Cytodyn

CytoDyn is a biotechnology company focused on developing leronlimab, an investigational humanized monoclonal antibody designed to bind to C-C chemokine receptor type five (CCR5), a protein believed to play a role in various diseases. Leronlimab is being studied for treating infectious diseases like HIV, cancer, and autoimmune conditions. It is a once-a-week subcutaneous injection that competitively binds to the CCR5 receptor, differentiating it from other CCR5 antagonists.

For HIV treatment, leronlimab acts as a viral-entry inhibitor, protecting healthy T-cells from infection by blocking the predominant HIV (R5) subtype from entering those cells. In October 2022, CytoDyn voluntarily withdrew its Biologics License Application (BLA) for leronlimab as a combination therapy in HIV patients with resistance to highly active antiretroviral therapy (HIV-MDR).

In non-alcoholic steatohepatitis (NASH), leronlimab demonstrated the ability to inhibit fatty liver development in a preclinical model. Clinical data from a Phase 2a trial showed that the 350 mg dose reduced mean change in hepatic fat fraction and fibro-inflammatory activity from baseline, indicating potential benefit.

For oncology, CytoDyn reported leronlimab showed a median progression-free survival of 6.2 months in metastatic triple-negative breast cancer patients treated with doses between 525-700 mg. Leronlimab earned Fast Track designation from the FDA for this indication.

In March 2024, the FDA lifted the partial clinical hold on leronlimab's HIV program, allowing CytoDyn to evaluate the therapy's effects on chronic inflammation. However, the company faced setbacks, including a securities fraud case against its former CEO and disputes with the CRO managing its trials.

In July 2024, CytoDyn reached a USD 12 million settlement with Amarex, resolving legal claims between the companies. The settlement provided non-dilutive cash, eliminated USD 14 million in accounts payable, and released a USD 6.5 million surety bond to CytoDyn.