Michael McMurphy Member of the Board of Directors, AREVA Med July 29, 2014 ~ Boston, MA
Overview of AREVA Med AREVA Med has two primary objectives: Industrialize the production of high purity lead-212 ( 212 Pb) Develop new anti-cancer radioimmunotherapy treatments using 212 Pb A few stages of development: 2005: TAO Project wins the ASDA 2006: R&D and small-scale production of 212 Pb 2009: AREVA Med is incorporated 2011: FDA authorizes clinical trials Today: Ongoing clinical trials Launching of industrial scale production More than 80 full-time employees R&D / Production Facilities: R&D site in Bessines, France 212 Pb production site in Bessines, France Metal chelator production in Dallas, TX 2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July p.2
AREVA Med is a team that shares these key values: Humility Simplicity Modesty Commitment Responsiveness Solidarity Enthusiasm Who is AREVA Med? A team of experts who contribute their collective intelligence: Business Management Science Engineering Logistics Corporate Support Quality & Regulatory Nuclear Power & Technology Ideas belong to everyone. A. Monteletang E. Banaga I. Verdier J. Torgue C. Tevissen C. White B. Jonas P. Bourdet 2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July p.3
What is AREVA Med? AREVA Med is an AREVA subsidiary specializing in the development of new innovative therapies to fight cancer. AREVA Med’s research is based on lead-212 ( 212 Pb), a rare alpha-emitting radioisotope. 212 Pb is a decay product of Thorium-232 ( 232 Th), which is a product of AREVA’s mining activities. 212 Pb is at the heart of radioimmunotherapy (RIT), an innovative approach that destroys cancer cells without damaging healthy cells Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July p.4
Alpha Radioimmunotherapy (RIT) What Are We Talking About? Targeting and destroying cancer cells with 212 Pb, without damaging surrounding healthy cells. Cancer cells express a specific antigen The chelator (TCMC) links the antibody to the isotope ( 212 Pb) The isotope ( 212 Pb) destroys the cancer cell The antibody (Trastuzumab) recognizes and targets the cancer cell’s antigen AREVA Med’s drug product: 212 Pb-TCMC-Trastuzumab 2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July p.5
Madagascar 1950s-1970s 1 Old mining deposit 2 Usine du Bouchet ( ) Where Does Our 212 Pb Come From? Thorium Decay Chain Pb Elution at Clinical Site Generator Production at LMT in Bessines 2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July p.6
Preclinical research & toxicology study for IND * Toxicology & imaging for IND Prostate cancer Ovarian cancer Clinical Trial * IND = Investigational New Drug, FDA authorization to initiate human trials Various indications SFEN Award Clinton Global Initiative Key partnerships: Major milestones Acquisition of Macrocyclics LMT Production Preclinical Research Lab 2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July p.7
Preclinical research & toxicology study for IND * Toxicology & imaging for IND Prostate cancer Ovarian cancer Clinical Trial * IND = Investigational New Drug, FDA authorization to initiate human trials Various indications SFEN Award Clinton Global Initiative Key partnerships: Major milestones Acquisition of Macrocyclics LMT Production Preclinical Research Lab 2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July p.8
2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July p.9 Clinical Trial: Overview Filed a new drug application with the FDA in 2010 Started recruiting patients in 2011 Open to patients with abdominal cancers Treated 16 patients so far Dose increases by 30% after each group of 3 patients Well tolerated so far Dose escalation continues
2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July p.10 Clinical Trial: Key players Ruby Meredith - Principal investigator at UAB (Birmingham, AL) Designed the clinical trial Responsible for the conduct of the study Responsible for the safety of the patients Eileen Banaga - QA Director Designed the quality systems for AREVA Med Responsible for the quality of the drug Christine White - Member of AREVA Med’s Advisory Board Ensures soundness of clinical program Provides expert opinion as a leader in RIT
2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July p.11 Roche partnership: Key players Sophie Kornowski-Bonnet Global Head of Roche Partnering Member of the Roche Corporate Executive Committee Based at Roche’s headquarters in Basel Corinne Le Goff President of Roche France
Accelerate clinical development Well tolerated so far, up to one year follow-up Treated 16 patients so far; dose escalation continues Recruiting patients at 2 clinical sites in the US Increase 212 Pb availability Increase capacity of the Maurice Tubiana Facility Develop industrial activities in the US Create US logistic and distribution network Next steps Continue to grow the team to support the clinical trial, R&D, 212 Pb production, and the partnerships 2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July p.12
Thank you