Sutro Biopharma, Inc. · NASDAQ:STRO
Sutro Biopharma — Technical Presentation (December 2020)
26 slides from Sutro Biopharma's technical presentation, Dec 4, 2020
Slide 1: KOL Discussion of STRO-002 Data
Lainie P. Martin, M.D. Leader, Gynecology/Oncology Program and Associate Professor of Medicine at Hospital of the University of Pennsylvania KOL Discussion of STRO-002 Data December 3, 2020 5:00pm ET | 2:00pm PT R. Wendel Naumann, M.D. Professor & Director of Gynecologic Oncology Research and Associ
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: Agenda for Today
Agenda for Today Topic Speaker Welcome and Introduction Forward Looking Statements Welcome and KOLs Introduction Ed Albini, Chief Financial Officer Bill Newell, Chief Executive Officer STRO-002 GM1 Data Discussion STRO-002 MOA Phase 1 Dose-Escalation Data Lainie P. Martin, M.D. STRO-002 Development
Slide 4: Meet the Investigators and Speakers
Meet the Investigators and Speakers Dr. Lainie P. Martin and Dr. R. Wendel Naumann Dr. Martin is a medical oncologist specializing in the treatment of gynecologic cancers. She was recruited to the University of Pennsylvania to serve as the Leader of the Gynecologic Medical Oncology Program. She is a
Slide 5: FolRα-Targeting ADC STRO-002 GM1 Phase 1 Dose Escalation Data Discussion
FolRα-Targeting ADC STRO-002 GM1 Phase 1 Dose Escalation Data Discussion Lainie P. Martin, M.D. STRO 002
Slide 6: STRO-002 is an optimized ADC using precisely positioned non-natural amino acids
Novel homogeneous antibody drug conjugate (ADC) using precisely positioned non-natural amino acids Targets FolRα, which is overexpressed in certain cancers including ovarian cancer Drug-antibody ratio of 4:1, with a proprietary cleavable hemiasterlin linker-warhead that is stable in circulation Inte
Slide 7: 31 Patients Are Evaluable for Response in Dose-Escalation
clinically active dose population 34 patients were treated at ≥ 2.9 mg/kg Q3W Dose levels associated with anti-tumor activity MTD not reached 4.3 and 5.2 mg/kg Q3W will be tested in Phase 1 dose-expansion 31 Patients Are Evaluable for Response in Dose-Escalation STRO 002 recist-evaluable population
Slide 8: STRO-002 GM1 Phase 1 Study Has a Two-Part Design
Phase 1 All comers, not selected on basis of FolRα levels IV infusion on Day 1 of 21-day cycles Activated at 10 sites First patient dosed March 2019 Key Objectives: Safety, Maximum Tolerated Dose, Recommended Phase 2 Dose, Pharmacokinetic Profile, Preliminary Efficacy (1) Illustration on dose-escala
Slide 9: Ovarian Patients Were Heavily Pre-Treated
Ovarian Patients In Dose-Escalation Study Were Heavily Pre-Treated Median 6 prior lines of therapy, including SOC, bevacizumab, PARPi, CPI, and clinical trials Characteristic All Patients (N=39) Age, median 61 years (range, 48–79) Tumor type, n EOC 31 (80%) Fallopian tube 6 (15%) Primary peritoneal
Slide 10: STRO-002 Was Generally Well Tolerated
All Safety Evaluable Patients Grade 1 N (%) Grade 2 N (%) Grade 3 N (%) Grade 4 N (%) Overall (N=39) N (%) Fatigue 8 (20.5) 17 (43.6) 4 (10.3) 0 29 (74.4) Nausea 15 (38.5) 10 (25.6) 0 0 25 (64.1) Constipation 12 (30.8) 12 (30.8) 0 0 24 (61.5) Neutropenia 0 1 (2.6) 9 (23.1) 13 ( 33.3) 23 (59.0) Arthr
Slide 11: Tumor Reduction Observed in Majority of Patients
STRO 002 (1) Maximum % change from baseline in sum of longest diameter in evaluable patients treated with STRO-002 at ≥ 2.9 mg/kg Q3W, N=31 (2) CR in patient treated at 2.9 mg/kg with resolution of peritoneal disease Objective Response per RECIST 1.1 RECIST-Evaluable Population (N=31) Responders 10
Slide 12: Tumor Regression and Control Over Time
Change from baseline (%) Weeks since first treatment 20 -30 -100 0 Best overall response PD SD PRu PR CR Treatment ongoing as of October 30, 2020 Change in Sum of Diameters for Target Lesions Over Time (N=31) (1) CR in patient treated at 2.9 mg/kg with resolution of peritoneal disease Note: Data as
Slide 13: Patient With Ongoing PR Remains on Study
Patient With Ongoing PR Remains on Study The patient achieved 74% tumor reduction after 4 cycles and remains on study (1) Confirmed PR after 4 cycles Baseline 3/16/20 06/29/20 57-year-old woman with platinum resistant ovarian cancer progressing after 4 prior regimens received STRO-002 at 5.2 mg/kg Q
Slide 14: Clinical Benefit Seen in Heavily Pre-Treated Patient Population
Weeks since first treatment Individual patients treated with STRO-002 Treatment Duration (1) and Response, Based on Evaluable Patients (N=31) Clinical Benefit Seen in Heavily Pre-Treated Patient Population Disease control rate of 74% at 12 weeks in RECIST-evaluable population STRO 002 Dose Level Tre
Slide 15: Responses Observed Across Heavily Pre-Treated Patients
Responses Observed Across Heavily Pre-Treated Patients PRs occurred with fixed dose regimen AND post dose adjustments Duration calculated as date of PD or time from first dose to last dose given Note: Data as of October 30, 2020 Individual patients treated with STRO-002 Treatment Duration(1) and Res
Slide 16: FolRα Expression by Immunohistochemistry
STRO 002 FolRα Expression by Immunohistochemistry (1) In emerging data, responses and anti-tumor activity observed across various FolRα expression levels H-score (Ventana FOLR1 assay) Individual Patients (N=13) PR SD PD PRu Best Overall Response (BOR) FOLR1 PS2+ Score: Weak/Absent Expression Moderat
Slide 17: Key Findings in Dose-Escalation Study
Key Findings in Dose-Escalation Study STRO-002 is a potentially important option for patients with limited treatment alternatives Neutropenia generally reversed within a week, without G-CSF. Peripheral neuropathy/arthralgia managed with dose reduction/delay without evidence of compromised efficacy 8
Slide 18: STRO-002 GM-1 Next Steps: Expansion Cohort and Development Plan
STRO-002 GM-1 Next Steps Expansion Cohort and Development Plan Arturo Molina, M.D., Sutro Biopharma Chief Medical Officer
Slide 19: Ovarian Cancer Dose-Expansion Trial Design Rationale
Determine optimal efficacious dose that is well-tolerated and maintains dose intensity STRO 002 Randomization between 4.3 mg/kg and 5.2 mg/kg Q3W Ovarian Cancer Dose-Expansion Trial Design Rationale Generate data in less heavily pre-treated population to inform registration study design Fresh or arc
Slide 20: Part 2 Dose-Expansion
Part 2 — Dose-Expansion Primary Endpoint: Objective Response Rate per RECIST 1.1 STRO 002 Endometrial Cancer Relapsed/refractory disease No standard of care treatment Tissue and FolRα-expression required prior to enrollment (level TBD) Ovarian Cancer Platinum-resistant: 1-3 prior regimens Platinum-s
Slide 21: Selected Ventana's Validated FolRα Assay
Moderate Low High PS2+ Scoring Categories: > 75% 2/3+ High 50-74% 2/3+ Moderate < 50% 2/3+ Low The FOLR1 Assay exhibits: A dynamic range of staining Crisp membrane staining Low cytoplasmic staining Low background staining PS2+ 40% PS2+ 65% PS2+ 100% Selected Ventana’s Validated FolRα Assay to Furthe
Slide 22: Path Forward for STRO-002 Clinical Development
Path Forward for STRO-002 Clinical Development Next steps for moving towards registration-directed study Exploring randomized doses of 4.3 & 5.2 mg/kg will inform dose for registration-directed studies Further dose optimization will be explored during dose-expansion Dose reductions or delays were no
Slide 23: Q&A Panel
Q&A Panel
Slide 24: Q&A Panel
Q&A Panel STRO 002 Lainie P. Martin, M.D. Medicine at Hospital of the University of Pennsylvania R. Wendel Naumann, M.D. Levine Cancer Institute, Atrium Health Bill Newell, Chief Executive Officer Arturo Molina, M.D. Chief Medical Officer Trevor Hallam, Ph.D. Chief Scientific Officer Ed Albini Chief
Slide 25: Acknowledgements
Acknowledgements Our gratitude to the women who chose to participate in this study and their families Thank you to the STRO-002-GM1 investigators and study staff for their diligence in caring for these patients STRO 002
Slide 26: Thank You
Thank You
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