PhageNova Bio, Inc. is a biotechnology company developing a unique approach to systemically administered targeted gene expression. The core technology relies on an engineered hybrid bacteriophage adeno-associated virus vector, developed at the The University of Texas MD Anderson Cancer Center by the Founders of the company, and subsequently fully and exclusively licensed to the company. Adeno-associated virus-bacteriophage (also referred to as “AAVP”) is a hybrid vector platform developed by combining the targeting capability of phage and the sustained gene expression of an adeno-associated virus. After significant preclinical research and a successful early round of financing, the company has prioritized a therapeutically active ligand-directed version of the vector that selectively localizes to multiple tumor types upon intravenous administration. The company is actively pursuing IND enabling studies and GMP manufacturing in order to carry out a Phase 1 clinical study in solid tumors.
Company Highlights:
- Proprietary, first in class, site-specific gene expression technology licensed from The University of Texas MD Anderson Cancer Center, initially targeting solid tumors
- Targeted gene expression: Enabled by AAV genomic components within an engineered ligand-directed bacteriophage genome (AAVP)
- PNB-001: Lead cancer asset for solid tumors undergoing enabling efforts, pivotal toxicology, and GMP manufacturing as part of an IND initiative
- PNB-V01 platform: Phage-based vaccination program initially targeting COVID-19 and undergoing evaluation with proof-of-concept expected 2H21
- Broad IP protection established for individual constructs and platform; recently filed patent applications
- Manufacturing: Scalable, cost-effective, rapid manufacturing capabilities for different targeting motifs and payloads; partnered with leading biologic CDMO
- Financing: Raised >$8M in equity financing since 2016 and >$10M in federal and private grants
- Collaboration Agreement with Rutgers, The State University of New Jersey
- Catalysts: IND filing for solid tumors; relaunch of two active INDs for prostate cancer and obesity using ligand-directed targeting; near-term data of COVID-19 vaccine strategy; pipeline validation for numerous targets; and new intellectual property grants and filings
Historical Milestones
Broad technology and intellectual property portfolio licensed from MD Anderson Cancer Center, covering core science behind lead construct (PNB-001) and additional targeting motifs
Closed $4M Series A Round of financing which was used for manufacturing, technology transfer, pilot toxicology, lead construct refinement and optimization, and broadening of technology portfolio
Engaged FUJIFILM Diosynth Biotechnologies as CDMO vendor to support construct optimization and eventual GMP manufacturing
Invited to be first tenant of the Thomas O. Daniel Research Incubator and Collaboration Center – the Bristol Myers Squibb (formerly Celgene) incubator in Summit, NJ
Expanded research team and launched platform-expanding research and development programs
Entered into Collaboration Agreement with Rutgers, The State University of New Jersey for further development of lead construct and future pursuits
Development of COVID-19 and broad vaccine platform, patent filings, including those for vaccine and pulmonary delivery technology developed through Collaboration Agreement and licensed from Rutgers, The State University of New Jersey
Initiated GMP manufacturing, pilot and pivotal toxicology, and IND submission preparation in advance of Phase 1 study for PNB-001 for solid tumors
Management, Team, Board, & Advisors
PhageNova Bio has a full management team in place to drive the company from its current stage of development through completion of its clinical development program
Mr. Jason Rifkin is an executive with extensive experience in developmental stage life sciences companies and has managed all aspects of company operations including clinical operations, business development, technology licensing and the raising of capital. Prior to his role at PhageNova Bio, Jason was President of PreScience Labs, an early stage oncology company where he oversaw the build-up of a Phase I clinical trial program. Prior to joining PreScience, Jason held a number of executive positions at Delcath Systems, Inc., a specialty pharmaceutical and medical device company focused on oncology. There, he oversaw the transition from a developmental stage company to a publicly traded commercial operation. At Delcath, Jason also served as Senior Vice President of Clinical Operations, where he oversaw the clinical development program and completion of Delcath’s Phase II and III clinical trials. Before joining Delcath, he practiced law with Fox Rothschild, serving as an associate in the Corporate Department-Pharmaceuticals and Biotechnology Group. Jason received a Bachelor’s Degree from the University of Pennsylvania, a Law Degree from Northeastern University School of Law and a Masters of Biotechnology from The University of Pennsylvania, School of Engineering and Applied Sciences.
Dr. Pasqualini is Professor of Radiation Oncology (Tenured), Division Chief, Radiation Cancer Biology, Department of Radiation Oncology, Rutgers New Jersey Medical School, Rutgers Cancer Institute of New Jersey Chancellor Scholar, Rutgers Biomedical and Health Sciences. Previously Dr. Pasqualini was the Helen Buchanan & Stanley Seeger Professor of Medicine and Experimental Diagnostic Imaging in the Division of Cancer Medicine at MD Anderson Cancer Center, she earned her PhD in Biochemistry from the Ludwig Institute for Cancer Research and the Institute of Chemistry at the University of São Paulo, Brazil. Dr. Pasqualini completed her research training at Harvard Medical School and the Harvard-Dana Farber Cancer Institute in Boston and at the Sanford-Burnham Medical Research Institute in San Diego. During her 14-year tenure at MD Anderson, Dr. Pasqualini has won international acclaim for her scientific contributions in cancer biology and drug development. Working with her husband, Dr. Arap, in their joint laboratory program, she has developed novel diagnostic and imaging tools for cancer and obesity. Their research has been supported by funding from the National Institutes of Health, the Department of Defense, and several philanthropic foundations including the American Association for Cancer Research, The Juvenile Diabetes Foundation, The Marcus Foundation, The Prostate Cancer Foundation, and the Susan G. Komen Breast Cancer Foundation. Dr. Pasqualini has published over 150 scientific studies and holds or has applied for more than 100 patents worldwide. Among her many honors are the Susan G. Komen Career Development Award in Basic Cancer Research (1999), The V Foundation Award on Translational Cancer Research (2001), The Living Legend Faculty Achievement Award from UT-MD Anderson Cancer Center (2005), the Edith and Peter O’Donnell Award from The Academy of Medicine, Engineering and Science of Texas (2009), and The Lombroso Award in Cancer Research from the Weizmann Institute of Science, Israel (2011). She has also been named as one of the nation’s “Top 400 Inventors.”
Mr. Rothwell Chairman of Emisphere Technologies Inc. (OTC: EMIS), a commercial stage, specialty pharmaceutical company since early 2012 and prior to that a Director of the Company from late 2009. Mr. Rothwell is also the Chairman of Speracura LLC, a healthcare consulting company from 2009 and the Chairman of the Pheo-Para Alliance, a nonprofit 501(C)3 organization since 2008. Mr. Rothwell was formerly Chairman of Sanofi from February 2007 to October 2009 in the U.S. He also served as Chief Executive Officer and President of Sanofi-Aventis from September 2004 to February 2007. Mr. Rothwell oversaw all domestic commercial operations as well as the coordination of Industrial Affairs and Research and Development activities in the U.S. From May 2003 to September 2004, Mr. Rothwell was President and Chief Executive Officer of Sanofi-Synthelabo, Inc. and was instrumental in the formation of Sanofi-Aventis U.S. in 2004. Prior to that, from January 1998 to May 2003, he served in various capacities at Pharmacia, including as President of the company’s Global Prescription Business. From January 1995 to January 1998, Mr. Rothwell also served as worldwide President of Rhone-Poulenc Rorer Pharmaceuticals and President of the company’s Global Pharmaceutical Operations. In his long career, Mr. Rothwell has also served as Chief Executive Officer of Sandoz Pharmaceuticals, Vice President of Global Marketing and Sales at Burroughs Wellcome, and Senior Vice President of Marketing and Sales for the U.S. for Squibb Corporation, which later became a Division of Bristol-Myers Squibb. Mr. Rothwell holds a Bachelor of Arts from Drew University and earned his J.D. from Seton Hall University. He formerly served on the PhRMA Board of Directors, as well as the Institute of Medicine’s Evidence-Based Medicine roundtable, the CEO Roundtable on Cancer, the Healthcare Businesswoman’s Association Advisory Board, the Board of Trustees for the Somerset Medical Center Foundation, the Board of Trustees for the HealthCare Institute of New Jersey, as a Trustee of the Corporate Council for America’s Children at the Children’s Health Fund, the Board of Directors of Agenus (NASDAQ: AGEN), the Board of Directors of Akrimax Pharmaceuticals LLC, Chairman of the Board of Directors of Archimedes Pharma LLC , Chairman of the Board of Directors of New American Therapeutics, and a member of the Board of Visitors for Seton Hall Law school.
Dr. Steven Libutti is the Director of the Rutgers Cancer Institute of New Jersey, Vice Chancellor for Cancer Programs for Rutgers Biomedical Health Sciences, the Senior Vice President for Oncology Services for RWJ Barnabas Health and is a tenured Professor of Surgery at the Rutgers Robert Wood Johnson Medical School. Dr. Libutti was the founding Director of the Montefiore-Einstein Center for Cancer Care, and served as the Associate Director of the Albert Einstein Cancer Center and Vice-Chairman of the Department of Surgery at Montefiore Medical Center and the Albert Einstein College of Medicine from 2009-2017. Dr. Libutti was a tenured Professor of Surgery and Genetics at the Albert Einstein College of Medicine in the Bronx, New York and a Professor of Surgery at the Uniformed Services University of the Health Sciences in Bethesda, Maryland. Dr. Libutti graduated from Harvard College and received his M.D. from the College of Physicians and Surgeons of Columbia University. Following his residency in Surgery, he completed a fellowship in Surgical Oncology and Endocrine Surgery at the National Cancer Institute (NCI) and was ultimately a tenured Senior Investigator and Chief of the Tumor Angiogenesis Section in the Surgery Branch, NCI. Dr. Libutti’s laboratory has focused on studies of the pathogenesis of neuroendocrine tumors and on the familial cancer syndromes MEN1 and vHL. His group developed some of the first mouse models of these conditions. Work from his laboratory has resulted in the development of gene expression signatures that are useful in distinguishing benign from malignant thyroid lesions. Dr. Libutti has received funding from both the intramural and extramural programs of the NCI since 1996. He has published over 250 peer reviewed journal articles and holds seven U.S. patents. He is the recipient of both NCI and NIH Director’s Awards. Dr. Libutti’s clinical interests are in endocrine and neuroendocrine tumors involving the thyroid, parathyroid, adrenal glands and pancreas. He is also a leader in regional cancer therapy and tumor targeted gene therapy and is the Editor-in-Chief of the Nature Journal Cancer Gene Therapy.
Mr. Keith Greenfield Founder and President of The Dover Group, a financial services provider and consulting practice. In addition to joining the Board of Directors of PhageNova Bio, Mr. Greenfield is assisting the Company with all business development related initiatives. Keith is on the board of AZTherapies, a company in a Phase III pivotal trial for prolonging or slowing down the onset of Alzheimer’s disease. Mr. Greenfield has been a co-founder and director of a number of biotechnology and healthcare related companies, including Imaging Biopharmaceutical and Zebra Pharmaceutical which later merged into Biostream prior to going public as Molecular Insight. Mr. Greenfield was a co-founder, director and EVP of Corporate Development at IQuum, Inc., a medical diagnostic company that was sold to Roche in 2014. Mr Greenfield also launched Open Field’s (1999), a nonprofit children’s theatre group with his wife Tina and now grown children, Kadie, Stephanie, Jordana and Jordan.
Dr. Wadih Arap is Professor of Medicine (Tenured), Director, Rutgers Cancer Institute of New Jersey at University Hospital, Division Chief, Hematology/Oncology Rutgers New Jersey Medical School. Previously he was the Stringer Professor of Medicine and Experimental Diagnostic Imaging and Deputy Chair of the Department of Genitourinary Medical Oncology in the Division of Cancer Medicine at MD Anderson Cancer Center. Dr. Arap earned his MD degree from the University of São Paulo Medical School in Brazil and completed his clinical training at Memorial Sloan-Kettering Cancer Center in New York. He earned his PhD in Cancer Biology from Stanford University and the Ludwig Institute for Cancer Research in La Jolla. During his 14-year tenure at M.D. Anderson, Dr. Arap gained international recognition for his expertise in the treatment of prostate cancer. His research focused on the development of new cancer drugs and therapies that could be precisely targeted to cancer cells. His research, supported by the National Institutes of Health, the Department of Defense, and several philanthropic foundations, has led to over 60 patents worldwide and the publication of over 150 scientific studies. Among his many honors are The V Foundation Award on Translational Cancer Research (2001), The Edith and Peter O’Donnell Award from The Academy of Medicine, Engineering and Science of Texas (2009) and his election to the American Society for Clinical Investigation.
Dr. Juri Gelovani is the world-renown pioneer of molecular-genetic in vivo imaging. In particular, he has invented the principles and patented methods for non-invasive imaging of reporter gene expression for monitoring the delivery and expression of therapeutic genes and genetically modified cells. His research interests include molecular imaging of cancer and the central nervous system using newly developed PET radiotracers and agents for hyperpolarized MR spectroscopic imaging, targeted molecular and gene therapies of cancer, adoptive immunotherapies, and stem cell therapies. He has published more than 200 papers and book chapters, edited a major book in molecular imaging in oncology, and was awarded multiple patents. Several diagnostic imaging compounds he developed are currently in clinical trials in cancer patients. Dr. Gelovani has earned the MD (1986) and PhD (1990) degrees in neurosurgery from the University of Tartu (Tartu. Estonia). He has completed his postdoctoral fellowship in 1991-1996 at the Department of Neurology, Memorial Sloan-Kettering Cancer Center (MSKCC, New York, NY), where subsequently (1996-2003) he has built a successful research program in molecular imaging and therapy of cancer. From 2003 to 2012 Dr. Gelovani worked at the University of Texas M.D. Anderson Cancer Center (MDACC, Houston, TX) where he served as a Professor and Chair of the Department of Experimental Diagnostic Imaging and Director of the Center for Advanced Biomedical Imaging Research (CABIR). From 2012 to 2020 Dr. Gelovani served as Professor and Chair of the Department of Biomedical Engineering, College of Engineering, Professor of Oncology, Neurosurgery, and OBGYN at the School of Medicine Wayne State University (WSU), the Leader of Molecular Imaging Program at the Karmanos Cancer Institute (Detroit, MI). From 2020, Dr. Juri Gelovani works an Associate Provost and at the United Arab Emirates University (UAEU, Al Ain, UAE) and Professor at the College of Medicine and Health Sciences at the UAEU. He maintains the Adjunct Professor position at WSU (Detroit, MI, USA) and Mahidol University (Bangkok, Thailand). Dr. Gelovani received multiple prestigious awards, including the International Fellow Award from the Alexander von Humboldt Foundation, the George and Barbara Bush Endowment for Innovative Cancer Research, and the Gold Medal of the Society for Molecular Imaging (SMI) for significant contributions to the field of molecular imaging. Dr. Gelovani served as president of the SMI and the Academy of Molecular Imaging (AMI), for which he received service awards. Also, Dr. Gelovani was the President of the World Molecular Imaging Society. He is a member of several grants review study sections at the National Institutes of Health (NIH), an Associate Editor of Molecular Imaging and Biology, and one of the Academic Editors of PLOS One. Dr. Gelovani was recognized for spearheading the development of a triage center in Hoboken, NJ, and leading the emergency medical team for decontamination and treatment of the most severely injured victims of the Sept. 11, 2001 terrorist attacks on the World Trade Center in New York (NY, USA).
Ms. Lisa Velardo is the founder and principle at Aspen Consulting, LLC, a provider of part-time CFO, Controller and Bookkeeping Services. Ms. Velardo is a CPA in Massachusetts and brings extensive finance and operational experience in various private industries with a focus on technology and life sciences. Her background offers strong financial management expertise in the areas of financial operations and reporting, budgeting and forecasting, revenue recognition, strategic planning, cash flow management contract negotiations, technical accounting and taxation. Prior to founding Aspen Consulting, Ms. Velardo served as the Director of Finance and Administration at Watermill Ventures. During her tenure at Watermill, Ms. Velardo advised on various strategic initiatives including recapitalizations, add-on acquisitions, cost reduction programs, negotiation of financing terms, sale leaseback transactions and exit alternatives. Ms. Velardo also led the due diligence process for various acquisitions and divestitures. Prior to Watermill, Ms. Velardo served as the Vice President of Finance and Administration at Vality Technology Inc., a $20 million data quality software firm. While at Vality, Ms. Velardo played an instrumental role in the successful acquisition of the company to Ascential Software Corporation. Prior to Vality, Ms. Velardo held senior financial positions at Engage, Inc. and Tonneson & Co., CPAs. Ms. Velardo is a Certified Public Accountant in Massachusetts since 1997 and received a B.S. in Business Administration from Merrimack College.
Medical Advisory Board Members
- Dr. David Bartlett, M.D. – Chair of the Allegheny Health Network Cancer Institute
- Dr. Alessandra Biffi, M.D. – Dana-Farber/Boston Children’s Cancer and Blood Disorders Center, Director of the Gene Therapy Program and Associate Professor of Pediatrics, Harvard Medical School
- Dr. Yuman Fong, M.D. – City of Hope Comprehensive Cancer Center, Sangiacomo Chair in Surgical Oncology, Chair and Professor, Department of Surgery, Professor of Experimental Therapeutics, Director, International Medicine, Surgical Oncologist
- Dr. Geoffrey Shapiro, M.D., Ph.D. – Dana-Farber Cancer Institute, Director, Early Drug Development Center; Clinical Director, Center for DNA Damage and Repair and Co-Leader, Developmental Therapeutics, Associate Professor, Medicine, Harvard Medical School
Investors
PhageNova Bio is financed with capital sourced from institutional investors, high-net worth individuals, and family office investors with a particular focus on the biotechnology space.