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CytoDyn has multiple shots on goal with its flagship drug leronlimab as cure for HIV, various cancers

Snapshot

Leronlimab is an antiviral agent candidate with fewer side effects, lower toxicity and less frequent doses than daily HIV therapies now in use

HIV-AIDS keyboard

Quick facts: CytoDyn

Price: 0.32 USD

OTCMKTS:CYDY
Market: OTCMKTS
Market Cap: $124.24 m
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  • CytoDyn’s main product candidate is leronlimab, 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 FDA has also given the greenlight to CytoDyn’s Phase 2 protocol for a combination therapy of leronlimab and Regorafenib to treat patients with metastatic colorectal cancer
  • In July, CytoDyn executed an exclusive licensing agreement with cell diagnostic company IncellDX to sell non-commercial grade quantities of its PA-14 antibody for use in the development of immunoassays for measuring CCR5 levels in human cells

What CytoDyn does:

CytoDyn Inc (OTCMKTS:CYDY), a Vancouver, Washington-based late-stage biotechnology company, is developing leronlimab (PRO 140) to battle multiple diseases. Most significantly, it 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.

At the helm of the company is Nader Pourhassan, who immigrated to the US from Iran as a teenager in 1977, two years before revolutionaries deposed the Shah. He holds a Ph.D. in mechanical engineering from the University of Utah. For 20 years, he managed his family business as well as authoring three books.

The company’s main product candidate is leronlimab, an injectable antibody that shows promise as an antiviral 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). The company agreed in 2012 to acquire leronlimab from its developer, Progenics Pharmaceuticals Inc (NASDAQ:PGNX).

CytoDyn is also exploring leronlimab's use in the treatment of cancer, inflammatory conditions and autoimmune diseases.

How is it doing:

On September 9, CytoDyn revealed that the US Food and Drug Administration has given the greenlight to its Phase 2 protocol for a combination therapy of leronlimab and Regorafenib to treat patients with metastatic colorectal cancer.

The FDA completed its safety review and allowed the company to proceed with its proposed clinical investigation. The 30-patient study is designed to test the hypothesis that a combination of injected leronlimab and Regorafenib taken orally will increase progression-free survival in patients with CCR5-positive metastatic colorectal cancer.

On a separate note, CytoDyn recently injected its first patient who has an aggressive type of breast cancer with leronlimab.

This treatment is in addition to the firm's ongoing Phase 1b/2 clinical trial on leronlimab for treating metastatic triple-negative breast cancer (mTNBC), for which it was granted fast-track status by the FDA in May this year.

It’s been a busy spell for the company which also filed an Investigational New Drug (IND) application and a Phase 2 clinical trial protocol with the US FDA for leronlimab to treat patients with non-alcoholic steatohepatitis (NASH).

NASH is a chronic liver disease characterized by liver inflammation and damage caused by a buildup of fat in the liver. Patients with this disease are often told they have a "fatty liver." The 60-patient, multi-center, placebo-controlled Phase 2 study is designed to test the safety and efficacy of leronlimab in adult patients with NASH. 

Since Pourhassan became CEO at the end of 2012, CytoDyn’s work on leronlimab as a therapy for HIV has proceeded from Phase 2 to the conclusion of a Phase 3 trial that could lead to commercial use. The company has so far successfully completed nine Phase 1/2/3 clinical trials using leronlimab in more than 700 people.

In August, Cytodyn said that a HIV monotherapy dose escalating trial with leronlimab topped expectations. The HIV-infected patients received 350 mg, 525 mg, or 700 mg of leronlimab once a week, with 150 patients showing “sustained viral suppression” after a year of monotherapy, the company said.

Separately, the rate of viral load suppression after 10 weeks of monotherapy was 68%, 94%, and 85% respectively for HIV-infected patients on a 350 mg, 525 mg, and 700 mg drug dose regimen.

In July, CytoDyn tapped Dr Jonah Sacha, a top AIDS research expert as the company’s senior science advisor. Dr Sacha will lead the development of leronlimab as a potential therapy for HIV pre-exposure prophylaxis (PrEP), and HIV cure.

Meanwhile, the FDA has requested an in-person meeting to discuss and potentially finalize the protocol for a trial of leronlimab as a single treatment for HIV patients.

Dr Pourhassan says a monotherapy with leronlimab, if approved, may allow patients with 'pill fatigue to maintain a disciplined compliance regimen.'

Leronlimab was previously granted Fast Track designation by the FDA for the treatment of HIV in combination with the “cocktail” known as highly active antiretroviral therapy (HAART), and for metastatic triple-negative breast cancer, a rare variety which doesn’t respond to some treatments

In November last year, the company completed its $15.4 million stock acquisition of privately held ProstaGene LLC, whose CEO, Richard Pestell, an oncologist, became CytoDyn’s chief medical officer and vice chairman. Pestell has published 500 published papers in peer-reviewed journals and controls the patents to Merck & Co Inc (NYSE:MRK ) and Pfizer Inc (NYSE:PFE) HIV drugs for use in cancer treatment.

Until Cytodyn can generate significant revenue, the company is financing its cash needs through public or private equity offerings, debt financings and strategic alliances. All told, the company has raised $200 million, according to Pourhassan.

Inflection points:

CytoDyn has many irons in the fire. As a result, a positive data readout for leronlimab in any one of the many clinical trial programs in the oncology, or HIV space can create serious momentum.

Just to recap, leronlimab is in a Phase IIb extension study for HIV as monotherapy; a rollover study for HIV as a combination therapy; Phase IIb/III investigative trial for HIV; Phase Ib/II trial for triple-negative breast cancer; and Phase II trial for graft-versus-host disease.

In July, CytoDyn executed an exclusive worldwide licensing agreement with cell diagnostic company IncellDX to sell non-commercial grade quantities of its PA-14 antibody for use in the development of immunoassays for measuring CCR5 levels in human cells. The late-stage biotechnology company’s PA-14 antibody is the diagnostic designation of the murine version of the flagship leronlimab drug.

CytoDyn will rely on this source of revenue and other funding platforms including licensing and partnering opportunities for the rest of the year as it tries to take its lead drug towards commercialization.  

In August, the FDA waived its fees for the company's pending Biologics License Application (BLA) for leronlimab as a combination therapy with HAART for HIV-infected patients.

What the boss says:

“Evolving prospects present many potential pathways to leverage the capabilities of leronlimab. We continue our product-readiness planning with Samsung BioLogics and look forward to preparing for our future with the objectives of benefiting patients and rewarding our shareholders,” CytoDyn CEO Nader Pourhassan has said.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

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Full interview: CytoDyn CEO says firm can be one of the top biotech...

CytoDyn Inc (OTCMKTS:CYDY) CEO Nader Pourhassan tells Proactive the biotech has dosed its first patient with metastatic triple-negative breast cancer using its flagship drug leronlimab, adding company has the chance of being one of the top biotech companies in the world, pending clinical...

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