MacroGenics is on a roll. Less than a year after striking a $1.1 billion antibody development deal with French drugmaker Servier, the Rockville, MD-based biotech has snagged a $10 million milestone for dosing the first patient in an early-stage study of their tumor-targeting drug MGA271.
Investigators are exploring the proper dose range for MGA271, an Fc-optimized monoclonal antibody that zeroes in on B7-H3, which is over-expressed on a variety of solid tumor types. In the Phase I MacroGenics plans to recruit 45 patients in three cohorts of 15 each; two will include different tumor types while a third involves patients with B7-H3-expressing tumors.
When MacroGenics inked this deal with Servier last fall the biotech was still in comeback mode from a disastrous failure of its lead drug, the diabetes treatment teplizumab, which had been in-licensed by Eli Lilly ($LLY). Servier subsequently jumped aboard MacroGenics' Dual-Affinity Re-Targeting (DART) platform, following Pfizer ($PFE) and Boehringer Ingelheim in a flurry of dealmaking.
Ironically, though, the primary investigators involved in the teplizumab study never backed away, even after Eli Lilly washed its hands of the drug after declaring it a failure. Just weeks ago the investigators, including UCSF vice chancellor Jeffrey Bluestone, announced that a new study landed clear efficacy data demonstrating that the drug was "strikingly effective" in preserving insulin-producing beta cells in a large segment of early-stage diabetes patients. MacroGenics now controls worldwide rights to the drug, which is being prepped for a new Phase III trial.
In the meantime, MacroGenics has a new revenue stream to work with from its collaborators.
"MGA271 has significant potential to treat a variety of solid tumors and we are very pleased to reach this milestone in the product candidate's ongoing development," said MacroGenics CEO Scott Koenig. "We intend to assess and prioritize future indications for MGA271 clinical trials based on data from these dose expansion cohorts and determine the best path forward to potential approval and commercialization."
- here's the press release