MorphoSys AG and Emergent BioSolutions will initiate a Phase I clinical study to evaluate the safety, tolerability, and clinical activity of MOR209/ES414 in patients with metastatic castration-resistant prostate cancer (mCRPC).

A few months ago, we talked about the beginning of the collaboration between MorphoSys and Emergent BioSolutions. Now, the fruit of their combined work, an immunotherapeutic protein iMOR209/ES414 is going to initiate phase I clinical study to evaluate the novel oncology immunotherapeutic MOR209/ES414 for prostate cancer. The protein was developed by Emergent using its proprietary ADAPTIRTM (modular protein technology) platform. Preclinical in vitro and in vivo studies have shown MOR209/ES414 redirects T-cell cytotoxicity towards cells expressing prostate specific membrane antigen (PSMA), an antigen commonly found in prostate cancer cells.

Comparison of Molecular Structures of Antibodies vs. ADAPTIR Modular Protein Technology

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Arndt Schottelius, Chief Development Officer of MorphoSys, said: “MOR209/ES414 has the potential to address a clear unmet medical need in prostate cancer. We are thus delighted to see this compound moving into the clinic as expected in early 2015. This is the fourth clinical candidate in our growing proprietary portfolio of compounds and increases the total number of clinical programs in our pipeline to 23.

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.

Barry Labinger, Executive Vice President and President Biosciences Division at Emergent BioSolutions added: “Emergent is pleased to announce the dosing of our first patient in this Phase 1 clinical study. Prostate cancer is the most common cancer in men, and there is a significant need for improved treatment options. We believe that the immunotherapeutic approach represented by MOR209/ES414 offers the promise of meaningfully improved outcomes for patients with mCRPC. We are excited to work with our partner MorphoSys, to evaluate the potential of MOR209/ES414 in the clinic.

By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare. You can check out its profile and other great biotech companies on LaBiotech Map.

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