CytoDyn yanks BLA submission for leronlimab in HIV, blames CRO

Published: Oct 31, 2022

By Alex Keown

BioSpace

The hits keep coming for embattled CytoDyn and its quest to bring leronlimab to market. The company withdrew its pending Biologics License Application for the monoclonal antibody in HIV Friday, citing concerns involving the contract research organization managing its trials.  

At this time, CytoDyn does not intend to seek regulatory approval of leronlimab as a potential treatment for HIV patients in the multi-drug resistant population who have resistance to highly active antiretroviral therapy.

In a brief conference call Monday morning, CytoDyn president Cyrus Arman said leronlimab met its primary endpoints in clinical trials but that issues with the CRO would likely prevent a successful regulatory submission.

The company believes approval is not likely without significant investments to confirm the safety and efficacy of the drug in the HIV multi-drug-resistant population, CytoDyn announced Friday.  

CytoDyn has filed claims against the CRO seeking damages resulting from the businesses’ breach of the Master Services Agreement, Arman said during the conference call.

The company has initiated three independent audits related to the quality of the data collection and oversight by the CRO, he added. Those audits led to the decision to withdraw the BLA.

“It’s critical to note this doesn’t underscore leronlimab’s performance in clinical trials,” Arman said.

CytoDyn anticipates publishing safety and efficacy data from a Phase IIb/III trial in the HIV-MDR population. Arman said the data should be strong enough to release leronlimab from the partial clinical hold it has been under since March for the HIV program. The publication will shine a light on the potential of leronlimab in multiple indications, he added. 

CytoDyn has addressed three of the five questions raised by the FDA related to the clinical hold and it is working on submissions for the other two issues. Those are expected to be turned over to the FDA in the next few months, Arman said.

Leronlimab is an investigational humanized IgG4 monoclonal antibody that is designed to bind to C-C chemokine receptor type 5, a protein on the surface of some immune system cells. CCR5 is believed to play a role in numerous disease processes.

Although the future of this particular HIV indication may be in doubt, Arman pointed to other areas where leronlimab has shown significant promise, including oncology and non-alcoholic steatohepatitis. 

“We have solid clinical signals in these indications,” Arman said. “We plan to reenter the clinic in those indications and believe these steps will allow us to further build on the strong signals we have seen in these indications.”

Arman noted that the areas of NASH and solid tumors represent multi-billions of dollars in potential value for CytoDyn. Leronlimab earned Fast Track designation from the FDA in triple-negative breast cancer.

CytoDyn has been beset this year by clinical holds as well as an executive shakeup. In January, Nader Pourhassan was terminated as CEO as the company began a search for a leader with the industry experience to bring leronlimab to market.

During Pourhassan’s tenure, the FDA issued a rare public scolding to the company over its assessment of leronlimab as a potential COVID-19 therapy. The regulator accused CytoDyn of misrepresenting its clinical trial results for that indication, BioSpace reported. 

In July, CytoDyn tapped Arman as its new head. At that time, Arman told BioSpace leronlimab is a “unique molecule with the potential to help many individuals, particularly with unmet medical needs.”

On Monday, he said he was aware of the issues with the CRO prior to joining CytoDyn but that the potential of the drug was what drew him to the company in the first place.

Source: BioSpace