Sanofi agreed to license Immune Design’s GLAAS™ drug discovery platform to develop new therapeutics for an undisclosed food allergy, in a deal that could net the Seattle immunotherapy company up to $168 million-plus, the companies said today.
Immune Design—fresh off raising $60 million before discounts, commissions, and expenses in an initial public offering that closed July 29—granted Sanofi an exclusive license to discover, develop and commercialize products to treat a food allergy described by the companies as “often life-threatening and growing.”
"Due to the immune dysfunction leading to allergic diseases, GLAAS' mechanism of action is well suited to correct the imbalance, allowing for the potential of new therapeutics in the targeted indication that currently uses century-old technologies,” Stephen Brady, chief business officer at Immune Design, said in a statement. “Our fourth agreement for the use of the GLAAS platform further demonstrates the broad applicability of this approach not only in cancer and infectious diseases, but now in allergic diseases as well.”
In return for the license, Sanofi paid Immune Design an undisclosed upfront payment, and agreed to pay up to $168 million tied to development and commercialization milestones, as well as tiered royalties on sales of approved products, the companies said.
GLAAS is based on the synthetic molecule glucopyranosyl lipid adjuvant (GLA), which selectively binds to the toll–like receptor 4 (TLR4). That binding 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 combined with a tumor antigen and injected into a patient, the combination is taken up by DCs, leading to production and expansion of immune cells called CD4 T helper lymphocytes with a Th1 phenotype.
While these CD4 T cells are specific to the tumor antigen taken up by the DCs, they generally cannot kill antigen-bearing tumor cells. Yet the CD4 T cells play a key role in helping to boost the anti-tumor immune response by expanding cytotoxic T cells that are specific to the same antigen, and by assisting other immune cells, including B lymphocytes that are precursor to antibodies and natural killer cells, which are important in the overall anti-tumor immune response.
According to Immune Design, GLAAS product candidates have the potential to target multiple types of cancer, as well as infectious, allergic and autoimmune diseases. GLAAS-based product candidates have been evaluated to date in over 1000 subjects in Phase I and Phase II trials demonstrating an acceptable safety profile and efficacy.
Today's deal is an outgrowth of a collaborative research arrangement inked by the companies in October 2011 to investigate the use of Immune Design's GLA in the field of allergy, on terms that were not disclosed at the time. Sanofi and Immune Design said they have generated a large set of preclinical data demonstrating that when given prophylactically or therapeutically, some formulations within GLAAS can shift the immune responses in a way that may result in significant protection and reduction from allergy symptoms.
Sanofi joins AstraZeneca’s MedImmune biologics R&D arm in partnering with Immune Design to use its GLAAS platform. In May, Immune Design said GLAAS was used in the Phase I clinical trial of medImmune’s MEDI7510, an investigational agent for respiratory syncytial virus (RSV). Also, in February, the first patient was treated in a Phase 1 clinical trial of ID-G305, a cancer immunotherapy investigational agent from the company’s GLAASTM platform.