CytoDyn Inc shared an update to its previously reported preliminary results from its Phase 1b/2 trials and compassionate use of its flagship drug candidate leronlimab to treat a total of 30 metastatic triple-negative breast cancer (mTNBC) patients.
The Vancouver, Washington-based late-stage biotechnology company said that decrease in circulating tumor cells (CTC) as reported using the LifeTracDx test developed by Creatv MicroTech Inc, after induction with leronlimab was associated with a 400%-to-660% increase in modified progression free Survival (mPFS), 12-month Progression Free Survival (PFS) and a 570%-to-980% increase in modified overall survival (mOS), and 12-month overall survival.
“Decreases in CTC after leronlimab induction were seen in 73% of the 30 patients in the study,” said the company, while adding that LifeTracDx appears “to aid as a parallel diagnostic tool in identifying patients that respond to leronlimab”.
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CytoDyn said that data from the 30 patients are “aligned with the premise that a majority of mTNBC patients respond to leronlimab if CTC reduction is observed following one leronlimab dose.”
In a statement, CytoDyn Chief Medical Officer and Chairman Scott Kelly said: “We are delighted with the results of both mPFS and mOS when compared to the standard of care treatment for mTNBC across Emergency Use, Compassionate Use, mTNBC, and our Basket Trial.”
“We anticipate the demand for new therapeutic options with limited toxicity and enhanced convenience for the patient to grow exponentially over the next decade. We believe this is further evidence that leronlimab has a promising role in the future of oncology to help alleviate the burden of cancer on patients and their loved ones.”
Kelly said the firm is “exploring opportunities” to enhance its oncology platform through pharmacological partnerships, academic partnerships, and “research on combining synergistic benefits of leronlimab in the tumor microenvironment”.
Meanwhile, CytoDyn CEO Nader Pourhassan said the results for 30 patients suggests that, with one blood test, the company may be able to predict which mTNBC patients will respond well to leronlimab, which is a “truly remarkable finding”.
"These exploratory findings will now enable us to proceed for further regulatory review. With today’s report, we are delighted that we are presented with the possibility of achieving first approval with HIV, COVID-19 or possibly now cancer,” said Pourhassan. “We are grateful for the multiple opportunities we have had to create and explore as possible uses for this wonderful drug, leronlimab. The testimonies of physicians and patients about the use of leronlimab in cancer, COVID-19, and HIV has been nothing short of a dream come true for me.”
The US Food and Drug Administration 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 combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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