Amidst Controversy, CytoDyn Reports Early Leronlimab Data in NASH, Breast Cancer
Controversial biotech company CytoDyn announced two separate stories about its drug leronlimab today, one for nonalcoholic steatohepatitis (NASH) and the other for metastatic triple-negative breast cancer (mTNBC).
Leronlimab is a viral-entry inhibitor, binding to CCR5, protecting T-cells from viral infection. As such, it is being developed for HIV. Its antiviral effects have resulted in it also being developed for COVID-19. Because CCR5 plays a role in tumor invasion, metastases and control of the tumor microenvironment, the drug is also being investigated for certain types of cancer. Additionally, CCR5 is involved in modulating immune cell tracking to inflammation sites, which explains the COVID-19 investigations as well as the NASH studies.
NASH is a form of fatty liver disease, similar to cirrhosis of the liver, but in people who drink little or no alcohol. In the Phase II NASH study, CytoDyn reported preliminary findings from five patients receiving leronlimab. The data suggests the fatty deposits were decreased by as much as 45% in all five patients compared to the baseline measurement. Fibrosis, or scarring, was reduced by as much as 10% in four of the five patients.
“We are encouraged by the preliminary results from the open label portion of our NASH trial,” stated, Chris Recknor, senior executive vice president of Clinical Operations for CytoDyn.
For the breast cancer study, CytoDyn updated results on patients receiving leronlimab who had CCR5+ mTNBC who had failed at least two lines of previous therapy. The ongoing data analysis is from 28 pooled patients, 16 from the company’s Compassionate Use Study, 10 from a Phase Ib/II trial and two from the Basket Study.
Three-quarters, or 75%, of the patients who showed a lower level of circulating cells after receiving leronlimab, demonstrated a 3600% increase in 12-month overall survival (OS) compared to a 980% increase in OS reported by CytoDyn on August 25, 2021. The updated data also hints at a 580% increase in 12-month Progression Free Survival (PFS) compared to up to a 660% increase in PFS they reported on August 25.
Nader Pourhassan, CytoDyn’s president and chief executive officer, said, “We believe these updated results are very strong. Our chief operating officer, Dr. Nitya Ray, is leading our team in preparing a Breakthrough Therapy application to be submitted to the FDA this week.”
CytoDyn has had more than its fair share of controversy this year. In May, the U.S. Food and Drug Administration (FDA) published a “Statement on Leronlimab,” a rare public scolding by the agency accusing the company of misrepresenting its clinical trial data for leronlimab’s use in COVID-19. The statement focused on results from two clinical trials, CD10 in 86 mild-to-moderate COVID-19 patients, and CD12, in 394 patients, focused on severe symptoms of respiratory symptoms associated with COVID-19.
In March, the company’s Phase III leronlimab trial missed the primary endpoint of minimizing symptoms and missed all secondary endpoints, including if the drug decreased mortality for COVID-19. But CytoDyn put a positive spin on the data, focusing on a subgroup of 62 patients on mechanical ventilation, arguing the drug resulted in a 24% decrease in all-cause mortality and a six-day reduction in hospitalization. They then issued a press release describing an “age adjustment” analysis alleging leronlimab decreased mortality in older patients.
The FDA stated, “It has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparison.”
In addition to the stock plunging 27%, a shareholder filed a class-action lawsuit against CytoDyn, alleging it made false and misleading statements about leronlimab’s effectiveness in treating COVID-19. Another similar lawsuit was filed in April.
On September 20, CytoDyn announced it had resolved its lawsuit against the activist investor group led by Paul Rosenbaum and Bruce Patterson. The investor group had issued more than 30 pages of “corrective and new disclosures, including the corrective disclosures previously made in connection with the Court’s Stipulated Order. The new disclosures demonstrate that the Activist Group was not forthcoming with shareholders about its conflicts of interest, sources of funding and agenda at the outset.”
Rosenbaum/Patterson Group had attempted what CytoDyn called “an illegal proxy contest to take over control of the Company’s Board of Directors.”
More recently, STAT published a story suggesting that CytoDyn had knowingly submitted an application to the FDA that was incomplete. CytoDyn then issued a statement alleging that STAT was calling itself a health care journalism publication but instead behaved as a stock market advisory group.