On July 7, 2021 Silverback Therapeutics, Inc. (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, reported a clinical supply agreement with Regeneron for Libtayo (cemiplimab) (Press release, Silverback Therapeutics, JUL 7, 2021, View Source [SID1234590284]). The supply agreement supports the evaluation of Libtayo, a PD-1 inhibitor, in combination with SBT6050, 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.
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"SBT6050’s unique ability to activate both innate and adaptive immune responses has the potential to enhance and expand the effectiveness of a PD-1 inhibitor in HER2-expressing solid tumors," said Naomi Hunder, M.D., Chief Medical Officer of Silverback. "We are eager to complete the ongoing dose escalation of SBT6050 combined with a PD-1 inhibitor, and look forward to working with Regeneron as we begin tumor-specific expansion cohorts."
In the first quarter of 2021, Silverback initiated treatment in Part 3 of the Phase 1/1b study to evaluate the activity of SBT6050 in combination with a PD-1 inhibitor in dose escalation. Under the terms of the agreement, Silverback will expand the ongoing Phase 1/1b trial to evaluate the combination of SBT6050 and Libtayo in tumor-specific dose expansion cohorts, initially in HER2-expressing non small cell lung cancer ("NSCLC") and gastric cancer.
Libtayo is a PD-1 blocking antibody being jointly developed and commercialized by Regeneron and Sanofi. Libtayo is approved for the first-line treatment of patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations, for adults with metastatic cutaneous squamous cell carcinoma ("CSCC") or locally advanced CSCC who are not candidates for curative surgery or curative radiation, and for patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor ("HHI") or for whom an HHI is not appropriate that is either locally advanced (full approval) or metastatic (accelerated approval).