Date: 2015-03-09
Type of information: Milestone
Compound: ES414/MOR209
Company: Morphosys (Germany) Emergent BioSolutions (USA - MD)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism: bispecific antibody. MOR209/ES414, is an anti-PSMA/anti-CD3 bi-specific antibody targeting prostate cancer, which was developed by Emergent using its proprietary ADAPTIR (modular protein technology) platform. Preclinical in vitro and in vivo studies have shown that MOR209/ES414 redirects T-cell cytotoxicity towards prostate cancer cells expressing Prostate Specific Membrane Antigen (PSMA), an antigen commonly found on such cells.
Disease: metastatic castration-resistant prostate cancer (mCRPC)
Details: * On August 20, 2014, MorphoSys and Emergent BioSolutions announced an agreement for the joint development and commercialization of ES414. The compound, to be renamed MOR209/ES414, is an anti-PSMA/anti-CD3 bi-specific antibody targeting prostate cancer, which was developed by Emergent using its proprietary ADAPTIR™ (modular protein technology) platform. Preclinical in vitro and in vivo studies have shown that MOR209/ES414 redirects T-cell cytotoxicity towards prostate cancer cells expressing Prostate Specific Membrane Antigen (PSMA), an antigen commonly found on such cells. MorphoSys and Emergent plan to initiate a Phase 1 clinical trial evaluating MOR209/ES414 in patients with metastatic castration-resistant prostate cancer (mCRPC) within the next six months. The initial phase of the trial will be conducted in the U.S. and Australia, with Emergent as the sponsor.
Financial terms: Under the terms of the agreement, MorphoSys gains worldwide commercialization rights excluding the U.S. and Canada, where Emergent will retain rights. Emergent will receive an upfront payment of $20 million and will be eligible to receive potential milestone payments of up to $163 million. The milestone payments are linked to specific events, including successful development of MOR209/ES414 in several indications and securing approval in certain territories. MorphoSys and Emergent will jointly develop MOR209/ES414, with MorphoSys bearing 64% and Emergent 36% of the total costs. Emergent will manufacture and supply clinical material from its manufacturing facilities in Baltimore, Maryland. Emergent will receive low single digit royalties on product sales in MorphoSys\'s territory and MorphoSys will receive tiered royalties from mid-single digit up to 20% on product sales in Emergent\'s territory. Additional financial details were not disclosed.
Latest news: * On March 9, 2015, Emergent BioSolutions and MorphoSys announced the initiation of a Phase 1 clinical study to evaluate the safety, tolerability, and clinical activity of MOR209/ES414 in patients with metastatic castration-resistant prostate cancer (mCRPC). Under the terms of the companies' co-development and commercialization agreement, achievement of this milestone triggers a payment of US $5 million by MorphoSys to Emergent.
