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Tokyo, Japan March 12, 2020  A client of Shin Nippon Biomedical Laboratories, Ltd. (hereafter, SNBL), CytoDyn Inc. (Vancouver, Washington, USA, hereafter CytoDyn) has filed an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in order to conduct a Phase 2 clinical trial using leronlimab (PRO 140) as a therapy for patients who have respiratory complications as a result of the novel coronavirus disease 2019 (COVID-19). COVID-19 is the respiratory disease that may result from contraction of SARS-CoV-2, which was recently declared a global pandemic by the World Health Organization (WHO). Researchers all over the world are working on therapeutic pharmaceuticals to treat COVID-19, and SNBL would like to introduce CytoDyn’s therapy.

Although COVID-19 has spread throughout the world and is a threat to both individuals and to society, research and development of therapeutics is progressing at a rapid pace around the world, including at CytoDyn. SNBL Group’s mission is to free patients from suffering, by supporting drug development and improving medical technology, and we sincerely hope that that therapeutic drugs will reach patients as soon as possible. SNBL contributes to that mission by working with clients such as CytoDyn.

About Leronlimab and COVID-19

According to CytoDyn’s press release on March 9, 2020, their trial using leronlimab will focus on patients that develop mild-to-moderate respiratory illness after transmission of COVID-19.

CytoDyn president and Chief Executive Officer Nader Pourhassan, Ph.D. states that “we believe leronlimab could reduce the inflammation which contributes to Acute Respiratory Distress Syndrome (ARDS).” The migration into areas of inflammation of tregs, which can inhibit the innate immune response against pathogens, can be mitigated by Leronlimab.  The serious damage in the lungs exhibited by some patients is caused by migration of macrophages and the release of inflammatory cytokines including TNF and IL-6 (called a cytokine storm). 

About Leronlimab

The US FDA have granted CytoDyn a “Fast Track” designation for two potential indications of leronlimab; for HIV as a combination therapy with HAART and for metastatic triple-negative breast cancer.  In late 2019, CytoDyn announced that they signed agreements to commercialize leronlimab after securing manufacturing contracts. Leronlimab masks a cellular receptor that is important in HIV infection

Leronlimab’s target is CCR5, a cellular receptor that is immunologically important. The CCR5 receptor is a protein located on the surface of various cells, including leukocytes and cancer cells. On leukocytes, they act as receptors for chemoattractants called chemokines. The CCR5 receptor is also required for HIV to infect healthy T cells. Recent studies identified the CCR5 receptor as an important target for many disease processes, including cancer metastasis and certain immunological conditions.

Leronlimab is a unique humanized monoclonal antibody that belongs to a new class of HIV / AIDS treatments that prevents HIV from using the CCR5 receptor as an entry gateway for healthy cells and protects healthy cells from viral infections, in comparison with HAART, the current standard of care for HIV, which allows the virus to enter the cell and start replicating before it can attack the virus. Other benefits of leronlimab include an improved safety profile, longer half-life, and reduced dosing frequency.

About CytoDyn

CytoDyn is a biotechnology company focused on developing innovative treatments for multiple therapeutic indications. Their lead candidate compound, leronlimab, belongs to a new class of therapeutics called viral entry inhibitors, and is one of the most advanced experimental monoclonal antibodies for the treatment of HIV.

About SNBL

Shin Nippon Biomedical Laboratories, Ltd. (hereafter, SNBL) is a preclinical contract research organization (CRO) that was founded in Kagoshima, Japan in 1957. SNBL’s mission is to free patients from suffering, by supporting drug development and improving medical technology, and has focused since its founding on the preclinical studies necessary for the development of pharmaceuticals, medical devices, and products such as regenerative medicine. Preclinical safety studies in drug development are conducted to clarify the characteristics of new drug candidate compounds and their in vivo effects with reliable data. SNBL’s strength is conducting preclinical safety and efficacy studies, and pharmaceutical companies, biotech ventures, universities and research institutions trust SNBL to provide the data they need for their invaluable research.

 SNBL and Medgaea Life Sciences, Ltd. (MDG) have signed an agreement for Medgaea Life Sciences to represent SNBL in Taiwan.

The pharmaceutical industry is growing in Taiwan with government support, concentrated around biopharmaceuticals. With its close location and commitment to quality, SNBL is a great choice for preclinical contract research for Taiwanese organizations.

MDG was established in Taiwan in 2005 and offers a variety of preclinical contract research services for medical devices, health foods, pharmaceuticals, and herbal remedies. SNBL and MDG have an excellent cooperative relationship.

The partnership between SNBL and MDG will offer an abundance of support for R&D of pharmaceuticals, medical devices, and regenerative medicine in Taiwan.