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South Korea’s Genexine begins human trial of coronavirus vaccine

Biotech firm Genexine Inc has launched a human clinical trial of an experimental COVID-19 vaccine in South Korea, saying it has become the first company in the country to test such a vaccine candidate on people.
Genexine said it enrolled the trial’s first participants on Friday, and that it expects preliminary data on safety, drug tolerance and immune response from the trial in September.
Shares of Genexine jumped more than 14% on Friday.
“If everything goes as planned, we aim to complete all stages of our human clinical trial by the end of 2021,” said a Genexine official.
Woo Jung-won, executive vice president in charge of Genexine’s development division, told Reuters the trial follows “positive results of our DNA vaccine in animal tests, including primates.”
Genexine’s phase 1 trial in South Korea will involve 40 healthy participants, with a second phase to be conducted in the second half of the year with 150 participants in countries including Indonesia and Thailand, a Genexine official told Reuters.
The project is a collaboration between the International Vaccine Institute, drug manufacturer Binex Co Ltd and biotech firm GenNBio Inc as well as the state-run Korea Advanced Institute of Science & Technology and Pohang University of Science & Technology.
The World Health Organization website lists 13 experimental coronavirus vaccines as currently being tested on humans.
South Korean pharmaceutical maker Celltrion Inc said early this month it aims to start an in-human COVID-19 drug trial in July. Others including SK Bioscience and Green Cross Corp have said they are at the beginning stage of COVID-19 vaccine development.
https://www.marketscreener.com/GENEXINE-INC-20705487/news/South-Korea-s-Genexine-begins-human-trial-of-coronavirus-vaccine-30794599/

SK Biopharmaceuticals price tops range for South Korea’s biggest IPO in 3 years

Drugmaker SK Biopharmaceuticals Co Ltd priced its initial public offering on Friday at the top of its indicative range, aiming to raise 959 billion won ($794 million) in South Korea’s biggest IPO in three years.
SK Biopharmaceuticals in November became the first South Korean company to receive U.S. Food and Drug Administration approval for an independently developed drug, called Xcopri, which is a treatment for epilepsy.
The drugmaker seeks to revive an IPO market hit by geopolitical concerns and fears of another outbreak of COVID-19.
SK Biopharmaceuticals’ shares priced at 49,000 won, the top end of a range of 36,000-49,000 won per share indicated in a regulatory filing earlier this month.
The pricing values the company at 3.8 trillion won.
It will be the largest IPO in Seoul since Celltrion Healthcare raised 1 trillion won in its offering in July 2017.
SK Holdings Co Ltd will own 75% of the company after listing, expected on July 2.

https://www.marketscreener.com/SK-HOLDINGS-CO-LTD-6500857/news/SK-Biopharmaceuticals-prices-at-top-of-range-for-South-Korea-s-biggest-IPO-in-three-years-30794618/?countview=0

Regeneron and Sanofi’s Dupixent OK’d in China for atopic dermatitis

China’s National Medical Products Administration has approved Regeneron Pharmaceuticals (NASDAQ:REGN) and collaboration partner Sanofi’s (NASDAQ:SNY) Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis.

Sanofi will commercialize there under the companies’ partnership agreement.

https://seekingalpha.com/news/3584472-regeneron-and-sanofis-dupixent-okd-in-china-for-atopic-dermatitis

GoHealth on deck for IPO

GoHealth (GHTH) has filed a preliminary prospectus for a $100M IPO.

The Chicago, IL-based online health insurance marketplace leverages machine-learning algorithms with long-term insurance behavioral data to help individuals find the optimal health insurance plan for their specific needs. It says its differentiated combination of a vertically integrated consumer acquisition platform and highly skilled and trained licensed agents have enabled it to enroll “millions” of people in Medicare and individual and family plans since its inception.

Consumers pay no fees to access its platform or for enrollment, education or other services. In general, it earns commissions from carriers when consumers sign up for their products.

2019 (predecessor period) Financials: Revenues: $231.0M (+2%); Commissions: $175.8M (+22%); Operating Expenses: $287.9M (+46%); Net Loss: ($57.1M) (-303%); Cash Flow Ops: $9.3M (+72%).

https://seekingalpha.com/news/3584457-gohealth-on-deck-for-ipo

Immuron teams with Aussie agency on therapeutic for gut-mediated pathogens

Immuron (IMRN) provides an update on research collaboration with the Naval Medical Research Center (NMRC), previously announced in October 2019.

Immuron has executed a research agreement with Australia’s national science agency, CSIRO to produce the new therapeutic against Campylobacter and Entero-Toxigenic Escherichia coli (ETEC) for clinical evaluation by the US Department of Defense.

The NMRC has submitted the Pre-IND information package to the FDA.

CSIRO has been engaged to produce a hyper-immune bovine colostrum product using vaccines developed by the NMRC. The current program is back on track and bovine colostrum is expected to be harvested in September 2020.

The company has also fully executed the Research Subaward Agreement with The Henry M. Jackson Foundation for advancement of Military Medicine Inc.

The drug substance and drug product will be manufactured by the year end and NMRC plans to initiate clinical development program to prevent acute infectious diarrhea early next year.

https://seekingalpha.com/news/3584462-immuron-teams-up-aussie-agency-to-develop-therapeutic-for-gut-mediated-pathogens

Treatment underway in study of uniQure gene therapy in Huntington’s disease

The first two participants have been treated in a 26-subject Phase 1/2 clinical trial evaluating uniQure’s (NASDAQ:QURE) AMT-130 in patients with Huntington’s disease (HD), an inherited neurodegenerative disorder characterized by the deterioration of physical and mental abilities caused by the progressive breakdown of nerve cells in the brain.

The first two patients will be observed for an initial 90-day period followed by a review of the results by the Data Safety Monitoring Board before additional patients are dosed.

The primary endpoint is safety. Secondary endpoints include efficacy measures.

AMT-130 is a one-time administered AAV5 gene therapy that carries an artificial microRNA designed to silence the huntingtin gene, mutations in which cause HD.

https://seekingalpha.com/news/3584467-treatment-underway-in-study-of-uniqure-gene-therapy-in-huntingtons-disease