CytoDyn receives FDA guidance for its HIV Biologics License Application dose justification report

CytoDyn Inc said it has received comments from the US Food and Drug Administration (FDA) on the company’s recently submitted dose justification report for its Vyrologix (leronlimab-PRO 140) drug, an important component to the company’s resubmission of its Biologics License Application (BLA) for HIV. The Vancouver, Washington-based late-stage biotechnology company is working to develop a significant advance in HIV treatment beyond the 'AIDS cocktail' combination of pills that has kept millions of people alive since the mid-1990s. In a statement, CytoDyn CEO Dr Nader Pourhassan said: “We are encouraged by the guidance and comments received from the FDA. Our management team and regulatory advisory team are confident that we will be able to successfully address these comments, allowing the further advancement of our BLA resubmission. In our view, this is a major step forward in our BLA process." READ: CytoDyn submits dose justification report on Vyrologix for HIV to the US Food & Drug Administration “This is an exciting period for CytoDyn. With the continuation of the BLA resubmission, the near-term initiation of two important coronavirus (COVID-19) trials in Brazil, and possibly a strong clinical trial in the US for COVID-19 long-haulers, the next two to three months could be transformative for the company,” he added. The FDA has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 plays a critical role in the ability of HIV to infect healthy T-cells and appears to be implicated in tumor metastasis and immune-mediated illnesses, such as non-alcoholic steatohepatitis (NASH), an advanced form of non-alcoholic fatty liver disease. The company successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected patients who were heavily treated. It also completed a Phase 2b/3 investigative trial with leronlimab used as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab as a monotherapy. If successful, it could support a label expansion approval. Clinical results to date from two trials have shown that leronlimab can maintain a suppressed viral load in a sub-population of R5 HIV patients who chose to switch from their daily pills regimen to a once-a-week subcutaneous dose of leronlimab. “Several patients on leronlimab’s Phase 2b extension arm have remained virally suppressed for almost 7 years and many patients in our Phase 2b/3 investigative trial are passing two and some four years of monotherapy with suppressed viral load,” said the company. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive