STRO-004 / Sutro Biopharma - LARVOL DELTA

Sutro Biopharma Announces First Cohort of Patients Dosed in Phase 1 Trial of STRO-004, a Next-Generation Tissue Factor ADC, in TF-Expressing Solid Tumors (GlobeNewswire) - "The Phase 1 open-label, multicenter trial is designed to evaluate the safety, pharmacokinetics, and preliminary anti-tumor activity of STRO-004 in patients with advanced TF-expressing solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, cervical cancer, colorectal cancer, pancreatic ductal adenocarcinoma, and bladder cancer....'We are deeply grateful to the patients and investigators participating in this study and look forward to sharing initial data in mid-2026'."

P1 data • Trial status • Bladder Cancer • Cervical Cancer • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Sutro Biopharma, Inc.

New P1 trial • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Sutro Biopharma Highlights Next-Generation ADC Innovation at Virtual R&D Day (GlobeNewswire) - "The presentation will include an overview of Sutro’s near- and long-term priorities, beginning with STRO-004, its potential best-in-class Tissue Factor ADC, which has now entered clinical development. The Company will also provide details on its dual-payload ADC programs, uniquely enabled by its proprietary cell-free platform, and reveal STRO-227, its first dual-payload candidate designed to target PTK7."

Clinical • New molecule • Solid Tumor

The Company received U.S. FDA clearance of its IND application for STRO-004, its potential best-in-class Tissue Factor ADC (GlobeNewswire) - "Sutro remains on track to dose the first patient in the first-in-human basket trial with STRO-004 before year-end."

IND • New trial • Solid Tumor

Sutro Biopharma Reports First Quarter 2025 Financial Results and Business Highlights (GlobeNewswire) - "Corporate and Program Updates:...STRO-004: Sutro’s novel exatecan Tissue Factor ADC has been prioritized as the Company’s lead program, with an initial focus on solid tumors. The Company is preparing to submit an IND and initiate a first-in-human study in the second half of 2025."

IND • Solid Tumor

Sutro Biopharma to Highlight its Next-Generation Exatecan and Dual-Payload ADC Programs in Presentations at AACR 2025 (GlobeNewswire) - "Sutro Biopharma...announced poster presentations at the upcoming 2025 American Association for Cancer Research (AACR) Annual Meeting...The presentations will cover preclinical activity and safety data for STRO-004, the Company’s novel exatecan Tissue Factor ADC, as well as showcase the unique advantages of Sutro’s XpressCF+ platform in enabling precise and efficient development of dual-payload ADCs....'In preclinical studies, STRO-004 consistently demonstrated potent, dose-dependent anti-tumor activity and a favorable safety profile across all tested doses....We look forward to continuing to investigate the full potential of STRO-004, as we complete IND-enabling studies and prepare to initiate a first-in-human trial later this year'."

New trial • Preclinical • Solid Tumor

Preclinical activity and safety of STRO-004, a novel ADC targeting tissue factor for solid tumors (AACR 2025) - "Consistent with this finding, only low levels of free exatecan could be detected. Based on these promising preclinical observations, STRO-004 is advancing to IND-enabling studies for the treatment of TF expressing malignancies."

Preclinical • Cervical Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Sutro Biopharma Announces Strategic Portfolio Review Resulting in the Prioritization of its Next-Generation ADC Pipeline (GlobeNewswire) - "STRO-004: Sutro’s novel exatecan Tissue Factor ADC, has been prioritized as the Company’s lead program, with an initial focus in solid tumors. The Company is preparing to submit an IND in the second half of 2025."

IND • Solid Tumor

Sutro Biopharma Reports Third Quarter 2024 Financial Results and Business Highlights (GlobeNewswire) - "Additional Pipeline Development and Collaboration Updates: (i) STRO-004, a tissue factor-targeting ADC, which features a drug-antibody-ratio (DAR) of eight exatecan payloads and site-specific linker design, demonstrated greater anti-tumor activity and lower toxicities than a tissue factor benchmark ADC in preclinical models. Sutro anticipates filing an IND for STRO-004 in the second half of 2025...; (ii) Sutro’s proprietary and partnered preclinical ADC portfolio has potential across a broad range of tumor types and the Company plans to deliver three INDs over the next three years."

IND • Preclinical • Solid Tumor

Sutro Biopharma Demonstrates Meaningful ADC Innovation with Five Presentations at the 15th Annual World ADC Conference (GlobeNewswire) - "Presentation Details:...Showcasing Clinical Update & Learnings for Luvelta Targeting Folate Receptor....Characterizing ADC Safety & Activity in Preclinical Development of STRO-004...."

Clinical data • Preclinical • Oncology

Sutro Biopharma Highlights Next-Generation ADC Innovation and Near-term Pipeline at Research Forum (GlobeNewswire) - "Data Highlights and Near-Term Pipeline Milestones:...Sutro anticipates filing an IND for STRO-004 with the U.S. Food & Drug Administration in the second half of 2025."

IND • Oncology

Sutro Biopharma Reports Second Quarter 2024 Financial Results, Business Highlights and Select Anticipated Milestones (GlobeNewswire) - "Additional Pipeline Development and Collaboration Updates:...Sutro plans to submit an IND for STRO-004 in 2025."

IND • Solid Tumor

Sutro Biopharma Reports Full Year 2023 Financial Results, Business Highlights and Select Anticipated Milestones (GlobeNewswire) - "STRO-002:...Enrollment of REFRαME-P1, a registration-enabling trial for pediatric patients with CBF/GLIS AML, is expected to be initiated in the second half of 2024....Additional Pipeline Development and Collaboration Updates: (i) Sutro plans to submit an IND for STRO-003, a ROR1-targeting ADC, in 2024; (ii) Sutro plans to submit an IND for STRO-004, a tissue factor-targeting ADC, in 2025."

IND • New trial • Acute Myelogenous Leukemia • Solid Tumor

Sutro Demonstrates Meaningful ADC Innovation with Five Presentations and One Poster at the 14th Annual World ADC Conference (GlobeNewswire) - "Sutro Biopharma, Inc...today announced that the company will have five presentations and one poster at the 14th Annual World ADC Conference, taking place in San Diego, October 16-19, 2023."

Clinical data • Preclinical • Hematological Malignancies • Oncology • Solid Tumor

Sutro Biopharma Reports Second Quarter 2023 Financial Results, Business Highlights and Select Anticipated Milestones (GlobeNewswire) - "Additional Pipeline Development: STRO-003, a ROR1-targeting ADC and STRO-004, a tissue factor-targeting ADC have INDs planned for Q1 2024 and Q1 2025, respectively."

IND • Oncology • Solid Tumor