Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Investor Presentation (September 2021)
23 slides from Cue Biopharma's investor presentation, September 2021
Slide 1: Corporate Presentation
Corporate Presentation Immune Responses, On Cue™ Nasdaq: CUE September 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 • Enabled by rational protein engineering to design immunotherapies therapeutics with potentiall
Slide 4: Cue Biopharma Drug Product Candidate Pipeline
Cue Biopharma Drug Product Candidate Pipeline NEXT ANTICIPATED TARGET SELECTION PRE-CLINICAL PHASE 1 MILESTONE PARTNER CUE-101 Monotherapy 2L+ (HPV) 1H 2022: Complete Phase 1b Cancer: CUE-101 + Keytruda 1L (HPV) 2H 2021: Initial Combo Results Asia Rights, with CUE-100 series option for China and der
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 T cell Activation = Poor Tolerability and Extremely Narrow Therapeutic Window
IL-2 Therapy Challenges: Non-selective T cell Activation = Poor Tolerability and Extremely Narrow Therapeutic Window Lack of Selectivity for Non-specific Activation of Wild Type (WT) IL-2 or IL-2 Variants Tumor-specific CD8+ T cells ALL CD8+ T cells CD8+ CD8+ CD8+ CD8 + CD8 + + CD8+ CD8 CD8+ + CD8+
Slide 7: A superior therapeutic strategy would selectively and specifically modulate only disease-relevant T cells
A superior therapeutic strategy would selectively and specifically modulate only disease-relevant T cells, while preserving patient safety and restoring the therapeutic capacity of the patient’s immune system. This is the core foundational principle that underscores our approach with the Immuno-STAT
Slide 8: CUE-100 Series: Designing an IL-2 Variant in Context of T Cell Receptor (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 9: CUE-100 Series: Directing IL-2 Activity to Tumor-specific T cells and Avoiding Serious Off-target Side Effects
CUE-100 Series: Directing IL-2 Activity to Tumor-specific T cells and Avoiding Serious Off-target Side Effects 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
Slide 10: CUE-100 Series: Opportunity to Maximize the Fullest Potential of IL-2
CUE-100 Series: Opportunity to Maximize the Fullest Potential of IL-2 IL-2-based CUE-100 series Immuno-STATs enable a larger therapeutic window for IL-2 effectiveness Wild Type IL-2 or IL-2 Variants CUE-100 Series LEGEND IL-2 BIASED EQUAL ACTIVATION IL-2R ENGAGEMENT OF TUMOR- OF ALL SPECIFIC T CELLS
Slide 11: CUE-101: Lead Clinical Candidate Designed to Selectively Prime and Expand HPV E7-Specific T cells
CUE-101: Lead Clinical Candidate Designed to Selectively Prime and Expand HPV E7-Specific T cells CUE-101 Immuno-STAT Design Clinical Rationale Signal 1 • HPV is recognized as a growing driver of head and HLA-A*02:01 + HPV-16 E711-20 peptide neck cancer in the US; despite treatment with current stan
Slide 12: 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 • 38 patients with recurrent/metastatic H&N cancer across 7 dose escalation cohorts Overview of PK CUE-101 Phase 1 • Dose proportional exposure Overview of Monotherapy PD CUE-101 Part A Phase D
Slide 13: CUE-101 Phase 1 Part B Clinical Observations: RP2D 4 mg/kg
CUE-101 Phase 1 Part B Clinical Observations: RP2D 4 mg/kg N = 10/12 Patients with Scans through C5 Clinical Responses N % Objective Response 1 10.0% (CR or PR confirmed ≥ 4 weeks) Durable Stable Disease 3 30.0% (SD sustained for ≥ 12 weeks*) Clinical Benefit Rate 4 40.0% (CR/PR + durable SD) *Requi
Slide 14: CUE-101: Confirmed PR with ~65% Reduction in Target Lesions
CUE-101: Confirmed PR with ~ 65% Reduction in Target Lesions Increase in HPV E7-specific CD8+ T cells with minimal Case History change in total T cells 9-Fold increase 10 10 • Prior therapy: 9 9 CD4+ T cells specific CD8+ T cells 8 CD8+ T cells (%of leukocytes) Fold-change in E7 8 – 1L cetuximab Fol
Slide 15: 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 16: 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 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, neoadjuvant study launched in Q3
Slide 18: CUE-102: Wilms Tumor 1 (WT1) IND on Track for 1Q 2022 Filing
CUE-102: Wilms Tumor 1 (WT1) IND on Track for 1Q 2022 Filing Human T cell expansion in vitro WT-1 Target Killing Molecular Design 80,000 60,000 WT137-45-specific CD8+ T cells WT137-45 40,000 20,000 20,000 [total cell count] donor 1 donor 2 IL-2 Variant 15,000 donor 3 (same as CUE-101) donor 4 donor
Slide 19: CUE-103: KRAS G12V Immuno-STAT
CUE-103: KRAS G12V Immuno-STAT Molecular Design KRASG12V T cell Expansion Molecular Design Single Chain KRAS7-16 G12V 8 %KRASG12V T cells G12V IST G12D IST IL-2 Variant 6 (same as CUE-101) HLA A:11 4 Fc Backbone (same as CUE-101) 2 • Builds on NCI (Rosenberg/Yang) studies that demonstrated clinical
Slide 20: 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 21: CUE-100 Neo-STAT: Universal Scaffold to Address Tumor Heterogeneity
CUE-100 Neo-STAT: Universal Scaffold to Address Tumor Heterogeneity Goal: To generate a universal immuno-STAT (IST) scaffold enabling more competitive development metrics (time and cost efficiencies). 25 Empty Top View Note empty % of CMV-specific CD8+ MHC clefts CMV CUE-100 Series IST T cells CMV N
Slide 22: Summary of Strategic Developments for CUE-100 Series
Summary of Strategic Developments for CUE 100 Series CUE-101 monotherapy data – Monotherapy holds promise of registration path for 3L+ HNSCC patients, and as a 2nd line therapy in CPS <1 patients who are not eligible for pembrolizumab • Clinical data de-risks CUE-101 as well as CUE-100 series • Demo
Slide 23: 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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