CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech developing its flagship leronlimab (PRO 140) antibody for multiple indications including HIV, announced Monday that the FDA has reviewed and accepted its plan to submit on a rolling basis, its planned Biologics License Application.
A biologics license application is a request to distribute a biologic across states. In most cases, it is generally submitted after an Investigational New Drug (IND) after the appropriate studies have been conducted, according to the FDA website.
CytoDyn Inc is working to develop a significant advance in HIV treatment beyond the “AIDS cocktail” combination of pills that has kept millions of people alive since the mid-1990s.
The company’s main product candidate leronlimab, is an injectable antibody that 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. The target of leronlimab is CCR5, a cell receptor that is the entry point for most strains of the human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS).
“We are extremely proud of the effort of our entire team to reach this very important milestone,” CytoDyn CEO Dr Nader Pourhassan said in a statement. “We are grateful to the FDA for its timely and professional review and acceptance of our request for a rolling review of our planned BLA for PRO 140. As previously announced, we expect to complete the first section (of three) of the BLA for PRO 140 with submission to the FDA in March 2019.”
Pourhassan earlier said the company is already arranging meetings with potential commercial partners to assess distribution and prepare for the drug’s anticipated approval.
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.
Separately, CytoDyn was able to reduce the incidence of human breast cancer metastasis in a mouse model for cancer with flagship drug leronlimab, by more than 98%.
The biotech has filed for Orphan Drug designation to treat triple-negative breast cancer. It announced earlier this year that it will expand pre-clinical animal studies into eight cancer indications driven in part on prior research by Dr Richard G Pestell, suggesting that CCR5 inhibition may disrupt signaling and ultimately the spread of CCR5+ circulating tumor cells.
The company’s Philadelphia lab, led by Dr Pestell, will conduct eight pre-clinical studies on melanoma, pancreatic, breast, prostate, colon, lung, liver and stomach cancer.
Contact Uttara Choudhury at [email protected]