On June 15, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported encouraging interim safety data from an ongoing Phase 1 dose escalation clinical trial of its product candidate STRO-001, a novel, specific and homogeneous anti-CD74 antibody-drug conjugate (ADC), as a potential therapy for patients with B-cell malignancies (Press release, Sutro Biopharma, JUN 15, 2019, View Source [SID1234537101]). The interim data from the trial includes 21 patients and separate dosing cohorts for multiple myeloma (10 MM patients) and non-Hodgkin lymphoma (11 NHL patients), was presented at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Amsterdam. The data also showed encouraging preliminary anti-tumor activity for the ADC, including one complete response (CR) and one partial response (PR) among a cohort of heavily pre-treated patients with DLBCL. Overall, STRO-001 was generally well-tolerated.
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"CD74 is expressed on B cells throughout differentiation and appears to be an attractive target for the treatment of non-Hodgkin lymphoma and multiple myeloma," said Dr. Nirav Shah, Assistant Professor of Medicine at Medical College of Wisconsin. "The interim safety results from the early dose escalation cohorts of the STRO-001 Phase 1 clinical trial are encouraging, especially considering the complete response seen in one of our patients."
Bill Newell, Sutro’s Chief Executive Officer added, "There is a continuing need for new treatment options for patients with B-cell malignancies as many patients relapse or become refractory to even the newest treatment regimens. STRO-001 was designed to directly target cancer cells to deliver a cytotoxic payload, an approach that enables greater precision in treating tumors. We view the data as encouraging and believe that STRO-001 can be an important new treatment option to address an unmet need for patients with B-cell malignancies."
The ongoing Phase 1, open-label, multicenter, dose escalation trial of STRO-001 is designed to evaluate the safety, tolerability and preliminary anti-tumor activity of STRO-001 in adults with B-cell malignancies. Based on interim data from the clinical trial through May 14, 2019, STRO-001 has been generally well-tolerated. The most common treatment emergent adverse events included fatigue, nausea, chills and infusion reactions. Neither ocular toxicity signals nor anti-drug antibodies have been observed and the maximum tolerated dose for both dosing cohorts has not been reached.
Sutro’s cell-free protein synthesis and site-specific conjugation (XpressCF+) platform technology was used to discover and develop STRO-001, a CD74-targeting ADC. STRO-001 contains a potent maytansinoid warhead conjugated to two specific sites (drug-to-antibody ratio of 2) using a stable non-cleavable linker. The interim data as of May 14, 2019, included 21 patients across two cohorts: cohort A for MM and cohort B for NHL. The patients enrolled in the trial were generally heavily pre-treated with a median of six lines of prior therapy. STRO-001 was administered as a 60-minute IV infusion on Days 1 and 15 of a 28-day cycle until disease progression or dose limiting toxicity. As of May 14, 2019, the MM cohort was at dose level 0.65 mg/kg and the NHL dose cohort was at 0.91 mg/kg. The trial continues to enroll patients in dose escalation in both MM and NHL cohorts. This trial is registered with clinicaltrials.gov identifier NCT03424603.