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: Tufts Center for the Study of Drug Development Impact Report. 2015.
YOUR NEEDS R&D Program Business SUPPORT PROMOTE ACCELERATE TRANSLATE 3
OUR EXPERTISE 1 5 2 Drugs 18 First-in- Sold to a In Phase I developed in class drugs BigPharma oncology Years 4 30% of the for the non-clinical Total Cost and early clinical development Instead of 8 years
B oost your program in oncology with E2DG Target validation and Lead optimization In vivo efficacy and safety* PK*/ADME and biomarkers evaluation GLP Toxicology GMP Manufacturing IND-enabling documentation and submission Phase I Clinical Studies E2DG core activities lead your R&D program to its POC in human (*) E2DG pharmacological team is compliant with FDA/EMA GLP standards.
Our Management Team Christophe Eugenia Mohamed MBA - CEO PhD - CSO MD - CMO Francois Ramiro Keyvan PhD - COO PhD – Preclinical Manager PhD – PK Expert
E2DG-added value Experience and expertise in oncology Translational approach Management efficiency Investigator network worldwide Strong medical input at each step 7
WHAT WE CAN DO FOR YOU ✓ Open up the GIVE potential of your lead ASSISTANCE ✓ Scientific support for on preclinical, your fundraising regulatory campaign strategies and CONDUCT Phase I clinical your preclinical, trials GIVE ADVICE PK and MANAGE your AND RISK Radiopharma R&D program ASSESSMENT studies in our on reported own facilities preclinical and clinical data ✓ Unblock and speed up your R&D program ✓ New Positioning of molecules to improve the 8 drug’s life cycle
Our Expertise during the past 20 years PreclinicalOncology ClinicalOncology OUR EXPERIENCE - TUMOR MODELS OUR EXPERIENCE - TUMOR TYPES Pediatric Solid tumors tumors Hematologic Medulloblastoma, SCLC, NSCLC, Solid tumors malignancies neuroblastoma TNBC, ER+ Breast, cholangiocarcinoma, Bladder, breast, ALL, AML, NHL, MM, colorectal, cholangiocarcinoma, MPD mesothelioma colorectal, glioblastoma, Hematologic glioblastoma, head & neck, liver, lung, melanoma, head & neck, liver, malignancies ovary, pancreatic, prostate, melanoma, ovary, renal, sarcomas, stomach, pancreatic, thyroid, and rare tumor types: BRD-NUT ALL, AML, NHL, MM, prostate, renal, MPD Ewing sarcoma 9
Our Expertise during the past 20 years Preclinical PK/PD Development Phase I Phase II/III BET inh (OTX015)* Galectin inh (OTX008)* PI3K inh 1 Cisplatin 2 CXCR4 inh 1 FDA Review/Approval Oxaliplatin 2 LDHA inh 1 Irinotecan 2 STAT3 inh 1 Docetaxel 2 Cathepsin S_MoAb 1 Vindesine 2 Lapatinib 3 LSD1 inh 1 Irinofulven 3 Bleomycin 2 FLT3 inh 1 Ibrutinib 3 Trabectidin 2 EGFR ligands_MoAb 1 Masitinib 3 Onapristone 3 Amifostine 2 Novel cytotoxic drugs 1 Palbociclib 3 Vinorelbine 2 Others undisclosed targets 1 Vemurafenib 3 IL-2 system release 1 IL-1 receptor inh 1 (1) between 2011-2018 (2) between 1996-2015 (3) between 2000-2015
A “first -in- class” drug in oncology developed by E2DG 2015 2013 2011 2014 2012 Proof of 3 Phase I a/b Sold to concept in The e drug was was (+ 200 patients) cancer Merck lice cense sed by our IND-Enabling clien ient fro rom MTP TPC studies 14 38 16 11 Peer-reviewed Presentations at Patents full papers Scientific meetings Application
HOW WE WORK WITH YOU Drug development Implementation Program / Quotation of the preclinical / Initial Delivery of the Delivery clinical program Contact Final Report 4 1 3 6 2 5 Contract NDA With milestones ➢ Fees-for-services Execution and priorities ➢ Special fees + Performance 2 weeks up to 2 months compensation ➢ Review of the scientific data ➢ Internal evaluation with technical experts ➢ Search for outsourcing solutions Project Management ➢ A dedicated PM for your study ➢ Follow-up meetings TeamBuilding ➢ Milestone Reporting Our scientific and medical team will discuss about your vision for the project and how we can support this
Some of our clients 13
Strong medical imput at each stage Tailored solutions to meet your drug development needs Contact information: www.e2dg.com CHRISTOPHE MAZARS, CEO 14 christophe.mazars@e2dg.com @E2DGr1 +33 1 83 75 86 32. Boulogne Billancourt, France
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