CytoDyn Signs Letter of Intent for the Joint Development and Licensing of Leronlimab in China with Longen China Group - Seite 2

About 2019 Novel Coronavirus
The 2019 Novel Coronavirus (2019-nCoV) was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China.¹ The origin of 2019-nCoV is uncertain and it is unclear how easily the virus spreads.² 2019-nCov is thought to be transmitted person to person through respiratory droplets, commonly resulting from coughing sneezing and close personal contact.³ Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals.⁴ For confirmed 2019-nCoV infections, symptoms have included fever, cough and shortness of breath.⁵ It is believed that symptoms of 2019-nCoV may appear in as few as two days or as long as 14 days prior to exposure, and that symptoms in patients have ranged from non-existent to severe and fatal.⁶ There are currently no known anti-viral treatments effective at suppressing 2019-nCoV.⁷

About Triple-Negative Breast Cancer
Triple-negative breast cancer (TNBC) is a type of breast cancer characterized by the absence of the three most common types of receptors in the cancer tumor known to fuel most breast cancer growth–estrogen receptors (ER), progesterone receptors (PR) and the hormone epidermal growth factor receptor 2 (HER-2) gene.⁸ TNBC cancer occurs in about 10 to 20 percent of diagnosed breast cancers and can be more aggressive and more likely to spread and recur.^9,10 Since the triple-negative tumor cells lack these receptors, common treatments for breast cancer such as hormone therapy and drugs that target estrogen, progesterone, and HER-2 are ineffective.¹¹

About Leronlimab (PRO 140)
The U.S. Food and Drug Administration (FDA) have granted a “Fast Track” designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.  Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including NASH.  Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).