Sutro Biopharma, Inc. · NASDAQ:STRO
Sutro Biopharma — AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2019
20 slides from Sutro Biopharma's conference presentation, Oct 30, 2019
Slide 1: STRO-002-GM1 Phase 1 Clinical Update
Arturo Molina, MD, MS Chief Medical Officer Oct 29th 2019 STRO-002-GM1 Phase 1 Clinical Update AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Application Boston, MA Exhibit 99.2
Slide 2: STRO-002-GM1 Phase 1 Clinical Trial Design
STRO-002-GM1 Phase 1 Clinical Trial Design First patient dosed March 2019 Key Objectives Part 1: Safety, MTD, RP2D, PK, ADA, preliminary efficacy Part 2: Response rates, duration of response, PFS (RECIST 1.1), safety, PK Key Inclusion and Exclusion Criteria Inclusion : Relapsed or relapsed/refractor
Slide 3: STRO-002-GM1 Phase 1 Clinical Trial Design
STRO-002-GM1 Phase 1 Clinical Trial Design Part 1 — Dose Escalation (1 Cohort: Ovarian) Part 2 — Dose Expansion (2 Cohorts) STRO-002 Dose Level 1 Dose Level 2 Dose Level n MTD 1.0 mg/kg 0.5 mg/kg RP2D n = 40 Ovarian n = 40 Endometrial Up to: Dose Level 3 Dose Level 4 STRO-002 is given by IV infusion
Slide 4: Study Overview Current Status - Oct 15, 2019 (1)
STRO-002-GM1 Study Overview Current Status - Oct 15, 2019 (1) STRO-002 has been well tolerated; most AEs are grade 1 and no DLTs have been observed 80% of AEs reported are grade 1; 15% grade 2 and 5% grade 3 No grade 4 or 5 events have been reported No prophylactic corticosteroid eye drops are being
Slide 5: Study Overview Current Status - Oct 15, 2019 (2)
STRO-002-GM1 Study Overview Current Status - Oct 15, 2019 (2) Preliminary PK profile reveals an estimated t1/2 for total antibody of 22-76 hours Exposure increased with dose in an apparent linear manner. Preliminary evidence of clinical benefit and anti-tumor activity has been observed in this heavi
Slide 6: List of STRO-002 Active Study Sites
List of STRO-002 Active Study Sites STRO-002-GM1 study: Medical College of Wisconsin, Dr. Denise Uyar Rocky Mountain Cancer Center, Dr. Sami Diab University of Chicago, Dr. John Moroney Thomas Jefferson University, Dr. Russell Schilder Levine Cancer Institute, Dr. Wendel Naumann Miami Cancer Institu
Slide 7: Dose Escalation Schema, STRO-002-GM1
Dose Escalation Schema, STRO-002-GM1 Current dose level, dose level 6 NONCONFIDENTIAL 29 October 2019
Slide 8: Baseline Characteristics
STRO-002-GM1 Baseline Characteristics Characteristic Total N=13 Age, median (range), years 61 (52-69) Median time from diagnosis in years (range) 6.5 years (1.3 - 17.1) ECOG performance status, median (range) 0 (0-1) 0, N (%) 7 (54) 1, N (%) 6 (46) Race/Ethnicity, N (%) Black or African American 2 (
Slide 9: TEAEs in >15% of Patients
STRO-002-GM1: TEAEs in > 15%of Patients Data as of Oct 15, 2019 TEAE- treatment emergent adverse events Treatment Emergent Adverse Events (TEAE) TEAE >15% Number of Subjects N=13 (%) Nausea 6 (46) Fatigue 5 (39) Headache 4 (31) Insomnia 4 (31) Vomiting 4 (31) Abdominal pain 3 (23) Dizziness 3 (23) T
Slide 10: Grade 3 Treatment Emergent Adverse Events
Grade 3 Treatment Emergent Adverse Events Grade 3 TEAE Adverse Event (Grade) Number of Subjects N=13 (%) Small intestine obstruction 2 (15) Neutropenia 2 (15) Dehydration 1 (8) Hypokalemia 1 (8) Hyponatremia 1 (8) Hematuria 1 (8) Neutropenia events (dose level 4.3 mg/kg and 6.0 mg/kg) were noted to
Slide 11: STRO-002 Treatment Duration
STRO-002 Treatment Duration 8 patients remain on STRO-002 as of Oct 15, 2019 Duration of study was calculated from first dose of STRO-002 until disease progression. All discontinuations were due to disease progression. Partial response (PR) and stable disease (SD) are measured by investigator using
Slide 12: STRO-002 Treatment Duration Arranged by Dose level
STRO-002 Treatment Duration Arranged by Dose level Weeks from First Dose NONCONFIDENTIAL 29 October 2019
Slide 13: Unconfirmed Target Lesion Response by RECIST 1.1
Unconfirmed Target Lesion Response, Cycle 3 Day 1 (C3D1) by RECIST 1.1 Progressive Disease +20% over Baseline Target lesion response -30% reduction 0.5 1.0 1.8 2.9 4.3 4.3 1.8 2.9 2.9 x Pt discontinued treatment x x x x C4 C10 C4 C5 C5 NONCONFIDENTIAL 29 October 2019
Slide 14: Confirmed Target Lesion Response by RECIST 1.1
Confirmed Target Lesion Response, Cycle 5 Day 1 (C5D1) by RECIST 1.1 2.9 2.9 0.5 Progressive Disease +20% over nadir Target lesion response -30% reduction C5D1 scans NONCONFIDENTIAL 29 October 2019
Slide 15: Percent Change in CA-125 from Baseline (N=13)
Percent Change in CA-125 from Baseline (N=13) Percent change from baseline of CA-125 levels. One patient with confirmed CA-125 response also has a confirmed PR per RECIST 1.1. Weeks from First dose 0 6 12 18 23 29 NONCONFIDENTIAL 29 October 2019
Slide 16: Percent Change in CA-125 from Baseline ≥ 1.8 mg/kg (N=11)
Percent Change in CA-125 from Baseline ≥ 1.8 mg/kg (N=11) Percent change from baseline of CA-125 levels. One patient with confirmed CA-125 response also has a confirmed PR per RECIST 1.1. Weeks from first dose 0 3 6 9 12 NONCONFIDENTIAL 29 October 2019
Slide 17: Preliminary Pharmacokinetic Summary
Preliminary Pharmacokinetic Summary Total Antibody (TAB), C1D1 LLOQ = 25ng/mL Dose Range:0.5-4.3 mg/kg Cmax range:9.7-118 µg/mL AUC0-tlast range:661-7928 h·µg/mL Half-life range:22-76h Dose mg/kg ID Cmax ng/mL tmax h clast ng/mL tlast h AUC0-tlast h·ng/mL 0.5 1037001 9680 1.083 32.8 336 661101 1.0 1
Slide 18: Study Overview Current Status Oct 15, 2019 (1)
STRO-002-GM1 Study Overview Current Status Oct 15, 2019 (1) STRO-002 has been well tolerated; most AEs are grade 1 and no DLTs have been observed 80% of AEs reported are grade 1; 15% grade 2 and 5% grade 3 No grade 4 or 5 events have been reported No prophylactic corticosteroid eye drops are being u
Slide 19: Study Overview Current Status Oct 15, 2019 (2)
STRO-002-GM1 Study Overview Current Status Oct 15, 2019 (2) Preliminary PK profile reveals an estimated half-life for total antibody of 22-76 hours Exposure increased with dose in an apparent linear manner Preliminary evidence of anti-tumor activity has been observed in this heavily pre-treated pati
Slide 20: STRO-002-GM1 Phase 1 Clinical Update
Arturo Molina, MD, MS Chief Medical Officer Oct 29th 2019 STRO-002-GM1 Phase 1 Clinical Update AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Application Boston, MA