Sutro Biopharma, Inc. engages in the drug discovery, development and manufacture of pharmaceutical products. It focuses on the next generation cancer and autoimmune therapeutics. The company was founded by James R. Swartz and Sutanto Widjaja on April 21, 2003 and is headquartered in South San Francisco, CA.
Clinical Trials
8
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2003
Completed
2
25.0%
Not yet recruiting
1
12.5%
Recruiting
1
12.5%
Terminated
3
37.5%
Withdrawn
1
12.5%
No approval data available
- Blood Cancer United acquired the remaining supply of luveltamab tazevibulin (Luvelta), an antibody-drug conjugate targeting FOLR1, after Sutro Biopharma discontinued development in March 2025. - The drug has shown meaningful benefit in CBFA2T3-GLIS2-rearranged AML, an ultra-rare pediatric leukemia with only 15–30% survival and approximately 17 new U.S. cases annually. - The nonprofit will distribute the drug at no cost through the FDA's compassionate use pathway, with current supply expected to last a few years and expiry through 2028. - One patient, Aspen Peck, has remained in remission since early 2022 after receiving luveltamab tazevibulin following relapse, exemplifying the drug's life-saving potential.
- Sutro Biopharma has dosed the first cohort of patients in a Phase 1 trial evaluating STRO-004, a next-generation antibody-drug conjugate targeting tissue factor in advanced solid tumors. - The trial will assess STRO-004's safety and preliminary anti-tumor activity across multiple cancer types including non-small cell lung cancer, pancreatic adenocarcinoma, and colorectal cancer. - STRO-004 features an innovative design with a drug-to-antibody ratio of 8 and demonstrated higher exposure compared to approved therapies in preclinical studies. - Initial clinical data from the dose-escalation study is expected to be reported in mid-2026.
- Sutro Biopharma received U.S. FDA clearance for its IND application for STRO-004, a potential best-in-class Tissue Factor ADC, with first patient dosing expected before year-end. - The company demonstrated favorable preclinical safety data for STRO-004 in non-human primate studies up to 50 mg/kg, the highest dose tested. - Sutro's dual-payload ADC collaboration with Astellas progresses with one program entering IND-enabling toxicology studies in Q1 2025. - Following organizational restructuring, the company maintains a cash runway into at least mid-2027 with $167.6 million in cash and securities as of September 30, 2025.
- Sutro Biopharma announced a major organizational restructuring that will reduce its workforce by approximately one-third to focus resources on advancing its three antibody-drug conjugate programs. - The restructuring, combined with expected milestone payments, extends the company's cash runway into at least mid-2027, providing funding through key clinical milestones for its ADC portfolio. - The company remains on track to advance STRO-004, its next-generation Tissue Factor-targeting exatecan ADC, into clinical trials this year with initial data expected in 2026. - Sutro's cell-free platform produces single- and dual-payload ADCs engineered to improve drug exposure, reduce side effects, and expand treatable tumor types for cancer patients.
- Sutro Biopharma has entered into a research collaboration with the FDA to develop reference materials that will improve regulatory standards and enhance analytical methods for antibody drug conjugate development. - The partnership will utilize Sutro's cell-free XpressCF® technology to precisely engineer ADCs with predefined attributes, combined with FDA's analytical capabilities to fully characterize these materials. - The collaboration involves Sutro and the FDA's Office of Pharmaceutical Quality jointly leading study design and selection of target antigens, payload-linkers, and drug conjugation sites representative of both approved and developmental ADCs. - Results from this collaboration are expected to enhance the FDA's capacity for analytical characterization of ADCs and improve quality assessments across the industry.
- Sutro Biopharma appointed Greg Chow as Chief Financial Officer effective June 2, 2025, bringing over 25 years of executive leadership experience in biotech finance and operations. - Chow previously served as CFO at multiple biotech companies including Freenome Holdings and Frontier Medicines, where he guided major financing rounds and strategic collaborations. - The appointment aims to strengthen Sutro's financial position as the company advances its pipeline of novel exatecan-based and dual-payload antibody drug conjugates through clinical milestones. - Sutro granted Chow equity compensation including 100,000 restricted stock units and options for 275,000 shares under the company's 2021 Equity Inducement Plan.
- Novo Nordisk undergoes significant executive restructuring following the departure of EVP Camilla Sylvest, with rare disease leader Ludovic Helfgott taking over expanded commercial strategy responsibilities. - Galapagos faces major leadership transition as CEO Paul Stoffels announces retirement plans while CFO Thad Huston departs, amid the company's ongoing transformation into a cell therapy-focused biotech. - Multiple biotechs including Hansa Biopharma, Creyon Bio, and Sutro Biopharma appoint new CEOs as the industry continues strategic realignment efforts. - Emerging companies across oncology, rare diseases, and AI-driven drug development strengthen their leadership teams with experienced executives from major pharmaceutical companies.
- Sutro Biopharma (STRO) has been downgraded by multiple financial firms following the company's decision to discontinue its lead program luvelta. - Citizens JMP lowered Sutro from Outperform to Market Perform, while Piper Sandler downgraded the stock from Overweight to Neutral with a price target reduction from $8 to $2. - Analysts expect Sutro shares to trade in line with the broader biotech market until clinical data from its early-stage antibody-drug conjugates pipeline emerges in 2026.
- Sutro Biopharma's luveltamab tazevibulin (luvelta) demonstrated a 32% overall response rate at the optimized dose of 5.2 mg/kg in platinum-resistant ovarian cancer patients, significantly outperforming the 13.8% rate seen at lower doses. - The FR𝛼-targeting antibody-drug conjugate showed consistent efficacy across all levels of FR𝛼 expression (≥25%), including patients with lower expression levels who aren't eligible for currently approved FR𝛼-targeting treatments. - Despite the promising clinical data presented at SGO 2025, Sutro Biopharma has announced it is deprioritizing investment in luvelta's development and is seeking out-licensing opportunities to continue advancing the treatment.
- Ipsen secured FDA approval for Onivyde in first-line pancreatic cancer treatment and gained approvals for Iqirvo and Kayfanda in the U.S. and EU markets, expanding their therapeutic portfolio. - The company strengthened its pipeline through strategic partnerships, including agreements with Sutro Biopharma, Foreseen Biotechnology, and DayOne Biopharmaceuticals for innovative oncology assets. - Looking ahead to 2025, Ipsen projects sales growth exceeding 5.0% and anticipates key regulatory decisions for Cabometyx in neuroendocrine tumors and tovorafenib in pediatric low-grade glioma.
