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 29, 2019
Slide 1: STRO-002-GM1 Phase 1 Clinical Update
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 Arturo Molina, MD, MS Chief Medical Officer Oct 29th 2019
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 relaps
Slide 3: STRO-002-GM1 Phase 1 Clinical Trial Design
STRO-002-GM1 Phase 1 Clinical Trial Design Part 1 — Dose Escalation Part 2 — Dose Expansion (1 Cohort: Ovarian) (2 Cohorts) MTD Dose Level n Up to: n = 40 Ovarian STRO-002 2.9 mg/kg Dose Level 4 RP2D 1.8 mg/kg Dose Level 3 n = 40 Endometrial 1.0 mg/kg Dose Level 2 0.5 mg/kg Dose Level 1 Key Objectiv
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 a
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
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 Ca
Slide 7: Dose Escalation Schema, STRO-002-GM1
Dose Escalation Schema, STRO-002-GM1 Current dose level, dose level 6
Slide 8: Baseline Characteristics
STRO-002-GM1 Baseline Characteristics Total Characteristic 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 Treatment Emergent Adverse Events (TEAE) Number of Subjects TEAE >15% N=13 (%) Nausea 6 (46) Fatigue 5 (39) Headache 4 (31) Insomnia 4 (31) Vomiting 4 (31) Abdominal pain 3 (23) Dizziness 3 (23) The emerging STRO-002 safety profile includes mostly mild adverse
Slide 10: Grade 3 Treatment Emergent Adverse Events
Grade 3 Treatment Emergent Adverse Events Grade 3 TEAE Number of Subjects Adverse Event (Grade) 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 t
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
Slide 12: STRO-002 Treatment Duration
STRO-002 Treatment Duration Arranged by Dose level 0 10 20 30 Weeks from First Dose
Slide 13: Unconfirmed Target Lesion Response, Cycle 3 Day 1 by RECIST 1.1
Unconfirmed Target Lesion Response, Cycle 3 Day 1 (C3D1) by RECIST 1.1 Target Lesion % change from Baseline 60 x x x C10 C4 C4 x C5 C5 1.8 40 2.9 Progressive 20 1.0 Disease +20% over 0.5 4.3 4.3 1.8 2.9 2.9 Baseline 0 -20 Target lesion -40 response -30% reduction -60 C3D1 scans x Pt discontinued tre
Slide 14: Confirmed Target Lesion Response, Cycle 5 Day 1 by RECIST 1.1
Confirmed Target Lesion Response, Cycle 5 Day 1 (C5D1) by RECIST 1.1 Cycle 5 Day 1% target lesions change from nadir Progressive 20 0.5 Disease 10 +20% over 2.9 2.9 nadir 0 -10 -20 Target lesion -30 response -30% -40 reduction -50 -60 -70 C5D1 scans
Slide 15: Percent Change in CA-125 from Baseline (N=13)
Percent Change in CA-125 from Baseline (N=13) 0 6 12 18 23 29 Weeks from First dose Percent change from baseline of CA-125 levels. One patient with confirmed CA-125 response also has a confirmed PR per RECIST 1.1.
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) 0 1.8 mg/kg 2.9 mg/kg 4.3 mg/kg % Change in CA-125 6.0 mg/kg -50 from Baseline -100 00 31 62 9 3 12 4 5 Weeks from first dose Percent change from baseline of CA-125 levels. One patient with confirmed CA-125 response also has a confirmed PR pe
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 AUC0- Dose Cmax tmax clast tlast ID tlast mg/kg ng/mL h ng/mL h h·ng/mL 0.5 1037001 9680 1.083 32.8 336 661101
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
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- treat
Slide 20: Headquarters
Headquarters 310 Utah Ave. Suite 150 South San Francisco, CA 94080 Phone: 650.392.8412 Fax: 650.872.8924 Web: www.sutrobio.com