CytoDyn has announced strong data from patients in its clinical trials involving CCR5 antagonist leronlimab (PRO 140) in metastatic triple-negative breast cancer (mTNBC) and metastatic breast cancer (MBC).
According to the firm, the new data derived from the first patient enrolled in the mTNBC Phase Ib/II trial did not indicate detectable levels of circulating tumour cells (CTC) with leronlimab in combination with carboplatin at 16 weeks of treatment.
Furthermore, the first patient experienced significant reductions in epithelial-mesenchymal transition (EMT) cells, dropping to zero following five weeks of the treatment and currently at zero EMT.
The new data drawn from the second patient enrolled in this trial did not indicate detectable levels of CTC with leronlimab in combination with carboplatin after two weeks of treatment.
Moreover, this patient indicated a 70% reduction in EMT cells following two weeks of treatment.
Similarly, initial data on the third patient in the mTNBC trial showed the CTC being dropped to zero following two weeks of treatment with leronlimab.
CytoDyn advisor and diagnostic partner IncellD founder and CEO Bruce Patterson said: “Remarkably, the new patient enrolled in the clinical trial showed a significant drop in CTC and a reduction of EMT cells, the putative metastatic cells from seven per 4mL of blood to two cells in just two weeks of treatment with leronlimab in combination with carboplatin.
“The rapid response to the treatment in a pattern that is identical to previous patients is equally as remarkable and supports a predictable method of action for this drug. Additionally, no adverse effects were observed in the clinical trials, further supporting leronlimab’s potential safety profile.”
New findings from the patient enrolled through an emergency investigational new drug (IND) who was suffering from stage 4 HER2+ MBC that had metastasised to the liver, lung and brain, did not indicate any new metastasis in the brain following treatment with leronlimab.
Prior to enrolment in the trial, the patient had 18 tumour spots in the brain. After two months of weekly 700mg doses of leronlimab, the patient had three identifiable lesions as indicated in an MRI.
A new round of radiation has been cancelled for the patient due to the results.
CytoDyn president and CEO Nader Pourhassan said: “We are excited to see this continuous spectacular data that further supports leronlimab as a potential game-changing treatment for patients living with cancer.
“As a company, our hope is to bring suffering patients safe and effective treatment options. 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.
“This is an extremely exciting time for CytoDyn as we continue to demonstrate our commitment to patients through the development of leronlimab.”