Celyad Oncology Sa · EURONEXT:CYAD
Celyad Oncology Sa — Celyad — Investor Presentation (September 2017)
29 slides from Celyad Oncology Sa's investor presentation, September 2017
Slide 1: Corporate Presentation September 2017
Bringing Breakthrough Pioneering Therapies to Patients with Life-Threatening Diseases Corporate Presentation September 2017
Slide 2: Disclaimer
Disclaimer In addition to historical facts or statements of current condition, this presentation contains forward-looking statements, including statements about the potential safety and feasibility of CYAD-01 cell therapy, including current and planned preclinical and clinical trials for Celyad’s pr
Slide 3: Celyad: Company overview
Celyad: Company overview Focused on the discovery and the development of specialized cell-based therapies to target cancer • Novel and proprietary CAR-T platform targeting treatment of solid and hematological tumors. • Lead candidate, CYAD-01 (CAR-T NKG2D), currently enrolling in Phase I THINK trial
Slide 4: Celyad's CYAD-01 (CAR-T NKG2D) pipeline
Celyad’s CYAD-01 (CAR-T NKG2D) pipeline 2015 2016 2017 2018 CLINICAL STAGE Autologous platform CM-CS1 Phase 1 Trial - Completed THINK - Acute Myeloid Leukemia HEMATO CANCER THINK - Multiple Myeloma INDICATIONS THINK - Ovarian cancer THINK - Colorectal cancer THINK - Pancreatic cancer THINK - Bladder
Slide 5: CYAD-01: A unique construct arming T-cells with a NK receptor
CYAD-01: A unique construct arming T-cells with a NK receptor to target and destroy cancer cells • One natural construct that capitalizes on the two main pillars of the immune system: NK cells and T-cells • A natural co-stimulating domain: DAP 10 • Same signaling domain as other CAR-T: CD3ζ 5
Slide 6: A single NK cell receptor binding 8 different ligands
A single NK cell receptor binding 8 different ligands NKG2D can bind to any of eight naturally occurring ligands known to be overexpressed in more than 80% of solid and hematological tumors NKG2D binding ligands: MICA MICB ULBPs 1-6 NKG2D ligands are expressed by stressed cells during infection, tum
Slide 7: NKG2D expresses ligands in broad range of cancer indications
NKG2D expresses ligands in broad range of cancer indications Expression of at least one of NKG2D ligands: • Triple negative breast cancers : 88% • Colorectal cancers : 88% • Ovarian cancers: 68% • Bladder cancers: 78% of the primary tumors and 100% of the metastases • Pancreatic cancers: 86% • NSCLC
Slide 8: CYAD-01: A novel paradigm to CAR-T
CYAD-01 : A novel paradigm to CAR-T The next frontier of cell therapy Next Generation CYAD-01 A cell transplant paradigm Less controlled In Vivo Controlled dosing and PK Increasing deliverability Expansion with potential for to reduce adverse events serious adverse events and increase Effectiveness
Slide 9: CYAD-01 Modes of action identified from syngeneic mouse models
CYAD-01 Modes of action identified from syngeneic mouse models • Eradication of established tumors by multiple infusions of CYAD-01 with no pre-conditioning chemotherapy • Short term persistence (7-10 days) • Direct target cell killing • Modulation of the local tumor microenvironment • Reduced numbe
Slide 10: CYAD-01 Syngeneic Models
CYAD-01 Syngeneic Models OVARIAN CANCER LEUKEMIA MULTIPLE MYELOMA 1. Barber, A. et al., J. Immunol (2009) 183(4):2365-72 Multiple dosing 2. Barber, A. et al., J. Immunol (2009) 183(11):6939-47 3. Barber, A. et al., J. Immunol (2008) 180(1):72-8 No pre-conditioning 4. Barber A. et al.,Exp. Hematol. (
Slide 11: CYAD-01: Mediate cytotoxicity and cytokine release during challenge with tumor cells
CYAD-01: Mediate cytotoxicity and cytokine release during challenge with tumor cells Demoulin et al. Future Oncology 2017 11
Slide 12: CYAD-01: Cell activity in vivo against established Panc-1 tumor cells
CYAD-01: Cell activity in vivo activity against established Panc-1 tumor cells Demoulin et al. Future Oncology 2017 12
Slide 13: In vitro potency of CYAD-01
In vitro potency of CYAD-01 Cytotoxicity 120 T a r g e t c e ll k illin g ( % ) 100 80 60 40 20 0 Cytotoxicity mediated by CYAD-01 CAR-T cells produced under GMP compliant conditions Kinetics of killing of pancreatic tumor cells by CYAD-01 CAR-T cells 13
Slide 14: CYAD-01 autologous clinical program includes various studies
CYAD-01 autologous clinical program includes various studies 2016 2017 2018 2019 2020 Open-label dose escalation Phase I study CM-CS-1 Study Single IV administration of CYAD-01 AML and MM relapsing post standard of care Open-label dose escalation Phase I study THINK Study Multiple IV administrations
Slide 15: CYAD-01: Clinical development plan THINK
CYAD-01: Clinical development plan A multinational (EU/US), open-label, dose escalation Phase 1 study THINK to assess the safety and clinical activity of multiple administrations of CAR-T NKG2D CAR-T NKG2D CAR-T NKG2D Phase 1 safety trial THINK Phase 1 trial • 1 administration • 3 administrations •
Slide 16: CYAD-01: Phase I safety trial successfully completed
CYAD-01: Phase I safety trial successfully completed 2015 2016 • Single administration, dose-escalation Phase I autologous CAR-T NKG2D study in patients with Acute Myeloid Leukemia and Multiple Myeloma CAR-T NKG2D Phase I Safety trial Dana Farber, last patient included in September 2016. ▪ 1 adminis
Slide 17: CYAD-01: THINK trial study design targeting seven refractory cancers
CYAD-01: THINK trial study design targeting seven refractory cancers Phase I dose escalation segment Phase I dose expansion segment 3 3 3 Bladder Solid tumors TN Breast 3x108 1x109 3x109 Colorectal All solid tumor types Ovarian Recommended dose Pancreatic 3 3 3 Hematological 3x108 1x109 3x109 tumors
Slide 18: CYAD-01: THINK trial (solid arm) promising early results at first dose level
CYAD-01: THINK trial (solid arm) promising early results at first dose level Promising early results at first dose level (3x108) • Two metastatic colorectal cancer patients reported as Stable Disease at 3- months follow-up* • Refractory pancreatic patient was in progression at the same time point •
Slide 19: CYAD-01 autologous clinical program includes various studies
CYAD-01 autologous clinical program includes various studies Open-label dose escalation Phase I study CM-CS-1 Study Single IV administration of CYAD-01 AML and MM relapsing post standard of care Open-label dose escalation Phase I study THINK Study Multiple IV administrations of CYAD-01 as stand alon
Slide 20: 2017 and 2018 clinical milestones
2017 and 2018 clinical milestones Q1 2017 Q2 2017 Q3 2017 Q4 2017 H1 2018 H2 2018 SOLID • Enrollment • Reporting • Reporting • Completion • Reporting • PFS 6- Dose 1 Dose 1 Dose 2 enrollment Dose 3 Month Data Completed Dose 3 • Completion • Enrollment enrollment • Start Expansion Dose 2 Expansion Se
Slide 21: 2017 and 2018 clinical milestones
2017 and 2018 clinical milestones Q1 2017 Q2 2017 Q3 2017 Q4 2017 H1 2018 H2 2018 Initiate Study Topline Data PFS 6-Month SHRINK Data Initiate Study Topline Data PFS 6-Month LINK Data Initiate Study Topline Data SIBLINK 21
Slide 22: Intellectual Property – Overview
Intellectual Property – Overview Three patent families covering autologous products pipeline • CYAD-01 (CAR-T NKG2D): two granted US patents, covering chimeric NK cell receptor CAR-Ts • CAR-T B7H6: pending applications in US, Europe, China and Japan on B7-H6 CAR-Ts B7-H6 is a ligand of the NKp30 rec
Slide 23: Intellectual Property – Allogeneic platform
Intellectual Property – Allogeneic platform One patent family covering allogeneic platform: • Three granted US patents, covering TCR-deficient T-cells, methods of producing them, and methods to use them to treat cancer • >10 applications pending in different jurisdictions • Allogeneic patent provide
Slide 24: Financial snapshot
Financial snapshot Cash Position: • €69 million as of June 30, 2017 • Enabling company’s activities through 2019 Ticker: Nasdaq (CYAD), Euronext Paris & Euronext Brussels (CYAD.BB) 24
Slide 25: Academic partnerships
Academic partnerships • Institut Curie is a world class research institution focusing on cancer and immunity, and positioning translational science at the heart of its approach • March 2016: Celyad entered into a 3 year collaboration with Institut Curie • CAR-T platform developed by Celyad was inven
Slide 26: Corporate partnerships
Corporate partnerships • Novartis is a global healthcare company based in Switzerland that provides solutions to address • ONO is a leader in cancer-immunotherapy in Japan the evolving needs of patients worldwide with the first approved checkpoint inhibitors, OPVIDO© • May 2nd, 2017: Celyad grants t
Slide 27: Management team
Management team 1. Christian Homsy, CEO 2. Patrick Jeanmart, CFO 3. Jean-Pierre Latere, COO 4. Frédéric Lehmann, VP Clinical Development & Medical Affairs 5. David Gilham, VP R&D 6. Georges Rawadi, VP Business Development & IP 1 2 3 7. Philippe Dechamps, Chief Legal Officer 8. Philippe Nobels, Globa
Slide 28: Celyad ADR programme
Celyad ADR programme Celyad ADRs trade on NASDAQ Benefits of ADRs to US investors • Symbol CYAD • Clear and settle according to US standards. • Cusip 151205000 • Offer the convenience of stock quotes and dividend payments in US dollars. • Ratio 1 ORD:1 ADR • Can be purchased/sold in the same way as
Slide 29: Thank you
Thank you Contact: [email protected] BELGIUM USA Celyad SA Celyad Inc. Axis Business Park Seaport East Rue Edouard Belin, 2 2 Seaport Lane B-1435 Mont-Saint-Guibert Boston, MA. 02210 +32(0) 10 39 41 00 +1 857-990-6900 www.celyad.com