1 confidential oms electrooncology precision tumor destruction and dna based cancer immunotherapy...

24
1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

Upload: leon-simpson

Post on 29-Dec-2015

220 views

Category:

Documents


2 download

TRANSCRIPT

Page 1: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL1

OMS ElectroOncology

Precision Tumor Destruction andDNA Based Cancer Immunotherapy

OTCBB: ONCS

Punit DhillonPresident & CEO

Page 2: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL2

Forward Looking Statement

Our commentary and responses to your questions may contain forward-looking statements, including comments concerning clinical trials and product development programs, evaluation of potential opportunities, the level of corporate expenditures, the assessment of OncoSec’s technology by potential corporate partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors that could cause actual results to differ materially from those set forth in our regulatory filings from time to time.

Page 3: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL3

Investment Overview• Cancer Therapy with OMS ElectroChemotherapy and OMS ElectroImmunotherapy

• Ablation platform selectively destroys cancer cells while leaving healthy tissue intact, dramatically improving patient quality of life

• Immunotherapy platform allows activation of both innate and adaptive immunity to kill cancer cells

• Drug-device combination using low dose bleomycin or DNA based cytokines

• Locally delivered with electroporation into targeted tumors/tissue

• Selective killing of cancer cells, preserving healthy tissue

• Extensive human clinical experience showing efficacy and strong safety profile in Phase 1 - 4 clinical trials of 400+ patients: cutaneous (BCC, SCC, melanoma), head & neck, breast, prostate, pancreatic tumors

• Near-term commercial potential, recurring sales model

Page 4: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL4

OncoSec Solution = OMS ElectroOncology

OncoSec’s treatment platform has two components:Anti-Cancer Agent OncoSec Medical System (OMS)

Chemotherapeutic Agent

(Bleomycin)

Cytokine Plasmid DNA

Construct (e.g. IL-12)

or

Drug-device combination• Razor-razor blade marketing strategy

with revenue from single use disposable; potential profit from proprietary biologics

Patent estate• Electric pulse generators and applicators• Electroporation conditions and methods

of use

Page 5: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL5

Electroporation Enhances Therapeutic Potency

Anti-cancer agent injected directly into tissue Tissue electroporation enhances cellular uptake

Electroporation dramatically enhances cellular uptake of a useful therapeutic agent

Cell poration; agent enters cells

Drug surroundscells

Electroporation: millisecond pulses increase cell permeability

Cells reseal, allowing agent to perform its

function

Page 6: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL6

OMS ElectrOncology Cancer Targets

OncoSec’s ElectroOncology has successfully treated a range of solid tumor cancers in humans

• Skin (Melanoma and Non-Melanoma)• Head & Neck• Breast• Prostate• Pancreatic

Page 7: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL7

OMS ElectoImmunotherapy

• DNA plasmids encoding for cytokines (e.g. IL-12) to stimulate the body’s immune system to kill cancer cells

• DNA plasmid encoding for cytokines in combination with OMS increased cellular uptake of DNA immunotherapeutic subsequent production/expression of IL-12

• Induces innate and adaptive anti-tumor immune responses • No unwanted immune responses and immunogenic effects associated

with protein IL-12 administered directly into the body• No unwanted immune responses and immunogenic effects often

attributed to viral vectors• Lead drug candidate is a DNA plasmid construct coding for interleukin-12

(IL-12)• Phase II clinical pipeline for several cancer indications based on positive

Phase I clinical data

Boosting the immune system to fight cancer

Page 8: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL8

OncoSec’s Lead Candidate: IL-12

1. DNA IL-12 uptake into tumor cells enhanced by electroporation

2. Cells produce and secrete IL-12

3. IL-12 recruits macrophages and cytotoxic T-cells and activates other pro-inflammatory responses – innate immune respone

4. Cancer cells and tumors at local treatment site destroyed

5. Selective systemic adaptive immune effect on remote, untreated cancer lesions

How it worksIL-12 recruits cytotoxic T-cells and macrophages

TH1

IL-12

TH1

B-cell

IFN-

Phagocytosis

IFN-

Inhibits tumor

angiogenesis

Apoptosis

Macrophage

Antibodies

Safe and effective local and systemic immune response and therapeutic benefit

Page 9: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL9

IL-12 Plasmid in Melanoma Mouse Model - I

Intratumoral delivery of IL-12 by electroporation demonstrated: • Cytokine expression within the tumor• Potential anti-angiogenic effect (prevents growth of blood vessels that feed tumor)• Tumor control in all treated animals• Long-term survival and resistance to challenge in melanoma model

Lucas et al., 2002, IL-12 plasmid delivery by in Vivo electroporation for the successful treatment of established subcutaneous B16.F10 melanoma, Molecular Therapy

Page 10: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL10

IL-12 Plasmid in Melanoma Mouse Model - II

Group Dose ElectroporationObjective Response

Complete Response

Females Males Females Males

1 0.05 mg Saline No 0% 0% 0% 0%

2 0.005 mg IL-12 No 0% 0% 0% 0%

3 0.005 mg IL-12 Yes 20% 20% 20% 20%

4 0.05 mg IL-12 No 20% 0% 20% 0%

5 0.05 mg IL-12 Yes 100% 80% 100% 80%

Tumor response at day 30 post-treatment

• Electroporation increased desired immune response and potency of DNA IL-12• Higher dose achieved significantly higher partial tumor response rates including

complete responses in one study cohort• Study also showed no significant toxicity associated with DNA IL-12

N = 50 animals; 10 animals per group; 5 females, 5 males per group.Heller et al., 2006, Evaluation of toxicity following electrically mediated IL-12 gene delivery in a B16 mouse melanoma model, Clin Can Res

Page 11: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL11

US Phase I Melanoma Trial Results• Dose escalation clinical study in patients with metastatic melanoma• Treatment with OMS and IL-12 completed in 24 patients at University of Southern

Florida, Moffitt Cancer Center• US Phase I results reported in Journal of Clinical Oncology (Daud et al, 2008):

• Study established efficacy, safety and tolerability• Evidence of systemic response (objective response) in 53% of patients with distal (remote)

metastases that were untreated• 15% of patients demonstrated 100% clearance of distal, non-treated tumors; only 0.25% could

be expected to spontaneously regress based on historic clinical data• Greater then 90% of locally treated lesions showed evidence of necrosis (histological biopsy)

BBA B C

D E F

Best in class Phase I study results support initiation of Phase II

study

Pre-Treatment Day 256 Day 637

Righ

t Fro

nt

Ches

t Wal

lRi

ght U

pper

Back

Page 12: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL12

Phase II Study Design for OMS-I100 (Melanoma)

Summary of clinical trial designTitle: Phase II trial of intratumoral pIL-12 electroporation in advanced stage

cutaneous and in transit malignant melanomaDesign: Single arm, open-label study

Patient population: MelanomaNumber of Subjects: 25

Endpoints: Primary:• Objective response rate (local and distant) at 6 monthsSecondary:• Local response rate• Progression free survival• Overall survival• Duration of distant response• Time to objective response• Safety of intratumoral IL-12 in vivo electroporation

First patient first visit: Q3 2011

Page 13: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL13

Phase II Study Design for OMS-I110 (MCC)

Summary of Clinical Trial Design:Title: A Phase II Study of Intratumoral Injection of Interleukin-12 Plasmid and in

vivo Electroporation in Patients with Merkel Cell Carcinoma Design: Single arm, open-label study

Patient Population: Merkel cell carcinomaNumber of Subjects: 15

Endpoints: 10 Endpoint: • IL-12 protein expression in tumor tissue at 3-4 weeks20 Endpoint:• Safety• Objective response rate (local and distant)• Overall survival• Time to relapse or progression• Immunologic effects of intratumoral pIL-12 injection with

electroporationFirst Patient First Visit: Q3 2011

Page 14: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL14

Phase II Study Design for OMS-I120 (CTCL)

Summary of Clinical Trial Design:Title: Phase II Trial of Intratumoral IL-12 Plasmid Electroporation In Cutaneous

Lymphoma Design: Open-label study; Simon’s 2-stage mini-max design

Patient Population: Cutaneous T-Cell LymphomaNumber of Subjects: Stage 1 = 10 pts; Stage 2 = 17 pts

Endpoints: 10 Endpoint: • Objective Response Rate (Local and Distant) at 6 months

20 Endpoint:• Safety • Progression free survival

First Patient First Visit: Q3 2011

Page 15: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL15

OMS ElectroChemotherapy

• Chemotherapeutic agent (bleomycin) delivered intracellularly with electroporation

• Chemical based ablation, unlike surgery, radio frequency ablation and cryotherapy that has the ability to selectively kill cancer

• Clinical and physician experience in late stage head & neck and skin cancer studies demonstrated therapy to be a safe, tissue sparing, easy to use, economical and highly effective alternative to surgery

• OncoSec’s new clinical development plan is to maximize the likelihood of clinical and regulatory success

Precision tumor ablation enhancing patient quality of life

Page 16: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL16

Treatment of Head and Neck Cancer

Electroporationapplied with applicator

Cancer cellsdestroyedwhilepreservinghealthytissue

Tumor injectedwithbleomycin

No removalof healthy

tissue

Page 17: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL17

Treatment of Skin Cancer

Surgery would have required cutting out portion of ear

OMS ElectroChemotherapy of basal cell cancer

30 DaysPost-treatment

120 DaysPost-Treatment

Pre-Treatment

90 DaysPost-Treatment

BCC of Earlobe Tumor cells turn black as they die

Natural wound healing No further evidence of tumor

Page 18: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL18

Cutaneous Cancer Therapy Clinical Data

•Complete response (CR) + partial response (PR) Heller et al., Cancer Vol. 83 (1), July 1, 1998

Complete response is similar to treatment by surgery, without removal of healthy tissue

Type # of Patients Objective Response * Complete Response

Basal Cell Carcinoma 18 56 of 56(100%)

51 of 56(91.1%)

Melanoma 10 84 of 85(98.8%)

75 of 85(88.2%)

Squamous Cell Carcinoma

1 1 of 1 (100%)

0 of 1(0%)

Kaposi’s Sarcoma 1 4 of 4(100%)

4 of 4(100%)

Totals 30 145 of 146(99.3%)

130 of 146(89.0%)

(H.Lee Moffitt Cancer Center – University of Florida)

Page 19: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL19

OncoSec Product Pipeline

Research and Development Preclinical Phase 1 Phase 2 Phase 3 Registration

Trial

ElectroImmunotherapy Program

Malignant Melanoma

Cutaneous T-Cell Lymphoma

Merkel Cell Carcinoma

ElectroChemotherapy Program

Head & Neck Cancer (Europe)

Skin Cancer (Europe)

Skin Cancer (United States)

Completed Planned

Page 20: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL20

OncoSec Competitive Advantages

Compelling stakeholder benefits and promise of market pull

• Improved cosmetic, functional and pain outcomes → patient preference

• Minimal tissue removal = simple post-op care → physician & payer preference

• Transcends tumor types & locations → physician preference

• Adjuvant therapy = easier adoption → physician preference

• Ease of use and higher income → physician preference

• Minimal upfront investment → institutional acceptance

• Fast procedure = operating room cost savings → payer preference

Benefits all aspects of healthcare including the Patient

Page 21: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL21

Board & Executive Management Team

Board of Directors Executive Management

Avtar Dhillon, M.D., ChairmanInovio Pharmaceuticals, MDS Capital (Lumira)

James DeMesa, M.D., DirectorStem Cell Therapeutics, Induce Biologics

Anthony E. Maida III, Ph.D., DirectorBioConsul Drug Development, Replicon Neurotherapeutics, Trellis Bioscience, CancerVax Corp.

Punit Dhillon, President & CEOInovio Pharmaceuticals, MDS Capital (Lumira)

Punit Dhillon, President & CEOInovio Pharmaceuticals, MDS Capital (Lumira)

Michael Cross, Ph.D., Chief Business OfficerMDS Capital, GrowthWorks, MDS Proteomics, Viventia Biotech

Veronica Vallejo, CPA, Vice President FinanceCBIZ MHM, Mayer Hoffman & McCann

Caryn Peterson, Ph.D., Vice President Regulatory AffairsFeRx, Amylin Pharmaceuticals, Hybertech

Paul Goldfarb, M.D., Medical DirectorScripps Health, University of California, San Diego

Brian McCluskey, B.Eng., Executive Director EngineeringTDI Instruments, Digirad Corp.

Ernest Kitt, Executive Director Clinical OperationsMedicinova, Vical Corp.

Page 22: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL22

Financial Information

Shares Issued & Outstanding: 56,856,000

Warrants: 13,456,000

Stock Option Pool: 75,512,000

Management & Affiliates Ownership: 51%

Formation Capital: $4.1M

Page 23: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL23

Commercialization Milestones• Based on leveraging large historical patient database

• Initiate multiple OMS ElectroImmunotherapy trials for skin cancers

• Initiate US pivotal OMS ElectroChemotherapy trials for skin cancer • Extend EU pre-marketing studies demonstrating pharmacoeconomic,

reimbursement, and QoL benefits

• Develop OMS ElectroImmunotherapy combination Phase II program for skin cancers

• Near-term commercialization strategy: initiate pivotal and pre-marketing clinical trials, secure early market adoption, expand physician use base:• Obtain marketing approvals and reimbursement coding• Sales and marketing through partnerships• Drive adoption via key opinion leaders, physician loyalty and advocacy groups

• Partner/co-develop in emerging countries: large and rapidly growing markets with both push and pull dynamics (device improvements)

Page 24: 1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL24

Business Opportunity Summary

$1B market for locally effective, tissue sparing tumor treatment

Cancer therapy using biologics and small molecules: diversified

Market exclusivity through potential orphan indications

Market ready with favorable pharmacoeconomics & quality of life benefits

Centers of Excellence/key opinion leaders to drive adoption

Management team with extensive drug, device, clinical, commercial and capital markets expertise