A French-American alliance

Multicenter collaboration to target dendritic cells for therapeutic vaccines

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NUTLEY, N.J.—A new international collaboration was recentlyannounced between several different academic and industry organizations. Thepublic-private partnership includes Roche, the French National Agency forResearch on AIDS and Viral Hepatitis (ANRS), the Baylor Research Institute(BRI, the research arm of Baylor Health Care System) and Inserm Transfert. Theorganizations will form a long-term collaboration for the development oftherapeutic vaccines for chronic infection, using a novel technology platformdeveloped by the Baylor Institute for Immunology Research (BIIR) and ANRS andInserm-associated research units to produce vaccines targeting dendritic cells.Financial details were not disclosed.
"The concept of this vaccine program originated from morethan 15 years of research in human dendritic cell biology and dendritic celltargeting at BIIR," says Dr. Yong-Jun Liu, vice president and chief scientificofficer at the BRI and director of the BIIR. "We are extremely excited to workwith the two world leaders in vaccine development and biologics research tomove the basic research discovery toward the clinic."
The collaboration will be overseen by a joint steeringcommittee formed of members from all four organizations, and it represents awealth of developmental and scientific experience.
Roche has extensive experience in protein engineering andbiologics, while the BRI is an expert in dendritic cell targeting and proteinfusion. Augustin Godard, head of licensing and strategic partnership at InsermTransfert, says the organization will work with Roche's alliance management toensure the partnership works and maintains synergy. Inserm Transfert will also provideguidance in issues of intellectual property, and Dr. Anna Laura Ross, head ofHIV Vaccine Research Office at the ANRS, says the ANRS brings with it twodecades of experience in vaccine development as well as "more than 20 years ofexperience in terms of conducting and being a sponsor of clinical trials in thefield of HIV."
The institutions will work together to identify and optimizepotential lead candidates, says Dr. Jean-Jacques Garaud, head of pharmaresearch and early development at Roche, and then develop the molecules inconcert 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 aco-development period extending through proof of concept. Roche will driveactivities for Phase III and beyond."
A vaccine collaboration between the ANRS and the BIIR, whichbegan in 2007, has resulted in lead candidates for HIV, hepatitis C virus (HCV)and tuberculosis (TB) vaccines based on targeting relevant antigens todifferent subpopulations of dendritic cells by way of receptors, for bothpreventative and therapeutic purposes. The platform that will be used allowsnovel fusion proteins to be created from a dendritic cell targeting antibody,viral antigens and linker sequences.
Bernard Brigonnet, chief operating officer and vicepresident of the BRI, adds that "should the partnership and Roche decide tochange antibodies to pick up a different option in order to get betterefficacy, we will continue supplying that technology platform as needed untilthey 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 thedevelopment of the vaccines, and with the beginning of the collaboration, Rochewill take over responsibility for producing a clinical batch, says Ross. Afterthe process has advanced to that point, the ANRS will take responsibility forthe initial clinical trials and entry into humans.
"Through our existing collaboration with Baylor, leveragingour recently established Vaccine Research Institute, and a commoninterest and desire to explore the power of dendritic cell targeting, thepieces naturally fell into place for this collaboration," says Godard. "Webelieve the complementary skills of the parties are also a key element for thefuture success of the project."
"This really is a case where we have a public-privatepartnership," says Ross. "It's a public-private partnership in which all of theparties remain completely and deeply involved all throughout the process. Andit's a very ambitious collaboration."

Roche/Ventana Medical Systems tapped for companion Dxtest
BOTHELL, Wash.—On April 12, Seattle Genetics Inc. andMillennium: The Takeda Oncology Co., announced a collaboration with Roche Groupmember Ventana Medical Systems Inc., in which Ventana will develop, manufacture and commercialize a molecularcompanion diagnostic test with the goal of identifying patients who mightrespond to treatment with ADCETRIS based on CD30 expression levels in theirtissue specimens.
As part of the ongoing clinical development of ADCETRIS,Millennium and Seattle Genetics are planning two Phase III studies that willuse 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) approvedADCETRIS in August 2011 for relapsed Hodgkin lymphoma (HL) and systemicanaplastic large-cell lymphoma (sALCL). A molecular companion diagnostic is notrequired 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 activatedT-cells and B-cells, including the malignant cells of HL and sALCL. Publishedliterature also reports CD30 expression in other cancers. Seattle Genetics iscurrently exploring the potential of ADCETRIS in two phase II clinical trialsto further characterize CD30 expression and evaluate antitumor activity ofADCETRIS. One trial is evaluating patients with non-Hodgkin lymphomas,including diffuse large B cell lymphoma, peripheral T-cell lymphoma and otherless common lymphoma subtypes, and the second trial is evaluating patients withnon-lymphoma malignancies, including multiple myeloma, leukemia and solidtumors. Data from both trials are expected to be reported at upcoming medicalconferences during 2012. ADCETRIS is not approved for treatment of thenon-Hodgkin lymphomas and non-lymphoma malignancies studied in these trials.
"We are pleased to work with Seattle Genetics and Millenniumto develop a companion diagnostic test for detecting CD30 expression levelsthat may assist in identifying additional patients who might benefit fromADCETRIS," said Doug Ward, vice president and general manager of VentanaTranslational Diagnostics, in a statement. "We believe that a personalizedhealthcare approach is particularly relevant for targeted agents such asADCETRIS, an antibody-drug conjugate, and this collaboration provides anopportunity to add to our growing pipeline of companion diagnostic tests."
Ventana Medical Systems Inc.

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