Celyad Oncology SA · EURONEXT:CYAD
Celyad Oncology SA — Celyad — Investor Presentation (January 2018)
24 slides from Celyad Oncology SA's investor presentation, Jan 22, 2018
Slide 1: Corporate Presentation January 2018
Bringing Breakthrough Pioneering Therapies to Patients with Life-Threatening Diseases Corporate Presentation January 2018
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: Focused on the discovery and development of specialized cell-based therapies to target cancer
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 THINK trial • CAR-T NKG2D target validated wi
Slide 4: Stress ligands, the making of an ubiquitous CAR-T
Stress ligands, the making of an ubiquitous CAR-T SIGNAL 1 CD19-CAR-T CYAD-01 CAR-T SIGNAL 2 scFv NKG2D • Derived from a CD8TM • Derived from (murine) antibody human NK receptor • 2nd generation CAR- DAP10 • Similar primary and CD28 T signaling CD3ζ secondary signaling CD3ζ • scFv targeting • NKG2D
Slide 5: NKG2D binds to stress induced ligands, expressed in a broad range of cancer indications
NKG2D binds to 8 stress induced ligands, expressed in a broad range of cancer indications Expression of at least one of NKG2D ligands: • Triple negative breast: 88% • Colorectal: 88% • Ovarian: 68% • Bladder: 78% of the primary tumors and 100% of the metastases • Pancreatic: 86% • NSCLC Lung: 92% (1
Slide 6: Beyond direct cell killing, inducing multi faceted attack on the tumor
Beyond direct cell killing, inducing multi faceted attack on the tumor RELEASE OF THE IMMUNOSUPPRESSION OF THE TUMOR MICROENVIRONMENT Immunosuppressive cells DIRECT TUMOR CELL KILLING Tumor cells Blood vessels CYAD-01 ANTI-NEOANGIOGENEIC EFFECT DRIVEN THROUGH TARGETING OF TUMOR ENDOTHELIAL CELLS EXP
Slide 7: CYAD-01 preclinical models showing activity with multiple injections and without pre-conditioning
CYAD-01 preclinical models showing activity with multiple injections and without pre-conditioning OVARIAN CANCER LYMPHOMA MULTIPLE MYELOMA Barber et al. 2009 J Immunol. 183(4):2365-72 Zhang et al., 2007 Cancer Res; 67: (22) Barber et al., 2011 Gene Ther. 18(5):509-16 7
Slide 8: FIM Phase I Study: acceptable safety profile and early signs of activity
FIM Phase I Study: CYAD-01 showed acceptable safety profile and shows early signs of activity 2015 2016 Safety Phase I • Run at Dana Farber Cancer Institute • CYAD-01 is safe at the dose levels tested ▪ 1 administration • One r/r AML Patient at highest dose (3x107) showed normalization of all ▪ No l
Slide 9: THINK Study design
THINK Study (THerapeutic Immunotherapy w/ NKG2D-based therapy) o 3 dose levels (3x108,1x109 and 3x109) THINK Trial 1st CYAD-01 (D1) 2nd CYAD-01 (D2) Tumor 3rd CYAD-01 (D3) Washout period assessment D-35 D-21 D1 D15 D29 D43 D57 ▪ 3 administrations End safety Apheresis ▪ Primary Endpoint: Safety &Tole
Slide 10: THINK Study: Primary endpoint – Safety – Interim Data
THINK Study: Primary endpoint – Safety – Interim Data THINK: Safety Profile in 15 Patients All adverse events if >= 2 patients Solid (n=8) and hematologic (n=7) cancer patients patients Dose-level 1 (solid and hematologic cohorts) and dose-level 2 (solid cohort) All AEs are unrelated to the investig
Slide 11: Early readout: Clinical activity in 3/3 relapsed refractory AML patients
Secondary Endpoint: Early readout: Clinical activity in 3/3 Relapsed Refractory AML Patients treated at the prespecified dose Best Response to date Months 1 2 3 4 5 6 Dose 1 CRi Demethylation Agent CR Dose 1 (MRD- Post HSCT) Dose 2 SD HI Demethylation Agent Treatment Cycle 1 • 1 Patient reached MLFS
Slide 12: Preliminary take away from AML patients with CYAD-01 as monotherapy
Preliminary take away from AML patients with CYAD-01 as monotherapy at intended dose (w/o preconditioning) • CYAD-01 active against AML tumor in 3/3 patients treated at the intended dose • Blast reduction in BM in patients up to and including at least the third injection • Hematological parameters i
Slide 13: CYAD-01 AML Clinical Development Plan
CYAD-01 AML Clinical Development Plan Boosting potency: Prolong durability as • Expansion stand-alone • Tumor debulking Multiple Treatment THINK Cycles in Expansion First FOCUS ON AML Standard CAR-T in Hematological Enhance preconditioning AML Tumors engraftment and regimen to induce preconditioning
Slide 14: AML is a large unmet medical need, distinct from B cell malignancies
AML is a large unmet medical need, distinct from B cell malignancies ALL CD 19 malignancies AML • 5.970 NCY • 68.2% 5 Y Survival • 21.380 NCY • 26.9% 5 Y Survival DLBCL • 27.650 NCY • 53% 5 Y Survival 14
Slide 15: Early readout: Signals of activity in CRC and Ovarian Cancers
Secondary Endpoint: Early readout: Signals of activity in CRC and Ovarian Cancers • Two out of three metastatic colorectal cancer patients reported as “stable disease” up to 3-months follow-up* • No toxicity signals to date ➢ Next steps: Higher dose, longer follow-up + SHRINK and LINK * Median progr
Slide 16: CYAD-01 clinical development plan in CRC
CYAD-01 clinical development plan in CRC Boosting potency through: Prolong durability as • Expansion stand alone • Tumor debulking • Homing Multiple Treatment THINK Cycles in Expansion Standard CAR-T Enhance CRC pre- preconditioning regimen engraftment and conditioning proliferation First FOCUS ON 1
Slide 17: Celyad Consolidated Clinical Development Plan
Celyad Consolidated Clinical Development Plan AACR ASCO ASH AACR ASCO ASH Clinical Trial 2018 2019 AML THINK Expansion AML Pre-conditioning AML SOC AML SIBLINK CYAD-02 AML CRC THINK CRC SHRINK CRC LINK CRC Pre-conditioning CRC CYAD-101 Allo 17
Slide 18: CYAD-101: Making allogeneic options feasible
CYAD-101: Making allogeneic options feasible • Engineered for CYAD-01 (NKG2D-based CAR-T cell) • Alloreactivity controlled through co-expression of an inhibitory peptide (termed a T cell receptor inhibitory molecule – TIM) to reduce TCR-signaling and thereby reduce GvHD. 22/01/2018 18
Slide 19: Abrogation of GvHD by the expression of TIM8 in allogeneic T cells
Abrogation of GvHD by the expression of TIM8 in allogeneic T cells The expression of TIM8 inhibits Tumor growth (orthotopic colorectal tumor in NSG mice) xGvHD in the NSG mouse is decreased following treatment with CYAD-101 10 11 C o n tro l 100 (p h o to n s / s e c / m m ) tC D 1 9 T c e lls 2 B i
Slide 20: Summary: Towards CAR-T leadership
Summary: Towards CAR-T leadership NKG2D platform; Autologous Cell Leveraging Stress Ligands Allogeneic CAR T Cell Therapy Manufacturing Paradigm shift based CAR-T Strong IP position Patents concerning TCR knockdown Building on early signals Process Development in CAR T cell therapy providing Improvi
Slide 21: Corporate partnerships
Corporate partnerships • May 2nd, 2017: Celyad grants to Novartis a non- • July 11th 2016: Celyad grants exclusive license to exclusive license for its allogeneic TCR-deficient ONO for the development and commercialization of CAR-T cells patents for two undisclosed targets allogeneic CYAD-01 T-cell
Slide 22: Financial snapshot
Financial snapshot Cash Position: • €40 million as of Sept 30, 2017 • Enabling company’s activities through first half of 2019 Ticker: Nasdaq (CYAD), Euronext Paris & Euronext Brussels (CYAD.BB) 22
Slide 23: 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, CLO 8. Philippe Nobels, Global Head Of Human
Slide 24: Thank you
Thank you Contact: investors@celyad.com 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