Celyad Oncology Sa · EURONEXT:CYAD
Celyad Oncology Sa — Investor Presentation (January 2019)
29 slides from Celyad Oncology Sa's investor presentation, January 2019
Slide 1: Pioneering breakthrough therapies for patients with life-threatening diseases
Pioneering breakthrough therapies for patients with life-threatening diseases Corporate Presentation January 2019
Slide 2: Forward-Looking Statements
Forward-Looking Statements This release may contain forward-looking statements, including statements regarding the safety and efficacy of CYAD-01 and CYAD-101 and the mAb manufacturing method used to manufacture this drug product candidate; statements concerning the ongoing and planned clinical deve
Slide 3: Company Overview
Company Overview Lead candidate is CYAD-01 – autologous CAR-T therapy leveraging the natural killer receptor NKG2D – currently in Phase 1 development for the treatment of hematological malignancies and solid tumors Proof of principle for CAR-T NKG2D approach supported by preliminary clinical results
Slide 4: CYAD-01 – Novel NKG2D-based CAR-T Overview of NKG2D
CYAD-01 – Novel NKG2D-based CAR-T NKG2D Target Overview of NKG2D ▪ NKG2D is an activating receptor expressed on natural killer (NK) cells which plays an important role in protection against infection and cancer DAP10 Costimulatory domain ▪ The receptor binds to eight stress induced ligands including
Slide 5: Advancing Clinical Pipeline
Advancing Clinical Pipeline Product Target Study Design Preclinical IND Submission Phase 1/2 Standalone THINK w/o Preconditioning Hematological malignancies and Solid tumors THINK Schedule optimization Cohort 10 w/o Preconditioning r/r AML / MDS Preconditioning CYAD-01 NKG2D DEPLETHINK with CyFlu r/
Slide 6: CYAD-01 – AML / MDS Program
“yi “ ~ cy = RAN | YAD-01 —AML / MDS Program
Slide 7: CYAD-01 Trial Designs in Hematological Malignancies
CYAD-01 Trial Designs in Hematological Malignancies THINK (1) Standalone without Preconditioning (1) THINK – Cohort 10 Schedule optimization without Preconditioning (2) DEPLETHINK Preconditioning with CyFlu CyFlu: cyclophosphamide and fludarabine. 7 (1) ClinicalTrials.gov Identifier: NCT03018405; (2
Slide 8: Overview of THINK Phase 1 Trial for Hematological Malignancies
Overview of THINK Phase 1 Trial for Hematological Malignancies ▪ Open-label, dose-escalation Phase 1 trial evaluating CYAD-01 without preconditioning chemotherapy or bridging therapy in relapse/refractory (r/r) hematological malignancies including AML, myelodysplastic syndromes (MDS) and multiple my
Slide 9: Review of Patient Status in THINK Trial in Hematological Malignancies
Review of Patient Status in THINK Trial in Hematological Malignancies Sixteen r/r AML, MDS, MM patients (6/3/7 at dose levels 1/2/3) Three MM patients at dose level 1 had no clinical response Thirteen r/r AML or MDS patients (3/3/7 at dose levels 1/2/3) Three r/r AML or MDS patients were non-evaluab
Slide 10: Interim Analysis from THINK Trial Demonstrates Clinical Activity of CYAD-01
Interim Analysis from THINK Trial Demonstrates Clinical Activity of CYAD-01 Without Preconditioning Chemotherapy Change in Bone Marrow Blast Count from Baseline (%) 100% 102-506 ▪ Clinical activity observed across all three dose 80% levels of CYAD-01 202-505 60% ▪ Potential induction of PR Change fr
Slide 11: Summary of CYAD-01 r/r AML/MDS Program
Summary of CYAD-01 r/r AML/MDS Program THINK THINK – Cohort 10 DEPLETHINK ▪ Encouraging clinical activity ▪ Amendment will assess a ▪ Dose escalation trial will with 40% of patients more frequent dosing evaluate a single injection of achieving CR and anti- schedule of CYAD-01 CYAD-01 following treat
Slide 12: CYAD-01 – Solid Tumor Program
CYAD-01 – Solid Tumor Program
Slide 13: CYAD-01 Trial Designs in Solid Tumor
CYAD-01 Trial Designs in Solid Tumor (1) THINK Standalone without Preconditioning THINK CyFlu Cohort (1) Preconditioning with CyFlu 1st CYAD-01 2nd CYAD-01 FOLFOX 3rd CYAD-01 Washout period SHRINK (2) D-21 D-7 D1 D31 D99 Concurrent with FOLFOX Apheresis Tumor assessment Surgery (1) ClinicalTrials.go
Slide 14: CYAD-01 in Solid Tumor – Best Clinical Responses
CYAD-01 in Solid Tumor – Best Clinical Responses SHRINK THINK THINK CyFlu with concurrent without preconditioning with preconditioning FOLFOX DL-1 DL-2 DL-3 DL-1 3x108 1x109 3x109 3x108 1x108 N=4 N=4 N=6 N=2 N=3 Best overall response Complete response - - - - Partial response - - - Assessment **1*°
Slide 15: Summary of CYAD-01 mCRC Program
Summary of CYAD-01 mCRC Program THINK THINK CyFlu SHRINK ▪ Standalone CYAD-01 without ▪ Early data shows CYAD-01 is ▪ Encouraging activity preconditioning was well well tolerated following observed in first dose level of tolerated standard preconditioning CYAD-01 with FOLFOX – ▪ Provides potential r
Slide 16: CYAD-101 Program
CYAD-101 Program
Slide 17: Background on CYAD-101
Background on CYAD-101 ▪ CYAD-101 is Celyad’s first non-gene edited, allogeneic CAR-T clinical candidate ▪ CYAD-101 co-expresses the company’s CYAD-01 CAR-T construct and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule) within a single vector ▪ In November 2018, the Compa
Slide 18: CYAD-101 Leverages TIM-mediated Inhibition of TCR Signaling
CYAD-101 Leverages TIM-mediated Inhibition of TCR Signaling CYAD-101 Endogenous TIM-incorporating The expression of TIM TCR/CD3 complex NKG2D CAR TCR/CD3 complex results in the competitive inhibition of CD3z and reduces signalling of the TCR complex leading to the potential reduction or elimination
Slide 19: Allogeneic shRNA Platform
=p \ SS a a test fe Allogeneic shRNA Platform
Slide 20: Developing a Next Generation, Non-Gene Edited Platform for CAR-T
Developing a Next Generation, Non-Gene Edited Platform for CAR-T ▪ In October 2018, Celyad announced it had entered into an exclusive agreement with Horizon Discovery Group for the use of its shRNA technology to generate a novel, next-generation, non-gene-edited allogeneic platform for CAR-T therapi
Slide 21: Benchmarking the shRNA Approach Against Gene-Editing Knockdown of TCR
Benchmarking the shRNA Approach Against Gene-Editing Knockdown of TCR in Primary T cells Equivalent knockdown compared to gene editing Primary human T cells selected after transduction with a retroviral vector encoding a single shRNA targeting CD3z shows equivalent knockdown of the TCR/CD3 complex a
Slide 22: Manufacturing
Manufacturing
Slide 23: Celyad's Manufacturing Expertise
Celyad’s Manufacturing Expertise ▪ 1,100 sq. meter facility in Mont-Saint-Guibert is AML mCRC equipped to supply all of Celyad’s expected clinical trials as well as support over 1,000 patients annually ▪ Manufacturing success rate of 93% (n=29) since implementation of last amendment ▪ Optimized proc
Slide 24: Strategy and Financials
Strategy and Financials
Slide 25: Strong Intellectual Property
Strong Intellectual Property Key U.S. Patents Strategic Validation ▪ Allogeneic T-Cell Technology (1) ▪ T-cell receptor deficient T-cell ▪ In May 2017, Celyad granted Novartis a non- compositions exclusive license for allogeneic TCR-deficient ▪ Method of producing T-cell receptor CAR-T cells patents
Slide 26: Upcoming Milestones
Upcoming Milestones First Quarter 2019 First Half 2019 Second Half 2019 ▪ In-vivo data from next- ▪ Updated data from dose level 3 ▪ Preliminary data from generation, allogeneic shRNA and initial data from Cohort 10 of alloSHRINK trial evaluating platform THINK trial evaluating CYAD-01 allogeneic CY
Slide 27: Financial Snapshot
Financial Snapshot ▪ Cash and short-term investments: €56 million as of September 30, 2018 ▪ Current cash expected to be sufficient to support the company’s activities into mid-2020 ▪ Basic Shares Outstanding: 11.9 million ▪ Ticker: Nasdaq (CYAD) and Euronext Paris & Brussels (CYAD.BR) 27
Slide 28: Proposed Roadmap to Success in CAR-T
Proposed Roadmap to Success in CAR-T Beyond Tomorrow ▪ “Crack the code” in solid tumors with an NKG2D- Today based CAR-T therapy ▪ Leverage our leading through well-established allogeneic approach and novel combination including CYAD-101, regimens to pursue ▪ Accelerate the clinical next-generation
Slide 29: Thank you
Thank you
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