About Orano Med

Tania Stallons, Principal Scientist

Based on an R&D program started in 2005 by our founder, Patrick Bourdet, Orano Med has developed new processes for producing high-purity lead-212 (212Pb), a rare radioactive isotope. 212Pb is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer.

The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.

Orano Med was officially created in 2009 and is an affiliate of the Orano Group.

  • Achievements

    Since its creation in 2009, Orano Med has reached several important milestones, contributing to significant breakthroughs in nuclear medicine.

    • First clinical trial with lead-212 (212Pb) launched in 2012; patient enrollment complete in 2014
    • First manufacturing facility to produce high-purity 212Pb operational since 2013
    • Strategic acquisition of Macrocyclics, world leader in chelating agent production
    • Strategic collaborations in cancer research:
      • Roche
      • National Cancer Institute (NCI)
      • University of Alabama at Birmingham (UAB) Cancer Center
      • University of Cincinnati (UC)
      • French National Institute of Health and Medical Research (Inserm)
      • University of California, San Diego (UCSD) Moores Cancer Center
      • RadioMedix
      • Morphotek
      • Nordic Nanovector

    Recognition and awards:

    • Clinton Global Initiative (CGI)
    • Marie Curie Medal from the French Society of Nuclear Energy (SFEN)
  • Strategy

    Laboratoire Maurice Tubiana (LMT)

     

    Confronted with the scarcity of radioisotopes suitable for targeted alpha therapy, Orano Med has developed a process for extracting and purifying 212Pb from an abundant supply of thorium derived from Orano’s former mining activities.

    Thanks to several patented innovations implemented in the cutting-edge Laboratoire Maurice Tubiana, Orano Med can produce high-purity 212Pb to conduct preclinical studies and clinical trials, and to develop new cancer treatments.

    Before new drugs become available to doctors and patients, researchers must demonstrate the drug’s therapeutic safety and efficacy. Orano Med and its scientific research partners are making great strides toward this end through extensive research.

    In 2012, Orano Med launched the first Phase 1 clinical trial with 212Pb. Since then, the focus is on moving other preclinical candidates into clinical development by continuing studies that target different pathologies using various vectors.

    Thanks to patented innovations and increased 212Pb production capacity achieved in the U.S. and in France, Orano Med now seeks to expand its partnership portfolio with academics and biotechs. 

    Interested in partnering with Orano Med?

    Please contact Nicolas.Bozovic@orano.group

     

  • Scientific Team

    Orano Med's Scientific Team

    Julien Torgue, Ph.D., Orano Med Chief Scientific Officer since 2010

    Orano Med’s scientific team is composed of qualified personnel with many years of cumulative expertise in the Targeted Alpha Therapy (TAT) field. This team has already proven its ability to bring new therapies to the clinic, and is now equipped with a preclinical lab dedicated to TAT with 212Pb.

    “Over the years, Orano Med has assembled a team of experienced scientists (chemists, biologists, experimentation) to support its internal and collaborative research programs.  Our in-house capabilities have allowed us to significantly speed up our research and collection of the necessary data to support additional Investigational New Drug (IND) applications.”

    Orano Med's Scientific Advisory Committee

    Orano Med's scientific development is supported by an international advisory committee composed of experts in the fields of oncology, radioimmunotherapy, and dosimetry.

    Joy Cavagnaro, PhD, DABT

    Joy Cavagnaro, PhD, Diplomate of the American Board of Toxicology (DABT), Fellow of the American Thoracic Society (ATS), Regulatory Affairs Certification (RAC) Fellow of the Regulatory Affairs Professionals Society (RAPS) is the President of Access BIO. Her career spans academia, the Contract Research Organization (CRO) and biotechnology industries, and government. During her tenure at the Center for Biologics Evaluation at the Food & Drug Administration (CBER/FDA) she was appointed to the Senior Biomedical Research Service (SBRS), served as FDA’s International Council for Harmonisation (ICH) safety topic lead and rapporteur for Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (ICH S6).  Before joining the FDA, Dr. Cavagnaro was principal study director for biotechnology products at Covance.  Prior to founding Access BIO, Dr. Cavagnaro was Vice President of Regulatory Affairs and Quality Assurance at Human Genome Sciences.

    Dr. Cavagnaro is Past Chair of Regulatory Affairs Professionals Society (RAPS) and the National Capital Area Chapter of Society of Toxicology (SOT).  She is a past councilor of the Biotechnology Specialty Section of the SOT, where she was recipient of the section's first Career Achievement Award.  She is Founder, Past Chair and ex-officio member of the leadership committee of BioSafe, an expert preclinical science committee within the Biotechnology Innovation Organization (BIO). She is Past North American Chair of the Drug Information Association (DIA)’s Biotech Community and Research and Development Liaison to the Atlanta Center for Nutrient Analysis (ACNA) Executive Committee.  She is Past Chair and current member of the Clinical and Regulatory Affairs Committee and past member of the Translational Science & Product Development Committee of the American Society of Gene & Cell Therapy (ASGCT). Dr Cavagnaro was the BIO representative to the 2006 Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) Early Stage Clinical Trials Taskforce.  She is currently a Chair of Chesapeake Research Review, Inc. (CRRI), an independent Institutional Review Board (IRB). Dr. Cavagnaro serves on many scientific advisory boards and consults and lectures internationally. She has also edited and authored chapters in “the BioBible” Preclinical Safety Evaluation of Biopharmaceuticals A Science-Based Approach to Facilitating Clinical Trials published by John Wiley & Sons, NJ.

    Ruby Meredith, MD, PhD

    Dr. Meredith is a Professor of Radiation Oncology at the University of Alabama at Birmingham and a Senior Scientist at the UAB Comprehensive Cancer Center.  Among her honors are an Endowed Chair established in her name, Best Doctors Listings for more than ten years, and induction as a Fellow in the American College of Radiation Oncology and the American Society for Therapeutic Radiology and Oncology.  She served on the Advisory Panel for the National Biotracer Facility Project, as well as multiple other radionuclide related councils.  These include over fifteen years on the Medical Internal Radiation Dosimetry committee of the Society of Nuclear Medicine and Molecular Imaging (SNMMI).  Her basic science background has facilitated the development and realization of multiple clinical trials.  She has been involved in 50 clinical trials for targeted radionuclide therapy and has served as a Principal Investigator for Orano Med’s Phase 1 clinical trial of Intraperitoneal 212Pb-TCMC-trastuzumab for HER-2 expressing malignancy.

    For more details:  http://www.uab.edu/medicine/radonc/en/faculty2/ruby-f-meredith-md-phd

    Brendan Prendergast, MD

    Dr. Prendergast is an Alpha Omega Alpha graduate of the University of Florida College of Medicine, where he graduated with Honors in Research.  He completed a medical internship at the Colorado Health Foundation in Denver, CO, followed by a residency in Radiation Oncology at the University of Alabama Birmingham (UAB).  While at UAB, Dr. Prendergast completed the Clinical and Translational Science Training Program and published ten manuscripts in peer-reviewed scientific journals.  He is a board-certified diplomate of The American Board of Radiology.

    Since 2013, Dr. Prendergast has been in community practice on Florida's Space Coast.  He currently holds an adjunct faculty appointment at the University of Central Florida College of Medicine and represents radiation oncology on the board of the Florida Society for Clinical Oncology.  In his clinical practice, Dr. Prendergast frequently administers radiopharmaceuticals for a variety of malignancies.  As an active user of alpha-emitting radionuclides, Dr. Prendergast is uniquely familiar with both the clinical and radiation safety issues of targeted alpha particle therapy.

    George Sgouros, PhD

    Dr. Sgouros is Professor of Radiology and Radiation Oncology, Director of Radiopharmaceutical Dosimetry Section of the Division of Nuclear Medicine, Johns Hopkins University, School of Medicine. He has been principal investigator or program leader on numerous grants with over twenty years experience in modeling and dosimetry of internally administered radionuclides with a particular emphasis on patient-specific dosimetry, alpha-particle dosimetry and mathematical modeling of radionuclide therapy. 

    Dr. Sgouros’s lab is currently engaged in pre-clinical research investigating targeted alpha-emitter therapy of metastatic cancer.  He is author on more than 100 peer-reviewed articles, as well as several book chapters and review articles. 

    He is chairman of the Medical Internal Radionuclide Dose (MIRD) Committee as well as steering committee member, of the American Association of Physicists in Medicine (AAPM), Task Group on Internal Emitter Dosimetry and member of the National Council on Radiation Protection and Measurements (NCRP) Committee on Uncertainties in Internal Radiation Dosimetry. 

    He has served as chairman of the Dosimetry & Radiobiology Panel at a Department of Energy Workshop on alpha-emitters in medical therapy and, in the early 90’s, provided the physics/dosimetry support for the first FDA-approved human trial of targeted alpha-emitter therapy.  He has also served on several NIH study sections and on the Oncological Sciences IRG Study Section Boundaries Team.

    Ben Thornton, PhD

    Ben Thornton, PhD, is an independent consultant to the biotechnology industry.  He has served as Senior Vice President of Technology at Pain Therapeutics Inc. Dr. Thornton served as Managing Director of Apovia, Inc. a subsidiary of Apovia AG. Dr. Thornton served as Executive Vice President of Research and Development of Apovia AG. Dr. Thornton is a Founder of Immune Complex Corporation and served as its President and Chief Executive Officer since 1996. He is recognized as an expert in pharmaceutical development and sits on the Board of Directors of the Infectious Disease Science Center of the Torrey Pines Institute for Molecular Studies (La Jolla).

    Dr. Thornton served as the Director of Research of the Pharmaceutical Research Institute (responsible for research centers in La Jolla, CA and Sydney, Australia). At Pain Therapeutics and formerly as Vice President of Research and Development at Apovia Pharmaceuticals, Dr. Thornton has been managing clinical trials worldwide for over 7 years. Prior to Immune, he served as Vice President of Preclinical Development and R&D for GeneMedicine, Inc., in Woodlands, Texas. Dr. Thornton served as Director of Pharmaceutical Research at RW Johnson (a Johnson & Johnson company) in San Diego and Australia for 15 years. He serves as Director of Zacharon Pharmaceuticals, Inc. He was a post-doctoral fellow at the Roche Institute of Molecular Biology. Dr. Thornton received his undergraduate degree from Abilene Christian University and his PhD from the University of Texas Graduate School of Biomedical Sciences (Houston).

  • Research Partners
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    Roche

     

    In 2012, Roche and Orano Med launched a strategic alliance; the objective is to create a novel, advanced alpha radioimmunotherapy platform to target and kill cancer cells. The agreement is focused on malignant disease with a high unmet medical need.  As part of this new alliance, Roche and Orano Med have built a research laboratory located in France. Operational since 2013, ARCoLab (AREVA Med Roche Common Laboratory) is dedicated to the co-development of targeted alpha therapy (TAT), an innovative and promising approach in the fight against cancer.  A joint team of researchers from both Roche and Orano Med currently evaluate the anti-tumor efficiency of TAT in different preclinical models.

     

    Since 2015, new partnerships have been signed with innovative biotechs around the world

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    RadioMedix

    In 2015, Orano Med and RadioMedix, a clinical phase biotechnology company focused in the development of  radiopharmaceuticals for targeted diagnosis and therapy of cancer, entered into an agreement to co-develop a novel treatment against neuroendocrine tumors (NETs) using Targeted Alpha Therapy with lead-212 (212Pb).

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    Morphotek

    In 2016, Orano Med and Morphotek, a subsidiary of Eisai Inc., entered into a collaborative project to assess the potential of a novel alpha radioimmunotherapy treatment targeting the supporting microenvironment of solid tumors.

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    Nordic Nanovector

    In 2016, Orano Med and Nordic Nanovector, a Norwegian biotech company focusing on the development and commercialization of novel targeted therapeutics in hematology and oncology, announced a collaboration agreement to investigate the potential of a 212Pb-conjugated anti-CD37 antibody for the treatment of leukaemias, orphan diseases with still significant unmet medical need.

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    National Cancer Institute (NCI)

    In 2008, Orano Med and the United States National Cancer  Institute  (NCI)  signed  a  Cooperative  Research and Development Agreement for the design of a new radiopharmaceutical drug using 212Pb.

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    University of Cincinnati

    In 2010, Orano Med and the University of Cincinnati Ohio collaborated on a preclinical study to develop a new treatment to combat prostate cancer.

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    French National Institute of Health and Medical Research (Inserm)

    In 2011, Orano Med signed a cooperative research agreement with the French National Institute of Health and Medical Research (Inserm).

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    University of Alabama at Birmingham (UAB)

    In 2012, Orano Med launched the first Phase 1 clinical trial using 212Pb at the University of Alabama at Birmingham (UAB).  The goal was to study the safety, distribution, pharmacokinetics, immunogenicity, and tumor response of intraperitoneal 212Pb-TCMC-trastuzumab in patients with human epidermal growth factor receptor type 2 (HER-2)-expressing malignancy.  The latest results were published in the Journal of Clinical Oncology.  

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    In 2015, Orano Med and five research partners received support from Bpifrance for the CARAT Project.

    CARAT (Consortium for alpha radiotherapy applications) is led by Orano Med to develop a French sector for the production of lead-212 and for treatments using this rare metal.

    Coordinated by Orano Med, CARAT unites EVEON, Triskem International, the Limoges University Hospital, the CRIBL* laboratory at Limoges University, and Subatech.  Classified as a decisive research and development project for competitiveness (PSPC), this project will receive 9.6 million euros in financing over a 3-½ year period under a program steered by the Commissariat Général à l’Investissement (CGI - French General Investment Commission).

    With the implementation of the CARAT project and thanks to our existing production facilities, Orano Med will have the opportunity to fulfill expected 212Pb clinical development needs.

    *Control of the B Cell Immune Response and Lymphoproliferations

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Contact

For more information about Orano Med, please contact:
Alison Tise
Tel.: + 1 (301) 841-1673

CEO Cancer Gold Standard
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Orano Med receives CEO Cancer Gold Standard accreditation