Partnering and Outlicensing Programs

Synageva has a variety of monoclonal antibody and cytokine programs in development – each with its own potentially attractive commercial advantages and opportunities. Our most advanced clinical program is SBC-014, a biosimilar G-CSF that has successfully completed a multicenter, global Phase 2 trial in the US, Europe, and Asia. We also have 2 partner programs in development.

Novel/Next Generation Monoclonal Antibodies

Monoclonal antibodies (mAbs) have become an increasingly important class of therapeutics with sales exceeding $40 billion in 2009. The development of newer mAbs and their application to large market, chronic conditions will continue to support substantial market expansion.

Monoclonal antibodies with high ADCC: Antibody-dependent cellular cytotoxicity (ADCC) has been identified as one of the critical mechanisms mediating the clinical efficacy of therapeutic antibodies, especially antibodies used for oncology indications. The SEP™ is an ideal platform to express cytotoxic mAbs. The SEP™ produces mAbs that are highly enriched with N-glycans on the Fc portion that enhance the mAbs's ADCC activity 10-100 fold. This optimized glycosylation is an inherent feature of the SEP™ system. Synageva has developed 2 next generation mAbs that harness this significant ADCC improvement:

SBC-201 is in preclinical studies and will target several oncologic indications including lymphomas and certain forms of leukemia. Representative ADCC data for SBC 201 are illustrated in the figure below. SBC-201 has also demonstrated superior in vivo ADCC in cynomologous monkeys versus an identical antibody structure made in CHO
SBC-202 is in preclinical studies and will target certain forms of breast cancer and potentially other gynecologic cancers.

ÜberMabs™: Through Synageva's own technology, as well as through partnerships with other companies, Synageva is exploring opportunities focused on antibodies with high affinity profiles. The objective would be to develop a portfolio of mAbs we refer to as ÜberMabs™ because they are monoclonal antibodies that combine high affinity for their target antigen with the high ADCC activity that comes from being produced in the SEP™.

Neutralizing antibodies with improved side effect profiles: These antibodies work by several mechanisms to inhibit or abolish the biological activity of a soluble antigen and block the antigen's ability to initiate a pathogenic cascade. Our scientists are applying the SEPTM to develop neutralizing antibodies with glycosylation patterns that could reduce potential adverse side effects associated with these mAbs. Monoclonal antibodies produced in this fashion may have better safety profiles and a broader therapeutic dose range. These programs are currently at the research stage.

Cytokines

Cytokine-based drug sales account for approximately 20% of the world pharmaceutical market. The life cycle of many cytokines has been extended by the development of longer acting, PEGylated versions that can be dosed less frequently. The leading PEG-cytokine on the market has established sales exceeding $3 billion.

Synageva has multiple next generation cytokines and a follow-on cytokine in development utilizing the company's SEP™ technology.

SBC-014 is an O-glycosylated G-CSF that has successfully completed a multi-center global Phase 2 clinical trial. This program is being developed via a biosimilar pathway in Europe.

SBC-055 is a PEG-cytokine that has completed Phase 1 clinical trials.

SBC-091 is a PEG-cytokine that has demonstrated significantly enhanced efficacy in animal studies versus currently available therapies. This compound is currently in preclinical development.