Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Investor Presentation (February 2021)
24 slides from Cue Biopharma's investor presentation, February 2021
Slide 1: Corporate Presentation
Corporate Presentation Immune Responses, On Cue™ Nasdaq: CUE | February 2021
Slide 2: Forward-Looking Statements Disclaimer
Forward-Looking Statements Disclaimer This presentation has been prepared by Cue Biopharma, Inc. (“we,” “us,” “our,” “Cue” or the “Company”) and is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities, nor shall there be any sa
Slide 3: Rationally Engineered Biologics to Harness Nature's Cues for Selective and Specific Immune Modulation
Rationally Engineered Biologics to Harness Nature’s Cues for Selective and Specific Immune Modulation
Slide 4: Disruptive Platform for Providing Selective T Cell Modulation
Disruptive Platform for Providing Selective T Cell Modulation Immuno-STAT Platform and Pipeline Advancements in 2020 CUE-101 Phase 1 monotherapy Combination study in 1L R/M SCCHN: CUE-300 Series for AI: study in 2L+ R/M SCCHN: Extended relationship with Merck to Initiated CUE-101 + KEYTRUDA, Complet
Slide 5: Immuno-STAT: Emulating Nature's Cues to Selectively Modulate T Cells
Immuno-STAT: Emulating Nature’s Cues to Selectively Modulate T Cells Platform Modularity T Cell Immuno-STAT Peptide Antigen Antigen-specific Co-Stimulatory/ T Cell Receptor Co-Regulatory Framework Peptide epitopes to target (TCR) Signal different diseases Co-Stim/Co-Reg Distinct biological signals,
Slide 6: CUE-100 series: An Optimized Scaffold for Selective Delivery of Engineered IL-2
CUE-100 series: An Optimized Scaffold for Selective Delivery of Engineered IL-2 to Tumor-specific T cells Immune Signaling Components CUE-100 Series “Signal 1” engagement of T cells via TCR: • Selective delivery of modified IL-2 to tumor-specific Tumor-Peptide T cells Loaded HLA • Enables priming an
Slide 7: CUE-101: Lead Clinical Candidate from CUE-100 Series
CUE-101: Lead Clinical Candidate from CUE-100 Series Signal 1 • CUE-101 is designed to selectively prime Signal 2 and expand HPV-specific T cells in vivo HPV-16 E711-20 peptide Co-stimulatory signal: presented by HLA-A*02:01 • HPV is an oncovirus (i.e., a virus that IL-2 variant (2 copies) causes ca
Slide 8: CUE-101: Phase 1 Clinical Development Network
CUE-101: Phase 1 Clinical Development Network Cue Biopharma has engaged a network of nationally recognized clinical investigators and 14 Phase 1 sites are now open • Emory Winship Cancer Institute | Nabil Saba • Karmanos Cancer Institute | Elizabeth Heath and Ammar Sukari • MD Anderson Cancer Center
Slide 9: CUE-101: Monotherapy Parts A & B
CUE-101: Monotherapy Parts A & B • Eligibility Part A: Monotherapy Dose Escalation - Part A & B: HPV+ H&N Cancer, R/M, ≥ 2nd Line SRC Completed Cohort 7 Dec 21 Completed dosing • Design (CUE-101 Q3W) 8.0 mg/kg of Cohort 7 - Part A: Dose Escalation (3+3 Pts) Cohort 6 PD & Activity 4.0 mg/kg - Part A:
Slide 10: CUE-101: PK Cohorts
CUE-101: PK Cohorts 1 - 5 105 105 2.0 mg/kg Patient @ 1 mg/kg [CUE-101] (ng/mL) Cycle 1 104 Cycle 2 1.0 mg/kg Cycle 3 [CUE-101] (ng/mL) 103 104 0.54 mg/kg Cycle 4 102 Cycle 5 0.18 mg/kg 101 103 0.06 mg/kg 0 24 48 72 96 0 4 8 2 6 0 4 8 2 6 12 14 16 19 21 24 26 28 31 33 Hours Post Start of Infusion 10
Slide 11: Emerging PD Metrics: Expansion of HPV E7-specific CD8+ T Cells
Emerging PD Metrics: Expansion of HPV E7-specific CD8+ T Cells of cells at C1D8 8 100 CD8 pre-dose at C1D8 CD8+ T T cells 80 frequency 6 Pt10 cells Pt13 Pt17 + T cells 60 + E7-specific over+ + inE7 Pt20 of Ki67 4 Pt21 Fold-changeof frequency 40 Pt23 % Ki67+ CD8 Fold-change Frequency 2 20 0 0 8) 1) 8
Slide 12: CUE-101 Demonstrates Clinical PoC for the Immuno-STAT Platform
CUE-101 Demonstrates Clinical PoC for the Immuno-STAT Platform Well tolerated throughout dose escalation Dose-proportional increase in PK with repeat dosing demonstrates sustained PK and exposure Dose proportional evidence of PD activity Observations of clinical activity in ongoing monotherapy dose-
Slide 13: Vision for Immuno-STAT Platform: Validate, Expand, and Accelerate
Vision for Immuno-STAT Platform: Validate, Expand, and Accelerate Platform Validation and Acceleration 1) Validate: De-risk CUE-100 Series assets with CUE-101 clinical data from mono, CPI combo and Immuno-STAT neoadjuvant studies, providing multiple registration paths CUE-100 Series HPV (CUE-101) Ph
Slide 14: CUE-100 Series Provides Antigen Versatility to Address Multiple Indications
Immuno-STAT Platform: CUE-100 Series Provides Antigen Versatility to Address multiple Indications Influenza MP158-66 CMV pp65495-503 MART-126-35 WT137-45 KRAS G12V7-16 tetramer-APC tetramer-APC mTCR-APC tetramer-PE tetramer-APC CONTROL CD8 tetramer-PE tetramer-PE tetramer-PE mTCR-PE tetramer-APC tet
Slide 15: Neo-STAT: Next-gen Evolution of the Immuno-STAT Framework
Neo-STAT: Next-gen Evolution of the Immuno-STAT Framework CUE-100 Neo-STAT Therapeutic scaffold Top manufactured in bulk Therapeutic scaffold receptive for chemical View conjugation of peptides that potentially: • Increases R&D efficiency and reduces cost of the generation of clinical grade material
Slide 16: Neo-STAT: Examples of Rapid Generation of "Active" Molecules
Neo-STAT: Examples of Rapid Generation of “Active” Molecules % of CMV-specific CD8+ CMV CUE-100 Series IST T cells CMV Neo-STAT + CMV Peptide MART-1 Neo-STAT % of MART-1-specific CD8+ MART-1 CUE-100 Series IST MART-1 Neo-STAT T cells + MART-1 Peptide CMV Neo-STAT SCV2 reactive CD8 T cells (naive) SC
Slide 17: Vision for Immuno-STAT Platform: Validate, Expand, and Accelerate
Vision for Immuno-STAT Platform: Validate, Expand, and Accelerate Platform Validation and Acceleration 1) Validate: De-risk CUE-100 Series assets with CUE-101 clinical data from mono, CPI combo and Immuno-STAT neoadjuvant studies, providing multiple registration paths CUE-100 Series HPV (CUE-101) Ph
Slide 18: CUE-301: Target Rationale and Therapeutic Hypothesis
CUE-301: Target Rationale and Therapeutic Hypothesis Target Rationale • Type 1 diabetes (T1D) is a chronic autoimmune disease resulting in severe loss of pancreatic β cells due to the targeting of islet cell autoantigens - Imbalances in the number and/or function of antigen-specific (AgS) autoreacti
Slide 19: CUE-301: Molecular Design
CUE-301: Molecular Design PI-DR4-PDL1 PD-L1 Engineered to provide functional attenuation of targeted cells Proinsulin76-90 Major proinsulin epitope, marker Class II DRB1*04 of autoreactivity, engineered for DR4 allele highly associated with T1D, enhanced binding affinity/stability engineered for enh
Slide 20: CUE-301: Inhibition of Proinsulin-specific T Cells In Vitro
CUE-301: Inhibition of Proinsulin-specific T Cells In Vitro D0 PBMC + pathogenic peptide Pathogenic T cell (orange) Non-cognate Cognate PDL1-IST PDL1-IST D10 Tetramer readout Expansion of Suppression of pathogenic pathogenic antigen- antigen-specific CD4 T cell specific CD4 T cells expansion CUE-301
Slide 21: CUE-301: Selective Suppression of Proinsulin Reactive T Cells In Vivo
CUE-301: Selective Suppression of Proinsulin Reactive T Cells In Vivo Untreated Mice IST Treated Mice IFN𝛄 ELISpot IFN𝛄 ELISpot 1400 1400 1000 1000 SFC per e6 cells SFC per e6 cells 600 600 300 300 200 200 HA HA 100 100 PI PI 0 0 0 8 10 12 14 16 18 20 0 8 10 12 14 16 18 20 Days Post Immunization…
Slide 22: CUE-301: Summary
CUE-301: Summary ü Generation of an Immuno-STAT molecule comprised of a Class II HLA (DRB1*04) along with the PD-L1 inhibitory ligand to selectively dampen autoreactive CD4+ T cells ü Treatment with CUE-301 significantly suppresses expansion of proinsulin- specific CD4+ T cells both in vitro and in
Slide 23: Key 2021 Milestones: Risk Reduction and Value Creation
Key 2021 Milestones: Risk Reduction and Value Creation 3 4 5 1 Expansion of dose 2 Select CUE-101 2 Initiate CUE-101 Initiate & expand Prepare for levels to determine monotherapy neoadjuvant study KRAS, CUE-102 optimal CUE-101 recommended to enable Immuno-STAT & (WT1/A02) monotherapy dose Phase 2 do
Slide 24: Thank you
Thank you Immune Responses, On Cue™ Nasdaq: CUE | February 2021
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