CytoDyn to share data on flagship drug leronlimab at the American Association of Cancer Research

CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech developing its flagship leronlimab (PRO 140) candidate for multiple indications, announced that it will present two studies at the annual five-day American Association of Cancer Research (AACR) meeting.

In March, Cytodyn filed an application with the US Food and Drug Administration (FDA) seeking fast-track designation for its injectable antibody for patients with metastatic-triple negative breast cancer.

The biotech company said a preclinical study of its drug candidate leronlimab showed a 98% reduction of breast cancer tumor metastasis after seven weeks. The FDA, according to CytoDyn, recently cleared its investigational new drug (IND) application to initiate a Phase 1b/2 study for the addition of leronlimab, also known as PRO 140, to existing therapies for metastatic triple-negative breast cancer.

READ: CytoDyn announces filing of FDA fast-track application for breast cancer treatment

The target of leronlimab is CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling, according to Vancouver, Washington-based CytoDyn.

The first study to be presented on April 1 will present data showing the expression of CCR5 in circulating tumor cells (CTCs) of HER2 metastatic breast cancer (mBC) patients and documents the correlation between CCR5 and HER2 expression in circulating tumor cells.

The second study will highlight murine xenograft data showing that CytoDyn’s leronlimab can effectively block human breast cancer metastases and enhance the cell killing ability of DNA damaging chemotherapy by selectively targeting the CCR5 receptor.

“The key discoveries being announced today potentially contribute to a shift in the treatment paradigm for metastatic breast cancer patients,” said Professor Richard G. Pestell, who is the chief medical officer and vice chairman of CytoDyn.

The sustained reduction in breast cancer metastatic spread in these preclinical studies with leronlimab is consistent with a growing understanding that CCR5, the target of leronlimab, plays an important role in the process of cancer spread by metastasis.

“There are three key findings from today’s presentations. First, we now know that CCR5 is overexpressed on CTCs of HER2 metastatic breast cancer patients. Second, we now show in xenograft models that leronlimab can effectively block CCR5 positive breast cancer metastasis,” said Dr Pestell.

“Third, the study has now shown in murine xenograft models that by reducing the ability of breast cancer cells to metastasize, thereby keeping the tumor more contained, leronlimab can potentially provide standard DNA damaging chemotherapies more time to work. Potentially providing significantly improved efficacy of existing cancer therapies with fewer side effects.”

CytoDyn has now opened a clinical trial (NCT03838367) that is assessing the efficacy of leronlimab in metastatic triple negative breast cancer and will measure circulating tumor cells in the enrolled patients.

CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a related biologics license application in 2019.

The company is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Story by ProactiveInvestors