- CytoDyn’s main product candidate is Vyrologix, an injectable antibody that shows promise as an anti-viral agent
- The company is preparing to release data from a Phase 2b/3 coronavirus study
- Two Phase 3 HIV trials have been completed
What CytoDyn does:
CytoDyn Inc (OTCMKTS:CYDY), a Vancouver, Washington-based late-stage biotechnology company, is developing Vyrologix (leronlimab or 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.
Vyrologix is an injectable antibody that shows promise as an antiviral agent with fewer side effects, lower toxicity and less frequent doses than daily therapies currently in use for the treatment of HIV.
The drug targets CCR5, a cell receptor that is the entry point for most strains of the human immunodeficiency virus (HIV), which causes AIDS. The company agreed in 2012 to acquire Vyrologix from its developer, Progenics Pharmaceuticals Inc (NASDAQ:PGNX).
Vyrologix has been 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, which a rare variety of the condition that doesn’t respond to some treatments.
CytoDyn is also exploring Vyrologix's use in the treatment of cancer, inflammatory conditions, autoimmune diseases and even the coronavirus (COVID-19).
How is it doing:
In August, CytoDyn shared an update to the previously-reported preliminary results from its Phase 1b/2 trials and compassionate use of its flagship drug candidate leronlimab to treat a total of 30 metastatic triple-negative breast cancer (mTNBC) patients.
The biotechnology company said that decrease in circulating tumor cells (CTC) as reported using the LifeTracDx test developed by Creatv MicroTech Inc, after induction with leronlimab was associated with a 400%-to-660% increase in modified progression free Survival (mPFS), 12-month Progression Free Survival (PFS) and a 570%-to-980% increase in modified overall survival (mOS), and 12-month overall survival.
CytoDyn said that data from the 30 patients are “aligned with the premise that a majority of mTNBC patients respond to leronlimab if CTC reduction is observed following one leronlimab dose.”
Earlier in the month, the company revealed it had received comments from the US Food and Drug Administration (FDA) on its recently-submitted dose justification report for its Vyrologix (leronlimab-PRO 140) drug, an important component to the company’s resubmission of its Biologics License Application (BLA) for HIV.
The FDA has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.
The company successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected patients who were heavily treated. It also completed a Phase 2b/3 investigative trial with leronlimab used as a once-weekly monotherapy for HIV-infected patients.
Also in August, CytoDyn announced that Brazil’s regulatory authority Agência Nacional de Vigilância Sanitária (ANVISA) had approved its previously-submitted clinical trial protocol for its flagship drug candidate leronlimab to start patient enrollment in the CD17 trial for severe coronavirus (COVID-19) patients.
The trial is intended to provide ANVISA with the requisite data to consider advancing the availability of leronlimab to Brazilians infected with COVID-19, said the company. The Phase 3 trial will be conducted in up to 35 clinical sites with 612 patients who are hospitalized and in need of oxygenation support.
Meanwhile in July, the company announced that drug candidate leronlimab had been granted US Patent No. 11,045,546 by the US Patent and Trademark Office (USPTO) for methods of treating COVID-19 infection.
The patent discloses methods of treating hyperinflammation — a common complication of COVID-19.
CytoDyn’s patent is expected to extend until June 15, 2040. The USPTO prioritized examination of CytoDyn’s patent application, resulting in the grant of this patent under the USPTO’s COVID-19 Prioritized Examination Pilot Program in just about one year.
Inflection points:
- Results from Phase 3 COVID-19 trial
- Address feedback from the FDA with regard to INDs and BLAs
- Continue to secure funding
What the boss says:
Commenting on its recent input from the FDA on the company’s Vyrologix (leronlimab-PRO 140) drug, CytoDyn CEO Dr Nader Pourhassan said in a statement: “We are encouraged by the guidance and comments received from the FDA. Our management team and regulatory advisory team are confident that we will be able to successfully address these comments, allowing the further advancement of our BLA resubmission. In our view, this is a major step forward in our BLA process."
Pourhassan added: “This is an exciting period for CytoDyn. With the continuation of the BLA resubmission, the near-term initiation of two important coronavirus (COVID-19) trials in Brazil, and possibly a strong clinical trial in the US for COVID-19 long-haulers, the next two to three months could be transformative for the company.”
Contact Sean at sean@proactiveinvestors.com
