CytoDyn’s potential treatment, leronlimab, is currently being tested for patients deemed ‘mild-to-moderately ill’ and ‘severely ill’ with COVID-19.
According to the company, the treatment is being administered to patients in the New York City area as part of Phase I, Phase III, and Phase IIb/III clinical trials.
In order to ensure supply, CytoDyn has signed an extended manufacturing agreement with Ajinomoto Bio-Pharma Services for aseptic fill-finish services.
The two partners had already been working together for production of leronlimab for other therapeutics indications.
CytoDyn is exploring the monoclonal antibody for use across a variety of indications, including against HIV as both a monotherapy and as part of a combination treatment, which are both at the Phase III stage.
The company has also taken the treatment to Phase II stage for triple-negative breast cancer and Phase II against a total of 22 solid tumor types.
Leronlimab blocks the CCR5 cellular receptor, which is thought to play a role in tumor metastases and is an indicator of disease status in some cancers. It also plays a role in inflammatory conditions by modulating immune cell trafficking to areas of inflammation, the company suggested.
Yesterday, CytoDyn announced that it had submitted a request to the US Food and Drug Administration for ‘compassionate use’ of patients currently ineligible for its two ongoing clinical trials for COVID-19 patients. Currently, the company has 49 patients enrolled for treatment.