Date: 2014-10-16
Type of information: Development agreement
Compound: herpes simplex virus (HSV) immune therapy (HSV-529, G103)
Company: Sanofi Pasteur (France) Immune Design (USA - WA)
Therapeutic area: Infectious diseases
Type agreement: development
Action mechanism: Immune Design’s GLAAS platform works in vivo and is based on a small synthetic molecule called GLA (glucopyranosyl lipid adjuvant). GLA selectively binds to the TLR4 receptor and causes potent activation of dendritic cells (DCs) leading to the production of cytokines and chemokines that drive a Th1-type immune response. When GLA is accompanied by an antigen and injected into a patient, the combination is taken up by DCs and leads to the production and expansion of immune cells called CD4 T helper lymphocytes with a Th1 phenotype. These CD4 T cells play a key role in boosting pre-existing cytotoxic T cells that are specific to the same antigen and providing help to other immune cells, including B lymphocytes that are the precursor to antibodies, and natural killer cells that are also important in the overall immune response. Sanofi Pasteur’s HSV vaccine candidate is classified as a replication-defective virus, where the virus possesses all the components of wild-type virus with the exception of two proteins that are involved in viral DNA replication. The vaccine candidate is still capable of infecting cells but does not have the necessary machinery to undergo replication and establish latent or long-term infection.
Because of these attributes, the candidate is capable of eliciting a broad immune response, both a B-cell and T-cell response that is directed against the majority of the antigenic components of the virus. The investigative vaccine is currently being studied in a phase I trial sponsored by the National Institutes of Health (NIH) in people with the infection as well as those without in the United States. Due to the lengthy follow-up of volunteers in the trial, results are expected in 2016.
Disease: herpes simplex virus (HSV) infections
Details: * On October 16, 2014, Sanofi Pasteur and Immune Design announced that they have entered into a broad collaboration for the development of a herpes simplex virus (HSV) immune therapy. Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration: Sanofi Pasteur will contribute HSV-529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate. The collaboration will explore the potential of various combinations of agents, including Immune Design’s GLAAS™ platform, with the goal to select the best potential immune therapy for patients.
The two companies will develop the products jointly through Phase II clinical trials, at which point Sanofi Pasteur intends to continue development of the most promising candidate and be responsible for commercialization.
Financial terms: Sanofi Pasteur will bear the costs of all preclinical and clinical development, with Immune Design providing a specific formulation of GLA from the GLAAS platform at its cost through Phase II studies. Immune Design will be eligible to receive future milestone and royalty payments on any product developed from the collaboration; other financial terms of the agreement have not been disclosed.
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