MacroGenics Up On Lifting Of Partial Hold On Cancer Candidate
Zacks Investment Research | Jan 27, 2019 09:37PM ET
MacroGenics, Inc. (NASDAQ:MGNX) announced that the FDA has lifted the partial clinical hold placed on phase I studies evaluating its antibody monoclonal candidate, MGD009. The company is developing the candidate as monotherapy and in combination therapies for treating various types of cancer.
Shares of MacroGenics closed 2.3% higher on Jan 25 following the news. The company’s shares have declined 41.5% in the past six months compared with the industry ’s fall of 5.1%.
The partial clinical hold was placed on the studies in December due to hepatic (liver-related) adverse events reported by the company as observed in the clinical studies. While the restriction put by the regulatory authority denied enrollment of new patients to the studies, it allowed continuation of treatment for the previously enrolled patients with a pre-assigned dose.
The company stated that it worked rapidly to provide a comprehensive response to the FDA by the end of December to avoid significant delay in the study. With the removal of the hold, the company will be able to enroll new patients.
MGD009 is a bispecific DART molecule, which redirects T cells to kill B7-H3 protein expressing cells involved in immune regulation. The candidate helps treat cancer as the targeted protein is over-expressed on a wide variety of cancer cells.
We note that a phase I study is evaluating MGD009 monotherapy in unresectable or metastatic B7-H3-expressing tumors while another phase I study is evaluating the candidate in combination with the company’s anti-pd-1 antibody candidate, MGA012, in relapsed or refractory cancer with similar tumors.
Apart from MGD009, MacroGenics is also evaluating an antibody drug conjugate candidate, MGC018, in advanced solid tumors.
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