CytoDyn Inc has announced more progress for its leronlimab candidate as a treatment for HIV, saying it has now submitted all the major sections of the chemistry, manufacturing, and controls (CMC) to the Food & Drug Administration (FDA) - the US regulator.
This CMC is a critical part of the biotech's Biologics License Application (BLA) for HIV - the request for permission to commercialize a product.
"We are pleased to get close to completion of our HIV full BLA submission," said Dr Nader Pourhassan, CytoDyn's CEO in a statement.
"We have only one more section (from the main three sections) to submit. With our resubmission of the non-clinical and CMC sections behind us, we are very excited to have our HIV and other activities back on track after the difficulties we experienced with our previous CRO."
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CytoDyn has successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected patients and the firm said it is now working diligently to resubmit its BLA for this HIV combination therapy since receiving a Refusal to File in July, 2020.
Pourhassan also noted: "Our CD15, Long-Hauler’s trial for COVID-19, was submitted for peer review yesterday, and we are also very close to submitting our manuscript of HIV CD02, Phase 3, data to a peer reviewed journal.
"We are extremely excited about both submissions. Also, in light of recent news about multi-drug resistance (MDR) HIV patients having problems with durable viral suppression, we are working on making a request to the FDA for approval of expanded use of leronlimab in the HIV, MDR population.
"We are grateful to CytoDyn’s new BLA team, under the supervision of Dr. Nitya Ray and his team, and previously Dr. Chris Recknor, for their excellent work in helping us to reach these milestones. We believe this will lead to a very successful 2022 for CytoDyn."
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel monoclonal antibody targeting the CCR5 receptor.
Contact the author at giles@proactiveinvestors.com