Ideaya Biosciences, Inc. · NASDAQ:IDYA
Ideaya Biosciences — Investor Presentation (March 2023)
33 slides from Ideaya Biosciences's investor presentation, Mar 7, 2023
Slide 1: IDEAYA Biosciences: Improving Lives Through Transformative Precision Medicines
March 2023 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: IDEAYA Biosciences Highlights
IDEAYA Biosciences Highlights Leading Synthetic Lethality (SL) focused biotechnology company advancing transformative precision medicine therapies for cancer patients • Broad Pipeline of Key Emerging Targets • 2023 Target Catalysts - Clinical Ph2: Darovasertib (PKC) Darovasertib (PKC) / Crizotinib
Slide 4: Synthetic Lethality
Synthetic Lethality The Next Frontier in Precision Medicine Oncology Synthetic Lethality provides a powerful approach to discover novel precision medicine therapies with patient biomarkers, including MTAP-deletion (~15% of solid tumors), BRCA/HRD (Breast, Prostate, Ovarian, Others), and high-MSI (15
Slide 5: IDEAYA Leadership Team and Scientific Advisory Board
IDEAYA Leadership Team and Scientific Advisory Board Experienced Team & Scientific Thought Leaders in Precision Medicine Oncology IDEAYA Executives & R&D Leadership Yujiro Hata, M.B.A. Darrin Beaupre, M.D., Ph.D. Michael White, Ph.D. Paul Stone, J.D. Chief Executive Officer, Director Chief Medical O
Slide 6: IDEAYA Synthetic Lethality Platform
IDEAYA Synthetic Lethality Platform Fully-Integrated Target, Biomarker, Drug Discovery and Translational Capabilities Translational Research and Opportunity Expansion Drug Discovery and Genomics – DNA and RNA Analysis Pharmacological Validation Proteomics – Protein Expression Profiling SL Target & B
Slide 7: IDEAYA Synthetic Lethality Platform
IDEAYA Synthetic Lethality Platform Synthetic Lethality Target and Biomarker Discovery and Validation Synthetic Lethality Target Discovery & Validation Platform IDEAYA SL Platform integrates extensive proprietary and public data sets with orthogonal and complementary content Bioinformatic analysis e
Slide 8: IDEAYA Synthetic Lethality Drug Discovery Platform
IDEAYA Synthetic Lethality Drug Discovery Platform Structure-Based Drug Design & Proprietary Chemical Library Enable “Hard to Drug” Targets Structural Biology & Structure Based Drug Design INQUIRE™ Proprietary Chemical Library Full suite of capabilities in structural biology, Expert-curated HTS libr
Slide 9: IDEAYA's Precision Medicine Oncology Pipeline
IDEAYA’s Precision Medicine Oncology Pipeline Building the Industry Leading Synthetic Lethality Focused Biotechnology Company Precision Medicine Pipeline Pre- IND Potential Modality/Indication Biomarker clinical Enabling Phase 1 Phase 2 Registrational Program Goals Collaborations Commercial (IDEAYA)
Slide 10: Darovasertib – Potential to Broadly Impact Uveal Melanoma
Darovasertib Darovasertib – Potential to Broadly Impact Uveal Melanoma Potential * First-in-Class and Best-in-Class in Neoadjuvant UM and Metastatic UM Mutations in GNAQ / GNA11 activate PKC Signaling, a genetic driver of Uveal Melanoma Darovasertib is an oral, potent and selective PKC inhibitor GNA
Slide 11: Darovasertib + Crizotinib – Clinical Experience in Heavily Pretreated MUM
Darovasertib + Crizotinib – Clinical Experience in Heavily Pretreated MUM Observed Unprecedented ORR% and DCR% with Potential First-Line Differentiation First-Line MUM (n=8 Evaluable): 50% ORR with 75% DCR First-Line MUM * Evaluable (n=8) Any-Line MUM (n=35 Evaluable): 31% ORR with 83% DCR ORR (4/8)
Slide 12: Darovasertib + Crizotinib Combo Phase 2 Clinical Efficacy
Darovasertib + Crizotinib Combo Phase 2 Clinical Efficacy Encouraging mPFS and mDOR in 1L and Any-Line MUM versus Historical Data in MUM Darovasertib + Crizozotinib Any-Line MUM (n=35) Clinical Efficacy Summary in Any-Line and First-Line MUM Median Study Follow-Up * • Any-Line: 7.8 months • First-Li
Slide 13: Darovasertib + Crizotinib Synthetic Lethality Combination Therapy
Darovasertib + Crizotinib Synthetic Lethality Combination Therapy Differentiated Clinical Efficacy in MUM+, ++ Targeting Ph 2 Clinical Data Update for Daro + Crizo Combination in First-Line MUM (ORR, PFS, n=~20) in Mid-2023 ## Darovasertib + Crizotinib Cabozantinib Selumetinib + Dacarbazine Tebentaf
Slide 14: Darovasertib + Crizotinib Clinical Development Plan in First-Line MUM
Darovasertib + Crizotinib Clinical Development Plan in First-Line MUM FDA Meeting on Potential Registration Enabling Trial Design in Q1 20231 Clinical Development Approach Randomized Integrated Phase 2/3 - Strategic Objectives • Optimize Probability of Success and Timing to Potential Approval Random
Slide 15: Darovasertib Monotherapy in Neoadjuvant Primary Uveal Melanoma
Darovasertib Monotherapy in Neoadjuvant Primary Uveal Melanoma High Unmet Need with Opportunity to Improve Patient Outcomes IDEAYA Phase 2 and IST ongoing to evaluate Darovasertib Current Treatment Approach following diagnosis of UM Phase 2 Study for (Neo)Adjuvant UM depends on tumor size and locati
Slide 16: Preliminary Clinical Proof-of-Concept for Darovasertib in (Neo)Adjuvant UM
Preliminary Clinical Proof-of-Concept for Darovasertib in (Neo)Adjuvant UM Observed 100% Tumor Reduction by RECIST in Primary Eye Lesion ^ Darovasertib Neoadjuvant Uveal Melanoma Reduction in Primary UM Lesions Treated with Darovasertib in UMφ or in Combination with Crizotinib in MUM • All primary o
Slide 17: Market Opportunity: Primary and Metastatic Uveal Melanoma
Market Opportunity: Primary and Metastatic Uveal Melanoma (Neo)Adjuvant Treatment Represents Substantial Expansion Opportunity for Darovasertib Uveal Melanoma (UM) – Darovasertib Clinical Strategy Market Landscape Overview in UM / MUM Uveal Melanoma (UM) Neoadjuvant Clinical Trials in Neoadjuvant UM
Slide 18: MAT2A Inhibition is Synthetic Lethal with MTAP Deletion
MAT2A MAT2A Inhibition is Synthetic Lethal with MTAP Deletion Strategies to address MTAP-/- Prevalence in ~15% of all Solid Tumors MTAP-MAT2A Synthetic Lethality Biology Endogenous Suppression in MTAP-/- PDX Models Methionine Robust association of MTAP-/- with partial MTAP Methylation Pathway Suppre
Slide 19: IDE397 demonstrates Broad Efficacy across MTAP-deficient PDX Models
IDE397 demonstrates Broad Efficacy across MTAP-deficient PDX Models Deep Regressions observed in NSCLC-squamous (LUSC), Esophageal and Bladder Cancers IDE397 Efficacy: 47 MTAP-/- PDX Models IDE397 In Vivo Efficacy in LUSC PDX Models TGI with IDE397 (30mpk) in MTAP-/- PDX Panel Blank blank Observed T
Slide 20: IDE397 Clinical Data Summary – Monotherapy Dose Escalation Cohorts
IDE397 Clinical Data Summary – Monotherapy Dose Escalation Cohorts ctDNA Molecular Response demonstrates Tumor Pharmacodynamic Modulation Molecular Response Waterfall (Baseline to C2D1) 586 135 97 100 90 80 76 = Cohort 5 and 6 Dose ctDNA Molecular Response: 70 = Cohort 1 to 4 Dose IDE397 Dose-Depend
Slide 21: MAT2Ai Combination Strategy
MAT2Ai Combination Strategy Clinical Combination focus on IDE397 + PRMT5MTA based on Compelling Preclinical Efficacy IDE397 + MTA-Cooperative PRMT5 Inhibitor enables Maximal Pathway Suppression* IDE397 + MTA-Cooperative PRMT5i Methionine * NSCLC MTAP-/- CDX Model Maximal Pathway Vehicle Suppression
Slide 22: IDE397 Phase 1/2 Clinical Development Plan
IDE397 Phase 1/2 Clinical Development Plan Clinical Strategy Focus on Select Monotherapy and High Conviction Combination IDE397 Development Candidate – Clinical Profile • Exposure-Dependent Pharmacokinetic (PK) Profile with low Cmax:Cmin • Monotherapy Expansion at Projected Clinically Active Dose *
Slide 23: IDEAYA's Potential First-in-Class Synthetic Lethality DDR Pipeline
IDEAYA’s Potential First-in-Class Synthetic Lethality DDR Pipeline Synthetic Lethality with Tumor-Promoting defects in DNA Repair Mechanisms IDE161 Pol Theta φ Werner φ PARG Inhibitor Helicase Inhibitor Helicase Inhibitor Clinical Candidate Development Candidate Preclinical Lead-Optimization Targeti
Slide 24: PARG Inhibition is Synthetic Lethal with HRD
PARG PARG Inhibition is Synthetic Lethal with HRD Novel, Mechanistically-Differentiated Target in a Clinically Validated Pathway PARG Activity is required to resolve DNA Repair PARG Inhibition is Mechanistically Distinct from PARPi Replication Stress Mechanisms of Tolerance PARGi PARPi ↓ ↓ Fork Reve
Slide 25: IDE161: Potential First-in-Class Phase 1 PARG Inhibitor
IDE161: Potential First-in-Class Phase 1 PARG Inhibitor IDE161 Profile: Potent, Selective with Favorable Properties IDE161 induces PAR Accumulation and Selective DDR Blank IDE161-induced Cellular PAR Accumulation • IDE161 is a potent, selective small molecule PARGi for tumors with HRD MSD PAR Assay
Slide 26: IDE161 shows Selective Sensitivity in HRD and Differentiation from PARPi
IDE161 shows Selective Sensitivity in HRD and Differentiation from PARPi IDE161 Sensitivity Profile in Cell Panel IDE161 Selective Sensitivity vs PARPi IDE161 Sensitivity in HRD Breast Cancer *Cellular response profiles reveal mechanistic * HRD cell lines are selectively sensitive * Response to IDE1
Slide 27: IDE161 is Active and Well-Tolerated in HRD ER+ Her2- Breast Cancer Models
IDE161 is Active and Well-Tolerated in HRD ER+ Her2- Breast Cancer Models Observed PARG inhibitor Activity is Distinct from PARP Inhibition Durable Disease Control in BRCA-altered Breast Cancer CDX Regression in BRCA-altered Breast Cancer PDX Models • * Durable regressions (vs ER+ / Her2- Breast Can
Slide 28: IDE161 Demonstrates Favorable Safety Profile in Preclinical Studies
IDE161 Demonstrates Favorable Safety Profile in Preclinical Studies Non-Clinical Pharmacology and Toxicology Studies Support Clinical Evaluation IDE161 Differentiates versus PARPi in Nonclinical Safety Studies • IDE161 well tolerated PARP inhibition causes myelosuppression in rat and dog at clinical
Slide 29: IDE161 Clinical Development Strategy
IDE161 Clinical Development Strategy First-in-Class Opportunity for Patients with Breast, Ovarian & Other Solid Tumors with HRD IDE161 Phase 1/2 – Mono Clinical Development Plan and Combination Options * IDE161 Monotherapy Dose Escalation and Expansion in HRD Tumors Dose Escalation Expansion Cohort:
Slide 30: Polymerase Theta (Pol Theta) Synthetic Lethality Program
Pol Theta Polymerase Theta (Pol Theta) Synthetic Lethality Program First-in-Class Helicase Inhibitor is Synthetic Lethal to HR and NHEJ Perturbation Role of Pol Theta in Tumor Biology Pol Theta Inhibitor Drug Discovery Pol Theta Inhibitor Synergy in HRD Pol Theta is an error-prone multi-domain Disco
Slide 31: Pol Theta Helicase Synthetic Lethality Program
Pol Theta Helicase Synthetic Lethality Program Targeting First-in-Human Phase 1 Clinical Trial Initiation in H1 2023 Pol Theta Helicase In Vivo Activity BRCA 1/2 Clinical Reversions Clinical Development Strategy Pol Theta Helicase Inhibitor + PARPi BRCA Reversions Mediated by MMEJ Pol Theta Helicase
Slide 32: Werner Helicase is Synthetic Lethal with Microsatellite Instability
Werner Werner Helicase is Synthetic Lethal with Microsatellite Instability Targeting Development Candidate in 2023 Werner Helicase Inhibitors Phenocopy Genetic SL in MSI-High Cancers In Vivo Efficacy in Xenograft Models Nanomolar Potency, Biochemical and Cellular Activity, and Selectivity over other
Slide 33: Synthetic Lethality Focused Precision Medicine Oncology Biotech
Synthetic Lethality Focused Precision Medicine Oncology Biotech First-in-Class Synthetic Lethality Pipeline and Leading SL Platform Broad Pipeline of Potential First-in-Class Synthetic Lethality Programs with large addressable patient populations in major solid tumor types, including Phase 2 (Darova
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