Sutro Biopharma, Inc. · NASDAQ:STRO
Sutro Biopharma — Luvelta Forum (January 2024)
38 slides from Sutro Biopharma's conference presentation, Jan 4, 2024
Slide 1: Luvelta Forum
Luvelta Forum Sutro Biopharma January 4th, 2024 1 NON CONFIDENTIAL
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation and the accompanying oral presentation contain “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than state
Slide 3: Today’s Agenda and Speakers
Today’s Agenda and Speakers Sutro Management Guest Speaker William J. Newell, J.D. Overview of Sutro and Luvelta Bradley Monk, M.D. Chief Executive Officer Professor, the Division of Gynecologic Oncology, University of Arizona College of Medicine and Creighton University Luvelta Clinical School of M
Slide 4: Luvelta: Exemplifies Sutro’s Innovation in ADC Development
Luvelta: Exemplifies Sutro’s Innovation in ADC Development Next-Generation ADCs Cell-free XpressCF® Luvelta FolRα-targeting ADC: A Have the Potential to Improve Proven Technology and Pipeline-in-a-Drug Opportunity Clinical Outcomes and Partnership Model Combinability • Promising clinical activity ha
Slide 5: Luvelta: Potential for Significant Commercial Opportunities
Luvelta: Potential for Significant Commercial Opportunities, Initially in Ovarian Cancer and Expanding to Additional FolRα Expressing Cancers Luvelta Potentially Doubles the Estimated Annual Incidence in FolRα-Expressing Patient Populations Addressable PROC Patients (U.S., Europe and Japan) Percent
Slide 6: Luvelta: Potential to Change the Treatment Landscape for FolRα Expressing Cancer
Luvelta: Potential to Change the Treatment Landscape for Patients with FolRα Expressing Cancer Precisely Designed ADC for Wide Therapeutic Index Potential to be Studied-to-date in Hemiasterlin payload first-to-market for 180+ patients across PROC patients with three indications • Tubulin Inhibitor l
Slide 7: Luvelta: Strategic Development Plan
Luvelta: Strategic Development Plan Aimed at Realizing the Full Potential Therapeutic Area Preclinical Phase 1/1B Phase 2/3 2024 Milestones • Part 1: LPI – 1H REFRαME-O1 Registrational Trial • Part 2: Open EU Sites– 2H Dose Escalation Complete Phase 1 program Ovarian Dose Expansion supported initiat
Slide 8: Clinical Overview
Clinical Overview 8 NON CONFIDENTIAL
Slide 9: Registrational Strategy Supported by Clinical Data from ~100 Treated Patients
Luvelta Registrational Strategy Supported by Clinical Data from ~100 Treated Patients Across all Doses Maximum Reduction in Tumor Target Lesions in RECIST-Evaluable Patients (N=92 Evaluable) 20% 3 in 5.2, 2 in 4.3, 2 in <=2.9, and 1 in >=5.6mg/kg -30% Partial response Ovarian Cancer Patients Total (
Slide 10: Compelling Anti-Tumor Activity and Tolerable Safety in Ovarian Cancer
Luvelta Demonstrated Compelling Anti-Tumor Activity and Tolerable Safety Broadly in Ovarian Cancer Phase 1: Phase 1: Dose Escalation Dose Expansion Escalation Combo w/ Bevacizumab Signal Seeking Plus G-CSF (Neutropenia Mgt) N = 39 N = 18 N = 44 N = 16 Optimal dose range Tolerable and active Establis
Slide 11: Substantial Improvement over Chemotherapy in PROC with TPS ≥25%
Luvelta Substantial Improvement over Chemotherapy (Historical Data) in Women with PROC with TPS ≥ 25% Maximum Reduction in Tumor Target Lesions in RECIST-Evaluable Patients (N=43) Luvelta 20% ORR = 28% DOR = 5.7 months PFS = 5.8 months Partial response -30% Historicial Chemo Starting dose, Q3W Data1
Slide 12: Monotherapy Safety Profile Manageable with Low Discontinuation Rate
Luvelta Monotherapy Safety Profile has been Manageable with Low Discontinuation Rate due to Neutropenia TEAEs (N=99) Neutropenia Preferred Term All Grade Grade 3+ • Primarily uncomplicated (febrile neutropenia < 5%) Incidence ≥35% Patients reporting at least one event 99 (100.0%) 86 (86.9%) • Well m
Slide 13: Registration Pathway
Registration Pathway 13 NON CONFIDENTIAL
Slide 14: Peds RAM-AML Positioned for Potential PRV; Trial Designs
Luvelta: Peds RAM-AML Strategically Positioned for Potential PRV and Accelerates Market Entry and Commercial Readiness for OC Eligibility Dose Finding Dose Expansion Key Endpoints • Relapsed/Refractory N = 3-6 • Complete remission (CR) 3.5 mg/kg rate CBFA2T3::GLIS2 AML IV q2w Lead in Dose • ≥ 5% Bon
Slide 15: Global REFRαME-O1 Trial Well Underway
Global REFRαME-O1 (GOG-3086 and ENGOT-79ov) Trial Well Underway Active Countries Planned Sites Trial Sites & Enrollment Austria (4)** Italy (14)** Australia (3/5)* 26 active sites across 5 countries Belgium (5)** New Zealand (3)** Canada (1/10)* Czech Republic (5)** Poland (4)** Targeting ~140 activ
Slide 16: Ability to Treat 8 out of 10 Women with Ovarian Cancer
Luvelta Demonstrated the Ability to Treat 8 out of 10 Women with Ovarian Cancer Due to FolRα expression ≥25% Treatment Eligibility is Driven Comparison of Potential Luvelta Population by FolRα Biomarker Test with Approved ADC Population Luvelta has demonstrated clinical activity in PROC patients TPS
Slide 17: Cohort with G-CSF: Designed to Effectively Manage Tolerability
Cohort with G-CSF: Designed to Effectively Manage Tolerability 17 NON CONFIDENTIAL
Slide 18: Safety Data to Mitigate High-grade Neutropenia with G-CSF
Designed to Provide Safety Data to Mitigate High-grade Neutropenia at Higher Dose with G-CSF in REFRaME-O1 Patient Baseline Characteristics Patient Status Total Patients Enrolled (N = 16) Ovarian Cancer Patients Total (N = 16) 5.2 mg/kg + G-CSF on D8 / Cycle Median age, years (range) 66 (36–86) Med
Slide 19: Prophylactic G-CSF Demonstrated Effective Reduction of Neutropenia
Use of Prophylactic G-CSF on Day 8 with 5.2mg/kg Dose Demonstrated Effective Reduction of Neutropenia Maximum Reduction in Tumor Grade 3+ Neutropenia Cohort A1 vs. Cohort with G-CSF2 Target Lesions (N=16) 20% Cycle 1 Cycle 1+2 100% 80% 71.4% 66.7% Percent Patients 60% 90.6% 73.7% -30% Reduction Redu
Slide 20: Luvelta Plus Bevacizumab Combination
Luvelta Plus Bevacizumab Combination 20 NON CONFIDENTIAL
Slide 21: Luvelta Plus Bevacizumab Initial Efficacy and Safety
Luvelta Plus Bevacizumab Combination Demonstrated Initial Efficacy and Safety in Relapsed/Recurrent Ovarian Cancer Patient Baseline Characteristics Patient Status 3.5 mg/kg 4.3 mg/kg 5.2 mg/kg Total Total Patients Enrolled (N = 18) Ovarian Cancer Patients N=6 N=9 N=3 N = 18 63 63 68 63 Median age, y
Slide 22: Bevacizumab Combination Results Supporting All-Comers Approach
Luvelta Plus Bevacizumab Combination Showed Promising Results to Potentially Support All-Comers Approach in Ovarian Cancer Maximum Reduction in Tumor Response Data Target Lesions (N=16) 50.0% 20% 44.4% 35.3% ORR 28.6% 22.2% -30% All Patients Bev Naïve Bev Treated FolRα FolRα (TPS <25%) (TPS ≥25%) N
Slide 23: No New Safety Signals in Luvelta Plus Bevacizumab
No New Safety Signals Observed in Luvelta Plus Bevacizumab Combination TEAEs (N=18) Neutropenia • Primarily uncomplicated (no TEAEs of febrile neutropenia) All Grade Preferred Term Grade 3+ • Managed with G-CSF usage Incidence ≥20% Patients reporting at least one event 18 (100%) 12 (66.7%) • Led to
Slide 24: Additional Clinical Development Plans
Additional Clinical Development Plans Endometrial RAM AML NSCLC 24 NON CONFIDENTIAL
Slide 25: Anti-Tumor Activity in Lower and/or Variable FolRα Expression Tumors
Luvelta: Demonstrated Compelling Anti-Tumor Activity and Manageable Safety Profile In Lower and/or Variable FolRα Expression Tumors Additional Indications Endometrial RAM AML1 NSCLC N = 17 N = 25 Preclinical Evidence of anti-tumor activity Meaningful clinical responses, including complete Single dos
Slide 26: Anti-tumor Activity in FolRα Endometrial Cancer: ESMO 2023
Luvelta Showed Evidence of Anti-tumor Activity in FolRα Expressing Endometrial Cancer: Data Presented at ESMO 2023 Maximum Reduction in Target Lesions* Consistent Safety Signals Observed TPS (%) 5 15 1 2 99 6 25 45 15 35 8 45 75 18 70 30 Total (N = 17) TEAEs, n (%) Most Common Events Any grade* Grad
Slide 27: Anti-Tumor Activity in Pediatric RAM Phenotype AML: ASH 2023
Luvelta Showed Anti-Tumor Activity in Pediatric RAM Phenotype AML: Data Highlighted at ASH 2023 Received Luvelta as Non-Fractionated Dosing Regimen Safety Overview (N=21*^) 1.0 censored Total (N = 21) TEAES occurring in ≥25% of patients 0.8 who received monotherapy with Luvelta *Luvelta EAP Any grad
Slide 28: Next-Generation ADCs
Next-Generation ADCs 28 NON CONFIDENTIAL
Slide 29: Luvelta Clinical Proof-of-Concept Addresses Key ADC Limitations
Luvelta Clinical Proof-of-Concept Potentially Addresses Key ADC Limitations Toxic Payload Linker FC Domain “Warhead” DAR 4 hemiasterlin Utilizes proprietary, high value FcγR-deficient ADCs mitigates • High potency tubulin inhibitor conjugation site to improve off-target toxicity • High ICD & bystand
Slide 30: Potent Anti-tumor Activity in Preclinical Models of NSCLC
Luvelta Shows Potent Anti-tumor Activity in Preclinical Models of NSCLC: Data Highlighted at AACR 2022, IND Planned for 1H 2024 Single dose of luvelta shows potent anti-tumor activity in primary Combination of luvelta and PD-1 blockade (Avelumab) patient-derived NSCLC model demonstrates benefit and
Slide 31: Next Generation Exatecan ADC Platform and Pipeline Development
Sutro’s Next Generation Exatecan ADC Platform and Pipeline Development ADC Liability Platforms Affected Cause Countermeasure Interstitial FcgR • Sutro (ROR1 & FcgR on alveolar lung WT IgG1 DXd, Exatecan deficient TF-Exatecan, macrophages STRO-003/-004) disease mAbs Lower potency than High DAR Top1/
Slide 32: Limitless Innovation: Approach to Future ADC Development
Limitless Innovation: Sutro’s Approach to Future ADC Development On-target Activity Improve- ments ADC Immunogenic Resistance Potency Cell Death Induction to Top1/Exatecan Dual Conjugate* DAR > 8* *Unique advantage of non-natural amino acid incorporation by Cell-free XpressCF® 32 NON CONFIDENTIAL
Slide 33: Commercial Opportunity
Commercial Opportunity 33 NON CONFIDENTIAL
Slide 34: FolRα is Broadly Expressed Across Multiple Indications
34 mRNA expression level (RMA, log2) 4 6 8 10 12 endometrium (27) ovary (51) kidney (34) bile duct (8) colorectal (61) breast (58) pancreas (44) stomach (38) esophagus (25) lung_NSC (131) other (15) upper_aerodigestive (32) urinary tract (27) chondrosarcoma (4) glioma (62) liver (28) medulloblastoma
Slide 35: Luvelta: Potential for Significant Commercial Opportunities
Luvelta: Potential for Significant Commercial Opportunities, Initially in Ovarian Cancer and Expanding to Additional FolRα Expressing Cancers Luvelta Potentially Doubles the Estimated Annual Incidence in FolRα-Expressing Patient Populations Addressable PROC Patients (U.S., Europe and Japan) Percent
Slide 36: Sutro’s Robust Pipeline of Product Candidates
Sutro’s Robust Pipeline of Product Candidates Demonstrates our Innovative Processes and Designed Intentionally to Expand Patient Benefit in Areas of High Unmet Need WORLDWIDE OR PROGRAM MODALITY/TARGET INDICATION DISCOVERY PRECLINICAL PHASE 1/1B PHASE 2/3 GEOGRAPHIC PARTNER SUTRO-LED PROGRAMS Ovaria
Slide 37: Luvelta FolRα-targeting ADC: A Pipeline-in-a-Drug
Luvelta Global REFRαME-O1 Next-Generation FolRα-targeting ADC: Registrational Trial ADCs Fueled A Pipeline-in-a-Drug Well Underway; by Proven Opportunity Potential to be 1st Cell-free XpressCF® Therapy for Women with Technology and Low/Medium FolRα Partnership Model Expression 37 NON CONFIDENTIAL
Slide 38: Question & Answer Session
Question & Answer Session 38 NON CONFIDENTIAL