 CVN293 was generally well-tolerated in healthy volunteers for up to 14-days of continuous dosing Dose-dependent exposure was observed with evidence of robust brain penetration Data supports potential advancement into Phase 2 for neurodegenerative diseases characterized by neuroinflammation such as Frontotemporal Dementia, AmyotrophicLateral Sclerosis, and Alzheimer’s Disease ‍ Cerevance has published the full results from the Phase 2 clinical trial of solengepras, in eClinicalMedicine, a peer-reviewed journal published by The Lancet Discovery Science Suite. The results demonstrated that solengepras, a potentially first-in-class, oral, once-daily, non-dopaminergic, GPR6 inverse agonist, significantly reduced OFF time in individuals with Parkinson’s disease and was generally well-tolerated. Cerevance is pleased to appoint Sarah Isabel Sheikh, M.Sc., B.M. B.Ch., MRCP, to its Board of Directors, effective immediately. Dr. Sheikh holds dual responsibilities at Takeda as the Head of Global Development for all therapeutic areas – Gastrointestinal and Inflammation, Neuroscience, Oncology, Plasma-Derived Therapies, and Vaccines – and as the Head of the Neuroscience Therapeutic Area. Cerevance announced the achievement of the second milestone in its research collaboration with Merck, known as MSD outside of the United States and Canada. The research collaboration, which was announced in August of 2022, focuses on the identification and validation of novel therapeutic targets for Alzheimer’s disease. The achievement of this milestone triggers a payment from Merck to Cerevance. Cerevance has appointed Dr. Sagar Vaidya, M.D., Ph.D., as Chief Medical Officer. Dr. Vaidya brings a wealth of experience in drug development, clinical research, and medical affairs, with a distinguished track record in advancing therapeutic programs for severe and life-threatening diseases. Cerevance achieves first milestone in research collaboration with Merck, known as MSD outside of the United States and Canada. The research collaboration, which was announced in August of 2022, focuses on the identification of novel therapeutic targets for Alzheimer’s disease. The achievement of this milestone triggers an undisclosed payment from Merck to Cerevance. Cerevance announced an initial closing of its Series B-1 Extension financing round that will add $47 million to the $51 million previously raised bringing the total Series B-1 raise to $98 million. Cerevance announces that the peer-reviewed journal, ACS Medicinal Chemistry Letters, has published the manuscript titled “Discovery of CVN293, a Brain Permeable KCNK13 (THIK-1) Inhibitor Suitable for Clinical Assessment”. ‍ Cerevance Announces Publication of CVN766 in Bioorganic & Medicinal Chemistry Letters describing the discovery and initial development of CVN766 in the peer-reviewed journal, Bioorganic & Medicinal Chemistry Letters. In the publication titled, “Discovery and first-time disclosure of CVN766, an exquisitely selective orexin 1 receptor antagonist” ‍ Cerevance Doses First Patient in ASCEND Phase 2 Clinical Study of CVN424, a First-in-Class, Non-Dopaminergic Therapy for the Treatment of Parkinson’s Disease ‍ Cerevance today announced that the first subject has been dosed in the Phase 1 clinical study evaluating the safety, tolerability, and pharmacokinetics of CVN293. ‍ ‍ Cerevance has been named by Fierce Biotech as one of the most promising early-stage biotechnology companies in the industry in 2023, showcased on this year’s Fierce 15 list. ‍ Cerevance to present a poster presentation at the upcoming Alzheimer’s Association International Conference (AAIC), taking place in Amsterdam, Netherlands, July 16 – 20, 2023. ‍ Cerevance to present an oral presentation at the upcomingAmerican Society of Clinical Psychopharmacology (ASCP) conference, taking place in Miami, Florida, May 30 – June 2, 2023. ‍ Cerevance today announced plans to present at the upcoming Neurodegeneration: New Biology Guiding the NextGeneration of Therapeutic Development conference, taking place in British Columbia, Canada, May 15 – 19, 2023. Cerevance today announced a poster presentation at the British Neuroscience Association (BNA) 2023 International Festival of Neuroscience in Brighton, United Kingdom being held April 23-26, 2023 Cerevance to present at two upcoming medicinal chemistry conferences: 7th RSC-BMCS / SCI Symposium on Ion Channels as Therapeutic Targets held March 27-28 in Cambridge, UK Binding Kinetics and Mechanistic PK/PD Modeling in Early Drug Discovery Conference held March 27-28 in Cambridge, UK Positive CVN424 Phase 2 data for Parkinson’s disease to be presented Presentation of NETSseq platform’s ability to reveal novel targets to inform CNS drug development Novel target, CVN417, for the potential treatment of Parkinson’s disease to be disclosed Proceeds will advance Cerevance’s potential first-in-class programs developed using proprietary NETSseq platform CVN424 for Parkinson’s disease will advance to Phase 2 monotherapy study in Q2 2023 CVN766 for negative and cognitive symptoms of schizophrenia will advance to Phase 2 study in Q4 2023 CVN293 for Amyotrophic Lateral Sclerosis will advance to Phase 1 study in Q3 2023 Cerevance today announced the publication in Organic Process Research and Development entitled, “Scalable Synthesis of CVN424, an Inverse Agonist of the GPR6 Receptor”. CVN766 was well tolerated with no serious adverse events CVN766, which has >1000-fold selectivity for the orexin 1 receptor, was well tolerated and showed no evidence of somnolence Data supports once a day dosing of CVN766 in future studies Presentation highlights a novel target identified for Alzheimer’s disease using Cerevance’s proprietary NETSseq platform Cerevance’s THIK-1 targeting inhibitor, C101248, demonstrated positive results in human and mouse cell based and electrophysiology assays relevant to neuroinflammation in neurodegenerative disease Data has been concurrently published in the peer-reviewed journal, Neuropharmacology Cerevance today announced a multi-year strategic research collaboration with Merck, known as MSD outside the United States and Canada, to identify novel targets for Alzheimer’s disease utilizing Cerevance’s proprietary Nuclear Enriched Transcript Sort sequencing (NETSseq) technology platform. ‍ Cerevance today announced the appointment of Craig Thompson to chief executive officer. Mr. Thompson brings over 25 years of commercial and marketing leadership experience in the biotech and pharmaceutical industries to the company. Cerevance today announced the completion of its Phase 2 clinical trial of CVN424, the company’s first-in-class, once-a-day, orally-delivered compound in development for the treatment of Parkinson’s disease. Cerevance Doses First Subjects in Phase 1 Clinical Trial of CVN766 ‍ Cerevance today announced the appointment of Mike Poole, M.D., FACP, to Cerevance’s Board of Directors. Cerevance, today announced the appointment of Carrie Ann Cook, a global business development executive with more than 20 years of experience in the pharmaceutical industry, as chief business officer ‍ Cerevance today announced the appointment of Naidong Ye, Ph.D., a seasoned chemist with extensive pharmaceutical industry experience, as vice president and head of chemistry, manufacturing and controls (CMC). Cerevance today announced the appointment of David Lubner, a senior finance executive with more than 25 years of experience in the life sciences industry, to Cerevance’s Board of Directors. Cerevance today announced positive results from a Phase 1b clinical trial evaluating the company’s oral compound, CVN058, in a biomarker study evaluating its potential as a treatment for cognitive impairment associated with schizophrenia (CIAS). ‍ Cerevance, a private drug discovery and development company focused on brain diseases, has expanded its Series B financing round, adding $20 million to the $45 million that it announced in April. Cerevance has closed a Series B financing, bringing in $45 million from new investors including GV (formerly Google Ventures), Bill Gates and Foresite Capital, as well as all of the company’s previous investors... ‍ Dr. Brennan is currently president and chief executive officer of Synlogic, Inc. (Nasdaq:SYBX), a clinical stage biotechnology company applying synthetic biology to beneficial microbes to develop novel, living medicines. Cerevance has formed a multi-year research alliance with Takeda Pharmaceutical Company Limited (“Takeda”) to identify novel target proteins expressed in the central nervous system and to develop new therapies against them for certain GI disorders. Cerevance, announced today the initiation of a Phase 2 clinical trial of CVN424, an oral, first-in-class compound that selectively modulates a novel, non-dopaminergic target selectively expressed in an important class of neurons in the striatum. Cerevance has appointed pharmaceutical industry veteran, James Summers, Ph.D., as a key scientific advisor to guide the company in its drug discovery and development efforts. Dr. Summers brings extensive experience in the discovery of... ‍ Cerevance, a clinical stage biopharmaceutical company advancing new medicines for brain diseases, has successfully completed its Phase 1 clinical trial of CVN424, the company’s first-in-class, orally-delivered compound in development for the treatment of Parkinson’s disease. Roland Bürli, Ph.D. as Vice President of Drug Discovery brings expertise in preclinical drug discovery, specializing in medicinal and synthetic chemistry, with a proven track record from hit identification through lead optimization, having led efforts that discovered six pre-clinical candidate molecules, including a program now in Phase II. Dawson brings 25 years of career experience spearheading drug discovery and development across companies based in the United States, Japan and the United Kingdom. Most recently, he served as Vice President of CNS drug development at Astex Pharmaceuticals, where he established and developed their global neuroscience research strategy. A twenty-year biotechnology industry veteran, Mr. Hibben has formed over $2 billion in platform and product-based R&D collaborations. Prior to joining Cerevance, Mr. Hibben served as Chief Business Officer at Catabasis where he led partnering activities. Cerevance, a clinical-stage drug discovery and development company focused on brain diseases, today announced the start of dosing in a Phase I first-in-human clinical trial of CVN424, an oral compound being developed for symptomatic treatment of Parkinson’s disease. Cerevance, a drug discovery and development company focused on brain diseases, today announced that it has received an additional equity investment as well as a non-dilutive cash payment in the first six weeks of 2018 totaling more than $10 million. Prior to joining Cerevance, Dr. Margolin served in several leadership roles at Sanofi-Genzyme over a 14-year period. There, he leveraged his expertise in designing and leading translational medicine initiatives as well as clinical trials from phase 1 to phase 4 across various neurologic and rare disease indications... Dr. Nathans is Professor of Molecular Biology and Genetics, Neuroscience and Ophthalmology at the Johns Hopkins University School of Medicine in Baltimore, Maryland, where his research focuses on molecular mechanisms of visual system development, function, and disease. He is also an Investigator in the Howard Hughes Medical Institute. ‍ Cerevance, a drug discovery and development company focused on brain diseases, today announced that it has signed an agreement with The Rockefeller University to license a novel technology for profiling specific cell populations in human brain tissue Cerevance, a drug discovery and development company focused on brain diseases, today announced that Rudolph Tanzi, Ph.D., has joined the company as a senior-level scientific advisor. Cerevance, a drug discovery and development company, today announced that Robert Malenka, M.D., Ph.D., has joined the company as a senior-level scientific advisor. Dr. Malenka is the Pritzker Professor of Psychiatry and Behavioral Sciences at Stanford University. The Dementia Discovery Fund, an innovative global investment fund managed by SV Life Sciences and launched in 2015 to develop disease modifying drugs for dementia, today announced a $5 million investment in the initial financing round of start-up drug discovery company, Cerevance. Takeda and Lightstone Ventures Participate in Series A Financing Former Takeda Cambridge UK employees, CNS programs moved to create turn-key discovery capabilities The ASCEND clinical study is evaluating whether CVN424, an investigational drug, is safe and effective in improving the motor and non-motor symptoms of Parkinson’s disease.