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CytoDyn to demonstrate superior potency of leronlimab in HIV patients at ASM Microbe 2019

The Vancouver biotech expects to complete the rolling review submission of the Biologics License Application for leronlimab with the FDA by the third quarter of 2019

Researchers in a lab
The US FDA has granted a “Fast Track” designation to leronlimab as a combination therapy with HAART for HIV-infected patients

CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech announced Wednesday that it would share the final results of a pivotal study of its flagship drug leronlimab (PRO 140) in heavily treatment-experienced HIV patients at the 2019 American Society for Microbiology (ASM) Microbe Conference.

The company has been selected to make both oral and poster presentations at the five-day ASM Microbe Conference starting on June 20 at the Moscone Center in San Francisco. It is the main forum for microbial sciences and connects top scientists.

READ: CytoDyn submits first part of biologics license application to FDA for flagship HIV drug leronlimab

“We are extremely proud to be able to present the results of our pivotal study for our lead drug candidate at this year’s ASM Microbe conference,” said CytoDyn Inc CEO Dr Nader Pourhassan in a statement. “The results of this pivotal study underpin the submission of our pending rolling Biologics License Application.”  

CytoDyn recently filed the non-clinical portion of a Biologics License Application for its flagship leronlimab as a combination therapy for HIV using the US Food and Drug Administration’s rolling review process.

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 HIV, which causes acquired immune deficiency syndrome (AIDS).

READ: CytoDyn forges deal with Samsung BioLogics to make $1B worth of leronlimab to meet expected demand

The CytoDyn team is working to complete the clinical and chemistry, manufacturing, and controls (CMC) information portion of the biologics license application.

The biologics license application is a request for permission to introduce a biologic product for interstate commerce.

“As previously announced, we expect to complete the rolling review submission of the BLA for leronlimab with the FDA by the third quarter of 2019,” said Dr Nader Pourhassan.

"Fast Track" designation

The US FDA has granted a “Fast Track” designation to leronlimab as a combination therapy with HAART for HIV-infected patients. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling.

Leronlimab has successfully completed nine Phase 1/2/3 clinical trials in over 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.

On a separate note, pivotal human immunodeficiency virus (HIV) monotherapy trial results with leronlimab (PRO 140) recently topped expectations. New data showed that a weekly dose of 525 mg and 700 mg of leronlimab yielded approximately a 90% response rate for HIV-infected patients who pass the first ten weeks of monotherapy without virologic failure.

The company said that if a 700 mg weekly dose of leronlimab is approved for combination therapy, the approval will serve as a foundation for a potential label expansion for leronlimab as a monotherapy for HIV.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter@UttaraProactive 

Quick facts: CytoDyn Inc.

Price: 2.66 USD

Market: OTCQB
Market Cap: $1.52 billion

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