Weekly cover : Companies Developing 2019-nCoV Vaccine
Companies Developing 2019-nCoV Vaccine
On January 30, as the first human-to-human transmission of 2019-nCoV was reported in the US, the World Health Organization (WHO) declared the outbreak a public-health emergency of international concern.
Until date, the new virus has infected more than ten thousand people and killed more than 300. There is no immediate cure and a vaccine could be years in the making.
On January 10, 2020, Chinese officials released its genetic code, in order to help scientists identify where the virus probably came from, how it could mutate as the epidemic progresses, and how to protect people from it.
The WHO leads the global search for a vaccine for this emerging coronavirus, including three funded by The Coalition for Innovations in Epidemic Preparedness (CEPI).
In San Diego, scientists from Inovio are using a relatively new form of DNA technology to develop INO-4800, a potential vaccine to reach human trials by the early summer.
Moderna Inc. in Massachusetts has also joined forces with the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate the development of vaccines.
The University of Queensland is focusing on a “molecular clamp” platform, which facilitates the development of targeted and rapid vaccines against enveloped viruses of class I and III. On February 3, CEPI and GSK announced the collaboration on this vaccine program. GSK will make available its established platform technology for a adjuvant vaccine to enhance the development of an effective 2019-nCoV vaccine.
Other than the three, the following companies are also working on developing a vaccine for the virus.
|Jan. 23||Novavax||successful experience in the production of MERS and SARS vaccine|
|Jan. 27||GeoVax Labs and BravoVax||Modified Vaccinia Ankara – Virus-Like Particle (MVA-VLP) vaccine platform||BravoVax is a vaccine developer in Wuhan, China.|
|Jan. 29||Johnson & Johnson||begin developing a vaccine for the virus|
|Jan. 31||Gilead Sciences||experimenting remdesivir in a small number of patients in China|
CEPI is an innovative partnership between public, private, philanthropic, and civil organizations, launched at Davos, Switzerland in 2017. CEPI was created in the aftermath of the Ebola outbreak in West Africa to provide funding to develop vaccines to stop future epidemics. To date, CEPI has committed to investing over $456 million in vaccine and platform development.
Gilead Sciences Partners with China to Test Ebola Drug as New Coronavirus Treatment
Gilead is working with Chinese health authorities to establish a randomized, controlled trial to determine whether remdesivir can be used safely and effectively for the 2019-nCoV treatment.
Gilead’s remdesivir was introduced to the first U.S. patient, a 35-year-old man who developed pneumonia after testing positively for the 2019-nCoV virus at the Providence Regional Medical Center Everett in Washington State.
The first reported use of an experimental drug from Gilead Sciences Inc. to combat the novel coronavirus has encouraged doctors to further test the drug.
At the request of treating physicians, and with the support of local regulatory agencies, on January 31, Gilead Sciences announced that the company is working closely with global health authorities to respond to the 2019-nCoV outbreak through the appropriate experimental use of its investigational compound remdesivir.
Gilead Sciences developed remdesivir as a cure for Ebola virus disease and Marburg virus infections, although it was subsequently also found to display strong antiviral activity against more distantly related viruses such as MERS. Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use.
About Gilead Sciences
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops and markets innovative medicinal products in areas of unmet medical needs in the United States, Europe and internationally.
Eisai Commences Joint Research and Development of Cancer Gene Panel Test with Personal Genome Diagnostics to Accelerate Next-generation Drug Discovery and Development
In Eisai’s “EWAY2025” medium-term business plan, Eisai is seeking research focused on the field of neurology and oncology to achieve personalized medicine.
On January 29, Eisai Co., Ltd. announced that it has signed a Joint Research and Development Agreement with Personal Genome Diagnostics Inc. (PGDx), a US bio-venture with liquid biopsy genomic expertise, for the cancer genetic panel test and started the research.
Cancer Evolution, a sequence of processes such as changes in cancer cells, recurrence / metastasis and the creation of drug resistance, and genetic abnormalities of drug resistance to existing anti-cancer agents, will be examined by Eisai using circulating tumor DNA (ctDNA) in the blood using its own gene panel testing technology.
Eisai will also identify genetic abnormalities of drug resistance to existing anti-cancer agents that will be the focus of a new drug discovery and use a cancer gene panel test to develop new anticancer drugs for clinical trials.
Furthermore, Eisai aims to build an oncology ecosystem in which a longitudinal trajectory of patients with cancer will be monitored, leading to the creation of cures for patients with cancer as well as diagnosis for cancer prediction and prevention.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. The company positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer.
Astellas Submits sNDA for Evrenzo ® (roxadustat) Treatment Approval for Chronic Kidney Disease-associated Anemia in Non-dialysis-dependent Japanese Patients
Chronic kidney disease (CKD) is a gradual loss of kidney function induced by kidney damage caused by conditions such as hypertension, diabetes or inflammatory conditions. One in every 10 people worldwide live with CKD. CKD is predicted to become the fifth most common cause of premature death globally by 2040.
Anemia is a common early complication of CKD which affects about 20 percent of CKD patients. Anemia is associated in dialysis and non-dialysis populations with significant morbidity and mortality, increasing both in prevalence and severity as kidney disease worsens.
Roxadustat received regulatory approval in Japan last September to treat CKD-related anemia in dialysis-dependent (DD) patients, and approved in China for both NDD and DD patients.
On January 30, Astellas Pharma and FibroGen submitted a supplemental new drug application (sNDA) to the Ministry of Health, Labour and Welfare in Japan seeking marketing approval for Evrenzo® (roxadustat) for the treatment of anemia associated with CKD in non-dialysis dependent (NDD) patients.
Roxadustat is an oral hypoxia-inducible factor (HIF) prolylhydroxylase (PH) inhibitor. Three studies in more than 500 Japanese patients support the sNDA for the use of roxadustat in NDD-CKD patients, which establish the profile within groups of patients.
About Astellas Pharma
Astellas Pharma Inc. is a Japan-based company primarily engaged in pharmaceutical product research, production, manufacture, and sales. The Company participates in the manufacture and sale of pharmaceutical products through its subsidiaries in Japan, the United States, Europe, China, Korea, Taiwan and other countries.
FibroGen, Inc. operates as a research-based pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutic agents. The Company has a global approach to the development and commercialization of its products.
Korea Expands Free Hepatitis A vaccine to 40s
According to Korea Centers for Disease Control and Prevention (KCDC), the number of Hepatitis A patients has considerably increased. Last year, there were 17,638 patients with hepatitis A in Korea, up 624 percent from 2,437 in 2018.
The Korea Centers for Disease Control and Prevention (KCDC) announced on January 31 the country’s free Hepatitis A vaccination program. The targets are the high-risk community of hepatitis A, which has been tested for antibody detection and has been confirmed as no antibody.
Koreans in their 20s to 40s who were not told but received treatment before 2020 may get vaccination, and take an antibody test. Those in their 40s will receive free vaccination.
Under the Act on Prevention and Management, the National Health Insurance will make public the personal information of the 40s with a medical history of hepatitis A treatment.
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