26th-28th

March 2018

McSAF SAS GLOBAL OVERVIEW

Labs : UFR Sciences Pharmaceutiques François Rabelais University, Tours, FR

HeadQuarters : 1 rue Claude Thion, 37000 Tours, FR

Location and partners

PROPRIETARY TECHNOLOGY

• Antibody-Drug Conjugates • Linker technologies • Site-specific & DAR control

R&D DIVERSIFICATION

• Bioconjugates

• Next Generation ADCs

• New Applications

CONTRACT RESEARCH ORGANIZATION Bio-Organic & Bioconjugate Chemistry

Spin-Off from “Molecular & Therapeutic Innovation” Team in France (Univ. F Rabelais, Tours)

Founded in Dec 2015

ONE EXPERTISE “Chemical Tools for Bioconjugation & Biodrugs”

A DEDICATED TEAM Highly qualified & wide range of expertise (biochemists and chemists with high level background in heterocyclic chemistry, medicinal chemistry, bioconjugate chemistry)

A NETWORK Experts, KOLs & strategic partners aiming to support your development & needs

A SPECIFIC & GLOBAL APPROACH Answer specific needs by providing customized solutions with high quality standards.

SERVICES

• Custom Synthesis & Process Optimization

• Chemical Modification of Biomolecules

• Tools, Intermediates & Reference Molecules

mAbs Bispecifics Fragments

Proteins Peptides

Etc … BIO

CO

NJU

GAT

ES

IND

ICAT

ION

S ★ Oncology ★ Immunology Others E.g. Fertility A

PP

LIC

ATIO

NS ★ Therapeutic

★ Diagnostic Others E.g. Green Chemistry

09-12 2015 Preliminary study/market

08 2016 Exclusive license agreement, WW

07 2014 ADC Patent filing

12 2015 McSAF SAS

Q1 2016 Recruitments Dir R&D, Dir Op

06-07 2016 Nomination iLAB

www.McSAF.fr

10 2016 JEI status

Q2 2017 BPI Financial support

Q4 2017 Recruitments R&D + BD

Scientific committee

06 2015 Winner of BPI

Emergence competition

Q1 2017 R&D team

reinforcement

Q3 2017 ANR + R&D EXT Prog agreement Région CVdL

Overview

0 7

71

22

4 11

16 22

17 14 9 6

1 0

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100

0 1 2 3 4 5 6 7 8

%

DAR McSAF ADC-HEAD 01 T-DM1

3 0 1

11

72

13 4

11 16

22 17 14

9 6 1

0

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%

DAR McSAF ADC-HEAD 02 T-DM1

PROPRIETARY TECHNOLOGY New Linker Technologies for ADCs

PATENT WO2015004400A1 New antibody-drug conjugates & uses in therapy.

Joubert N. ; Viaud-Massuard MC. ; Respaud R.

Filed on 07.2014 WW exclusive license from UFRT

(08.2016)

Reduction Rebridging

MAIN ADVANTAGES Site-Specific & DAR Control Technologies

leading to more homogeneous ADC species

No prior re-engineering of the mAb &

retention of native structure & functionalities

Great stability of the coupling, minimizing

undesired release of payload in plasma

Head 02

DAR Control

TECHNOLOGY • Head 01 : Next Generation Maleimide

Technology • Head 02 & 03 : New heterocyclic Technology

Head 01

Our proprietary technology

Our proprietary technology

STABILITY ADC-Head 1:

T=0 T=57

Conditions: T=0 to T=57 days in PBS pH 7,4 / 4°C / no formulation Very good stability even without formulation

Steric exclusion chromatography (SEC)

In vitro potency of ADC-Head 1:

T=0 Aggregates Oligomers Monomer

% 5 6 89

T=57 Aggregates Oligomers Monomer

% 5 8 86

Concentration (nM)

0

25

50

75

100

125

150

0,001 0,1 10 1000

T226

0,001 0,1 10 1000

MCF-7

0,001 0,1 10 1000

BT-474

Viab

ility (%)

Cell lines: MCF-7 (HER2-) / BT-474 and T226 (HER2+) Similar activity to T-DM1

Study carried out by Xentech, on T226 HER2+ cell line developed by Xentech.

ACRONYM MabCHEM

TITLE Impact of BioDrug modifications on in vitro & in vivo effects

FUNDING Centre - Loire Valley Region (ARD2020 Fund on BioTherapies)

PROGRAM

DURATION 3 years, 2017 - 2020

SCIENTIFIC

PROJECT

Taking a global overview exploring new concepts for both mAb and ADC optimization, this program aims to: - develop specific knowledge and technologies for mAb stability

enhancement toward enzymatic cleavage - develop new generations of ADCs with an original controlled release of the

drug.

ACRONYM ADC-AgroMed

TITLE Conjugation between an allosteric modulator and an anti-RFSH nanobody for

medical and veterinary applications

FUNDING Centre - Loire Valley Region

PROGRAM

DURATION 2 years, 2016-2019

SCIENTIFIC

PROJECT

Today, in order to stimulate follicular growth, recombinant or extractive

hormone agonists of the FSH receptor are intensively used. The side effects

and unsatisfactory outcomes resulting from these treatments give us the

opportunity to find an alternative. This project aims to build a nanobody, a

small antibody fragment against the FSH receptor, which will be covalently

linked to a drug able to stimulate the reproduction mechanism for veterinary

and medical use.

VHH

Recombinant Protein

Active Molecule

Linker

Fertility

Impact of biodrug

modifications

GLOBAL COLLABORATIVE R&D PIPELINE

ACRONYM ADC NEW PAYLOADS

TITLE New Immunoconjugates for HER2 breast cancers

FUNDING Centre - Loire Valley Region (APR IR 2017)

PROGRAM

DURATION 3 years, 2018 - 2021

SCIENTIFIC

PROJECT

The project aims to design and evaluate new ADCs made by the

combination of an anti-HER2 antibody (specifically targeting the tumour),

and a new generation of payloads, distinct from the usual cytotoxic drugs

commonly developed in the field of ADCs.

GLOBAL COLLABORATIVE R&D PIPELINE

ACRONYM DBABTol

TITLE Design and development of new bispecific antibody conjugates with immunosuppressive drugs for inducing & regulating immune tolerance

FUNDING ANR (French National Research Agency)

PROGRAM

DURATION 3 years, 2017 - 2020

SCIENTIFIC

PROJECT

The limitations of cell therapy using dendritic cells, key cells in the immune response, have been clearly demonstrated by the number of clinical trails showing no patient benefit. Our ambition is to develop in-situ DC subset targeting entities, using a bispecific antibody linked to immunosuppressive drugs to induce a tolerant status in humans.

IS drug bsAb

… to be continued…

Cardiovascular disease Other Cancers

Imagery Diagnostic

Immune tolerance

Breast cancer

Spin-off from the “Molecular & Therapeutic Innovation” Team in France (GICC, University of

Tours), McSAF is a young innovative company, founded in December 2015. McSAF is specialised in

bio-organic and bioconjugates chemistry, with a specific focus on developing and providing Best-

In-Class Technologies and R&D services to BIO Industries, with the aim of supporting their current

developments in biomolecules of interest.

Our core expertise covers therapeutic peptides, proteins and antibodies, but also drug conjugates,

especially antibody-drug conjugates (ADCs), for which we have acquired a worldwide exclusive

licence from UFRT, and developed a specific know-how regarding new linker technologies.

Our team, led by our two co-founders, the CEO and the scientific director, is composed of a

scientific department with 3 researchers and a Ph.D. student, managed by an R&D and studies

director, and is completed by one person in charge of the business development.

We are engaged in 3 main activities:

• Technology Provider: new linker technologies specific to ADC development, which aim to

answer actual needs in terms of site-specific & DAR control technologies

• Service Provider: from custom synthesis to biomolecule modification & optimization

• Innovation: we are engaged in several internal and external R&D programs relating to both

bioconjugates in general, and next generation ADCs for novel applications.

www.mcsaf.fr

Contact:

AUDREY DESGRANGES, Business Development,

contact@mcsaf.fr - +33(0) 247 250 154