Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Investor Presentation (March 2022)
22 slides from Cue Biopharma's investor presentation, March 2022
Slide 1: Corporate Presentation
Corporate Presentation Immune Responses, On Cue™ Nasdaq: CUE March 2022
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: Cue Biopharma's Vision
Cue Biopharma’s Vision • Harnessing natural signals (“Nature’s Cues”) for tailored immune activation against cancers to enhance efficacy and tolerability Leading the next wave of disruptive, breakthrough • Enabled by rational protein engineering to design immunotherapies therapeutics with potentiall
Slide 4: Immunotherapy Has Transformed Oncology Treatment
Immunotherapy Has Transformed Oncology Treatment Checkpoint inhibitors provided early insights that immunotherapy has the potential to eradicate cancer, however many challenges remain – Overall response rates for checkpoints are 15-25%, depending on tumor type – Many tumors show an absence of T cell
Slide 5: Need for Selective Increase of Cancer-specific Cytotoxic T cells in the Tumor
Successful Cancer Immunotherapy: Need for Selective Increase of Cancer-specific Cytotoxic T cells in the Tumor A minute fraction of a patient’s baseline T cell repertoire (likely < 0.1%) is tumor-specific • Limited Efficacy CD8+ CD8+ • Lack of Selectivity • Poor tolerability m o dulation ) CD8+ Sub-
Slide 6: Immuno-STATs: Designed to Selectively Increase Cancer-specific Cytotoxic T cells
Immuno-STATs: Designed to Selectively Increase the Number of Cancer- specific Cytotoxic T cells in the Tumor 1 2 Manufacturable {Target the right T cell + Activate the right T cell} • Ab-based modular design • Ab-like manufacturability and CMC • Highly stable (> 3-year stability) T cell Activation S
Slide 7: IL-2: Indiscriminate Activation = Lack of Therapeutic Index
IL-2: Indiscriminate Activation = Lack of Therapeutic Index Wild Type IL-2 or IL-2 Variants Lack of Selectivity for Non-selective Activation of Tumor-specific CD8+ T cells CD8+ T cells CD8+ CD8+ CD8+ CD8+ CD8+ CD8+ Examples • WT IL-2 (aldesleukin) • “Not-alpha” IL-2 variants (e.g., NKTR-214) • Tumor
Slide 8: CUE-100 Series Immuno-STATs: Enabling a Therapeutic Index for IL-2
CUE-100 Series Immuno-STATs: Enabling a Therapeutic Index for IL-2 Exploiting TCR and IL-2 co-engagement to selectively activate tumor-specific T cells ANTI-TUMOR IRRELEVANT CUE-100 series is an innovative modality > T CELL T CELL targeting IL-2 directly to anti-tumor T cells +++ +/- Lead candidate
Slide 9: CUE-101: Lead Clinical Candidate to Prime and Expand HPV E7-Specific T cells
CUE-101: Lead Clinical Candidate Designed to Selectively Prime and Expand HPV E7-Specific T cells • HPV induces several epithelial cancers including a significantly increasing fraction of head and neck cancer • HPV-16 E7 is a viral proto-oncogene and contains a highly conserved and immunogenic T cel
Slide 10: CUE-101 is a Beachhead for Clinical PoC and Platform De-risking
CUE-101 is a “Beachhead” that Provides Clinical PoC and Platform De-risking CUE-101 has been dosed in >50 patients • Demonstrates anti-tumor activity both as a monotherapy in 3L r/m HNSCC patients, and in combination with KEYTRUDA® (pembrolizumab, Merck’s anti-PD-1 therapy) in 1L r/m HNSCC Highlight
Slide 11: CUE-101 Monotherapy: Tumor Biopsies Show T cell Infiltration and Necrosis
CUE-101 Monotherapy: Patient Tumor Biopsies Reveal Evidence of T cell Infiltration and Tumor Necrosis Patient Example (1mg/kg): Patient Example (2mg/kg): Tumor Necrosis and T cell Infiltration on Treatment with CUE-101 Activated T cell Infiltration in Tumor pre- vs. post-CUE-101 Immune cell infiltra
Slide 12: CUE-101-01 Response/Durable Stable Disease
CUE-101-01 Response/Durable Stable Disease (RP2D 4 mg/kg N = 16/18 patients evaluable for Response) Responses N % Objective Response 1 6.3% (CR or PR confirmed ≥ 4 weeks) Durable Stable Disease (SD sustained for ≥ 12 weeks*) 6 37.5% Clinical Benefit (CR/PR + durable SD) 7 43.8% *Requires SD at ≥ 2 c
Slide 13: CUE-101: Confirmed PR in Monotherapy with Supporting PD Metrics
CUE-101: Confirmed PR in Monotherapy with Supporting PD Metrics Change from Baseline (CFB) in Sum of Diameters Increase in HPV E7-specific CD8+ T cells with minimal of Target Lesion(s) change in total T cells Case History 9-Fold increase 10 10 CD4+ T cells • Prior therapy: 9 9 specific CD8+ T cells
Slide 14: Overall Survival: Monotherapy Patients Across All Cohorts
Overall Survival: Monotherapy Patients Across All Cohorts ** Response symbols indicate patient experienced PR or Durable SD during the study. Onset and duration of the response is not indicated on the plot. © 2022 CUE BIOPHARMA 14
Slide 15: CUE-101: Dose Escalation in Combination with Pembrolizumab
CUE-101: Dose Escalation in Combination with Pembrolizumab Pembrolizumab Combination Dose Escalation 4.0 Cohort 3 Enrolling Pembrolizumab CUE-101 Dose 200 mg, Q3W (mg/kg) 2.0 Cohort 2 Dosing complete, no DLTs A 1.0 Cohort 1 Dosing complete, no DLTs C Cohort 1 D • 1 patient with durable SD (off treat
Slide 16: Clinical PoC with CUE-101 Provides a Springboard for Expansion
Clinical PoC with CUE-101 Provides a Springboard for Expansion into Large Indications with Unmet Need CUE-101 in r/m HNSCCC Rapid Expansion into Broad Indications with Significant Unmet Need provides Clinical PoC & Platform De-risking KRAS Broad Universe of G12V/D/R Addressable Solid and Heme HPV WT
Slide 17: CUE-102: Wilms Tumor (WT1) – IND on Track for 1Q 2022 Filing
CUE-102: Wilms Tumor 1 (WT1) – IND on Track for 1Q 2022 Filing T cell expansion from healthy subject In vivo expansion of WT1 T cells (in HLA- Molecular Design and AML patient A02 transgenic mice (99% sequence identity to CUE-101) A. Vehicle A. QW Vehicle CUE-102 Q3W QWCUE-102 CUE-102 CUE-102 Q3 Hea
Slide 18: CUE-102: Monotherapy First-in-Human Phase 1 Trial
CUE-102: Monotherapy First-in-Human Phase 1 Trial CUE-102-01 is a Phase 1, FIH study to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary anti-tumor activity of CUE-102 in subjects who are HLA A*0201-positive, have WT1-positive, recurrent/metastatic cancers, and have fai
Slide 19: Broad International IP Position
Broad International IP Position 50+ Patent Families Includes 4 in-licensed from the Albert Einstein College of Medicine 80 Patents and 286 Pending Applications Patents, PCTs and national filings cover all aspects of Cue Biopharma’s Immuno-STAT™ and other platforms Patent Term for Cue Biopharma Produ
Slide 20: Competitive Positioning and Differentiation
Competitive Positioning and Differentiation Recent clinical trial disappointments in the IL-2 space reinforce and support our premise that systemic, non-specific IL-2 administration with no selectivity for anti-tumor T cells will not provide a therapeutic index, nor demonstrable therapeutic benefit
Slide 21: Capital Runway, 2022 Milestones and Use of Proceeds
Capital Runway, 2022 Milestones and Use of Proceeds Present cash runway into Q3, 2023 Focused and disciplined use of proceeds provides potential cash runway extension CUE-101 (HPV HNSCC) exemplifies/de-risks/validates the IL-2 CUE-100 series: – CUE-101 Monotherapy trial evidencing single agent activ
Slide 22: Thank you
Thank you Rationally Engineered Biologics to Restore Immune Balance by Harnessing Nature’s Cues for Selective and Specific Immune Modulation