The
FDA granted fast track designation to leronlimab for use in combination
with carboplatin for the treatment of patients with CCR5-positive
metastatic triple-negative breast cancer.
Leronlimab
(PRO 140, CytoDyn Inc.) is an investigational humanized IgG4 monoclonal
antibody that blocks CCR5, a cellular receptor believed to play key
roles in tumor invasion and metastasis.
Agents
that block CCR5 have been shown to block tumor metastases in laboratory
and animal models of aggressive breast cancer and prostate cancer.
“This
[fast track designation] is an important acknowledgement of the
potentially paradigm-shifting therapy option in metastatic
triple-negative breast cancer,” Richard Pestell, MD, PhD, vice chairman
and chief medical officer of CytoDyn, said in a company-issued press
release. “Currently, there are no enduring treatment options for
[patients with metastatic triple-negative breast cancer] and we thank
the FDA for recognizing the potential of leronlimab [in this setting].”
Enrollment is underway for a study designed to evaluate the agent for patients with metastatic triple-negative breast cancer.
CytoDyn
expects to submit a biologics license application to the FDA this year
for leronlimab as part of combination therapy for patients with HIV.
The CCR5 receptor also may play a key role in modulating immune cell trafficking to sites of inflammation.
CytoDyn
is conducting a phase 2 study of leronlimab to support the concept that
the CCR5 receptor on engrafted cells is key for the development of
acute graft-versus-host disease. The FDA previously granted orphan drug
designation to leronlimab for the prevention of GVHD.
Explore more about oncology and research in the field at: http://bit.ly/2xaW3zT
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