MorphoSys, Emergent Biosolutions Form Development & Manufacturing Pact

MorphoSys AG, a developer of antibodies and related technologies, and Emergent BioSolutions Inc., a specialty pharmaceutical company, have formed an agreement for the joint development and commercialization of ES414 (to be renamed MOR209/ES414), a drug to treat prostate cancer.

Under the agreement, MorphoSys gains worldwide commercialization rights, excluding the US 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.

MorphoSys and Emergent plan to initiate a Phase I 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.

MOR209/ES414 is a targeted immunotherapeutic protein, which activates host T cell immunity specifically against prostate cancer cells expressing Prostate Specific Membrane Antigen (PSMA), an antigen commonly overexpressed on prostate cancer cells. The MOR209/ES414 molecule was constructed using Emergent’s ADAPTIR technology platform and selectively binds to the T cell receptor on cytotoxic T cells and PSMA on tumor cells. MOR209/ES414 contains two pairs of binding domains, each targeting a unique antigen, linked to opposite ends of an immunoglobulin Fc domain to extend the half-life and enable use of a purification process typical of lg-based molecules. In preclinical studies, MOR209/ES414 has been shown to redirect T cell cytotoxicity towards prostate cancer cells expressing PSMA.

ADAPTIR bispecific proteins are modular, single chain polypeptides that comprise two separate binding domains, a hinge segment, and an effector domain (huFc). They have a differentiated structure from monoclonal antibodies and can generate a unique signaling response. Some ADAPTIR molecules, like MOR209/ES414, may mediate T cell cytotoxicity by redirecting T cells against tumor cells. In addition, monospecific ADAPTIR proteins may mediate complement dependent cytotoxicity and Fc dependent cytotoxicity, similar to monoclonal antibodies.

Source: MorphoSys

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