Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — ASCO 2024 Oral Presentation
17 slides from Cue Biopharma's conference presentation, May 23, 2024
Slide 1: A Phase 1 Dose-escalation and Expansion Study of CUE-101 in HPV16+ R/M HNSCC
A Phase 1 Dose-escalation and Expansion Study of CUE-101, Given as Monotherapy and in Combination with Pembrolizumab, in Patients with HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Cancer (R/M HNSCC) Douglas Adkins1, A. Dimitrios Colevas2, Christine H. Chung3, Cristina P. Rodriguez4, Jong
Slide 2: Disclosures
2 Disclosures • Employer: Washington University in St Louis. • Consultant or Scientific Advisory Board: Adlai Nortye USA, Boehringer Ingelheim, Cue Biopharma, Calliditas, Eisai, EMD Serono, GenMab, GSK, Immunitas, Inhibrx, Jazz Pharmaceuticals, Kura Oncology, Merck, Merck KGaA, Merus, Natco Pharma,
Slide 3: Key Results
3 Key Results • CUE-101 given as monotherapy or with pembrolizumab was safe and tolerable. • Second-Line treatment with CUE-101 monotherapy resulted in an ORR of 5%; however, the median OS was 20.8 months. • First-Line treatment with CUE-101 + pembrolizumab resulted in an ORR of 46%. The 12-month OS
Slide 4: CUE-101: Mechanism of Action
4 CUE-101: Mechanism of Action “Selective Engager of Tumor-specific T Cells” Components: • 2 HPV-16 E7 epitopes that are presented to the T cell by HLA-A02:01 • 4 Affinity-attenuated IL-2 molecules Properties: • Selective activation and expansion of HPV16-specific T cells • Limited non-selective T c
Slide 5: Objectives/Endpoints
5 Objectives/Endpoints • Dose Escalation § Determine RP2D of CUE-101. § Determine RP2D of CUE-101 plus pembrolizumab. § Endpoints: Adverse events, DLTs (cycle 1), & markers of biologic activity. • Dose Expansion § Determine ORR with CUE-101 given as 2L treatment of CPI- and/or platinum-pretreated di
Slide 6: Hypotheses/Statistics
6 Hypotheses/Statistics • Hypotheses § CUE-101 monotherapy or with pembrolizumab would be tolerable. § The ORR with 2L CUE-101 would be at least 20%. § The ORR with 1L CUE-101 + pembrolizumab would be at least 35%. • Statistical Analysis Plan § RP2D was determined using a Bayesian Logistic Regressio
Slide 7: Study Design
7 Study Design Dose Escalation Dose Expansion CUE-101 CUE-101 • 7 dose cohorts (n=3-9 pts) • CUE-101 (RP2D) • Dose levels: 0.06-8.0 mg/kg Q3W • ~20 patients CUE-101 + Pembrolizumab CUE-101 + Pembrolizumab • 3 dose cohorts (n=3 pts) • CUE-101 (RP2D) + • Dose levels: 1.0-4.0 mg/kg Q3W Pembrolizumab Q3
Slide 8: Eligibility
8 Eligibility • All patients § R/M HNSCC § Tumor HPV16+ by mRNA ISH and p16+ by IHC (centrally confirmed) § HLA-A*0201 genotype (centrally confirmed) § ECOG Performance Status 0 or 1 § Adequate organ function • CUE-101 § Prior CPI and/or platinum agent • CUE-101 + Pembrolizumab § No prior therapy fo
Slide 9: Baseline Characteristics
Baseline Characteristics 9 Monotherapy Combination Treatment Arm (N=49) (N=31) Age (years) Mean (range) 64 (48-82) 65 (43-79) Sex Male 47 (95.9%) 30 (96.8%) Female 2 (4.1%) 1 (3.2%) PD-L1 CPS < 20 __ 18 (58.1%) ≥ 20 13 (41.9%) Lines of Therapy for R/M HNSCC§ Median (range) 3 (1-10) 0 • CPI 49 (100%)
Slide 10: Adverse Events with CUE-101 (All Patients)
10 Adverse Events with CUE-101 (All Patients) 50 40 DLT Grade < 3 • 1 patient (anemia) Patients % 30 Grade ≥ 3 • Occurred at 1 mg/kg 20 10 RP2D • 4 mg/kg IV Q3W 0 ia C ia h A ue yp s n m a hr g W sio cre ills ph a at ea ia N ia C cre ion ip d t d ac d Vo se ys he D ug H Dy tio rt n st se gh Re se m
Slide 11: Adverse Events CUE-101 + Pembrolizumab (All Patients)
Patients % Fa 10 20 30 40 50 60 70 0 ti N gue H au yp s ot C ea hy h W ro ills ei id gh is td F m ec ev In re er PRESENTED BY: fu as si R on Co ed as H r ug h yp ea h m e ct ac rte io ul ns n op io Douglas Adkins, MD ap n C A ula on n r e Eo stip mia si at no io p n H He hi yp ad lia on ac at he r D
Slide 12: 2L CUE-101 (4 mg/kg)
12 2L CUE-101 (4 mg/kg) ORR 5% • 1 PR (n=20) • DoR: 9.7 mos Median OS 20.8 months (95% CI 10.0, NA) Data Extract: 01-May-2024. PRESENTED BY: Douglas Adkins, MD
Slide 13: 1L CUE-101 (4 mg/kg) + Pembrolizumab: Change from Baseline in Target Lesions
1L CUE-101 (4 mg/kg) + Pembrolizumab (n=24) 13 ORR: 46% • 95% CI 25.6, 67.2 Change from Baseline In Target Lesions (%) • 1 CR, 10 PR Data Extract: 01-May-2024. PRESENTED BY: Douglas Adkins, MD
Slide 14: 1L CUE-101 (4 mg/kg) + Pembrolizumab: Change from Baseline in Target Lesions
14 1L CUE-101 (4 mg/kg) + Pembrolizumab mDOR not reached Change from Baseline in Target Lesions (%) Data Extract: 01-May-2024. PRESENTED BY: Douglas Adkins, MD
Slide 15: 1L CUE-101 (4 mg/kg) + Pembrolizumab
1L CUE-101 (4 mg/kg) + Pembrolizumab Progression-Free Survival Overall Survival Median: 5.8 mos 12-Month OS: 95.5% Data Extract: 01-May-2024. PRESENTED BY: Douglas Adkins, MD
Slide 16: Key Results
16 Key Results • CUE-101 given as monotherapy or with pembrolizumab was safe and tolerable. • Second-line treatment with CUE-101 monotherapy resulted in an ORR of 5%. • First-line treatment with CUE-101 + pembrolizumab resulted in an ORR of 46% and a 12-month OS was 95.5%. PRESENTED BY: Douglas Adki
Slide 17: Acknowledgements
17 Acknowledgements • To all co-authors. • To all patients who participated in this trial, their family and caregivers, and to all site investigators and study personnel. This study was sponsored by Cue Biopharma Inc. and conducted in collaboration with LG Chem, a subsidiary of LG Corp., Seoul, Sout