Presentation is loading. Please wait.

Presentation is loading. Please wait.

Michael McMurphy Member of the Board of Directors, AREVA Med July 29, 2014 ~ Boston, MA.

Similar presentations


Presentation on theme: "Michael McMurphy Member of the Board of Directors, AREVA Med July 29, 2014 ~ Boston, MA."— Presentation transcript:

1 Michael McMurphy Member of the Board of Directors, AREVA Med July 29, 2014 ~ Boston, MA

2 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 2014 - p.2

3 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 2014 - p.3

4 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. 2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July 2014 - p.4

5 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 2014 - p.5

6 Madagascar 1950s-1970s 1 Old mining deposit 2 Usine du Bouchet (1957-1971) Where Does Our 212 Pb Come From? Thorium Decay Chain 3 212 Pb Elution at Clinical Site Generator Production at LMT in Bessines 2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July 2014 - p.6

7 2008200920102011201220132014 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 2014 - p.7

8 2008200920102011201220132014 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 2014 - p.8

9 2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July 2014 - 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

10 2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July 2014 - 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

11 2014 Women In Nuclear Conference – Michael McMurphy / AREVA Med – 29 July 2014 - 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

12 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 2014 - p.12

13 Thank you


Download ppt "Michael McMurphy Member of the Board of Directors, AREVA Med July 29, 2014 ~ Boston, MA."

Similar presentations


Ads by Google