nuvoxpharma - btb japan
TRANSCRIPT
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NuvOx Pharma Oxygen Nanotechnology Platform – Cancer
and Other Life Threatening Conditions
NuvOx Pharma, LLC, 1635 E. 18th St., Tucson, AZ, 85719 www.nuvoxpharma.com
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Introduction
NuvOx developing drugs that deliver oxygen to hypoxic tissue to treat life
threatening conditions
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Snapshot
Clinical stage biopharmaceutical company Phase Ib clinical trial in brain cancer Product over 100x more effective than others in é O2 Preclinical data in multiple indications Drug currently produced at NuvOx
$7.4M raised $3.1M grants; $4.3M equity – A Series 1&2 In addition founders contributed $1.8M
Active in R&D partnering discussions
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Product Development Status
Development Status Formulation components have been modified to assure a patent estate potential as a barrier to competition
Manufacturing Lab Scale is 5-‐15 L with 400-‐1200 10 mL vials/~$2 material costs per dose.
Stability for lab scale batches are 6+ months Process development and optimization under way to increase stability to beyond 1 year
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Technology – Description
Manaufacturing Process DDFP mixed with surfactant and buffered
aqaueous solution High pressure homogenization makes
Nanoemulsion
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NVX 2% DDFPe Emulsion Stability Data Critical Quality Attributes are monitored and displayed below from over 12 in-house batches.
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Oncology Indication 1 million Cancer Pa.ents per year in US treated with Radia.on Therapy
Hypoxic Tumors are Resistant to Radia.on Therapy Require 3x higher dose
Cannot increase the dose – side effects
Results in incomplete tumor kill and tumor recurrence.
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Tumor Hypoxia is Prevalent
Reviewed in Vaupel, P. et al., Antioxidants & Redox Signaling, 9: 1221, 2007
0 10 20 30 40 50 60
Tissue Oxygenation, Normal Vs Tumor, (partial presure of O2
in mm of Hg)
Normal Tumor
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Solution – Increase Oxygenation
Complete reversal of radiation resistance in hepatoma and é survival in pancreatic cancer
pO2 in Tumor Tissue vs. Time. NVX-108 given at t = 10 mins
0% 20% 40% 60% 80%
No Treatment
RAD RAD + NVX-‐108
% Survival at 30 days
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Pre-Radiation Therapy 4 weeks after radiation + TMZ + NVX-108
Phase 1b Started in Glioblastoma Multiforme
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TOLD MRI
Pre–infusion images (top) and post-infusion images (bottom) TOLD MRI confirms tumor re-oxygenation at 0.17 cc/kg NVX-408
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Sample curve fitting for tumor ROI
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TOLD MRI Tumor T1 Values (ms)
Set # Mean Std
1 (pre) 1533.3 82.2
2 (post) 1115.6 30.9
3 (pre) 1665.3 196.9
4 (post) 1088.9 42.5
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Net Present Value for Cancer Indications
Assumptions: First Product Sales GBM 2018, NSC Lung 2020, Other Cancers 2022 $1,000 per dose, Rindopepimut - $100,000 per patient, VAL-083 -$67,200 per patient.
Tumor Type Worldwide ($M)
Glioblastoma $63
Lung Cancer (NSC) $1,648
Other Cancers Prostate Cancer, Pancreatic, Head and Neck
$3,349
Total NPV $5,059
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Additional Indications
Animal Studies Show Improved Outcomes in Additional Indications Heart Attack and Stroke – ~ 80% reduction in tissue damage Hemorrhagic Shock – 100% survival with 40% blood loss – Air Force Traumatic Brain Injury -‐ Navy Sickle Cell Crisis/Acute Chest Syndrome
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Clinical Status In this Adaptive Dose Escalation phase, we believe we are the MTD and are confirming that in our clinical trial in Australia.
After which the trial design calls to add 6 patients with full PK workup with the primary endpoint being safety and secondarily 6-‐month survival.
With this PK/Safety our strategy is to file an IND for a multi-‐center cancer study.
If no signal of improved survival we will consider other indictions.
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Cancer U of A, BNI, Stanford, Monash Univ. (Aus), NCI, RTOG, Ribomed
Stroke U of Arkansas, U of A, UCLA, NINDS
Heart Attack U of A, IMCOR (Sao Paolo, BR), NHLBI
Traumatic Brain Injury US Navy
Hemorrhagic Shock US Air Force
Sickle Cell Univ. of Pittsburgh, NHLBI
Acute Respiratory Distress Syndrome
U of A
NuvOx Collaborations
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Rabbits - 18F-MISO PET images and brain tissue specimens, top control and bottom NVX-108 treatment
Decreased Stroke Brain Damage by 85%
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% In
farc
t Vol
ume
at 2
4 Hr
s
0
2
4
6
8
10
12
14
No Treatment 0.1 mL/kg DDFPe
** p=0.008
• Repetitive IV bolus doses of 0.1 cc/kg DDFPe every 90 minutes commencing 1 hr post stroke onset
• Rabbits euthanized 24 hours post stroke onset; % infarct volume quantitated
Woods, S. D., et al. "Progress in Dodecafluoropentane Emulsion as a Neuroprotective Agent in a Rabbit Stroke Model." Molecular neurobiology 48.2 (2013): 363-367.
0.51% brain infarct
3.39% brain infarct
85% reduction is significant at p=0.008
Decreased Stroke Brain Damage by 85%
N=16
N=9
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100% Survival in Hemorrhagic Shock
Time (min)
0 60 120 180 240 300 360 420
Ga
s e
xch
an
ge
(m
L/m
in*k
g)
0
3
6
9
12
CO2 production (n=3)
O2 consumption (n=3)
Time of death
Hemorrhage
Bone break
V
Blood loss by end of hemorrhage: 27.2 +/- 0.5 mL/kgBlood loss at The End: 31.1 +/- 0.6 mL/kg
Time (min)0 60 120 180 240 300 360 420
Gas e
xchange (
mL/m
in*k
g)
0
3
6
9
12
CO2 production (n=4)O2 consumption (n=4)
Hemorrhage
DDFPe
V
Bone break Blood loss at end of hemorrhage: 27.5 +/- 0.1 mL/kgBlood loss at euthanasia: 32.7 +/- 0.4 mL/kg
Pigs - Tyssebotn et. al. Study Final Report to USAMRMC, 2008.
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Competitive Advantages Reduced Development Risk Core technology Approved in Europe as an ultrasound contrast agent $100 million spent by licensor developing core technology Used safely in 2,200 patients
5 patents issued, 5 pending
12 years exclusivity for each first-‐in-‐class indication
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Collaboration Outline
Partner makes an equity investment in NuvOx with option to negotiate an R&D Partnership
NuvOx provides relevant pre-‐clinical/clinical data to support product development in the Region
Collaboration terms for Development
NuvOx to provide DDFPe for evaluation and clinical development
Exclusive commercial rights for the Region
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NuvOx Pharma Thank You!!
NuvOx Pharma, 1635 E. 18th St., Tucson, AZ, 85719
[email protected] office: 520-‐624-‐6688
www.nuvoxpharma.com