Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Investor Presentation (May 2019)
28 slides from Cue Biopharma's investor presentation, May 2019
Slide 1: Corporate Presentation: Immune Responses, On Cue
Corporate Presentation Immune Responses, On Cue™ Nasdaq: CUE May 2019 Copyright © 2019. Cue Biopharma
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: Cue Biopharma
Cue Biopharma • Publicly listed company, founded in 2015 out of the Albert Einstein College of Medicine around breakthrough technology enabling selective modulation of disease relevant T cells directly in a patient’s body • Recently received first IND approval, allowing initiation of a translation-l
Slide 4: Vision and Approach
Vision and Approach Vision Harness the specificity and diversity of the immune system to cure complex human diseases and fundamentally transform patient lives Approach Deploy rational protein engineering with our Immuno-STATTM platform to develop biologics that selectively and specifically modulate
Slide 5: Immune Balance: A Key Component of Human Health
Immune Balance: A Key Component of Human Health 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 Cu
Slide 6: Immune Synapse: Determines T Cell Modulation and Fate
Immune Synapse: Determines T Cell Modulation and Fate Nature’s Cues Signal 1 Signal 2 Selectivity / Specificity Induction / Control T Cell Receptor (TCR) Receptor Receptor T Cell Peptide OR HLA (MHC) Antigen Presenting Peptide- Cell (APC) MHC (pMHC) Co-Stimulatory Co-Inhibitory Source: Dustin ML. “T
Slide 7: The Immuno-STAT: Emulating Nature's Cues
The Immuno-STAT: Emulating Nature’s Cues Immuno-STAT (Selective Targeting and Alteration of T cells) Signal 2 Signal 1 Fc We have rationally engineered the Immuno-STAT to selectively activate disease-relevant T cells 7 5/28/19
Slide 8: Immuno-STAT Framework
Immuno-STAT Framework Key Points of Differentiation Signal 1 • “Ready-to-engage” biologic that specifically A stabilized peptide-MHC complex targets and selectively modulates disease (pMHC) to engage disease relevant T cells relevant T cells • Not dependent on barriers of natural antigen presentatio
Slide 9: Immuno-STAT Modularity
Immuno-STAT Modularity Signal 2 Signal 1 Fc Domain MHC/HLA Co-stimulatory Peptide Epitopes (IgG1, IgG4, etc.) (A:02, A:11, A:24, etc.) (IL-2, CD80, PD-L1, etc.) (HPV-E7, WT1, etc.) A:02 A:11 A:24 IgG1 Access to Many Patient Populations Access to Many Disease Targets 9 5/28/19
Slide 10: Value Creation Strategy
Value Creation Strategy Immuno-Oncology Expansion of tumor-specific effector T cells • Demonstrate Immuno-STAT proof of concept in the clinic with CUE-101 • Asia partnership with LG Chem expands pipeline and patient coverage CUE-100 Series Chronic Infectious Disease Autoimmune Disease Reversal/expan
Slide 11: Immuno-STAT CUE-100 Series
Immuno-STAT CUE-100 Series Signal 1: HLA-A*02:01 + Peptide Signal 2: IL-2 Variant CUE-100 Series Incorporates • HLA class I (A*02:01; A*11:01; A*24:02) • IL-2 variant (affinity attenuated against IL-2R alpha and beta subunits) Manufacturability of CUE-100 molecules follows standard upstream and down
Slide 12: Immuno-STATs Drive Selective Expansion of Human T Cells
Immuno-STATs Drive Selective Expansion of Human T Cells Treated Control Antigen-specific T cells CD8+ 12 5/28/19
Slide 13: Immuno-STATs Drive Selective Expansion of Human T Cells
Immuno-STATs Drive Selective Expansion of Human T Cells Treated Control Antigen-specific T cells Immuno-STAT Treated CD8+ 13 5/28/19
Slide 14: Immuno-STATs Expand a Diverse T Cell Repertoire
Immuno-STATs Expand a Diverse T Cell Repertoire T Cell Expansion with CMV Immuno-STAT T Cell Expansion with Peptide Stim (Ex vivo CMV Peptide + IL2) Donor 1 Donor 1 Antigen-specific T cells Following 10-day Following 10-day stimulation stimulation Donor 2 Donor 2 Following 10-day Following 10-day st
Slide 15: CUE-101 for HPV-Driven Malignancies
CUE-101 for HPV-Driven Malignancies CUE-101 Immuno-STAT™ Design Clinical Rationale and Signal 1: Proposed Mechanism of Action HLA-A*02:01 + HPV-16 E7 peptide • HPV-16 E7 protein is a primary driver of tumorigenesis • The E7 peptide presented by CUE-101 is a highly conserved T cell epitope and is imm
Slide 16: CUE-101 Clinical Development Strategy
CUE-101 Clinical Development Strategy • Initial Protocol: CUE-101 monotherapy dose escalation and expansion in high need recurrent/metastatic (R/M) setting for head and neck squamous cell carcinoma (HNSCC) ‒ Patients screened for HPV16+ and HLA A*02:01+ ‒ Phase I monotherapy in advanced setting (aft
Slide 17: Phase I Synopsis
Phase I Synopsis A PHASE 1, FIRST-IN-HUMAN, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF CUE-101 MONOTHERAPY IN PATIENTS WITH HPV+ RECURRENT/ METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) CUE-101 administered by intravenous (IV) infusion once every 3 weeks as monotherapy Part A: Dos
Slide 18: Key CUE-101 Readouts Toward Clinical Proof of Concept
Key CUE-101 Readouts Toward Clinical Proof of Concept CUE-101 and CUE-100 Series Validation Phase I Part A Phase I Part B Supporting Studies Neoadjuvant Safety & Tolerability Clinical Immune Modulation & Biologic Activity Readouts Anti-Tumor Activity Translation-led strategy to show therapy-induced
Slide 19: CUE-101 Studies Supporting Translational Clinical Strategy
CUE-101 Studies Supporting Translational Clinical Strategy In Vitro In Vivo ü Selective binding to HPV-specific CD8+ T ü Selective expansion of HPV-specific CD8+ T cells cells in the tumor and in the periphery ü Dose-dependent induction of effector function ü Inhibition of tumor growth and prolonged
Slide 20: CUE-101 In Vitro Activity
CUE-101 In Vitro Activity Selective Binding Intact Effector Function Expansion of HPV Specific HPV-specific CD8+ T cells HPV-specific CD8+ T cells T Cells From PBMCs > 40X Immuno-STAT (nM) Immuno-STAT (nM) increase CMV-specific CD8+ T cells CMV-specific CD8+ T cells Immuno-STAT (nM) Immuno-STAT (nM)
Slide 21: CUE-101 Expanded CD8+ T Cells Exhibit Polyfunctionality
CUE-101 Expanded CD8+ T Cells Exhibit Polyfunctionality Antigen-specific CD8+ T Cells Non-antigen-specific CD8+ T Cells Media Control PMA/ionomycin Positive Control T2+SL9 peptide (SLYNTVATL) Negative Control T2+E7 peptide Demonstrates Selectivity (YMLDLQPETT) Polyfunctional CD8+ T cells are associa
Slide 22: CUE-101 Surrogate Activity in Preclinical Model
CUE-101 Surrogate Activity in Preclinical Model TC1 Tumor Model: Improved Specific T Cell Expansion Induction of Survival (mono vs combo w/ 80 in Tumors Long Term Memory anti-PD-1) 60 cells CD8 40 1500 % AgS among T % Tumor-specific 30 Tumor volume (mm3) 1200 20 p=<0.0001 10 900 0 600 1 10 bo e -1 c
Slide 23: CUE-101 vs Wild-Type IL-2: Mitigating Systemic IL-2 Risk
CUE-101 vs Wild-Type IL-2: Mitigating the Risk Associated with Systemic 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 23 5/28/19
Slide 24: Pipeline
Pipeline Program Discovery Optimization IND-Enabling Phase I Development Partner CUE-100 Series – MHC Class I / IL-2 CUE-101 Asia Rights (HPV E7 / IL-2) CUE-102 Asia Rights (WT1 / IL-2) CUE-103 (Undisclosed / IL-2) Asia Rights CUE-200 Series – MHC Class I / CD80 and 4-1BBL CUE-201 CUE-300 Series – M
Slide 25: Broad Opportunity in WT-1 Expressing Cancers
Broad Opportunity in WT-1 Expressing Cancers US + EU5 US + EU5 US + EU5 WT1 WT1 Under Active Indication Annual 5-year Annual Expression Expression Clinical Incidence1 OS2 Deaths1 IHC3 PCR4 Investigation5 AML 40,000 30% 20,000 >75% 90% Juno (TCR-T), Atara Bio (CTL), Medigene (Vaccine), Sellas (Vaccin
Slide 26: Investment Highlights
Investment Highlights Differentiated • Rationally designed Immuno-STAT biologics for selective and specific engagement of disease-relevant T Platform cells in a patient’s body without the need for ex vivo expansion • CUE-100 − With IND now approved, generate safety data and demonstrate initial biolo
Slide 27: Management Team
Management Team Dan Passeri, M.Sc., J.D. Anish Suri, Ph.D. Kenneth Pienta, M.D. President and CEO SVP and CSO Acting CMO • More than 20 years of • More than 20 years of • Professor of Oncology at experience managing experience in immuno- Johns Hopkins University drug discovery and oncology, autoimmu
Slide 28: Thank You
Thank You Immune Responses, On Cue™ Copyright © 2019. Cue Biopharma