OncoSec Medical Incorporated · OTC:ONCSQ
OncoSec Medical — Investor Presentation (October 2016)
37 slides from OncoSec Medical's investor presentation, October 2016
Slide 1: OncoSec: Arming the Immune System to Fight Cancer
ONCOSEC TM ARMING THE IMMUNE SYSTEM TO FIGHT CANCER October 2016 NASDAQ: ONCS0
Slide 2: Forward Looking Statements
Forward Looking Statements Our commentary and responses to your questions may contain forward looking statements, as described in the Private Securities Litigation Reform Act of 1995. These include comments concerning clinical trials and product development programs, evaluation of potential opportun
Slide 3: OncoSec Corporate Overview
OncoSec Corporate Overview Immuno-Oncology Product Portfolio ImmunoPulse® uses local intratumoral immunotherapy to overcome tumor immune tolerance Platform focused on reversing the immuno-suppressive tumor microenvironment Capable of delivering multiple immune molecules in a single treatment P
Slide 4: OncoSec Investment Highlights
OncoSec Investment Highlights Proprietary immunotherapy platform (ImmunoPulse®) designed to overcome tumor immune tolerance – Ideal for combination with anti-PD-1/PD-L1 therapies; ImmunoPulse® IL-12 can drive tumor infiltrating lymphocytes (TILs) and stimulate anti-cancer immune activity – Can gen
Slide 5: OncoSec Management Team
OncoSec Management Team Punit Dhillon Chief Executive Officer Sharron Gargrosky, PhD Chief Clinical and Regulatory Richard Slansky Officer Chief Financial Officer Robert H. Pierce, MD Sheela Mohan-Peterson Chief Scientific Strategist Chief Legal and Compliance Officer 4
Slide 6: Core Clinical Pipeline
Core Clinical Pipeline Aligned to Pursue Combination Approaches PRECLINICAL PHASE I PHASE II PHASE III Metastatic Melanoma Melanoma Combination Study IL-12 + Anti- PD-1 (KEYTRUDA®) Triple Negative Breast Cancer Solid Tumors 5 Orange = Monotherapy with IL-12 | Green = Combination Therapy | Blue = New
Slide 7: Core Technology: ImmunoPulse
Core Technology: ImmunoPulse® Overcoming Tumor Immune Tolerance via Intratumoral Immunotherapy Trains immune system to target and attack cancer Local delivery targets tumors directly triggering a systemic (abscopal) response with limited systemic exposure Ability to deliver a wide-variety of p
Slide 8: ImmunoPulse IL-12
ImmunoPulse® IL-12 Local Delivery Triggers Systemic Anti-Tumor Immune Response Uses DNA-encoded interleukin-12 Delivered directly to tumor in vivo; (IL-12), a potent pro-inflammatory stimulates local immune response, cytokine and subsequently, systemic effect ① Injection of ② Intratumoral ③ IL-1
Slide 9: OncoSec's Platform Solution
OncoSec’s Platform Solution Addressing the Problem of Tumor-Induced Immune Subversion ④ Trafficking and T- ⑤ Infiltration of T-cell cell to Tumors into Tumors CX3CL1 CXCL9 LFA1/ICAM1 CXCL10 CCL5 VEGF Endothelin B receptor ③ Priming and ⑥ Recognition of T- Activation cell into Tumors CD28 CD137 T-cel
Slide 10: ImmunoPulse IL-12 May Address Large Population of Anti-PD-1 Non-Responders
ImmunoPulse® IL-12 May Address Large Population of Anti-PD-1 Non-Responders Anti-PD-1 therapy can re- Anti-PD-1/PD-L1 mAB Tumor Type Non-Response invigorate ‘exhausted’ T cells, allowing them to attack and kill Melanoma ~60 – 80% immunogenic tumor cells Triple Negative Majority of patients lack
Slide 11: Addressing the Unmet Need of Low-TIL Tumors
Addressing the Unmet Need of Low-TIL Tumors Driving Immunogenicity to Overcome Anti-PD-1 Non-Response PD-1 PD-L1 PD-1 x PD-L1 Data suggest ImmunoPulse® IL-12 can Responder enhance immunogenicity ImmunoPulse® IL-12 and convert T cell poor (or low TIL) tumors into T cell inflamed tumors ImmunoPuls
Slide 12: Phase II Metastatic Melanoma Study Design
Phase II Metastatic Melanoma Study Design PRIMARY OBJECTIVE: SECONDARY OBJECTIVES: Best overall response rate (bORR) Safety and tolerability evaluated by modified “Skin” RECIST Median overall survival criteria Objective response rate by irRC Median progression free survival Regression ra
Slide 13: Phase II Metastatic Melanoma Data
Phase II Metastatic Melanoma Data Drives Local and Systemic Anti-Cancer Immune Response Best Overall Complete Patients with regression Disease Response Rate* Response Rate* of at least one non- Control Rate* treated lesion COMPLETE RESPONSE: Pre-Treatment Treated Scalp Lesions - Day 180 * By Modifie
Slide 14: Phase II Merkel Cell Carcinoma Study Design
Phase II Merkel Cell Carcinoma Study Design PRIMARY OBJECTIVE: SECONDARY OBJECTIVES: Demonstrate ImmunoPulse® IL-12 leads Safety and tolerability to increased local expression of IL-12 in Efficacy – local and systemic tumor microenvironment Immunologic changes and biomarkers STUDY DESIGN: CL
Slide 15: Phase II Merkel Cell Carcinoma Data
Phase II Merkel Cell Carcinoma Data ImmunoPulse® IL-12 Can Drive Antigen-Specific CD8+ T Cells in Patients 3 months Immediately Negative Control Pre-treatment Pre-treatment Pre-treatment MCC-specific tetramer +2 weeks +8 months +10 months Post-treatment Post-treatment Post-treatment Distant Post-tre
Slide 16: ImmunoPulse IL-12 Can Increase TILs
ImmunoPulse® IL-12 Can Increase TILs Critical Priming of Tumors for Response to Checkpoint Inhibitors ImmunoPulse® IL-12 can convert T cell poor tumors to T cell rich tumors, which are more likely to respond to anti-PD-1 therapies Metastatic Melanoma Merkel Cell Carcinoma Pre-ImmunoPulse® IL-12 Post
Slide 17: Long-Term Follow-Up Clinical Melanoma Data: Study Schema
Long-Term Follow-Up Clinical Melanoma Data: Study Schema Prospective study of ImmunoPulse® IL-12 monotherapy in advanced melanoma ImmunoPulse® IL-12 Schedule 1-5-8 Retrospective analysis of ImmunoPulse® (N=18) IL-12-treated patients who received subsequent PD-1/PDL1 inhibitors Repeat cycle every 12
Slide 18: ImmunoPulse IL-12 May Enhance Response Rates to PD-1/PD-L1 Blockade
ImmunoPulse® IL-12 May Enhance Response Rates to PD-1/PD-L1 Blockade Patients who received ImmunoPulse® Without With IL-12 and later went on to receive a Response Intervening Intervening TOTAL PD-1/PD-L1 inhibitor demonstrated a Rate Therapy Therapy N=14 high response rate (64% BORR*; N=8 N=6 n=14
Slide 19: Biomarker Assay Accurately Predicts Response to Anti-PD-1 Therapies
Biomarker Assay Accurately Predicts Response to Anti-PD-1 Therapies Study led by the University of California, San Francisco may help bring the benefits of checkpoint inhibitors to an increased number of patients. Patients with partially exhausted CD8+ T cells infiltrating melanoma tumors accura
Slide 20: Phase II Metastatic Melanoma Combination Study
Phase II Metastatic Melanoma Combination Study RATIONALE COLLABORATORS Tumors need TILs for patients to respond to anti-PD-1 therapies Priming tumor microenvironment with IL-12 and promoting T-cell recruitment may enhance response to KEYTRUDA (pembrolizumab) First trial focused on addressing r
Slide 21: Pilot Triple Negative Breast Cancer (TNBC) Study
Pilot Triple Negative Breast Cancer (TNBC) Study RATIONALE COLLABORATORS Response rates to checkpoint therapies in pre-selected TNBC population were only 18% to 33% in preliminary reports ImmunoPulse® IL-12 may drive an inflammatory response in TNBC patients, increasing response to anti- PD-1 th
Slide 22: Accelerated Approval Trial Design of ImmunoPulse IL-12 and Keytruda
Accelerated Approval Trial Design of ImmunoPulse® IL-12 and Keytruda in Stage III/IV Melanoma Multicenter Phase II Trial of intratumoral pIL-12 + electroporation in combination with pembrolizumab (Keytruda) in patients with Stage III/IV melanoma who are refractory to pembrolizumab treatment Patien
Slide 23: A Market Primed for Significant Growth
A Market Primed for Significant Growth Addressing a Great Unmet Medical Need in Oncology Percentage of cancer Projected market value of Patients with solid tumors treatment regimens that will checkpoint therapies, such that will not respond to be immunotherapy-based as anti-PD-1 treatments* checkpoi
Slide 24: Combination Therapy with Anti-PD-1/PD-L1 U.S. Market Opportunity
Combination Therapy with Anti-PD-1/PD-L1 U.S. Market Opportunity OncoSec is the only company focused on addressing a melanoma patient population that is non-responder/refractory to anti-PD-1/PD-L1 Melanoma market in the US is growing In 2022, the melanoma market is projected to reach $2.2 billion
Slide 25: Clinical Data Highlighted in Peer-Reviewed Scientific Journals
Clinical Data Highlighted in Peer-Reviewed Scientific Journals Journal Article Title Findings PD-1 blockade induces responses “Responder” patients to anti-PD-1 by inhibiting adaptive immune treatment require pre-existing resistance CD8+ T cells Phase I Trial of Interleukin-12 10% of patients experie
Slide 26: OncoSec's Intellectual Property
OncoSec’s Intellectual Property Freedom to operate in critical areas (Licenses) ImmunoPulse® IL-12 EP intratumoral delivery of immune stimulators Exploit existing IP Lifecycle management Data exclusivity Improvements Design patents Build broad new IP portfolio to address business needs
Slide 27: Development Milestones
Development Milestones Key CY 2016 Value Drivers Present preliminary clinical and biomarker data from the Phase II melanoma combination clinical trial Define clinical and regulatory objectives to initiate melanoma combination registration study in 2017 Announce device developments in the field of ge
Slide 28: OncoSec Investment Highlights
OncoSec Investment Highlights Proprietary immunotherapy platform (ImmunoPulse®) designed to overcome tumor immune tolerance – Ideal for combination with anti-PD-1/PD-L1 therapies; ImmunoPulse® IL-12 can drive tumor infiltrating lymphocytes (TILs) and stimulate anti-cancer immune activity – Can gen
Slide 29: Thank You
THANK YOU NASDAQ: ONCS SCAN THE CODE to download our complete Investor Overview www.OncoSec.com/ONCS-Investor-Package October 2016 P 855-662-6732 OncoSec Headquarters: E [email protected] 5820 Nancy Ridge Drive W www.oncosec.com San Diego, CA 92121 28
Slide 30: Appendix
APPENDIX 29
Slide 31: Rationale for Combination of ImmunoPulse IL-12 and Anti-PD-1 Blockade
Rationale for Combination of ImmunoPulse® IL-12 and Anti-PD-1 Blockade Hypothesis: Activation of the PD-1 checkpoint in distant, untreated tumors blunts the effectiveness of TILs generated by ImmunoPulse® IL-12 PD-1 Blockade 30
Slide 32: Phase I/II Clinical Trials in Combination with Checkpoint Inhibitors in Advanced Melanoma
Phase I/II Clinical Trials in Combination with Checkpoint Inhibitors in Advanced Melanoma Company Investigational MoA Immunotherapy Estimated Primary Data Agent/ RoA Combination Agent Readout Apexigen APX005M (IT) Anti-CD40 antibody Ipilimumab (anti-CTLA-4) 2Q2019 Celldex Therapeutics Varlilumab (IV
Slide 33: Phase II Metastatic Melanoma Data
Phase II Metastatic Melanoma Data ImmunoPulse® IL-12 Demonstrates Anti-Tumor Activity Response Category* N (%) CR PR Complete Response (CR) 4 (14%) SD PD Partial Response (PR) 5 (17%) **Stable Disease (SD) 5 (17%) Progressive Disease (PD) 15 (52%) Overall Response Rate 9 (31%) (CR + PR) Disease Cont
Slide 34: Distant Tumor Effect in B16 Melanoma Tumor Model
Distant Tumor Effect in B16 Melanoma Tumor Model Primary Tumor Response Contralateral Tumor Response A. B. ImmunoPulse® IL-12 leads to regression of treated tumor ImmunoPulse® IL-12 significantly reduces growth of untreated (contralateral) tumors ImmunoPulse® IL-12 monotherapy range of ~10-4
Slide 35: Tumor-Specific Neo-Antigen Response Following Treatment in B16-OVA Melanoma
Tumor-Specific Neo-Antigen Response Following Treatment in B16-OVA Melanoma A. Untreated B. IT-pIL12-EP C. % SIINFEKL tetramer+ SIINFEKL+ tetramer SIINFEKL+ tetramer Untreated IT-pIL12-EP CD44 CD44 The untreated B16-OVA mice failed to demonstrate a significant expansion of SIINFEKL+ CD8 T cells
Slide 36: Clinical and Scientific Advisors
Clinical and Scientific Advisors Dr. Daud is a longstanding member of OncoSec’s Melanoma Advisory Board and serves as Chief Clinical Strategist for OncoSec. He is a clinical professor of hematology/oncology at University of DEV SCI CLI MEL Adil Daud, MD California, San Francisco (UCSF), and Director
Slide 37: OncoSec: Arming the Immune System to Fight Cancer
ONCOSEC TM ARMING THE IMMUNE SYSTEM TO FIGHT CANCER 3 NASDAQ: ONCS6
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