Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Cowen & Co. 40th Annual Healthcare Conference 2020
24 slides from Cue Biopharma's conference presentation, Mar 2, 2020
Slide 1: Corporate Presentation
Corporate Presentation Immune Responses, On Cue™ Nasdaq: CUE | March 2020 Cowen & Co. 40th Annual Healthcare Conference | March 2, 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: Corporate Highlights
Corporate Highlights Disruptive Platform for Focused Execution Against Strategic Partnerships to T Cell Modulation In Vivo Platform Validation Accelerate Expansion • Distinct mechanism of action for • CUE-101 in Phase 1 for R/M HPV+ • LG Chem collaboration to expand selective modulation of disease-
Slide 4: Emulating Nature’s Cues to Selectively Modulate T Cells
Emulating Nature’s Cues to Selectively Modulate T Cells Co-Stimulatory/ T Cell Immuno-STAT Co-Regulatory T Cell Receptor Receptor (TCR) Signal 1 Signal 2 Signal 2 Signal 1 Induction/ Selectivity/ Control Specificity FC Co-Stimulatory/ Major Co-Regulatory Histocompatibility Fc Signal Complex (MHC) An
Slide 5: Immuno-STAT Modularity
Immuno-STAT Modularity Peptide Co-stim/Co-reg Peptide epitopes to target Distinct biological signals, different diseases including cytokines; cell-surface receptors; and/or other targeting modalities (e.g., scFv, etc.) MHC Fc Backbone Different HLA alleles to Fc engineering to dial in or out address
Slide 6: Pipeline
Pipeline TARGET SELECTION PRE-CLINICAL PHASE 1 LATE CLINICAL PARTNER CUE-101 (HPV E7 / A02) CUE-100 CUE-102 (WT1 / A02) IL-2 Asia Rights to Three Oncology CUE-102 (WT1 / A24) Targets CUE-200 CUE-103 (Undisclosed) CD80 & 4-1BBL CUE-201 (Undisclosed) CUE-300 CUE-301 (Proins / DR4) PD-L1 & Collaboratio
Slide 7: CUE-100 Series: Exploiting IL-2 via Rational Protein Design
CUE-100 Series: Exploiting IL-2 via Rational Protein Design Immune Signaling Components CUE-100 Series Optimized for desired biological activity through two single amino acid changes • Abrogates binding to IL-2R alpha Attenuated IL-2 • Reduces binding affinity to IL-2R beta Side View Maintains IL-2
Slide 8: CUE-100 Series: Mechanistic Differentiation Over Emerging “Not Alpha” IL-2 Landscape
CUE-100 Series: Mechanistic Differentiation Over Emerging “Not Alpha” IL-2 Landscape Wild Type IL-2 “Not Alpha” IL-2 CUE-100 IL-2 Series (e.g., Proleukin) (e.g., THOR-707) (e.g., CUE-101) IL-2R⍺ > = = = = << IL-2Rβ Non-tumor Anti-tumor Non-tumor Anti-tumor Non-tumor Anti-tumor Treg Treg Treg IL-2Rγ
Slide 9: CUE-101: Lead Clinical Candidate for HPV-Driven Malignancies
CUE-101: Lead Clinical Candidate for HPV-Driven Malignancies CUE-101 Immuno-STAT Design Clinical Rationale • CUE-101 is designed to selectively prime and expand Signal 1: HPV-specific T cells in vivo HLA-A*02:01 + HPV-16 E711-20 peptide • HPV is recognized as a growing driver of head and neck cancer
Slide 10: CUE-101: Directing IL-2 to the “Right” T Cells
CUE-101: Directing IL-2 to the “Right” T Cells Selective Binding Intact & Selective Effector Function 90 HPV-specific CD8+ T cells CMV-specific CD8+ T cells % CUE-101 Bound Cells HPV E711-20 CD8+ T Cells 80 CMV pp65495-503 CD8+ T Cells 70 Naive CD8+ T Cells 60 50 40 30 20 10 0 0.001 0.01 0.1 1 10 10
Slide 11: CUE-101: In Vitro Expansion of HPV E7-Specific T Cells
CUE-101: In Vitro Expansion of HPV E7-Specific T Cells Vehicle-Treated CUE-101-Treated 107 Immune Cell Subsets (absolute counts) 106 105 104 103 102 E711-20-Specific CD8+ T Cells 101 100 0.01 0.1 1 10 100 1000 10000 [CUE-101] (nM) E711-20-specific CD8+ T cells CD4+ T cells CD8+ T cells CD4+ CD25+ Fo
Slide 12: CUE-101: Mitigating the Risk Associated with Systemic WT IL-2 Activation
CUE-101: Mitigating the Risk Associated with Systemic WT IL-2 Activation • PBMC from healthy human donors were stimulated for 18 hours with increasing amounts of CUE-101 or recombinant human IL-2 • Cytokine production was assessed in culture supernatant by MSD 12 © 2020 CUE BIOPHARMA
Slide 13: CUE-101: Foundational Data Published in CCR
CUE-101: Foundational Data Published in CCR In Vitro ü Selective binding to HPV-specific CD8+ T cells ü Dose-dependent induction of effector function ü Expansion of HPV E7 T cells from human PBMCs ü Mitigation of risk associated with systemic IL-2 activation Animal Model ü Selective expansion of HPV
Slide 14: CUE-101: Ongoing First-In-Human Study
CUE-101: Ongoing First-In-Human Study • Design (CUE-101 Q3W) Part A: Monotherapy Dose Escalation - Part A: Dose Escalation (3+3) - Part A: Safety Expansion (Up to 9 Patients) Cohort N - Part B: Dose Expansion (10-20 Pts at RP2D) Cohort 3 • Eligibility RP2D:BED/MTD - Part A & B: HPV+ H&N Cancer, R/M
Slide 15: 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 • MGH/Harvard and Dana Farber Cancer Institute: Sara Pai and Lori Wirth • Moffitt Cancer Center: Christ
Slide 16: CUE-101: Clinical Development Plan
CUE-101: Clinical Development Plan 2019 2020 2021 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 H&N R/M 2L+ CUE-101 Monotherapy Parts A & B Safety and Immunologic Effect H&N R/M 1L CUE-101 + anti-PD-1 Combotherapy H&N Neoadjuvant Other HPV-Driven Cancers TBD 16 © 2020 CUE BIOPHARMA
Slide 17: Building Blocks of IO Growth Strategy
Building Blocks of IO Growth Strategy • Increase R&D efficiency via chemical attachment of antigens to HLA Scalability • Enables targeting of multiple tumor antigens, including post-translationally modified peptides and neo-antigens Neo- STATTM Antigen & • Address broader set of tumors (i.e., WT1, K
Slide 18: CUE-100 Series Extensibility: CUE-102 and KRAS
CUE-100 Series Extensibility: CUE-102 and KRAS CUE-101 CUE-102 KRAS A02 HPV WT1 KRAS G12V Allele Expansion A24 WT1 A11 KRAS G12V Clinical Preclinical Target Selection 18 © 2020 CUE BIOPHARMA
Slide 19: Neo-STAT: Next-gen Evolution of the Immuno-STAT Framework
Neo-STAT: Next-gen Evolution of the Immuno-STAT Framework CUE-100 Neo-STAT Top Therapeutic scaffold receptive for View Therapeutic scaffold chemical conjugation of peptides, that manufactured in bulk potentially: • Increases R&D efficiency and reduces cost of the generation of clinical grade materia
Slide 20: Neo-STAT Driven T cell Expansion is Comparable to the Immuno-STAT Format
Neo-STAT Driven T cell Expansion is Comparable to the Immuno-STAT Format CMV CUE-100 Series Immuno-STAT CMV CMV Neo-STAT Responsive MART-1 Neo-STAT Donors MART-1 CUE-100 Series Immuno-STAT MART-1 MART-1 Neo-STAT CMV Neo-STAT Responsive Donors 20 © 2020 CUE BIOPHARMA
Slide 21: Restoring Immune Balance
Restoring Immune Balance Autoimmune Disease Over Stimulation Requires inhibition of pathogenic effector T cells and/or selective activation of Tregs Balance Suppression Requires expansion of tumor-specific effector Cancer & T cells or reversal of Infection exhausted T cells Outside of immuno-oncolog
Slide 22: Immuno-STAT Dampens Autoreactive CD4+ T cells
Immuno-STAT Dampens Autoreactive CD4+ T cells D0 PBMC + pathogenic peptide Proinsulin76-90 Pathogenic T cell (orange) Class II DRB1*04 Non-cognate (GAD65) Cognate (Proins) PD-L1 PD-L1 PD-L1 Immuno-STAT Immuno-STAT Fc (Effector-less) D10 Tetramer readout No Patho. Patho. Patho. Peptide Peptide Peptid
Slide 23: Early Intervention with Immuno-STAT Selectively Reduces Proinsulin Responsive CD4+ T Cells in Transgenic Mice
Early Intervention with Immuno-STAT Selectively Reduces Proinsulin Responsive CD4+ T Cells in Transgenic Mice Treatment with Immuno-STAT starting on Day 1 post immunization selectively suppresses expansion of PI-reactive cells without inhibiting expansion of HA-reactive cells Note: HA307-319 is a we
Slide 24: Corporate Highlights
Corporate Highlights Disruptive Platform for Focused Execution Against Strategic Partnerships to T Cell Modulation In Vivo Platform Validation Accelerate Expansion • Distinct mechanism of action for • CUE-101 in Phase 1 for R/M HPV+ • LG Chem collaboration to expand selective modulation of disease-
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