Download IRAD Corporate Presentation

IRAD ONCOLOGY
Corporate
Presentation
April, 2014
New Company
! 
Clinical stage company developing
first-in-class therapeutics for the
treatment of patients with glioblastoma
! 
IRAD-425 given with temozolomide
after radiotherapy to treat patients
with newly-diagnosed glioblastoma
multiforme (GBM)
Corporate Highlights
Medical Need
•  Best Standard of Care unchanged since 2005
•  Median overall survival is 14.6 months
Proven Team
•  Experienced, seasoned team
•  Expert in drug and business development
Large Market
•  $1 billion market, orphan indication
•  Same Standard of Care in the US and Europe
•  EGFR-targeted 125I kills only cancer cells
Unique
Partner • toPhase
commercialize
2a data: 38% increase in survival (20.2
Technology
months) in newly diagnosed glioma patients
Still Mostly Untreatable…
Ted Kennedy …despite his
access to the best medical
treatment available…lost the
fight for his life just 15 months
after his diagnosis.
Contrast MRI Scan
Glioblastoma Multiforme (GBM)
! 
Grade IV glioma - most malignant, invasive, difficultto-treat primary brain tumor
! 
10,000 new gliomas in US and ~ 15,000 in Europe/
year
! 
GBM median survival 14.6 months with current
standard of care (SOC)*
!  Recur locally and grow rapidly
!  98% patients die from these tumors, < 30% 2 year and <10%
5 year survival**
! 
WW glioma market ~ $1B, US market ~ $380MM/yr
*Stupp R. N Engl J Med Volume 352;10:987-996 March 10, 2005
**Stupp R. Lancet Oncol. May;10(5):459-66. 2009
Strong Management
! 
Deirdre Gillespie, MD, MBA: CEO
!  La Jolla Pharmaceutical Company, Vical, DuPont Merck,
Novartis
! 
David Woo, Ph.D: President, CSO & Co-founder
! 
! 
Pfizer, Amgen, Ligand, Centocor
Linda Pullan, Ph.D: CBO
!  Pullan Consulting, Amgen, Kosan, Astra Zeneca
! 
Caryn Peterson: VP Regulatory Affairs
! 
! 
DSConsulting, Ascenta, Amylin, Hybritech
Julie Burgess, CPA: VP Finance
!  Otonomy, Apricus, Phenomix, KPMG
IRAD-425
IRAD-425 combines:
!  Iodine-125 (125I) – very local tumor kill
!  A unique radioisotope, which emits “Auger
electrons” and when concentrated in the
nuclear DNA, the radiation kills the cell.
!  EGFR Antibody - targeting
!  Targets the Epidermal Growth Factor
receptor expressed on up to 95% of adult
GBM cancer cells
Path Lengths of Beta Radiation
High energy Beta particles (e.g. 131I* 90Y)
- multiple cells exposed to radiation
β
Low energy Auger electrons (125I)
- all the radiation dose is deposited inside the cell
Auger Electrons
*
131I
also emits gamma radiation which contributes
to higher radiation doses to major organs
Antibody Targeting and Radioisotopes
Proven Treatment Approaches in
Cancer
!  Antibody Drug Conjugates (ADC) - antibodies
conjugated to cytotoxic drugs/toxins
!  Two ADCs now FDA-approved for cancer: ADCETRIS®,
KADCYLA
!  First generation radiolabeled antibodies carried
radioisotopes to treat Non-Hodgkins Lymphoma Zevalin (90Y) and Bexxar (131I)
!  IRAD-425
combines EGFR mAb and
125I
Completed Phase 2 Study Design
! 
Open label, single center, prospective study N=192
! 
Newly diagnosed GBM patients underwent surgery
and external beam radiation (standard care), and then
received:
!  IRAD-425 or
!  Temozolomide (TMZ) + IRAD-425
! 
Dose: 50 mCi IRAD-425 IV once weekly for 3
consecutive weeks every 3 months until tumor
progression
! 
Primary endpoint: overall survival
! 
Ineligible patients or those that declined acted as
controls
IRAD 425 Treatment Approach
Grade III/ IV
Gliomas
Debulking
Surgery
30 days post surgery
XRT 2Gy 5 days/wk for 6 wks
TMZ 75 mg/m2/qd x 21d
30 days treatment break
TMZ 150-200mg/m2/qd
D1-D5 q28d for 6 -12 cycles
IRAD 425 (50mCi) wkly for 3 wks
Every 3 months until progression
IRAD-425 38% Improvement in
Median Overall Survival
XRT+TMZ + IRAD-425
CTL
XRT+TMZ+IRAD425
IRAD-425
XRT+IRAD425
CTL
Li et al, Neurosurgery 113, 192- 198, 2010,
Phase 2a Survival in Newly Diagnosed
GBM Patients
Surgery plus:
MOS
2 year
survival
XRT + TMZ + IRAD-4251
20.4 m
40%
25%
XRT + IRAD-425
14.5 m
25%
10%
XRT + TMZ2
14.6 m2
<30%3
<10%3
12.2 m
7%
<2%
XRT
1Survival
2Current
5 year
survival
data analysis independently verified by SWOG statistical center
standard of Care. Stupp R. N Engl J Med Volume
352;10:987-996 March 10, 2005
3Stupp R. Lancet Oncol. May;10(5):459-66. 2009
Summary Phase 2a Safety
"  192 treated GBM patients:
!  7 (3.6%) had Grade 1 or 2 acute adverse events
!  3 transient flushing, 2 nausea, 2 hypotension
!  3 had Grade 1 skin irritation at injection site
!  4 became HAMA positive
!  No grade 3 or 4 toxicities
"  No additional toxicity observed in patients receiving
TMZ
Next Generation Radiotherapeutic
!  Targets cancer cells sparing healthy cells – minimal
off-target effects
!  Higher potency results in lower radiation dose
!  Longer half life allows for easy distant shipment
!  Ready-to-use vial, intravenous outpatient
administration, and minimal exposure to others
!  Standard mAb manufacture, simple to radiolabel
! 
Potential first line treatment of GBM –
additive to standard of care
IRAD-425 Phase 2 Dosing Study
!  Determine MTD when administered weekly for 4-8
weeks
!  Enroll patients who successfully complete surgery
followed by concomitant radiotherapy and TMZ
!  Personalized dosing design, starting dose 50mCi
!  Dose adjusted over time to determine highest safe
patient-specific dose on a weekly schedule
!  Pharmacokinetic assessments in all patients
!  From FPI, 12 months to complete
Development Timeline
2014
2015
2016
2017
Pre-IND
meeting, EU,
IND
GMP Antibody
Production
Ongoing CMC Activities
Tumor Uptake
Study
Phase 2 Dosing
& PK
Randomized
Study
1.75 years
3.5 years
2018
2019
Barriers to Competition
!  Orphan indication in the US, EU & Japan
!  7 years in US
!  10 years in Europe
!  In-process IP – method of use
!  Biologic – 12 years data exclusivity (FDA)
!  Exclusive access to data from phase 2a study
completed at the Hahnemann Hospital in 2008
!  Exclusive access to EGFR antibody cell line
!  Exclusive access to Dr. Brady’s Investigatorsponsored IND
Recent Out-licensing Deals Involving
Phase1/2 Cancer Products
Date
Out-license
In-License Phase
Indication
Upfront Potential
M$
Total M$
2012
Symphogen
E. Merck
2
Colorectal
$25
$614
2012
Genmab
J&J
2
Multiple Myeloma
$55
$1055
2011
FivePrime
HGS
1
Biliary
$50
$495
2010
Array
Novartis
2
Biliary
$45
$467
2009
Exelixis
Sanofi
2
Bone
$140
$1161
2009
Merrimack
Sanofi
2
Ovarian
$60
$530
2009
Ardea
Bayer
2
Pancreatic
$35
$407
2009
Gobeimmune
Celgene
2
Pancreatic
$40
$270
Deal Average
$52
$623
Ovarian
$35
Purchase
Company
2012
VentiRx
Celgene
2
Table only includes transactions where financial terms have been disclosed
Summary
!  Unique, targeted therapy for patients with newlydiagnosed GBM
!  38% increase in median survival in P2a
!  Next generation, easy-to-dose-and-administer
radiotherapy, minimal exposure to others
!  Major unmet medical need
!  $1 billion WW opportunity, orphan indication
!  Experienced, proven management team
!  Development complete in <5.5 years for $24M
!  Clear exit path