welcome! 10th anniversary event - site · statements in this document to reflect any change in its...

Welcome!10th anniversary event

Wednesday, January 31st 2018 Mont-Saint-Guibert

Welcome

Serge GobletBoard Member

Introduction

Michel Lussier MS BME, MBAChairman of the Board

Agenda & Speakers

4

5:30 – 7:00pm Presentations• Welcome, by Serge Goblet, Member of the Board of Directors, Celyad• Introduction and agenda, by Michel Lussier MS BME, MBA, Chairman of the Board of Directors, Celyad• Cancer and Celyad’s technology, by Sophie Agaugue, PhD, R&D Manager, Celyad• 2017 Progress and Learnings , by Christian Homsy, MD, MBA, CEO, Celyad• AML and Celyad’s potential, by Xavier Poire, MD, Service Hématologique Adulte, Institut Roi Albert II,

Clinique universitaire de St-Luc• CYAD-01 rationale in colorectal cancer, by Alain Hendlisz, MD, PhD, Head of the Gastro-Enterology Unit,

Medical Oncology Clinic, Jules Bordet Institute• Celyad’s Clinical Development Plan, by Frédéric Lehmann, MD, PhD, VP of Clinical Development

&Medical Affairs, Celyad• Celyad’s R&D strategy, by Peggy Sotiropoulou, PhD,R&D Manager, Celyad• Celyad’s SNOWY project, by Valérie Steenwinckel, PhD, Industrialization Director, Celyad• 2017 – Progress and learnings, by Christian Homsy, MD, MBA, CEO, Celyad• Willy Borsus, Minister-President of Wallonia• Closing, by Christian Homsy, MD, MBA, CEO, Celyad• Q&A

7:00 – 9:00pm Cocktail & Networking

Forward looking statements

Forward-looking statements In addition to historical facts or statements of current condition, this presentation contains forward-looking statements, including statements about the potentialsafety and feasibility of CYAD-01 cell therapy, including current and planned preclinical and clinical trials for Celyad’s product candidates; the clinical and commercialpotential of these product candidates and the adequacy of Celyad’s financial resources; Celyad’s intellectual property portfolio, including plans related thereto;Celyad’s expectations regarding its strategic collaborations and license agreements with third parties, including Novartis, Celdara Medical, and Dartmouth College,and the potential impact of such collaborations on Celyad’s future financial condition; and Celyad’s expected cash burn, which reflect Celyad’s current expectationsand projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differmaterially from those expressed or implied by the forward-looking statements. These forward-looking statements are further qualified by important factors andrisks, which could cause actual results to differ materially from those in the forward-looking statements, including risks associated with conducting clinical trials; therisk that safety, bioactivity, feasibility and/or efficacy demonstrated in earlier clinical trials or preclinical studies may not be replicated in subsequent trials or studies;risks associated with the timely submission and approval of anticipated regulatory filings; the successful initiation and completion of clinical trials, including its clinicaltrials for CYAD-01; risks associated with the satisfaction of regulatory and other requirements; risks associated with the actions of regulatory bodies and othergovernmental authorities; risks associated with obtaining, maintaining and protecting intellectual property, Celyad’s ability to enforce its patents against infringersand defend its patent portfolio against challenges from third parties; risks associated with competition from others developing products for similar uses; risksassociated with Celyad’s ability to manage operating expenses; and risks associated with Celyad’s ability to obtain additional funding to support its business activitiesand establish and maintain strategic business alliances and business initiatives. A further list and description of these risks, uncertainties and other risks can be foundin Celyad’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in its Annual Report on Form 20-F filed with the SEC on April 4, 2017 andsubsequent filings and reports by Celyad. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. Theseforward-looking statements speak only as of the date of publication of this document. Celyad expressly disclaims any obligation to update any such forward-lookingstatements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any suchstatement is based, unless required by law or regulation.

5

We kindly remind you that this presentation will be video recorded. The video will be posted on Celyad’s website shortly after the event.

Cancer and Celyad’s technology

Sophie Agaugue, PhDR&D Manager

6

What is cancer ?

02/02/2018 7

Normal cells grow, divideand die in an orderly fashion

02/02/2018 7

Cancer cells do not die, they just grow and divide in an uncontrolled way

Genetic, environmental factors

2 types of cancer: solid and liquid

A tumor is a micro-environment by itself

Primary tumor

Metastases

02/02/2018 8

How does the immune system fight against cancer ?

02/02/2018 9

But this is not enough: tumor microenvironment impedes activation of the immune system

Immune Suppression Immune Activation

02/02/2018 10

How to make our own immune cells fight cancer ? The explosion of immunotherapy

Antibody approach: Breaks the tumor inhibitoryeffect on immune system

Cellular approach: Accelerates the immune effect against the tumor

02/02/2018 11

Tumorantigen

T-cells need to be “armed” to fight Cancer

CAR-T cells =tumor specific –

gene modified T-cells

Issues: low frequency of tumorspecific T-cells in patientsNo good tumor specific antigen to select T-cells

02/02/2018 12

How to « arm » a T-cell: standard CAR-T construct

ChimericAntigenreceptor

scFV (single chain variable

fragment)

Signalling domain

Chimeric Antigen Receptor (CAR) T-cell

02/02/2018 13

CD19 CAR-T: an extraordinary technology that has now come to the market

02/02/2018 14

CYAD-01 a unique CAR-T combining properties of NK and T cells

CYAD-01: a unique construct only developed at Celyad in clinical development

+

02/02/2018 15

A Single NK Cell Receptor Binding 8 Different Ligands expressed in the majority of tumors

02/02/2018 16

Cancer type Expression of at least one NKG2D ligand

Bladder carcinoma 96% (mets 100%)

TNBC 100%

Colorectal cancer 100%

Ovarian carcinoma 84%

Pancreatic cancer 90%

Lung cancer (NSCLC) 100%

AML 100%Dulphy et al unpublished data

Celyad’s unpublished data

CYAD-01 cells destroy diverse types of tumors and prolong survival of mice

PANCREATIC CANCER

Demoulin et al. Future Oncology 2017

02/02/2018 17

Barber et al. 2009, J Immunol

OVARIAN CARCINOMA

Zhang et al. 2007, Cancer Res

LYMPHOMA

Beyond direct killing, inducing multifaceted attack on the tumor

02/02/2018 18

Lonez et al., BMJ Open, 2017

2017 – Progress and learnings

Christian Homsy, MD, MBACEO

19

THINK Trial

20

▪ First patients in January 2017▪ First experience in oncology

▪ 3 administrations▪ Primary Endpoint: Safety &Tolerability▪ Secondary Endpoint: Efficacy as

Monotherapy (w/o preconditioning)▪ Hematological & solid tumors

THINK Study (THerapeutic Immunotherapy w/ NKG2D-based therapy)

▪ Seven advanced refractory tumor indications

▪ Global development: EU and USA

o 3 dose levels (3x108,1x109 and 3x109)

Apheresis

1st CYAD-01 (D1)2nd CYAD-01 (D2)

3rd CYAD-01 (D3)

End safety

D1 D15 D29

Tumor assessment

D43 D57D-21

Washout period

13 weeks w/o any other non-investigational cancer therapy

D-35

Total: 15 patients (10 at pre-defined dose)

- All adverse events are unrelated to CYAD-01- No critical toxicity events related to date

> THINK confirms the safety profile of CYAD-01

THINK study: Status Report

21

THINK Trial

Safety


- Further improvement of manufacturing process achieved- First dose of dose-level 3 produced & administered> Celyad’s manufacturing process optimized


22

THINK Trial

Feasibility


- Hematological arm: CYAD-01 active in 3/3 AML patients (w/o pre-conditioning): - 1 MLFS – World Premiere- All blast reduction during treatment- All hematological improvements

- Solid arm: CYAD-01 resulted in 2 out of 4 Stable Diseases for CRC patients and 1 ovarian cancer

- 6 patients out of 10 treated at the per-protocol dose reached Stable Disease (SD) till Complete Response (CR)

> THINK validates the activity of NKG2D


23

THINK Trial

Clinical activity

Complete dose escalation

Plan expansion phase with second cycle of treatmentpotentially improving response durability

Going forward

24

THINK Trialin 2018

Hematological Solid

3 new studies 3 new studies

Acute Myeloid Leukemia(AML)

Xavier Poiré, MDUnité de greffe médullaire

Service d’Hématologie Adulte

Institut Roi Albert II

Cliniques Universitaires St-Luc (Bruxelles)

25

Acute Myeloid LeukemiaWhere are we and where are we going to?

Xavier Poiré, MDUnité de greffe médullaire

Service d’Hématologie AdulteInstitut Roi Albert II

Cliniques Universitaires St-LucBruxelles

31/01/2018

Normal hematopoiesis

X. Poiré, 31/01/2018 27

Cellular division and leukemogenesis

X. Poiré, 31/01/2018 28

How does chemo/radiotherapy work?

X. Poiré, 31/01/2018 29

CHEMO/RT

Induction and consolidation therapies

X. Poiré, 31/01/2018 30

INDUCTION CONSOLIDATION

Normal hematopoiesis

Leukemic cells

4-6 weeks

GOOD LEUKEMIA

BAD LEUKEMIA

60-70% SURVIVAL

10-20% SURVIVAL

Allogeneic stem cell transplantation

X. Poiré, 31/01/2018 31

BAD LEUKEMIA

NORMAL STEM CELLS

IMMUNE CELLS

Allogeneic stem cell transplantation

X. Poiré, 31/01/2018 32

Conditionnement Greffe Prévention GvHD

ChimioRadiothérapie

ImmunosuppressionGlobules blancs

Aplasie

Diarrhée

MuciteFièvre

Transfusion

4-6 weeks

Relapse?

50% SURVIVAL

DLI

Immunotherapy – CAR-T cells

X. Poiré, 31/01/2018 33

IMMUNE CELLS

CAR-T cells – does it work?

X. Poiré, 31/01/2018 34

AML and MDS… What are the challenges?

X. Poiré, 31/01/2018 35

NKG2D CAR-T cells

X. Poiré, 31/01/2018 36

NKG2D CAR-T cells – Does it work in AML/MDS?

X. Poiré, 31/01/2018 37

+8/del(7)(q22q36), FLT3/NPM1 wild-type DNMT3A mutation

Normal cytogenetics46,XY,i(7)(p10)[2]/46,XY[18]DNMT3A/IDH2 mutations

46,XY,i(7)(p10)[3]/46,XY[17]

Negative NGS pannel

Advanced ColoRectal Cancer: the path towards

Immunotherapies

Alain HENDLISZ MD, PhD

Head of the Gastro-Enterology Unit, Medical Oncology Clinic

Jules Bordet Institute

+

Alain Hendlisz

Institut Jules Bordet, Université Libre de BruxellesNovembre 2017

Advanced ColoRectal Cancer: the path towards Immunotherapies

Colorectal Cancer: Belgian Overview

4607 men

3597 women

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

Incidence

CRC incidence in men and women

Total: 8204

CRC is 3rd most common cancer in men &

2nd most common cancer in women

* Belgian Cancer Registry, Cancer Incidence in Belgium 2011, available at http://www.kankerregister.org

Belgian Registry 2012

CRC STAGE TREATMENT5-YEAR SURVIVAL

RATE (%)

Stage I • Surgery 74

Stage II• Surgery• Chemotherapy

37-67

Stage III• Surgery• Chemotherapy

28-73

Stage IV• Cryo- or radiofrequency ablation• Chemotherapy• Targeted therapy

6

5%

39%

36%

20%

Localized

Regional

Distant

Unknown

CRC Stage at Diagnosis

Colorectal Cancer: stages & survival

Schmoll Ann Oncol 2012ASCO www.cancer.org 2012

http://www.cancer.org/

+ ESMO Guidelines

Van Cutsem et al. Ann Oncol. 2014

L1

L2

L3

L3

mCRC: Treatments over Time

0 10 20 25

SURVIE GLOBALE (MOIS)

155 30 35 40 45

Saltz1

Goldberg3

Saltz5

Bokemeyer7

Saltz1

Douillard2

Hurwitz4

Falcone6

Douillard2

Douillard9

Van Cutsem8

Passardi10

5-FU/LV bolus 12.6

FOLFOX 19.5

XELOX/FOLFOX + bevacizumab NO16966 21.3

FOLFOX + cetuximab OPUS (KRAS) 22.8

IFL 14.8

5-FU/LV infusion 14.1

IFL + bevacizumab AVF2107g 20.3

FOLFOXIRI Italian GONO Trial 22.6

FOLFIRI 17.4

FOLFOX + panitumumab PRIME (KRAS) 23.9

FOLFIRI + cetuximab CRYSTAL (KRAS) 23.5

FOLFOX or FOLFIRI ITACA 20.6

FOLFOX or FOLFIRI + bevacizumab ITACA 20.6

Stintzing14

Schwartzberg13mFOLFOX6 + bevacizumab PEAK (RAS) 28.9

mFOLFOX6 + panitumumab PEAK (RAS) 41.3

FOLFIRI + bevacizumab FIRE-3 (RAS) 25.0

FOLFIRI + cetuximab FIRE-3 (RAS) 33.1

Lenz15FOLFOX or FOLFIRI + bevacizumab CALGB 80405 (RAS) 31.2

FOLFOX or FOLFIRI + cetuximab CALGB 80405 (RAS) 32.0

Bokemeyer12

Ciardiello11

FOLFOX + cetuximab OPUS (RAS) 19.8

FOLFIRI + cetuximab CRYSTAL (RAS) 28.2

2014

2014

2014

2000

2004

2008

2011

2000

2000

2004

2007

2000

2011

2011

2014

2013

2014

1. Saltz. NEJM 2000. 2. Douillard. Lancet 2000. 3. Goldberg. J Clin Oncol 2004 4. Hurwitz. NEJM 2004 5. Saltz. J Clin Oncol. 2008 6. Falcone J Clin Oncol 2007

7. Bokemeyer. Ann Oncol 2011 8. Van Cutsem. J Clin Oncol 2011. 9. Douillard. J Clin Oncol 2011 10. Passardi. J Clin Oncol 31, 2013 11. Ciardiello. J Clin Oncol 2014 12. Bokemeyer. J Clin Oncol 2014 13. Schwartzberg. J Clin Oncol. 2014 14. Stintzing. Ann Oncol 2014 15. Lenz. Ann Oncol. 2014

Median Survival29,8 months

(95% CI 26·0–34·3)

Median Survival25,8 months(22·5–29·1)

Cremolini et al, Lancet Oncol 2015

Metastatic ColoRectal Cancerdifferent valid strategies

+

Koopman, Lancet 2007

CAIRO 1 trial

Metastatic ColoRectal Cancerdifferent strategies-same results

Median survival17.4 mo

(95% CI15.2–19.2)


(95% CI 14.3–18.1)

HR 0.92 (95% CI 0.79–1.08)

p=0.3281

mCRC

Non Resectable

65%

Resectable

15%

AggressiveTreatment

Response

ConservativeTreatment

Control

Therapeutic Strategies

Maybe Resectable

20%

Palliative Treatment

75 + 20 %5%

Cure

Strategy influences Treatment: ‘Why’ comes before ‘How’

Metastatic ColoRectal Cancer:

Defining Principles of Chemotherapy

Principle nr 1

Principle nr 2 Use all drugs available

Principle nr 3 Efficacy and Toxicity with number of drugs combined

Primum non nocere

+

Koopman, Lancet 2007

CAIRO 1 trial

Metastatic ColoRectal CancerLong-Term Results Disappointing


(95% CI15.2–19.2)


(95% CI 14.3–18.1)

HR 0.92 (95% CI 0.79–1.08)

p=0.3281

Active immunotherapy

Adoptive cell transferimmunotherapy

IL-2IFNIL-15IL-21

Peptide vaccineDC vaccineGenetic vaccine

OX40

CD137

CD40

PD-1

CTLA-4

T cell cloningTCR or CAR

genetic engineering

General Approaches for Cancer Immunotherapy

Pembrozilumab in metastatic CRC

Le DT NEJM 2015

Checkmate 142: Nivolumab & Ipilimumab MSI-H mCRC

Overman et al J Clin Oncol 2018

MSI = 5-10 % of the mCRC patients

140 2 4 6 8 10 12

Weber et al. J Clin Oncol 2012 & 2015

Toxicity Immune Checkpoint Inhibitors

Rash, pruritusLiver toxicityDiarrhea, colitisHypophysitis

Wks

Toxi

city

Gra

de

+ CONCLUSIONS

mCRC remains major Health Issue in Industrialized World

Huge Progresses in Therapeuties allow Treatment Personnalization

Hope in Immunotherapies but currently only for MSI-H patients

Promising new immunotherapies are currently being explored

What is next?

CYAD-01Clinical Development

Frédéric Lehmann, MD, PhDVP of Clinical Development & Medical Affairs

56

CYAD-01 (aka NKR-2 CAR-T)

Multiple cancer indications

Hematological indications Solid cancer indications

CYAD-01: Clinical Development Plan Overview

• r/r AML patient has reached a MLFS with CYAD-01 withoutpre-conditioning lymphodepletion

• Reinforces confidence and the validity of NKG2D ligands as a target

THINK Study Stand alone THINK Study

1st objective clinical responsein the Phase I dose escalation

(1st dose-level)

57



Hematological indications


Solid cancer indicationsOverall Safety Overview


58





THINK Study


• Safety: No DLT at dose-level 1

• 2nd dose-level (1.109/dose) ongoing

Data as of December 31, 2017

• Clinical status

59



Solid cancer indications

THINK Study


• Safety: No DLT at dose-level 1&2

• 3rd dose-level (3.109/dose) activated


• Clinical status

Two out of four metastatic colorectal cancer patients treated at per-protocol dose reported as“stable disease” up to 3-months follow-up*+

* Median progression free survival in these patients under standard of care is between 1.9 and 3.2 months(e.g. regorafinib or trifluridine/tipiracil).

+ Fifth CRC patient treated at a dose lower then per-protocol dose did not show signs of clinical activity

60




THINK Study


THINK Study Stand alone


Protocol Amendment

Increase the durability of the early signs of clinical activity

by increasing the number of CYAD-01 injections (>3)

61




THINK Study


THINK Study Stand alone

AML-SHRINK Study

DEPLETHINK StudySIBLINK Study

SHRINK Study

DEPLETHINK Study

LINK Study

Concurrent with SoC

Preconditioning (CY-Flu)

Loco-regional

2018




AML-SHRINK Study SHRINK StudyConcurrent with SoC

1. Immediate tumor debulking by the standard of care

2. Synergism effect by combination standard treatment and CYAD-01

• Increase the NKG2D ligand expression on tumor tissues

• Better proliferation & expansion of CYAD-01 due to the lymphopenia status

• Better CYAD-01 infiltration into the tumor environment

• Induce an antigen spreading boosting the adaptive memory immune response

Open-label dose escalation Phase I study

Multiple IV administrations of CYAD-01, concurrently with standard therapy for a specific disease

62



DEPLETHINK StudySIBLINK Study

DEPLETHINK StudyPreconditioning (CY-Flu)

1. Evaluate the “standard” lymphodepletion preconditioning (CAR-T paradigm )

2. Increase the CYAD-01 expansion and persistence

3. Improve anti-tumor activity/synergism effect


CYAD-01 + Preconditioning lymphodepletion chemotherapy

Phase I refractory cancer pts

63



LINK StudyLoco-regional


Multiple hepatic transarterial administrations

Unresectable liver metastases from colorectal cancer pts

1. Lower systemic toxicity

2. Higher and persistent concentration of

the CYAD-01 infused cells into the tumor

64


CYAD-01 (aka NKR-2 CAR-T)CYAD-01 (aka NKR-2 CAR-T)

CYAD-01: Integrated Clinical Development with data end 2018

65

What lies ahead

Peggy Sotiropoulou, PhDR&D Manager

02/02/2018 67

1st Challenge: Fratricide in vitro and in vivo

CYAD-01

NKG2D

CYAD-01

NKG2D

NKG2DLNKG2DL

Self-fratricide

(suicide)

Fratricide

(canibalism)

CYAD-01

NKG2D

NKG2DL CYAD-01

NKG2D

NKG2DL

CD314

68

Self-fratricide

(suicide)

Fratricide

(canibalism)

• No in vitro fratricide

• Production of required amount of cells made possible

CYAD-01

NKG2D

NKG2DL

CYAD-02: Elimination of ligands

CYAD-01

NKG2D

NKG2DLs

CYAD-01

NKG2D

Autologous

CAR-T cellproduction

Infusion

2nd Challenge: Time-consuming process in the autologous setting

Allogeneic

CAR-T cellproduction

Off the shelfCAR T CAR TCAR T CAR T CAR T CAR T

02/02/2018 70

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.

CYAD-101: Allogeneic approach of CYAD-01

71

3rd ChallengeTo increase efficacy of CAR T therapy in solid tumors

Hartman et al,

EMBO Mol Med 2017He

ma

top

oie

tic

So

lid

02/02/2018

Homing InfiltrationFace

immunosuppressive microenvironment

Targeting tumour heterogeneity

CYAD-03NKG2D CAR-T cells in solid and recalcitrant tumors

Mig

ratio

n to

ward

s th

e tu

mo

ur

Tumor-

tropic

factors

What is next?Automation,

towards a new paradigm

Valerie Steenwinckel, PhDIndustrialization Director

Intensely Focused on Manufacturing Improvements in Anticipation of Commercial Ready Product

74

• Evolution from drug product manufactured in academic setting (DFCI) towards a commercial-ready process that is reproducible and scalable, with attractive COGs

• Legacy method (LY process) failed to consistently yield drug product with target T cell numbers

• Of 15 patients treated at December 31, 2017, 10 were dosed at per-protocol intended dose and 5 were treated at lower doses

• New manufacturing process is currently being used in the clinic

• mAb manufacturing process inhibits NKG2D expression on the T cell surface during production• Enables significantly higher cell numbers than the legacy process• Validated in both in vivo and ex vivo models• CMC amendments to THINK protocol are in effect with applicable regulators• First patient treated January 2018

• Continued focus on next-generation process improvements, including automated and closed system approach

Celyad would like to develop an automated machine that will allow to bring CAR-T cell therapies to all patients in the most cost effective and efficient manner.

02/02/2018 75

Automation Program Mission

Why it is important to automate?

• Ease of manufacturing

• Increase reproducibility

• Reduce time of manipulation

• Ease of Tech transfer to potential other sites

• Decrease batch failure (human error)

• Cost of good reduction

• Less operator time per batch

• Less environmental needs/control

02/02/2018 76

• Scalability

• Increased capacity of centralized manufacturing approach

• Footprint

• Parallel processing

• Possibility adapt to market demand

• De-centralized model

• Point of Care approach (machine in hospital)

To treat large number of patients Celyad needs to automate and close the production process

02/02/201877

Ideal features of the machine:

• Automated with closed system from start to end

• Minimal Operator interactions

• Ultra Low batch failure

• Parallel batch production

• Ultra-low cost of Goods of disposable

• Able to evolve towards point of care when market will growth

...Like GMP in a box

Celyad has already evaluated the close system manufacturing options

• Evaluated and selected the core technologies that could be used to automate our CAR-T process (ex: washing, concentration,…)

• Tested the complete concept with a prototype (in house)

• Mature the concept to be compatible with PoC: cartridge based approach with parallel processing

02/02/2018 78

Example of cartridge and machine

Conclusion

Christian Homsy, MD, MBA

CEO

79

Conclusion: Towards CAR-T leadership

80

NKG2D platform;Leveraging Stress Ligands

based CAR-T

Autologous Cell ManufacturingParadigm shift

Allogeneic CAR T Cell Therapy

Building on early signals

Improving outcomes

Process Development

Improved yields and CoGs

Strong IP position

Patents concerning TCR knockdown in CAR T cell therapy providing broad

coverage in the field

Initial focus on AML and CRC

Execution

Continuing Development Plan

Broaden indications beyond AML and CRC

Automation

Making Autologous Cell Therapies feasible and cost effective Allogeneic NKG2D Platform

Development of TIM8-CYAD 01 (CYAD-101)

Towards Point of Care Processing

Enabling large indicationsAllogeneic TIM Platform

Developing broad based Allogeneic CAR –T products

Willy Borsus

Minister-President of Wallonia

81

Closing

Christian Homsy, MD, MBA

CEO

82

Q&A

83

Merci!Dank u!

Thank you!

84

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