Bolt Biotherapeutics, Inc. · NASDAQ:BOLT
Bolt Biotherapeutics — ESMO Congress 2023
9 slides from Bolt Biotherapeutics's conference presentation, Oct 23, 2023
Slide 1: RP2D selection and pharmacodynamic data of BDC-1001 in HER2-expressing solid tumors
Recommended phase 2 dose (RP2D) selection and pharmacodynamic data of the first-in-human immune- stimulating antibody conjugate (ISAC) BDC-1001 in patients with advanced HER2-expressing solid tumors Bob T. Li,1 Keun-Wook Lee,2 Mark D. Pegram,3 Manish R. Sharma,4 Jeeyun Lee,5 Alexander Spira,6 Yoon-K
Slide 2: Declaration of Interests
Bob Li, MD DECLARATION OF INTERESTS Commercial Interests Nature of Relationship Amgen, AstraZeneca, Boehringer Ingelheim, BOLT Biotherapeutics, Consultant/Advisor (uncompensated) Daiichi Sankyo, Genentech, Lilly Amgen, MORE Health Academic Travel Support Karger Publishers, Shanghai Jiao Tong Univers
Slide 3: BDC-1001: Novel, First-in-Class Boltbody Immune-Stimulating Antibody Conjugate (ISAC)
28Apr2023 BDC-1001: Novel, First-in-Class BoltbodyTM Immune-Stimulating Antibody Conjugate (ISAC) Molecular Structure Proposed Mechanism of Action (MOA) • BDC-1001 consists of • Local activation of the innate immune system • Antibody: trastuzumab biosimilar • Generates a durable tumor-targeted adapt
Slide 4: Trial Overview and Data Update Since ASCO 2023
Trial Overview and Data Update Since ASCO 20231 Phase 1 dose escalation results & RP2D selected • 131 patients with 16 different HER2-expressing solid tumor types; 18 cohorts (doses: 0.5 – 20 mg/kg IV; schedules: q3w, q2w, q1w) • BDC-1001 well tolerated up to 20 mg/kg q1w as monotherapy and in combi
Slide 5: Improved BDC-1001 Efficacy Since ASCO: New CR, Additional Long-Term SDs
Improved BDC-1001 Efficacy Since ASCO:1 1 New CR, 2 Additional Long-Term SDs, and 3 Patients Have Now Received Therapy ≥ 1 Year q3w (N = 44)2 Efficacy at RP2D, 20 mg/kg q2w, in evaluable HER2+ tumors • Monotherapy (n=7) • 1 CR, 1 PR (ORR = 29%) • 43% had disease control ≥24 weeks Day • 57% achieved
Slide 6: BDC-1001 Upregulates TLR Signaling, Myeloid, and T Cell Pathways in Clinical Responders
BDC-1001 Upregulates TLR Signaling, Myeloid, and T Cell Pathways in Clinical Responders, Consistent with MOA Innate Immunity Adaptive Immunity TLR Signaling Pathway Macrophage Function Antigen Processing T Cell-Inflamed p=0.038 p=0.012 p=0.010 p=0.028 PR or SD ≥ 24 weeks (n=4) Methods • Matched tumo
Slide 7: Increases in Select Innate and Adaptive Immune Signatures in q2w Cohorts, Not q1w
Increases in Select Innate Immune and Adaptive Immune Signatures Were Observed in Patients in the q2w Cohorts, but Not in q1w Cohorts Cytotoxic Lymphocyte M1 Macrophage Activated Dendritic Cell Immune Signature p=0.05 p=0.11 p=0.05 Log2 Fold Change Log2 Fold Change Log2 Fold Change q2w q1w q2w q1w q
Slide 8: Summary and Next Steps
Summary and Next Steps BDC-1001, a novel ISAC targeting HER2, is well tolerated with encouraging clinical activity • Clinical activity across all cohorts (n=131): 1 CR, 5 PRs, and 14 SDs ≥ 24 weeks • At RP2D, 20 mg/kg q2w (n=141): 1 CR, 3 PRs (29% ORR), and 4 SDs ≥ 24 weeks • No drug-related alopeci
Slide 9: Thank you to the patients and all the Investigators and their teams
Thank you to the patients and all the Investigators and their teams European Society for Medical Oncology (ESMO) Via Ginevra 4, CH-6900 Lugano T. +41 (0)91 973 19 00 esmo@esmo.org esmo.org