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Developing Targeted Therapeutics
Providing Safe and Effective Treatment Options for Patients with Leukemias, Lymphomas and
Solid Tumor Cancers
2Copyright © 2018 Trovagene, Inc.
Forward-Looking Statements
Certain statements in this presentation are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Trovagene's expectations, strategy, plans or intentions.
These forward-looking statements are based on Trovagene's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. While the list of factors presented in the 10-K is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
3Copyright © 2018 Trovagene, Inc.
Investment ThesisNasdaq: TROV
Oncology Focus
► Onvansertib – only first-in-class, 3rd
generation oral Polo-like Kinase 1 (PLK1) inhibitor in development
► Three active Investigational New Drug (IND) Applications: Hematologic and Solid Tumor Cancers
► Completed and published Phase 1 study in solid tumor cancers
► Orphan Drug Designation in Acute Myeloid Leukemia (AML) in the U.S. and Europe
► Biomarker strategy to identify patients most likely to respond to treatment
► Funding to advance development programs well into 2019
Attractive Investment Thesis Oncology Drug Development Expertise
► Clinical development programs in three key indications of significant medical need for new treatment options
– Phase 1b/2 in Acute Myeloid Leukemia in combination with standard-of-care chemotherapy
– Phase 2 in metastatic Castration-Resistant Prostate Cancer in combination with Zytiga®
– Phase 1b/2 in metastatic Colorectal Cancer in combination with FOLFIRI + Avastin®
► Working with leading investigators and cancer institutions across the U.S.
► Demonstrated synergy of onvansertib in combination with standard-of-care drugs
► Proven safety, tolerability and preliminary data demonstrating treatment response
► Patent protection out to 2032 and beyond
4Copyright © 2018 Trovagene, Inc.
Onvansertib Market Opportunity
650
1,265
1,470
2,2162,070
1,056
1,750
0
500
1000
1500
2000
2500
3000
2020 2021 2022 2023 2024 2025 2026 2027 2028
Market Potential By Indication Per Year of TreatmentEstimated Total ~10.5 Billion1
Breast
Small Cell Lung
Sale
s ($
Milli
ons)
Approximate Year of FDA Approval
AML
Colorectal
Prostate
Pancreatic
Ovarian
12018 statistics https://seer.cancer.gov/statfacts/html/common.html
5Copyright © 2018 Trovagene, Inc.
Licensed Global Development & Commercialization Rights to Onvansertib (PLK1 Inhibitor) from NMS
► Largest oncology research and development company in Italy and highly regarded throughout Europe and US
► Leader in protein kinase drug development (Polo-like Kinase Inhibitors)
► Identification and validation of molecular targets focused on driver oncogenes
► Excellent track record licensing innovative drugs to pharma/biotech companies including: Genentech (Roche), Ignyta (Roche), Novartis
► Oncology specialized contract development and manufacturing organization
► cGMP compliant and FDA validated production of API (active pharmaceutical ingredient) and finished dosage forms
► Analytical services, clinical supply management and CMC regulatory support
6Copyright © 2018 Trovagene, Inc.
Nerviano Oncology Portfolio Success
Licensed Preclinical Phase 1 Phase 2 Phase 3 Registered
Encorafenib (B-RAF IP) Melanoma Braf mutation in combination with binimetinib
Entrectinib (TRK, ROS, ALK) Non-Small Cell Lung
Milciclib (CDK, other kinases) Thymic Cancer
MPS1 Inhibitor Solid Tumors
Onvansertib (PLK1 inhibitor) AML, mCRPC, mCRC
ADC (PNU-652)
ADC (NMS-P945)
► Excellent track record licensing innovative drugs to pharma/biotech companies that have subsequently received FDA breakthrough status and priority review designation
7Copyright © 2018 Trovagene, Inc.
Partnering Strategy
► Engaging in clinical trial collaborations across a number of major tumor types
► Identifying regional pharma partners for collaboration (Japan, Europe)
► Establishing partnerships to fund clinical trials (Phase 1b/2 mCRC)
8Copyright © 2018 Trovagene, Inc.
Strategy for Developing Onvansertib
► 3 active INDs in place enabling clinical development in hematologic and solid tumor cancers
► Leveraging a proven cancer target, PLK1
► Integrating biomarkers to identify patients most likely to respond to treatment
► Orphan Drug Designation in AML
► Combination therapy with already approved drugs– Phase 1b/2 trial of onvansertib + cytarabine or decitabine in Acute Myeloid Leukemia (AML) – Phase 2 trial of onvansertib + Zytiga® in metastatic Castration-Resistant Prostate Cancer
(mCRPC)– Phase 1b/2 trial of Onvansertib + FOLFIRI and Avastin® in metastatic Colorectal Cancer (mCRC)
► Phase 1b/2 trial-ready in pancreatic, ovarian, breast and lung cancer
9Copyright © 2018 Trovagene, Inc.
Onvansertib – Pipeline Within a MoleculeOpportunities in Leukemias/Lymphomas and Solid Tumors
Preclinical Phase 1 Phase 2
Solid Tumor Cancers
Leukemias & Lymphomas
Metastatic Castration-Resistant Prostate (CRPC)Phase 2 trial in combination with Zytiga® (abiraterone acetate)/prednisone
PancreaticPhase 1b/2 trial ready
Colorectal (CRC)Phase 1b/2 trial in combination with FOLFIRI + Avastin ®
OvarianPhase 1b/2 trial ready
BreastPhase 1b/2 trial ready
Small Cell Lung Phase 1b/2 trial ready
Acute Myeloid Leukemia – Orphan Drug Designation in the U.S. and EuropePhase 1b/2 trial in combination with low-dose cytarabine (LDAC) or Decitabine
► Three active Investigational New Drug (INDs) Applications in place with the FDA
10Copyright © 2018 Trovagene, Inc.
Advancement of PLK Inhibitor Drug Class
► 1st Generation PLK Inhibitors– GSK – 461364– BI – 2536
2010 - 2014
Limited Clinical Activity
Off-Target Toxicities
IV (Intravenous Formulation)
PanPLK Inhibitors
2012 - 2016
PLK1 Proven Drug Target
Phase 2/3 Trials in Combination with
SOC demonstrated Clinical Response
Lethal Infections Led to
Discontinuation
PanPLK IV
Long Half-life
► 2nd Generation PLK Inhibitors– BI – Volasertib
11Copyright © 2018 Trovagene, Inc.
Onvansertib: First-in-Class, 3rd Generation PLK1 with Best-in-Class Attributes
12Copyright © 2018 Trovagene, Inc.
Onvansertib: Selective Only for PLK1 No Off-Target Adverse Events
► PLK1 is a master regulator of cell division
► Onvansertib has demonstrated safety and tolerability
► Phase 1 Safety Study:
– No dose-limiting toxicities at the recommended Phase 2 dose (24 mg/m2)
– No gastrointestinal, mucositis or alopecia
– Expected myelosuppressive effects observed (thrombocytopenia and neutropenia) deemed related to the mechanism-of-action and reversible
– No other clinically relevant safety findings were observed
13Copyright © 2018 Trovagene, Inc.
PLK1: Established Target for Cancer Therapy
► Polo-like Kinase 1 (PLK1)
– Belongs to a family of kinases (PLK1,2,3,4,5)
– Dysfunction leads to cancer formation and progression
– Over-expressed in dividing cancer cells
– Inhibition leads to cancer cell death
PLK1 Plays a Critical Role in Initiation, Maintenance and Completion of Mitosis
1Liu et al- PLK1, A Potential Target for Cancer Therapy; Translational Oncology – Vol. 10 – pp. 22-32; February 2017
Cell-cycle arrest
14Copyright © 2018 Trovagene, Inc.
Onvansertib: Highly-Selective Only for PLK1
► Tested against >260 kinases
► PLK1 was the only active target (IC50 of 2nM)
1Data on File, Trovagene, Inc.
Selective PLK1 Inhibitor
Causes cancer cell death by G2M arrest
► Onvansertib blocks cell division (mitosis)
PLK MemberOnvansertibIC50* (μM)
PLK1 0.002
PLK2 > 10
PLK3 > 10
Tumor Cell Division
Onvansertib Blocks Tumor Cell Division
15Copyright © 2018 Trovagene, Inc.
Onvansertib Combination Therapy Strategy
► Cornerstone of precision cancer medicine
► Demonstrated synergy with chemotherapies and targeted therapeutics
► Enhances efficacy (targets key pathways by synergy or additive effect)1
► Reduces drug resistance, while providing therapeutic benefits1Mokhtari, R et al - Combination Therapy in Combatting Cancer – Oncotarget, 2017, Vol. 8 (No. 23), pp: 38022-38043
16Copyright © 2018 Trovagene, Inc.
Onvansertib: Synergy May Enhance Efficacy of Standard of Care (SOC) Therapies1
Onvansertib Synergistic in
Combination with SOC Therapies
Zytiga®
(abiraterone)Avastin®
(bevacizumab)
Cytarabine
Doxorubicin
Cisplatin
Gemzar®
(gemcitabine)
Velcade®
(bortezomib)
Quizartinib
Beleodaq(belinostat)
Camptosar®
(Irinotecan)
Venclexta®
(venetoclax)
Taxol®
(paclitaxel)
Acute Myeloid LeukemiaChronic Lymphocytic Leukemia
Colorectal
T-Cell Lymphoma
ColorectalBreast
Non-Small Cell Lung
Acute Myeloid Leukemia
PancreaticBreast
OvarianNon-Small Cell Lung
Leukemias (Acute Myeloid Leukemia)
LeukemiasLymphomas
OvarianBreast
OvarianBladder
Non-Small Cell LungSmall-Cell Lung
PancreaticBreast
OvarianNon-Small Cell Lung
Multiple Myeloma
Prostate
1Data on File, Trovagene, Inc. Onvansertib current clinical trials
17Copyright © 2018 Trovagene, Inc.
Clinical Trial Roadmap
Acute Myeloid Leukemia (AML)
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Colorectal Cancer (mCRC)
18Copyright © 2018 Trovagene, Inc.
Clinical Advisors and Collaborators
Jorges Cortes, MD Filip Janku, MD, PhD
David Einstein, MD Glenn Bubley, MD Michael Yaffe, MD, PhD
Sandra Silberman, MD, PhD
Afsaneh Barzi, MD Heinz-Josef Lenz, MD, FACP Daniel Ahn, DO
19Copyright © 2018 Trovagene, Inc.
Acute Myeloid Leukemia1
Significant Need for New Treatment Options
► Aggressive hematologic malignancy of immature blood cells
► 20,000 new cases, 10,400 deaths annually, and 5 year survival rate of 25%
► Treatment options vary based on patient condition / age, but can include:
– Chemotherapy / Radiation / Stem Cell Transplant
► Preclinical in-vitro and in-vivo data demonstrate efficacy of Onvansertib* as single agent and in combination with drugs used to treat AML
*Orphan Drug Designation granted for Onvansertib by the FDA September, 2017 and by the EMA in July, 2018 ;1National Cancer Institute SEER 2016; 2Valsasina et al., Mol Cancer Ther; 11(4) April 2012
Acute Myeloid Leukemia
20Copyright © 2018 Trovagene, Inc.
Onvansertib Positioning in AMLPatient Selection Algorithm
AML Diagnosis 18,3761
cases/year
Eligible for Induction Treatment~11,000
Relapsed
& Refractory
30-50% 3,300 to
5,500
Onvansertib in combination with standard-of care chemotherapy and/or targeted therapeutics2
Responders 50-70%
Ineligible for
Induction Treatment
~7,400
Consolidation Treatment
1Visser et al. (2012), Eur J Cancer (48). Estimated cases in EU27 per year; 2e.g. Midostaurin for FLT3 mutation
21Copyright © 2018 Trovagene, Inc.
Ongoing Phase 1b/2 Clinical Trial in AML
Phase 1b: Dose escalation to assess safety and identify recommended Phase 2 dose
► Administered orally, once daily on days 1-5 of each cycle (21-28 days)
12 mg/m2
18 mg/m2
27 mg/m2
40 mg/m2
Phase 2: Assess safety and preliminary antitumor activity
► Efficacy Endpoints: Rate of complete response (CR + CRi) defined as morphologic leukemia-free state (MLF)
► Exploratory Endpoints: Evaluation of pharmacodynamic and correlative biomarkers
Onvansertib in Combination with Either Low-Dose Cytarabine or Decitabine in Patients with Acute Myeloid Leukemia (AML)
Completed
Completed
CompletedCompleted
60 mg/m2
Enrolling
22Copyright © 2018 Trovagene, Inc.
Anti-Leukemic Activity
► Of the 26 patients evaluable for safety, 19 patients had an evaluable bone marrow biopsy to assess anti-leukemic activity
► Preliminary efficacy in the evaluable population showed includes 3 patients achieving complete response (CR) and 1 patient achieving complete response with incomplete hematologic recovery (CRi)
Onvansertib + Decitabine Onvansertib + LDAC
23Copyright © 2018 Trovagene, Inc.
Patient Cases
► 07-035: 76 year-old male, diagnosed with AML in 2015; treated with induction chemotherapy; relapsed in December 2018; entered trial in January 2019 on onvansertib 40mg/m2+ decitabine
► Patient reached CR as of the end of cycle 2 and is currently in cycle 3
► % bone marrow blasts decreased from 20% (at screening) to less than 5% at the end of cycle 2; circulating blasts remained low during the entire treatment (0.2 to 2.2%)
CR
0
5
1 0
1 5
2 0
2 5
D a y s o f c y c le
% o
f bla
sts
1 22
C y c le 1
1
C y c le 2
29
C irc u la tin g b la s ts
B o n e m a rro w b la s ts
► 05-030: 68 year-old female with MDS progressed after 6 cycles of azacytidine; diagnosed with AML in September 2018; entered trial in October 2018 on onvansertib 27mg/m2 + decitabine
► Onvansertib dose reduced to 18mg/m2 at cycle 5
► Patient reached CRi at then end of cycle 4 and is in cycle 6
► % bone marrow blasts decreased from 20% (at screening) to 1% (cycle 4) and circulating blasts decreased from 43% (C1D1) to 1% (C4D21)
0
1 0
2 0
3 0
4 0
5 0
D a y s o f c y c le
% o
f b
last
s
1 22 1 21 1 1 21
C y c le 1 C y c le 2 C y c le 3 C y c le 4
21
B o n e m a rro w b la s ts
C irc u la tin g b la s ts
CR
CRi
► 03-037: 83 year-old male with prior Cytarabine and Decitabine treatment. 7+3 Decitabine maintenance; entered trial in December 2018 on onvansertib 40mg/m2 + Cytarabine
► Patient reached MLFS at then end of cycle 2 and CR at the end of cycle 4
► % bone marrow blasts decreased from 10% (at screening) to 4% (cycle 2)
► 07-009: 75 year-old male, diagnosed with AML in 2009; treated with induction chemotherapy; relapsed March 2018; entered trial April 2018 on onvansertib 12mg/m2 + decitabine
► Onvansertib dose increased to 18mg/m2 cycle 6; 27mg/m2 cycle 10
► Patient reached PR at end of cycle 4 and CR at the end of cycle 11
► % bone marrow blasts decreased from 94% (at screening) to <5% (cycle 11) and circulating blasts decreased from 92% (C1D1) to 2.2% (C11D22)
CR
0
5
1 0
1 5
% o
f b
las
ts
1 5 10 17 22
C y c le 1
1 5 9 15 22 1 5 9 15 22 1
C y c le 2
5 8
B o n e m a rro w b la s ts
C irc u la tin g b la s ts
D a y s o f c y c le
C y c le 3 C y c le 4
0
2 5
5 0
7 5
1 0 0
D a y s o f c y c le
% o
f l
eu
ko
cy
tes
C 1 C 2 C 3 C 4 C 5 C 6 C 7
B o n e m a rro w b la s ts
C 8
L e g e n d
22 1 22 1 22 1 22 1 22 1 22 1 22 1 22 1 22 1 22 1 22
C 9 C 1 0 C 1 1
24Copyright © 2018 Trovagene, Inc.
PLK1 Inhibition Can Be Monitored Through pTCTP Status
► In the Phase 1b AML trial, 8 out of the 22 subjects (36%) tested showed a decrease in % pTCTP at 3h post-dose compared to pre-dose
1Cucchi et al., Anticancer Res., 2010
TCTP
PLK1
TCTP
P
P
Onvansertib
PLK1
TCTP
TCTP
Onvansertib
P
No Onvansertib
Target Engagement12 mg/m2
01-0020h 3h
pTCTP
TCTP
07-009
27 mg/m2
08-027 05-030
40 mg/m2
07-0360h 3h 0h 24h 0h 3h 0h 3h
► pTCTP as a marker of PLK1 activity:
– PLK1 phosphorylates the translational control tumor protein (TCTP) on serine 461
– pTCTP was identified as a specific marker for PLK1 activity in in-vivo preclinical models1
12 mg/m2
07-004
0h 3h
pTCTP
TCTP
07-013
27 mg/m2
01-024 07-033
No Target Engagement40 mg/m2
07-035
0h 3h 0h 3h 0h 3h 0h 3h
25Copyright © 2018 Trovagene, Inc.
PLK1 Inhibition by Onvansertib is Correlated with Higher Response to Treatment
► Patients with target engagement had a significantly higher decrease in bone marrow blasts compared to patients with no-target engagement
► 4 out of the 7 patients with target engagement had a decrease in bone marrow blasts ≥50%
► Conversely, only 1 out of the 9 patients with no-target engagement showed a decrease in bone marrow blasts upon treatment
T a rge t
E n g a g emen t
N o Ta rg
e t
E n g a g emen t
0
1 0 0
2 0 0
3 0 0
%b
last
s re
lativ
e t
o b
ase
line * *
% Bone Marrow Blast Change Relative to Baseline
p=0.009
% Bone Marrow Blast Reduction from Baseline
-1 5 0
-1 0 0
-5 0
0
5 0
1 0 0
1 5 08 0 0
9 0 0
1 0 0 0
%ch
an
ge
fro
m b
ase
line
T a rg e t E n g a g e m e n t
N o T a rg e t E n g a g e m e n t
*patient sample had low % circulation blasts (~1%) and showed a 40% reduction in pTCTP
*
26Copyright © 2018 Trovagene, Inc.
Simple Blood Test for Predicting Response
to Onvansertib
► Biomarker assay uses a blood sample to test whether a patient has a greater
likelihood to respond to Onvansertib
► If patient is positive for biomarker assay, then drug is administered
► Blood test examines the extent that Onvansertib inhibits PLK1 enzymatic activity
(called target engagement) within circulating cancer cells
pTCTP
TCTP
- +
Onvansertib
pTCTP
TCTP
- +
Onvansertib
Patient receivesa single dose of
onvansertibAssess target engagement
Pre-dose sample
3h post-dosesample
Obtain 2 vials of blood from
patientTreatment vial,Onvansertib
Control vial,Vehicle
Treat blood sample with onvansertib or vehicle control
Assess target engagement
Ex-vivo sampling (in development)
In-vivo sampling (current method)
27Copyright © 2018 Trovagene, Inc.
Metastatic Castration-Resistant Prostate CancerOpportunity to Increase Duration of Response to Therapy
► 25,000 men die from metastatic prostate cancer annually and the five-year survival rate is 37%2
► Treatments – Zytiga® (Johnson & Johnson)/prednisone– Xtandi® (Astellas/Pfizer)
► Ongoing need to increase duration of response to treatment– Patients develop resistance within 9-15 months4 and do
not respond well to subsequent therapies
► Preclinical studies demonstrate synergy between Onvansertib and Zytiga®
– PLK1 inhibition improves abiraterone efficacy by repressing the androgen signaling pathway3,4
12017 Annual Report on Prostate Disease – Harvard Health Publications; 2GlobalData. Prostate Cancer—Global Drug Forecast and Market Analysis to 2023. Apr, 2015; 3 National Cancer Institute Metastatic cancer. Mar, 2013. Available at: http://www.cancer.gov/about-cancer/what-is-cancer/metastatic-fact-sheet; 4GAntonarakis, Emmannel – Current Understanding of Resistance to Abiraterone and Enzalutamide in Advanced Prostate Cancer; Clinical Advances in Hematology & Oncology – May 2016 – Volume 14, Issue 5
Prostate Cancer
28Copyright © 2018 Trovagene, Inc.
Ongoing Phase 2 Clinical Trial in mCRPC
Efficacy EndpointsEffect of Onvansertib in combination with Zytiga®/prednisone on disease control assessed by prostate-specific antigen (PSA) decline or stabilization pre- and post-treatmentSafety EndpointSafety of Onvansertib in combination with Zytiga®/prednisoneExploratory EndpointTarget inhibition of PLK1, evaluation of relevant biomarkers and correlation with patient response and genomic profile
Onvansertib in Combination with Zytiga® and Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Dosing Regimen
Onvansertib – 24 mg/m2
Days 1-5 (21-Day Cycle) + Zytiga®/prednisone daily
4 Cycles = 12 Weeks Disease Control based on PSA level
Duration Evaluation
29Copyright © 2018 Trovagene, Inc.
Early PSA Response Observed with Addition of Onvansertib to Daily Zytiga®
D a y -60
D a y -32
D a y -6
C 1D 1
C 1D 8
C 2D 1
C 2D 8
C 3D 1
C 4D 1
C 5D 10
1 0
2 0
3 0
4 0
5 0
T ro v 5 3 _ 0 3 -0 1 3 _ P S A le v e ls
PS
A (
ng
/mL
)
D a y 1 D a y 8 5
E ff ic a c y e n d p o in t
2 5 % o f b a s e lin e P S A (C 1 D 1 )
C T C s A R V 7 +
D a y -6 is th e s c re e n in g P S A v a lu e .
Abiraterone Abiraterone + Onvansertib
Efficacy evaluation at Day 85
► 6 patients have completed 4 cycles (3 months) of treatment with onvansertib + abiraterone
► 2 of 6 patients had observed declines in PSA levels after dosing with onvansertib
► To date, 1 patient has achieved the efficacy endpoint of disease stabilization based on PSA levels (primary endpoint)
► PSA trajectory in patient achieving primary efficacy endpoint changed from 100% increase (16.05ng/ml to 34.23 ng/ml) in the 60 days prior to adding Onvansertib to only an 8.4% increase during 84 days on treatment
► Tumor assessed at Cycle1 Day 1 as a variant known as AR-V7, considered an aggressive tumor that is resistant to anti-androgen therapy
CT scan at end of 12 weeks (efficacy endpoint) indicates ~30% tumor shrinkage
30Copyright © 2018 Trovagene, Inc.
Colorectal Cancer: Unmet need in mCRC
► 140K new cases of CRC in 2018 with 64.5% 5 year survival1
– ~51K deaths per year from mCRC1
► Tumor biomarkers drive therapy decisions for 1st line mCRC therapy2
– ~50% mCRC is RAS mutant (Kras)– Targeted therapies exclude patients with RAS
mutations
► Large unmet need in RAS mutant CRC2
– No targeted therapies are available for RAS mutant CRC
– Standard-of-care is chemotherapy (FOLFOX/FOLFIRI)– 2nd line therapies have ~5% response rate in metastatic
CRC (mCRC)
1https://seer.cancer.gov/statfacts/html/colorect.html; 2King et al, Frontline Strategies for Metastatic CRC, 2016, Amer J Hem/Onc; Loree&Kopetz, Recent Developments in treatment of mCRC, 2017, Ther Adv Med Onc;
Colorectal Cancer
31Copyright © 2018 Trovagene, Inc.
Onvansertib: Synergy in Combination with Irinotecan (FOLFIRI)► Combination of Onvansertib with
Irinotecan significantly reduces tumor growth compared to either drug alone
► In 3 independent models tested, Onvansertib induced maximal tumor regression of ~84% compared to vehicle
► Kras mutation is a biomarker for Onvansertib sensitivity
► KRAS mutated NIH3T3 cells showed higher sensitivity to Onvansertib compared to KRAS wild-type (WT) cells1
MutatedWild Type
1Investigator Brochure, Data-on-file, Trovagene
Vehicle
Onvansertib 45 mg/kg
Onvansertib 60 mg/kg
Irinotecan 45 mg/kgIrinotecan 45 mg/kg + Onvansertib 45 mg/kg
32Copyright © 2018 Trovagene, Inc.
Planned Phase 1b/2 Clinical Trial in mCRC
Phase 1b: Dose escalation to assess safety and identify recommended Phase 2 dose
► Administered orally, once daily on days 1-5 every 14-days (2 courses per 28-day cycle)
12 mg/m2
15 mg/m2
18 mg/m2
Phase 2: Assess safety and preliminary antitumor activity
► Efficacy Primary Endpoint: Objective response rate (ORR) in patients who receive at least 1 cycle (2 courses) of Onvansertib in combination with FOLFIRI and bevacizumab
► Efficacy Secondary Endpoint: Preliminary efficacy defined as complete response (CR) plus partial response (PR) plus stable disease (SD)
Onvansertib in Combination with FOLFIRI + Avastin for Second-Line Treatment of Metastatic Colorectal Cancer in Patients with a Kras Mutation
33Copyright © 2018 Trovagene, Inc.
Key Inflection Points – Q2’19 – Q1’20
Clinical Development Q2’19 Q3’19 Q4’19 Q1’20
Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome (MDS) –Investigator Initiated
ü AACR Phase 1b Data Presentation (4/1)
ü FDA Meeting Phase 2 AML and biomarker plans (4/8)
ü Phase 2 AML trial enrolling (6/6)
ü ESMO Phase 2 Data Presentation (9/27)
ü MDS – Investigator Initiated trial enrolling
ü ESH Phase 2 Data Presentation (10/24)
ü ASH Phase 2 Data Presentation (12/7)
ü MDS initial safety and efficacy data readout
ü Phase 2 AML trial data readout
metastatic Castration-Resistant Prostate Cancer (mCRPC
ü AACR Data Presentation (4/2)
ü Arm B – 14-day schedule enrolling (4/25)
ü Asian-Pacific Prostate Cancer Conference Presentation (8/24)
ü ESMO Data Presentation (9/27)
ü EMUC Conference presentation of safety and preliminary efficacy from 14-day dosing schedule (11/14-17)
ü ASCO-GU Phase 1b safety and efficacy data (2/13)
metastatic Colorectal Cancer (mCRC)
ü Sites activated and enrolling patients (5/1)
ü Clinical collaboration with large-cap biotech
ü Gastrointestinal Oncology Conference (10/10-11) Preliminary Phase 1b safety and efficacy data
ü ASCO-GI Phase 2 efficacy data (1/23-25)
34Copyright © 2018 Trovagene, Inc. 34
Thank You
For additional information please contact: [email protected]