SNBL has announced their intention to participate in the development of a prophylactic DNA vaccine for SARS-CoV-2, the disease which causes COVID-19. The role of SNBL is to plan and conduct the preclinical safety studies of the DNA vaccine, which has collaboratively been developed by AnGes, Inc. and Osaka University, in order to conduct the clinical trial as early as possible. This vaccine uses plasmid DNA technology which means that it can be produced faster than attenuated vaccines. DNA vaccines are safe and work by inoculating a plasmid encoding the protein of the target pathogen.
SNBL's mission is to free patients from suffering, by supporting drug development and improving medical technology, and participation in this project gives SNBL the chance to do so for those suffering from the novel coronavirus.
On April 7, 2020, Japanese Prime Minister Shinzo Abe declared a state of emergency in 7 areas of Japan due to COVID-19, including large cities such as Tokyo and Osaka. This does not apply to the areas in which SNBL's two major laboratories are located.
SNBL has already taken measures to keep our employees safe, such as increasing teleworking and securing supplies. We are doing what we can to keep people safe through research into vaccine and drug therapy safety.
SNBL is dedicated to business continuity while striking a balance with the safety of our employees, clients, and stakeholders. For more information on our business continuity plan, please contact firstname.lastname@example.org.
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).
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.
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.
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 will be exhibiting at the American College of Toxicology from November 17 to 20, 2019. If you are at ACT please pop by Booth #103 and let's chat about how we can support your drug development program.