A French-American alliance
NUTLEY, N.J.—A new international collaboration was recently announced between several different academic and industry organizations. The public-private partnership includes Roche, the French National Agency for Research on AIDS and Viral Hepatitis (ANRS), the Baylor Research Institute (BRI, the research arm of Baylor Health Care System) and Inserm Transfert. The organizations will form a long-term collaboration for the development of therapeutic vaccines for chronic infection, using a novel technology platform developed by the Baylor Institute for Immunology Research (BIIR) and ANRS and Inserm-associated research units to produce vaccines targeting dendritic cells. Financial details were not disclosed.
“The concept of this vaccine program originated from more than 15 years of research in human dendritic cell biology and dendritic cell targeting at BIIR,” says Dr. Yong-Jun Liu, vice president and chief scientific officer at the BRI and director of the BIIR. “We are extremely excited to work with the two world leaders in vaccine development and biologics research to move the basic research discovery toward the clinic.”
The collaboration will be overseen by a joint steering committee formed of members from all four organizations, and it represents a wealth of developmental and scientific experience.
Roche has extensive experience in protein engineering and biologics, while the BRI is an expert in dendritic cell targeting and protein fusion. Augustin Godard, head of licensing and strategic partnership at Inserm Transfert, says the organization will work with Roche’s alliance management to ensure the partnership works and maintains synergy. Inserm Transfert will also provide guidance in issues of intellectual property, and Dr. Anna Laura Ross, head of HIV Vaccine Research Office at the ANRS, says the ANRS brings with it two decades of experience in vaccine development as well as “more than 20 years of experience in terms of conducting and being a sponsor of clinical trials in the field of HIV.”
The institutions will work together to identify and optimize potential lead candidates, says Dr. Jean-Jacques Garaud, head of pharma research and early development at Roche, and then develop the molecules in concert to the point of clinical proof-of-concept. The partnership, he notes, “extends throughout the lifecycle of the vaccines that could be developed.” Garaud says the partners “will collaborate closely throughout, with a co-development period extending through proof of concept. Roche will drive activities for Phase III and beyond.”
A vaccine collaboration between the ANRS and the BIIR, which began in 2007, has resulted in lead candidates for HIV, hepatitis C virus (HCV) and tuberculosis (TB) vaccines based on targeting relevant antigens to different subpopulations of dendritic cells by way of receptors, for both preventative and therapeutic purposes. The platform that will be used allows novel fusion proteins to be created from a dendritic cell targeting antibody, viral antigens and linker sequences.
Bernard Brigonnet, chief operating officer and vice president of the BRI, adds that “should the partnership and Roche decide to change antibodies to pick up a different option in order to get better efficacy, we will continue supplying that technology platform as needed until they have a clinical candidate that’s ready to go into the clinic, first in HIV, second in HCV and third in TB.”
Together with the BRI, the ANRS has been behind the development of the vaccines, and with the beginning of the collaboration, Roche will take over responsibility for producing a clinical batch, says Ross. After the process has advanced to that point, the ANRS will take responsibility for the initial clinical trials and entry into humans.
“Through our existing collaboration with Baylor, leveraging our recently established Vaccine Research Institute, and a common interest and desire to explore the power of dendritic cell targeting, the pieces naturally fell into place for this collaboration,” says Godard. “We believe the complementary skills of the parties are also a key element for the future success of the project.”
“This really is a case where we have a public-private partnership,” says Ross. “It’s a public-private partnership in which all of the parties remain completely and deeply involved all throughout the process. And it’s a very ambitious collaboration.”
Roche/Ventana Medical Systems tapped for companion Dx test
BOTHELL, Wash.—On April 12, Seattle Genetics Inc. and Millennium: The Takeda Oncology Co., announced a collaboration with Roche Group member Ventana Medical Systems Inc., in which Ventana will develop, manufacture and commercialize a molecular companion diagnostic test with the goal of identifying patients who might respond to treatment with ADCETRIS based on CD30 expression levels in their tissue specimens.
As part of the ongoing clinical development of ADCETRIS, Millennium and Seattle Genetics are planning two Phase III studies that will use the companion diagnostic, one in CD30-positive cutaneous T-cell lymphoma (CTCL) and the other in CD30-positive mature T-cell lymphomas (MTCL).
The U.S. Food and Drug Administration (FDA) approved ADCETRIS in August 2011 for relapsed Hodgkin lymphoma (HL) and systemic anaplastic large-cell lymphoma (sALCL). A molecular companion diagnostic is not required for the current FDA-approved indications for ADCETRIS.
CD30 is a member of the tumor necrosis factor receptor (TNFR) family and is a characteristic cell surface receptor for activated T-cells and B-cells, including the malignant cells of HL and sALCL. Published literature also reports CD30 expression in other cancers. Seattle Genetics is currently exploring the potential of ADCETRIS in two phase II clinical trials to further characterize CD30 expression and evaluate antitumor activity of ADCETRIS. One trial is evaluating patients with non-Hodgkin lymphomas, including diffuse large B cell lymphoma, peripheral T-cell lymphoma and other less common lymphoma subtypes, and the second trial is evaluating patients with non-lymphoma malignancies, including multiple myeloma, leukemia and solid tumors. Data from both trials are expected to be reported at upcoming medical conferences during 2012. ADCETRIS is not approved for treatment of the non-Hodgkin lymphomas and non-lymphoma malignancies studied in these trials.
“We are pleased to work with Seattle Genetics and Millennium to develop a companion diagnostic test for detecting CD30 expression levels that may assist in identifying additional patients who might benefit from ADCETRIS,” said Doug Ward, vice president and general manager of Ventana Translational Diagnostics, in a statement. “We believe that a personalized healthcare approach is particularly relevant for targeted agents such as ADCETRIS, an antibody-drug conjugate, and this collaboration provides an opportunity to add to our growing pipeline of companion diagnostic tests.”
Ventana Medical Systems Inc.