Neuvivo is dedicated to creating therapeutics for the treatment of Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases. We are investigating a patented macrophage-targeted technology, NP001, designed to address chronic inflammation, a key factor in the progressive loss of motor function in ALS.
To date, the treatment has received Orphan Drug and Fast Track designation by the FDA as it addresses a clear unmet medical need. We are diligently working to move this compound toward regulatory approval, with the goal of delivering an effective new treatment to reduce the suffering caused by ALS.Current research points to compromised macrophage function as a critical factor in many other CNS diseases, such as Parkinson’s Disease and Alzheimer’s Disease, suggesting that NP001 may potentially have a role in addressing a range of CNS diseases.
ALS is a neurological disorder that causes the loss of motor neurons with grave consequences for the patient. There are approximately 40,000-50,000 people living with ALS in the US and Europe. There are just two active ingredients currently approved to treat the disease, but both have limitations.
Neuvivo has developed NP001, a proprietary small molecule investigational therapeutic that in clinical trials has shown an ability to slow the progression of the disease in patients age 40-65. Clinical trials* of NP001 to date have not suggested any drug-related serious adverse events.
Neuvivo is working closely with leading ALS clinicians, researchers, and regulatory authorities to develop an effective and safe treatment for people living with ALS – as efficiently as possible.
Miller RG, Block G, Katz JS, Barohn RJ, Gopalakrishnan V, Cudkowicz M, et al. Randomized Phase 2 trial of NP001-a novel immune regulator: Safety and early efficacy in ALS. Neurol Neuroimmunol Neuroinflamm. 2015;2(3):e100.
Neuvivo has completed two Phase 2 trials, providing data demonstrating NP001’s potential to slow the progression of ALS and to protect motor neurons. To date, the trials have not suggested any drug-related serious adverse events.
Neuvivo is now in a position to initiate Phase 2 studies in Parkinson’s Disease, Alzheimer’s Disease and Vascular Dementia.
NP001 has strong IP protection.
Early patents relating to the technology are under license from the University of California, San Francisco.
Ari Azhir, PhD has over 25 years of experience as a senior executive and CEO and founder of multiple biotech companies – drawing from her experience at international pharmaceutical organizations including: Roche, Becton Dickinson, Intermune and Accuson. She has successfully commercialized and brought more than 20 healthcare products to market, ranging from small molecule treatments for CNS and dermatology, to disruptive medical device technologies. These technologies include flow cytometry products at Becton Dickinson and ultrasound devices at Accuson, where she held executive management positions. In addition to management roles, Dr. Azhir has served as Director of the Board at a range of public, private and Pre-IPO concerns.
Dr. Azhir is named as the key inventor and patent holder on 12 patents and has an extensive background building companies with strong IP portfolios.
Dr. Azhir completed a BSC in Biochemistry and Mathematics and an MPh in Biophysics from King’s College, London, and a PhD in Biophysics from King’s College. She completed her post-doctoral training at Liege University, Belgium.
Michael S. McGrath, MD, PhD is Professor, Departments of Laboratory Medicine, Pathology, and Medicine at The University of California San Francisco (UCSF). He has authored over 200 scientific articles in the fields of AIDS, cancer and neurological disease since joining UCSF in 1985 and has recurring NIH funding to support his research programs in excess of $1.5M per year.
Dr. McGrath has been a pioneer in the recognition of the role that inflammation, and especially macrophages, play in multiple diseases. His recent focus has been on the study of macrophage activation in the pathogenesis of ALS and other chronic diseases.
Dr. McGrath maintains an extensive resume in HIV and oncology as well. His career in HIV began early in the HIV epidemic as Assistant Professor of Medicine, AIDS/Oncology Division, University of California and San Francisco General Hospital. He also began serving as an ad hoc grant reviewer for the NIMH, NCI, NIAID and the VA and joined the Scientific Advisory Board for The American Foundation for AIDS Research (AmFAR) where he continues to serve.
Dr. McGrath earned his BS in Biology at the University of Minnesota. He obtained his MD at Stanford University School of Medicine and his PhD in Cancer Biology also at Stanford.
Vern Norviel is a partner at Wilson Sonsini Goodrich and Rosati focusing on Innovation and Patents. Mr. Norviel has three decades of experience counseling promising life science companies and working closely with them to develop successful patent and IP strategies. Before joining Wilson Sonsini in 2003, Mr. Norviel was the general counsel and corporate secretary of Perlegen Sciences, and prior was senior vice president and general counsel as an early employee at Affymetrix, the company that developed and pioneered DNA chip technology. He is annually recognized among the country’s top life science attorneys in Chambers USA and has been named one of California’s top IP attorneys by the Daily Journal.
His interest in science and medicine prompted Mr. Norviel to be the first attorney to have their entire genome sequenced and made accessible via a public database.
Mr. Norviel currently serves as a member of the Board of the Wilson Sonsini Foundation.
ARI AZHIR, PhD
Chief Executive Officer
Ari Azhir, PhD has over 25 years of experience as a senior executive and CEO and founder of multiple biotech companies – drawing from her experience at international pharmaceutical organizations including: Roche, Becton Dickinson, Intermune and Accuson. She has successfully commercialized and brought more than 20 healthcare products to market, ranging from small molecule treatments for CNS and dermatology, to disruptive medical device technologies. These technologies include flow cytometry products at Becton Dickinson and ultrasound devices at Accuson, where she held executive management positions. In addition to management roles, Dr. Azhir has served as Director of the Board at a range of public, private and Pre-IPO concerns.
Dr. Azhir is named as the key inventor and patent holder on 12 patents and has an extensive background building companies with strong IP portfolios.
Dr. Azhir received a BSc in Biochemistry and Mathematics from King’s College, London. She did her graduate work in Biophysics at King’s College and completed her post-doctoral training at Leige University, Belgium.
MIKE MCGRATH, MD, PhD
Chief Scientific Officer
Michael S. McGrath, MD, PhD is Professor, Departments of Laboratory Medicine, Pathology, and Medicine at The University of California San Francisco (UCSF). He has authored over 200 scientific articles in the fields of AIDS, cancer and neurological disease since joining UCSF in 1985 and has recurring NIH funding to support his research programs in excess of $1.5M per year.
Dr. McGrath has been a pioneer in the recognition of the role that inflammation, and especially macrophages, play in multiple diseases. His recent focus has been on the study of macrophage activation in the pathogenesis of ALS and other chronic diseases.
Dr. McGrath maintains an extensive resume in HIV and oncology as well. His career in HIV began early in the HIV epidemic as Assistant Professor of Medicine, AIDS/Oncology Division, University of California and San Francisco General Hospital. He also began serving as an ad hoc grant reviewer for the NIMH, NCI, NIAID and the VA and joined the Scientific Advisory Board for The American Foundation for AIDS Research (AmFAR) where he continues to serve.
Dr. McGrath earned his BS in Biology at the University of Minnesota. He obtained his MD at Stanford University School of Medicine and his PhD in Cancer Biology also at Stanford.
MATTHEW W. DAVIS, MD, RPH
Chief Medical Officer
Dr. Davis has over 25 years of extensive experience leading the development, approvals, and launches of small molecules, biologics and devices. Dr. Davis most recently was the Chief Operating Officer and Chief Medical Officer at Tiziana Life Sciences, whose lead asset modulated the innate immune system. In his career, Dr. Davis has served as Chief Medical Officer of several multinational pharmaceutical companies including Endo Pharmaceuticals and Lupin. At URL Pharma he spearheaded three NDA approvals and was the inventor on all 17 Orange Book listed patents for Colcrys®. He was instrumental in the sale of URL Pharma to Takeda for over $2B including performance-based contingent earnout payments.
Dr. Davis matriculated to the University of Pennsylvania as an undergraduate. He received his Pharmacy Degree from Temple University and his Medical Degree from the Medical College of Pennsylvania. Dr. Davis undertook his surgical training at Brown University and his Urology training at Washington Hospital Center.
DAN STOKELY,
Chief Financial Officer
MARC COOLEY, MBA
Head of Commercialization
MARK HENDERSON, PhD
VP of Technical Operations
ARI AZHIR, PhD
Chief Executive Officer
Ari Azhir, PhD has over 25 years of experience as a senior executive and CEO and founder of multiple biotech companies – drawing from her experience at international pharmaceutical organizations including: Roche, Becton Dickinson, Intermune and Accuson. She has successfully commercialized and brought more than 20 healthcare products to market, ranging from small molecule treatments for CNS and dermatology, to disruptive medical device technologies. These technologies include flow cytometry products at Becton Dickinson and ultrasound devices at Accuson, where she held executive management positions. In addition to management roles, Dr. Azhir has served as Director of the Board at a range of public, private and Pre-IPO concerns.
Dr. Azhir is named as the key inventor and patent holder on 12 patents and has an extensive background building companies with strong IP portfolios.
Dr. Azhir received a BSc in Biochemistry and Mathematics from King’s College, London. She did her graduate work in Biophysics at King’s College and completed her post-doctoral training at Leige University, Belgium.
MIKE MCGRATH, MD, PhD
Chief Scientific Officer
Michael S. McGrath, MD, PhD is Professor, Departments of Laboratory Medicine, Pathology, and Medicine at The University of California San Francisco (UCSF). He has authored over 200 scientific articles in the fields of AIDS, cancer and neurological disease since joining UCSF in 1985 and has recurring NIH funding to support his research programs in excess of $1.5M per year.
Dr. McGrath has been a pioneer in the recognition of the role that inflammation, and especially macrophages, play in multiple diseases. His recent focus has been on the study of macrophage activation in the pathogenesis of ALS and other chronic diseases.
Dr. McGrath maintains an extensive resume in HIV and oncology as well. His career in HIV began early in the HIV epidemic as Assistant Professor of Medicine, AIDS/Oncology Division, University of California and San Francisco General Hospital. He also began serving as an ad hoc grant reviewer for the NIMH, NCI, NIAID and the VA and joined the Scientific Advisory Board for The American Foundation for AIDS Research (AmFAR) where he continues to serve.
Dr. McGrath earned his BS in Biology at the University of Minnesota. He obtained his MD at Stanford University School of Medicine and his PhD in Cancer Biology also at Stanford.
VERN NORVIEL, JD
Vern Norviel is a partner at Wilson Sonsini Goodrich and Rosati focusing on Innovation and Patents. Mr. Norviel has three decades of experience counseling promising life science companies and working closely with them to develop successful patent and IP strategies. Before joining Wilson Sonsini in 2003, Mr. Norviel was the general counsel and corporate secretary of Perlegen Sciences, and prior was senior vice president and general counsel as an early employee at Affymetrix, the company that developed and pioneered DNA chip technology. He is annually recognized among the country’s top life science attorneys in Chambers USA and has been named one of California’s top IP attorneys by the Daily Journal.
His interest in science and medicine prompted Mr. Norviel to be the first attorney to have their entire genome sequenced and made accessible via a public database.
Mr. Norviel currently serves as a member of the Board of the Wilson Sonsini Foundation.
GREGG FERGUS
Gregg is the former President and COO of Ion Torrent, a market-leading company that pioneered an efficient and cost-effective approach to DNA sequencing and sold to Life Technologies.
Gregg’s previous executive roles include Chief Commercial Officer of Cellular Dynamics International and Senior Vice President of Sales and Global Operations at Affymetrix, Inc. He was an Executive in Residence at RW Baird/Baird Venture Partners.
From 2014-2020, Gregg was Chief Executive Officer and Chief Commercial Officer of 4Catalyzer, a Guilford, Connecticut-based startup accelerator dedicated to democratizing healthcare and maximizing societal impact. Gregg co-founded, managed and sat on the boards of the 4Catalyzer companies and raised more than $800M in capital. Butterfly Network, QSi and Hyperfine all seeded by 4Catalyzer, went public in 2021.
Gregg is an alumnus of UW-Madison with a degree in Bacteriology and has remained involved in the university as a strategic advisor for Healthy Minds Institute and Wisconsin Institutes of Discovery. Gregg is a member of the Board of AIQ, Verda Bio and LÜM.
VIRIT VICHITVADAKAN
Virit is currently a General Partner at PrimeStreet Capital, the fund management arm of the PrimeStreet Group, where he oversees the venture capital, private equity, and tactical opportunities businesses. Prior to his current role, Virit was Head of Investment Banking at PrimeStreet Advisory. Virit’s previous positions outside of PrimeStreet Group includes serving as a team lead in the Financial Advisory and Services Department, Investment Banking Division at Bank of Ayudhya Public Company Limited and serving as Regional Market Development Manager at Thaicom Public Company Limited covering Asia Pacific, China, and India, and working in marketing and brand communications at SAATCHI & SAATCHI covering Proctor & Gamble in the Southeast Asia, Australia, and China markets.
ROBERT BAFFI, PHD, MBA,
Dr. Baffi, a Venture Partner at Samsara BioCapital, LLC, brings over 30 years of extensive experience in the biopharmaceutical sector, specifically in product development and commercialization. Dr. Baffi has contributed to the approval and commercial success of 28 products and has authored numerous papers, patents and a book “Making a Habit of Quality.” He has a proven track record in drug development, regulatory affairs, strategic partnerships and preparing the commercialization of products for rare diseases. Prior to joining Samsara BioCapital, LLC, Dr. Baffi had a 20-year career at BioMarin Pharmaceuticals, Inc., where he served as President of Global Manufacturing & Technical Operations, overseeing manufacturing, process development, quality, logistics, engineering and analytical chemistry. Prior to joining BioMarin Pharmaceuticals, Inc., Dr. Baffi was at Genentech, Inc. for 14 years.ROBERT MILLER, MD
Robert Miller, MD is a Clinical Professor of Neurology and Neurological Sciences at Stanford University Medical School and the Director of the Forbes Norris ALS Research Center at the California Pacific Medical Center (CPMC) in San Francisco. Dr. Miller was the lead author of the AAN evidence-based practice parameters for managing the disease, published in 1999 and the updated in 2009. He has been active in ALS clinical trials and is the chair of the Western ALS Study Group, an organization that has carried out numerous clinical trials in ALS. He was the chair of the ALS Outcomes Research group, ALS CARE, and later ALS Connection, resulting in numerous publications about quality of care and outcomes in ALS. He is involved with several collaborative efforts to find better markers for disease progression and better treatments for ALS, including Chair of the Pacific ALS Consortium, a statewide research group in California.
JEREMY M. SHEFNER, MD, PhD
Jeremy M. Shefner, MD, PhD is Kemper and Ethel Marley Professor and Chair of Neurology, Senior Vice President, Barrow Neurological Institute, Executive Chair of Neurology, University of Arizona in Phoenix, Chief Medical Officer of Clinical Research, Barrow and St. Joseph’s Hospital and Medical Center, Chair of Neurology Creighton University School of Medicine in Phoenix. He co-founded the Northeast ALS Clinical Trials Consortium, the largest and most active consortium in the world dedicated to ALS. Dr. Shefner is board certified in neurology, and he specializes in ALS and neuromuscular disorders. Dr. Shefner’s research focuses on biomarker development and the clinical therapeutics of ALS and spinal muscular atrophy. He has published approximately 200 papers in peer-reviewed journals and has served on multiple grant review panels.
Dr. Shefner received his PhD from the University of Illinois in Urbana-Champaign, and his MD from Northwestern University Medical School in Chicago. He completed his residency training at the Harvard Longwood Neurology Training Program in Boston and completed a fellowship in neuromuscular disease at the Brigham and Women’s Hospital in Boston.
MICHAEL SNYDER, PhD
Michael Snyder is the Stanford Ascherman Professor and Chair of Genetics and the Director of the Center of Genomics and Personalized Medicine, Stanford University School of Medicine. His lab is recognized as the first to perform a large-scale functional genomics project in any organism and he is recognized for combining novel “omics” technologies to perform the first-ever longitudinal integrative personal omics profile (iPOP) of people to assess disease risk and monitor disease states for personalized medicine.
Seminal findings from the Snyder laboratory include the discovery that much more of the human genome is transcribed and contains regulatory information than was previously understood, and a high diversity of transcription factor binding occurs both between and within a species. Additional advancements made by Dr. Snyder and his lab include the development of proteome chips, high resolution tiling arrays for the entire human genome, methods for global mapping of transcription factor binding sites, paired end sequencing for mapping of structural variation in eukaryotes, de novo genome sequencing of genomes using high throughput technologies, and RNA-Seq.
Dr. Snyder is a cofounder of biotechnology companies, including Protometrix (now part of Life Technologies), Affomix (now part of Illumina), Excelix, Personalis, Qbio, January AI and Mirvie, and he presently serves on the board of a number of companies. He gained his BA, Chemistry and Biology, from University of Rochester, NY and his PhD from the California Institute of Technology. He did Postdoctoral Research at the Stanford University School of Medicine under Dr. Ronald Davis. He was in the Dept of Molecular, Cellular and Developmental Biology, Yale University, New Haven, CT prior to his appointment at Stanford. He is the author of “Genomics and Personalized Medicine: What Everyone Needs to Know”.
PETER BARTON HUTT, JD
Peter Barton Hutt is senior counsel in the Washington, DC law firm of Covington & Burling LLP, specializing in Food and Drug Law. From 1971-75 Peter was the Chief Counsel for the FDA where he led the adoption of key regulations including a process to reevaluate the safety and efficacy of all biological products licensed in the last hundred years.
He was responsible for the legislation that became the Drug Listing Act of 1972 and the Medical Device Amendments of 1976. He created the requirement of preambles for all FDA regulations, initiated the use of guidelines for informal FDA policy, and established the use of regulatory letters/warning letters. Notably while at the agency, he wrote the proposed procedural regulations that govern all FDA administrative actions to this day.
Peter worked with congressional staff on the Orphan Drug Act of 1983, the Drug Price Competition and Patent Term Restoration Act of 1994, and at the request of the House and Senate staff, he drafted the legislation that became the Food and Drug Administration Modernization Act of 1997. He has continued to work on FDA-related legislation, most recently on the 21st Century Cures Act of 2017 and PDUFA VII. He has testified before the House and Senate more than 100 times either as counsel accompanying a witness or as a witness.
Peter has been a member of the National Academy of Medicine since its formation in 1971 and served as a consultant to President Obama’s Council of Advisors on Science and Technology. He has been a member of the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS and five Office of Technology Assessment advisory panels. As a member of the FDA Science Review Subcommittee, he published a major analysis that resulted in Congress doubling FDA appropriations during 2008-2013.
For the past 29 consecutive years, Peter has taught a full course on Food and Drug Law at Harvard Law School. He is the lead co-author of the text used to teach Food and Drug Law at law schools throughout the country.
He was named by The Washingtonian magazine as one of Washington’s 100 most influential people; by the National Law Journal as one the 40 best health care lawyers in the United States; and by Global Counsel as the best FDA regulatory specialist in Washington, DC. Peter was presented the Distinguished Alumni Award by FDA and the Lifetime Achievement Award for research advocacy by the Foundation for Biomedical Research.
JOSEPH E. GILLIAM
BRUCE FORREST, MD, PhD
Bruce Forrest, MD, PhD possesses specialty expertise in, but not limited to, vaccines and biopharmaceuticals development in both major and emerging markets. Dr. Forrest has established a reputation for innovative solutions to complex product development challenges through a broad perspective and understanding of the pharmaceutical industry. In addition, Dr. Forrest has extensive experience and field knowledge of the pharmaceutical development environment in Asia, especially Japan, where he served as Board Member, Corporate Officer and Executive Director (Head) of R&D for Wyeth K.K. He oversaw the local product approvals for etanercept and gemtuzumab ozogamicin, as well as product registration submissions for a pneumococcal conjugate vaccine, bazedoxifene, temsirolimus, venlafaxine and tigecycline; and was responsible for developing a successful strategy for the integration of development activities across the major markets in East Asia. During his career in the pharmaceutical and medical device industry, Dr. Forrest was the clinical leader for several major vaccine programs, including: a meningococcal C conjugate vaccine; a live, rotavirus vaccine; a pneumococcal conjugate vaccine; and live attenuated influenza vaccine. As a Senior Vice President at Wyeth Pharmaceuticals, Bruce Forrest was responsible for all late phase development activities in Wyeth Vaccines Research leading both clinical and pharmaceutical science development. Dr. Forrest received his BS and MD from the University of Adelaide, Australia and his MBA from Warwick Business School.The team at Neuvivo is committed to developing groundbreaking treatments for ALS and other motor neuron diseases.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
