The partnership with Shire
In 2016, we announced an exclusive research, option and license agreement with Baxalta Incorporated and Baxalta GmbH, which subsequently became subsidiaries of Shire PLC. Under the agreement Symphogen granted Shire an option to obtain, upon the achievement of certain development milestones, an exclusive, worldwide license under our technology to develop, make, and commercialize antibody therapies directed at certain agreed oncology targets and pharmaceutical products containing those antibodies.
Under the agreement, we received an upfront payment of DKK 1.2 billion in 2016. The aggregated potential deal value of the collaboration is estimated at DKK 11 billion plus royalties on worldwide sales.
By the end of 2017, one clinical trial had been initiated under the Shire agreement, a Phase 1 trial with Sym021, a mAb discovered by us that binds PD-1 and blocks binding of the inhibitory ligands PD-L1 and PD-L2, thus releasing PD-1-mediated inhibition of the immune response. This is the first study to test Sym021 in humans. The primary purpose of this study is to determine if Sym021 is safe and tolerable for patients with locally advanced/ unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available.
Collaboration and license agreement with Genentech
As a validation of our ability to apply the mAb technology to disease areas outside of cancer, we entered in 2008 into a collaboration and license agreement with Genentech Inc., a member of the Roche Group, for the identification of antibody therapeutics against undisclosed infectious disease targets. Under the terms of the agreement, Genentech made an upfront payment to us as well as an equity investment in Symphogen. We are eligible for milestone payments exceeding DKK 700 million (USD >100 million) upon the successful achievement of certain research and development milestones, as well as single-digit royalties on worldwide sales.
Under the terms of the collaboration, Genentech is now sponsoring the development of Sym009 for the treatment of certain methicillin-resistant or methicillin-sensitive strains of staphylococcus aureus (MRSA). Sym009 is currently in a Phase 1b clinical trial. The trial evaluates DSTA4637S, an investigational medicine containing Sym009 conjugated to an antibiotic agent, for the potential treatment of Staphylococcus aureus (S.aureus) infections. Sym009 was originally discovered by isolating antibodies from individuals exposed to S.aureus using Symphogen’s patented Symplex technology.