CytoDyn Inc. announced that new data shows that a weekly dose of 525 mg and 700 mg of leronlimab yielded approximately a 90% response rate for those HIV-infected patients who pass the first 10 weeks of monotherapy without virologic failure. Approximately 30% of subjects fail within the first 10 weeks of monotherapy on a 525 mg dosage and 17% at a dosage of 700 mg. Those patients who pass the first 10 weeks of monotherapy on a 525 mg dose have reached an average total of 32 weeks with sustained viral load suppression.
CytoDyn has recently filed the first of three sections of its BLA with the U.S. FDA for leronlimab for 700 mg weekly dose as a combination therapy with HAART for HIV-infected patients. The FDA previously granted Fast Track Designation and Rolling Review for leronlimab, which facilitates frequent interactions with the FDA review team. The Rolling Review process allows CytoDyn to submit individual sections of the BLA for review, rather than waiting on FDA review until all three major sections are completed and filed. The CytoDyn team is actively completing the remaining two sections of the BLA. If a 700 mg weekly dose of leronlimab is approved for combination therapy, the approval will serve as a foundation for a potential label expansion for leronlimab as a monotherapy for HIV.
CytoDyn has reached agreement with single cell diagnostics company IncellDx, Inc. to perform CCR5 genotyping and quantitative CCR5 expression profiling on cells potentially infectible by HIV to bring precision medicine to HIV therapeutics. Recent discussions with Dr. Bruce K. Patterson, CEO and Founder of IncellDx, Inc. and a top expert in CCR5, has revealed that through certain laboratory tests looking at the genetics and expression of CCR5 in individual patients, CytoDyn may more closely match the most effective dose for each HIV monotherapy patient to achieve viral suppression. This dose could be 350 mg, 525 mg, or 700 mg depending on the individual CCR5 receptor density of each patient.
“We are excited to help development efforts for the first self-injectable, subcutaneous monotherapy for HIV patients,” stated Dr. Patterson, whose work has also identified a role of CCR5 in immune cells that regulate the immune response against cancer. CytoDyn believes similar laboratory tests may ultimately prove to be of value in the areas of oncology and immunology as well.
“If leronlimab is proven to be a successful monotherapy and is approved by FDA, it would be a game changer for HIV patients, offering a safe, highly effective, durable, once weekly treatment option,” stated Dr. Nader Pourhassan, President, CEO and director of CytoDyn. “We are excited that our response rate with the 525 mg and 700 mg dosages is close to 90% for those patients who pass the first 10 weeks of monotherapy without virologic failure,” added Dr. Nader Pourhassan. “We believe HIV patients who have R5-tropic virus may respond to monotherapy with a different dose structure depending on their CCR5 density of each T-cell. We will explore a CCR5 receptor occupancy test and genotyping tests for each patient prior to initiating monotherapy with the goal of determining the right dose for each patient.” Dr. Pourhassan continued, “If we are successful, it would represent a major step forward in personalized medicine for treatment of HIV patients.”