Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Q2 2021 Earnings Presentation
27 slides from Cue Biopharma's earnings presentation, Aug 17, 2021
Slide 1: Q2 2021 Investor Update Call
Q2 2021 Investor Update Call Immune Responses, On Cue™ Nasdaq: CUE August 17, 2021
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: Agenda
Agenda • Introduction and 2Q-FY21 Highlights Dan Passeri, CEO • IL-2-based CUE-100 series Anish Suri, President and CSO • CUE-101 Clinical Update Dr. Ken Pienta, Acting CMO Dr. Matteo Levisetti, SVP, Clinical Development • Pipeline Progress Anish Suri, President and CSO • 2Q-FY21 Financial Results &
Slide 4: Cue Biopharma's Vision
Cue Biopharma’s Vision • Harnessing natural signals (“Nature’s Cues”) for tailored immune activation against cancers Leading the next wave of disruptive, breakthrough • Enabled by rational protein engineering to design immuno-therapies therapeutics with potentially enhanced selectivity addressing th
Slide 5: Interleukin-2 (IL-2): A Proven Therapy, but with Significant Limitations and Liabilities
Interleukin-2 (IL-2): A Proven Therapy, but with Significant Limitations and Liabilities • IL-2 is an approved immuno-therapy for melanoma and renal cell carcinoma (RCC) • Lack of selectivity and safety of IL-2 treatment have precluded its fullest potential in cancer immunotherapy • E.g., vascular-l
Slide 6: IL-2 Therapy Challenges: Non-selective T cell Activation
IL-2 Therapy Challenges: Non-selective T cell Activation = Poor Tolerability and Poor Therapeutic Performance as Monotherapy Lack of Selectivity for Non-specific Activation of Wild Type IL-2 or IL-2 Variants Tumor-specific CD8+ T cells ALL CD8+ T cells + CD8 CD8+ CD8 + CD8+ CD8+ CD8+ CD8+ CD8+ CD8+
Slide 7: CUE-100 Series: Designing an IL-2 Variant in Context of TCR Engagement
CUE-100 Series: Designing an IL-2 Variant in Context of TCR Engagement Molecular structure exploits TCR and IL-2 engagement to tune optimal signal amplitude for CD8+ T cell activation TUMOR-SPECIFIC p-HLA (2X) NON-TUMOR-SPECIFIC T CELLS T CELLS CUE-100 series Immuno-STAT Selective engagement tumor-
Slide 8: CUE-100 Series: Preferential Activity of IL-2 on Tumor-specific T cells
CUE-100 Series: Preferential Activity of IL-2 on Tumor-specific T cells Focused Activity on Biased Activation and Expansion of Tumor- IL-2 Immuno-STAT Tumor-specific T cells specific T cells (or “TCR-engaged” T cells) +++ CUE-100 series CD8 CD8+ CD8+ + CD8+ IL-2 + CD8+ CD8+ p-HLA CD8+ CD8 CD8+ CD8+C
Slide 9: CUE-100 Series: Opportunity to Maximize the Fullest Potential of IL-2
CUE-100 Series: Opportunity to Maximize the Fullest Potential of IL-2 Wild Type IL-2 or IL-2 variants CUE-100 Series IL-2 IL-2R EQUAL BIASED ACTIVATION ENGAGEMENT OF TUMOR-SPECIFIC OF ALL T CELLS T CELLS p-HLA +++ +++ +/- +++ TCR NON TUMOR-SPECIFIC TUMOR-SPECIFIC NON TUMOR-SPECIFIC TUMOR-SPECIFIC T
Slide 10: CUE-101: Lead Clinical Candidate Designed to Selectively Prime and Expand HPV E7-Specific T cells
CUE-101: Lead Clinical Candidate Designed to Selectively Prime and Expand HPV E7-Specific T cells © 2021 CUE BIOPHARMA 10
Slide 11: CUE-101: Ongoing Monotherapy First-in-Human Phase Trial
CUE-101: Ongoing Monotherapy First-in-Human Phase 1 Trial No maximal tolerated dose (MTD) observed in patients dosed up to 8 mg/kg Part A: Monotherapy Dose Escalation Part B: Monotherapy Expansion (Q3W, 3 + 3 design, with expansion up to 9 patients per cohort) (up to 20 total patients) 8.0 Dosing co
Slide 12: CUE-101: Lead Clinical-Stage Asset from IL-2 Based CUE-100 Series
CUE-101: Lead Clinical-Stage Asset from IL-2 Based CUE-100 Series Cohort 6 dose (4.0mg/kg Q3W) selected as RP2D with dose expansion ongoing Enrollment • 38 patients with recurrent/metastatic H&N cancer across 7 dose escalation cohorts Efficacy Overview of CUE-101 Phase 1 • 1 confirmed PR and 8 confi
Slide 13: CUE-101-01: Patient Characteristics of CUE-101 Monotherapy
CUE-101-01: Patient Characteristics of CUE-101 Monotherapy (N=39) Age (years) Mean (range) 63.8 (48-82) Sex Male 38 (97.4%) Female 1 (2.6%) ECOG 0 17 (43.6) 1 22 (56.4) Prior Lines of Therapy* Median (range) 3 (1-6) • Platinum Based 35 (89.7%) • Checkpoint Inhibitor 36 (92.3%) o PD-1 33 (84.6%) § Ni
Slide 14: CUE-101-01: Treatment Emergent Adverse Events
CUE-101-01: Treatment Emergent Adverse Events Treatment Related Adverse Events All Adverse Events (N=42) (N=42) Preferred Term ≥ Grade 3 All Grades ≥ Grade 3 All Grades Overall Frequency 9 (21.4%%) 28 (66.7%%) 18 (42.9%%) 34 (81.0%%) Fatigue 2 (4.8%) 12 (28.6%) 2 (4.8%) 17 (40.5%) Anaemia 1 (2.4%) 2
Slide 15: Cohort 6 PK: Low Inter-Patient Variability and Sustained Exposure
Cohort 6 (4mg/kg) PK: Low Inter-Patient Variability and Sustained Exposure with Repeat Dosing 105 [CUE-101] (ng/mL) 100 nM 104 110-002 10 nM 103 110-007 1 nM 101-006 102 0.1 nM 101 0 48 96 4 2 0 8 6 4 2 0 8 14 19 24 28 33 38 43 48 52 Hours Post Start of Infusion 110-002 MHC 1 E7 exposures 110-007 MH
Slide 16: PD Data from Cohort 6: Rational Design and Mechanistic Activity of CUE-101
PD Data from Cohort 6: Underscores the Rational Design and Mechanistic Activity of CUE-101 Notable increase in NK cells post Transient increase in CD4+ Foxp3+ dosing with CUE-101 T cells post dosing with CUE-101 NK Cell Frequency Treg Frequency 80 80 % of CD45+ cells % of CD45+ cells 60 60 40 40 20
Slide 17: CUE-101: Tumor Necrosis and T Cell Infiltrates in Target Lesions
CUE-101: Tumor Necrosis and T Cell Infiltrates in Target Lesions Case History • Prior therapy: Immunostaining Hematoxylin and Eosin Stain (CD8+ T cells = rose; PD-LI = brown) – 1L chemotherapy – 2L pembrolizumab • Progressive disease prior to enrollment • Treated in metastatic 3L setting with 1.0 mg
Slide 18: CUE-101: Increase in Tumor Infiltrating T Cells (TILs)
CUE-101: Increase in Tumor Infiltrating T Cells (TILs) Case History Pre-dose Cycle 3 Day 1 • Prior therapy: 1500 – 1L chemotherapy CD3+GZMB+ cells – 2L pembrolizumab 1000 • Progressive disease prior to enrollment 500 • Treated in metastatic 3L setting with 2.0 mg/kg 0 CUE-101 Q3W (Cohort 5) PRE C3D1
Slide 19: CUE-101: Confirmed PR with ~57% Reduction in Target Lesions
CUE-101: Confirmed PR with ~ 57% Reduction in Target Lesions Increase in HPV E7-specific CD8+ T cells with minimal Case History change in total T cells 9-Fold increase 10 • Prior therapy: 10 9 9 CD4+ T cells specific CD8+ T cells 8 CD8+ T cells (%of leukocytes) Fold-change in E7 8 – 1L cetuximab Fol
Slide 20: Confirmed PR in Patient Treated at RP2D
Confirmed PR in Patient Treated at RP2D FEB 2021 JUN 2021 ~57% reduction in left hilar lesion © 2021 CUE BIOPHARMA 20
Slide 21: CUE-101: Multiple Shots on Goal for Potential Registration Paths
CUE-101: Multiple Shots on Goal for Potential Registration Paths Monotherapy • 3rd line therapy for HPV+ head and neck cancer • Potential option for 2nd line therapy in CPS <1 patients who are not eligible for pembrolizumab Combination therapy • First line HPV+ Head and Neck cancer in combination wi
Slide 22: CUE-102: Wilms Tumor 1 (WT1) IND on Track for 1Q 2022 Filing
CUE-102: Wilms Tumor 1 (WT1) IND on Track for 1Q 2022 Filing Clinical Rationale Molecular Design • Top ranked cancer antigen by the National Cancer Institute (NCI) • WT1 is a known tumor driver with low risk of immune escape as WT137-45 the tumor is dependent upon WT1’s oncogenic role IL-2 Variant •
Slide 23: CUE-102: Supporting Biology and Nonclinical Data
CUE-102: Supporting Biology and Nonclinical Data Priming and expansion of WT137-45-specific CD8+ T cells in vitro and in vivo T cell expansion in vitro T cell priming and expansion in vivo 80,000 60,000 WT137-45-specific CD8+ T cells 40,000 20,000 20,000 [total cell count] donor 1 donor 2 15,000 don
Slide 24: Expansion of Modular CUE-100 Series Into Broad Range of Cancers
Expansion of Modular CUE-100 Series Into Broad Range of Cancers KRAS 400,000 Broad Universe of Addressable WT1 TCR Targets with the 350,000 Incident Cases Harboring Target CUE-100 Series 300,000 HPV 250,000 • Viral Antigens (HPV, EBV) 200,000 • Cancer-Testes Antigens (WT1, MAGE) 150,000 100,000 • Li
Slide 25: Cue Biopharma, Inc: Q2 2021 Financial Highlights
Cue Biopharma, Inc: Q2 2021 Financial Highlights © 2021 CUE BIOPHARMA 25
Slide 26: Cue Biopharma Drug Product Candidate Pipeline
Cue Biopharma Drug Product Candidate Pipeline NEXT ANTICIPATED TARGET SELECTION PRE-CLINICAL PHASE 1 MILESTONE PARTNER CUE-101 Monotherapy 2L+ (HPV) 1H 2022: Complete Phase 1b Cancer: CUE-101 + Keytruda 1L (HPV) 2H 2021: Initial Combo Results Asia Rights, with CUE-100 series option for China and der
Slide 27: Q2 2021 Investor Update Call
Q2 2021 Investor Update Call Immune Responses, On Cue™ Nasdaq: CUE August 17, 2021