STRASBOURG, France, June 21 /PRNewswire-FirstCall/ -- Transgene S.A. announces today that it has executed a Cooperative Research and Development Agreement (CRADA) Letter of Intent with the National Cancer Institute (NCI) for the development of novel melanoma treatments with Steven A. Rosenberg, M.D., Ph.D., Chief, Surgery Branch. Dr. Rosenberg has identified and characterized a number of melanoma tumor-associated antigens, including gp100 and MART-1, and has developed a lymphodepleting non-myeloablative regimen used for adoptive cell therapy (ACT). The goal of this collaboration is to produce viral-based vectors encoding gp100 or MART-1 and to use these vectors to immunize individuals against malignant melanoma. These immunizations may be given in conjunction with ACT involving tumor antigen-specific T lymphocytes.
The collaboration may also involve new uses of ACT. This innovative technique developed by Dr. Rosenberg’s laboratory at the NCI consists of an in-vitro conditioning and amplification of a patient’s own tumor-antigen specific cytotoxic-directed lymphocytes, then restoring these lymphocytes to the patient following a lymphodepleting non-myeloablative chemotherapy. This regimen results in the in-vivo expansion and enhanced activity of these cytotoxic lymphocytes. To date, of the 35 melanoma patients treated by ACT in a Phase II clinical trial, 18 patients (51%) achieved an objective response, with three patients exhibiting a complete response (Dudley et al. 2005 J Clin Oncol 23:2346-57).
Transgene and the NCI will evaluate new candidate cancer vaccines, with the objective to assess the boosting effect of the vaccination on the lymphocytes’ activity. These novel vaccines will be designed by Transgene using viral vectors to express Dr. Rosenberg’s melanoma antigens. Such a vaccination has already demonstrated increased in-vivo clonal expansion and maintenance of adoptively transferred tumor-antigen specific cytotoxic lymphocytes in preclinical models. The NCI will conduct pre-clinical evaluation of the vaccines and plans to sponsor a Phase I/II trial, planned for 2007.
“We are very excited by the prospect of combining our proprietary vaccine technology with the ACT approach developed by Dr. Rosenberg’s team. We are looking forward to working with Dr. Rosenberg in designing new treatments for melanoma and we are proud to be associated with one of the most promising approaches in the field of cancer immunotherapy,” said Dr. Jean-Yves Bonnefoy, Chief Scientific Officer of Transgene.
About Transgene:
Transgene is a France-based biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The company has three compounds in Phase II trials and one compound in a Phase I study. Transgene has bio-manufacturing production capacities for viral-based vectors and technologies available for out-licensing. For further information about Transgene, please visit www.transgene.fr
Press Contacts: Transgene Capital MS&L Image 7 Philippe Poncet Shaun Brown Estelle Guillot-Tantay +33-3-88-27-91-21 Mary Clark Tiphaine Hecketsweiler +44-(0)20-7307-5330 +33-1-53-70-74-93
This press release contains forward-looking statements referring to the planned pre-clinical production and development of certain viral vectors for use in a cooperative research and development program. However, pre-clinical development work does not always result in a product which can be used for further development testing due to currently unknown technical issues and challenges.
Transgene S.A.
CONTACT: Transgene, Philippe Poncet, +33-3-88-27-91-21, Capital MS&L,Shaun Brown, Mary Clark, +44-(0)20-7307-5330, Image 7, EstelleGuillot-Tantay, Tiphaine Hecketsweiler, +33-1-53-70-74-93
