Cardiff Oncology, Inc. · NASDAQ:CRDF
Cardiff Oncology — Trovagene — Corporate Update (October 2018)
20 slides from Cardiff Oncology's corporate update, Oct 24, 2018
Slide 1: Company Update, October 24th, 2018
Company Update Wednesday, October 24th, 2018 Exhibit 99.1
Slide 2: Licensed Drug Candidate from NMS: Onvansertib, a PLK1 Inhibitor
Licensed Drug Candidate from NMS Onvansertib – Polo-like Kinase 1 (PLK1) Inhibitor Largest oncology research and development company in Italy Developed anthracycline class of drugs (doxorubicin) Leader in protein kinase drug development (Polo-like Kinase Inhibitors) Identification and validation of
Slide 3: Nerviano Oncology Portfolio Success
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 Onvansert
Slide 4: Onvansertib: First-in-Class 3rd Generation PLK1
Onvansertib First-in-Class 3rd Generation PLK1 Best-in-Class Attributes
Slide 5: Strategy for Oncology Drug Development
Strategy for Oncology Drug Development Taking a precision cancer medicine approach to develop Onvansertib (PCM-075) Leveraging a proven cancer target, PLK1 Incorporating predictive clinical biomarkers Combining Onvansertib with already approved drugs Phase 1b/2 trial of Onvansertib + cytarabine or d
Slide 6: Clinical Development Roadmap
Clinical Development Roadmap Acute Myeloid Leukemia Prostate Cancer Colorectal Cancer
Slide 7: Orphan Drug Designation (ODD) in AML
Orphan Drug Designation (ODD) in AML In the U.S. and Europe Regulatory and Financial Incentives Market Exclusivity
Slide 8: Japan Partnering Initiative
Japan Partnering Initiative Complementary therapeutic combination with already approved drug Enhance efficacy and market sustainability
Slide 9: Ongoing Phase 1b/2 Clinical Trial in AML
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 Endp
Slide 10: Biomarker Strategy in AML
Biomarker Strategy in AML Biomarkers will be measured and correlated with pharmacokinetic drug levels to assess: Treatment effects by measuring % blast cells in blood and bone marrow Inhibition of PLK1 by Onvansertib (Target Engagement) Correlating underlying tumor genetics with treatment response G
Slide 11: Onvansertib Phase 1b AML Trial
Onvansertib Phase 1b AML Trial % of Leukemic Cells in Blood Onvansertib + LDAC Onvansertib + Decitabine %Leukemic Cells in Bone Marrow (Trovagene analysis) LDAC Decitabine %Leukemic Cells in Bone Marrow (Clinical site analysis) LDAC Decitabine
Slide 12: Target Engagement: Monitoring PLK1 Inhibition Upon Treatment
Target Engagement: Monitoring PLK1 Inhibition Upon Treatment TCTP PLK1 TCTP P No Onvansertib P Onvansertib PLK1 TCTP TCTP Onvansertib P Onvansertib inhibits PLK1 kinase activity resulting in reduction in PLK1 substrates phosphorylation; Translational Control Tumor Protein (TCTP) is phosphorylated by
Slide 13: Ongoing Phase 2 Clinical Trial in mCRPC
Ongoing Phase 2 Clinical Trial in mCRPC Efficacy Endpoints Effect of Onvansertib in combination with Zytiga®/prednisone on disease control assessed by prostate-specific antigen (PSA) decline or stabilization pre- and post-treatment Safety Endpoint Safety of Onvansertib in combination with Zytiga®/pr
Slide 14: PLK1 and Abiraterone Acetate (Zytiga) in mCRPC
PLK1 and Abiraterone Acetate (Zytiga®) Metastatic Castration-Resistant Prostate Cancer (mCRPC) All metastatic prostate cancer patients become castration-resistant PLK1 dependent microtubule dynamics promotes androgen receptor (AR) signaling1,2 PLK1 inhibition improves abiraterone efficacy3 Inhibitio
Slide 15: PSA: NCCN Recommended Biomarker for mCRPC
PSA: NCCN Recommended Biomarker Trial Eligibility and Efficacy for mCRPC1 PSA is a validated biomarker assessing disease stability or progression Prostate Cancer Clinical Trials Working Group (PCWG)1 has set criteria for the use of blood PSA levels: Trial eligibility (defining progression) Initial a
Slide 16: Biomarker Strategy in mCRPC
Biomarker Strategy in mCRPC PSA Assessment of Disease Control CTCs Baseline Genomic Correlations with Response Tissue Baseline Tumor Profiling for Predicting Synergy PBMC’s Assess PLK1 Target Inhibition ctDNA Dynamic Changes Associated with Treatment
Slide 17: Colorectal Cancer: Unmet Need in mCRC
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 wild-type: FOLFOX/FOLFIRI + AntiEGFR therapy ~50% mCRC is RAS mutant (KRAS): FOLFOX/FOL
Slide 18: Onvansertib in Pre-Clinical CRC: Synergy with Irinotecan
Onvansertib in Pre-Clinical CRC Synergy with Irinotecan In vitro: CRC cell lines are sensitive to Onvansertib: 25/27 cell lines tested had an IC50<1uM and 10 had an IC50<0.1uM Onvansertib is synergistic with paclitaxel, cisplatin, SN-38 and irinotecan In-vivo: Onvansertib inhibits tumor growth of CR
Slide 19: Value Creation Milestones
Value Creation Milestones In our Acute Myeloid Leukemia trial (AML): We anticipate reaching our maximum tolerated dose and recommended Phase 2 dose within the next couple of months; Enrolling patients in Phase 2 in the first half of 2019; Providing efficacy and safety data readouts throughout the ye
Slide 20: For additional information or questions please contact
For additional information or questions please contact: ir@trovagene.com