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NanoVector. Combination Product for Targeted Delivery of Cancer Therapy Biologic + Drug Larta Institute 2009 Life Science Venture Forum Al Bender, CEO 919-878-8464 abender@nanovectorinc.com. Overview. Biologic nanoparticle drug delivery platform First Indication: Metastatic melanoma
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NanoVector Combination Product for Targeted Delivery of Cancer Therapy Biologic + Drug Larta Institute 2009 Life Science Venture Forum Al Bender, CEO 919-878-8464 abender@nanovectorinc.com
Overview • Biologic nanoparticle drug delivery platform • First Indication: Metastatic melanoma • Pre-IND studies to begin Q4 2009 • Seeking A-round financing of $1.5M • $3.1M non-dilutive funding planned • To fund studies required to file for IND • Experienced management team • Nanoparticle drug delivery platform technology is highly sought after.
Targeted Delivery of Cancer Drugs • Avoidance of dose-limiting side effects • Much lower drug dose to achieve efficacy • Increased safety allows for more potent drugs • Nuclear targeting unique to NanoVector • Overcomes multi-drug resistance • Increases efficacy • Can kill the elusive cancer stem cell
Opportunity for >$1B/yr Drug • Cancer is 2nd leading cause of death: 565,650 • 1,237,180 new cases in USA • Cancer Drug market = $74B in 2012 Sources: BioPharm InsightTM: American Cancer Society
Unique Biologic Nanoparticle • Nanotechnology is a chemistry-dominated industry • Difficult chemistry problems limit success: • Synthesis • Cost • Consistency • Loading • Unloading specificity • Others….. • NanoVector’s nanoparticle optimized by millions of years of evolution • Difficulties with synthetic nanoparticles do not apply • Therapeutic, cost and manufacturing advantages • Value proposition similar to mammalian viruses being use successfully in vaccines today.
Chemotherapy agent Hidden from cell defenses Stage 2: Nuclear targeting delivers anti-cancer drug to site of action, bypassing resistance Biologic Enables Nuclear Targeting Stage 1: Cancer-specific cell targeting
+ Differentiated Nanoparticle • 75% of product features comes for free from nature • Automatic switch to release cargo once inside cells • Delayed release that enables nuclear targeting • Non-toxic • Robust, stable in blood and biofluids • Natural loading of drug • No premature leakage of cargo • Natural platform for adding last component: cell targeting molecules
Divalent Ion Extraction & Addition Reversibly Open & Close Holes in the Capsid
Biologic Simplifies Manufacturing Plants Bio-reactor 1020 (1Kg) Nanoparticles every 3-4 weeks All Identical – Very Low Cost
IP Barriers to Entry Licensed 2 patents from NCSU funded by $1.8M of Grants • Viral Nanoparticle Cell-Targeted Delivery Platform –Provisional, filed 05-21-07 • RCNMV as Drug Delivery Platform • Extension of 2-Stage Nuclear Targeting • Nanoparticle Delivery Agent - US, PCT allowed; others pending • 2-Stage Nuclear Targeting
NanoVector Lead Drug: NVI-9010 • Targeting: 50% of all solid tumors; 75% of metastasized tumors; 100% of melanoma • First indication: Metastatic Melanoma • Orphan Status for underserved cancer • Therapeutic: Already approved by FDA • FDA 505B II approval – Different Dosage • Targeting to increase efficacy of Non-Melanoma drug
In-vivo Safety/PK Testing of Plant Virus • Toxicity: • Massive I.V. dose showed no adverse effects. • Immunogenicity: • No existing antibodies in human Sera and Plasma • No antibodies after 1 week • No antibodies after Booster shot monitored for 3 weeks • Biodistribution: • Rapid distribution and excretion • No accumulation in organs • Conclusions: • Nanocarrier is well tolerated
In-Vivo POC for A375 Targeting • Safety Endpoint • Dox in PVN at 5X MTD • Represents >9 loaded & targeted PVNs per cell in the animal’s body • No PVN fatalities or observed adverse effects - even at Dox doses that would be lethal outside PVN • PVN delivery of Dox to tumor plus apparent increased tolerability verifies potential for dramatically increased therapeutic index 300% Increase 50% Increase Adjusted for % active tumor
Competition Meets Requirement Partially Meets Requirement Does not meets Requirement
Management and Advisors • Management • Albert Bender, Ph.D. – CEO. Founder and CEO of four venture backed startup companies. • Bruce Oberhardt, Ph.D. – President and CSO. Founder/Inventor of Cardiovascular Diagnostics “CoaguChek” and successful IPO • New Hire – VP Business Development. • Scientific Advisors • Professor Stefan Franzen, Ph.D. – Founder/Technical Advisor. Professor Biophysical and Biological Chemistry at NCSU. • Professor Steven Lommel, Ph.D. – Founder/Technical Advisor. Professor of Plant Pathologyand Genetics • Douglas Tyler, M.D. – Medical Advisor. Medical Director, Surgical Oncology Clinic, Duke University Medical Center • David J. Adams, Ph.D. – Oncology Advisor. Duke Cancer Center. • Professor Howard Reisner, Ph.D. – Immunology Advisor; UNC Department of Pathology.
IND Financing Value Creation NVI 9010 Grants and Loans $3.1M $8.5M B-Round $1.5M A-Round Pharma Partner InVivo Pre-IND Phase 1 Phase 2A/2B On-Going • Formulation • Cell studies • Animal testing NDA 2009 2010 2011 2012 2013 2014 2015
Metastatic Melanoma Targeted Drug: Highlights • Unique combination product: Biologic + Drug • Effective targeting validated • Efficacy Study to be completed in Q3 • Highly suited to deliver highly toxic compounds • Pre-IND studies to begin Q4 2009 Contact: Albert Bender NanoVector, Inc. Cary, NC 27513 (919) 607-4515 abender@nanovectorinc.com www.nanovectorinc.com