Sutro Biopharma, Inc. · NASDAQ:STRO
Sutro Biopharma — European Hematology Association Meeting 2019
22 slides from Sutro Biopharma's conference presentation, Jun 17, 2019
Slide 1: Preliminary Results of a Phase 1 Dose Escalation Study of STRO-001
Preliminary Results of a Phase 1 Dose Escalation Study of the First-in-Class Anti-CD74 Antibody Drug Conjugate (ADC), STRO-001, in Patients with Advanced B-Cell Malignancies June 15, 2019 European Hematology Association Meeting Arturo Molina, MD, MS Chief Medical Officer Exhibit 99.1
Slide 2: Summary and Conclusions (1)
Summary and Conclusions (1) STRO-001 is the first ADC generated with novel cell-free protein synthesis technology and site-specific conjugation to be tested in the clinic. STRO-001 has been generally well tolerated. Most AEs are grade 1 or 2. MTD has not been reached. Enrollment is ongoing at: 0.65
Slide 3: Summary and Conclusions (2)
Summary and Conclusions (2) No ocular toxicity signals have been observed. Two thromboembolic DLTs have been observed in 2 patients with very bulky disease (>15 cm) and other pre-existing factors for thrombosis. Preliminary PK profile in 3 patients reveals an estimated half-life for total antibody o
Slide 4: STRO-001: Overcoming Therapeutic Window Limitations of 1st Generation ADCs
STRO-001: Overcoming Therapeutic Window Limitations of 1st Generation ADC’s Property Description Stability Safety Homogenous design results in a single species product creating more precise dosing and potential for improved therapeutic index Warhead is covalently conjugated to two specific sites on
Slide 5: STRO-001 in Multiple Myeloma
STRO-001 in Multiple Myeloma Potent preclinical anti-tumor activity Bioluminescent Imaging of Tumor Cells Survival in MM1S-luc Xenograft Model STRO-001 Results in Significant Reduction of Tumor Burden in Single Doses of 1, 3 and 10 mg/kg STRO-001 Results in Meaningful Survival Benefits Source: Sutro
Slide 6: STRO-001 in DLBCL and Mantle Cell
STRO-001 in DLBCL and Mantle Cell Promising preclinical efficacy and anti-tumor activity Single dose IV 10 mg/kg of STRO-001 Induced Complete Tumor Regression in All 7 Mice and Resulted in No Tumor Re-Growth 90 Days Post Treatment Tumor Growth in Murine Xenograft DLBCL Model Survival in Murine Xenog
Slide 7: STRO-001-BCM1 Phase 1 Clinical Trial Design
STRO-001-BCM1 Phase 1 Clinical Trial Design MTD Advanced and/or Refractory Multiple Myeloma Advanced and/or Refractory NHL Dose Level 2 Dose Level n RP2D RP2D Clinical data will drive expansion Part 1 — Dose Escalation (2 Cohorts) Part 2 — Dose Expansion (4 Cohorts) n = 40 Multiple Myeloma n = 40 DL
Slide 8: STRO-001-BCM1 Study – Patient Demographics
Characteristic Cohort A (MM) N =10 Cohort B (NHL) N=11 Total N=21 Age, median (range), years 64.5 (42-80) 64 (21-82) 64 (21-82) Median time from diagnosis in years (range) 6.4 (1.3-13.6) 3.2 (1.0-29.8) 4.0 (1.0-29.8) ECOG performance status, median (range) 1 (0-2) 1 (0-2) 1 (0-2) 0, N (%) 4 (40) 3 (
Slide 9: STRO-001-BCM1 Study – Patient Demographics
Characteristic Cohort A (MM) N =10 Cohort B (NHL) N=11 Total N=21 Disease Subtype, N (%) Multiple myeloma 10 (100) N/A 10 (48) Follicular lymphoma N/A 3 (27) 3 (14) Marginal zone lymphoma 1 (9) 1 (5) Mantle cell lymphoma 1 (9) 1 (5) DLBCL 4 (36) 4 (19) Burkitt’s lymphoma 1 (9) 1 (5) DLBCL/FL 1 (9) 1
Slide 10: STRO-001 Initial Safety Data Profile
Anti-drug antibodies (ADA) have not been detected Enrollment is ongoing in the 3+3 escalation at 0.65 mg/kg in MM cohort and 0.91 mg/kg in NHL cohort STRO-001 STRO-001 was generally well tolerated, most AEs are Grade 1 & 2 No ocular toxicity signals have been observed Thromboembolic DLTs have been o
Slide 11: Treatment Emergent AEs in ≥15% of Patients
Treatment Emergent Adverse Events (TEAE) TEAE ≥ 15% Number of Subjects N=21 (%) Fatigue 6 (29) Chills 6 (29) Nausea 5 (24) Fever 5 (24) Cough 4 (19) Infusion related reaction 4 (19) The emerging STRO-001 safety profile includes mostly mild adverse events- 91% of all AEs are grade 1 or 2. Observance
Slide 12: Grade ≥3 Treatment Emergent AEs
Grade ≥3 Treatment Emergent AEs Grade ≥ 3 TEAE Adverse Event (Grade) Number of Subjects N=21 (%) Thromboembolic event (3,5) 2 (10) Fall (3) 1 (5) Hyponatremia (3) 1 (5) Lung infection (3) 1 (5) Pleural effusion (3) 1 (5) Pneumothrorax (3) 1 (5) Urinary tract infection (3) 1 (5) All grade ≥ 3 events
Slide 13: Dose Limiting Toxicities in Two High-Risk Patients
Dose Limiting Toxicities in Two High-Risk Patients Dose Limiting Toxicities Summary Cohort A (MM) 0.65 mg/kg Grade 5 thromboembolic event- Patient passed away suddenly 8 days after first dose of study treatment. An autopsy revealed patient had extensive bilateral pulmonary embolism as cause of death
Slide 14: Initial Pharmacokinetic Profile Suggests Dose Proportionality
Initial Pharmacokinetic Profile Suggests Dose Proportionality Log-linear plot of total antibody serum concentrations vs time by dose (mg/kg) group Pharmacokinetic parameters after the first intravenous dose of STRO-001. Preliminary PK profile in 3 patients reveals estimated half-life for total antib
Slide 15: No Detectable Anti-Drug Antibodies (ADA) to STRO-001
No Detectable Anti-Drug Antibodies (ADA) to STRO-001 DOSE LEVEL 0.05 MG/KG 0.075 MG/KG 0.15 MG/KG 0.27 MG/KG 0.43 MG/KG 0.65 MG/KG 4 SAMPLES 4 SAMPLES 3 SAMPLES 2 SAMPLES 3 SAMPLES 1 SAMPLES 2 SAMPLES 7 SAMPLES 3 SAMPLES 3 SAMPLES - - NO NO NO NO NO NO COHORT A (MM) COHORT B (NHL) ADA PRESENT? 32 av
Slide 16: STRO-001: Phase 1 Study Duration of Study Treatment
STRO-001: Phase 1 Study Duration of Study Treatment Preliminary anti-tumor activity (1 CR and 1 PR) has been observed in two patients with DLBCL. Duration of study was calculated from first dose of STRO-001 until disease progression or patient experienced a DLT as of May 14, 2019 Weeks from First Do
Slide 17: Complete Response to STRO-001 in a Patient with DLBCL
Patient is an 82-year-old man diagnosed with Stage III diffuse large B-cell lymphoma (DLBCL), non-GC type in 2015 Treatment prior to study entry: CHOP-R, Rituximab/lenalidomide Bendamustine/rituximab Obinituzumab/gemcitabine/oxaliplatin Patient received 12 doses of STRO-001, and had a complete respo
Slide 18: Complete Response in a Patient with DLBCL
Complete Response in a Patient with DLBCL 13 June, 2019 Baseline Scan: Right inguinal lymph node, 34.2 x 15.6 mm, SUV 5.52 Spleen 94 mm Overall Deauville : 4 Cycle 3 Day 1 Scan: Right inguinal lymph node, 25.3 x 12.7 mm, SUV 2.65 Spleen 72 mm Overall Deauville : 2 Complete response
Slide 19: Partial Response to STRO-001 in a Patient with DLBCL
64 year old man diagnosed with double-hit DLBCL in August 2017 Treatment prior to study entry: CHOP-R x 1 and da-EPOCH x 6 between Aug 2017–Nov 2017 Rituximab, ifosfamide, carboplatin, etoposide (RICE) with IT prophylaxis from Dec 2017 – Jan 2018 for refractory disease Rituximab and XRT in Feb 2018
Slide 20: Summary and Conclusions (1)
Summary and Conclusions (1) STRO-001 is the first ADC generated with novel cell-free protein synthesis technology and site-specific conjugation to be tested in the clinic. STRO-001 has been generally well tolerated. Most AEs are grade 1 or 2. MTD has not been reached. Enrollment is ongoing at: 0.65
Slide 21: Summary and Conclusions (2)
Summary and Conclusions (2) No ocular toxicity signals have been observed. Two thromboembolic DLTs have been observed in 2 patients with very bulky disease (>15 cm) and other pre-existing factors for thrombosis. Preliminary PK profile in 3 patients reveals an estimated half-life for total antibody o
Slide 22: Preliminary Results of a Phase 1 Dose Escalation Study of STRO-001
Preliminary Results of a Phase 1 Dose Escalation Study of the First-in-Class Anti-CD74 Antibody Drug Conjugate (ADC), STRO-001, in Patients with Advanced B-Cell Malignancies June 15, 2019 European Hematology Association Meeting Arturo Molina, MD, MS Chief Medical Officer
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