Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Oppenheimer Annual Healthcare Life Sciences Conference 2024
30 slides from Cue Biopharma's conference presentation, Feb 13, 2024
Slide 1: Cue Biopharma, Inc.
Cue Biopharma, Inc. Oppenheimer Annual Healthcare Life Sciences Conference Nasdaq: CUE February 13, 2024
Slide 2: Disclaimers
Disclaimers 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 securities in an
Slide 3: Vision
Vision Translating “Nature’s Cues” ü Created selective T cell engagers for into breakthrough precision immunotherapy immunotherapies ü Demonstrated clinical efficacy with paradigm shifting data ü Platform modularity addresses significant unmet need in oncology and autoimmunity © 2024 CUE BIOPHARMA 3
Slide 4: Therapeutic Platform Has Potential to Restore Immune Balance
Cue Biopharma's Therapeutic Platform has the Potential to Restore Immune Balance to Address Two Major Causes of Human Suffering and Mortality Cancer Autoimmune Disease • 20 million new cases worldwide • 4% of the world’s population • 2 million new cases in US in 2021 alone • 24 million cases in the
Slide 5: Immuno-STAT Platform: Turning Nature's Selectivity into Effective Drugs
Immuno-STAT Platform: Turning Nature’s Selectivity into Effective Drugs Immuno-STAT™ Platform T CELL Selective delivery of signals APC to disease-specific T cells Engagement of TCRs of disease-specific T cells Costimulatory/ Inhibitory signal HLA Stabilized pHLA (TCR binder) Cancer: Tumor-specific T
Slide 6: Oncology
Oncology
Slide 7: CUE-100 Series: Best-in-Class IL-2-based T Cell Engagers
CUE-100 Series: Best-in-Class IL-2-based T Cell Engagers ü Generation of a Therapeutic Index for IL-2 Ø Selective targeting of IL-2 to tumor-specific T cells ü Clinical Validation and PoC (>100 Patients Treated) Ø Monotherapy efficacy in late-stage cancer patients Ø Greater than doubling of ORR and
Slide 8: Platform Modularity Enables Targeting Many Different Cancers
Platform Modularity Enables Targeting Many Different Cancers Structural similarity creates potential regulatory and development efficiencies Clinical-stage Assets WT1 KRASG12D Off-the-Shelf Application for HPV KRASG12V Precision Cancer PRAME Immunotherapy MAGE-A4 COL6A3 CUE-101 CUE-102 Head & Neck ✓
Slide 9: CUE-101: Clinical Validation and Efficacy in HPV+ Head and Neck Cancer
CUE-101: Clinical Validation and Efficacy in HPV+ Head and Neck Cancer CUE-101 Locally HPV-16 E7 1L Advanced 2L+ R/M IL-2v R/M CUE-101 CUE-101 + KEYTRUDA Neoadjuvant Adjuvant Fc Status Phase IA/IB Phase IA/IB IST IST Fully Enrolled Fully enrolled Ongoing Planned Abbreviations: Doubled mOS vs. SOC Do
Slide 10: CUE-101 Monotherapy: Substantial Increase in Survival in 2L+ Patients
CUE-101 Monotherapy: Substantial Increase in Survival in 2L+ Patients CUE-101 Survival Curve CUE-101 Median Overall Survival vs. Anti-PD-1 Historical Benchmarks1,2 20.8* MONTHS 7.5 8.4 OPDIVO 2L KEYTRUDA 2L CUE-101 2L+ Overall survival (months) in the 20 patients treated with CUE-101 monotherapy (4
Slide 11: CUE-101 Monotherapy: Tumor-Specific T Cell Expansion and Infiltration
CUE-101 Monotherapy: Tumor-Specific T Cell Expansion and Infiltration T cell infiltration into tumors post-CUE-101 treatment Pretreatment Post-treatment CD3 = T cells GZMB = Granzyme B © 2024 CUE BIOPHARMA 11
Slide 12: CUE-101 + Keytruda: Potential Best-in-Class 1L Regimen
CUE-101 + Keytruda: Potential Best-in-Class 1L Regimen for Patients with HPV+ R/M HNSCC Overall Response by RECIST: ORR=11/24 (46%); DCR 18/24 (75%) (1) KEYNOTE 048 Study; Burtness B et al, Lancet 2019; (2) Harrington et al, J Clin Oncol 2022. Data Extract: 06-Feb-2024. Includes 24/25 patients in Re
Slide 13: CUE-101 + Keytruda: Notable Increase of PFS in 1L Patients
CUE-101 + Keytruda: Notable Increase of PFS in 1L Patients (cross-study comparison of historical benchmark) CUE-101 + Keytruda CUE-101 + Keytruda Median PFS Progression Free Survival vs. Anti-PD-1 Historical Benchmark* * Kaplan-Meier estimate of median PFS 8.3 months [95% CI; 5.0, NA] in the 25 pati
Slide 14: Immuno-STATs: Expanding Patient Reach and Enhancing Efficacy for CPIs
Immuno-STATs: Expanding Patient Reach and Enhancing Efficacy for CPIs Reported Overall Response Rate with PD-1/PD-L1 Monotherapy 1 100% 80% CUE-101+CPI CUE-102 60% Opportunity to enhance historically low responses with 46% CPI monotherapy through combination regimens 40% 20% 19% 0% l ric t er l n a
Slide 15: CUE-102
CUE-102
Slide 16: CUE-102: Second Clinical Program Targeting WT1-Positive Cancers
CUE-102: Second Clinical Program Targeting WT1-Positive Cancers CUE-102 Colorectal Gastric Ovarian WT1-Positive WT1 37-45 Pancreatic R/M IL-2v 1L Locally Advanced 2L+ R/M Breast, Lung, GBM, Others R/M AML, MDS, ALL, Others Fc Regimen CUE-102 CUE-102 +/- SoC 99% sequence identity to CUE-101 ‒ FDA cle
Slide 17: Significant Unmet Need in Patients with WT1-Positive Cancers
Significant Unmet Need in Patients with WT1-Positive Cancers 100,000 Current CUE-102 Phase 1 Trial Annual Deaths in Patients with WT-1+ Cancers Expansion Opportunities 80,000 60,000 US & EU-5 40,000 20,000 0 Gastric Ovarian Pancreatic Colorectal Adult ALL Glioblastoma AML Breast MDS Lung TOTAL: 220,
Slide 18: Selective Expansion of WT1-Specific T Cells Demonstrated in Patients
Selective Expansion of WT1-Specific T Cells Demonstrated in Patients Pretreatment Post-treatment Patient A Tetramer APC Pretreatment Post-treatment Patient B Tetramer PE Increased frequency of WT1-specific CD8+ T cells are observed following CUE-102 treatment. Representative plots are shown from pre
Slide 19: CUE-102 Treatment: Reductions in Target Tumors
CUE-102 Treatment: Reductions in Target Tumors Gastric Cancer Patient Ovarian Cancer Patient 80 % Change from Baseline Target Lesions over Time % Change from Baseline Target Lesions over Time 60 40 20 0 -34% -30% -20 -40 -60 -80 Baseline Week 6 Week 12 Week 18 Week 24 Week 30 Week 36 Ø Disease Contr
Slide 20: CUE-100 Series: IL-2 Immunotherapy with Breakthrough Potential
CUE-100 Series: IL-2 Immunotherapy with Breakthrough Potential üClinical Efficacy: Selective targeting of IL-2 to tumor-specific T cells achieves significantly greater efficacy without compromising patient safety üRegistration Path (CUE-101): Clear alignment on next steps following recent FDA intera
Slide 21: Autoimmune Disease
Autoimmune Disease
Slide 22: Resetting Immune Balance for Autoimmune and Inflammatory Diseases
Resetting Immune Balance for Autoimmune and Inflammatory Diseases Evolution in Disease Management • Potential for enhanced efficacy and Future: curative outcomes Resetting • Avoids global immunosuppression Immune • Conducive to early intervention Balance across many inflammatory diseases • Limited e
Slide 23: CUE-301: Designed for Selective Inhibition of Autoreactive T Cells
CUE-301: Designed for Selective Inhibition of Autoreactive T Cells PoC with modulation of Proinsulin-specific T cells in T1D 500 400 PD-L1 IFN-g-SFC Promotes functional attenuation of 300 targeted self-reactive T cells Proinsulin76-90 200 Major proinsulin epitope Class II DRB1*04 100 DR4 allele high
Slide 24: CUE-401: Designed for Selective Treg Induction and Expansion
CUE-401: Designed for Selective Treg Induction and Expansion CUE-401 MOA can be broadly developed for CUE-401 results in many different autoimmune diseases induction of FOXP3+ Tregs CUE-401 IL-2 Variant Same as in CUE-100 series IL-2 TGF-β* CD25 IL-2R TGFBR Allows for simultaneous delivery of Fc Bac
Slide 25: CUE-401: Quantitatively & Qualitatively Superior to IL-2 Muteins
CUE-401: Quantitatively & Qualitatively Superior to IL-2 Muteins CD25-biased FOXP3+ IL-2 muteins Treg Focus on a minor population of FOXP3+ pre-existing nTregs FOXP3+ Limited Treg FOXP3+ Treg Treg Treg Expansion Two Key MOAs: 1) Convert non-Tregs à iTregs 2) Expand pre-existing nTregs FOXP3+ Treg FO
Slide 26: CUE-401 Harnesses Multiple Signals to Induce Tregs
CUE-401 Harnesses Multiple Signals to Induce Tregs FOXP3 Control IL-2 alone TGF-β alone CUE-401 CFSE CUE-401 provides both IL-2 and TGF-β activating signals that are necessary for iTreg differentiation © 2024 CUE BIOPHARMA 26
Slide 27: CUE-401 Treatment: Protection from Autoimmune Gastritis
CUE-401 Treatment: Protection from Autoimmune Gastritis Control Gastritis Scores (Day 1 & 14) (Day 62) Healthy Control CUE-401 (Day 1 & 14) Short-term treatment with CUE-401 results in significant long-term protection from gastritis and tissue destruction Source: Sponsored Research Collaboration wit
Slide 28: Immuno-STAT Platform: Positioned for Near-term Value Inflection
Immuno-STAT Platform: Positioned for Near-term Value Inflection Milestones CUE-101 Monotherapy 1Q 2024: Registration Path Defined in Alignment with FDA 1H 2024: Provide Ph1B Readout CUE-101 + Pembrolizumab Mid 2024: Define Ph2/3 Registration Trial CUE-101 Neoadjuvant (IST) Mid 2024: Translational Bi
Slide 29: Investment Summary
Investment Summary • Established clinical PoC with our two lead oncology programs – Well characterized safety, tolerability, and efficacy both as monotherapy and combination therapy • Clinical data sets generated to date have the potential to shift the treatment paradigm – Demonstrated meaningful in
Slide 30: Thank you
Thank you Translating “Nature’s Cues” into breakthrough immunotherapies
Cue Biopharma — Oppenheimer Annual Healthcare Life Sciences Conference 2024 on 6ix