OTC QB: SVON
Corporate Overview
OCTOBER 7, 2014
Corporate Overview OTC QB: SVON OCTOBER 7, 2014 Safe Harbor - - PowerPoint PPT Presentation
Corporate Overview OTC QB: SVON OCTOBER 7, 2014 Safe Harbor Statement Certain statements included in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results
OTC QB: SVON
OCTOBER 7, 2014
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Certain statements included in this press release are forward-looking statements within the meaning
statements expressed or implied herein as a result of a variety of factors, including, but not limited to: the Company’s ability to integrate the Fabrus science and operations; the Company’s ability to continue as a going concern; the Company’s ability to recruit patients for its clinical trial; the ability of the Company to consummate additional financings; the development of the Company’s gene and antibody technology; the approval of the Company’s patent applications; the current uncertainty in the patent landscape surrounding small inhibitory RNA and the Company’s ability to successfully defend its intellectual property
the Company’s research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company’s products; the timing and success of the Company’s preliminary studies, preclinical research and clinical trials; competition and the timing of projects and trends in future operating performance; and the quotation of the Company’s common stock on an over- the-counter securities market, as well as other factors expressed from time to time in the Company’s periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with the Company’s periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
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Clinical stage oncology and immunology company focused on the discovery, development and acquisition
Proprietary technology platforms
– Cow antibody scaffold allows drugging of previously
inaccessible targets
– Arrayed Antibody discovery technology enables
differentiated screening
– eIF5A gene technology broadly regulates cell death
and survival
Platform validated by multiple first-in-class drug candidates and drug discovery collaborations with large pharma 108 issued patents (31 U.S., 77 foreign) with multiple pending applications Company leadership with a proven track record New corporate identity (formerly Senesco/Fabrus)
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Discovery Preclinical Phase 1 Phase 2 Phase 3
SNS01-T
(nanoparticle; eIF5A )
SVN-001
(Cow Antibody, Kv1.3)
SVN-002
(Human Antibody)
SVN-003
(Chimerasome; insulin receptor)
Other Internal Targets
(Antibodies; GPCRs, ion channels)
Undisclosed* Undisclosed*
* Collaboration: Sevion activities expected to begin Q4 2014 Oncology – MM, DLCBL Autoimmune/Inflammation Oncology - RCC Oncology - RCC Oncology Oncology Oncology
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Only a small fraction of potential targets are effectively addressed with current antibody technology (hybridoma, display)
Current Technology Soluble Proteins Sevion Technology Membrane Proteins Sevion employs two approaches to drugging novel targets Cow antibodies Arrayed libraries
(i.e. TNFa)
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Unique ultra long structure enables binding to otherwise intractable targets (such as crevices, pores, channels,
antibodies cannot) Humanization of the cow scaffold enables therapeutic use Novel intellectual property on composition of cow antibodies and humanization (in-licensed from Scripps and internal)
Ultra long CDR3 antibodies are unique to cows
Wang et.al. (2013) Cell 153: 1379-1393
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Fundamentally differentiated from phage display and hybridoma technologies
IgG format - manufacturing Cell surface screening Faster, more relevant hits Unique activities
DNA – human genome project
Tens of thousands of antibodies
High-throughput, parallel protein production High-throughput gene synthesis
Bioinformatics
High throughput cell sorting (FACS) allows us to rapidly screen multiple targets simultaneously directly on the cell
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Proprietary enabling platform for internal pipeline development, lead discovery for out-licensing, and drug discovery collaborations
Pharma validation: BMS - discovery
in oncology Additional collaborations pending
Validated Platform
Generated antibodies to over 25 targets Antagonist and modulator antibodies discovered and engineered against GPCR targets Unique antibodies/epitopes against common targets like Her2, and ErbB3 identified Novel cow scaffold engineered and validated against an ion channel (Kv1.3) with pM range activity
Composition of matter and use patent claims on SVN001 and SVN002
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Plays critical role in modulating activity of effector memory T-cells (TEM) T-cell activation plays a role in autoimmune disease: arthritis, psoriasis, IBD, GVHD, MS and others Scorpion venom treatment effect on MS (Lancet 2:1021 (1983)) later shown to be due to blockade of the Kv1.3 ion channel
Venom/bioactive peptide
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Safety – Intact Immune System: Selective against TEM cells, T-cell compartment remains intact, leaving the immune system capable of fighting infections. Limitations of current therapies are related to AE’s due to broad immunosuppression Ultra Potent: pM IC50’s in human blood and T-cell activation assays Half-Life: IgG Fc region affords long t1/2 (potential once a month SQ dosing) Medical Need: More than a third of patients across all indications are non-responsive to anti-TNF treatments Novel MOA/Reversible: Inhibiting the Kv1.3 target suppresses multiple key inflammatory
T-cell activation and is reversible
Inhibition of T-cell activation by a humanized cow antibody
TNFa (A450, sem) 0.15 0.3 0.45 0.6 0.001 0.01 1 10 100 1000 ec50=0.2nM (nM)
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(currently undisclosed) which is highly expressed in Clear Cell Renal Carcinoma. Target is associated with blood vessel sprouting/angiogenesis, independent
prognosis in ccRCC May solve anti-VEGF resistance, which
SVN002 binds to a target
Colored urogram (X-ray) of the left kidney of a patient with renal clear cell carcinoma (blue). Credit: Sovereign, ISM/Science Photo Library
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Preclinical studies for this program are support by collaborations with University of North Carolina Cancer Center 600” 500” 400” 300” 200” 100” 0” 5 10 15 20 25 30 35
Treatment
PBS Antibody Days Tumor Volume (mm3) PBS Antibody
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GPCRs Pores/Pumps Ion Channels Posttranslational Modifications Multiprotein Complexes Non-Protein Targets
Carbohydrates Nucleic acids Sulfation Glycosylation
Our Target Market
Antibodies against membrane targets Novel approach to enable
Soluble Proteins Extracellular Domains
TNF VEGF EGFR Her2 CTLA4 IgE
Current Antibody Market
Hybridoma & display platforms Restricted to soluble and extracellular domains Inability to make purified antigen and immune restriction
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These two proteins act as a biological switch to promote cell death or survival
Lysine Hypusine eIF5A eIF5A
Amino Acid Amino Acid Call Death Survival Cancer Apoptosis
Targeted for cancer treatment (SNS01-T)
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First in class therapeutic with three components
siRNA to suppress pro-survival hypusine Proapoptotic plasmid expressing stable mutated eIF5A Polyethylenimine (PEI) forming nanoparticle for RNA/DNA
Only gene therapy/siRNA in Multiple Myeloma Phase I/II Study
Cohorts 1-3 completed, DLT reached in cohort 4 2/4 patients in Cohort 3 have SD after 6 weeks Most frequent AEs are infusion reactions and thrombocytopenia Results of Cohort 4 expected 2H 2014
Composition of matter and use patent claims
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Ronald A. Martell
CEO, Sevion
Vaughn Smider, M.D., Ph.D.
CSO, Sevion
Harlan Waksal, M.D. (chair)
Founder, Imclone Systems
Philip Frost, M.D.
Chairman TEVA, CEO OPKO
Christopher Forbes
Vice President, Forbes Media, LLC
John Braca
Former partner SROne (Glaxo Smith-Kline)
David Rector
Principal David Stephen Group
Steven Rubin
COO, OPKO Health
Ticker: Stock Exchange: Recent Stock Price: 52 Week Range: SVON OTC QB $1.74 $1.28 - $6.35 Cash on Hand as of June 30, 2014 Cash Operating Expenses – June 30, 2014 Cash Operating Expenses – June 30, 2014 (Pro-Forma to Include Fabrus, Inc.) $6,100,000 $5,100,000 $8,100,000 Capitalization Table as of June 30, 2014 Common Equivalents Average Range Common Stock Outstanding 13,846,361 Preferred Stock (580 shares) 290,000 $2.00 Warrants 7,237,774 $4.77 $1.00 - $60.00 Options 979,304 $9.49 $2.65 - $140.00 Fully Diluted 22,353,439
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Advance two antibodies to the clinic in 18-24 months Evaluate Phase 1 data and determine development path for SNS01-T In-license new product candidates and synergistic technologies that are consistent with therapeutic area and/or scientific focus Establish robust pipeline of oncology/ immunology antibodies Secure additional drug development partnerships
Become the preeminent, next-generation biologics company with best and first in class product candidates and technologies
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