Pharma COVID Roundup: News from J&J, Moderna, Fujifilm, and Sinovac
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The latest on manufacturing and potential treatments for COVID-19 with news from J&J, Moderna, Fujifilm, Sinovac, the European Medicines Agency, Gavi, and others.

J&J Initiates Global Phase III Trial of COVID-19 Vaccine Candidate
Johnson & Johnson (J&J) has launched a large-scale, multi-country Phase III trial for its COVID-19 vaccine candidate, JNJ-78436735.

The initiation of the trial follows positive interim results from the company’s Phase I/IIa clinical study. Following discussions with the US Food and Drug Administration (FDA), the Phase III trial will enroll up to 60,000 volunteers globally and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

J&J says it remains on track to meet its goal of providing one billion doses annually of the vaccine. It anticipates that the first batches of the COVID-19 vaccine, if proven to be safe and effective, will be available for emergency use authorization in early 2021.

The vaccine uses the company’s AdVac technology, which uses an adenovirus as a vector (a carrier), which has been genetically modified so that it can no longer replicate in humans and cause disease. The technology was also used to develop and manufacture the company’s Ebola vaccine, which has been approved by the European Commission, and for the constructs of its vaccine candidates respectively for Zika, respiratory syncytial virus, and HIV.

The Phase III trial is being initiated in collaboration with the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

In parallel, the company has also agreed in principle to collaborate with the UK government on a separate Phase III trial in multiple countries to explore a two-dose regimen of its COVID-19 vaccine candidate.

Source: Johnson & Johnson


Canadian Gov’t Ups Supply Contract for Modern’s COVID-19 Vaccine
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, reports the Canadian government has increased its confirmed order commitment of mRNA-1273, the company’s mRNA vaccine candidate against COVID-19, to 20 million doses.

The Canadian government maintains the option for an additional 36 million doses. This updated agreement comes as Moderna’s Phase III trial has enrolled more than 75% of its participants, of which 11,879 have received their second vaccination as of September 18, 2020.

Moderna says it remains on track to be able to deliver up to 56 million doses of its COVID-19 vaccine to Canada beginning in 2021. The Canadian vaccine supply will be sourced from Moderna’s European production capacity with its strategic manufacturing partner, Lonza, and Laboratorios Farmacéuticos Rovi of Spain, a pan-European pharmaceutical company and CDMO, for fill–finish services.

Source: Moderna


Sixty-Four Countries Join Global Initiative for COVID-19 Vaccine Development, Manufacturing
Sixty-four developed countries have joined the COVID-19 Vaccines Global Access (COVAX) Facility, a global initiative that brings together governments and manufacturers to deliver COVID-19 vaccines.

The COVAX Facility is part of COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, a global initiative to provide governments with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms and produced by multiple manufacturers. COVAX is led by Gavi, a global public health partnership, the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership focused on vaccine development against emerging infectious diseases, and the World Health Organization (WHO).

The COVAX Facility has received commitments from 64 higher-income economies, including commitments from 35 economies as well as a joint effort between the European Commission, 27 European Union member states, Norway, and Iceland. The 64 members of the facility will be joined by 92 low- and middle-income economies eligible for support for the procurement of vaccines through the Gavi COVAX Advance Market Commitment (AMC). The AMC is a financing instrument aimed at supporting the procurement of vaccines. More than 150 (156) economies are now either committed to or eligible for the COVAX Facility.

The agreements also commit higher-income governments to provide an upfront payment to reserve doses by October 9, 2020. These funds will be used to accelerate the scale-up of vaccine manufacturing to secure two billion doses of vaccine, enough to vaccinate one billion people, assuming the vaccine requires a two-dose regimen.

The COVAX Facility will now start signing formal agreements with vaccine manufacturers and developers to secure the doses needed to end the acute phase of the pandemic by the end of 2021. This is in addition to an ongoing effort to raise funding for both R&D and for the procurement of vaccines for lower-income countries via the Gavi COVAX AMC.

The Gavi COVAX AMC has raised around $700 million from sovereign donors as well as philanthropy and the private sector against an initial target of $2 billion in seed funding needed by the end of 2020.

Source: Gavi the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization


EMA OKs Dexamethasone as COVID-19 Therapy
Following a review by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), the EMA is allowing the use of the steroid, dexamethasone, as a treatment option for hospitalized COVID-19 patients who require oxygen therapy from supplemental oxygen to mechanical ventilation.

The EMA says that companies that market dexamethasone medicines can request this new use to be added to their product’s license by submitting an application to national medicines agencies or to the EMA.

Source: European Medicines Agency


Fujifilm Reports Positive Phase III Results of Influenza Drug for COVID-19
Fujifilm Toyama Chemical reports that Avigan, its antiviral drug being evaluated to treat COVID-19, has met the primary endpoint in a Phase III trial conducted in Japan for patients with COVID-19.

The efficacy primary endpoint is time-to-negative conversion of detectable SARS-CoV 2, the virus that causes COVID-19, in viral RNA in RT-PCR assays and for the alleviation of symptoms (as measured by body temperature, oxygen saturation, and chest images).

Fujifilm began a Phase III trial of Avigan in Japan in March 2020 for COVID-19 patients with non-severe pneumonia. Fujifilm says it will conduct a detailed analysis of the data obtained in this trial and will work to file an application for partial changes to include the additional indication in its regulatory filing as early as October (October 2020).

Approved for manufacture and sale in Japan as an influenza antiviral drug, Avigan selectively inhibits RNA polymerase necessary for influenza virus replication, according to information from the company. Due to this mechanism of action, the company says it is expected that Avigan may have an antiviral effect on COVID-19.

To meet the requests of the Japanese government to increase stockpiles of Avigan and by other countries to supply the drug, Fujifilm says it has been working to increase production of Avigan in collaboration with strategic partners.

Source: Fujifilm


Sinovac Begins Phase III Trials of COVID-19 Vaccine
Sinovac Biotech, a Beijing, China-based biopharmaceutical company, has commenced Phase III trials in Turkey for CoronaVac, its inactivated COVID-19 vaccine candidate.

The company says the Phase III clinical trial uses an adaptive design, and all participants will be enrolled in a step-by-step basis. In the first stage, 1,300 healthcare workers between the ages of 18-59 years old will be randomly selected to receive two doses of vaccine or placebo at a two-week interval. In the second stage, approximately 12,000 members of the general population between the ages of 18-59 years old will be enrolled to receive two doses of vaccine or placebo at a two-week interval.

The company has conducted Phase I/II trials in China of CoronaVac in adults and elderly volunteers. The company reports that the vaccine appeared to be well tolerated for different dosage and no serious vaccine-related adverse events were reported. In addition to Turkey, the company has partnered with several companies outside of China for Phase III efficacy studies.

Source: Sinovac


Arca Biopharma Submits IND Application for COVID-19 Drug
Arca Biopharma, a Westminster, Colorado-based company developing genetically targeted therapies for cardiovascular diseases, has submitted an investigational new drug (IND) application with the US Food and Drug Administration (FDA) to evaluate AB201, a small recombinant protein being developed as a potential treatment for RNA virus-associated disease, initially focusing on COVID-19, for the treatment of patients hospitalized with COVID-19.

Pending FDA feedback, Arca says it anticipates initiating the Phase IIb portion of a sequential Phase IIb/III clinical evaluation of AB201 as early as the fourth quarter of 2020.

Source: Arca Biopharma


NIH Awards $23 M in Contracts for Digital Health Services for COVID-19
The National Institutes of Health (NIH) has awarded seven contracts, with a potential total value of $22.8 million, to companies and academic institutions to develop digital health services to address COVID-19.

The digital health services include tools, such as smartphone apps, wearable devices, and software, which can identify and trace contacts of infected individuals, keep track of verified COVID-19 test results, and monitor the health status of infected and potentially infected individuals.

The contracts are being awarded in two phases. Phase One a will be used to demonstrate feasibility of the project. After assessment of Phase One results, a contractual option for Phase Two would provide additional funding for further development of the awardee’s program and demonstration of utility in response to the pandemic. If all seven projects were to move into the second phase, the total value of the contracts in this network would be $22.8 million. The awardees have one year to complete both phases.

The full list of the seven companies awarded the contracts can be found here.

Source: National Institute of Biomedical Imaging and Bioengineering

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