Cancer and Autoimmune Diseases - We are armed to fight! October 2018 - OSE Immunotherapeutics
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Cancer and Autoimmune Diseases
We are armed to fight!
October 2018 1
Forward Looking Statement
This presentation contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics.
They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE
Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other
factors they believe to be appropriate.
These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their
declensions and conjugations and words of similar import.
Although the OSE Immunotherapeutics’ management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and
other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally
beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the
forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are
not guarantees of future performance.
This presentation includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 28 April 2017 under the number
R.17-038 including the 2016 Financial results, all available on the OSE Immunotherapeutics’ website.
Other than as required by applicable law, OSE Immunotherapeutics issues this presentation at the date hereof and does not undertake any obligation to update or revise the forward-
looking information or statements.
This presentation does not constitute an offer to sell the shares or soliciting an offer to purchase any of the Shares to any person in any jurisdiction where such an offer or solicitation is
not permitted. The Shares may not be offered or sold, directly or indirectly, may be distributed or sent to any person or into any jurisdiction, except in circumstances that will result in the
compliance with all applicable laws and regulations. Persons into whose possession this presentation may come are required to inform themselves about, and to observe all, such
restrictions. The Company accept no responsibility for any violation by any person, whether or not it is a prospective purchaser of Shares, of any such restriction.
The information contained in this presentation has not been independently verified and no commitment, representation or warranty, express or implied, is given by the Company or
anyone of its directors, officers or respective affiliates or any other person and may not serve as the basis for the veracity, completeness, accuracy or completeness of the information
contained in this document (or for any omission of any information in this presentation) or any other information relating to the Company or its affiliates. The information contained in this
document is provided only as of the date of this document and may be subject to update, supplement, revision, verification and modification. They can be modified significantly. The
Company is not subject to an obligation to update the information contained in this document and any opinion expressed in this document is subject to change without notice. The
Company, its advisers, its representatives cannot be held responsible in any manner whatsoever for any loss of any nature whatsoever resulting from the use of this document or its
contents or otherwise related in any way to this document.
This document contains information relating to the Company's markets and the positioning of the Company in these markets. This information is derived from various sources and
estimates of the Company. Investors cannot rely on this information to make their investment decision.
2
OSE Immunotherapeutics
Company Overview
OSE’s Technological Platform: From Target
Identification to Product Validation and Beyond
An integrated operational immunology research platform
Intertwined with academic research Common locations,
Founded in 2012 01 mixed team
IPO in 2015 (€ 21.1 M)
Listed on EuroNext Paris, EPA ticker OSE 02 Fully translational Constant collaboration with clinicians,
pre-clinical humanized models
As of June 30, 2018
Turn over € 20.6 M - Net profit € 8.9 M 03 Leveraging a unique experience of 25 years of clinical
immunology in transplant
Current Cash balance € 18.6 M
Financial visibility until 2H of 2019
04 Connected internationally with top academic centers
Potential additional cash influx of € 27 M could be
generated by milestone payments related to partnerships
3
OSE Immunotherapeutics
Investor Highlights
Ongoing Phase 3 program with first results 4 programs expected to enter the clinic
expected end of 2019 before the end of 2018
A potential of €1.5 B milestone payments Additional first-in-class products in
in auto-immune diseases and in immuno-oncology discovery/early clinical covering immuno-oncology
through partnerships with top pharmaceuticals. (myeloid checkpoints) and autoimmune indications.
4
Our Strategy
Rooted in Immunology, Delivering First-in-Class Products
DEVELOP PARTNER
To leverage world-class clinical immunology expertise and a validated
R&D platform to deliver first-in-class targets addressing unmet needs
in:
Our developmental pipeline has
Immuno-oncology repeatedly been validated through
• T-cell activation through neoepitopes premier international, academic and
industrial partnerships that cover R&D
• Transforming tumor micro-environment suppressive cells into
effector cells and increase shareholder value
Auto-immune diseases
• Down-regulating T effector cells to decrease immunological reactivity
• Up-regulating regulatory T-cells to develop immune tolerance
5
First-in-Class Portfolio
Immuno-Oncology and Auto-Immune Diseases
Humanized Pre-Clinical
PROGRAM Indication Phase 1 Phase 2 Phase 3 Partners
lead POC
IMMUNO-ONCOLOGY
Tedopi® NSCLC EU-US-Isr
Advanced 2018
Tedopi®
pancreatic Combo with PD1
OSE-172
Various cancers 2018
SIRP⍺
OSE-703
Various cancers 2019
IL-7R
AUTO-IMMUNE DISEASES
FR104 Rheumatoid
2018
CD-28 arthritis
OSE-127 Ulcerative Colitis
2018
IL-7 R Sjögren syndrome
First-in-class product
6
First-in-Class Portfolio
Immuno-Oncology and Auto-Immune Diseases
Humanized Pre-Clinical
PROGRAM Indication Phase 1 Phase 2 Phase 3 Partners
lead POC
IMMUNO-ONCOLOGY
Tedopi® NSCLC EU-US-Isr
Advanced 2018
Tedopi®
pancreatic Combo with PD1
Our lead product: Tedopi®
• A proprietary combination of neoepitopes aimed at stimulating T-lymphocytes
• Currently in Phase 3 clinical trial in advanced NSCLC post checkpoint inhibitor (CKI) failure
• Planned Phase 2 with CKI in aggressive pancreatic cancer
First-in-class products
7
Tedopi®
An Alternative Approach to Cytotoxic T-Cell Activation
NEOEPITOPES / HLA / TCR binding:
Mandatory to activate cytotoxic T-cell response
Neoepitopes: Small peptides deriving from tumor
specific antigens expressed in various cancers,
1st T-lymphocyte activation signal
Tedopi®
• A proprietary combination of 9 optimized « neoepitopes »
+ 1 epitope giving universal T helper response
• Restores the immuno-surveillance of cancer cells in HLA-A2 positive responder patients
• Induces early T-cell memory responses
• Strong patent family plus orphan status in the US
8
Tedopi®
For Non-Small Cell Lung Cancer (NSCLC) after checkpoint inhibitor failure
LUNG CANCER:
2ND MOST COMMON CANCER
234,030 154,050
In the United States1
NEW CASES IN 2018 DEATHS IN 2018
NSCLC = 80-85% of all lung cancers
2014 2024
• Checkpoint inhibitors are rapidly becoming the first line
standard of care for NSCLC and are expected to command
a significant portion of the market by 2024
• Tedopi® is being explored as a second-line therapy in
NSCLC patients following CKI failure and has the chance to
capture a share of this market
2014–2024 NSCLC market size2
1 American Cancer Society. Facts & Figures 2018. American Cancer Society. Atlanta, Ga. 2018. 9
2 K Nawaz & RM Webster. The non-small-cell lung cancer drug market. Nature Reviews Drug Discovery v15, pages 229–230 (2016) DOI: 10.1038/nrd.2016.42
10
Tedopi® in NSCLC:
A Potential Breakthrough post Check-Point failure patients
• Despite tremendous progress, failure is still the norm for advanced patients in
NSCLC
• Neoepitopes burden is a key marker for CKI efficacy
• Tedopi® MOA and Phase 2 results: rationale for combination
• Market potential post-CKI failure
1011
NSCLC 2018: Despite Progress, Treatment Failure is Still the Norm
Strong Medical Need: Treatment Option Post-CKI Failure
2015
NEJM, 2015, DOI: 10.1056/NEJMoa1504627
2018
NEJM, 2018, DOI: 10.1056/NEJMoa1801005 NEJM, 2018, DOI: 10.1056/NEJMoa1801946 1112
Resistance to PD-1/PD-L1 Checkpoint Inhibitors: Suspected Mechanisms
HLA downregulation as one of the main reason
Tedopi®
12Tedopi® Phase 2 results
Increased survival in Poor Prognosis Patients
Correlation between immune responses and survival
CORRELATION BETWEEN EPITOPE
TEDOPI®
RESPONSES AND SURVIVAL (pTedopi® Phase 2 results in advanced NSCLC (stage IIIb & IV)
after at least first line failure: long term survival in 64 ITT patients
Surviving Patients Following 2 Year Treatment With Tedopi®
67% of the patients enrolled in the
Phase 2 study were metastatic
MEDIAN OVERALL SURVIVAL: 17 MONTHS
65.5% received more than 2
previous lines of treatment
9% of Brain Metastasis patients**
25%
Promising clinical results in this
difficult patient population.
Strong improvement in the long
term survival rate in patients with
# of Days
poor prognosis factor*
Survival in the literature is at 1% for stage IV NSCLC 14
**J. Nemunaitis, abstr 1202 brain metastasis WORLD CONFERENCE ON LUNG CANCER 2015Tedopi® Phase 3 Clinical Trial in Advanced NSCLC Patients
After Immune Checkpoint Inhibitor Escape
Potential benefit in patients who have
previously failed CKI treatment
Enrolment of approximately 100 patients to be
expanded to a total of 325 patients depending
Invasive or metastatic on survival data
Amended protocol Stage Second or third
accepted by Authorities line treatment Primary Endpoint:
and IRB to restart After CKI failure Overall Survival (OS)
ATALANTE 1 recruitment
Secondary Endpoints:
2 step-study Step 1: 100 NSCLC patients Progression-free survival, Quality of Life,
Overall response rate, Tolerance
Potential breakthrough therapy following
PD-1 or PD-L1 tumour progression
https://www.clinicaltrials.gov/ct2/show/NCT02654587
15Tedopi®: For Pancreatic Cancer
3rd MOST DEADLY CANCER 44,330
55,440
In the United States1
NEW CASES IN 2018 DEATHS IN 2018
leading to 44,330 deaths per year
• Worldwide Incidence: 337,000 Cases = 330,000 Projected Number of Pancreatic Cancer Patients
Cases With Mortality2 Eligible for Treatment in 2018
Diagnosed in 2018: 55,440
• The Five Year Survival With Pancreatic Cancer
Rate Is 9% Patients Treated: 34,373
• There Is A Lack Of Effective Therapies With Receiving 1L Treatment: 27,498
Minimal Side Effects Receiving 2L Treatment: 10,999-13,749
1 American Cancer Society. Facts & Figures 2018. American Cancer Society. Atlanta, Ga. 2018. 16
2 Globocan 2012 (World Health Organization)Tedopi®: Phase 2 Study in Pancreatic Cancer
The Potential to Address High Therapeutic Needs Combining Tedopi® with PD-1 Checkpoint Inhibitor
Phase 2 Study
To evaluate Tedopi® as a maintenance
therapy, alone or in combination with CKI
and evaluated versus Folfiri (current second-
line SoC)
Sponsored by GERCOR: HLA-A2 positive patients
a cooperative group of with stable disease
digestive oncology experts, who received 4 months
international recognition of Folforinox Control
(the current SoC) TEDOPI® Group
TEDOPI® + Folfiri alone
CKI (standard
protocol)
1 American Cancer Society. Facts & Figures 2018. American Cancer Society. Atlanta, Ga. 2018. 17
2 Globocan 2012 (World Health Organization)First-in-Class Portfolio
Immuno-Oncology and Auto-Immune Diseases
Humanized Pre-Clinical
PROGRAM Indication Phase 1 Phase 2 Phase 3 Partners
lead POC
IMMUNO-ONCOLOGY
OSE-172
Various cancers 2018
SIRP⍺
OSE-172 (antagonist of SIRP⍺)
• First-in-class myeloid checkpoint transforming suppressive cells into effector cells within tumor micro-
environment
• Planned Phase 1 end of 2018
• License and collaboration agreement with Boehringer Ingelheim (April 2018) to develop OSE-172 in
multiple cancer indications
First-in-class product
18A Strategic Partner of Choice
for OSE-172
Sales > 16B€ R&D > 3B€
“The objective for the next wave of cancer immunology therapeutics is to alert the immune system (…)”
Jonathon Sedgwick, VP & Global Head, Cancer Immunology Boehringer Ingelheim
COMBINATION POTENTIAL GLOBAL EXECUTION CAPABILITIES
INTERNAL PARTNERSHIPS GLOBAL FOOTPRINT COLLABORATION
Anti-PD1 Vira Therapeutics
Anti LAG 3 (oncolytic viruses) Europe Sarah Cannon RI
SMAC mimetics CureVac Americas (57 sites in the US)
IL23-i (mRNA vaccines) Asia
“We are excited to partner with OSE Immunotherapeutics to develop this promising, novel cancer immunotherapy (…)”
Jonathon Sedgwick, VP & Global Head, Cancer Immunology Boehringer Ingelheim
19OSE-172
Joint Development Agreement
Global Immuno-oncology Partnership to develop
OSE-172
€15 M upfront
Upfront payment
April 2018
Up to €15 M
Short term payments
Initiation of Phase 1
Up to €1.1 B
Milestone payments
+ Royalties on sales
Boehringer Ingelheim has acquired the rights to develop, register and commercialize OSE-172
and will bear all costs for this product development
20OSE-172: Tackles Myeloid Suppressive Cells (MDSC, TAM)
Activates Anti-Tumor Macrophages and Dendritic Cells Function
OSE-172
First-In-Class
OSE IMMUNOTHERAPEUTICS DISCOVERY: SIRPα IS EXPRESSED BY MDSCS AND TAMS AND CONTROLS THEIR DIFFERENTIATION
STRONG PATENT POSITION 2014-2015-2016-2017
OSE-172 inhibits MDSC and macrophages M2 pro-tumorigenic cells and increases M1 anti-tumorigenic cells. In addition,
OSE-172 is not binding human T-cells, allowing strong T-cell proliferation.
24th Molecular Medicine TRI-CONFERENCE, Feb 2017
21OSE-172: Inhibits Cancer Growth
Breast Triple Negative Model – MDSC/TAM Involvement in Breast Cancer*
OSE-172 has demonstrated its impact on the Tumor Micro-Environment by switching M2 pro-tumorigenic
macrophages into M1 anti-tumorigenic macrophages whilst increasing effector memory CD8 T-cells
Orthotopic 4T1 mouse breast cancer model**
1500
C T R L A b (n = 2 3 )
a S IR P a (n = 2 0 )
)
1250
3
T u m o r v o lu m e (m m
1000
750
500
250
0
0 5 10 15 20 25 30 35
D ays
*Tumor-associated macrophages: unwitting accomplices in breast cancer malignancy Carly Bess Williams et al.; npj Breast Cancer (2016) 22
**AACR 2018 Poster Durand J, Gauttier V et al.OSE-172
An Original Approach to CD47 Blockade in Humans
23First-in-Class Portfolio
Immuno-Oncology and Auto-Immune Diseases
Humanized Pre-Clinical
PROGRAM Indication Phase 1 Phase 2 Phase 3 Partners
lead POC
IMMUNO-ONCOLOGY
OSE-703 Various cancers 2019
OSE-703: Cytotoxic targeted mAb IL-7 R, in collaboration with MSKCC
First-in-class product
24OSE-703: Targeting the Interleukin-7 Receptor
Research Collaboration with MSKCC, NY
OSE-703 : cytotoxic monoclonal antibody against the alpha chain of Interleukin-7 Receptor (IL-7R)
• IL-7R is aberrantly expressed on tumor cells
• OSE-703 has an engineered IgG1 Fc-tail that helps to improve binding to FcgR (e.g. CD16) and thus
increases three types of antibody mediated cytotoxicity:
• Antibody Dependent Cell-mediated Cytotoxicity (ADCC)
• Antibody-dependent cellular phagocytosis (ADCP)
• Complement-dependent cytotoxicity (CDC)
The antibody induced dose-dependent killing of tumor cells according to IL7Ra expression level, for example
on acute T-cell leukemia or mesothelioma cells.
First-in-class products
*Kei Suzuki et al.; J Clin Oncol 31:490-498. ©, 2012 25
*Tumoral IL-7 Receptor is a Potential Target for Lung Adenocarcinoma Immunotherapy
Ming-Ching Lee et al. ; WORLD CONFERENCE ON LUNG CANCER 2017OSE-703
Research Collaboration with MSKCC
Strategic research collaboration: Memorial Sloan
Objectives
Kettering Cancer Center, New York
1. Investigate OSE-703 for solid tumors
2. Identify product’s efficacy profile and
Prasad S. Adusumilli, M.D., FACS
development approach
• Thoracic surgeon
• Expertise in tumor immunology and CAR-T-cell NSCLC: poor prognosis demonstrated in large series of
immunotherapy patients with IL-7R expressed on tumor cells*
Determine OSE-703’s potential in other solid tumors
Leveraging MSKCC and Dr. Asudumilli’s expertise in
immuno-oncology and CAR T-cell immunotherapy
*Kei Suzuki et al.; J Clin Oncol 31:490-498. ©, 2012 26
*Tumoral IL-7 Receptor is a Potential Target for Lung Adenocarcinoma Immunotherapy
Ming-Ching Lee et al. ; WORLD CONFERENCE ON LUNG CANCER 2017First-in-Class Portfolio
Immuno-Oncology and Auto-Immune Diseases
Humanized Pre-Clinical
PROGRAM Indication Phase 1 Phase 2 Phase 3 Partners
lead POC
AUTO-IMMUNE DISEASES
FR104 Rheumatoid
2018
CD-28 arthritis
OSE-127 Ulcerative Colitis
2018
IL-7 R Sjögren syndrome
First-in-class product
27FR104
CD28-Antagonist- Immunotherapy Licensed to Janssen Biotech
• CD28-antagonist a key receptor
on effector T lymphocytes
FR-104
• Positive Phase 1 completed,
Phase 2 planned for 2018
• Targeted indication: rheumatoid
arthritis, partnership with
Janssen Biotech
€10 M upfront Up to €145 M
Option exercise fee Royalties on sales
Milestone payments
July 2016
28OSE-127
IL-7 Receptor Antagonist - License Option to Servier
• OSE-127: Antagonist of the
Interleukin-7 α-receptor or CD127,
control of pathogenic T-cells
• Targeted pathologies: Ulcerative
Colitis and other auto-immune
diseases (Sjögren syndrome)
• License option agreement with
Servier in Dec. 2016: Phase 1
OSE-127 planned in 2018
€10.25 M upfront €30 M Total potential €272 M
Two-step option fee Milestone payments and
December 2016
Phase 2 completion UC & Sjögren royalties on sales
29Current Industrial Partnerships
Up to €1.5 B in Potential Milestones + Royalties
FR104 OSE-127 OSE-172
€10 M upfront €10.25 M upfront €15 M upfront
Option exercise fee Upfront payment
August 2016 December 2016 April 2018
€30 M Up to €15 M
Up to €145 M
2 step option fee Short term payments
Milestone payments
Phase 2 completion UC & Sjögren Initiation of Phase 1
Up to €272 M Up to €1.1 B
+ Royalties on sales Milestone payments Milestone payments
+ Royalties on sales + Royalties on sales
Up to €1.5 B
Milestone payments
+ Royalties on sales
30Current Academic & Public Partnerships
Financing and Innovation
OSE-127 OSE-172
TEDOPI® OSE-703
EFFIMab EFFI-Clin
Objective: Objective: Objective: Objective:
Clinical development Clinical development Phase 2 in pancreatic cancer Product efficacy profile and
until phase 2 until phase 2 in combination with PD1-I development strategy
Partners: Partners: Partner: Partner:
Next step: Next step: Next step: Next step:
Phase 1 initiation in Phase 1 initiation in Phase 2 initiation in Development strategy in
solid tumors
2018 2018 2018 Potential CAR-T
31Experienced Management Team
From Discovery to Market
Dominique Costantini, M.D., Maryvonne Hiance, Vice Chairman
Immunology, Chairman, & Director of Strategy
• Director of Early Development, Roussel- • SangStat Atlantic, DrugAbuse Sciences
HMR-Sanofi • Founder & CEO Effimune
• Founder & CEO BioAlliance Ph. (Onxeo) • Chairman of France Biotech
• Founder & CEO OSE Pharma Association
Bernard Vanhove, COO
Alexis Peyroles, CEO R&D, Int’l Scientific Collaborations
• MBA London Imperial College, EDHEC • Head of Research CNRS
• Sanofi Japan/Eastern countries • INSERM and ITUN (transplantation)
• Guerbet/G. M. Latin America (Brazil) • Co-founder and COO Effimune
Anne-Laure Autret-Cornet,
Chief Financial Officer
• Auditor, Deloitte
• Finance & Administration, Effimune
3233
Experienced Management Team
From Discovery to Market
Bérangère Vasseur, M.D., CMO IO Frédérique Corallo, M.D., CMO AIDs
• Broad experience in oncology • Specializing in immunology
development • Janssen Cilag, Roussel-HMR-Sanofi
• At Roche and • Biogen, Medical Director
at several biotechnology
companies
Nicolas Poirier, CSO Emilienne Soma, PharmD, Ph.D.,
• Ph.D. Immunology Director of Pharma Program
• CRTI - Center for Research in Development
Transplantation • Experience in R&D management
and Immunology , Nantes
• And in alliances in
several biotechnology companies
Jean-Pascal Conduzorgues, PharmD,
Qualified Person (QP)
• Expertise in pharmaceutical development and drug
management for clinical trials
• Experience in pharmaceutical strategy and 33
implementation in biotechnology companiesOur International Network
Scientific Advisors and Collaborators
Leslie Kean Giuseppe Giaccone Prasad Adusumilli Tom Mc Donald Katryn Wood Bert ‘t Hart Masayuki Miyasaka
C.H. - Seattle NIH - Washington MSKCC – New York Queen Mary – London NDS – Oxford BPRC – Rijswijk Suita – Osaka
Luis Rizzo Richard Pierson Régis Josien Gilles Blancho – Benjamin Besse Christophe Louvet
A. Einstein - Sao Paulo SOM - Baltimore INSERM – Nantes Nantes IGR – Paris IMM/GERCOR – Paris
34OSE Immunotherapeutics – a High Potential Clinical-stage Biotech
Key Takeaways
Major immuno-oncology programs
addressing unmet needs:
Tedopi®: In Phase 3 (NSCLC)
Entering Phase 2 (pancreatic cancer) A potential of €1.5 B milestone payments in
auto-immune diseases and in immuno-oncology
OSE-172: Entering Phase 1 through partnerships with top pharmaceuticals
OSE-703: Pre-clinical in solid tumor / NSCLC
Projected catalysts that drive near term value:
Q4 2018:
Tedopi® pancreatic cancer entry into Phase 2
Additional first-in-class products in discovery/early
OSE-172: entry into clinical Phase 1-2
clinical covering immuno-oncology (myeloid checkpoints) OSE-127: entry into clinical Phase 1
and auto-immune indications FR104: entry into clinical Phase 2
Progress of the portfolio
OSE-703 – MSKCC collaboration
R&D new targets
35Contacts: A Significant Player
Dominique Costantini, Chairman, Director of Early Development
dominique.costantini@ose-immuno.com Head Office
+33 6 13 20 77 49 22, boulevard Bénoni Goullin
44200 Nantes, France
Alexis Peyroles, CEO
alexis.peyroles@ose-immuno.com Paris Office
+33 6 11 51 19 77 Pépinière Paris Santé Cochin
29, rue du Faubourg St-Jacques
75014 Paris, France
Company information: http://ose-immuno.com/en/
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