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CytoDyn’s leronlimab reduces by more than 98% human breast cancer metastasis in mouse xenografts

Based on strong results in its preclinical animal study, CytoDyn files for Orphan Drug designation for triple-negative breast cancer
A researcher in a lab
Leronlimab is an injectable antibody that also shows promise as an anti-viral agent with fewer side effects, lower toxicity and less frequent doses than daily therapies now in use for the treatment of HIV

CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech announced Wednesday that it was able to reduce by more than 98%, the incidence of human breast cancer metastasis in a mouse xenograft (tissue graft) model for cancer through six weeks with its flagship leronlimab (PRO 140) antibody.

As part of CytoDyn's recent acquisition of ProstaGene, CytoDyn received control of a prestigious lab in Philadelphia led by the company’s chief medical officer Dr Richard G Pestell. The company announced on Tuesday that the Philadelphia lab will conduct eight pre-clinical studies on melanoma, pancreatic, breast, prostate, colon, lung, liver and stomach cancer. CytoDyn pegged the cost of running the preclinical studies for the eight cancers and submission of Phase 2 IND applications at roughly $1.5 million.

READ: CytoDyn to initiate 8 preclinical animal studies with leronlimab for multiple cancers

Leronlimab (PRO 140) is a humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that plays multiple roles with implications in HIV infection, tumor metastasis, and immune signaling.

Based on the results, CytoDyn announced its plans for the expansion of pre-clinical animal studies into eight cancer indications, driven in part on prior research by Dr Pestell, suggesting that CCR5 inhibition may disrupt signaling and ultimately the spread of CCR5+ circulating tumor cells.

In Dr Pestell’s research laboratory, pre-clinical studies were conducted on mice using Pfizer’s HIV drug maraviroc in breast and prostate cancer.  Results were most encouraging using these CCR5 inhibitors, which ultimately led Dr Pestell to design experiments applying leronlimab (PRO 140) to metastatic mouse models. The results of this pre-clinical study using leronlimab (PRO 140) in mice showed a reduction in breast cancer metastasis of more than 98% over the six-week period of the study.

The mouse xenograft model is designed to mimic human breast cancer metastasis. The biotech said it is optimistic after finding more than 98% reduction in tumor metastasis over a six-week period in the mouse model. The “temporal equivalency” of the six weeks study, may be up to six years in humans, pointed out the company.

“These positive pre-clinical results are very promising, and it gives new hope for future treatment options to cancer victims all over the world,” said CytoDyn CEO Dr Nader Pourhassan in a statement. “We are working diligently to present an abstract of this data in conference as soon as possible.”

The CEO said their findings could result in “new treatment options of this kind” for late-stage cancer patients, who often experience deadly metastasis.

“Should CytoDyn’s mouse xenograft breast cancer metastasis studies using leronlimab (PRO 140) correlate in humans as Pfizer’s drug maraviroc did in colon cancer, in a trial conducted in Germany, this could open new possibilities for treatment options for breast cancer,” said Dr Pourhassan.

He said the company was looking forward to interim data from its human trial in triple-negative breast cancer, which is expected to be available within the next few months.

“If interim results are positive, we will promptly file for breakthrough therapy designation,” said Dr Pourhassan. “Negotiation of potential licensing opportunities has started on several fronts. We hope to reach a definitive deal regarding a commercialization partnership for HIV and/or GvHD, which would further enhance the trajectory of our company.”

Contact Uttara Choudhury at [email protected]

Follow her on Twitter@UttaraProactive 


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