![]() ![]() SBT6050 is the first of a new class of targeted immuno-oncology agents designed to direct a TLR8 agonist linker-payload to activate myeloid cells in tumors expressing moderate to high levels of HER2. An archived replay will be available shortly after the conclusion of the event. A live webcast, including slides, can be accessed through the Events section of the Company’s website at. Silverback’s management team will host a conference call today at 6:30 AM ET. Silverback will be discussing details of its expanded clinical development strategy on the scheduled investor webcast today.Ĭonference Call and Webcast on Thursday, September 16, 2021, at 6:30 AM ET SBT6050 targets the pertuzumab binding domain of HER2 and is designed to be used in combination with standard of care agents, including trastuzumab-containing regimens. In addition, stable disease was reported in seven patients. Pharmacodynamic activity is maintained with repeat dosing of SBT6050.Įarly signals of anti-tumor activity were observed in a heavily pre-treated, heterogeneous population.Īmong 18 evaluable patients for tumor types of interest, one patient with HER2 IHC 2+ NSCLC had a confirmed partial response (-55% per RECIST 1.1 criteria), maintained at the most recently available scan obtained at 36 weeks post-enrollment, and 8 weeks after discontinuing study treatment. SBT6050 induces pharmacologic activity indicative of myeloid and NK/T cell activation at all dose levels, with effects plateauing at 0.6 mg/kg. ![]() Linear exposure is evidence of saturation of receptor mediated clearance.Ĭonjugate stability was assessed using a highly sensitive assay, and no active levels of SBT6050’s free payload were detected in the blood and any amount of free payload was absent in 98% of all blood samples tested. SBT6050 exposures increased with dose and exhibited a linear PK profile at 0.6 mg/kg and higher. These DLTs resolved with supportive care.Ĭytokine release syndrome (CRS) > Grade 2 was not observed at any dose level. These were mostly Grade 1 or 2 in nature, and no Grade 4 or higher related adverse events were reported.Īt higher dose levels, dose limiting toxicities (DLTs) were observed and included Grade 3 hypotension, injection site reaction, fever, and hypoxia. The most frequent treatment-related adverse events were consistent with immune activation, and included injection site reactions, fever and chills, hypotension, nausea, vomiting, and fatigue. “The signals of anti-tumor activity are encouraging and its complementary mechanism of action with standard-of-care agents makes SBT6050 attractive for combination regimens.” “The adverse event profile thus far has been very manageable and importantly, suggests the potential to combine with other standard of care agents,” said Samuel Klempner, MD, Medical Oncologist at the Massachusetts General Hospital. Patients received between 1 and 17 doses of SBT6050.Īs a monotherapy and in combination with pembrolizumab, SBT6050 was generally well-tolerated, with an adverse event profile that is consistent with immune system activation and considered on-mechanism. SBT6050 dose levels ranged from 0.3 to 1.2 mg/kg in the monotherapy dose escalation arm (Part 1), and 0.15 and 0.3 mg/kg in the pembrolizumab combination arm (Part 3). “We look forward to moving into expansion cohorts and to expanding our clinical development plan to include combination with standard-of-care trastuzumab-containing regimens.”Īs of August 1, 2021, 40 patients with advanced or metastatic HER2-expressing or amplified solid tumors were enrolled into the SBT6050-101 trial. ![]() “Over this past year, we have gathered compelling data with clear signals of SBT6050’s pharmacological activity, marked by the activation of both the innate and adaptive immune response in patients,” said Laura Shawver, Ph.D., chief executive officer of Silverback. (Nasdaq: SBTX) (“Silverback”), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, today presented interim clinical results from a Phase 1/1b clinical study of SBT6050 as a monotherapy and in combination with pembrolizumab in patients with advanced or metastatic HER2-expressing or amplified solid tumors, at the 2021 European Society for Medical Oncology Congress. SEATTLE-( BUSINESS WIRE)-Silverback Therapeutics, Inc. ![]()
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