Powerful, Tumor-agnostic Immunotherapy Treatment - ONCOSEC'S PLATFORM TO ATTACK VISCERAL, CUTANEOUS AND SUBCUTANEOUS TUMORS
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Powerful, Tumor-agnostic Immunotherapy Treatment
NASDAQ: ONCS
ONCOSEC’S PLATFORM TO ATTACK VISCERAL, CUTANEOUS AND SUBCUTANEOUS TUMORS SEPTEMBER 2019
FORWARD LOOKING STATEMENTS
To the extent statements contained in the following retain key scientific or management personnel; (viii) the
presentations are not descriptions of historical facts anticipated timing of clinical data availability; (ix) the
regarding OncoSec Medical Incorporated, they should be anticipated timing of commercial launch of ImmunoPulse®
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product development activities and clinical trials; (ii) our Form 10-K filed with the Securities and Exchange
ability to develop and commercialize our product Commission, as updated by its subsequent filings with the
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business candidates and opportunities; (iv) our and our undertake no obligation to publicly update any forward-
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commercialize our product candidates and to improve the investigational drug and device products have not been
manufacturing process; (v) the size and growth potential of approved or cleared by the FDA.
the markets for our product candidates, and our ability to
serve those markets; (vi) the rate and degree of acceptance
of our product candidates; (vii) our ability to attract and
2
The Promise of How Checkpoint Inhibitors Work
Immunotherapy Has Yet 1
Molecular switches known as
to Be Fully Realized
checkpoints normally prevent T-cells
from attacking healthy tissue
When these checkpoints, such as PD-1
2 and PD-L1, are hijacked by cancer cells,
the immune system’s T-cell response is
switched off, allowing tumors to grow
THE PROMISE
Instead of cytotoxic agents, Checkpoint inhibitors flip the switch
use the body’s own immune system 3 back on, freeing the immune response
against tumors so that T-cells are activated and
Immunotherapy in many forms destroy the cancer cells
— like checkpoint therapy —
have had unprecedented success in
halting or shrinking cancer
Yet, there are still too many
patients who are not benefiting
from these therapies
3
Checkpoint Powerful drugs (like KEYTRUDA®) have been highly
Non-response successful for some patients, but not the majority
in 60-90% 90% of cancers are solid tumors. Of these:
of Cases
% OF CHECKPOINT
TUMOR TYPE NON-RESPONDERS
MELANOMA ˜60-80% ~30% ~70%
Hot Tumors Cold Tumors
TRIPLE NEGATIVE BREAST ˜95% Have T-cells and Have immunosuppressive cells
cancer fighters
HEAD AND NECK ˜68-86% Respond to
Have few or no T-cells
checkpoint therapies Do not respond to
CERVICAL ˜86% checkpoint therapies
SUBCUTANEOUS
T-CELL LYMPHOMA ˜57% There is an industry effort
underway to improve response rates through
new therapies or additional therapies 4
TAVO™ is a proinflammatory signaling cytokine designed
TAVO™ is Capable of
to enhance local delivery and uptake of DNA based
interleukin IL-12 directly into tumors. Administered locally
Reversing Resistance
at the tumor site, TAVO™ plasmid IL-12 kicks off a chain
reaction that spurs the cells to manufacture more IL-12,
to Checkpoint
which turns the tumor hot and enables checkpoint
therapies to be effective
Therapies
Well Tolerated Intratumoral Approach
TAVO™ leverages IL-12, a
with Abscopal Effect
naturally occurring Clinical data in five tumor types
chemical in the body; showing evidence of anti-tumor
intratumoral approach activity with whole body
avoids systemic toxicity (abscopal) effect
Cold to Hot Sustainable
Clinical data shows TAVO™ Highly scalable with low
induces local expression of manufacturing costs,
IL-12, converting potentially offering an
immunologically suppressed innovative treatment option
“cold” tumors into T-cell well below the cost of other
inflamed “hot” tumors biologic drug therapies
5
Benefits of Electroporation (EP)
Gene Delivery System
Rapid Transfection Versatile
More rapid than Wide array of molecules can
A non-invasive, traditional chemical or
biologic cell transfection
be transfected, and can be
applied to a broad selection
non-chemical, techniques of cell types
non-toxic method
that is easy
Surface & Visceral Non-Invasive
to perform Lesions Electroporation gene delivery
Beyond cutaneous and is noninvasive, nonchemical,
subcutaneous; tumors nontoxic method of cell
can be accessed with an transfection, applicable to a
endoscope, bronchoscope, wide array of immunologically
catheter, or trocar relevant molecules
6
Seamless Delivery
of Plasmid IL-12 + Energy
Step 1: TAVO™ Injection
Multiple copies of IL-12 coded DNA
plasmids to produce immune
modulatory proteins are injected
directly into the tumor using a
conventional needle and syringe.
Step 2: Applicator Insertion
The applicator’s tip needle array is
inserted into the tumor, up to a
depth of 15mm.
Genpulse™
Generator Sub / Cutaneous
Applicator
Step 3: Electroporation Fixed electrical field
Electrical pulses, activated by a foot intensity. Momentary Handle with electrode
switch administered between electrical pulses (100 needed array disposable
hexagonal needle electrodes µsec duration and 300 tip. Applicator 0.5 or 1.0
increases the permeability of cell millisecond interval). cm in diameter. Needle
membranes, facilitating uptake Pulses activated by foot array hexagonal.
(“transfection”) of IL-12 coded DNA switch. 16 lbs. 12.5” w x Adjustable needles 1-15
into cells. 5.5” h x 13” d mm.
Entire procedure takes approximately 30 minutes 7
Pipeline is Well Diversified with
Multiple Growth Opportunities
REGIMEN TRIAL INDICATION N PARTNER PHASE 1 PHASE 2 PIVOTAL
TAVO™+
KEYNOTE-695 Advanced Melanoma ~100
pembrolizumab
TAVO™ +
TAVO™ + Triple Negative Breast
EP Gene Delivery
TAVO pembrolizumab
KEYNOTE-890
Cancer (TNBC)
~25
Squamous cell
TAVO™ + epacadostat OMS-131 (INVESTIGATOR carcinoma head and ~34
+ pembrolizumab SPONSORED STUDY)
neck (SCCHN) cancer
TAVO™ + HER2- Proof of Concept
HER2+ Breast Cancers -
plasmid vaccine Study
TAVO™TAVO
+ VLA
+ VLA
Intravital microscopy Proof of Concept
Solid tumors -
(IVM) + TAVO™ + VLA Study
CAR-T CART
CAR-T Monotherapy +
Combo with TAVO™
-
TNBC/other solid
tumors
-
FDA Fast Track
KEYNOTE-695
Ongoing registration-directed, PD-1 checkpoint
resistant metastatic melanoma trial provides a
pathway towards accelerated approval
GRANTED FAST TRACK AND ORPHAN DRUG DESIGNATIONS
Fast-track makes Program for patients Must meet
TAVO™ eligible for with no FDA RECIST (tumor
accelerated approval approved treatment shrinkage) criteria
program options – demonstrating
that TAVO™
works
9
US Market Focusing First on Metastatic Melanoma
Opportunity in the United States
91,000 diagnosis 9,000 deaths
each year each year
90%
of all cancer cases
are solid tumors
Incidence of melanoma US melanoma market
on the projected to almost
1.6M new cases of solid
tumors in the US
rise (1.4% yearly
for a decade)
double from $2B in
less than 10 years
15,000 9,000 2,700
Patients receiving PD-1 refractory PD-1 refractory
PD-1 inhibitors patients with accessible
lesions
10Why the KEYNOTE-695
Partnership Works and Potentially Benefit to OncoSec
Helps to Address an Unmet Need
Enhancing the efficacy of an
existing drug is easier to
commercialize
Offers a bigger market
opportunity than a
KEYTRUDA® is an Effective Immunotherapy monotherapy
Joint committee established to
guide development
Registration-directed
study in progress VARIETY OF WIDELY USED Benefit to Merck
TUMOR TYPES
KEYNOTE-695 By increasing access to the
remaining 70% currently
untreatable patients, TAVO™ has
the potential to dramatically
increase market share for
WELL TOLERATED HIGHLY KEYTRUDA
EFFECTIVE
11P R E L I M I N A R Y D ATA
Metastatic Melanoma
KEYNOTE-695
100 PATIENTS TO BE ENROLLED - ONGOING
TAVO™ + KEYTRUDA® (pembrolizumab) for Checkpoint Refractory
Metastatic/Recurrent Melanoma
4 PRs and 1 CR out Durable responses Responders are Responders
of 21 patients observed patients with bulky demonstrating
evaluated by RECIST disease regression of distant
v1.1 as of 12/15/18 visceral lesions
Patient no longer treated
with TAVO™ as there are no
accessible lesions
Patient continues
maintenance pembrolizumab
BASELINE 12 WEEKS 24 WEEKS Notes: PR = partial response ;
CR = complete response 12Commercialization Targeted for 2021
EARLY 2019 2021
Pre-BLA Meeting Potential FDA Accelerated Approval
with FDA of TAVO™ for Metastatic Melanoma
TAVO™ is US Orphan Designated
and KEYNOTE-695 is a fast track
Potential US development program. OncoSec
Regulatory 2020
plans to seek accelerated approval
Timeline Submission of BLA for
Accelerated Approval
2019 Early 2020 LATE 2021
Obtain CE Mark for Meetings with EU EMA Conditional
to-be-marketed Rapporteurs Approval of TAVO™ for
Awarded EU small-
medium enterprise (SME) GenPulse Device Metastatic Melanoma
and ATMP designations by
Potential EU EMA’s Committee on
Regulatory Advanced Therapeutics LATE 2020
Timeline (CAT)
File MAA for Conditional
Approval in EU and File
Device Application in EU
13Bringing TAVO™ UNPARALLELED
to Australian Melanoma ACCESS TO A
Patients MARKET IN NEED
15,000 5 Min
15k Australians will be 1 Australian is
EMERGE IS AN AUSTRALIAN PHARMACEUTICAL
diagnosed with melanoma diagnosed with melanoma
COMPANY FOCUSED ON MARKETING AND SALES OF
skin cancer in 2019 every 5 minutes
HIGH QUALITY MEDICINE TO THE HOSPITAL SECTOR
Emerge Brings TAVO™ 1,000 This collaboration gives OncoSec an
edge amongst other clinical-stage
to Australian 1k patients who have companies developing treatment
failed checkpoint
Melanoma Patients
therapies for refractory metastatic
inhibitors or targeted melanoma...
therapy may be eligible …and could lead to
to try TAVO™ through this
Eligible through SAS provides certain program potential revenue
Australia’s Special qualifying patients access to generation as
Access Scheme (SAS) TAVO™ before regulatory
approval
early as 2H 2019
14P R E L I M I N A R Y D ATA KEYNOTE-890
Metastatic TNBC 25 PATIENTS
Rapid tumor reduction TO BE ENROLLED - ONGOING
TAVO™ + KEYTRUDA® (pembrolizumab) for mTNBC previously
of 20% or greater at 3
treated with chemotherapy +/- CPI month evaluation
2 PRs and 3 SDs with tumor Patients averaged 3 prior lines of Responses included a deep response
reduction out of first 10 unsuccessful chemo/radiation in a patient w/ multiple liver, bone
patients evaluated by and nodal metastases
RECIST v1.1 as of 5/22/19
Representative post-
treatmentOMS-140
Completed images ofstudy;
a
patient
TAVO™ with
as a primary
monotherapy,
refractory
single inflammatory
agent treatment,
right of
images breast TNBCwith
a patient
refractory TNBC
TAVO treated
Treated right
right chest Treated left left
Treated Untreated
Post-TAVO Untreated exophytic
exophytic left
chest wall disease breast disease right chest wall left axillary skin nodule
wall disease breast disease axillary skin nodule 15
Notes: PR = partial response ;FUTURE OPPORTUNITIES
TAVO™ is Tumor Agnostic
Renal Cell Ovarian Head/Neck
Carcinoma Triple
Negative
Bladder Colorectal Giving life to the promise of
Pancreatic Breast immunotherapies
across cancer types
HI
Few cancers are highly
infiltrated or “HOT” - most
LYMPHOCYTES
fall on a spectrum from warm
(cold-acting) to cold
TAVO™ is widely
applicable, we plan to
expand our studies to include a
wider range of tumors that do
LO not respond well to checkpoints,
including traditionally “cold”
VERY COLD COLD WARM HOT VERY HOT
16The Power of INTRODUCING THE
VLA: Visceral Lesion Applicator
TAVO™ for Visceral
Lesions
Based on encouraging and consistent
data and a clear unmet demand, we Flexible catheter- Rigid trocar-based
designed a platform based applicator applicator
to reach visceral lesions
CAN BE USED WITH
Endoscope
Bronchoscope
Lower voltage
Apollo generator to be Trocar
used with VLA
Cystoscope 17Melanoma KEYNOTE-695
Strong Financial TAVO™ Received ATMP Classification COMPLETED
Position & Key
Initiate European Sites 2H 2019
Complete Enrollment 1H 2020
Milestones Top-line Data Readout
Accelerated Approval Filing in US
2H 2020
2H 2020
None >12 MO. TNBC KEYNOTE-890
Current Cash Complete Enrollment 2H 2019
Debt Runway* Preliminary Data Update 2H 2019
Top-line Data Readout 1H 2020
$31.4M 10.6M
Cash & Shares Next Gen Product & VLA
Equivalent* O/S ✢ Announce Next Gen Product COMPLETED
Initiate Phase 1 2020
Head & Neck TRIFECTA Study
First Patient Dosed COMPLETED
Complete Enrollment 2020
* As on 5.28.19
✢ As on 6.14.19 18Established Biotech Leaders
WITH A TRACK RECORD OF SUCCESS
BOARD OF DIRECTORS
Daniel J. O’Connor, JD
MANAGEMENT Chief Executive Officer & Director
Avtar Dhillon, M.D.
Daniel J. O’Connor Kellie Malloy Foerter Co-Founder/Chairman
President/Director/CEO Chief Clinical Punit Dhillon
Development Officer
Co-Founder/Director
Jim DeMesa, M.D., M.B.A.
Director
Christopher G. Twitty, PhD Keir Loiacono
Chief Scientific Officer Vice President, Legal
Joon Kim, JD
and Corporate Development, Director
Chief Compliance Officer Robert E. Ward
Director
Sara Bonstein, MBA
CFO/COO Robert W. Ashworth, Ph.D Margaret R. Dalesandro, Ph.D.
Senior Vice President, Director
Regulatory, Quality/CMC
CLINICAL ADVISOR
John Rodriguez
Vice President, Alain Algazi, M.D.
Product Engineering
19OncoSec is
Positioned
Positive tumor Well tolerated, natural
shrinkage/response data being solution to increase the
generated by our lead pipeline efficacy of checkpoint
for Success with product, TAVO™, across
multiple solid tumor types
therapies
TAVO™
Expanding device Fast track status and
development and clinical partnership with Merck
studies into solving for provides opportunity for
new tumor types to serve more robust drug
a wider set of patients development
Strong financial position with
no debt
20Thank You Gem Hopkins
HEAD OF CORPORATE COMMUNICATIONS
858.210.7334
ghopkins@oncosec.com
HEADQUARTERS SCIENTIFIC LAB & RESEARCH
24 NORTH MAIN STREET 3565 GENERAL ATOMICS CT.
PENNINGTON, NJ SAN DIEGO, CAYou can also read
