CytoDyn Inc. (OTCQB:CYDY) has revealed strong updated results from its current cancer study on leronlimab, a monoclonal antibody investigational drug the company is developing, suggesting a sharp rise in survival rates.
The study uses varying doses of the drug to treat 28 patients with CCR5+ Metastatic Triple-Negative Breast Cancer (mTNBC), who had failed at least two lines of previous therapy.
A 12-month analysis of 28 mTNBC patients receiving leronlimab suggests an increase of 3,600% in 12-month overall survival (OS) in 75% of patients with a lower level of circulating cells after leronlimab induction, or at baseline, compared to a 980% increase in overall survival reported by the company on August 25 this year, the Vancouver and Washington-based late-stage biotechnology company said in a statement.
The ongoing updated analysis is from 28 pooled patients, 16 from its Compassionate Use Study, 10 from the Phase 1b/2 Study, and 2 from the basket study.
READ: CytoDyn says Brazil approves pivotal Phase 3 clinical trial of leronlimab in critically ill coronavirus patients
The updated analysis also demonstrates a 580% increase in 12-month Progression Free Survival (PFS), compared to up to a 660% increase in PFS reported by the company on August 25, 2021. The results were determined by the LifeTracDx test developed by Creatv MicroTech Inc. The test also appears to help as “a parallel diagnostic tool” in identifying patients that respond to leronlimab, said the company.
In a statement, CytoDyn CEO Nader Pourhassan 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 United States Food and Drug Administration (FDA) this week.”
Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. It includes more intensive FDA guidance on an efficient drug development program, and eligibility for rolling review and priority review.
Phase 2 NASH open label leronlimab trial
In a separate statement, CytoDyn shared preliminary results from the first five patients treated with leronlimab in its open label Phase 2 trial for Non-alcoholic steatohepatitis (NASH), an advanced form of non-alcoholic fatty liver disease.
The preliminary findings from five patients treated with leronlimab suggested fatty deposits were lowered on all 5 patients by as much as 45%, as compared to the baseline measurement. In addition, fibrosis was also lowered by as much as 10%, in 4 out of 5 patients as compared to the baseline measurement (one patient exhibited no change in fibrosis).
The Phase 2 trial for 90 patients is designed to test whether leronlimab may inhibit the devastating liver fibrosis associated with NASH. As previously reported, the company’s preclinical study demonstrated strong positive data, highlighting leronlimab's potential in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to NASH.
“Inhibition of CCR5 has been shown to be effective in reducing fibrosis in animal models of NASH liver fibrosis,” noted the company.
Nonalcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease in adults worldwide, according to researchers. There are currently no FDA-approved treatments for NASH, and it is expected to be the number one cause of liver transplants. About 30 to 40 percent of adults in the US are living with NAFLD, and 3 to 12 percent of adults in the US are living with NASH.
Chris Recknor, who is the senior executive VP of Clinical Operations, at CytoDyn said the company is “encouraged” by the preliminary results from the open-label portion of its NASH trial.
“The CT reduction from baseline for these patients is approximately 40 msec, which would be consistent with an observed reduction in fibrosis on biopsy,” added Recknor. “We expect data lock in December with results from the 700 mg double blind placebo-controlled Part 1 and the remaining Part 2 open label with 350 mg.”
The company said it is working on a new Phase 2b/3 protocol to include biopsy to start in January 2022 with Cato Research LLC, which has “extensive experience with NASH trials.”
“We believe these early findings represent a very significant therapeutic opportunity for patients suffering from this disease, encouraging us to aggressively pursue a NASH indication with potential for Breakthrough Therapy designation,” said Pourhassan. “Our team is currently preparing the BTD application for 350 mg arm, which could include 10 patients’ data by mid-November. We are also very optimistic for our 700 mg arm, which was double blinded; and we hope to unblind the data and announce those results in early December.”
The FDA has already granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic cancer. The first indication is a combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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