BioTuesdays

CytoDyn submits non-clinical portion of BLA for combination HIV therapy

CytoDyn Logo

CytoDyn (OTCQB:CYDY) submitted the first of three sections of its BLA to the FDA for leronlimab, for use in combination with highly active antiretroviral therapy for the treatment of HIV.

Leronlimab is humanized monoclonal antibody that targets CCR5, a receptor by which HIV enters immune cells. In addition to its potential as an antiviral agent, CytoDyn is developing leronlimab for cancer indications, based on CCR5’s likely involvement in tumor invasion and metastasis.

Leronlimab for HIV has been granted fast track designation and a rolling review process by the FDA.

Sign up for the BioTuesdays weekly newsletter

Get the latest news on the healthcare industry’s corporate and clinical developments, executive moves, and market updates. Every Tuesday, in your inbox.