Our Mission
Innova Therapeutics is dedicated to developing innovative cancer therapies for patients which have inadequate treatment options.
About Us
Innova Therapeutics was founded on the research conducted by Co-founders Nancy Klauber-DeMore, MD, FACS, Professor of Surgery and BMW Endowed Chair Cancer Research, Medical University of South Carolina (MUSC) and Cam Patterson, MD, MBA who is currently the Chancellor, University of Arkansas for Medical Sciences.
Innova Therapeutics is a Charleston, South Carolina based biotechnology company developing a monoclonal antibody (mAb) platform targeting a protein that is highly expressed in various solid cancers and shown to correlate with patient outcome. The lead humanized mAb has been selected and is designated as IVT-8086. Innova’s platform technology is initially focused on targeting cancers including pediatric osteosarcoma, sarcomas, breast cancer and pancreatic cancer. The opportunity for this anticancer therapy as a monotherapy and in combination with other chemotherapy agents will expand across other solid tumors.
SFRP2 is also being evaluated as an important target across human cancers, where expression levels have been shown to correlate with patient outcome. A diagnostic is in development which will be assessed as a potential marker for early cancer detection, as well as a prognostic marker for assessing treatment benefit and cancer reoccurrence.
Innova Management Team
Dr. Robert Ryan
Co-Founder and CEO
Dr. Robert Ryan is currently the CEO of Innova Therapeutics. Dr. Ryan was previously CEO and co-founder of Scioderm, which is a company that developed a topical therapy for the orphan disease, Epidermolysis Bullosa. Scioderm was the first Biotech to receive “Breakthrough Therapy” designation from the FDA. Dr. Ryan led the successful sale of Scioderm to Amicus in September 2015.
Dr. Ryan has more than 30 years of research/pharmaceutical/biotech experience, spanning the global development process from preclinical through Phase IV in many therapeutic areas including oncology (16+ years), infectious diseases, GI and metabolic diseases, pain, neurology, dermatology, respiratory, cardiovascular). Dr. Ryan previously held senior regulatory positions at PPD, INC Research, and Quintiles, in addition to senior preclinical, program management and clinical positions with Roche, Bristol-Myers Squibb (BMS), Celtic Pharma, UCB, Atherogenics, and Pfizer.
Dr. Ron Nardi
Executive VP Development
Dr. Nardi has broad therapeutic experience as a Research and Development Executive having spent more than 35 years involved across the spectrum of drug discovery and drug development responsibilities from target identification through clinical pharmacology, clinical development and global regulatory affairs including multiple drug approvals in several therapeutic categories. Prior to his experience at Innova Therapeutics he served in various senior positions at Scioderm, the International Partnership for Microbicides, and Ferring Pharmaceuticals. Earlier in his career he managed discovery research activities in several large pharmaceutical companies including Glaxo and Warner-Lambert Pharmaceutical Research. Dr. Nardi has a Ph.D in pharmacology and toxicology.
Dr. Nardi’s experience in multiple therapeutic categories includes cardiovascular diseases (CAD and heart failure), gastrointestinal disease (IBD, ulcer disease, GERD), endocrinology (infertility, brain-gut peptides) and oncology (prostate, sarcomas).
Michael Zimmer, MBA
Chief Financial Officer
Michael Zimmer is a highly experienced executive who brings 30 years of experience as a business leader in various roles including Finance, Accounting, Operations, Supply Chain, Business and Employee Development. He is the Past CFO and President / CEO for ARIES ALLIANCE Company with global operations in the U.S., France, UK, Canada, Russia, Singapore, China and Japan. Mr. Zimmer worked for Price Waterhouse Coopers in Auditing and Consulting, and brings experience with M&A and MBO transactions, Bank Financing, Capital Acquisitions, Site Selection and Incentive Plans, and Negotiations.
Dr. Nancy DeMore
Co-Founder, Clinical and Scientific Consultant
Dr. DeMore is Professor of Surgery, Medical Director of the MUSC Breast Center, and Program Director of the MD/PhD Program at MUSC. Dr. DeMore completed her Surgical Oncology Fellowship at Memorial Sloan Kettering Hospital, and Cancer Research Fellowship at Harvard Medical School. She is a practicing surgical oncologist with research interest in tumor angiogenesis and immunology.
Willistine Lenon
Executive VP Clinical Operations
Willistine Lenon has more than 27 years of clinical operation experience in the pharmaceutical/ contract research organization (CRO) industries globally including conducting of trials in the US, Canada, Latin America, Europe, Australia, and Pan-Asia. Ms. Lenon’s therapeutic expertise in clinical trials is broad in areas including Oncology, Dermatology, Analgesia, Cardiovascular, Genitourinary, hematology, Metabolic Disorders, Neurology, Ophthalmology, Pulmonary/Allergy, and Rheumatology.
Steve Cole
Head of Business Development
Mr. Cole has broad experience in the pharmaceutical industry having held management positions at Abbott Laboratories, G.D. Searle, and A.H. Robins. He was also Head of the Far Eastern section of the PMA. He lived in Japan and his consulting company has done numerous licensing and acquisition deals. Mr. Cole has served as a director for a number of companies and in a corporate governance and audit committee as a financial expert for a publicly traded company.
Mr. Cole graduated from the University of Wisconsin in 1957. After serving as an officer in the United States Army, he received a master’s degree from the American Graduate School for International Business following graduate studies at the University of Michigan.
Scientific Advisory Board
William D. Tap, MD
Chief, Sarcoma Medical Oncology Service, Memorial Sloan Kettering Cancer Centere VP Development
Dr. Tap is the Chief of the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center in New York. He is a medical oncologist who specializes in the treatment of patients with soft tissue and bone sarcomas and the development of novel therapies in rare cancers and neoplasms. Bill’s academic research interests are focused on understanding the genetic and molecular nuances of sarcoma with an emphasis on identifying and validating therapeutic targets, treatment biomarkers, and modeling drug resistance. Bill received his MD from Jefferson Medical College, was a resident in Internal Medicine at the Vanderbilt University Medical. enter, and a fellow in Hematology and Medical Oncology at the UCLA Medical Center in Los Angeles, CA.
Elizabeth Claire Dees, MD, MSc
Professor of Medicine, Division of Hematology and Oncology, UNC Hospital
Dr. Dees is a practicing medical oncologist, an active member of the UNC Breast Center, and the founding chair of the Developmental Therapeutics (Phase I trials) Working Group at UNC. She is the co-leader of the Clinical Research Program at UNC Lineberger. Dr. Dees completed her internship and residency in internal medicine at the Brigham and Women’s Hospital in Boston and her medical oncology fellowship training at the Johns Hopkins Oncology Center where she worked with the Phase I trials group and the breast cancer program.
Nancy Klauber-DeMore, MD, FACS
Co-founder, BMW Endowed Chair in Cancer Research at Medical University of South Carolina (MUSC)
Dr. DeMore is Professor of Surgery, Medical Director of the MUSC Breast Center, and Program Director of the MD/PhD Program at MUSC. Dr. DeMore completed her Surgical Oncology Fellowship at Memorial Sloan Kettering Hospital, and Cancer Research Fellowship at Harvard Medical School. She is a practicing surgical oncologist with research interest in tumor angiogenesis and immunology.
Cam Patterson, MD, MBA
Co-founder, Chancellor of the University of Arkansas for Medical Sciences (UAMS)
Prior to being named Chancellor at UAMS, Dr. Patterson was previously the Senior Vice President and Chief Operating Officer at New York Presbyterian Hospital/Weill-Cornell Medical Center in New York, from 2014-2018; and the Physician-in-Chief of the UNC Center for Heart and Vascular Care, the Chief of the Division of Cardiology, and the Director of the McAllister Heart Institute at the University of North Carolina at Chapel Hill from 2001-2014. Dr. Patterson research interests are in the areas of angiogenesis and vascular development, cardiac hypertrophy, protein quality control, and translational genomics and metabolomics.
Our Innovative Technology
Innova Therapeutics is developing a monoclonal antibody (mAb) platform targeting a protein that is highly expressed in various solid cancers and shown to correlate with patient outcome. Innova’s platform technology is initially focused on targeting cancers including pediatric osteosarcoma, sarcomas, breast cancer, multiple myeloma and pancreatic cancer. The opportunity for this anticancer therapy as a monotherapy and in combination with other chemotherapy agents will expand across other solid tumors.
The focus on pediatric osteosarcoma as one of the initial targets will allow a fast-regulatory approval, with the opportunity to obtain a Rare Pediatric Disease priority review voucher. Because Priority Review Vouchers (PRVs) may be sold, a secondary market for the vouchers has emerged, with revenue ranging between $80M and $350M.
Recent data which has been published has demonstrated that in pancreatic ductal adenocarcinoma (PDAC) SFRP2 is regulated by KRAS, which is the most lethal mutation seen in pancreatic cancer….blockage of this pathway should have beneficial outcomes to patients with this cancer. In patients with PDAC, SFRP2 is prognostic for survival.
Program Overview
Innova has Developed a Novel Anti-Cancer Platform and Diagnostic
Secreted frizzled-related protein-2 (SFRP2) is a novel anticancer therapeutic target that is highly expressed across most solid cancers (including primary and metastatic disease). SFRP2 is secreted in tumor cells, endothelial cells, and activated T-cells. SFRP2 selectively modulates the non-canonical Wnt/Calcium (Ca2+)-signaling cascade in different cancers, which plays a role in a series of cellular processes including angiogenesis, cell survival, cell growth and migration as well as oncogenesis and metastasis (Figure 1). SFRP2 binds to the frizzled 5 precursor (FZD5) receptor and activates the calcineurin/nuclear factor (NFATc3) pathway.
Innova has developed a monoclonal antibody (mAb) platform targeting SFRP2 that is highly expressed in various solid cancers and shown to correlate with patient outcome. The lead humanized mAb has been selected and is designated as IVT-8086. IVT-8086 has been shown to antagonize SFRP2 by selectively blocking the non-canonical Wnt/Ca2+ pathway.
IVT-8086 selectively inhibits SFRP2 in cancer and has multi-faceted activities including:
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Reduced tumor growth (primary and metastatic disease), including increased apoptosis of tumor cells
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Rescues T Cell dysfunction including T Cell exhaustion, impacting expression of PD-1 and CD-38
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Reduced angiogenesis resulting in reduced migration and metastasis
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Impacts tumor associated macrophages (TAMs) by shifting balance to increase M1 “attack” TAMs and IFN-Ỵ
IVT-8086 monotherapy treatment has demonstrated efficacy (with no adverse safety effects) in multiple animal models implanted with either human xenografts or genetically engineered mouse model (GEMM) cell lines. In addition, combination therapy with IVT-8086 and PD-1 mAb has demonstrated synergistic efficacy with no noted safety concerns. SFRP2 has been further validated as an important molecular target in human cancers, where expression levels haves been shown to correlate with patient outcome.
Recent data which has been published has demonstrated that in pancreatic ductal adenocarcinoma (PDAC) SFRP2 is regulated by KRAS, which is the most lethal mutation seen in pancreatic cancer….blockage of this pathway should have beneficial outcomes to patients with this cancer. In patients with PDAC, SFRP2 is prognostic for survival.
SFRP2 has been further validated as an important molecular target across human cancers, where expression levels have been shown to correlate with patient outcome. A diagnostic is in development which will be assessed as a potential diagnostic for early cancer detection, as well as a prognostic marker for assessing therapeutic benefit of treatments and assessment of potential reoccurrence of cancer.
Publications
Nasarre, P.; Garcia, D.I.; Siegel, J.B.; Bonilla, I.V.; Mukherjee, R.; Hilliard, E.; Chakraborty, P.; Nasarre, C.; Yustein, J.T.; Lang, M.; et al. Overcoming PD-1 Inhibitor Resistance with a Monoclonal Antibody to Secreted Frizzled- Related Protein 2 in Metastatic Osteosarcoma. Cancers 2021, 13, 2696. https://doi.org/10.3390/cancers13112696
Huang C, Ye Z, Wan J, Liang J, Liu M, Xu X, Li L. Secreted Frizzled-Related Protein 2 Is Associated with Disease Progression and Poor Prognosis in Breast Cancer. Dis Markers. 2019 Mar 3;2019:6149381.
Peterson YK, Nasarre P, Bonilla IV, Hilliard E, Samples J, Morinelli TA, Hill EG, Klauber-DeMore N. Frizzled-5: a high affinity receptor for secreted frizzled-related protein-2 activation of nuclear factor of activated T-cells c3 signaling to promote angiogenesis. Angiogenesis. 2017;20(4):615-28.
Tsuruta,JK, Schaub, NP, Rojas, JD,StreeterJ, Klauber-DeMore, N, Dayton, P (2017) Optimizing ultrasound molecular imaging of secreted frizzled related protein 2 expression in angiosarcoma. PLoSONE 12(3):e0174281.
Techavichit P, Gao Y, Kurenbekova L, Shuck R, Donehower LA, Yustein JT. Secreted Frizzled-Related Protein 2 (sFRP2) promotes osteosarcoma invasion and metastatic potential. BMC Cancer. 2016 Nov 8;16(1):869.
Tsuruta JK, Klauber-DeMore N, Streeter J, Samples J, Patterson C, Mumper RJ, Ketelsen D, Dayton P. Ultrasound molecular imaging of secreted frizzled related protein-2 expression in murine angiosarcoma. PLoS One. 2014 Jan 29;9(1):86642
Fontenot E, Rossi E, Mumper R, Snyder S, Siamakpour-Reihani S, Ma P, Hilliard E, Bone B, Ketelsen D, Santos C, Patterson C, Klauber-DeMore N. A novel monoclonal antibody to secreted frizzled-related protein 2 inhibits tumor growth.Mol Cancer Ther. 2013 May;12(5):685-95.
Courtwright A, Siamakpour-Reihani S, Arbiser JL, Banet N, Hilliard E, Fried L, Livasy C, Ketelsen D, Nepal DB, Perou CM, Patterson C, Klauber-Demore N. Secreted frizzle-related protein 2 stimulates angiogenesis via a calcineurin/NFAT signaling pathway. Cancer Res. 2009 Jun 1;69(11):4621-8.
Siegel JB, Nasarre P, Hsu L, Mukherjee R, Gormley M, Richardson B, Khan I, Morningstar JE, Hilliard E, O'Bryan JP, Helke KL, Spruill L, Dolloff NG, Klauber-DeMore N. Secreted frizzled related-protein 2 is prognostic for human pancreatic cancer patient survival and is associated with fibrosis. Cancer Biomark. 2023;38(3):287-300. doi: 10.3233/CBM-220044. PMID: 37955079.
News
Hollings Cancer Center -
Protein implicated in tumor growth found to be heavily associated with pancreatic cancer.
November 14, 2023
Dr. Demore Publication in Cancers on IVT-8086 Treatment for Osteosarcoma was Top 10 Most Cited Papers in 2021 in the Section “Pediatric Oncology”
In Historic Visit to MUSC, US First Lady Jill Biden Meets with Dr. Demore to Discuss IVT-8086 Breast Cancer Therapy
Hollings Researcher Honors Memory of Lost Friend, Finds Potential Treatment for Aggressive Pediatric Osteosarcoma
Klauber-DeMore Recognized for Spirit of Academic Innovation in Cancer Research
Innova Therapeutics Received Orphan Drug Designation from the FDA for IVT-8086 for the Treatment of Osteosarcoma
Innova Therapeutics Receives Rare Pediatric Disease Designation from the FDA for New Osteosarcoma Treatment
Innova Therapeutics files Applications for Orphan Drug and Rare Disease Designations for Osteosarcoma
Get in Touch
Innova Therapeutics
465 West Coleman Blvd
Mt. Pleasant, SC 29464
9192740703
