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Sutro Biopharma (NASDAQ: STRO) is a clinical-stage biopharmaceutical company pioneering next-generation oncology therapeutics through its proprietary cell-free XpressCF® platform. This page provides centralized access to official news, including clinical trial updates, strategic partnerships, and financial developments.
Investors and researchers will find timely updates on the company’s innovative antibody drug conjugates (ADCs) and bispecific antibody programs. Content categories include clinical milestones, regulatory filings, collaboration announcements, and manufacturing advancements.
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Sutro Biopharma (NASDAQ: STRO) has initiated the REFRαME-L1 global Phase 2 study of luveltamab tazevibulin (luvelta) for non-small cell lung cancer (NSCLC) patients with Folate Receptor-α (FRα) expressing tumors. The trial is now open for enrollment, with initial data expected in H1 2025. Luvelta, an antibody drug conjugate (ADC), shows promise in treating NSCLC patients with lower FRα expression profiles. The study targets a significant unmet need, as lung cancer is the leading cause of cancer-related deaths worldwide, with a 5-year survival rate as low as 8% for metastatic disease. Approximately 30% of adenocarcinoma NSCLC patients have FRα expression, making it an attractive therapeutic target.
Sutro Biopharma (NASDAQ: STRO) reported its Q2 2024 financial results and business highlights. Key points include:
- Updated data from the Phase 1b study of luvelta with bevacizumab to be presented at ESMO 2024
- Phase 3 trial of luvelta for platinum-resistant ovarian cancer is underway
- Registration-enabling trial for pediatric AML patients expected in H2 2024
- Phase 2 trial for NSCLC treatment to start in H2 2024
- As of June 30, 2024, Sutro had $426.0 million in cash, equivalents, and marketable securities
- Q2 2024 revenue was $25.7 million, up from $10.4 million in Q2 2023
- Total operating expenses for Q2 2024 were $74.4 million
Sutro Biopharma announced the appointment of Dr. Barbara Leyman as Chief Business Development Officer, effective July 8, 2024. Dr. Leyman brings 20 years of life science industry experience to Sutro and has a strong track record in business development, investing, and corporate strategy. Sutro's CEO, Bill Newell, highlighted her arrival at a critical time as the company progresses luvelta in two registration-directed trials. Dr. Leyman has previously held leadership roles at GenEdit, Lyell Immunopharma, and Calico Life Sciences. She was also a Head of Life Sciences Investment Fund at LRM and served on various biopharmaceutical boards. As part of her induction, Dr. Leyman received stock options and restricted stock units, vesting over four years.
Sutro Biopharma announced its Q1 2024 financial results, highlighting significant progress in its clinical pipeline. Key achievements include FDA clearance for a Phase 2 NSCLC trial with luvelta and ongoing Phase 2 studies for luvelta in ovarian cancer and in combination with bevacizumab. Sutro's cash position is strong with $267.6 million in cash and investments, bolstered by $75 million from the Ipsen licensing deal and $75 million from an equity offering. Despite a slight revenue increase to $13.0 million, operating expenses rose to $69.6 million, resulting in a net loss. The company is preparing for several clinical and corporate milestones in 2024, aiming to advance its ADC technologies.
Sutro Biopharma, Inc. announced the initiation of the randomized portion (Part 2) of the REFRαME-O1 trial for platinum-resistant ovarian cancer. 50 patients have been enrolled for Dose-Optimization (Part 1). Luvelta, a novel ADC targeting Folate Receptor-α, shows promise in addressing high unmet medical needs in PROC patients. The Phase 3 trial aims to evaluate the efficacy and safety of luvelta versus chemotherapy in women with PROC.