Cue Biopharma, Inc. · NASDAQ:CUE
Cue Biopharma — Jefferies Virtual Healthcare Conference 2020
22 slides from Cue Biopharma's conference presentation, Jun 4, 2020
Slide 1: Corporate Presentation
Corporate Presentation Immune Responses, On Cue™ Nasdaq: CUE Jefferies Virtual Healthcare Conference | June 4, 2020
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: Corporate Highlights
Corporate Highlights Disruptive Platform for Focused Execution Against Strategic Partnerships to T Cell Modulation In Vivo Platform Validation Accelerate Expansion • Distinct mechanism of action for • CUE-101 in Phase 1 for R/M HPV+ • LG Chem collaboration to expand selective modulation of disease-
Slide 4: Emulating Nature's Cues to Selectively Modulate T Cells
Emulating Nature’s Cues to Selectively Modulate T Cells T Cell Immuno-STAT Co-Stimulatory/ Co-Regulatory T Cell Receptor Receptor (TCR) Signal 1 Signal 2 Signal 2 Signal 1 Induction/ Selectivity/ Control Specificity FC Co-Stimulatory/ Major Co-Regulatory Histocompatibility Fc Signal Complex (MHC) An
Slide 5: Immuno-STAT Modularity
Immuno-STAT Modularity Peptide Co-stim/Co-reg Peptide epitopes to target Distinct biological signals, different diseases including cytokines; cell-surface receptors; and/or other targeting modalities (e.g., scFv, etc.) MHC Fc Backbone Different HLA alleles to Fc engineering to dial in or out address
Slide 6: Pipeline
Pipeline TARGET SELECTION PRE-CLINICAL PHASE 1 LATE CLINICAL PARTNER CUE-101 (HPV E7 / A02) CUE-100 CUE-102 (WT1 / A02) IL-2 Asia Rights to CUE-102 (WT1 / A24) CUE-101, CUE- 102, and CUE-103 CUE-103 (Undisclosed) CUE-200 KRAS / A11 CD80 & 4-1BBL CUE-201 (Undisclosed) CUE-300 CUE-301 (Proins / DR4) P
Slide 7: CUE-100 Series: Exploiting IL-2 via Rational Protein Design
CUE-100 Series: Exploiting IL-2 via Rational Protein Design CUE-100 Series Immune Signaling Components Affinity modified IL-2: • Minimize Treg activation Modified Side View IL-2 • Selective activity on tumor-specific T cells, while sparing activation of irrelevant T cells • Differentiated MoA over “
Slide 8: CUE-101: Lead Clinical Candidate for HPV-Driven Malignancies
CUE-101: Lead Clinical Candidate for HPV-Driven Malignancies CUE-101 Immuno-STAT Design Clinical Rationale • CUE-101 is designed to selectively prime and expand Signal 1: HPV-specific T cells in vivo HLA-A*02:01 + HPV-16 E711-20 peptide • HPV is recognized as a growing driver of head and neck cancer
Slide 9: CUE-101: Phase I Clinical Development Network
CUE-101: Phase I Clinical Development Network • Emory Winship Cancer Institute: Nabil Saba • Karmanos Cancer Institute: Elizabeth Heath and Ammar Sukari • MD Anderson Cancer Center: Bonnie Glisson • MGH/Harvard and Dana Farber Cancer Institute: Sara Pai and Lori Wirth • Moffitt Cancer Center: Christ
Slide 10: CUE-101: Ongoing First-In-Human Study
CUE-101: Ongoing First-In-Human Study • Eligibility Part A: Monotherapy Dose Escalation - Part A & B: HPV+ H&N Cancer, R/M 2L+ Cohort N • Design (CUE-101 Q3W) - Part A: Dose Escalation (3+3 Pts) Cohort 4 - Part A: PD & Activity Expansion (Up to 9 Pts) Cohort 3 RP2D:BED/MTD - Part B: Dose Expansion (
Slide 11: CUE-101: Part A Dose Cohorts
CUE-101: Part A Dose Cohorts CUE-101 IL-2 Content CUE-101 Dose Relative to CUE-101 Relative to Approved Cohort CUE-101 Dose Approved Proleukin Dose IL-2* Content Proleukin Dose (0.037 mg/kg) (nmol/kg) (2.4 nmol/kg) 0.06 mg/kg Cohort 1 ✓ ~ 1.6x 1.1 ~ 0.46x (starting dose) Cohort 2 ✓ 0.18 mg/kg ~ 4.9x
Slide 12: CUE-101: Safety & Activity Observations from Cohorts 1-3
CUE-101: Safety & Activity Observations from Cohorts 1 – 3 Safety • Multiple patients receiving multiple injections indicates favorable safety and tolerability profile • No drug-related DLTs in cohorts 1-3 • Cohort 4 still being analyzed in the safety review period Activity • PK data from the first
Slide 13: CUE-101 Exposures from Cohorts 1-3
CUE-101: Exposures from Cohorts 1 - 3 104 Pt. 9 Pt. 8 0.54 mg/kg [CUE-101] (ng/mL) Pt. 7 103 Pt. 6 Pt. 5 0.18 mg/kg Pt. 4 102 Pt. 3 Pt. 2 0.06 mg/kg Pt. 1 101 0 24 48 72 96 0 4 8 12 14 16 Hours Post Start of Infusion CUE-101 exhibits dose-proportional increases in exposure in line with projections f
Slide 14: Exposure is Consistent Upon Repeated Administration
CUE-101: Exposure is Consistent Upon Repeated Administration Pt. 1 Pt. 4 103 104 Pt. 5 104 [CUE-101] (ng/mL) [CUE-101] (ng/mL) [CUE-101] (ng/mL) Cycle10 43 Cycle 4 Cycle 4 Cycle 3 1033 Cycle 102 Cycle 3 Cycle 2 Cycle 2 102 Cycle 2 Cycle 1 Cycle 12 10 Cycle 1 101 101 101 0 24 48 72 96 0 4 8 0 24 48 7
Slide 15: Expansion of E7-specific T Cells
CUE-101: Expansion of E7-specific T Cells Pt. 5 Day 0 (Pre-Dose) Day 21 0.20 E7-specific CD8+ T cells [% of total CD8+ T cells] 0.15 0.10 0.05 0.00 e 1 1 pr 2D 3D C C Pt. 9 Day 0 (Pre-Dose) Day 21 0.25 E7-specific CD8+ T cells [% of total CD8+ T cells] 0.20 0.15 0.10 0.05 0.00 e 1 pr 2D C Preliminar
Slide 16: CUE-101: Cohort 2 Patient Case Study
CUE-101: Cohort 2 Patient Case Study Day 0: Baseline Tumor Day 42: 2 Cycles of CUE-101 Monotherapy Scan at day 42 (after 2 cycles of CUE-101) indicates reduction of >1cm target lesion At day 84 the repeat scan showed sustained regression of the target lesion, and at that point the patient was confir
Slide 17: Platform Expansion: IO Growth Strategy
IO Growth Strategy Platform Validation CUE-101 Phase I Immuno-STAT CUE-100 (A02/HPV) Mono Multiple registration Phase I paths available Platform Expansion CUE-102 CPI Combo De-risk CUE-100 (A02/WT1) Phase I series pipeline assets through Neo-Adj CUE-101 CUE-102 Other HPV+ (A24/WT1) Cancers Additiona
Slide 18: Immuno-STATs Demonstrate Selective T Cell Expansion
Immuno-STATs Demonstrate Selective T Cell Expansion HPV (CUE-101) WT1 (CUE-102) KRAS IST KRAS-specific CD8+ T cells 400 300 15000 WT1-specific CD8+ T cells E7-specific CD8+ T cells [total cell count] [total cell count] [total cell count] 300 200 10000 200 100 5000 100 0 0 0 -2 -1 0 1 2 3 4 0 1 2 3 4
Slide 19: Neo-STAT: Next-gen Evolution of the Immuno-STAT Framework
Neo-STAT: Next-gen Evolution of the Immuno-STAT Framework CUE-100 Neo-STAT Top Therapeutic scaffold receptive for View Therapeutic scaffold chemical conjugation of peptides, that manufactured in bulk potentially: • Increases R&D efficiency and reduces cost of the generation of clinical grade materia
Slide 20: Primary Human T Cell Expansion: Neo-STAT = Immuno-STAT
Primary Human T Cell Expansion: Neo-STAT = Immuno-STAT CMV CUE-100 Series Immuno-STAT CMV CMV Neo-STAT Responsive MART-1 Neo-STAT Donors MART-1 CUE-100 Series Immuno-STAT MART-1 MART-1 Neo-STAT CMV Neo-STAT Responsive Donors 20 © 2020 CUE BIOPHARMA
Slide 21: Corporate Development Strategy
Corporate Development Strategy • Continue to generate clinical metrics for CUE-101 demonstrating safety, tolerability and clinical activity to de-risk CUE-101, CUE-100 series, as well as Immuno-STAT framework Validate • Establish therapeutic synergy with checkpoint inhibition through clinical collab
Slide 22: Key 2020 Milestones
Key 2020 Milestones 1 PK/PD results from the Phase 1 CUE-101 clinical trial in 2Q20 2 Clinical responses from the Phase 1 CUE-101 clinical trial via RECIST criteria in 2H20 3 Initiate CUE-101 combination trial with Keytruda in 1L SCCHN in 2H20 4 Initiate and extend IND-enabling activities for CUE-10
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