Morphotek, a subsidiary of Japanese pharmaceutical firm Eisai, has started enrolment of paediatric patients with relapsed/refractory solid tumours in a Phase I clinical study with MORAb-004, an investigational monoclonal antibody that binds to endosialin/tumour endothelial marker-1 (TEM-1).
Children's Oncology Group (COG) is responsible for carrying out the open-label Phase I trial, which is aimed at evaluating the safety, tolerability and pharmacokinetics of MORAb-004 administered in weekly intravenous infusions in paediatric patients.
COG study chair for the trial Robin Norris said MORAb-004 is an antibody to target TEM-1/endosialin.
"Its mechanism of action may eventually offer a new approach in our efforts to develop cancer treatments," Norris said.
The Ludwig Institute for Cancer Research (LICR) has granted exclusive worldwide rights to Morphotek for the development and commercialisation of MORAb-004.
Developed based on Morphodoma technology, MORAb-004 targets endosialin, a protein expressed on cells associated with tumours and tumour blood vessel cells.
Dr Lloyd Old's laboratory at LICR discovered the endosialin protein as well as a precursor monoclonal antibody specific for endosialin, which is related to MORAb-004.
The antibody binds itself to the target expressed on tumour associated pericytes, tumour stromal cells and directly on a subset of malignant cells.
MORAb-004 is currently under development for the treatment of solid tumours, colorectal cancer, sarcoma, metastatic soft tissue sarcoma and metastatic melanoma.
The company has also received FDA orphan drug designation for MORAb-004 for the treatment of soft tissue sarcoma.
Morphotek director of clinical operations John Heyburn said: "New agents are needed for cancer treatment and our strategy of using collaborations with leading research groups provides us unique development opportunities."
The organisation is engaged in the development of protein and antibody products via the use of a new and proprietary gene evolution technology.
The technology has been used in a variety of cell lines and organisms in the development of pharmaceutical products in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery and enhanced output traits for commercial applications.