CytoDyn Inc. (OTCQB:CYDY), a late-stage biotechnology company developing its flagship drug leronlimab for multiple indications, revealed that it has initiated the resubmission of its Biologics License Application (BLA) for HIV (human immunodeficiency virus) under rolling review consistent with guidance from the US Food and Drug Administration (FDA).
In a statement, CytoDyn CEO Nader Pourhassan said: “We are pleased to begin the HIV BLA resubmission process with continued guidance from the FDA. Due to the work of our management and regulatory advisory team, we believe the application’s issues have been successfully addressed, allowing us to advance the process.”
He added: “The resubmission will include non-clinical and chemistry, manufacturing, and controls (CMC) sections during November, followed by submission of the clinical section in Q1 of 2022. Meanwhile, we are very excited that patients who participated in the CD02, pivotal, Phase 3 trial, who needed to continue with leronlimab, are now reaching, in some cases, 4 years with suppressed viral load in an extension arm of our CD02 trial.”
READ: CytoDyn says US FDA accepts revised rolling review timeline for resubmission of its biologics license application
Pourhassan said that CytoDyn will also file for “expanded access use” of leronlimab for a fee to multidrug-resistant HIV patients who might need leronlimab urgently, “possibly as soon as next week.”
“CytoDyn ultimately selected a new BLA team to replace its prior contract research organization. While a difficult decision, it was in the company’s best interest due to the revisions needed in many areas of the BLA,” said Pourhassan. “We would like to thank our partners who worked over the past year to get us to where we are today. This is an exciting step for CytoDyn, and we look forward to sharing continued positive developments.”
The FDA has granted Vancouver, Washington-based company, Fast Track, designation to explore two potential indications using leronlimab to treat HIV and metastatic triple-negative breast cancer (mTNBC).
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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