SBT6290 / ARS Pharma - LARVOL DELTA

A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Silverback Therapeutics | N=225 ➔ 0 | Trial completion date: May 2025 ➔ Mar 2022 | Recruiting ➔ Withdrawn | Trial primary completion date: Jan 2025 ➔ Mar 2022

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Breast Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • HER-2 • NECTIN4

A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=225 | Recruiting | Sponsor: Silverback Therapeutics | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Breast Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • HER-2 • NECTIN4

A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=225 | Not yet recruiting | Sponsor: Silverback Therapeutics

Combination therapy • New P1/2 trial • Breast Cancer • Head and Neck Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • HER-2 • NECTIN4

Silverback Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update (Businesswire) - "Selected go forward dose of 0.3 mg/kg SBT6050 in combination with anti-PD-1 therapy in expansion cohorts. Silverback is prioritizing combination with Libtayo in gastroesophageal and non-small cell lung cancers and plans to initiate these expansion cohorts in the fourth quarter of 2021....SBT6290 (Nectin4-TL8 ImmunoTAC): Silverback remains on track to initiate the phase 1/1b trial in the first quarter of 2022, and plans to enroll patients with bladder, non-small cell lung, triple negative breast, and head and neck cancers in dose escalation."

New P1 trial • New trial • Bladder Cancer • Breast Cancer • GastroEsophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Triple Negative Breast Cancer

[VIRTUAL] Immunomodulatory Antibody Conjugates for the Treatment of Cancer & Chronic Viral Infections (ADC-USA 2021) - "Synopsis An overview of Silverback’s ImmunoTAC (Immunomodulatory Targeted Antibody Conjugate) technology platform Discussing the discovery and development of ImmunoTAC molecules containing a TLR8 agonist payload designed to stimulate local activation of myeloid cells Examining how broad and versatile potential of the ImmunoTAC platform is exemplified by oncology (SBT6050 and SBT6290) and virology (SBT8230) development candidates"

Immune Modulation • Infectious Disease • Inflammation • Oncology • TLR8

[VIRTUAL] SBT6290, a systemically administered Nectin4-directed TLR8 ImmunoTAC™ product candidate, is designed for tumor-localized activation of myeloid cells (AACR 2021) - "Systemic administration of a SBT6290 surrogate in mice bearing Nectin4-expressing tumors results in intra-tumoral myeloid and T cell activation and increased overall survival. The preclinical data described here demonstrate the potential for SBT6290 to drive anti-tumor responses and support continued preclinical development of SBT6290 for Nectin4-expressing tumors."

IO biomarker • Bladder Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • NECTIN4 • TIGIT • TLR8

Silverback Therapeutics Reports First Quarter 2021 Financial Results (Businesswire) - "SBT6050 (HER2-TLR8 ImmunoTAC) continues to advance through monotherapy and pembrolizumab combination dose escalation arms of the Phase 1/1b clinical study. Silverback is on track to deliver interim clinical data from the monotherapy dose escalation arm of the study in the second half of 2021....GLP toxicology studies have commenced for SBT6290 (Nectin4-TLR8 ImmunoTAC), with an IND submission anticipated in the fourth quarter of 2021."

IND • P1 data • Oncology • Solid Tumor

Silverback Therapeutics to Present SBT6290 Preclinical Data at the AACR 2021 Annual Conference (Businesswire) - "Silverback Therapeutics, Inc…will present preclinical data on its second product candidate, SBT6290, at the American Association of Cancer Research (AACR) 2021 Annual Conference, taking place virtually April 10-15. The data highlight the ability of SBT6290, a systemically administered Nectin4-directed TLR8 ImmunoTAC product candidate, to selectively activate myeloid cells in the tumor microenvironment, a promising approach to overcome resistance mechanisms associated with most current immunotherapies...'We will continue to evaluate SBT6290 in GLP toxicology studies and anticipate submitting an IND for this program in the fourth quarter of 2021.'"

IND • Preclinical • Oncology

"Nectin4 is nectar, just ask Nectin Therapeutics, and these guys at $SBTX 1858 - SBT6290, a systemically administered Nectin4-directed TLR8 ImmunoTAC™ product candidate, is designed for tumor-localized activation of myeloid cells #AACR21 Silverback Therapeutics" (@PDRennert)

Oncology • NECTIN4 • TLR8

Silverback Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Corporate Updates (Businesswire) - “SBT6050…Enrollment is ongoing in Part 1 of the study (SBT6050 monotherapy dose escalation) and treatment has been initiated in Part 3 of the study (SBT6050 plus pembrolizumab dose-escalation). Silverback is on track to deliver interim clinical data from Part 1 of the study in the second half of 2021; SBT6290…IND application is expected in the fourth quarter of 2021. The initiation of a Phase 1/1b clinical study is anticipated in the first quarter of 2022.”

IND • New P1 trial • P1 data • Oncology • Solid Tumor