Slide 1: Safety and efficacy of Bel-sar (AU-011), a Virus-like-Drug-Conjugate in NMIBC
Safety and efficacy of Bel-sar (AU-011), a Virus-like-Drug-Conjugate (VDC) in patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Max Kates, M.D., Sabine D. Brookman-May, M.D., Joseph McQuaid, M.D., Jennifer Linehan, M.D., Xianne Penny, PhD, , Gautam Jayram, M.D., Piyush Agarwal, M.D., Joseph J
Slide 2: Investigational Product Candidates
Investigational Product Candidates This presentation discusses product candidates that are under preclinical or clinical evaluation and that have not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Until finalized in a clinical study
Slide 3: Background
Background • Current standard of care for NMIBC leaves a large, unmet medical need: Bel-sar injection NIR light • High recurrence rates (689 nm) • Need for repeat surgeries and adjuvant treatments Necrotic tumor cells DAMPS and neoantigens • AU-011 is a focally administered, Virus-like-Drug- Conjuga
Slide 4: Phase 1 trial of bel-sar for bladder cancer designed to evaluate safety, feasibility, and mechanism of action
Phase 1 trial of bel-sar for bladder cancer designed to evaluate safety, feasibility, and mechanism of action Single dose window of opportunity study in NMIBC all-comers Histopathological assessment completed at time of standard of care TURBT Part 1 (n=5) Part 2 (n=~10) bel-sar alone bel-sar + focal
Slide 5: Efficacy data: Ta Intermediate-Risk NMIBC
Efficacy data: Ta Intermediate-Risk NMIBC 4/5 patients demonstrated CR; 5/5 patients with immune response in target tumor aFor purposes of this analysis, Clinical complete response defined as absence of tumor cells on histopathologic evaluation. bBladder urothelial field effect: absence of tumor cel
Slide 6: Efficacy data: Ta High-Risk NMIBC
Efficacy data: Ta High-Risk NMIBC 1/5 patients demonstrated CR; 5/5 patients with immune response in target tumor aClinical complete response defined as absence of tumor cells on histopathologic evaluation. bBladder urothelial field effect: absence of tumor cells in non-target lesions. cImmune respo
Slide 7: Visual and Immune Response
Visual and Immune Response Patient A3; Intermediate-Risk NMIBC Tumor: Before bel-sar H&E: After bel-sar CD4: After bel-sar Tumor: After bel-sar Lymphoid follicles were observed, Significant infiltration of CD4+/CD8+ T-cells suggesting a strong adaptive immune in both treated and untreated tumors, re
Slide 8: Mature Tertiary Lymphoid Structures (TLS) in Target (Treated) Lesion
Mature Tertiary Lymphoid Structures (TLS) in Target (Treated) Lesion: Active Immunosurveillance After Bel-sar Treatment CD3: T cells CD20: B cells CD23: Follicular Dendritic Cells (FDC) (Found in B cell follicles, only present in mature TLS) PNAd: Peripheral Node Addressin (Stains for high endotheli
Slide 9: Early Tertiary Lymphoid Structures (TLS) in Distant Non-Target (Non-Treated) Lesion
Early Tertiary Lymphoid Structures (TLS) in Distant Non- Target (Non-Treated) Lesion: Urothelial Immune Field Effect After Bel-sar Treatment CD3: T cells CD20: B cells CD23: Follicular Dendritic Cells (FDC) (Found in B cell follicles, only present in mature TLS) PNAd: Peripheral Node Addressin (Stai
Slide 10: Conclusions
Conclusions • Dual mechanism of action demonstrated with Virus-like Drug Conjugate: • Tumor cell necrosis with clinical complete response • Strong local immune response (active immunosurveillance) with generation of mature TLS • Extensive urothelial field effect in NMIBC with early TLS visualized in