The Emergent-developed MOR209/ES414 molecule is an immunotherapeutic protein, which has shown in preclinical in vitro and in vivo studies its ability to redirect T-cell cytotoxicity towards cells expressing prostate specific membrane antigen (PSMA), an antigen commonly found on prostate cancer cells.
The open-label Phase I clinical study will be conducted in two stages to evaluate the safety, tolerability, and clinical activity of MOR209/ES414, which was constructed using Emergent’s Adaptir technology platform.
Emergent BioSolutions, Biosciences Division executive vice-president and president Barry Labinger said: "Emergent is pleased to announce the dosing of our first patient in this Phase I clinical study.
"We believe that the immunotherapeutic approach represented by MOR209/ES414 offers the promise of meaningfully improved outcomes for patients with mCRPC."
The primary objective of stage I 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.
The primary objective of stage II 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.
Around 130 patients are expected to be enrolled in this open-label phase 1 clinical study that will be conducted in the US and Australia.
As part of the co-development and commercialization agreement between the companies, a milestone payment of $5m will be made by MorphoSys to Emergent.
Approximately 230,000 new Prostate cancer cases are annually recorded in the US or 900,000 new cases annually worldwide.
Image: Micrograph of prostatic adenocarcinoma, conventional (acinar) type, the most common form of prostate cancer. Photo: courtesy of Nephron.