Clinical-stage biopharmaceutical company MacroGenics has begun patient dosing in a Phase I dose expansion cohort trial of MGA271, an Fc-optimised monoclonal antibody that targets B7-H3-expressing tumour types.
The commencement of dosing triggered a $10m milestone payment to MacroGenics from its partner, Les Laboratoires Servier.
Expected to complete the trial in 2014, the study’s dose expansion portion will assess safety and pharmacokinetics at a weekly dose of 15mg/kg of MGA271, in addition to evaluating the potential anti-tumour activity.
MacroGenics president and CEO Dr Scott Koenig said MGA271 has significant potential to treat a variety of solid tumours.
“We intend to assess and prioritise future indications for MGA271 clinical trials based on data from these dose expansion cohorts and determine the best path forward to potential approval and commercialisation,” Koenig said.
A total of 45 patients will be enrolled in the US within three cohort groups, two with specific tumour types of 15 patients each, and a third cohort composed of other B7-H3-expressing tumour types.
In the fourth quarter of 2013, Servier plans to assess MGA271 in 45 additional cancer patients.
Around 26 patients representing 15 different types of tumours were enrolled in the dose escalation portion of the Phase I trial, while ten patients received additional cycles of MGA271 treatment and all have had stable disease at the first tumour re-assessment.
With no dose-limiting toxicity, mild or moderate infusion reactions were the most frequent adverse events in the trial.
Servier research and development president Dr Emmanuel Canet said, “The various product candidates included in our two alliances with MacroGenics, including MGA271 and three oncology DART programs, are advancing as we had hoped.”