MASS Opportunities
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Transcript MASS Opportunities
Corporate Presentation
July 28, 2015
Safe Harbor Statement
This presentation contains forward-looking statements under the meaning of the Private
Securities Litigation Reform Act of 1995. These statements give our current expectations or
forecasts and use words such as “anticipate,” “estimate,” “believe,” and other words of
similar meaning. Any or all of the forward-looking statements in this presentation may turn
out to be wrong. They can be affected by inaccurate assumptions we might make or by
known or unknown risks and uncertainties including but not limited to, the efficacy of our
technology and its efficacy at acceptable dosage levels, the ability to raise capital when
needed and on reasonable terms, successful clinical trial results, developing the necessary
manufacturing processes and gaining all necessary regulatory approvals. Consequently, no
forward-looking statement can be guaranteed and actual results may differ materially.
Additional information concerning factors that could cause actual results to materially differ
from those in the forward-looking statements are contained in our reports to the Securities
and Exchange Commission including our 10-Q, 8-K and 10-K reports. However, we
undertake no obligation to publicly update forward-looking statements, whether as a result
of new information, future events or otherwise. We note these factors for investors as
permitted by the Private Securities Litigation Reform Act of 1995.
Corporate Overview
• Most advanced Vascular Targeting Agent in clinic
• Lead compound (CA4P) in six human trials
• Indications- Solid tumors (oncology) and neo-vascular
retinal disease (ophthalmology)
• FDA fast track & orphan drug designations
• Multiple second-generation compounds being
developed
• $35.5 million cash on hand as of June 30, 2004
• 2004 projected burn rate $10 - $12million
Advantages of Vascular Targeting
•Damages existing micro-vessels newly formed in
tumors and ocular disorders
•Disrupts the cytoskeleton of endothelial cells causing
a physical change of cell shape from flat to round
•Induces shutdown of blood flow
•Starves tumor of oxygen, nutrients, waste pathway
•Absence of significant cytotoxic side effects to normal
tissue
Published Papers on Combretastatins 1994-2003
50
40
30
20
10
0
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003
Most Recent Developments
• 12/2003:
• 4/2004:
• 4/2004:
• 5/2004:
• 5/2004:
Announced plans to expand ophthalmology research
efforts following dramatic response of myopic macular
degeneration patient
OXiGENE Strengthens Clinical Trial Advisory Board
with Appointment of Retinal Surgeon Eugene de Juan,
Jr., M.D.
OXiGENE's Combretastatin A4 Prodrug Granted
European Union Orphan Medicinal Product
Designation for Anaplastic Thyroid Cancer
Anti-tumor activity with no unexpected toxicity reported in
Phase Ib/II combination trials of CA4P with Carboplatin and
Paclitaxel.
Biological response in decreased foveal thickness via Optical
Coherence Tomography (OCT) noted in patient in wet AMD trial.
Lead compound: Combretastatin A4P
Results of OXiGENE Phase I Sponsored Trials
•Approximately 100 patients dosed
•CA4P administered as a single-agent
•Advanced oncology patients
•Compound well-tolerated
•Most frequent side effects at MTD
-Tumor pain, Headache, Fatigue, Nausea
•Blood-flow reduction monitored
•14 clinical effects
Activity Data (all studies)
Site
Regimen (mg/m2)
Tumor type
Best
“Response”
Duration
CWRU
36 q 21 d
Lung
SD
4 cycles
CWRU
60 q 21 d
A. Thyroid
CR
9 cycles
CWRU
90 q 21 d
Pancreas
20%
2 cycles
CWRU
60 q 21 d
Colon
SD
24 cycles
CWRU
50 q 21 d
M. Thyroid
SD
14 cycles
UPENN
6x5
Renal
SD
4 cycles
UPENN
42 x 5
M. Thyroid
SD
7 cycles
UPENN
56 x 5
Renal
SD
4 cycles
UPENN
56 x 5
Fibrosarcoma
PR
7 cycles
UPENN
75 x 5
Pancreas
20%
7 cycles
UPENN
65 x 5
M. Thyroid
SD
29 cycles
UPENN
65 q x 5
M. Thyroid
SD
7 cycles
CRC
68 weekly
Adrenocortical
SD
7 cycles
MRI Parameter Images, (CRC)
Pre-treatment
24 Hrs Post-treatment
Ktrans
Pelvic leiomyosarcoma, 52 mg/m2, Patient #31
Dynamic Contrast Enhanced - Magnetic Resonance Imaging (DCE-MRI) using
the paramagnetic contrast agent gadopentetate dimeglumine (Gd-DTPA)
CA4P Clinical Programs
Phase
II
Indication
Advanced anaplastic thyroid cancer
Combination
Expected
Patient
Enrollment
Single agent
32
Doxorubicin/cisplatin
Radiotherapy
33
Radiotherapy
30
Carboplatin and
paclitaxel
60
I/II
Newly diagnosed anaplastic thyroid cancer
I/II
Advanced carcinoma of the lung, head/neck,
prostate
I/II
Advanced ovarian cancer
I/II
Advanced colorectal cancer
mAb A5B7
35
I/II
Wet age-related macular degeneration
Single agent
15
Combination effect of CA4P with Carboplatin and
Paclitaxel in ES-2 ovarian carcinoma model
1200
Tumor volume
1000
800
Control
CA4P
600
Carboplatin + Paclitaxel
400
CA4P + Carboplatin + Paclitaxel
200
0
11
15
19
22
26
29
Days post inoculation
33
36
40
100mg/kg weekly
Post Phase I Reported Interim Data
• 50 patients treated in various combination settings
(Chemo, XRT, Antibody)
• No unexpected toxicity observed
• Primary side effects include headache, fatigue,
hypertension, tumor pain
• Good evidence of reduced tumor blood flow
• Anti-tumor activity observed
Post Phase I Activity Data - Cancer
• Advanced Ovarian Trial
–
–
–
–
–
12 evaluable patients enrolled
(1) PR via RECIST in Ovarian
(4) PR via CA-125 ovarian cancer marker
(5) Stable disease
2 PR’s included above were resistant to previous
Carboplatin treatments
– Compound well-tolerated
– No CA4P related SAE’s or DLT’s
CA4P Oncology Strategy
•
•
•
•
•
Advance rapidly to registration
Investigate multiple indications
Combinations with multiple treatment modalaties
Utilize Orphan Drug designations when applicable
Open new combination trials
Second-generation Compounds
•
Oxi4503
–
–
–
–
–
Lead pre-clinical candidate
Dual mechanism of action
Synthetic manufacturing process completed
Accepted by Cancer Research UK for clinical
development
Phase I trials to begin in 2004
Second-generation Compounds
• Oxi6197
– Structurally distinct from OXiGENE's
Combretastatin platform of VTAs
– Collaboration with National Cancer Institute
– Go/No Go development decision by NCI in 2004
• Oxi8007
– Wide therapeutic window
– Excellent blood flow shutdown with low toxicity
in animal models
– State of the art pre-clinical testing in
ophthalmology
Clinical Strategy for CA4P
• Ophthalmology
– First VTA to enter into non-life threatening disease
indication
– Positive preclinical studies conducted at Johns Hopkins
and University of Cambridge
– Wet AMD Trial at Johns Hopkins (Phase I/II) by IV
– File IND for clinical trial in MMD
– Investigate topical administration
Retinal Photo Comparison
Normal Retina
Wet AMD
CA4P Treatment Inhibits Corneal
Neovascularization
No Treatment
a50
CA4P (IV) Treatmenta
mg/kg CA4P IV [qdx5] x 2
Admin. CA4P @ day 10
Phase I/II Wet AMD Interim Data
•
•
•
•
6 patients treated in dose escalating wAMD trial
1 patient treated with MMD treated under emergency IND
No Grade 3 or 4 toxicities or SAE’s observed
Primary side effects headache, hypertension, body
temperature increase
• MMD patient improved visual acuity to 20/20
• Biological response in decreased foveal thickness via
Optical Coherence Tomography (OCT) noted in 1 patient
Upcoming Events
•
October 24-29
ESTRO Conf.
Amsterdam
-Dr. Peter Hoskins -- P Ib Radio. H&N, Lung, Prostate
•
File IND in 2nd half 2004-- Myopic Macular Degeneration
•
File IND in 2005 – Multi-center Ovarian Cancer trial
•
Enter OXi4503 into Phase I in Q4 2004
•
Launch new trial with chemotherapy in new cancer indication
in 2004
Management Team
Frederick Driscoll
Scott Young, RAC, MPH
President and Chief
Executive Officer
Chief Operating Officer
David Chaplin, Ph.D.
Jim Murphy
Chief Scientific Officer and
Head of Research and
Development
Vice President and Chief
Financial Officer
Clinical and Scientific Advisors
Håkan Mellstedt, M.D.,Ph.D.
Professor Karolinska Institute
Chairman CTAB
Lee Rosen, M.D.
Director
UCLA Cancer Program
Margaret A. Tempero, M.D.
President Elect ASCO
UCSF Cancer Ctr.
Robert S. Kerbel, Ph.D.
Professor of Oncology
University of Toronto
Jan B. Vermorken, M.D., Ph.D.
Prof. of Oncology & Dept. Head
Univ. Hosp. of Univ. of Antwerp
Eugene de Juan, Jr., M.D.
Professor of Ophthalmology
Keck School of Medicine Univ. of Southern
California
Dietmar W. Siemann, Ph.D.
Prof. Of Oncology
Univ. of Florida College of Medicine in
Gainesville
Adrian Harris, M.D.
Professor Of Clinical Oncology
University of Oxford
Summary: Why OXiGENE represents an
excellent investment opportunity
• CA4P is 1st in class in clinical development
• Targeting two large & rapidly growing markets
• Secured FDA fast track and orphan drug status and
EMEA orphan drug status
• Broad IP portfolio-COM coverage through 2021
• CA4P continues to demonstrate an acceptable safety
profile and anti-tumor activity
• Strong Balance Sheet
• Exciting pre-clinical compounds
• Strategic relationships