IDEAYA Biosciences, Inc. · NASDAQ:IDYA
IDEAYA Biosciences — Investor Day (December 2021)
25 slides from IDEAYA Biosciences's investor day presentation, Dec 7, 2021
Slide 1: Darovasertib Investor Day
Darovasertib Investor Day December 7, 2021 NASDAQ: IDYA IDEAYA Biosciences Improving Lives Through Transformative Precision Medicines
Slide 2: Safe Harbor Statement
Safe Harbor Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future financial performance of IDEAYA Biosciences, Inc. (the “Company”) and involve known and unknown risks, uncertainti
Slide 3: Welcome and Introduction
Welcome and Introduction Yujiro Hata – President and Chief Executive Officer IDEAYA Biosciences 3
Slide 4: Welcome to our Participants and Guest Speaker
Welcome to our Participants and Guest Speaker Darovasertib Investor Day – December 7, 2021 Meredith McKean, M.D. Sarah Cannon Research Institute at Tennessee Oncology, Associate Director, Melanoma and Skin Cancer Research 4
Slide 5: IDEAYA's Precision Medicine Oncology Pipeline
IDEAYA’s Precision Medicine Oncology Pipeline Building the Industry Leading Synthetic Lethality Focused Biotechnology Company Precision Medicine Pipeline Modality/Indication Biomarker Preclinical IND Enabling Phase 1 Phase 2 Program Goals Collaborations Commercial (IDEAYA) Monotherapy Cohort Expansi
Slide 6: Agenda
Agenda Welcome and Introduction Yujiro Hata, President and Chief Executive Officer Metastatic Uveal Melanoma (MUM): Clinical Landscape & Efficacy Benchmarks Matt Maurer, M.D., VP, Clinical Oncology and Medical Affairs Darovasertib (PKC) / Crizotinib (cMET) Synthetic Lethal: Mechanistic Rationale, Pr
Slide 7: Metastatic Uveal Melanoma: Clinical Landscape & Efficacy Benchmarks
Metastatic Uveal Melanoma (MUM): Clinical Landscape & Efficacy Benchmarks Matt Maurer, M.D., Vice President, Clinical Oncology and Medical Affairs IDEAYA Biosciences 7
Slide 8: Clinical Landscape
Clinical Landscape 1st Line MUM Study: HLA-A2 Positive (~40-50% of MUM population) Early Development Phase 1/2 • Targeted: FAKi + MEKi; FHD-286 (BRM / BRG1) • IO: Nivo + Rela (Lag3); Alrizomadlin (MDM2-P53) + Pembro; * LNS8801 (GPER agonist) +/- Pembro BLA – Pending FDA Review • Tebentafusp (IMCgp10
Slide 9: Darovasertib Monotherapy Overall Survival in Heavily Pre-Treated MUM
Darovasertib Monotherapy Overall Survival in Heavily Pre-Treated MUM Overall Survival favorable compared to Historical Pretreated Synthetic Control Arm 1,2 Baseline Characteristics N=81 (%) < 65 57 (70.4) Age >=65 24 (29.6) F 41 (50.6) Sex M 40 (49.4) 0 61 (75.3) ECOG PS 1 20 (24.7) Normal 26 (32.1)
Slide 10: Darovasertib / Crizotinib Synthetic Lethal: Mechanistic Rationale
Darovasertib (PKC) / Crizotinib (cMET) Synthetic Lethal: Mechanistic Rationale, Preclinical and Translational Data Mike White, Ph.D., Senior Vice President and Chief Scientific Officer IDEAYA Biosciences 10
Slide 11: Darovasertib PKCδ/ε Inhibitor in Uveal Melanoma
Darovasertib (IDE196) PKCδ/ε Inhibitor in Uveal Melanoma GNAQ/11 mutations (>90% UM) highjack PKC signaling for tumorigenic transformation Uveal Melanoma • Primary Uveal Melanoma is typically treated with radiation and/or enucleation • Metastatic Uveal Melanoma (MUM) occurs in approximately 50% of p
Slide 12: Synthetic Lethal Combination: Darovasertib (PKC) + Crizotinib (cMET)
Synthetic Lethal Combination: Darovasertib (PKC) + Crizotinib (cMET) In metastatic disease, cMET activation by liver-derived HGF may substitute for PKC signaling Metastatic Uveal Melanoma HGF HGF HGF HGF • High cMET expression is associated with metastatic cMET progression • HGF promotes cancer cell
Slide 13: Synthetic Lethal Combination: MET Signature Score
Synthetic Lethal Combination: Darovasertib (PKC) + Crizotinib (cMET) Translational Research supports Darovovasertib + Crizotinib Combination Clinical Phase 1 Data Association Preclinical Synergy * Clinical response to Darovasertib monotherapy *\ Darovasertib + Crizotinib synergy observed in associat
Slide 14: Phase 1/2 Combination: Clinical Efficacy and Adverse Event Profile
Darovasertib (PKC) / Crizotinib (cMET) Phase 1/2 Combination: Clinical Efficacy and Adverse Event Profile Meredith McKean, M.D., Sarah Cannon Research Institute at Tennessee Oncology, Associate Director, Melanoma and Skin Cancer Research 14
Slide 15: Darovasertib + Crizotinib Combination Safety Summary
Darovasertib + Crizotinib Combination Safety Summary Manageable Side Effect Profile (n=22 at Phase 1/2 Combination Expansion Dose) Low Rates of Drug Related SAEs Frequency of Drug-Related AEs (>10% Total) Safety Summary n=22 (%) Adverse Event Grade 1 Grade 2 Grade 3 Total * * Diarrhea 36% 36% 5% 77%
Slide 16: Preliminary Darovasertib + Crizotinib Phase 2 Expansion Dose Efficacy
Preliminary Darovasertib + Crizotinib Phase 2 Expansion Dose Efficacy Encouraging Clinical Activity in heavily pretreated Metastatic Uveal Melanoma Daro + Crizo Expansion Dose Cohort, n=16 with >1 post-BL scan Early Clinical PoC of PKC + cMET Synthetic Lethal 100% of patients observed tumor shrinkag
Slide 17: Darovasertib + Crizotinib Combination Preliminary Efficacy
Darovasertib + Crizotinib Combination Preliminary Efficacy Examples of Responses with significant Anti-Tumor Activity Patient Example 1 Patient Example 2 • 70+ year old patient with ongoing response at 6 months • 60+ year old patient with ongoing response at 4 months • Priors: Ipi+Nivo, Chemoemboliz
Slide 18: Potential Registrational Strategies and Evaluation of Expansion Opportunities
Darovasertib Potential Registrational Strategies and Evaluation of Expansion Opportunities Matt Maurer, M.D., Vice President, Clinical Oncology and Medical Affairs IDEAYA Biosciences 18
Slide 19: Darovasertib + Crizotinib SL Combination Therapy
Darovasertib + Crizotinib SL Combination Therapy Differentiated Novel Treatment Mechanism in MUM Darovasertib + Crizotinib Cabozantinib Selumetinib + Dacarbazine Tebentafusp Target / Mechanism PKC + cMET cMET MEK + Chemotherapy HLA-A2-0201 Bi-Specific Ab Study Name NCT03947385 Alliance A091201^ SUMI
Slide 20: Darovasertib Clinical Preferred Plan
Darovasertib Clinical Preferred Plan Potential Scenarios – Pending Regulatory Guidance H1 2022 Single-Arm Phase 2 Randomized Phase 2 Expansion of Current Single-Arm Trial in pretreated patients with New Randomized Phase 2 Trial further enrollment to registration-enabling combination arm in pretreate
Slide 21: PKC-cMET SL: Evaluation of Potential Indication Expansion Ongoing
PKC-cMET SL: Evaluation of Potential Indication Expansion Ongoing Additional MET-Amplified / MET High Expression Tumors PKC-epsilon and MET Amplified Tumors *\ • PKC-epsilon has been reported in literature to control HGF-dependent cMET traffic, signaling and cell migration • Evaluating potential opp
Slide 22: Population Analysis: GNAQ/11 Melanomas and Additional MET-Amplified Tumors
Darovasertib Population Analysis: GNAQ/11 Melanomas and Additional MET-Amplified / High Expression Tumors Paul Stone, Senior Vice President and Chief Financial Officer IDEAYA Biosciences 22
Slide 23: Patient Population Analysis
Darovasertib Patient Population Analysis GNAQ/GNA11 Melanoma & Additional MET-Amplified / High Expression Tumors Addressable GNAQ/11 Patients MUM, Adjuvant UM and GNAQ/11 Skin Melanoma * Patient Population (1000’s) • No FDA Approved Therapies for MUM or GNAQ/11-Tumors US / EU5 • Evaluating opportuni
Slide 24: Closing Remarks and Analyst Q&A
Closing Remarks and Analyst Q&A Yujiro Hata – President and Chief Executive Officer IDEAYA Biosciences 24
Slide 25: Closing Remarks – Darovasertib Investor Day
Closing Remarks – Darovasertib Investor Day Darovasertib (PKC) and Crizotinib (cMET) Synthetic Lethal (SL) Combination • Novel PKC plus cMET SL mechanism discovered in IDEAYA labs; Darovasertib is a potential 1st-in-class PKC inhibitor • Established early Ph 1/2 clinical proof-of-concept of PKC-cMET