CytoDyn Inc (OTCMKTS:CYDY) said Tuesday that the first patient of a new Phase 1b/2 clinical trial for its metastatic triple-negative breast cancer (mTNBC) treatment, leronlimab, reported encouraging initial results.
In a statement, the Vancouver, Washington-based late-stage biotechnology company said circulating tumor cells in the patient’s blood decreased significantly after leronlimab therapy at both two-week and five-week time points.
Furthermore, a reduction in CCR5 expression on presumed metastatic tumor cells was evident, reported the company.
READ: CytoDyn's triple-negative breast cancer drug leronlimab given to first patient in clinical trial
“We are excited to be involved with CytoDyn in evaluating the efficacy of leronlimab in metastatic triple-negative breast cancer," said IncellDx CEO Bruce Patterson.
Efficacy against the most aggressive tumor type
“These results at both two-week and five-week time intervals post-leronlimab therapy indicate initial efficacy against this most aggressive tumor type. Moreover, the reduction of CCR5 expression on EMT cells may prove to be significant, as high CCR5 expression is believed to be crucial for metastases,” he added.
The treatment of mTNBC with leronlimab in the Phase 1b/2 trial is in addition to metastatic breast cancer patients treated with leronlimab under an emergency use investigational new drug.
The results of the trial will determine the company’s regulatory fate, particularly whether it will seek Breakthrough Therapy Designation and accelerated approval with the US Food and Drug Administration.
Fast Track designation for mTNBC
Leronlimab has been granted Fast Track designation for metastatic triple-negative breast cancer by the FDA, based on a greater than 98% reduction of metastatic tumor volume in a murine xenograft model.
Leronlimab was previously granted Fast Track designation for mTNBC based on its metastatic tumor reduction rate of more than 98% in mice and for part of a combination therapy in patients with HIV.
“Today marks yet another significant milestone in our company’s history, advancing CytoDyn’s clinical development in oncology. Although these are early results in our first patient, we are encouraged by the reduction in both circulating tumor cells and tumor size,” said CytoDyn CEO Nader Pourhassan.
The CytoDyn boss said the company’s safety record with leronlimab, and preclinical results in multiple oncology trials in various cancer indications, solidifies its vision to explore oncology indications.
“We are optimistic about the opportunity to provide a potential new therapeutic option for the women that are diagnosed with invasive breast cancer each year in the United States,” said Pourhassan.
“We wish to thank the women who have agreed to participate in our trials and will endeavor to provide each of them with clinical benefit," he added.
CytoDyn is developing leronlimab (PRO 140) to battle multiple diseases. Leronlimab has already completed nine clinical trials and been given to 800 patients in HIV treatment programs, Pourhassan said, without a single drug-related serious adverse event.
The drug itself works as an inhibitor of CCR5, a protein that plays a role in tumor invasion and metastasis. Blocking CCR5 has been shown to reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer.
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