Powerful, Tumor-agnostic Immunotherapy Treatment - ONCOSEC'S PLATFORM TO ATTACK VISCERAL, CUTANEOUS AND SUBCUTANEOUS TUMORS - Equisolve
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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®
considered “forward-looking statements,” as described in IL-12; (x) our ability to meet our milestones; (xi) our
the Private Securities Litigation Reform Act of 1995, that expectations regarding our ability to obtain and maintain
reflect management’s current beliefs and expectations. You intellectual property protection; (xii) the level of our
can identify forward-looking statements by words such as corporate expenditures; (xiii) the assessment of our
“anticipate,” “believe,” “could,” “estimate,” “expect,” technology by potential corporate partners; and (xiv) the
“forecast,” “goal,” “hope,” “hypothesis,” “intend,” “may,” impact of capital market conditions on us. Forward-looking
“plan,” “potential,” “predict,” “project,” “should,” “strategy,” statements are subject to known and unknown factors,
“will,” “would,” or the negative of those terms, and similar risks and uncertainties that may cause actual results to
expressions that convey uncertainty of future events or differ materially from those expressed or implied by such
outcomes. Forward-looking statements are not assurances forward looking statements. These statements are also
of future performance and include, but are not limited to, subject to a number of material risks and uncertainties that
statements regarding: (i) the success and timing of our are described in OncoSec’s most recent Annual Report on
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
candidates; (iii) our plans to research, discover, evaluate Securities and Exchange Commission. Undue reliance
and develop additional potential product, technology and should not be placed on forward-looking statements. We
business candidates and opportunities; (iv) our and our undertake no obligation to publicly update any forward-
partners’ ability to develop, manufacture and looking statements, except as required by law. OncoSec’s
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
checkpoints normally prevent T-cells
to Be Fully Realized 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
at the tumor site, TAVO™ plasmid IL-12 kicks off a chain
Reversing Resistance reaction that spurs the cells to manufacture more IL-12,
which turns the tumor hot and enables checkpoint
to 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 KEYNOTE-890 ~25
TAVO pembrolizumab Cancer (TNBC)
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 therapies for refractory metastatic
Melanoma Patients 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
Initiate European Sites
COMPLETED
2H 2019
Position & Key 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 Positive tumor Well tolerated, natural
Positioned shrinkage/response data being
generated by our lead pipeline
solution to increase the
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, CASEPTEMBER 2019| NASDAQ:ONCS 1
© 2019, OncoSec Medical IncorporatedFORWARD-LOOKING STATEMENTS
To the extent statements contained in the following presentations are not descriptions of historical facts regarding OncoSec Medical
Incorporated, they should be considered “forward-looking statements,” as described in the Private Securities Litigation Reform Act
of 1995, that reflect management’s current beliefs and expectations. You can identify forward-looking statements by words such as
“anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “hope,” “hypothesis,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “strategy,” “will,” “would,” or the negative of those terms, and similar expressions that convey
uncertainty of future events or outcomes. Forward-looking statements are not assurances of future performance and include, but
are not limited to, statements regarding: (i) the success and timing of our product development activities and clinical trials; (ii) our
ability to develop and commercialize our product candidates; (iii) our plans to research, discover, evaluate and develop additional
potential product, technology and business candidates and opportunities; (iv) our and our partners’ ability to develop, manufacture
and commercialize our product candidates and to improve the manufacturing process; (v) the size and growth potential of 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 retain key scientific or management personnel; (viii) the anticipated timing of clinical data
availability; (ix) the anticipated timing of commercial launch of ImmunoPulse® IL-12; (x) our ability to meet our milestones; (xi) our
expectations regarding our ability to obtain and maintain intellectual property protection; (xii) the level of our corporate
expenditures; (xiii) the assessment of our technology by potential corporate partners; and (xiv) the impact of capital market
conditions on us. Forward-looking statements are subject to known and unknown factors, risks and uncertainties that may cause
actual results to differ materially from those expressed or implied by such forward looking statements. These statements are also
subject to a number of material risks and uncertainties that are described in OncoSec’s most recent Annual Report on Form 10-K
filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange
Commission. Undue reliance should not be placed on forward-looking statements. We undertake no obligation to publicly update
any forward-looking statements, except as required by law. OncoSec’s investigational drug and device products have not been
approved or cleared by the FDA.
2
© 2019, OncoSec Medical IncorporatedKEY INVESTMENT HIGHLIGHTS
• TAVO: IL-12 plasmid based-technology designed to reverse resistance to checkpoint inhibitors
• Evidence of whole-body / abscopal effect, both as a monotherapy and in combinations with CPIs
• Intratumoral delivery eliminates systemic toxicity – strong safety profile in over 150 patients
• KEYNOTE-695: TAVO + KEYTRUDA in metastatic melanoma patients who are definitive PD-1 failures
• Preliminary data from KEYNOTE-695 demonstrating a clinically relevant response rate >20%
• On track to file for U.S. Accelerated Approval in 2020 and is Orphan and Fast Track designated
• KEYNOTE-890 is a phase 2 study of TAVO plus KEYTRUDA in metastatic TNBC, representing a high
unmet medical need
• Extremely ”cold” tumor type, with only ~5-10% response rate to CPI’s
• Preliminary data update expected in 2H 2019
• Next generation device capable of treating internal lesions
• Expect to initiate Phase 1 trials in 2020
3
© 2019, OncoSec Medical IncorporatedINTERLEUKIN 12 (IL-12) IS A POWERFUL IMMUNOREGULATORY CYTOKINE
• Potent, well-characterized, pro-
inflammatory cytokine
• Shown to make the tumor
microenvironment (TME) immunogenic
• Targets innate cells allowing for productive
Th1 adaptive immune responses
• Safer, local delivery with “systemic”
benefits
• STRONG INNATE AND ADAPTIVE immune
activation without observed systemic IL-12
toxicity
• Drives adaptive resistance in the tumor
4
© 2019, OncoSec Medical IncorporatedTAVO CAPABLE OF REVERSING RESISTANCE TO CPI’S
CHECKPOINT INHIBITORS (CPIs) INTRATUMORAL IL-12
• “Checkpoint inhibitors” or “CPIs” • IL-12 is a potent pro-inflammatory
block the suppression of CTLs cytokine that promotes activation of
• Specific immune cells called CTLs
“Cytotoxic T Lymphocytes” (CTLs) • IL-12, when administered directly into
can destroy cancer cells the tumor, is able to increase frequency
of anti-tumor CTLs – thereby making
• Tumors produce immune The majority of patients
the tumor “hot”
checkpoint inhibitors that with cancer do not benefit
suppress the activity of CTLs and from CPIs because their • The anti-tumor activity of CPIs is
prevent them from performing tumors are immunologically greater with intratumoral CTLs
their cancer-fighting role “cold,” or lacking immune
cells, including CTLs
5
© 2019, OncoSec Medical IncorporatedTAVO’S OPPORTUNITY IS SIGNIFICANT
% of Checkpoint
Tumor Type
90%
Non-Responders
Melanoma ~60-80%
Of all cancer
cases are solid
tumors Triple Negative Breast ~95%1
TAVO
1.6M
Head and Neck ~68-86%3,4
Survival
Cervical ~86%2
New cases of
solid tumors in
the U.S.6 Subcutaneous T Cell
~57%
Lymphoma
Traditional Therapies
1 ASCO 2017, KEYNOTE-086 Study; 2 Merck PR, June 12, 2018 ; 3 Ferris et al., N Engl
J Med. 2016; 4 Seiwert et al., Lancet Oncl. 2016 ; 5J Hematol Oncol. 2018; 11: 15; 6
https://seer.cancer.gov 6
© 2019, OncoSec Medical IncorporatedINTRATUMORAL DELIVERY OF TAVO
PROCEDURE
GENPULSE TM Generator Step 1: TAVO Injection
Trillions of IL-12 coded DNA plasmids to
produce immune modulatory proteins are
injected directly into the tumor using a
conventional needle and syringe
Applicator
Step 2: Applicator Insertion
Handle with electrode needle array
disposable tip. Applicator 0.5 or 1.0 cm The applicator’s tip needle array is inserted
in diameter; needle array hexagonal. into the tumor, up to a depth of 15mm
Adjustable needles, 1 to 15 mm.
Step 3: Electroporation
Electrical pulses, activated by a foot switch,
administered between hexagonal needle
electrodes increases the permeability of cell
Fixed electrical field intensity, 6 electrical pulses, 100 μsec duration and 300 millisec
membranes, facilitating uptake (“transfection”)
interval. Pulses activated by foot switch. 16 lbs, 12.5” W x 5.5” H x 13” D of IL-12 coded DNA plasmids into cells
IL-12 transfected cells express and secrete IL-12 into the tumor microenvironment (TME)
IL-12 expression in the TME enhances immunomodulatory molecules to promote local tumor inflammation
IL-12 expression in the TME induces systemic immune activation and T-cell education for a systemic anti-tumor immune response
7
© 2019, OncoSec Medical IncorporatedTAVO + KEYTRUDA
Phase 2
Phase 1 Phase 2 Registration-Enabled Phase 3
Phase 1 Dose-escalation of Metastatic Melanoma
Actively enrolling
OMS-100 TAVO monotherapy in metastatic melanoma patients Completed
Melanoma Planning
Underway
TAVO + pembrolizumab in melanoma patients with
OMS-102
immunologically
ImmunoPulse®cold
IL-12tumors
+ pembrolizumab in melanoma patients with
immunologically cold tumors
KEYNOTE-695/OMS-103 TAVO + pembrolizumab registration-enabled study in R/R melanoma in partnership
with Merck
TAVO monotherapy biomarker study in
OMS-140 triple negative breast cancer (TNBC)
TNBC
ImmunoPulse® IL-12 monotherapy biomarker study in
KEYNOTE-890/OMS-141 TAVO + anti-PD-1 in (TNBC) in partnership with Merck
triple negative breast cancer (TNBC)
Cervical Cancer OMS-150 TAVO + pembrolizumab in patients with metastatic cervical cancer
OMS-131 TAVO + IDO + checkpoint inhibitor in R/R squamous cell
H&N
carcinoma of the head and neck (SCCHN)
8
© 2019, OncoSec Medical IncorporatedTAVO OPPORTUNITY IN METASTATIC MELANOMA IN THE U.S.
Diagnoses in U.S. Deaths in U.S.
each year(1) each year(1) Patients Receiving PD-1 Inibitors
~15,000 in U.S.
PD-1 Refractory Patients
• Response rates of re-
Available care - BRAF positive ~9,000 in U.S.
treatment in a post-anti-
immunotherapy as patients
PD-1 setting do not exist
first line option treated with
BRAF/MEK • 5% among ALL PD-1 Refractory
inhibitors patients is a reasonable Patients with Accessible Lesions
approximation ~2,700 in U.S.
• The incidence of diagnosed melanoma has been on an upwards trend,
with a yearly growth rate of approximately 1.4% for the past decade STRATEGY
• In 2014, the National Cancer Institute's SEER program estimated ~1.17 M OBTAIN ACCELERATED APPROVAL FOR PD-1
prevalent diagnosed melanoma patients in the U.S.
REFRACTORY PATIENTS AND THEN MOVE INTO
• The U.S. melanoma market is projected to almost double from ~$2 B in
EARLIER LINES OF TREATMENT
less than 10 years, driven by growing prevalence and entrance of novel
therapies
(1) https://seer.cancer.gov
9
© 2019, OncoSec Medical IncorporatedTAVO IN METASTATIC MELANOMA - TRADITIONAL DEVELOPMENT
Clinical Study Finding
Dose-Escalation Metastatic Melanoma Strong safety profile with early efficacy results
Repeat Dose (OMS-100) Abscopal tumor response
Retrospective Analysis (OMS-100) Evidence of priming for anti-PD-1 response
Combination with Pembro (OMS-102) Evidence of efficacy in predicted PD-1 non-responders
Combination with Pembro (OMS-103) Assess efficacy and safety in PD-1 non-responders
KEYNOTE-695 REGISTRATION-ENABLED UNDER ACCELERATED APPROVAL PROGRAM
Accelerated Approval Program
FDA can reduce the bar for approval in cases
where there is an unmet medical need for a
TAVO IS U.S. & KEYNOTE-695 IS serious condition or in cases where an
ONCOSEC WILL SEEK ACCELERATED APPROVAL experimental drug is being added to an
approved drug
10
© 2019, OncoSec Medical IncorporatedCOMPLETED: MULTI-CENTER PHASE 1 & PHASE 2 MONOTHERAPY TAVO IN
METASTATIC MELANOMA STUDIES
OMS-100 PHASE 2 MONOTHERAPY DATA HAS BEEN
OMS-100 PHASE 2 RR DATA (n=26) PRESENTED AT SEVERAL MAJOR MEDICAL MEETINGS,
Regression of at Least INCLUDING, 2016 AACR, 2017 SMR AND 2018 MELANOMA
ORR CR One Non-Treated Lesion DCR BRIDGE CONFERENCE AND IS CURRENTLY PENDING
PUBLICATION IN RELEVANT MEDICAL JOURNALS
30% 21% 46% 77% PHASE 1 REPRESENTATIVE EXAMPLE
Treated Lesions Residual
Numbered lesions on
• TAVO demonstrated the chest were CHEST
pigmentation
macrophages
anti-tumor efficacy after only one treated
treatment cycle
• Complete tumor regression was seen Untreated Lesions
No lesions on the back
in 21% of patients were injected or BACK Seborrheic
• electroporated Keratosis
TAVO caused local necrosis and
increased TIL infiltrate Pre-treatment Day 256 Day 637
• TAVO was shown to be safe and well- CR AFTER ONLY ONE CYCLE OF TAVO, REGRESSION OF ALL LESIONS
tolerated 11
© 2019, OncoSec Medical IncorporatedCOMPLETED: PHASE 2 STUDY OF TAVO + PEMBRO
PATIENTS WITH “COLD” TUMORS (OMS-102)
• Open-label, Phase 2 Multicenter Study • Stage III-IV Melanoma
• Primary Endpoint: BORR based on RECIST v1.1 • 3 week treatment cycles with 200 mg pembrolizumab
• Secondary Endpoint: DOR, PFS, OS administered as a 30 minute IV infusion
• Eligible patients using biomarker assay < 25% • 22 patients treated with TAVO on days 1, 5 and 8 of every
CTLA4hiPD1hi TIL phenotype other cycle (every 6 weeks)
LOW TILS PREDICTING KEYTRUDA
ALONE RESPONSE RATE ~5-10%
ANTICIPATED CPI
NON-RESPONDER
12
© 2019, OncoSec Medical IncorporatedTAVO + PEMBRO DELIVERS DURABLE RESPONSES IN 50% OF PATIENTS
(OMS-102)
DURABLE RESPONSES 102-001-003
102-001-004
102-001-009
Best overall response rate (BORR) of 50% (11/22) 102-001-013
102-001-020
102-001-022
• 43% [9/21] achieved RECIST v1.1 BORR 102-001-026
102-001-028
Complete response (CR) rate of 41% (9/22) 102-001-030
102-001-032
102-007-003 *
• 38% [8/21] achieved RECIST v1.1 durable CR 102-001-009
102-001-024
102-001-029 Complete response
Disease control rate (DCR) of 59% (13/22) 102-001-017 Partial response
Stable response
102-001-023
Progressive disease
• 52% [11/21] achieved RECIST v1.1 DCR 102-001-016
102-007-008
Continuing treatment
Days on IP-Tavo-EP + pembrolizumab
102-001-019
Days on pembrolizumab only
Progression free survival (PFS) of 57% at 15 months 102-001-002 Days off treatment w/continued response
102-001-001
102-001-007
* Off study – patient decision
Duration of response (DOR) of 100% (11/11) at >36 months 102-001-011
3 6 12 15 18 21 24 27 30 33
Time (months)
DATA PRESENTED AS AN
ORAL PRESENTATION
AT SITC 2017 13
© 2019, OncoSec Medical IncorporatedKEYNOTE-695: CURRENTLY NO DURABLE RESPONSES IN CHECKPOINT
REFRACTORY MELANOMA
There is currently NO APPROVED
THERAPY in the “salvage” setting for
checkpoint inhibitor-refractory
metastatic melanoma patient
populations1
- KOLs consider ~10% response rate
clinically meaningful as this is what they
could elicit with additional chemotherapy
however responses achieved with
chemotherapy are not durable
- Tolerability is an important consideration
in this heavily pretreated population
1. NCCN Guidelines. Melanoma. v3.2018; 2. Schachter J, et al. Lancet. 2017;390(10105):1853-1862; 3. Weber J, et al. Lancet Oncol . 2016 ; 17(7): 943–955; 4. Shoushtari et al. JAMA Oncology 2017;
14
© 2019, OncoSec Medical IncorporatedKEYNOTE-695: REVERSING RESISTANCE TO PD-1 WITH TAVO + KEYTRUDA
• Single arm Phase 2b Registration-
enabled study
• Primary outcome: ORR based on
• Pathologically documented unresectable melanoma, Stage III/IV, with
histological or cytological confirmed diagnosis of unresectable melanoma RECIST v1.1
with progressive locally advanced or metastatic disease • ~100 patients at sites in US, Australia &
• All patients must be refractory to anti-PD-1 mAbs (pembrolizumab or Canada
nivolumab according to their approved label) and must meet all of the
following criteria:
- Received 4+ doses of anti-PD-1
- Progressive disease after anti-PD-1 mAb according to RECIST v1.1 ✓ ORPHAN DESIGNATION
- Documented disease progression ≤12 weeks of the last dose of anti-PD-1 ✓ FAST TRACK
• No intervening therapies permitted in-between anti-PD-1 failure and • Breakthrough
TAVO/KEYTRUDA combination • Accelerated Approval
• Prior treatment with an approved BRAF inhibitor if BRAF mutation-positive
15
© 2019, OncoSec Medical IncorporatedKEYNOTE-695: PRELIMINARY RESPONSE RATE DATA
AS OF DECEMBER 15, 2018 FOR FIRST 21 PATIENTS
• 4 PRs and 1 CR out of 21 evaluated patients • Assessments by blinded independent review or
(~24% ORR) investigator at either Cycle 5 (~3 months) or Cycle 9
(~6 months) based on RECIST v1.1
• Durable responses observed, all responding
• Immunological response correlates to clinical
patients still on study from 6 to 10 months
response
• Responders are patients with bulky disease • Responses observed in treated and untreated lesions
• Responders demonstrating regression of distant • Only one TAVO related Grade 3 SAE of cellulitis
visceral lesions reported and resolved
Patient Response Assessment ORR Tracking at ~24%
A CR per Investigator at Cycle 9 Study size of ~100 to enable potential detection of clinically
B PR per BIRC at Cycle 5 meaningful response rate (>or=20 %) with a 95% confidence interval
C PR per BIRC at Cycle 5 2 of the responding patients no longer being treated with TAVO
D PR per Investigator at Cycle 5 because there are no TAVO accessible lesions
E PR per Investigator at Cycle 9 Currently ~33 treated, 21 evaluated and 16 patients on study
CR, complete response; PR, partial response; SD, stable disease; BIRC, Blinded Independent Review Committee; PD/DC, progressive disease/discontinued;
Cycle 5 is ~3 months; Cycle 9 is ~6 months 16
© 2019, OncoSec Medical IncorporatedKEYNOTE-695: PATIENT A
WHITE FEMALE WITH STAGE IVA MELANOMA
Baseline 12 Weeks 24 Weeks
17
IMAGES OF BASELINE VS. 12 AND 24 WEEKS © 2019, OncoSec Medical IncorporatedKEYNOTE-695: PATIENT E
WHITE MALE WITH STAGE IVB MELANOMA
IMAGES OF BASELINE VS. 12 WEEKS AND 24 WEEKS
TUMOR FLARE, NECROSIS,
Baseline
AND RESPONSE
12 weeks Regression of mediastinal node
and parenchymal lung metastases
24 weeks
18
© 2019, OncoSec Medical IncorporatedKEYNOTE-695: NEAR TERM REGULATORY APPROVALS IN US AND EU
Potential US Regulatory Timeline Potential EU Regulatory Timeline
Obtain Advanced Therapy Medicinal
COMPLETED Pre-BLA Meeting at FDA COMPLETED
Product (ATMP) Designation
Submission of BLA for Accelerated Obtain CE Mark for to-be-marketed
2H 2020 2019
Approval GenPulse Device
Potential FDA Accelerated Approval 1H 2020 Meetings with EU Rapporteurs
2021
of TAVO for Metastatic Melanoma
File MAA for Conditional Approval in EU
2H 2020
File Device Application in EU
TAVO IS U.S. ORPHAN DESIGNATED &
KEYNOTE-695 IS FAST TRACKED EMA Conditional Approval of TAVO for
2H 2021
ONCOSEC WILL SEEK ACCELERATED APPROVAL Metastatic Melanoma
19
© 2019, OncoSec Medical IncorporatedTAVO POTENTIAL IN CERVICAL CANCER: A HIGH UNMET MEDICAL NEED
OMS-150
•Single-arm Phase 2b study REGULATORY 511K New Cases WW
each year(1)
247K Deaths WW
each year(1)
•Primary endpoint - ORR by BIRC based on RECIST v1.1 Orphan designation
•Patients with histologically confirmed diagnosis of metastatic Fast Track
cervical cancer
•80 patients
Breakthrough
Accelerated Approval 13K Diagnoses in U.S.
each year(2)
4K Deaths in U.S.
each year(2)
•3 week treatment cycles with commercially available KEYTRUDA
administered as a 30-minute IV infusion day 1 of every cycle (flat
dose of 200 mg) and treated with TAVO on days 1, 5 and 8 every 6
Available care: For PD-L1 + TAVO + KEYTRUDA
weeks
Chemo- patients, post- to achieve a ORR
KEYTRUDA® ACCELERATED APPROVAL HISTORY AND
therapy as chemo receiving greater than
TAVO + KEYTRUDA RATIONAL
o June, 2018, KEYTRUDA received Accelerated Approval for the first line option KEYTRUDA(3) KEYTRUDA alone
treatment of advanced cervical cancer with disease progression ORR 14.3% (14%)
during or after chemotherapy
o Accelerated Approval was based on a single-arm 98 patient study
demonstrating a 14% overall response rate (ORR) "Conducting research that can lead to promising new therapies for women facing cervical
o The goal of the study is to improve upon KEYTRUDA’S 14% cancer and other gynecological malignancies is central to our mission, and this collaboration is
response rate, with the addition of TAVO, to ~25% ORR and file an exciting opportunity to bring our esteemed network and expertise in quality scientific
for Accelerated Approval with OMS-150 research to the table. We're grateful to play a role in the TAVO trial and look forward to
o Underserved patient population and high medical need: advancing this therapy through the clinic."
KEYTRUDA is only the second drug in 30 years to be approved for
Larry J. Copeland, MD, Gynecologic Oncology Group Foundation President
the treatment of cervical cancer and Professor of Medical Oncology at The Ohio State University
20
(1) Global Burden of Disease Cancer Collaboration, Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-years for 29 Cancer Groups, 1990 to 2016: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2018 Nov 1;4(11):1553-1568. doi: 10.1001/jamaoncol.2018.2706
(2) https://seer.cancer.gov/
(3) https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
© 2019, OncoSec Medical Incorporated
(4) Stevanovic, et al., Treatment of Metastatic Human Papiliomavirus-Associated Epithelial Cancers with Adoptive Transfer of Tumor-Infiltrating T Cells, ASCO 2018, Abstract #3004TAVO IN METASTATIC TNBC: HIGH UNMET MEDICAL NEED
REGULATORY
Orphan designation
Fast Track
OMS-140: COMPLETED & PRESENTED AT SAN KEYNOTE-890 Breakthrough
ANTONIO BREAST CANCER CONFERENCE ‘18 • ONGOING: Single arm Phase 2 study Accelerated Approval
cycle TAVO
• Patients Enrollment completed (N=10) • Primary endpoint - ORR based on RECIST v1.1
• 6 patients enrolled to date
Chromogenic IHC
Treatment-Related Increase in Intratumoral CD8+ TIL in • Patients with histologically confirmed diagnosis of inoperable
Treated Lesions (4/10)
locally advanced or metastatic TNBC and at least 1 prior line of
approved systemic chemotherapy or immunotherapy
• 25 patients
• 3 week treatment cycles with pembrolizumab administered as
a 30-minute IV infusion day 1 of every cycle (flat dose of 200
mg) and treated with TAVO on days 1, 5, 8 every 6 weeks
Treated Untreated
right chest exophytic
wall and left axillary
left breast skin nodule
disease
Tumor reduction observed in patients who received off-protocol nivolumab 21
© 2019, OncoSec Medical IncorporatedFINANCIAL SUMMARY & ANTICIPATED MILESTONES
FINANCIAL SUMMARY ANTICIPATED MILESTONES
TAVO Receive ATMP Classification COMPLETE
As of May 28, 2019
Initiate European Sites 2H 2019
• Cash & Equivalent = $31.4M Melanoma
Complete Enrollment 1H 2020
KEYNOTE-695
• Shares O/S = 10.6M Top-line Data Readout 2H 2020
• No debt
Accelerated Approval Filing in US 2H 2020
• Cash runway is > 12 months
Complete Enrollment 2H 2019
TNBC
Preliminary Data Update 2H 2019
KEYNOTE-890
Top-line Data Readout 1H 2020
Next Generation Announce Next Gen Product COMPLETE
Product Candidate
& VLA Initiate Phase 1 2020
22
© 2019, OncoSec Medical IncorporatedLEADERSHIP AND BOARD OF DIRECTORS
Daniel J. O’Connor, JD Keir LoIacono, JD Daniel J. O’Connor, JD
Vice President Legal and Corporate Development, President, Director & Chief Executive Officer
President, Director & Chief Executive Officer
Chief Compliance Officer
Alain Algazi, M.D.
Sara Bonstein, MBA Clinical Strategic Advisor – OncoSec Avtar Dhillon, M.D.
Chief Financial Officer & Chief Operating Officer Associate Professor - UCSF Helen Diller Family Co-Founder/Chairman
Comprehensive Cancer Center
Christopher G. Twitty, PhD John Rodriguez Punit Dhillon
Chief Scientific Officer Vice President, Product Engineering Co-Founder/Director
Kellie Malloy Foerter Robert W. Ashworth, Ph.D Jim DeMesa, M.D., M.B.A.
Chief Clinical Development Officer Senior Vice President, Regulatory Director
Robert E. Ward
Director
Joon Kim, JD
Director
Margaret R. Dalesandro, Ph.D.
Director
23
© 2019, OncoSec Medical IncorporatedEast Coast West Coast
24 North Main Street 3565 General Atomics Court
Pennington, NJ San Diego, CA
Will O’Connor
Stern Investor Relations
212.698.8694
will@sternir.com
24
© 2019, OncoSec Medical Incorporated25 © 2019, OncoSec Medical Incorporated
MEDICAL HISTORY: PATIENT A
WHITE FEMALE WITH STAGE IVA MELANOMA
Medical History
• Female 71 years
• Prior surgery on skin excisions, wide excisions
• Stage IVA, multiple basal cell carcinomas & squamous cell
• No radiotherapy
carcinomas
• Metastatic disease in LNs (distant), lung and subcutaneous
• Constipation, insomnia, anxiety, and night sweats
• Hypothyroidism, vaginal prolapse, BCC, and SCC
Melanoma History
October 2015
• Diagnosis of melanoma Pembrolizumab 100 mg IV Q3 wk Ipilimumab 100 mg IV Q3 wk Nivolumab 150 mg IV Q2 wk
• Skin excision (Apr 2017 – 27 Sep 2017) Nivolumab 50 mg IV Q3 wk (15 Jan 2018 – 26 Mar 2018)
9 cycles (23 Oct 2017 – 26 Dec 2017) 4 cycles
4 cycles
Clinical trial
2015 2017 2018 OMS-I103
(PISCES)
November 2015 March 2017
• Wide local excision Local recurrence:
• Wide excision of forehead
• 3 core biopsies
26
IV, intravenous; Q2 wk, every 2 weeks; Q3 wk, every 3 weeks.
© 2019, OncoSec Medical IncorporatedKEYNOTE-695 HISTORY: PATIENT A
24 MAY 2018 – 26 NOVEMBER 2018
Treatment as per protocol cycle 1 – 9
• IT-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks)
• Pembrolizumab (200 mg IV): Day 1 of each 3-week cycle
10 May 2018:
Screening 14 August 2018 (cycle 5, day 1): 26 November 2018 (cycle 9, day 1):
• Melanoma, stage IVA, Tumor response at 12 weeks Tumor response at 24 weeks
with skin lesions • Partial Response / BIRC First at • Complete Response / Investigator
• ECOG PS: 0 Timepoint Assessment Assessed
May – December 2018
Adverse events Cycle 1 – 9
• Grade 1 pruritus: related to pembrolizumab; not related to tavo or EP
• Grade 1 night sweats: not related to any of the treatments or EP
• Grade 2 diarrhea: related to pembrolizumab and tavo; not related to EP
• Grade 2 overactive bladder: not related to any of the treatments or EP
CR, complete response; ECOG, Eastern Cooperative Oncology Group; EP, electroporation; IT-tavo-EP, intratumoral injection of tavo with electroporation; IV, intravenous; 27
LN, lymph node; PR, partial response; PS, performance status; tavo, plasmid interleukin-12. © 2019, OncoSec Medical IncorporatedPATIENT A
IMAGES OF BASELINE VS. 12 AND 24 WEEKS
Baseline 12 weeks 24 weeks
28
© 2019, OncoSec Medical IncorporatedPATIENT A
CT IMAGES OF BASELINE VS. 12 AND 24 WEEKS
Baseline 12 Weeks 24 Weeks
29
© 2019, OncoSec Medical IncorporatedPATIENT A
INTRATUMORAL GENE EXPRESSION
30
© 2019, OncoSec Medical IncorporatedPATIENT A
INTRATUMORAL GENE EXPRESSION
31
© 2019, OncoSec Medical IncorporatedMEDICAL HISTORY: PATIENT B
WHITE MALE WITH STAGE IVB MELANOMA
• Male 65yrs / Stage IV Medical History
• Metastatic disease in LNs (distant), lung, and subcutaneous
• Osteoarthritis with bilateral hip replacements, benign prostatic hyperplasia, basal cell carcinoma removal on neck, pontaneous pneumothorax
• Prior surgery on lesion on abdominal wall, dissection left groin, sentinel and right axillary LN. No radiotherapy
Melanoma History
September 2016 October 2017 February 2018
February 2014 • Distant recurrence: Excision
• Diagnosis melanoma • Local recurrence: • Disease progression in LN and lungs
Excision right subcutaneous lesion in left after 7 cycles
• Excision of primary lesion forearm
right abdominal wall abdominal wall
• Distant LN, lung metastases
Clinical trial
KEYNOTE-695
2014 2016 2017 2018
Pembrolizumab 150 mg IV Q3 wk
May 2017 (13 Oct 2017 – 16 Feb 2018)
March
March 2014
2014 7 cycles
•• Wide
Wide local
local resection
resection right
right abdominal
abdominal wall
wall • Local recurrence: Wide
•• Sentinel
Sentinel LN
LN dissection
dissection left
left groin
groin excision right abdominal wall
• Right axillary node dissection
32
IV, intravenous; LN, lymph node; Q3 wk, every 3 weeks. © 2019, OncoSec Medical IncorporatedKEYNOTE-695 HISTORY: PATIENT B
16 APRIL 2018 – 18 OCTOBER 2018
Treatment as per protocol cycle 1 – 9 (27 weeks)
• IT-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks)
• Pembrolizumab (200 mg IV): Day 1 of each 3-week cycle
9 April 2018:
Screening
• Melanoma, Stage IVB, 9 July 2018 (cycle 5, day 1): 28 September 2018 (cycle 9, day 1):
with subcutaneous Tumor response at 12 weeks Tumor response at 24 weeks
lesions, lung and LN • Partial Response / BIRC First at • Partial Response / Investigator
involvement Timepoint Assessment Assessed
• ECOG PS: 0
Continue on study
April – October 2018
Adverse events cycle 1 – 9
• Grade 1 injection site pain: not related to pembrolizumab or tavo; related to EP
ECOG, Eastern Cooperative Oncology Group; EP, electroporation; IT-tavo-EP, intratumoral injection of tavo with electroporation; IV, intravenous; LN, lymph node; PR, 33
partial response; PS, performance status; tavo, plasmid interleukin-12. © 2019, OncoSec Medical IncorporatedPATIENT B
CT IMAGES OF BASELINE VS. 12 WEEKS
Baseline 12 weeks
TL1
Baseline 12 weeks
Regression of distant, untreated hilar node lesion
Response confirmed at 24 weeks
34
TL, target lesion. © 2019, OncoSec Medical IncorporatedMEDICAL HISTORY: PATIENT C
WHITE MALE WITH STAGE IVA MELANOMA
Medical History
• Male 71 yrs / Stage IVA • Left thigh excision, left groin dissection, wide local excision of left groin.
• Metastatic disease in LNs (distant) and No radiotherapy
skin • Constipation
Melanoma History
Dec 2017 March 2018
October 2013 Dabrafenib 150 mg PO BID • Disease progression • Disease progression
March 2016
• Diagnosis of Trametinib 2 mg PO QD
• Left groin dissection
BRAF+ melanoma (Dec 2016 – Dec 2017)
12 cycles
Clinical trial
KEYNOTE-695
2013
2014 2016 2016 20172017 2018 2018
Pembrolizumab 200 mg IV Q3 wk
December 2013 October 2016 (28 Sep 2017 – 22 Mar 2018)
• Left thigh excision • Wide local excision left groin 7 cycles
35
BID, twice-daily; IV, intravenous; PO, oral; QD, once-daily; Q3 wk, every 3 weeks. © 2019, OncoSec Medical IncorporatedKEYNOTE-695 HISTORY: PATIENT C
26 APRIL 2018 – 30 OCTOBER 2018
Treatment as per protocol cycle 1 – 9 (27 weeks)
• IT-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks)
• Pembrolizumab (200 mg IV): Day 1 of each 3-week cycle
12 April 2018:
Screening
• Melanoma, stage IVA, with 17 July 2018 (cycle 5, day 1): 11 October 2018 (cycle 9, day 1):
subcutaneous lesions and Tumor response at 12 weeks Tumor response at 24 weeks
distant LN involvement • Partial Response / BIRC First at • Partial Response / Investigator
• ECOG PS: 0 Timepoint Assessment assessed of target lesions
Continue on study
April – October 2018
Adverse events cycle 1 – 9
• Grade 1 hematoma: not related to pembrolizumab; related to TAVO or EP
• Grade 3 intramedullary rod insertion: SAE; not related to any of the treatments or EP
• Grade 1 headache: not related to any of the treatments or EP
• Grade 1 joint swelling: not related to any of the treatments or EP
• Grade 1 hemoserous ooze: not related to pembrolizumab; related to TAVO or EP
ECOG, Eastern Cooperative Oncology Group; EP, electroporation IT-tavo-EP, intratumoral injection of tavo with electroporation; IV, intravenous; LN, lymph node; PD, 36
progressive disease; PR, partial response; SD, stable disease; tavo, plasmid interleukin-12. © 2019, OncoSec Medical IncorporatedPATIENT C
CT IMAGES OF BASELINE VS. 24 WEEKS
Baseline
24
Weeks
Net radiographic response 37
© 2019, OncoSec Medical IncorporatedPATIENT C
TUMOR FLARE, NECROSIS, AND RESPONSE
Baseline
16 weeks
24 weeks
38
© 2019, OncoSec Medical IncorporatedPATIENT C
IMMUNOLOGIC IMPACT VIA MIHC
CD3+/CD8+/PD-1+
61-004-102
Screen
004-102 008-101 004-103
Tumoral PD-L1+
61-004-102
C2D1
004-102 008-101 004-103
39
© 2019, OncoSec Medical IncorporatedMEDICAL HISTORY: PATIENT D
WHITE FEMALE WITH STAGE IVA MELANOMA
Medical History
• Female 52 years / Stage IVA
• Metastatic disease in LNs (local/regional)
• Decreased hearing, memory loss, back/joint pain, lymphedema, anemia, fatigue, night sweats, obstructive sleep apnea, nerve damage on the back,
peripheral neuropathy, hot flashes, chronic headaches, itchy skin, dilation and curettage, hypothyroid, polypectomy
• Left thigh biopsy, left thigh wide local excision, left thigh wide local excision with sentinel LN biopsy,left thigh shave biopsy
• No radiotherapy
Melanoma History
June 2018
October 2016 • Disease progression
March 2016 • Left thigh wide local excision
• Diagnosis of melanoma Pembrolizumab 200 mg IV Q3 wk
with sentinel LN biopsy
• Left thigh biopsy (29 Jan 2018 – 18 Jun 2018)
7 cycles
KEYNOTE-695
2016 2018
August 2016 January 2018
• Left thigh wide • Left thigh shave
local excision biopsy 40
IV, intravenous; LN, lymph node; Q3 wk, every 3 weeks.
© 2019, OncoSec Medical IncorporatedKEYNOTE-695 HISTORY: PATIENT D
16 JULY 2018 – 5 OCTOBER 2018
Treatment as per protocol cycle 1 – 5 (12 weeks)
25 June 2018: • IT-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks) 5 October (cycle 5, day 1):
Screening • Pembrolizumab (200 mg IV): Day 1 of each 3-week cycle Tumor response at 12 weeks
• Melanoma, stage IVA, • Partial Response / Investigator
with skin lesions Assessed
• ECOG PS: 0
Continue on study
June – October 2018
Adverse events cycle 1 – 5
• Grade 1 injection site pain, injection site bruise, injection site soreness: not related to pembrolizumab or TAVO; related to EP
• Grade 1 muscle ache: not related to pembrolizumab or TAVO; related to EP
• Grade 1 sinus infection: not related to any of the treatments or EP
• Grade 1 epidermal hyperplasia: not related to any of the treatments or EP
• Grade 1 macules: not related to any of the treatments or EP
• Grade 1 nausea: not related to any of the treatments or EP
• Grade 1 emesis: not related to any of the treatments or EP
• Grade 1 and 2 diarrhea: related to pembrolizumab; not related to TAVO or EP
CR, complete response; ECOG, Eastern Cooperative Oncology Group; EP, electroporation; IT-tavo-EP, intratumoral injection of tavo with electroporation; IV, intravenous; 41
PD, progressive disease; PR, partial response; PS, performance status; tavo, plasmid interleukin-12. © 2019, OncoSec Medical IncorporatedPATIENT D
IMAGES OF BASELINE VS. 12 WEEKS
Baseline
12 weeks
ONLY 25% OF 160 (~40 LESIONS) LESIONS WERE TREATED GLOBAL RESPONSE
42
© 2019, OncoSec Medical IncorporatedPATIENT D
CT IMAGES OF BASELINE VS. 24 WEEKS
Baseline
24 weeks
Net radiographic response 43
© 2019, OncoSec Medical IncorporatedMEDICAL HISTORY: PATIENT E
WHITE MALE WITH STAGE IVB MELANOMA
• Male 81 years / Stage IVB Medical History
• Metastatic disease in lung and LNs (distant)
• BCC, SCC, keratoses, hiatal hernia, hypertriglyceridemia, knee replacement, back pain, artery surgery, thyroid
nodule, GERD, type II DM, sinus bradycardia, hypertension, and constipation
• Preauricular biopsy, facial skin wide local excision, parotidectomy, auriculectomy, mastoidectomy, and Moh’s
surgery
• No radiotherapy Melanoma History
May 2018
October 2017 • Disease progression
• Diagnosis of melanoma Nivolumab 240 mg IV Q2 wk
• Left inferior preauricular face- (14 Mar 2018 – 23 May 2018)
punch biopsy 6 cycles
KEYNOTE-695
2014
2017 2016 2018 2017 2018
December 2017
• Wide local excision of left facial skin June 2018
• Near total left parotidectomy • Moh’s surgery
• Partial left auriculectomy
• Left mastoidectomy 44
DM, diabetes mellitus; GERD, gastroesophageal reflux disease; IV, intravenous; Q2 wk, every 2 weeks.
© 2019, OncoSec Medical IncorporatedKEYNOTE-695 HISTORY: PATIENT E
27 JUNE 2018 – 19 DECEMBER 2018
Treatment as per protocol cycle 1 – 5 (12 weeks)
• IT-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks)
• Pembrolizumab (200 mg IV): Day 1 of each 3-week cycle
20 June 2018:
Screening
12 December (cycle 9, day 1):
• Melanoma, stage IVB, with
Tumor response at 26 weeks
skin lesions and lung and
19 September (cycle 5, day 1): • Partial Response / Investigator Assessed
distant LN involvement
Tumor response at 12 weeks
• ECOG PS: 1
• Partial Response / Investigator Assessed
June – December 2018
Adverse events cycle 1 – 5
• Grade 1 fatigue: not related to any of the treatments or EP
• Grade 1 weight loss: possibly related to pembrolizumab; not related to TAVO or EP
• Grade 2 body odor: not related to pembrolizumab; related to TAVO and EP
• Grade 1 pruritus: possibly related to pembrolizumab; not related to TAVO or EP
CR, complete response; ECOG, Eastern Cooperative Oncology Group; EP, electroporation IT-tavo-EP, intratumoral injection of tavo with electroporation; IV, intravenous; 45
LN, lymph node; PD, progressive disease; PR, partial response; PS, performance status; tavo, plasmid interleukin-12. © 2019, OncoSec Medical IncorporatedPATIENT E
IMAGES OF BASELINE VS. 12 AND 24 WEEKS
Baseline
12 weeks Regression of mediastinal node and
parenchymal lung metastases
24 weeks
46
© 2019, OncoSec Medical IncorporatedOMS-140 TNBC PATIENT 1
MEDICAL HISTORY
January 2015: January 2016:
June 2014: November 2015:
Right chest wall and Chest wall March 2016:
Dx’d (6 months post- FDG-PET enlarging
left axillary relapse progression Clinical and CT
partum) inflammatory right internal mammary
during carboplatin: progression
IDC with oligometastases nodes and biopsy +
FDG-PET and biopsy + Consent to clinical
to left contralateral ALN skin nodules left chest
trial OMS-140
2014 2015 2016
April 2016:
Dose-dense ACT November 2014: Restart Xeloda pIL-12 EP Days 1, 5, 8 to left chest
Adjuvant carboplatin AUC 6 (2 cycles) wall and breast lesions
q3 weeks (4 cycles planned)
October 2014: February – March 2016:
February – September 2015: Eribulin mesylate
Right Mastectomy/ALND:
Xeloda 1500 mg/m2 BID D1-14
+LVI, residual disease (0.4 cm),
q 21 days (6 cycles completed)
4/19 LN+
+ local XRT (R chest wall/nodes
and L axilla)
47
© 2019, OncoSec Medical IncorporatedOMS-140 TNBC PATIENT 1
PROTOCOL AND POST-PROTOCOL TREATMENT
Untreated exophytic left
axillary skin nodule
April 4, 2016 – May 2, 2016:
Cycle 1, Day 1 – Day 28 (post Bx)
Patient received all 3 per-protocol injections
• Left axillary nodule (control) - UNTREATED May 5, 2016:
• Right chest wall and Left breast - TREATED
May 5, 2016:
Off-protocol (compassionate use)
Nivolumab IV q 2 weeks
Rapid clinical response
Completed 10 cycles August 24, 2016:
October, 2016:
Disease progression (PD) in mediastinal nodes,
but no PD at sites present at time of pIL 12 EP
48
© 2019, OncoSec Medical IncorporatedOMS-140 TNBC PATIENT 1
REPRESENTATIVE POST-TREATMENT IMAGES
Representative post-treatment images of a patient with primary refractory inflammatory right breast TNBC
Treated right Treated left Untreated
chest wall disease breast disease exophytic left
axillary skin
nodule
TNBC, triple negative breast cancer. 49
© 2019, OncoSec Medical IncorporatedOMS-140 TNBC PATIENT 2 (T2N0M0)
MEDICAL HISTORY July 2017:
Clinical PD –
enlarging right
October 2015: breast nodule and
May 2014: December 2015:
CT shows multiple non-healing scalp
Dx’d clinical stage IIA CT-guided lung
spiculated pulmonary February 2017: metastases
metaplastic TNBC of the biopsy +
nodes and single Palliative XRT to Consent to clinical
right breast trial OMS-140
lesion at T10 (Bx -) right hip/femur
609.310.0644
2014 2015 2016 2017
Best response: SD
Preoperative January 2015: January 2016:
July 2017:
Dose-dense AC (no Whole breast XRT Clinical trial of nab-
Cycle 20 atezolizumab
response) GT paclitaxel + atezolizumab
(minimal response)
October 2016:
D/C nab-paclitaxel for August 2017:
fatigue TAVO Days 1, 5, 8 to
October 2014: right breast lesion
Right lumpectomy with
50
residual disease (2 cm) © 2019, OncoSec Medical IncorporatedYou can also read
