Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Investor Presentation (October 2020)
20 slides from Cue Biopharma's investor presentation, October 2020
Slide 1: Corporate Presentation
Corporate Presentation Immune Responses, On Cue™ Nasdaq: CUE October 2020
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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 sale of any s
Slide 3: Novel Platform to Harness the Power of the Immune System
Novel Platform to Harness the Power of the Immune System Disruptive Platform for Platform Modularity Focused Clinical Execution Disease-Relevant T Cell Enables Targeting to De-Risk and Validate Modulation In Vivo Numerous Indications Platform • The Immuno-STAT™ • Immuno-STAT can incorporate • CUE-10
Slide 4: Emulating Nature's Cues to Selectively Modulate T Cells
Emulating Nature’s Cues to Selectively Modulate T Cells T Cell Immuno-STAT Framework Co-Stimulatory/ Antigen-specific Co-Regulatory T Cell Receptor Signal (TCR) 1 i g nal S Signal 2 Signal 1 Induction/ Selectivity/ Control Specificity 2 Fc nal Sig • Single molecule Co-Stimulatory/ Major • Stable, of
Slide 5: Emulating Nature's Cues to Selectively Modulate T Cells: Platform Modularity
Emulating Nature’s Cues to Selectively Modulate T Cells Immuno-STAT Platform Modularity T Cell Framework Peptide Antigen Co-Stimulatory/ Antigen-specific Co-Regulatory T Cell Receptor Peptide epitopes to target Signal (TCR) different diseases MHC 1 i g nal Different HLA alleles to address S Signal 2
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 • CUE-101 is designed to selectively prime and expand HPV-specific T cells in vivo Signal 1 • HPV is an oncovirus (i.e., a virus that causes cancer) and in Signal 2 the U.S. and E.U. it is responsible for over 70% of head and HPV-16 E711-20 peptid
Slide 8: Platform Validation: Path from Concept to Clinical Application
Platform Validation: Path from Concept to Clinical Application Deploy rational protein engineering to design core biologics scaffold for IL-2-based CUE-100 series CUE-101, lead clinical candidate from CUE-100 series, obtained IND approval in May 2019 for monotherapy in R/M HNSCC (2L+) CUE-101 demons
Slide 9: CUE-101: Ongoing Monotherapy First-In-Human Study
CUE-101: Ongoing Monotherapy First-In-Human Study Part A: Monotherapy Dose Escalation • Eligibility (Part A and B) - HPV-16+ Head and Neck Cancer Cohort N - Recurrent/Metastatic (R/M) Currently - Second Line or Greater (2L+) dosing Cohort 6 • Design (CUE-101 Q3W) Cohort 5 - Part A: Dose Escalation (
Slide 10: CUE-101: Part A Dose Cohorts
CUE-101: Part A Dose Cohorts CUE-101 Dose CUE-101 IL-2 Molar Content Relative Cohort (mg/kg) to Approved Proleukin Dose Cohort 1 ✓ 0.06 ~ 0.46x Cohort 2 ✓ 0.18 ~ 1.4x Cohort 3 ✓ 0.54 ~ 4.3x Cohort 4 ✓ 1.0 ~ 8.0x Cohort 5 ✓ 2.0 ~ 16.0x Cohort 6 ✓ 4.0 ~ 32.0x Cohort 7 8.0 ~ 64.0x Average prior lines o
Slide 11: CUE-101 PK and PD: Dose-Proportional & Repeat Exposures
CUE-101 PK and PD: Dose-Proportional & Repeat Exposures from Cohorts 1 – 4, and Evidence of PD Activity Examples of comparable exposure upon repeated dosing Cohort 1 N=3 0.06 mg/kg Cohort 2 N=3 0.18 mg/kg Cohort 3 N=3 0.54 mg/kg Cohort 4 N=6 1.0 mg/kg Examples of T cell expansion post-dosing Pt. 5 P
Slide 12: CUE-101: Cohort 2 Patient #6 Case Study
CUE-101: Cohort 2 Patient #6 Case Study Day 0: Baseline Tumor Day 42: 2 Cycles of CUE-101 Monotherapy Scan at Day 42 (after 2 cycles of CUE-101) indicates reduction of >1 cm target lesion Patient received multiple prior lines of therapy, including checkpoint inhibition At Day 84 the repeat scan show
Slide 13: CUE-101: Phase I Clinical Development Network
CUE-101: Phase I Clinical Development Network • Emory Winship Cancer Institute: Nabil Saba • Karmanos Cancer Institute: Elizabeth Heath and Ammar Sukari • MD Anderson Cancer Center: Bonnie Glisson • Memorial Sloan Kettering Cancer Center: Lara Dunn • MGH/Harvard and Dana Farber Cancer Institute: Sar
Slide 14: 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 15: Neo-STAT: PoC with Viral and Tumor T Cell Antigens
Neo-STAT: PoC with Viral and Tumor T Cell Antigens CUE-100 Neo-STAT CMV CUE-100 Series IST Therapeutic scaffold CMV Neo-STAT Top % of CMV-specific CD8+ manufactured in bulk MART-1 Neo-STAT View T cells Peptide antigen of interest MART-1 CUE-100 Series IST % of MART-1-specific CD8+ MART-1 Neo-STAT CM
Slide 16: Immuno-STATs and Neo-STATs are Designed to Restore Immune Balance
Immuno-STATs and Neo-STATs are Designed to Restore Immune Balance Immuno-STATs: • Expand disease-specific Teffs • Re-activate exhausted Teffs onse p • Inhibit and/or deplete Tregs Res m une Im ↓ Tregs tive Ove r ac • Autoimmunity ↑ Teffs • Chronic inflammation • Metabolic inflammation • Susceptibili
Slide 17: Platform Expansion: Corporate Development and Growth Strategy
Corporate Development and Growth Strategy Platform Validation and Acceleration Validate: De-risk CUE-100 series pipeline assets with CUE-101 clinical data from Immuno-STAT mono, CPI combo and neoadjuvant trials providing multiple registration paths CUE-100 Series CUE-101 (A02/HPV) Phase 1 Mono Platf
Slide 18: Recent Publications Underscore Potential Mechanistic Advantages
Recent Publications Underscore Potential Mechanistic Advantages Dem of th onstrate e s solid Immun that the tumo o-S co rs an TAT ca re scaf d dir n fo ectly penetra ld enga te ge T ILs Sept. 2020 18 © 2020 CUE BIOPHARMA
Slide 19: Corporate Accomplishments and 2020 Guidance
Corporate Accomplishments and 2020 Guidance Key Accomplishments 2020 Guidance • Ongoing timely enrollment through Cohorts 1-5 in our In 2H20: dose-escalation Phase 1 CUE-101 monotherapy trial • Evaluate clinical responses in Phase I CUE-101 via • Safety clearance to initiate enrollment of Cohort 6 R
Slide 20: Thank you
Thank you Immune Responses, On Cue™ Nasdaq: CUE