MorphoSys AG, one of the world's leading biotechnology companies focusing on fully human antibodies, and multinational specialty biopharmaceutical company, Emergent BioSolutions have entered to an agreement for the joint development and commercialisation 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.
Under the terms of the agreement, MorphoSys gains worldwide commercialisation rights excluding the US and Canada, where Emergent will retain rights. Emergent will receive an upfront payment of US$20 million and will be eligible to receive potential milestone payments of up to US$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 per cent and Emergent 36 per cent 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 per cent on product sales in Emergent's territory. Additional financial details were not disclosed.
Dr. Arndt Schottelius, chief development officer of MorphoSys, added: "We are pleased to be working with Emergent BioSolutions. We believe MOR209/ES414 has the potential to be an important therapy for prostate cancer, where there is a pressing need for better treatments. The preclinical data suggest that the molecule has a number of potential advantages over other drug candidates in this indication. Our goal is to combine our capabilities with those of Emergent to enable the fastest possible development and commercialisation of MOR209/ES414."
Barry Labinger, executive vice president and president Biosciences Division at Emergent BioSolutions, stated: "Emergent looks forward to collaborating with MorphoSys to potentially address important unmet needs amongst patients suffering from prostate cancer. Our companies bring complementary capabilities, compatible cultures and values, and a shared commitment to the highest quality development and commercialisation of MOR209/ES414. We expect to begin clinical development within the next six months. We are encouraged by our partnership with MorphoSys and the continued interest of multiple parties in our ADAPTIR platform."
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 US and Australia, with Emergent as the sponsor.