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CytoDyn Seeking to Expand Enrollment in Study Based on Promising Leronlimab Data

NEW YORK – CytoDyn announced Friday that based on the continued promising activity seen in early investigations of its CCR5 antagonist leronlimab in molecularly defined subsets of metastatic breast cancer patients, the company wants to rapidly expand enrollment in the clinical trial and enroll patients with other kinds of solid tumors.

In a Phase Ib/II trial, the firm is investigating previously untreated CCR5-positive, triple-negative metastatic breast cancer patients who test negative for estrogen receptors, progesterone receptors, and excess HER2 protein, but test positive for CCR5 overexpression. The expression statuses of patients are confirmed prior to trial admittance using an immunohistochemistry test. In late December, the company presented positive data from a metastatic TNBC patient and a stage IV HER2-positive metastatic breast cancer patient.

Updated data from the first patient treated with leronlimab and chemotherapy carboplatin showed that there was no detectable level of circulating tumor cells at 16 weeks. Additionally, the patient saw their epithelial mesenchymal transition (EMT) cells ─ which are indicative of cancer progression ─ reduced to zero.

The stage IV HER2-positive patient treated with leronlimab and carboplatin also had no detectable levels of circulating tumor cells after two weeks of treatment. This patient had a 70 percent reduction in EMT cells during this treatment period. Prior to the trial, the second patient had 18 identifiable tumor spots in her brain. Following two months of treatment with weekly doses of 700 mg of leronlimab, there were only three identifiable lesions when assessed with MRI.

Initial data from the third patient reports that circulating tumor cells dropped to zero and EMT cells were reduced after two weeks of treatment with leronlimab.

No adverse effects have been observed so far in the trial.

The company believes that the initial data are promising enough to explore the activity of the drug in a histology-agnostic fashion. "Today, we have heard from over 50 individuals who are waiting to be treated with leronlimab, and our regulatory team is reaching out to the FDA to organize an emergency Type C meeting to discuss the data evidenced in our clinical trials," said CytoDyn CEO Nader Pourhassan. "All patients' oncologists and CytoDyn's thought leaders will convene an urgent meeting to discuss strategy in order to bring immediate awareness of leronlimab's potential for all patients with solid tumors, which could represent approximately 22 different forms of cancer."