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Bolt Biotherapeutics Presents Preliminary Results from Phase 1/2 Trial of Lead HER2-targeting Boltbody™ ISAC BDC-1001 at ASCO 2021
Poster showcases positive preliminary data from first 20 patients treated with the HER2-targeting Boltbody™ ISAC BDC-1001 as of January 29th cutoff
About this update from Bolt Biotherapeutics, Inc.
[{"type":"text","content":"Poster showcases positive preliminary data from first 20 patients treated with the HER2-targeting Boltbody™ ISAC BDC-1001 as of January 29th cutoff dateMonotherapy dose expansion and anti-PD-1 antibody combination parts of study expected to start in 2H 2021 REDWOOD CITY, Calif., June 04, 2021 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, today announced that a poster presentation discussing preliminary data from the Phase 1/2 clinical trial of BDC-1001, Bolt’s lead candidate, was presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually from June 4-8, 2021. The poster is titled “Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors.” BDC-1001 is a human epidermal growth factor receptor 2, or HER2, ISAC comprised of a HER2-targeting biosimilar of trastuzumab conjugated to one of Bolt’s proprietary TLR7/8 agonists, for the treatment of patients with HER2-expressing solid tumors, including HER2-low tumors. As of January 29, 2021, Bolt had treated 20 patients and BDC-1001 appeared to be well tolerated with mild to moderate adverse events; no dose-limiting toxicities or drug-related serious adverse events were observed. Clinical activity was seen in the form of stable disease, reductions in tumor volume including a confirmed partial response and increases in pharmacodynamic markers that Bolt believes are consistent with its proposed mechanism of action. “This poster reinforces the favorable safety and tolerability demonstrated in the first 20 patients treated with BDC-1001 in this first-in-human study in patients with HER2-expressing cancers,” said Manish R. Sharma, M.D., of START Midwest, a principal investigator in Bolt’s ongoing BDC-1001 Phase 1/2 trial. “We have seen signs of activity, including a patient with a confirmed partial response and others with stable disease, in a population with diverse tumor types and a median of four prior lines of therapy.” The BDC-1001 Phase 1/2 trial is expected to enroll up to a total of 390 patient...