CytoDyn Inc said that the US Food and Drug Administration (FDA) has accepted its revised “rolling review” timeline for the upcoming resubmission of its biologics license application (BLA) for leronlimab as a combination therapy for highly treatment-experienced HIV patients.
A rolling review enables a drug company to submit completed sections of its BLA for review by the FDA, rather than waiting until every section of the BLA is complete before the entire application is reviewed.
The late-stage biotechnology company also announced that it expects the non-clinical and CMC (chemistry, manufacturing and controls) sections of the BLA to be resubmitted to the FDA in November 2021. The clinical section of the BLA is anticipated to be completed and resubmitted during the first quarter of calendar 2022, it added.
READ: CytoDyn announces study to evaluate potential synergistic effects of Leronlimab with immune checkpoint blockade
“We are very pleased with the continued rolling review status of our upcoming BLA resubmission, which is expected to reduce the overall review time,” CytoDyn president and CEO Dr Nader Pourhassan said in a statement.
“Our BLA team, led by Drs Recknor and Ray, have remained so dedicated over the past several months to successful resubmission of our BLA, deserve kudos for this confirmation. With our new CROs (contract research organizations), we are very excited about the progress that we expect to achieve in the upcoming six months in not only HIV, but NASH (nonalcoholic steatohepatitis), cancer, and coronavirus (COVID-19) indications,” he added.
The FDA has granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat HIV and metastatic cancer. The first indication is a combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
The company said it is working with the FDA for a new long-hauler’s trial, which it hopes to start in November 2021. It intends to explore indications for stroke-based upon its experiences and results from Right-to-Try patients.
Given that leronlimab crosses the blood-brain barrier, the company said it is also exploring an indication for Alzheimer’s.
Contact the author at stephen.gunnion@proactiveinvestors.com