CytoDyn Inc (OTCQB:CYDY) has announced that its flagship drug candidate, leronlimab, has been granted US Patent No. 11,045,546 by the US Patent and Trademark Office (USPTO) for methods of treating coronavirus (COVID-19) infection.
The patent discloses methods of treating hyperinflammation — a common complication of COVID-19.
The Vancouver, Washington-based late-stage biotechnology company said 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.
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“The granted claims relate to methods of facilitating normalization of the CD4 T cell/CD8 T cell ratios or increasing CD8 T cell frequency in SARS-CoV-2 infected subjects, comprising administering leronlimab or a binding fragment,” the company said.
CytoDyn noted that treated subjects may have mild, moderate, or severe COVID-19, exhibit no symptoms associated with COVID-19, or have cytokine release syndrome, acute respiratory distress syndrome (ARDS), hemophagocytic lymphohistiocytosis (HLH), or macrophage activation syndrome.
In addition, CytoDyn said the claimed methods include options for administering one or more therapeutic agent to the patient like an antiviral agent, a non-CCR5 immunomodulatory agent, a CCL5 binding agent, an immune checkpoint molecule inhibitor, or any combination.
In a statement, CytoDyn chief medical officer Scott Kelly said: “We are very pleased that the USPTO has recognized the beneficial clinical outcomes through the granting of this important patent. We are continuing to document numerous biomarkers through laboratory analyses to further support the clinical outcomes demonstrated by the patients in our trials and are confident this will further advance our regulatory goals in the US and abroad.”
Meanwhile, CytoDyn CEO Dr Nader Pourhassan said the collaboration among the firm’s clinicians and legal team “underscores” the multiple opportunities for leronlimab.
“Our steady push to reach the finish line includes our BLA for HIV, which we believe to be back on track, pursuit of Breakthrough Therapy designation based on significant positive results from our COVID-19 long-haulers trial (CD15), initiation of two COVID-19 trials in Brazil in the near future, reaching the targeted enrollment of 60 patients in our Phase 2 NASH trial ahead of the previously scheduled timeline with trial results expected before year-end, and many more developments anticipated later this year,” added Dr Pourhassan.
The US Food and Drug Administration (FDA) has granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic cancer. The first indication is a combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
Leronlimab binds to CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including nonalcoholic steatohepatitis (NASH). It has been studied in 16 clinical trials involving more than 1,200 people and has met its primary endpoints in a pivotal Phase 3 trial where leronlimab was combined with HIV standard care in patients with multi-drug resistance.
In addition, leronlimab reduced human breast cancer metastasis by more than 97% in a murine xenograft model. As a result, CytoDyn is conducting two clinical trials, one, a Phase 1b/2 in mTNBC, which was granted Fast Track designation by the FDA in 2019, and a second, a Phase 2, basket trial which encompasses 22 different solid tumor cancers.
The CCR5 receptor also plays a key role in modulating immune cell trafficking to sites of inflammation. After completing two clinical trials with COVID-19 patients (a Phase 2 and a Phase 3), CytoDyn initiated a Phase 2 investigative trial for COVID-19 long-haulers suffering long-term fatigue, sleep disorders and shortness of breath.
CytoDyn is also conducting a Phase 2 clinical trial for NASH to evaluate the effect of leronlimab on liver steatosis and fibrosis. There are no FDA approved treatments for NASH, which is a leading cause of liver transplant.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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