Welcome to our dedicated page for Sutro Biopharma news (Ticker: STRO), a resource for investors and traders seeking the latest updates and insights on Sutro Biopharma stock.
Sutro Biopharma, Inc. (NASDAQ: STRO) is a clinical-stage biopharmaceutical company based in South San Francisco, focused on the discovery, development, and manufacturing of next-generation cancer therapeutics. The company leverages its proprietary cell-free protein synthesis platform, XpressCF®, to produce novel antibody-drug conjugates (ADCs) and bispecific antibodies that target cancer cells with precision, aiming to offer improved safety and efficacy over traditional treatments.
Key products in Sutro's pipeline include STRO-001, designed for patients with multiple myeloma and non-Hodgkin lymphoma, and STRO-002 (also known as luveltamab tazevibulin or 'luvelta') for the treatment of ovarian and endometrial cancers. The company has recently initiated Phase 2/3 clinical trials for luvelta in platinum-resistant ovarian cancer (PROC) and is progressing towards trials for endometrial cancer. Sutro is also exploring additional indications, including non-small cell lung cancer and a rare pediatric form of acute myeloid leukemia (AML).
Recent achievements include the appointment of Dr. Hans-Peter Gerber as Chief Scientific Officer and the presentation of promising preliminary data for luvelta in endometrial cancer at ESMO 2023. Financially, Sutro reported cash and investments totaling $321.1 million and an additional $34.0 million in Vaxcyte common stock as of September 30, 2023, providing a projected cash runway into the first half of 2025.
Sutro's innovative approach is not limited to its product pipeline. The company operates the world's only cGMP cell-free manufacturing facility in San Carlos, California, giving it a strategic advantage in the biopharmaceutical industry. Sutro's numerous partnerships and collaborations have generated about $785 million in payments through September 2023, reflecting the significant value of its platform.
Sutro continues to build a robust pipeline and high-value collaborations, including recent partnerships with healthcare-focused institutional investors. The company has a strong financial outlook and a growing portfolio of clinical-stage candidates aimed at transforming cancer treatment. For more information, visit Sutro Biopharma.
Sutro Biopharma announced positive results from the dose-optimization portion of the REFRαME-O1 trial for luvelta in platinum-resistant ovarian cancer. The selected 5.2 mg/kg starting dose achieved a 32% objective response rate in evaluable patients, with a disease control rate of 96%. The trial included patients with ≥25% FRα expression levels, potentially benefiting 8 out of 10 PROC patients.
The study demonstrated manageable safety profiles with 32% of patients experiencing Grade 3 or higher neutropenia, but no febrile neutropenia. The ongoing registrational trial (Part 2) will enroll approximately 500 patients, randomized between luvelta and standard chemotherapy. The company is targeting an Accelerated Approval application in mid-2027.
Sutro Biopharma (NASDAQ: STRO) reported Q3 2024 financial results and business updates. The company plans three IND applications in the next three years based on next-generation ADC technology. Two new clinical trials are underway: REFRαME-P1 for pediatric leukemia and REFRαME-L1 for non-small cell lung cancer. Recent data showed a 56% response rate for luvelta in combination with bevacizumab. Financial highlights include $388.3 million in cash and equivalents, revenue of $8.5 million (down from $16.9 million in Q3 2023), and operating expenses of $76.4 million. The company realized a $32.1 million gain from selling Vaxcyte shares.
Sutro Biopharma (NASDAQ: STRO) announced five presentations at the 15th Annual World ADC Conference in San Diego, November 4-6, 2024. The presentations cover various aspects of ADC innovation, including: dual-payload ADCs development, clinical updates on Luvelta targeting folate receptor, preclinical development of STRO-004, cell-free protein synthesis for site-specific conjugation, and optimization of high DAR and dual payload ADCs. The presentations will be available on Sutro's website after the event.
Sutro Biopharma has initiated REFRαME-P1, a registration-enabling trial of luveltamab tazevibulin (luvelta) for pediatric patients with CBF/GLIS AML. The study follows encouraging compassionate use data presented in December 2023, showing 42% complete remission in patients with ≥5% blasts. CBF/GLIS AML is a rare, aggressive leukemia affecting infants and young children, with an average onset age of 18 months and over 80% chemotherapy resistance rate. The global trial will evaluate luvelta's efficacy and safety in children under 12 years with CBF/GLIS AML, with most sites planned to open by year-end.
Sutro Biopharma (NASDAQ: STRO) is hosting an investor webcast to showcase its proprietary cell-free platform and next-generation ADC innovation. The company highlights three approaches: increasing potency safely with higher drug-antibody ratio exatecan ADCs, combining payloads to overcome tumor resistance with dual-payload ADCs (ADC2), and delivering immunostimulatory ADCs (iADC) that combine immune activation with cytotoxic payloads.
Key highlights include:
- STRO-004, a tissue factor-targeting ADC, demonstrated greater anti-tumor activity and lower toxicities in preclinical models
- Plans to file an IND for STRO-004 in the second half of 2025
- Dual-payload ADCs (ADC2) show increased anti-tumor activity in preclinical models
- iADCs provide a novel mechanism of action, bridging innate and adaptive immunity
- Sutro plans to deliver three INDs over the next three years
Sutro Biopharma (NASDAQ: STRO), a clinical-stage oncology company specializing in site-specific and novel-format antibody-drug conjugates (ADCs), has announced an inducement grant under Nasdaq Listing Rule 5635(c)(4). On September 16, 2024, the Compensation Committee of Sutro's Board of Directors granted 60,000 restricted stock units (RSUs) of Sutro common stock to a new employee.
The grant was made as an inducement for the employee's acceptance of employment with Sutro. The RSUs are subject to the terms of Sutro's 2021 Equity Inducement Plan. Vesting will occur over four years, with one-fourth of the shares vesting on the one-year anniversary of the employee's hire date and annually thereafter, contingent on the employee's continued service with Sutro.
Sutro Biopharma (NASDAQ: STRO) announced updated data from its Phase 1b study of luveltamab tazevibulin (luvelta) in combination with bevacizumab for epithelial ovarian cancer (EOC) at ESMO 2024. Key findings include:
- 56% objective response rate at the recommended phase 2 dose (RP2D) of 4.3 mg/kg luvelta with 15 mg/kg bevacizumab
- 35% overall response rate across all dose ranges
- Efficacy observed regardless of Folate Receptor-α (FRα) expression
- No new safety signals compared to individual agents
- Expansion phase ongoing with 23 additional patients; data expected in H1 2025
The combination shows promise as a non-biomarker driven approach for EOC treatment, potentially benefiting a broader patient population.
Sutro Biopharma (NASDAQ: STRO), a clinical-stage oncology company specializing in antibody drug conjugates (ADCs), has announced a Research Forum to showcase its pipeline of next-generation ADCs. The event is scheduled for October 10, 2024, at 1:30 p.m. PT / 4:30 p.m. ET and will be accessible via live webcast.
Investors and interested parties can join the presentation by visiting https://ir.sutrobio.com/news-events/ir-calendar. For those unable to attend the live event, an archived replay will be made available on the company's website following the presentation.
This forum represents an opportunity for Sutro Biopharma to highlight its innovative approach to ADC development and provide insights into its near-term pipeline, potentially impacting investor interest and the company's stock performance.
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
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