Upload
others
View
4
Download
0
Embed Size (px)
Citation preview
We Position Oncology Drugs with Precision
JP Morgan 2017 1
Biotech Showcase 2017Peter Buhl Jensen CEO MD DMScOncology Venture
DRP™ Core Applications
2
PATIENT AS THE STARTING POINT
Pembrolizumab
cisplatin
Nivolumab
Anastrozole
5-FU
Bortezomib
Bosutinib
Brentuximab vedotin
Cabozantinib
Crizotinib
Carfilzomib
Cetuximab
Dasatinib
Denileukin diftitox
Erlotinib hydrochloride
Everolimus
Exemestane
Fulvestrant
Gefitinib
Ibritumomab tiuxetan
Imatinib mesylate
Ipilimumab
Lapatinib ditosylate
Doxorubicin
Nilotinib
Ofatumumab
Panitumumab
Pazopanib
Pertuzumab
Pralatrexate
Regorafenib
Rituximab
Belinostat
Sorafenib tosylate
Sunitinib malate
Tamoxifen
Temsirolimus
Toremifene
Tositumomab
131I-tositumomab
Trastuzumab
Tretinoin
Vandetanib
Vemurafenib
Vorinostat
Ziv-aflibercept
DRUG AS THE STARTING POINT
JP Morgan 2017
Digital Precision Gene Expression Pharmaco-omics - a Validated Drug Response Predictor Platform
Percentage of Patients for WhomDrugs are Ineffective
JP Morgan 2017 3
75%CANCER
• Monthly costs of newly approved Cancer drugs are
now >10.000 USD per patient
• Products for hard to treat cancers may be approved
with 20-30% response rate
• But only 2½ % of products in development get
approval
• Very often safety is ok and some patients benefit - but not enough to warrant approval
• No technology as broadly applicable and useful in ‘non-targeted drugs’ to find the patients who will
benefit until now
FDA 10/20/2013
Great in some patients
- and we willfind them
JP Morgan 2017 5
CONFIDENTIAL
6
Our Product Pipeline
JP Morgan 2017 7
Focused on EFFICACY CANCER INDICATION SCREENING PHASE 2 RANDOMIZED PHASE 3 OR PIVOTAL
END POINT
Metastatic Breast Durable Remission
Metastatic Breast (Cadila)Aimed at FDA EMA filing 3 years?
Prostate (Cadila) Durable Remission
Head & Neck (Cadila) Durable Remission
Esophagus (Cadila) Durable Remission
Skin (Cadila) Durable Remission
CANCER INDICATION SCREENING PHASE 2 RANDOMIZED PHASE 3 OR PIVOTAL
RESPONSE RATE BEFOREDRP SCREEN
Prostate 10% in unselected patients
Ovarian 13% in unselected patients
Liver Complete Responders in previous studies
CANCER INDICATION SCREENING PHASE 2 RANDOMIZED PHASE 3 OR PIVOTAL
STATUS
Multiple Myeloma Screening started. Phase 2 application submitted
Metastatic Breast Screening Started
2X Oncology et al.
JP Morgan 2017 8
SPV for Women's Cancers – seed round 3½ million secured and Series A commencing
Product Indication SCREENING PHASE 2 RANDOMIZED PHASE 3
OR PIVOTAL
RESPONSE RATE BEFORE DRP SCREEN
2X-111 TOP2# liposomal-GSH
Metastatic Breast41% had reduction in tumor in phase 2
2X-111 TOP2# Liposomal-GSH
Brain tumors (Glioblastoma)
40% had disease control, 14% had tumor reductions of >=20% in previous phase 2
2X- 121 PARP#Metastatic Breast
46% disease control., 7% PR in previous phase 1
2X-131 TOP1#Ovarian Cancer
~ 25 % partial response (PR) in ovarian cancer, ~40% PR and stable disease (SD) in breast cancer in previous phase 2
OV-SPV 2
Tyrosine kinase # SCREENING PHASE 2 RANDOMIZED PHASE 3 OR PIVOTAL
RESPONSE RATE BEFORE DRP SCREEN
Renal cancer Test in biopsies from phase 3 trial On par with commercial product
Liver cancer Test in biopsies from rand. phase 2 trial On par with commercial product
Understanding Complexity
JP Morgan 2017 9
To Solve Complex Problems
VS
Traditional Single point mutation Pathway view Oncology Venture - Data driven, Systems biology (network) view
SHORTEN Development Time
INCREASE Probability of Success REDUCE Capital Investment
INCREASE Sales
Understanding complexity to gain Precision
JP Morgan 2017 10
We Go Further than Competitors
JP Morgan 2017 11
In vitro Model
0 20 40 60 80 100
0.00
0.01
0.02
0.03
0.04
0.05
Prediction score
Den
sity
responders (CR+PR)
nonresponders (SD+PD)
P=0.11
P=0.11
Clinical Relevance Filter
0 20 40 60 80 100
0.00
0.01
0.02
0.03
0.04
0.05
Prediction score
Den
sity
responders (CR+PR)
nonresponders (SD+PD)
P=0.01
P=0.01
Utility in Clinic
0 20 40 60 80 100
0.00
0.01
0.02
0.03
0.04
0.05
Prediction score
Den
sity
responders (CR+PR)
nonresponders (SD+PD)
P=0.003
P=0.003
Drug Specific
DRP™ Biomarkers
Validating DRP™
JP Morgan 2017 12
- 32 clinical retrospective trials of many approved anti-cancer drugs
- 80% success rate robust biomarkers
- Bio markers enable selection of likely responders to enroll in clinical trials
LEVEL 1: generally sufficient for CE-IVD labeling / FDA: prospective trial(s) w/archival samples
LEVEL 2: strong data set, requires a confirmatory study: blinded, prospective trial with archival samples DRP™
DRP™ Usage Example
JP Morgan 2017 13
Predicting Who Should Have 5FU
Time (DAYS)
5FU
Survivalwithoutchemotherapy
2X
SUR
VIV
AL
Colon Cancer survival doubled
Cisplatin DRP™ in OV Lung Cancer Study
JP Morgan 2017 14
Valid for all indications
Bottom 50%
Top 50% p = 0.08 HR = 1.9
Top 20% p = 0.08 HR = 2.5
Top 10% p = 0.05 HR = Inf
P-values shown are for the logrank test. The more sensitive Cox proportional hazards regression gives a univariate p=0.007 and a multivariate(Including age, stage & histo) p=0.013
The 10% with the best cisplatin DRP™ ALL survived
Lung Cancer survival doubled
2X
Scalable Patient Selection with DRP™
JP Morgan 2017 15
>1100
20
JP Morgan 2017 16
Intelligent Targeted Cisplatin
• Lipid-based, nano-encapsuled formulation preciselydelivers cisplatin at tumor site
• Now including patients selected via DRP™ in phase 2study
• Activity seen in Breast, Esophagus, Skin and ColonCancer
• Partnership with Cadila: four phase 2 studies, onephase 3 study
• Market for Breast Cancer treatment ~ 8 billion USD2014, expected to reach 18 billion USD by 2022
Complemented by LiPlaCis DRP™ for patient population enrichment
JP Morgan 2017 17
Immuno-Oncology Drug with Unique MOA
• Imitates T-cells, inducing apoptosis of malignant cells
• Now screening Multiple Myeloma patients for afocused phase 1b/2 trial
• Big demand for MM treatment: market value 2014 over7 billion USD
• Cancer immunotherapy drug market estimated to 35billion USD by 2023
Complemented by APO010 DRP™ for patient population enrichment
APO010 Mechanism of Action
JP Morgan 2017 18
Tested in Over 1300 Patients - Effective for Several Indications
• Semi-synthetic drug, originating from natural productisolated from fungus Omphalotus Illudens
• Exerts anti-tumor activity by producing DNA adductsthat can only be repaired by the TC-NER pathway
• Screening patients to include in P.O.C. study.Focused phase 2 multi-center trial in SE & DK to beinitiated during spring 2017
• Market for Prostate Cancer drugs expected to triplefrom 2,5 billion USD 2013 to 7,6 billion in 2022
• Average treatment cost USD 40´/patient --> significantpotential for Irofulven
Complemented by Irofulven DRP™ for patient population enrichment
OV Business Facts
JP Morgan 2017 19
• Oncology Venture was formed in 2012 by Danish andUS oncology specialists, as a spin-off to MedicalPrognosis Institute (MPI.ST)
• Listed as Oncology Venture AB , Stockholm, Sweden onJuly, 2015 (OV.ST)
• Initial tock share rate: SEK 7.40
• Stock share rate per January 7, 2017: SEK 52.5
• 3 capital raises in 18 months,
• Raised a total of 7 million USD at 7.4, 10 and 29 SEK
• Market value per January 7, 2017: 60 million USD
We offer 2 types of investments in Oncology Precision
JP Morgan 2017 20
Oncology Venture listed in Stockholm (OV.ST)
SPV’s 2X Oncology Private US company based in Boston
with 3 promising phase 2 products
Women’s Cancers – Series A
OV-SPV2 Private Danish company w. Big Pharma TKI
New SPV’s New Product Opportunities
SHORTEN Development Time
INCREASE Probability of Success
REDUCE Capital Investment
INCREASE Sales
The Vision
JP Morgan 2017 21
Plans Going Forward
Help cancer patients get the accurate treatment right away
Create a global business based on the unique access to response prediction technology
Let’s Talk!
ULLA Buhl
Oncology Venture
Chief Operating Officer
Founder
JAMES Cullem
Oncology Venture
Vice President, Corporate Development
+1 (978) 500-0863
NIKOLAJ Buhl Jensen
Oncology Venture
CFO
PETER Buhl Jensen
Oncology Venture
CEO
Founder