IDEAYA Biosciences, Inc. · NASDAQ:IDYA
IDEAYA Biosciences — Investor Presentation (November 2024)
45 slides from IDEAYA Biosciences's investor presentation, Nov 11, 2024
Slide 1: IDEAYA Biosciences
November 2024 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 Precision Medicine Oncology Biotechnology Company Advancing Potential First-in-Class Therapies Broad Pipeline of 5 Clinical Programs with Multiple Target Milestones and Catalysts PHASE 2/3 PHASE 1/2 PHASE 1 PRECLINICAL DAROVASERTIB (PKC) IDE397 (MAT2A) IDE161 (P
Slide 4: Leading Functional Genomics and Synthetic Lethality Platform
Leading Functional Genomics and Synthetic Lethality Platform The Next Frontier in Precision Medicine Oncology Functional Genomics and Synthetic Lethality provides a powerful approach to discover novel precision medicine therapies with patient biomarkers, including MTAP-deletion (~15% of solid tumors
Slide 5: IDEAYA Precision Medicine Oncology Platform
IDEAYA Precision Medicine Oncology 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 Targe
Slide 6: IDEAYA Functional Genomics and Synthetic Lethality Platform
IDEAYA Functional Genomics and Synthetic Lethality Platform Novel Target and Biomarker Discovery and Validation Target and Biomarker Discovery & Validation Platform IDEAYA Functional Genomics Platform integrates proprietary and public data sets with orthogonal and complementary content Bioinformatic
Slide 7: IDEAYA Precision Oncology Drug Discovery Platform & IND Engine
IDEAYA Precision Oncology Drug Discovery Platform & IND Engine AI/ML & Structure Based Drug Design to Deliver Potential First-in-Class Development Candidates Structural Biology & Structure Based Drug Design AI/ML Enabled Computational Drug Discovery* Full suite of capabilities in structural biology,
Slide 8: IDEAYA's Potential First-in-Class Precision Medicine Oncology Pipeline
IDEAYA’s Potential First-in-Class Precision Medicine Oncology Pipeline Potential Commercial Modality/Indication Biomarker Pre-clinical IND Enabling Phase 1 Phase 2 Program Goals / Achievements Collaborations Registrational (IDEAYA) +cMET1 Combination Phase 2 (AA) / Phase 3 registrational trial ^ – G
Slide 9: Darovasertib – Potential to Broadly Impact Uveal Melanoma
Darovasertib Darovasertib – Potential to Broadly Impact Uveal Melanoma * Potential First-in-Class and Best-in-Class in (Neo)adjuvant 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 G
Slide 10: Daro + Crizo Phase 2 Efficacy: First-Line MUM and Any-Line MUM
Daro + Crizo Phase 2 Efficacy: First-Line MUM and Any-Line MUM Oral Presentation Compelling Overall Response Rate (ORR) by RECIST 1.1 Observed 60% Darovasertib + Crizotinib Phase 2 Confirmed 45% ORR and 90% DCR 50% Response by RECIST 1.1 Evaluable First-Line MUM (n= 20) Best Tumor Response (%) 40% F
Slide 11: Daro + Crizo Phase 2 Efficacy: HLA-A2-Negative and HLA-A2-Positive MUM
Oral Presentation Daro + Crizo Phase 2 Efficacy: HLA-A2-Negative and HLA-A2-Positive MUM Clinical Combination Observes Clinical Efficacy Irrespective of HLA-A2 Status HLA-A2 Negative (n=31) HLA-A2 Positive (n=19) * First-Line: 42% ORR; 100% DCR * First-Line: 60% ORR; 100% DCR Any-Line: 29% ORR; 94%
Slide 12: Observed 94% ctDNA Molecular Response Rate with Deep & Sustained MRs
Oral Presentation Observed 94% ctDNA Molecular Response Rate with Deep & Sustained MRs* Any-Line MUM Patients Treated with the Darovasertib + Crizotinib Combination Molecular Response Regardless of BAP1 Mutation Molecular Response Correlates with RECIST Response ^ * * Normalized ctDNA (log AUC / Tot
Slide 13: Median PFS in First-Line, Any-Line and Hepatic-Only MUM
Median PFS in First-Line, Any-Line and Hepatic-Only MUM Oral Presentation Observed Compelling Median Progression Free Survival with Encouraging Trend Any-Line MUM Swimlane Plot Darovasertib + Crizotinib Phase 2 Median Progression Free Survival • First-Line (n=20): 7.1 months • Any-Line (n=63): 6.8 m
Slide 14: 2-Year PFS Kaplan Meier Curve: Daro + Crizo in Any-Line MUM
2-Year PFS Kaplan Meier (KM) Curve: Daro + Crizo in Any-Line MUM* Daro + Crizo Combo Observes a Promising 2-Year PFS KM Curve and a “Long Tail” Effect 2-Year PFS Kaplan Meier Curves in MUM Daro + Crizo Any-Line MUM* • N=63 Tebentafusp 1L MUM (registrational trial)** • N=252 Tebentafusp Control Arm 1
Slide 15: Darovasertib + Crizotinib Combination Clinical Summary in MUM
Darovasertib + Crizotinib Combination Clinical Summary in MUM Highly Differentiated Clinical Efficacy & AE Profile Observed+, ++ Cabozantinib Mono / Darovasertib + Crizotinib Selumetinib + DTIC Ipi + Nivo Tebentafusp Crizotinib Mono Target / Mechanism PKC + cMET cMET MEK + Chemotherapy CTLA4 + PD1 H
Slide 16: Accelerated Approval Trial Design in First-Line HLA-A2 Negative MUM
Accelerated Approval Trial Design in First-Line HLA-A2 Negative MUM FDA Guided Design: Open Label Ph2/3 Evaluation of Daro + Crizo vs. Investigator's Choice ^ FDA Project FrontRunner: Target First-Line approval strategy to enhance patient benefit in MUM FDA Accelerated Approval: Address unmet need i
Slide 17: Darovasertib Neoadjuvant Therapy: Ph2 Company Sponsored & Ph2 IST UM Trials
Darovasertib Neoadjuvant Therapy: Ph2 Company Sponsored & Ph2 IST UM Trials 61% (19 of 31) Observed Eye Preservation and 49% (24 of 49) with >30% Tumor Reduction* 60.0 ~59% (29 of 49) observed >20% Tumor Reduction Clinical Efficacy (n=49) ~49% (24 of 49) observed ≥ 30% Tumor Reduction Evaluable Pati
Slide 18: Darovasertib Neoadjuvant Therapy: Swimlane Plot
Darovasertib Neoadjuvant Therapy: Ph2 Company Sponsored & Ph2 IST UM Trials Swimlane Plot (n=49)* Risk Assessment 61% (19 of 31) Eye Preservation Rate Observed in Enucleation Patients Typical time to ≥ 30% Tumor Shrinkage is ~2 Months Typical Time for Conversion from Enucleation to Plaque is ~5.5 Mo
Slide 19: Phase 2 Darovasertib Neoadjuvant UM IST Results in Enucleation Patients
Phase 2 Darovasertib Neoadjuvant UM IST Results in Enucleation Patients Oral Presentation Pre & Post Darovasertib Treatment Radiation Plaque Planning and Vision Implications Reduced Radiation to Critical Structures & Baseline & Post Baseline Measurements Plaque Treatment Plan Potential Improvement i
Slide 20: Darovasertib Neoadjuvant UM Phase 3 Trial Design for Regulatory Approval
Darovasertib Neoadjuvant UM Phase 3 Trial Design for Regulatory Approval Paradigm Shifting Opportunity to Save the Eye and Protect Vision Primary Endpoints* • Cohort 1: Time to Vision Loss • Cohort 2: Eye Preservation Primary Local Therapy (e.g. enucleation, plaque) Secondary Endpoints • Cohort 1 an
Slide 21: Darovasertib and Uveal Melanoma Patient Journey
Darovasertib and Uveal Melanoma Patient Journey High Unmet Need and Multiple First-Line Opportunities in UM and MUM* +95% of UM patients harbor GNAQ/GNA11 mutation Uveal Melanoma Patient Journey Neoadjuvant UM Adjuvant UM MUM Daro + Crizo No FDA Approved No FDA Approved Therapies* No FDA Approved Th
Slide 22: Annual Incidence of Pre-Metastatic UM
Annual Incidence of Pre-Metastatic UM* North America, Europe, and Australia High Unmet Need: No FDA-Approved Therapies for Pre-Metastatic Uveal Melanoma Projected Addressable UM Total Prevalence is Multiples of Annual Incidence Pre-Metastatic Uveal Melanoma z Others Small Tumors Medium Tumors Large
Slide 23: 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 Methylation Pathway Suppression in MTAP(-/-) Squamous Lung (LUSC) MTAP SDM
Slide 24: IDE397 Demonstrates Broad Efficacy across MTAP-Deletion PDX Models
IDE397 Demonstrates Broad Efficacy across MTAP-Deletion 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 Tu
Slide 25: IDE397: Phase 2 Potential First-in-Class MAT2A Inhibitor
IDE397: Phase 2 Potential First-in-Class MAT2A Inhibitor ~48k U.S. Annual Incidence in MTAP-Deletion NSCLC and Urothelial Cancer High Unmet Need: No FDA-Approved Therapies for MTAP-Deletion Solid Tumors U.S. Annual Incidence in Priority Tumor Types U.S. Annual Incidence in Potential Expansion Tumor
Slide 26: IDE397 Demonstrates Manageable Safety Profile at RP2D of 30mg QD
IDE397 Demonstrates Manageable Safety Profile at RP2D of 30mg QD Treatment-Emergent Adverse Events (TEAE) & Treatment-Related Adverse Events (TRAE) Treatment Emergent & Treatment Related Adverse Events in Safety Population, n= 28 Safety Profile Summary: • No treatment related TEAE (≥ 15%) TRAE disc
Slide 27: IDE397 Phase 2 Clinical Efficacy in MTAP-Deletion NSCLC & Urothelial Cancer
IDE397 Phase 1 Clinical Efficacy in MTAP-Deletion NSCLC & Urothelial Cancer Best Response by RECIST 1.1 at 30mg QD Phase 2 expansion dose* Efficacy by RECIST 1.1* ~ 33% ORR by RECIST 1.1 = 9 PR or CR out of 27 Evaluable Pts 27 9 of 9 responses have been confirmed Best Response, n (%) Best Response b
Slide 28: IDE397 Clinical Efficacy: Time on Treatment at 30mg QD
IDE397 Phase 1 Clinical Efficacy in MTAP-Deletion NSCLC & Urothelial Cancer Time on treatment at 30mg QD Ph2 Expansion Dose NSCLC & Urothelial Cancer Efficacy Evaluable Patients Treated at 30 mg (n=27)* Urothelial Cancer AdenoNSCLC Squamous NSCLC Complete Response Partial Response Stable Disease Pro
Slide 29: IDE397 Molecular Responses and ctDNA Reduction
IDE397 Phase 1 Clinical Efficacy in MTAP-Deletion NSCLC & Urothelial Cancer Molecular Responses and ctDNA reduction with IDE397 treatment ctDNA Analysis Summary: ctDNA Molecular Response (MR) Analysis (n=21)*, IDE397 30mg QD • ctDNA reduction observed 1 in all subjects with evaluable samples ~81% (1
Slide 30: IDE397 Confirmed CR by RECIST 1.1 in Urothelial Carcinoma Patient
IDE397 Confirmed CR by RECIST 1.1 in an Urothelial Carcinoma Patient With MTAP-Deletion Case Report and CT-Scan Images Baseline Characteristics: Urothelial CA with MTAP-Deletion: Maintained Complete Response at Week 18 60+ years old male urothelial Baseline Week 18 carcinoma Treatment History: • Neo
Slide 31: IDE397 Confirmed PR by RECIST 1.1 in Urothelial Cancer Patient
IDE397 Confirmed PR by RECIST 1.1 in Urothelial Cancer Patient with MTAP-Deletion Case Report and CT-Scan Images Baseline Characteristics: Urothelial Cancer MTAP-Deletion Patient: Partial Response at Week 6 70+ years old male with urothelial cancer with MTAP- Baseline Week 6 deletion Treatment Histo
Slide 32: IDE397 Confirmed PR by RECIST 1.1 in Adeno NSCLC Patient
IDE397 Confirmed PR by RECIST 1.1 in Adeno NSCLC Patient with MTAP-Deletion and KRAS G12D Mutation Case Report and CT-Scan Images Baseline Characteristics: NSCLC MTAP-Deletion Patient: Partial Response at Week 18 70+ years old Adeno NSCLC male w/ MTAP-KRAS G12D Baseline Week 18 Treatment History: •
Slide 33: IDE397 + Sacituzumab Govitecan Confirmed Partial Response in Urothelial
IDE397 + Sacituzumab Govitecan Confirmed Partial Response by RECIST 1.1 in Urothelial with MTAP-Deletion and FGFR3-TACC3 Fusion Case Report and CT-Scan Images Baseline Characteristics: Urothelial Cancer MTAP-Deletion Patient: Partial Response at Week 12 CT-Scan 60+ years old male with Baseline Week
Slide 34: IDE397 + SG Observed Rapid >95% ctDNA Reduction
IDE397 + Sacituzumab Govitecan Observed Rapid >95% ctDNA Reduction in Urothelial Cancer with MTAP-Deletion Molecular Responses and ctDNA reduction with IDE397 + SG treatment ctDNA Analysis Summary: ctDNA Molecular Response (MR) Analysis (n=2)* 1 • 2 of 2 Urothelial Cancer MTAP-deletion patients on 1
Slide 35: IDE397 Clinical Combination Strategy in MTAP-Deletion NSCLC
IDE397 Clinical Combination Strategy in MTAP-Deletion NSCLC Phase 1 Study of IDE397 + AMG 193 (Amgen PRMT5) Clinical Combination Enrolling IDE397 + MTA-Cooperative PRMT5i Alternative mRNA Splicing Analysis Preclinical Efficacy IDE397 + MTA-Cooperative PRMT5 Inhibitor Blank Combination IXCH Highly Pe
Slide 36: TRODELVY + IDE397 Combination in MTAP-Deletion Urothelial Cancer
TRODELVY® + IDE397 Combination in MTAP-Deletion Urothelial Cancer Disordered methionine metabolism underpins IDE397 combination opportunity with TOP1i-based ADC IDE397 perturbs both nucleotide pools and mRNA splicing in MTAP-/- cells Metabolic perturbation by IDE397 IDE397 provokes DDR selectively i
Slide 37: IDE397 Phase 1/2 Clinical Development Plan in MTAP-Deletion Solid Tumors
IDE397 Phase 1/2 Clinical Development Plan in MTAP-Deletion Solid Tumors Strategic Focus in Select Monotherapy Indications and High Conviction Clinical Combinations IDE397 is strategically well positioned to evaluate both monotherapy and clinical IDE397 – Clinical Profile combinations in MTAP-deleti
Slide 38: IDE161: Potential First-in-Class Phase 1 PARG Inhibitor
IDE161: Potential First-in-Class Phase 1 PARG Inhibitor PARG inhibition is synthetic lethal with HRD/replication stress PARG Inhibition is Mechanistically Distinct from PARPi IDE161 is a potent and selective PARG inhibitor Induction of DNA damage, persistent replication stress and checkpoint activat
Slide 39: IDE161: TOP1-Payload ADC Combo Rationale
IDE161: Potential First-in-Class Phase 1 PARG Inhibitor TOP1-Payload ADC Combo Rationale & Potentially Broad Development Opportunity High conviction mechanistic rationale for PARG + Top1 Payload ADCs Robust combo efficacy with TOP1i in lung cancer CDX models blank blank 3000 Vehicle, PO IDE161 100 m
Slide 40: IDE034: Potential First-in-Class B7H3/PTK7 TOP1i Payload Bi-Specific ADC
IDE034: Potential First-in-Class B7H3/PTK7 TOP1i Payload Bi-Specific ADC Dual Tumor-Associated Antigen Targeting for Potential Enhanced Therapeutic Window IDE034: B7H3/PTK7 Bispecific Ab-TOP1i ADC* B7H3+/PTK7+ Expression PDX Model Mean Tumor Volume (mm3) ± S.E.M. Anti-B7-H3 Anti-PTK7 3000 2500 2000
Slide 41: IDE161 Phase 1/2 Clinical Development Plan in HRD Solid Tumors
IDE161 Phase 1/2 Clinical Development Plan in HRD Solid Tumors Strategic Focus in Endometrial, Colorectal, Prostate, Breast & Other Solid Tumor Types IDE161 Phase 1/2 – Monotherapy and Combination Clinical Development Plan Preliminary IDE161 monotherapy clinical efficacy observed, including RECIST I
Slide 42: IDE705 (GSK101): Potential First-in-Class Pol Theta Helicase Inhibitor
Pol Theta IDE705 (GSK101) : Potential First-in-Class Pol Theta Helicase Inhibitor Phase 1 in Combination with Niraparib (PARPi) Pol Theta Helicase In Vivo Activity BRCA 1/2 Clinical Reversions Clinical Development Strategy IDE705(GSK101) + PARPi BRCA Reversions Mediated by MMEJ Pol Theta Helicase PA
Slide 43: IDEAYA's AI/ML Enabled Drug Discovery Platform and IND-Engine
IDEAYA’s AI/ML Enabled Drug Discovery Platform and IND-Engine IND Clearance and Multiple Potential First-in-Class Development Candidates (DCs) Targeted in Q4 2024 WRN Helicase Multi-Pronged Strategy in MTAP-/- AI/ML-Enabled IND-Engine blank k k Target Discovery IDE275 (GSK959) Werner Helicase Next G
Slide 44: IDE275 (GSK959): Potential First-in-Class Werner Helicase Inhibitor
Werner IDE275 (GSK959): Potential First-in-Class Werner Helicase Inhibitor IND Clearance for Phase 1 Trial Werner Helicase Synthetic Lethal with High-MSI Werner Helicase Inhibitors Phenocopy Genetic SL in MSI-High Cancers Nanomolar Potency, Biochemical and Cellular Activity, and Selectivity over oth
Slide 45: Building a Fully-Integrated Biotech in Precision Medicine Oncology
Building a Fully-Integrated Biotech in Precision Medicine Oncology Foundational Potential First-in-Class Clinical Pipeline and Drug Discovery Platform CLINICAL PROGRAMS DEVELOPMENT CANDIDATES PRECLINICAL PROGRAMS Ph 2/3 – Darovasertib 1 Targeting Multiple DCs in H2 2024, Ph 2 – IDE397 (MAT2A) 1 incl
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