Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Investor Presentation (March 2023)
26 slides from Cue Biopharma's investor presentation, March 2023
Slide 1: Cue Biopharma, Inc. – Immune Responses, On Cue
Cue Biopharma, Inc. Immune Responses, On Cue™ Nasdaq: CUE March 2023
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: Well Positioned for Potential Breakthrough: Clinical Validation and Platform De-risking
Well Positioned for Potential Breakthrough: Clinical Validation and Platform De-risking • Monotherapy efficacy in late-stage cancer patients – single-agent activity • Significant increase to date in ORR in combination with CPI • Favorable tolerability (>65 patients dosed, no VLS, CRS etc.) • Ab-base
Slide 4: Well Positioned for Potential Breakthrough: Capitalized into 2H'24
Well Positioned for Potential Breakthrough: Capitalized into 2H’24 with current forecasted burn • Fiscal discipline and program prioritization provides capital into 2H’24 • CUE-101 and CUE-102 address significant patient segments in solid cancers • CUE-401 partnership with Ono Pharmaceuticals subsid
Slide 5: Vision Approach
Vision Approach • Generate a new class of bispecific T-cell Translating “Nature’s Cues” engagers, termed Immuno-STATs™, for into protein therapeutics selective modulation of disease specific T cells – Approach in oncology: TCR-selective targeting of co- stimulatory signals, or activation signals, e.
Slide 6: CUE-100 Series ISTs: Tumor-specific T cell Engagers Enabling a Therapeutic Index for IL-2
CUE-100 Series ISTs: Tumor-specific T cell Engagers Enabling a Therapeutic Index for IL-2 © 2023 CUE BIOPHARMA 6
Slide 7: Clinical Validation and Platform De-risking
Clinical Validation and Platform De-risking
Slide 8: CUE-101 Provides Clinical PoC and Platform De-risking
CUE-101 Provides Clinical PoC and Platform De-risking HPV E7 • CUE-101 Monotherapy in 3L+ R/M HNSCC • CUE-101 + Pembrolizumab Combination in 1L R/M HNSCC CUE-101 • CUE-101 Neo-adjuvant Trial in locally/advanced HNSCC Head & Neck* Anal – Trial ongoing at Washington University in St. Louis Cervical Pe
Slide 9: CUE-101 Monotherapy Patient Data: PK, PD and Tumor Infiltration
CUE-101 Monotherapy Patient Data: PK, PD and Tumor Infiltration T cell infiltration into tumors post-CUE-101 Tx Tumor necrosis post-CUE-101 Tx © 2023 CUE BIOPHARMA 9
Slide 10: CUE-101 Monotherapy: Patterns of Clinical Efficacy in 3L+ R/M HNSCC Patients
CUE-101 Monotherapy: Patterns of Clinical Efficacy in 3L+ R/M HNSCC Patients Patient A Patient B Patient C Percent Change from Baseline (CFB) in Percent Change from Baseline Percent Change from Baseline (CFB) in Sum of Diamieters of Target Lesion(s) HPV cfDNA Sum of Target Lesions Sum of Diamieters
Slide 11: Overall Survival in Monotherapy 4 mg/kg Patients
Overall Survival in Monotherapy 4 mg/kg Patients Swimmer plot updated 05-Jan-2023 for a pending K-M analysis. Status indicators for survival and response were updated 29-Jan-2023 to reflect current patient status. All patients have failed prior therapies including CPIs. = mOS for 2L (CPI) © 2023 CUE
Slide 12: Complementary Mechanisms with CUE-101 + Checkpoint Inhibition
Complementary Mechanisms with CUE-101 + Checkpoint Inhibition Complementary MoA with CUE-101 Preclinical studies demonstrated enhanced response and and anti-PD-1 survival following CUE-101 + anti-PD-1 combo therapy CUE-101 + Anti-PD-1 treatment 100 90 Overall Survival (%) 80 p=0.003 70 Vehicle 60 50
Slide 13: CUE-101 in Combination with Pembrolizumab in 1L R/M HNSCC
CUE-101 in Combination with Pembrolizumab in 1L R/M HNSCC: 40% ORR at 4 mg/kg RP2D (vs. 19% historical ORR with pembro alone) SITC November 2022 20 30 60 15 10 20 10 10 20 90 PD-L1 Expression (CPS) © 2023 CUE BIOPHARMA 13
Slide 14: CUE-101: Clinical Validation and Platform De-risking
CUE-101: Clinical Validation and Platform De-risking ü Tolerability at Efficacious doses ü Demonstration of single-agent anti-tumor efficacy – RECIST-based PR and DSD in 3L+ R/M HNSCC patients – mOS benefit emerging from survival follow-up ü Significant enhancement of clinical efficacy in combinatio
Slide 15: CUE-102 Wilms Tumor 1 (WT1): Broad Potential Opportunity in Multiple Solid and Heme Cancers
CUE-102 Wilms Tumor 1 (WT1): Broad Potential Opportunity in Multiple Solid and Heme Cancers Molecular Design (99% sequence identity to CUE-101) • IND approval for CUE-102 harnessed the clinical de-risking observed with CUE-101, leading to potential advantages: – Clinical development efficiencies (ap
Slide 16: CUE-101 Accelerates CUE-102 Clinical Development by Enabling Dose Escalation to Start at 1 mg/kg
CUE-101 Accelerates CUE-102 Clinical Development by Enabling Dose Escalation to Start at 1 mg/ kg Part A: CUE-101 Monotherapy Dose Escalation Part B: Monotherapy Expansion ( 3 + 3 design, with expansion up to 9 patients per cohort) (up to 20 total patients) 8.0 Cohort 7 CUE-101 Dose (mg/kg), Q3W 4.0
Slide 17: Executive Summary: Immuno-STAT (IST) Platform
Executive Summary: Immuno-STAT (IST) Platform • CUE-100 series generates a therapeutic index for IL-2 by selective targeting of anti-tumor T cells, which presents a broad opportunity for addressing many cancers – Strategy for creating a therapeutic index can be deployed for any other cytokine or imm
Slide 18: BROAD Opportunities for CUE-100 Series in Cancer Immunotherapy
BROAD Opportunities for CUE-100 Series in Cancer Immunotherapy Clinical PoC with CUE-101 Provides a Springboard for Platform Expansion into Broad Indications Clinical-stage Assets KRAS “Empty” WT1 PRAME HLA HPV Broad Universe of MAGE Addressable Solid IL-2 etc and Heme Cancers HLA CUE-101 CUE-102 CU
Slide 19: Autoimmune
Autoimmune
Slide 20: CUE-AI: Pipeline of Novel Biologics for Resetting Tolerance
CUE-AI: Pipeline of Novel Biologics for Resetting Tolerance CUE-400 Series Immuno-STATs pHLA IL-2 Variant PD-L1 PD-L1-based CUE-300 Series (Ag-specific Approach) FC Backbone CUE-401 TGF-b Variant CUE-401 Lead Selected Non-Classical HLA-G Immuno-STAT Examples Initial Feasibility with Broad IP Coverag
Slide 21: CUE-401 Overview
CUE-401 Overview • Highly Differentiated Opportunity to Reset Immune Balance ‒ CUE-401 induces new Tregs and expands pre-existing nTregs ‒ CUE-401’s MoA demonstrates in vivo conversion of autoreactive T cells into Tregs, which is a fundamental mechanism for re-setting immune balance ‒ Vast therapeut
Slide 22: CUE-401: Short-term Treatment Results in Long-term Protection from Autoimmune Gastritis
CUE-401: Short-term Treatment Results in Long-term Protection from Autoimmune Gastritis Healthy control PBS CUE-401 Gastritis Scores 16 P=0.0012 12 Score 8 4 0 PBS CUE-401 PBS CUE-401 Collaboration w/ Dr. Rich DiPaolo, SLU • CUE-401 treatment results in significant protection from tissue destruction
Slide 23: CUE-401: Potential to Address Unmet Patient Needs Across T Cell Mediated Inflammatory Diseases
CUE-401: Potential to Address Unmet Patient Needs Across a Broad Range of T Cell Mediated Inflammatory Diseases Solid Organ GVHD MS NMO Crohn’s PD ALS UC Bold = Active industry FTD trials with IL-2 muteins and tolerance approaches Asthma T Cell Mediated Inflammatory Diseases Lupus COPD RA AD PsA Pso
Slide 24: Well Positioned for Potential Breakthrough: Clinical Validation and Platform De-risking
Well Positioned for Potential Breakthrough: Clinical Validation and Platform De-risking • Monotherapy efficacy in late-stage cancer patients – single-agent activity • Significant increase to date in ORR in combination with CPI • Favorable tolerability (>65 patients dosed, no VLS, CRS etc.) • Ab-base
Slide 25: Platform Developments for Sustained Value Creation
Platform Developments for Sustained Value Creation Oncology • Emerging as solution provider of selective cancer-specific T cell activation: exemplified by CUE-101 – CUE-101 clinical data will drive near-term value (monotherapy/combination with CPi – CUE-102 clinical data will further validate platfo
Slide 26: Thank You
Thank You Immune Responses, On Cue™ Harnessing the Potential of the Human Immune System to Treat Cancer