Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Investor Presentation (November 2021)
25 slides from Cue Biopharma's investor presentation, November 2021
Slide 1: Corporate Presentation
Corporate Presentation Immune Responses, On Cue™ Nasdaq: CUE November 2021
Slide 2: Forward-Looking Statements Disclosure
Forward-Looking Statements Disclosure 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: Cue Biopharma's Vision
Cue Biopharma’s Vision • Harnessing natural signals (“Nature’s Cues”) for tailored immune activation against cancers to enhance efficacy and tolerability Leading the next wave of disruptive, breakthrough • Exploit evolutionary selectivity of the immune system immunotherapies enabled by rational prot
Slide 4: CUE-100 Series: Changing the Therapeutic Landscape
CUE-100 Series: Changing the Therapeutic Landscape NEXT ANTICIPATED TARGET SELECTION PRE-CLINICAL PHASE 1 MILESTONE PARTNER CUE-101 HLA:A02 Monotherapy 2L+ (HPV) 1H ‘22: Top-line Phase 1b data Cancer: CUE-101 + Keytruda 1L (HPV) 2Q ‘22: Initiate Dose Expansion Asia Rights, with CUE-100 series option
Slide 5: Immunotherapy Has Transformed Oncology Treatment
Immunotherapy Has Transformed Oncology Treatment Checkpoint inhibitors provided early insights that immunotherapy has the potential to eradicate cancer, however many challenges remain – Overall response rates for checkpoints are 15-25%, depending on tumor type – Many tumors show an absence of T cell
Slide 6: IL-2 Therapy Challenges: Non-selective Immune Activation
IL-2 Therapy Challenges: Non-selective Immune Activation = Poor Tolerability and Poor Therapeutic Performance Wild Type IL-2 or IL-2 Variants Lack of Selectivity for Non-specific Activation of Tumor-specific CD8+ T cells ALL CD8+ T cells CD8+ CD8+ CD8+ CD8 + CD8 + + CD8+ CD8 CD8+ + CD8+ CD8+ CD8+ CD
Slide 7: CUE-100 Series: Designing an IL-2 Variant in Context of TCR Engagement
CUE-100 Series: Designing an IL-2 Variant in Context of T Cell Receptor (TCR) Engagement Molecular structure exploits concurrent TCR and IL-2R engagement to activate tumor-specific CD8+ T cells TUMOR-SPECIFIC p-HLA (2X) NON TUMOR-SPECIFIC CUE-100 series T CELLS T CELLS Immuno-STAT Selective engageme
Slide 8: CUE-100 Series: Directing IL-2 Activity to Tumor-specific T cells
CUE-100 Series: Directing IL-2 Activity to Tumor-specific T cells and Enhancing Tolerability and Efficacy Focused Activity on Biased Activation and Expansion of Tumor- IL-2 Immuno-STAT Tumor-specific T cells specific T cells (or “TCR-engaged” T cells) +++ CUE-100 series CD8+ CD8+ CD8+ CD8+ IL-2 CD8+
Slide 9: CUE-100 Series: Opportunity to Maximize the Fullest Potential of IL-2
CUE-100 Series: Opportunity to Maximize the Fullest Potential of IL-2 The CUE-100 series has the potential of enabling a broad therapeutic window to enhance IL-2 clinical effectiveness Wild Type IL-2 or IL-2 Variants CUE-100 Series LEGEND IL-2 BIASED EQUAL ACTIVATION ENGAGEMENT OF TUMOR- IL-2R OF AL
Slide 10: CUE-100 Series: Validate, Expand and Accelerate
CUE-100 Series: Validate, Expand and Accelerate Platform Validation CUE-100 Series Phase 1 Mono in 2L+ Currently in RP2D dose CUE-101 (A02): HPV E7 R/M HNSCC expansion Immuno-STATs Signal 1 Phase 1 CPI Combo in 1L Currently in dose HLA-A*02:01 + HPV-16 E711-20 R/M HNSCC escalation Phase 1 Neoadjuvan
Slide 11: CUE-101: Lead Clinical-stage Asset from IL-2 based CUE-100 Series
CUE-101: Lead Clinical-stage Asset from IL-2 based CUE-100 Series Phase 1 Part A Dose Escalation Completed and Part B Expansion Enrolling • 38 patients with recurrent/metastatic H&N cancer across 7 dose escalation cohorts • 15 patients treated at the RP2D (4 mg/kg) Overview of PK CUE-101 Phase 1 • D
Slide 12: Preliminary Tumor Responses for CUE-101 Monotherapy at the RP2D
Preliminary Tumor Responses for CUE-101 Monotherapy at the RP2D (4 mg/kg) Responses N % Objective Response 1 7.7% (CR or PR confirmed ≥ 4 weeks) Durable Stable Disease 5 38.5% (SD sustained for ≥ 12 weeks*) Clinical Benefit 6 46.2% (CR/PR + durable SD) Data extracted from EDC 03-Nov-2021 (7 patients
Slide 13: CUE-101: Confirmed PR with ~54% Reduction in Target Lesions
CUE-101: Confirmed PR with ~ 54% Reduction in Target Lesions Increase in HPV E7-specific CD8+ T cells with minimal change in total T cells Case History 9-Fold increase 10 10 CD4+ T cells • Prior therapy: 9 9 specific CD8+ T cells 8 CD8+ T cells Fold-change in E7 (%of leukocytes) 8 Fold-change 7 7 –
Slide 14: CUE-101: Tumor Necrosis and T Cell Infiltrates in Target Lesions
CUE-101: Tumor Necrosis and T Cell Infiltrates in Target Lesions Case History • Prior therapy: Immunostaining Hematoxylin and Eosin Stain – 1L chemotherapy (CD8+ T cells = rose; PD-LI = brown) – 2L pembrolizumab • Progressive disease prior to enrollment • Treated in metastatic 3L setting with 1.0 mg
Slide 15: CUE-101: Increase in Tumor Infiltrating T Cells (TILs)
CUE-101: Increase in Tumor Infiltrating T Cells (TILs) Case History Pre-dose Cycle 3 Day 1 • Prior therapy: 1500 – 1L chemotherapy CD3+GZMB+ cells – 2L pembrolizumab 1000 • Progressive disease prior to enrollment 500 • Treated in metastatic 3L setting with 2.0 mg/kg 0 CUE-101 Q3W (Cohort 5) PRE C3D1
Slide 16: Part C: Dose Escalation of CUE-101 in Combination with Pembrolizumab
Part C: Dose Escalation of CUE-101 in Combination with Pembrolizumab Part C: Pembrolizumab Combination Dose Escalation Cohort 2 (2mg/kg) 4.0 Cohort 3 Enrolling Pembrolizumab CUE-101 Dose 200 mg, Q3W (mg/kg) 2.0 Cohort 2 Dosing complete, no DLTs 1st patient has confirmed SD 1.0 Dosing complete, no DL
Slide 17: CUE-101: Potential for Multiple Registration Paths
CUE-101: Potential for Multiple Registration Paths Monotherapy • 2nd line+ therapy for HPV+ head and neck cancer Combination therapy • First line HPV+ Head and Neck cancer in combination with pembrolizumab Neoadjuvant therapy • Early treatment in neoadjuvant setting (study launched in 2H 21) © 2021
Slide 18: CUE-100 Series: Validate, Expand and Accelerate
CUE-100 Series: Validate, Expand and Accelerate Platform Validation and Expansion CUE-100 Series Phase 1 Mono in 2L+ CUE-101 (HPV E7) Immuno-STATs R/M HNSCC Phase 1 CPI Combo in 1L R/M HNSCC Phase 1 Neo-Adj in locally/advanced HNSCC Phase 1 Adj in recurrent HNSCC CUE-102 (WT-1) IND filing 1Q 2022 Pl
Slide 19: CUE-102: Targeting Wilms Tumor (WT1) – IND Filing 1Q 2022
CUE-102: Targeting Wilms Tumor 1 (WT1) – IND Filing 1Q 2022 Molecular Design CUE-102 Selectively Expands WT-1-specific T Cells WT137-45 80 250 (Fold-change over background) media ctrl] T cells medium ctrl] background) -specific CD8+ T cells T cells # Tetramer+ CD8+ T cells 200 IL-2 Variant 60 CD8CD8
Slide 20: CUE-103: KRAS G12V Proof of Concept for Targeting KRAS Mutations
CUE-103: KRAS G12V Proof of Concept for Targeting KRAS Mutations Molecular Design CUE-103 Selectively Expands KRASG12V-specific T Cells Molecular Design Single Chain KRAS7-16 G12V 8 %KRASG12V T cells G12V IST IL-2 Variant G12D IST 6 (same as CUE-101) HLA A:11 4 Fc Backbone (same as CUE-101) 2 0 • Br
Slide 21: Expansion of Modular CUE-100 Series Into Broad Range of Cancers
Expansion of Modular CUE-100 Series Into Broad Range of Cancers KRAS WT1 Broad Universe 400,000 HPV of Addressable 350,000 Incident Cases Harboring Target TCR Targets with 300,000 CUE-100 Series 250,000 200,000 • Viral antigens (HPV, EBV) 150,000 • Cancer-Testes Antigens 100,000 (WT1, MAGE) 50,000 •
Slide 22: Platform Acceleration
CUE-100 Series: Validate, Expand and Accelerate Platform Validation and Expansion CUE-100 Series Phase 1 Mono in 2L+ CUE-101 (HPV E7) R/M HNSCC Immuno-STATs Phase 1 CPI Combo in 1L R/M HNSCC Platform Acceleration Phase 1 Neo-Adj in locally/advanced HNSCC Phase 1 Adj in recurrent HNSCC CUE-102 (WT-1)
Slide 23: CUE-100 Neo-STAT: Off-the-Shelf Universal Scaffold
CUE-100 Neo-STAT (NST): “Off-the-Shelf” Universal Scaffold to Address Tumor Heterogeneity and Platform Scalability Empty HLA Neo-STAT Neo-STATs (NST) and Immuno-STATs (IST) NSTs with SARS-CoV2 Epitope Expand CD8+ Stabilized through Rapid conjugation of engineering tumor epitopes Exhibit Comparable A
Slide 24: Summary of Strategic Developments for CUE-100 Series
Summary of Strategic Developments for CUE 100 Series CUE-101 Clinical Development – Monotherapy holds promise of registration path for 2L+ HNSCC patients • Clinical data de-risks CUE-101 as well as CUE-100 series • Demonstrates attractive PK/exposure and tolerability profile with evidence of clinica
Slide 25: Thank you
Thank you Rationally Engineered Biologics to Restore Immune Balance by Harnessing Nature’s Cues for Selective and Specific Immune Modulation
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