CytoDyn submits first part of biologics license application to FDA for flagship HIV drug leronlimab

CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech announced Monday that it has filed the non-clinical portion of a Biologics License Application for its flagship leronlimab (PRO 140) as a combination therapy for HIV using the US Food and Drug Administration (FDA)’s rolling review process. 

Leronlimab is an injectable antibody that shows promise as an anti-viral agent with fewer side effects, lower toxicity and less frequent doses than daily therapies now in use for the treatment of the human immunodeficiency virus (HIV).

The target of leronlimab is CCR5, a cell receptor that is the entry point for most strains of HIV, which causes acquired immune deficiency syndrome (AIDS).

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In March, CytoDyn said the FDA reviewed and accepted the company’s request and plans to submit, on a rolling basis, its planned biologics license application for leronlimab.

“This is the most important milestone yet in CytoDyn’s history,” CytoDyn CEO Dr Nader Pourhassan said in a statement. “We continue to execute on the submission of our BLA and are well positioned for potential revenue in 2020, subject to final approval.”

Pourhassan said the company is working to complete the clinical and chemistry, manufacturing, and controls (CMC) information portion of the biologics license application.

“We are also currently evaluating certain licensing opportunities relating to the commercialization of leronlimab upon approval,” said Pourhassan.

The biologics license application is a request for permission to introduce a biologic product for interstate commerce.

The non-clinical portion constitutes the first of three sections of the BLA submission for leronlimab as a combination therapy with HAART for HIV-infected patients. The FDA earlier granted Fast Track designation and recently agreed to a rolling review for leronlimab, which facilitates frequent interactions with the FDA review team.

The rolling review process allows CytoDyn to submit individual sections of the BLA for review, rather than waiting on an FDA review until all three sections are completed and filed.

Leronlimab (PRO 140) is a humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that plays multiple roles with implications in HIV infection, tumor metastasis, and immune signaling.

Since Pourhassan became CEO at the end of 2012, CytoDyn’s work on leronlimab as a therapy for HIV has proceeded from Phase 2 to the conclusion of a Phase 3 trial that could lead to commercial use.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Story by ProactiveInvestors