EARLY DRUG DEVELOPMENT GROUP Paris, France www.e2dg.com - - PowerPoint PPT Presentation
EARLY DRUG DEVELOPMENT GROUP Paris, France www.e2dg.com @E2DGr1 Moving drugs beyond the Valley of Death Development Cost Number of ($M) Compounds 300 1000 30 100 3 10 0.3 1 6 2 4 8 10 12 Years Our Expert rtise Sources:
Paris, France
@E2DGr1 www.e2dg.com
1 10 100 1000 0.3 3 30 300
2 4 6 8 10 12
Years
Sources: Tufts Center for the Study of Drug Development Impact Report. 2015.
Development Cost ($M) Number of Compounds
Our Expert rtise
SUPPORT ACCELERATE TRANSLATE
PROMOTE 3
Drugs developed in
First-in- class drugs
In Phase I
Sold to a BigPharma
for the non-clinical and early clinical development
Instead of 8 years
Total Cost
GMP Manufacturing IND-enabling documentation and submission Phase I Clinical Studies Target validation and Lead optimization In vivo efficacy and safety* PK*/ADME and biomarkers evaluation GLP Toxicology
(*) E2DG pharmacological team is compliant with FDA/EMA GLP standards.
Ramiro PhD – Preclinical Manager Keyvan PhD – PK Expert Eugenia PhD - CSO Francois PhD - COO Christophe MBA - CEO Mohamed MD - CMO
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GIVE ASSISTANCE
regulatory strategies and Phase I clinical trials MANAGE your R&D program CONDUCT your preclinical, PK and Radiopharma studies in our
✓ Unblock and speed up your R&D program ✓ New Positioning of molecules to improve the drug’s life cycle GIVE ADVICE AND RISK ASSESSMENT
preclinical and clinical data ✓ Open up the potential of your lead ✓ Scientific support for your fundraising campaign
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OUR EXPERIENCE - TUMOR TYPES
Solid tumors
Bladder, breast, cholangiocarcinoma, colorectal, glioblastoma, head & neck, liver, lung, melanoma,
renal, sarcomas, stomach, thyroid, and rare tumor types: BRD-NUT
Hematologic malignancies
ALL, AML, NHL, MM, MPD
OUR EXPERIENCE - TUMOR MODELS
Hematologic malignancies
ALL, AML, NHL, MM, MPD
Solid tumors
SCLC, NSCLC, TNBC, ER+ Breast, cholangiocarcinoma, colorectal, mesothelioma glioblastoma, head & neck, liver, melanoma, ovary, pancreatic, prostate, renal, Ewing sarcoma
Pediatric tumors
Medulloblastoma, neuroblastoma
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Phase II/III
FDA Review/Approval
Vindesine 2 Bleomycin 2 Trabectidin 2 Amifostine 2 Vinorelbine 2 Cisplatin2 Oxaliplatin 2 Irinotecan 2 Docetaxel 2 Lapatinib3 Irinofulven 3 Ibrutinib 3 Masitinib 3 Onapristone 3 Palbociclib 3 Vemurafenib 3
(1) between 2011-2018 (2) between 1996-2015 (3) between 2000-2015
PK/PD Development Phase I Preclinical
BET inh (OTX015)* Galectin inh (OTX008)*
PI3K inh1 CXCR4 inh1 LDHA inh1 STAT3 inh1 Cathepsin S_MoAb1 LSD1 inh1 FLT3 inh1
EGFR ligands_MoAb1 Novel cytotoxic drugs 1
IL-2 system release1 IL-1 receptor inh1
Others undisclosed targets1
Presentations at Scientific meetings
Peer-reviewed full papers
Patents Application
The e drug was was lice cense sed by our clien ient fro rom MTP TPC
2014 2013 2012 2011 2015
Proof of concept in cancer
IND-Enabling studies 3 Phase I a/b (+ 200 patients) Sold to Merck 11
Initial Contact NDA Execution
With milestones and priorities
Contract
Delivery of the Final Report
TeamBuilding
Our scientific and medical team will discuss about your vision for the project and how we can support this
➢Fees-for-services ➢Special fees + Performance compensation
➢ A dedicated PM for your study ➢Follow-up meetings ➢Milestone Reporting
➢ Review of the scientific data ➢ Internal evaluation with technical experts ➢ Search for outsourcing solutions
2 weeks up to 2 months
Drug development Program / Quotation Delivery Implementation
clinical program
Project Management
1 2 3 4 5 6
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Contact information:
CHRISTOPHE MAZARS, CEO christophe.mazars@e2dg.com +33 1 83 75 86 32. Boulogne Billancourt, France
@E2DGr1 www.e2dg.com
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