Date: 2015-03-09
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Emergent BioSolutions (USA - MD) Morphosys (Germany)
Product: MOR209/ES414
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
Therapeutic area: Cancer - Oncology
Country: Australia, USA
Trial
details: The study will be conducted in two stages. The primary objective of Stage 1 is to identify the maximum tolerated dose (MTD) of MOR209/ES414 administered intravenously, with weekly dosing for three months and bi-weekly thereafter, to patients with mCRPC. The secondary objectives are to evaluate the tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of MOR209/ES414. Within Stage 2, the primary objective is to evaluate clinical activity in patients that have or have not received prior chemotherapy, while secondary objectives are to further characterize the safety profile, PK, PD, and immunogenicity of MOR209/ES414. This open-label Phase 1 clinical study will be conducted in the U.S. and Australia, with a planned enrollment of up to 130 patients. (NCT02262910)
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. The study will be conducted in two stages. The primary objective of Stage 1 is to identify the maximum tolerated dose (MTD) of MOR209/ES414 administered intravenously, with weekly dosing for three months and bi-weekly thereafter, to patients with mCRPC. The secondary objectives are to evaluate the tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of MOR209/ES414. Within Stage 2, the primary objective is to evaluate clinical activity in patients that have or have not received prior chemotherapy, while secondary objectives are to further characterize the safety profile, PK, PD, and immunogenicity of MOR209/ES414. This open-label Phase 1 clinical study will be conducted in the U.S. and Australia, with a planned enrollment of up to 130 patients.
