Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Investor Presentation (January 2018)
33 slides from Cardiff Oncology's investor presentation, Jan 8, 2018
Slide 1: Transforming Patient Care with Targeted Cancer Therapeutics
Transforming Patient Care with Targeted Cancer Therapeutics Company Overview | january, 2018 Company Overview January 2017 Exhibit 99.1
Slide 2: Forward-Looking Statements
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 sim
Slide 3: Lead Asset: PCM-075
Lead Asset: PCM-075 PCM-075 is an oral, highly-selective Polo-like Kinase 1 (PLK1) inhibitor Trovagene licensed exclusive global development and commercialization rights from Nerviano Medical Sciences in 2017 Nerviano is the current manufacturer and has bulk material and finished product available f
Slide 4: Trovagene Snapshot
Trovagene Snapshot NASDAQ: TROV 2017 Year-End Cash: $8.2M Shares Outstanding: 52.8M Oncology Focus PCM-075, the only oral, selective PLK1 inhibitor to enter clinical trials 2 active INDs: Hematologic and Solid Tumor Cancers Completed and published Phase 1 safety study in solid tumor cancers Orphan D
Slide 5: PCM-075: A Best in Class PLK1 Inhibitor Targeting Hematologic and Solid Tumor Cancers
PCM-075: A Best in Class PLK1 Inhibitor Targeting Hematologic and Solid Tumor Cancers Acute Myeloid Leukemia (AML) Metastatic Castration-Resistant Prostate Cancer (mCRPC) Phase 1b/2 Phase 2 Combination of PCM-075 with standard-of-care chemotherapy to extend response to treatment in AML patients inel
Slide 6: Pipeline Assets
Pipeline Assets Indication (Target) Preclinical Phase 1 Phase 2 Non-Hodgkin Lymphoma Acute Myeloid Leukemia – Orphan Drug Designation TROV-052 Phase 1b/2 open-label clinical trial in combination with standard-of-care ongoing Indication (Target) Preclinical Phase 1 Phase 2 Phase 1 Advanced Solid Tumo
Slide 7: PLK1 – Cancer Therapeutic Target
PLK1 – Cancer Therapeutic Target Key Regulator of Cell Division PLK1 is the master regulator of the cell- cycle and the last checkpoint prior to cell division (G2/Mitosis phase)1-6 Inhibition of PLK causes mitotic arrest in prometaphase (polo arrest) and subsequent cell death (apoptosis)1–4 Over-exp
Slide 8: PLK1 Overexpressed in Numerous Cancers
PLK1 Overexpressed in Numerous Cancers Publications Illustrate Broad Application “In our view, combined therapies targeting other relevant pathways together with Plk1 may be vital to combat issues observed with monotherapy, especially resistance.” July 2016 PLK1 Inhibitors in Cancer Therapy: From La
Slide 9: PLK Inhibitor Landscape
PLK Inhibitor Landscape Drug/Company Drug Target(s) Development Stage Cancer Types Studied Status Volasertib1 Boehringer Ingelheim Non-specific (Pan) PLK1,2,3 Inhibitor Phase 3 (AML) AML Solid Tumors Failed Phase 3 trial due to infections, most likely the result of not administering prophylactic ant
Slide 10: Clinical Efficacy PLK Inhibitor Drug Class Experience
Clinical Efficacy PLK Inhibitor Drug Class Experience Increased response rate and improved survival in AML patients ineligible for intensive induction therapy Demonstrated response across all AML genetic subgroups and had a clinically manageable safety profile PLK Inhibition Increased Overall Surviv
Slide 11: PCM-075 – Highly-Selective for PLK1
PCM-075 – Highly-Selective for PLK1 Highly Selective Short Half-Life Acceptable Safety Profile Broad Applicability Orally Available
Slide 12: PCM-075 – Selective PLK1 Inhibitor
PCM-075 – Selective PLK1 Inhibitor Tested against >260 kinases and PLK1 was the only active target with IC50 of 2nM Selectivity driven by polar interaction with the carboxyl side chain of Glutamate 140 position of PLK11 1Data on File, Trovagene, Inc. Selective PLK1 Inhibitor Induces tumor cell death
Slide 13: PCM – Synergistic in Combination
PCM 075 – Synergistic in Combination High PLK1 expression is associated with the most aggressive forms of hematologic malignancies and solid tumor cancers PCM-075’s synergistic activity potentially enhances the efficacy of numerous standard-of-care therapies 1Alphabetical order. 2Preclinical data on
Slide 14: Acute Myeloid Leukemia (AML) Combination of PCM-075 with FLT3 Inhibitor
Acute Myeloid Leukemia (AML) Combination of PCM-075 with FLT3 Inhibitor Evaluation of Efficacy of PCM-075 for MV-4-11 Human Acute Myeloid Leukemia (AML) Xenograft Model in NOD.SCID Mice 1Kindler et al, Blood 2010; 116:5089-10. 2Stone et al, N Engl J Med 2017; 377:454-64. 3Data on File at Trovagene,
Slide 15: Why PCM-075
Why PCM-075 Characteristic Benefit PCM-075 Oral; 24-Hour Half-Life Enables sustaining drug levels without compromising safety ✓ Selective for PLK1 Provides highly-targeted therapy for G2/M cell-cycle division checkpoint Reversible, on-target side effects, consistent with the expected mechanism of ac
Slide 16: PCM-075 – AML
PCM-075 – AML Enhancing standard-of-care in patients ineligible for intensive induction therapy
Slide 17: Acute Myeloid Leukemia Market Opportunity
Acute Myeloid Leukemia Market Opportunity1 AML: aggressive hematologic malignancy Incidence: 20,000* new cases and 10,400 deaths annually in the U.S. Prognosis: 5 year survival rate is 25% Treatment options vary based on patient condition / age, but can include: Chemotherapy Radiation Stem cell tran
Slide 18: How PCM-075 Fits Within Treatment Pathway for Acute Myeloid Leukemia
How PCM-075 Fits Within Treatment Pathway for Acute Myeloid Leukemia AML Diagnosis 20,0001 cases/year Eligible for Induction Treatment 12,000 Relapse & Refractory 30-50% 4,000 to 6,000 TROV-052 Phase 1b/2 AML Study: to assess the safety and efficacy of PCM-075 in combination with standard-of-care Re
Slide 19: Compelling Pre-Clinical Data Supports Phase 1b/2 Study
Compelling Pre-Clinical Data Supports Phase 1b/2 Study Response observed in various xenograft models as a single agent and in combination1 Compound Median Survival Time (days) Placebo 28 Cytarabine 36 PCM-075 62* In Vivo Disseminated Leukemia Model (AML-NS8 Cells) Treatment with PCM-075 Started 20 D
Slide 20: Phase 1b/2 Study in Acute Myeloid Leukemia
Phase 1b/2 Study in Acute Myeloid Leukemia TROV-052 dose escalation; safety and efficacy in combination with standard-of care (n=74): NCT03303339 SCREENING DOSING (DAYS/CYCLE) PCM-075 Chemotherapy 1 11 - 28 Study Design Dose escalation (starting at 12 mg/m2) in Phase 1b with expansion cohort at maxi
Slide 21: Biomarker Assessment to Measure Drug Activity and Effect on Tumors
Biomarker Assessment to Measure Drug Activity and Effect on Tumors Biomarkers will be measured and correlated with pharmacokinetic drug levels to assess: Inhibition of PLK1 enzymatic activity by assessing inhibition of TCTP phosphorylation Blockage of cell division (G2/M arrest) Tumor DNA biomarkers
Slide 22: PLK1 Enzymatic Activity Biomarker for PCM-075 inhibition
PLK1 Enzymatic Activity Biomarker for PCM-075 inhibition1 PCM-075 (µM): 0 .01 .032 .1 .32 1 3 10 pTCTP Total TCTP 1Trovagene, data on file PLK1 activity: as measured by pTCTP (Translationally Controlled Tumor Protein) which is activated by PLK1 1Trovagene Data on file Vehicle (DMSO) PCM-075 Positive
Slide 23: Molecular Profiling and Patient Response
Molecular Profiling and Patient Response1 AML Genomic Subgroup Frequency of Patients Most Frequently Mutated Genes (%) DNA Panel RNA Panel NPM1 mutation 27% NPM1(100), DNMT3A(54), FLT3(39), NRAS(19), TET2(16), PTPN11(15) ✓ Mutated chromatin, RNA-splicing genes, or both 18% RUNX1(39), MLLPTD(25), SRS
Slide 24: PCM-075 – Solid Tumors
PCM-075 – Solid Tumors Combination therapy with chemo and targeted therapies to extend treatment response and overall survival
Slide 25: Successful Phase 1 Safety Study Completed in Solid Tumors
Successful Phase 1 Safety Study Completed in Solid Tumors* Phase 1 Study Design 19 of 21 patients enrolled administered PCM-075 orally, once daily for 5 consecutive days, every 3 weeks PCM-075 Study Results Included: colorectal, pancreatic, lung, sarcomas, hepatocellular, ampullary, prostate, ovaria
Slide 26: Metastatic Castration-Resistant Prostate Cancer (mCRPC) Market Opportunity
Metastatic Castration-Resistant Prostate Cancer (mCRPC) Market Opportunity 25,000 men progress to metastatic prostate cancer resistant to standard androgen-deprivation therapy, anually1 Five-year survival rate of 37%2 Risk of metastases increases as the disease progresses; most common metastases are
Slide 27: PCM-075 + Abiraterone Synergy
PCM-075 + Abiraterone Synergy PCM-075 plus abiraterone suggested increased sensitivity when compared to abiraterone alone, showing decreased viability of mCRPC tumor cells1 Combination appears to enhance the PCM-075 mechanism of action of arresting cells during mitosis1 There continues to be a large
Slide 28: PCM-075 Phase 2 mCRPC Clinical Trial
PCM-075 Phase 2 mCRPC Clinical Trial PCM-075 in Combination with Abiraterone and Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Principal Investigator – Dr. David Einstein, Beth Israel Deaconess Medical Center Open-label trial to evaluate safety and efficacy of P
Slide 29: PCM-075 Phase 2 mCRPC Clinical Trial Endpoints
PCM-075 Phase 2 mCRPC Clinical Trial Primary Endpoint Efficacy: To observe the effects of PCM-075 in combination with abiraterone and prednisone on disease control as assessed by prostate-specific antigen (PSA) decline or stabilization Exploratory Endpoints Pharmacodynamic biomarker evaluation and g
Slide 30: Looking Ahead
Looking Ahead ) trovagene
Slide 31: 2017 Milestones and 2018 Goals
2017 Milestones and 2018 Goals PCM-075 licensed from Nerviano Medical Sciences COMPLETED MILESTONES 2018 GOALS DATA PRESENTATION 2017 2018 Study: TROV-052 Phase 1b/2 AML study receives FDA ”may proceed” Study: TROV-052 Phase 1b/2 AML study initiation Study: TROV-053 Phase 2 mCRPC protocol submitted
Slide 32: Takeaways
Takeaways PLK1 is an established cancer target; the PLK inhibitor drug class has demonstrated clinical activity in AML PCM-075 is the only oral, selective PLK1 inhibitor to enter clinical trials 2 clinical studies: TROV-052 in AML and TROV-053 in mCRPC Preliminary clinical date in AML and mCRPC in 2
Slide 33: Thank you
Thank you for more information, please email: ir@trovagene.com