Gilead initiates Phase III studies for remdesivir, an investigational antiviral drug, Moderna ships batch of vaccine for Phase I study, and GSK provides adjuvants.

Gilead Sciences Initiates Studies of Investigational Antiviral Remdesivir for Coronavirus

Gilead Sciences has announced the initiation of two Phase III clinical studies to evaluate the safety and efficacy of remdesivir, an investigational antiviral drug, in adults diagnosed with COVID-19 (novel). These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases, beginning in March 2020.

The studies will assess two dosing durations of remdesivir, administered intravenously. The initiation of these studies follows the US Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug filing for remdesivir for the treatment of COVID-19.

The new clinical studies expand the ongoing research into remdesivir, which includes two clinical trials in China’s Hubei province led by the China–Japan Friendship Hospital as well as the recently initiated clinical trial in the US led by the National Institute of Allergy and Infectious Diseases (NIAID) of the US National Institutes of Health. Gilead has donated drugs and provided scientific input for these studies, with results from those in China expected in April 2020.

The Gilead studies will evaluate two dosing durations of remdesivir. One study will randomize approximately 400 patients with severe clinical manifestations of COVID-19 to receive either five or 10 days of remdesivir. The second study will randomize approximately 600 patients with moderate clinical manifestations of disease to receive five or 10 days of remdesivir or standard of care alone. The primary endpoint of both studies is clinical improvement, as described below.

Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. Working with government agencies, non-governmental organizations and local regulatory authorities, Gilead is providing remdesivir to qualified patients with COVID-19 on a compassionate use basis for emergency treatment outside of ongoing clinical studies.

Source: Gilead Sciences

Moderna Ships mRNA Vaccine Against Novel Coronavirus for Phase I Study

Moderna, a Cambridge, Massachusetts-based clinical stage biotechnology company specializing in messenger RNA (mRNA) therapeutics and vaccines, has released the first batch of mRNA-1273, the company’s vaccine against the novel coronavirus, for human use. Vials of mRNA-1273 have been shipped to the National Institute of Allergy and Infectious Diseases (NIAID), a part of the US National Institutes of Health (NIH) to be used in a planned Phase I study in the US.

mRNA-1273 is an mRNA vaccine against the novel coronavirus encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators at the NIAID Vaccine Research Center. The S protein complex is necessary for membrane fusion and host-cell infection and has been the target of vaccines against the coronaviruses responsible for Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). Manufacture of the batch of mRNA-1273 was funded by the Coalition for Epidemic Preparedness Innovations, an Olso, Norway-headquartered public–private coalition that seeks to derail epidemics by speeding up the development of vaccines.

mRNA-1273 was delivered from the company’s cGMP facility in 42 days from sequence selection. The company’s manufacturing plant in Norwood, Massachusetts manufactures Moderna’s portfolio of mRNA development candidates, including vaccines and therapeutics. To date, the company has produced and released more than 100 batches from its Norwood site for human clinical trials. mRNA-1273 is part of the company’s core prophylactic vaccines modality, which has had six positive Phase I clinical readouts across six different vaccines over the past four years.

Source: Moderna

GSK and China’s Clover Biopharmaceuticals To Research Coronavirus Vaccine Candidate

GlaxoSmithKline (GSK) and Clover Biopharmaceuticals, a Chengdu, China-based clinical-stage biopharmaceutical company, have entered into a research collaboration for Clover’s protein-based coronavirus vaccine candidate (COVID-19 S-Trimer). GSK will provide Clover with its pandemic adjuvant system for further evaluation of S-Trimer in preclinical studies. With in-house, commercial-scale cGMP biomanufacturing capabilities in China, Clover could potentially rapidly scale-up and produce large-quantities of a new coronavirus vaccine.

An adjuvant is added to some vaccines to enhance the immune response, thereby creating a stronger and longer lasting immunity against infections than the vaccine alone. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, thereby allowing more vaccine doses to be produced.

Under the research collaboration, Clover would combine GSK’s pandemic adjuvant system and Clover’s S-Trimer as a vaccine candidate. Upon knowing the genomic DNA sequence of the newly-identified SARS-CoV-2 virus as of January 2020, Clover scientists started designing the viral spike (S)-protein construct and completed its gene synthesis. Utilizing Clover’s patented Trimer-Tag technology, Clover has produced an S-Trimer subunit vaccine that resembles the native trimeric viral spike via a rapid mammalian cell-culture based expression system. Clover’s proprietary Timer-Tag technology has been recognized by antibodies produced by multiple previously infected coronavirus patients.

Source: GlaxoSmithKline

WuXi Biologics, Vir Biotechnology Partner in Antibody Development and Mfg for Coronavirus

WuXi Biologics, a contract biologics manufacturer, and Vir Biotechnology, a San Francisco-based biopharmaceutical company, have formed a development and manufacturing collaboration to advance and produce human monoclonal antibodies for the potential treatment of coronavirus disease 2019 (COVID-19), a disease caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

Under the terms of the agreement, the companies will work together on the clinical development, manufacturing, and commercialization of Vir’s proprietary antibodies. WuXi Biologics will conduct cell-line development, process and formulation development, and initial manufacturing for clinical development. If the antibodies receive regulatory approvals, WuXi Biologics has the rights to commercialize therapies in Greater China, and Vir has the rights to commercialize therapies in all other markets worldwide.

Vir has identified a number of monoclonal antibodies (mAbs) that bind to SARS-CoV-2. These antibodies were isolated from individuals who had survived a Severe Acute Respiratory Syndrome (SARS) infection. The company is conducting research to determine if its antibodies, or additional antibodies that it may be able to identify, can be effective as treatment and/or prophylaxis against SARS-CoV-2.

Source: WuXi Biologics

Harvard University, a China Research Institute Receive $115 M in Funding for Coronavirus Research

Through a five-year collaborative research initiative, Harvard University and Guangzhou Institute for Respiratory Health in China will share $115 million in research funding for the novel coronavirus provided by China Evergrande Group. The research will involve the Harvard Medical School and the Harvard T.H. Chan School of Public Health in partnership with the Guangzhou Institute of Respiratory Health in China and Zhong Nanshan, a pulmonologist and epidemiologist and head of the Chinese 2019n-CoV Expert Taskforce and a member of the Chinese Academy of Engineering. The purpose of the research is to elucidate the basic biology of the virus and its behavior and to inform disease detection and therapeutic design. The main areas of investigation will include: (1) rapid, more accurate diagnostic tests , including point-of-care testing; (2) understanding the body’s immune response and host-pathogen interaction , including identification of biomarkers that can help monitor the infection course and disease progression and forecast the onset of critical illness and life-threatening complications among infected patients; (3) vaccines to prevent infection; (4) antiviral therapies that shorten the duration of the illness and mitigate symptoms among those infected; and (5) treatments for those with severe disease.

Source: Harvard Medical School

Tonix Pharmaceuticals, Southern Research Partner for COVID-19 Vaccine

Tonix Pharmaceuticals, a New York-based clinical-stage biopharmaceutical company, has formed a strategic collaboration with Southern Research, a Birmingham, Alabama-based not-for-profit research group, to support the development of a vaccine, TNX-1800 (live modified horsepox virus vaccine for percutaneous administration) to protect against the new coronavirus disease, COVID-19, based on Tonix’s proprietary horsepox vaccine platform. 

Tonix is developing TNX-801 (live horsepox virus vaccine for percutaneous administration) as a potential smallpox preventing vaccine for the US strategic national stockpile and as a monkeypox preventing vaccine. The company believes that its proprietary horsepox virus has the potential to serve as a vector for vaccines to protect against other infectious agents.  The new research collaboration will develop and test a potential horsepox vaccine that expresses protein from the virus that causes COVID to protect against the disease.

Under the terms of the research collaboration, Southern Research will test one or more vaccine constructs in the Tonix horsepox vector that express one or more proteins or protein fragments from the virus that causes COVID-19.  The first such potential vaccine is TNX-1800.  

Source: Tonix Pharmaceuticals