A Cancer Immunotherapy Company
Harnessing the Human Immune System To Diagnose and Treat Cancer January 2015 January 2015
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A Cancer Immunotherapy Company Harnessing the Human Immune System To - - PowerPoint PPT Presentation
A Cancer Immunotherapy Company Harnessing the Human Immune System To Diagnose and Treat Cancer January 2015 January 2015 1 Disclaimer Disclaimer Forward Looking Statements THIS PRESENTATION CONTAINS FORWARD LOOKING STATEMENTS AND
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Forward Looking Statements THIS PRESENTATION CONTAINS FORWARD‐LOOKING STATEMENTS AND PROJECTIONS. THE COMPANY MAKES NO EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY AS TO THE COMPLETENESS OF THIS INFORMATION OR, IN THE CASE OF THE PROJECTIONS, AS TO THEIR ATTAINABILITY OR THE ACCURACY AND COMPLETENESS OF THE ASSUMPTIONS FROM WHICH THEY ARE DERIVED, AND IT IS EXPECTED THAT EACH PROSPECTIVE INVESTOR WILL PURSUE HIS, HER, OR ITS OWN INDEPENDENT INVESTIGATION IT MUST BE RECOGNIZED THAT ESTIMATES OF THE COMPANY’S PERFORMANCE ARE NECESSARILY SUBJECT TO A
HIGH DEGREE OF UNCERTAINTY AND MAY VARY MATERIALLY FROM ACTUAL RESULTS. IN PARTICULAR, THIS PRESENTATION CONTAINS STATEMENTS, INCLUDING WITHOUT LIMITATION THE PROJECTIONS, THAT CONSTITUTE “FORWARD‐LOOKING STATEMENTS” WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. THESE STATEMENTS APPEAR IN A NUMBER OF PLACES IN THIS PRESENTATION AND INCLUDE, BUT ARE NOT LIMITED TO, STATEMENTS REGARDING THE COMPANY’S PLANS, INTENTIONS, BELIEFS, EXPECTATIONS AND ASSUMPTIONS, AS WELL AS OTHER STATEMENTS THAT ARE NOT NECESSARILY HISTORICAL FACTS. THE COMPANY COMMONLY USES WORDS IN THIS MEMORANDUM SUCH AS “ANTICIPATES,” “BELIEVES,” “PLANS,” “EXPECTS,” “FUTURE,” “INTENDS,” AND SIMILAR EXPRESSIONS TO IDENTIFY FORWARD‐LOOKING STATEMENTS AND PROJECTIONS. YOU ARE CAUTIONED THAT THESE FORWARD‐LOOKING STATEMENTS AND PROJECTIONS ARE NOT GUARANTEES OF FUTURE PERFORMANCE AND INVOLVE RISKS AND UNCERTAINTIES. THE COMPANY’S ACTUAL RESULTS MAY DIFFER MATERIALLY FROM THOSE IN THE FORWARD‐LOOKING STATEMENTS AND PROJECTIONS DUE TO VARIOUS FACTORS, INCLUDING COMPETITION MARKET FACTORS GENERAL ECONOMIC CONDITIONS AND THOSE DESCRIBED IN THE “RISK FACTORS” INCLUDING COMPETITION, MARKET FACTORS, GENERAL ECONOMIC CONDITIONS AND THOSE DESCRIBED IN THE “RISK FACTORS”
FACTORS THAT COULD CAUSE THESE DIFFERENCES. 2
– Intersection is the intact human immune system – Antibody discovery platform leverages vaccine program in clinical trials
– In‐licensed portfolio of therapeutic cancer vaccines from Memorial Sloan‐Kettering Cancer Center – Two vaccines (sarcoma and ovarian cancer) in late Phase 2 POC with 2016 readout – Neuroblastoma vaccine received Orphan Drug Designation; on track to enter Phase 2 in 2015 p g g
– Discovered novel human antibodies from blood samples of patients vaccinated with the licensed vaccines – Lead antibody program, HuMab 5B1, targeting metastatic pancreatic cancer, to enter Phase 1 in 2H2015 with early data readout by year end for diagnostic and therapeutic indications
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J D id H
MabVax Avanir Xenerex
K C h
F d F P id t d CEO
Founder, President & CEO Board Member MabVax, Avanir, Xenerex Biosciences, Dura, Schering‐ Plough, Key, BMS
Philip Livingston, M D
Memorial Sloan Kettering Cancer Center
Ken Cohen
Founder, Former President and CEO
Synbiotics, Canji
Robert Hoffman
Senior VP Finance & CFO of Arena Pharmaceuticals, CFO Polaris Group,
M.D.
Founder & Chief Science Officer
Gregory Hanson
Chief Financial Officer Avanir, First Cornerstone, Brinson Patrick Securities, Mast Therapeutics, Xxsys Technologies, Member FASB Advisory Committee
Jeffery Ravetch, M.D., Ph.D
Rockefeller University, National Academy of Sciences and Institute
Sciences and the American p y g L‐3 Communications
Wolfgang Scholz, Ph.D.
Founder & Vice President Avanir, Xenerex Biosciences, Tanabe Research Laboratories USA, Desmos, Scripps Research Institute Sciences and the American Association for Advancement of Science
Paul Maier
Former CFO Seqenom Inc., Former
h i l Founder & Vice President Antibody Discovery Institute
Paul Maffuid, Ph.D.
Vice President Product De elopment & Operations AAIPharma Services, Biopharmalogics, Arena Pharmaceuticals, Amylin, Pharmaceuticals
Michael Wick, M.D., Ph.D.
Associate Professor Harvard Medical School. Development & Operations Pharmaceuticals, Amylin, Magellan Labs, Cabrillo Labs, Glaxo Research Institute
Philip Livingston, M.D.
Corporate Officer
Corporate Officer
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2014 2015 2016 Partner
5B1 Antibody PET Agent
2014 2015 2016
Pancreatic Cancer Diagnostic
Partner
MSKCC/ NIH Early Phase 1 Results YE2015 Completion
5B1 Therapeutic Antibody 5B1 Antibody Drug Conjugate
Pancreatic & Colon Cancer Therapeutic Agent
MSKCC/ Gallus Heidelberg
Pancreatic & Colon
Early Phase 1 Results YE2015 Completion
Preclinical Work GMP Mfg. and Tox 5B1 Antibody Drug Conjugate
Sarcoma Vaccine
Adjuvant Therapy to Prevent Recurrence and Prolong Survival Phase 2 POC Trial
Heidelberg Pharma MSKCC
Cancer Therapeutic
Phase 2 OS Results Preclinical Work GMP Mfg. and Tox Sarcoma Vaccine Ovarian Vaccine
Phase 2 POC Trial
MSKCC NIH/GOG/ MSKCC
Adjuvant Therapy to Prevent Recurrence and Prolong Survival Phase 2 POC Trial
OS Results 1H2016 Phase 2 OS Results 1H2016 Neuroblastoma Vaccine MSKCC/NIH NANT/SKC
Initiate Phase 2 Trial
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Positive Phase 1 Trial Completed Vaccine Mfg. IND
– All patients enrolled and vaccinated and minimal expense for survival follow‐up
– Childhood cancer with 700 new cases per year and received US FDA as Orphan Drug Designation – Phase 1 trial in neuroblastoma completed with strongly encouraging results on time to progression and survival
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13 230 21 880 13,230 100,000 21,880 174,000
Medical Management Of Recurrent Disease
Medical Management Of Recurrent Disease
p p g
Clinical Program Status
patients initiated in July 2010 at 20+ sites p p g
Clinical Program Status
patients at 13 sites
p y
and OS
Commercial Opportunity
sales y p p OS
Commercial Opportunity
sales
All incidence and survival date from National Cancer Institutes SEER data
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Favorable Results From Phase 1 Clinical Trial
complete, very good partial, or partial remission.
alive alive
have relapse rate of 40% to 60% and therapies have significant toxicities therapies have significant toxicities Transitioning to Phase 2 Clinical Trial
Phase II clinical material awarded
Clin Cancer Res 2014;20:1375‐1382. Published February 11, 2014.
NANT Scientific Review Committee
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Vaccine Delivered to
Multiple Patients
(Range 7 to 68)
Each Patient Immune System Generates Response to Vaccine Best Antibodies
Best Antibody Cloned & Expressed Patient Receives Fully‐Human B A ib d Best Antibodies Identified
11 Cloned & Expressed As Monoclonal Best Antibody As Monoclonal
useful biomarker for pancreatic cancer O l tl lid t d d b FDA
attractive molecular target
metastatic spread1
still alive (median: 197 weeks post vaccination)
d f
2 1. Ben‐David T, Sagi‐Assif O, Meshel T, et al. Immunol Lett 2008; 116: 218‐24.20, 2. Personal communication with lead investigator at MSKCC
remains disease free at 5+ years2
MSKCC
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13 CONFIDENTIAL – MabVax Therapeutics, Inc.
Pancreas ductal Sigmoid colon Lung adenocarcinoma
Pancreas, ductal adenocarcinoma, stage III Sigmoid colon, carcinoma stage IIIB (Ɨ) Lung, adenocarcinoma, Stage IB Ovary, metastatic carcinoma from colon Lymph node, metastatic carcinoma , IIIA Urinary bladder, muscinous adenocarcinoma, stage IV
Unpublished data. All work performed at Pathology Department, MSKCC
14 CONFIDENTIAL – MabVax Therapeutics, Inc.
Normal Tissue Stain
B t d t
Brain neg Breast + Colon + Kid
Breast, ducts Sigmoid colon, goblet cells
Kidney neg Liver neg Lung neg Lymph node neg
Lymph node neg Muscle neg Pancreas + Placenta neg
Pancreas, exocrine
Skin neg Spleen neg Stomach neg 15
Unpublished data. All work done at Pathology Department MSKCC
The co‐registration of FDG‐PET and computed tomography (CT) (left) and planar sections of FDG‐PET only (right) displayed minimal tumor detection of the tracer with a high uptake in highly metabolic tissues Acquired
89Zr radiolabed‐5B1 antibody (89Zr‐
5B1) PET image of the same mouse co‐ registered with CT exhibited exceptional tumor detection of the BxPC3‐luc tumor xenografts.
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DMS‐79 SCLC
Co 10 100 30 ntr
µg µg µg Day 0 Week 5
Cell injection: 5 million DMS79 cells into hind flank of 6 weeks
Treatment: Start on Day 21 after tumors are grown to 193±64
3 H
I G 1 (0 1 ) i i i k Cells: 0.5 million Colo205‐luc cells injected IV on day 0 into 5‐8 weeks old female SCID mice. Treatment: r5B1 i.p. injection on Day 4 after tumor cell
Taxol (0.2 mg/dose) was administered iv on days 23,30, 37 and
p<0.01 (**) and p<0.001 (***), N=5. Treatment: r5B1 i.p. injection on Day 4 after tumor cell
two weeks and once a week for next 7 weeks. Five of 10 control animals shown in imaging, 1 animal dead by week 5.
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1800
BXPC3 s.c
1400
Con
Capan 2 s.c.
1000 1200 1400 1600 is Title con H I G
600 800 1000 1200 volume (mm³)
IgG Gem 5B1 IgGGEM 5B1GEM 200 400 600 800 Ax HuIgG 5B1 Taxel 5B1+Taxel
200 400 600
5 8 1 5 8 1 5 8 1 5 8 1 5 8 2 6 9 3 7 4 8 1 5 2 9 6 3
Tumor v
5B1GEM Day 14 Day 17 day 21 day 24 day 28 day 31 day 34 Day 37 Day 41 Day 44 Day 48 Day 51
Arrow stands for treatment day. blue: taxol, red. mAb
Mouse: CB17 SCID 6 weeks old Cell injection: 1 million BxPC3 cells subcutaneous injection. Treatment: 5B1 500ug/100ul/ms i p twice a week for 4 weeks
Day 15 Day 18 Day 21 Day 25 Day 28 Day 31 Day 35 Day 38 Day 41 Day 45 Day 48 Day 51 Day 55 Day 58 Day 62 Day 66 Day69 Day 73 Day 77 day 80 day 84 day 88 day91 day 95 Day 102 Day 109 Day 116 Day 123
Mouse: CB17 SCID 6 weeks old Cell injection: 1 million Capan2 cells subcutaneous injection. Treatment: 5B1 500ug/100ul/ms i. p, twice a week for 4 weeks. Taxol at 200ug/mouse. once a week for 4 weeks. Treatment begins
Tumor volume measurement: length x width x width x 0.5 Cell injection: 1 million Capan2 cells subcutaneous injection. Treatment: 5B1 1mg/ms twice a week for 4 weeks. Gemcitabine at 150mg/kg/mouse. Twice a week for 4 weeks. Treatment begins on day 15. Tumor volume measurement: length x width x width x 0.5
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BrdU Cell Proliferation Assay with BxPC3 and Colo205 Cells. WST‐I Assay with Jurkat Cells As Control
ADC ADC
ADC ADC ADC ADC
ADC ADC
in vitro and in vivo cytotoxicity in two pancreatic cell lines known to express sialyl Lewisa E i th ti i d
ADC ADC ADC ADC
toxin to antibody without apparent loss of specificity and binding efficiency
Single dose Rx on day 0, median values shown (Group2 had one outlier/non‐ responder). Dose dependent mean tumor inhibition by 5B1‐ADC but not 5B1
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efficiency
target antigen‐negative cells
Poten al Pa ent Popula on
Colon/Rectal Ini al Metasta c
Pancrea c Ini al Metasta c Colon/Rectal Subsequent Metasta c
16,945 23,270 56,480 Total
Rectal Not Metasta c Pancrea c Not Metasta c
Total
All incidence and survival date from National Cancer Institutes SEER data
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As of Sept Nasdaq Capital Market Initial Listing As of Sept. 30, 2014 Assets Current assets ( $ 3.5 cash) 3.9 $ M PP&E 0.1 M Initial Listing Requirement Goodwill 6.1 M Total assets 10.1 $ M Liabilities, preferred stock and stockholders equity $ Accounts payable 0.7 $ M Accrued liabilities 1.8 M Warrant liability 0.3 M Total current liabilities 2.8 M Redeemable preferred stock 1.8 M Stockholders equity 5.5 M $ 5.0 M Total liabilities, preferred stock and stockholders equity 10.1 $ M 23 q y 10.1 $ M
Common Stock
Dec. 31, 2014 Public Float Common Stock 2.9 M 2.3 M Preferred Stock
A‐1 * 0.9 M
B
M
C (Common Stock Exchange) ** 0.1M Subtotal common stock and preferred stock as t d 5 3 M
Market has absorbed 700,000+ new shares in last quarter of 2014 from conversions and Rule 144 li ibilit
converted 5.3 M Excludes 1.3M warrants to purchase common stock at $1.80 to $3.61 a share*
144 eligibility
* Contains certain anti‐dilution rights if a financing is below conversion
exercise price ** Effective Sept 4, 2014, MabVax created Series C preferred stock with no liquidation preference
common stock, to exchange for common stock to allow large holders to exercise warrants for common
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stock and stay below 4.99% voting rights
MacroGenics 913
MacroGenics, 913 Oncomed, 723
Five Prime, 496 Xencor, 517 Immunomedics, 439
Sorrento , 278 Peregrine, 256 Northwest Bio, 337
MabVax $100/Share Advaxis, 156 Argos, 187
MabVax $50/Share MabVax $20/Share
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MabVax, 5 Globeimmune, 44
MabVax $10/Share
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