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
10
20
30
40
50
60
70
80
90
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
10
20
30
40
50
60
70
80
90
100
0 1 2 3 4 5 6 7 8
%
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,
[email protected] - +33(0) 247 250 154