WavoDyne Therapeutics Inc. is a new company formed for the purpose of commercializing a group of novel small molecule therapeutics which have displayed exceptional potency in preclinical models for the treatment of memory and cognitive disorders resulting from neuroinflammatory processes. The Company’s product pipeline represents 20 years of innovative research which has been funded by $25 mm of various grants from the National Institute of Health. WavoDyne Therapeutics has entered into a licensing transaction with the University of Rochester Medical Center, the site of preclinical research that generated our portfolio of clinical drug candidates. The license provides WavoDyne Therapeutics exclusivity on a series of patented novel drug candidates which have high selectivity for inhibition of the Mixed Lineage Kinases. The Company anticipates commencing a Phase 1 clinical study by 1Q2017 with its lead drug candidate, URMC-099, which will target the treatment of POCD (Postoperative Cognitive Dysfunction). Another Ph. 1 study with this drug candidate is planned to commence in 2017 for the treatment of cognitive disorders associated with MS. The treatment of cognitive disorders associated with HAND and Parkinson’s Disease also figure prominently in the Company’s project plans. Based on standard drug development timelines, regulatory requirements, and the timely completion of our pivotal clinical trials, WavoDyne expects to launch its first product for the treatment of POCD in the 2021-2022 timeframe.
Founder, Chairman and CEO – Dr. Jim New
Jim’s industry experience spans the science and business elements of commercial pharmaceutical operations on both the branded and generic sides of the business. After 8 years of basic research experience as a medicinal chemist, he moved into product licensing and business development functions, and from there progressed into Mergers and Acquisitions. Collectively, he has worked at BMS, GSK, Pfizer and Novartis for over a period of 21 years. In 2002, he was co-founder of Abrika Pharmaceuticals, a generic drug company specializing in controlled-release products, which was acquired by Actavis in 2007. Since 2007, Jim has expanded his biotech experience by being CEO of Lifecycle Pharma ( now known as Veloxis Pharmaceuticals ), AIKO Biotech, and most recently Neurotrope Bioscience ( NTRP; OTCBB.) He has a B.A. in Biology from SUNY Geneseo, a M.S. in Biochemistry from the Univ. of Maine at Orono, a Ph.D. in Medicinal Chemistry from SUNY Buffalo, and a M.B.A. from Columbia.
Dr. Jim New – Chairman, CEO and Director
Dr. New has served as the Chairman, Chief Executive Officer and a director of the Company since the Company’s inception in February 2015. Dr. New is also the Founder of WavoDyne Therapeutics.
Jim’s industry experience spans the science and business elements of commercial pharmaceutical operations, as well as both the brand and generic pharmaceutical product development functions in the industry.
His roles at big pharma companies include 8 years of basic research as a medicinal chemist, and a further 14 years of increasing responsibilities that included product / technology licensing, corporate development, worldwide business development, and lastly leading the M&A function for a multinational healthcare company. In these senior executive capacities he has worked for Bristol-Myers Squibb, GlaxoSmithKline, Pfizer and Novartis. He is known for his ability to manage complex cross-cultural and cross-border negotiations involving collaborations on products in late stage development which require large capital commitments in support of their commercial launch strategies. Further details on some of his noteworthy accomplishments in this effort are listed below.
In the Licensing and Development Department at Pfizer, Jim managed the project flow and business development initiatives of 9 senior level Licensing executives who were targeting collaborations or acquisitions of products in the final stages of their development process at other pharma or biotech companies. He took a primary role in several landmark deals forged by Pfizer in the 1994-1998 timeframe. The first of these was the worldwide “Strategic Marketing Alliance on Celebrex® and Bextra® forged with Searle. These products were the first-in-class Cox-2 selective anti-inflammatories to launch in the U.S. market. Also during this timeframe, he crafted three cornerstone agreements enabling the commercial scale manufacturing of recombinant human insulin which was to launch into the market under the brand name Exubra®. These agreements involved the greenfield construction of an insulin manufacturing plant in Frankfurt, Germany, with Aventis, and two additional manufacturing agreements with Nektar Therapeutics on the commercial scale production of powdered insulin and the inhaler device which would be used in both Type 1 and 2 diabetics.
Moving to Novartis in 1999 as Head of Worldwide Business Development, he led a large BD group with operations in the U.S., Switzerland and Japan which supported product and technology licensing functions for the pharmaceutical division. Significant transactions in this role as Head of the group included: a worldwide “Strategic Marketing Alliance on Zelmac® with BMS”, which was the first partial serotonin agonist indicated for the treatment of c-IBS; the Xolair® Collaboration with Genentech which included a “ Joint Commercialization Agreement” and “Supply and Manufacturing Agreement” providing a platform for the launch of this IgG humanized monoclonal antibody for the treatment of allergic asthma; a 6 Year “ Research Alliance with Vertex targeting Protein Kinase Inhibitors”; in-licensing of the “ Ritalin controlled-release product line from Celgene” for the treatment of ADD, and; an Ex-U.S. Marketing Alliance on Starlix® with Merck KgaA.
Midway through his 3 year tenure with Novartis he moved into the newly established M & A function in Novartis which had responsibility for targeting business and product acquisitions in support of the Company’s 5 operating divisions which included Ciba Vision, Sandoz Generic Drugs, Pharma, Animal Health and Consumer Health ( OTCs ). In this role the following acquisitions were completed: the Starlix® product rights for the treatment of Type 2 diabetes in the U.K. and Ireland; acquisition of Estalis / Menorest® HRT brands from Rhone Poulenc Rorer in Europe, and; acquisition of the French company Negma Pharmaceuticals, through which Novartis secured worldwide product rights to the statin LIVALO®, now sold in the U.S. by Eli Lilly.
In 2002, Jim was co-founder of an innovative generic drug company in Fort Lauderdale called Abrika Pharmaceuticals. This effort involved the formation of a vertically integrated pharmaceutical product development organization with a commercial scale manufacturing plant specializing in formulation and production of controlled-release generic drugs such as Wellbutrin®, transdermal Duragesic®, and Ambien®. Abrika was sold to Actavis in 2007 for $235 mm. Through a series of private placements, and a Strategic Product Collaboration Agreement with Par Pharmaceuticals, Jim raised approximately $60 mm to finance the growth and product marketing efforts of Abrika.
Subsequent to the trade-sale of Abrika, he was CEO of Lifecycle Pharma in Copenhagen, and most recently CEO of AIKO Biotechnology.
Immediately prior to launch of WavoDyne Therapeutics, Jim co-founded Neurotrope Biosciences in October 2012, where he served as CEO and Director on the Board of Directors until August 2014. Neurotrope’s research program is focused on Alzheimer’s Disease.
Dr. New received his undergraduate degree in Biology at SUNY Geneseo, a M.S. degree in Biochemistry at the University of Maine, his Ph.D. in Medicinal Chemistry at the University of Buffalo, and his MBA degree from Columbia Business School. He is the lead inventor on 8 patents and 25 original scientific publications.
David Klein – Director
David H. Klein is a special advisor to the CEO of the University of Rochester Medical Center ( URMC ), a professor of public health sciences in the UR School of Medicine and Dentistry and an executive professor of health care management in the UR Simon Business School.
Mr. Klein was the chief executive officer of The Lifetime Healthcare Companies (TLHC) headquartered in Rochester, NY which includes Excellus BlueCross BlueShield (BCBS), Univera Healthcare, Lifetime Health Medical Group, Lifetime Care (home care agency), EBS-RMSCO Benefit Solutions (benefits consulting firm and third party administration) and MedAmerica (long term care insurance company). Mr. Klein had been a senior executive with TLHC and its predecessor companies since 1986, serving as CEO since 2003. He was a director of the national Blue Cross Blue Shield Association (BCBSA) and America’s Health Insurance Plans.
Mr. Klein serves as director of CTG, a NASDAQ traded information technology services and solutions company. He is a member of the Cressey & Company Distinguished Executives Council. He is associated with Francisco Partners serving as a director of the startups, Landmark Health which is focused on creating a home care centric medical group to care for complex, chronically ill patients and Avalon Healthcare Solutions, a laboratory benefits management company. He is a director of Cerebral Assessment Systems, an angel funded startup cognitive impairment diagnostics company; Cogito, an angel/venture funded early stage behavioral analytics company; iVantage, a Great Point Partners funded early stage health care performance management information company; and PharmAdva, an angel/venture funded startup automated home medication adherence system manufacturer. He also serves as an advisor to companies offering services to health care providers and payers as well as to medical device and pharmaceutical manufacturers. Current engagements include Sutherland Health Solutions.
Mr. Klein serves as chair of the New York eHealth Collaborative which oversees New York State’s electronic medical records interoperability program. Mr. Klein is a member of the Johns Hopkins University Carey School of Business Healthcare Advisory Board.
He has been the chair of United Way of Greater Rochester and an American Cancer Society Capital Campaign to establish a new Rochester Hope Lodge. He has been president of the local Boy Scout Council and director of Northeast Region, Boy Scouts of America. He is a Boy Scouts’ Distinguished Eagle Scout and the recipient of their Silver Beaver and Silver Antelope awards.
Mr. Klein received his Bachelor of Science from Rensselaer Polytechnic Institute and his Master of Business Administration from the University of Chicago.
Theresa Mazzullo - Director
Theresa Mazzullo is the CEO of Excell Partners, a seed stage venture fund with $14 Million under management. She has a 30 year track record in business, finance and entrepreneurship. Prior to joining Excell, Theresa was President & Principal of EPIC Advisors, Inc., a 401(k) recordkeeping company with $1.5 Billion in plan assets. She managed a successful sale of that company in 2005. In her role as Excell’s CEO, her duties include company solicitation, deal screening, governance, compliance, community integration, finance and fundraising. Theresa received her BA Degree from Spring Hill College and a Graduate Banking Degree from the ABA’s Stonier Graduate School.
Theresa serves on several community and economic development Boards. She is a Member, Finger Lakes Regional Economic Development Council & Co-Chair of the Council’s Entrepreneurship & Innovation Committee; Executive Board & Treasurer, Greater Rochester Enterprise; Board Member, High Technology Rochester; Member of the University of Rochester Technology Development Committee; Trustee, Farash Foundation; Member: Investment Advisory Committee, Governor Cuomo’s $50M Innovation Fund.
Dr. Joseph P. Vacca – Director
Dr. Joseph P. Vacca is currently the CSO of Highline Therapeutics which is a drug incubator for early stage programs identified by Highline Therapeutics. Dr. Vacca has an extensive background in the drug discovery industry. He earned his BS in chemistry in 1977 from St. John Fisher College, Rochester, New York, and obtained his PhD degree in Organic Chemistry under Professor Peter T. Lansbury Sr. at the State University of New York at Buffalo (New York).
He joined Merck Research Laboratories in 1981 and made major contributions to many approved drugs including the HIV protease inhibitor CRIXIVAN™ (indinavir sulfate), the HIV integrase inhibitor Isentress™ (raltegravir); the first generation HCV protease Inhibitor vaniprevir (VanihepTM, Japan only) and the combination product ZepatierTM (grazoprevir/elbasvir), the second generation HCV protease Inhibitor/NS5A protein Inhibitor combination that was recently approved by the FDA.
Dr. Vacca retired from Merck in 2011 and took a role as Senior Vice President of Early Success Sharing Partnerships at WuXi AppTec Limited in early 2012. He recently left WuXi in Sept. 2015 to begin his consulting practice and helped establish the first Highline portfolio company Kyras Therapeutics where he serves as interim CSO. Dr. Vacca has over 100 publications and patents and is the holder of many awards including a Merck Directors Award (1998); PhRMA Discoverers Award (1999); Intellectual Property Owners "National Inventor of the year Award" (1997); European Inventor of the Year (non-EU nation) (2007); ACS "Award for Creative Invention" (1999); and was a named a Merck Research Laboratories Presidential Fellow in 2008.
He was recently named to the American Chemical Society Medicinal Chemistry Hall of Fame (Aug. 2012) and was also named a “Hero of Chemistry” (along with the research team) for his role in the discovery and development of the HIV integrase inhibitor IsentressTM.