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Thursday, July 16, 2020

China gives the go-ahead for human trials of BioNTech’s COVID vaccine candidate

China has approved an early-stage trial in humans of German firm BioNTech’s (22UAy.F) (BNTX.O) experimental COVID-19 vaccine, its local partner Shanghai Fosun Pharmaceutical (600196.SS) (2196.HK) said on Thursday.
The potential vaccine is one of the two most advanced candidates that BioNTech is working on with its partner Pfizer Inc (PFE.N) and they received “fast track” status this week from the U.S. Food and Drug Administration which is designed to speed up the regulatory review process.
Fosun Pharma said in a filing that a unit will initiate a Phase I clinical trial of BNT162b1 “as soon as possible once it is ready”.
It is licensed to exclusively develop and commercialize COVID-19 vaccine products developed by using BioNTech’s mRNA technology in mainland China, Hong Kong, Macau and Taiwan.
The candidate is one of at least 23 being tested on humans in a frantic global race to find a vaccine the world is counting on to end a pandemic that has infected more than 13 million people and killed more than half a million.
Prior to the latest approval, Chinese researchers and companies have moved eight vaccine candidates into different phases of human trials at home and abroad.
Fosun Pharma agreed in March to pay up to $85 million in licensing fees to use BioNTech’s proprietary mRNA technology and invest $50 million for a stake in the German firm.


China’s Sinopharm begins late stage trial of COVID-19 vaccine in UAE

Chinese state-owned pharmaceutical company Sinopharm has begun Phase III clinical trials of a COVID-19 vaccine in Abu Dhabi using up to 15,000 volunteers, the government in the capital of the United Arab Emirates said on Thursday.
The human trial is a partnership between Sinopharm’s China National Biotec Group (CNBG), Abu Dhabi-based artificial intelligence and cloud computing company Group 42 (G42) and the Abu Dhabi Department of Health.
The study, which began on Wednesday, is the world’s first Phase III trial of an inactivated vaccine, G42 Healthcare CEO Ashish Koshy said. Inactivated vaccines are well known and have been used against diseases such as influenza and measles.
No COVID-19 vaccine has yet been approved for commercial use. According to a WHO summary of the state of vaccine development for COVID-19, there are 23 potential vaccines in human trials, with three of them in or starting large-scale late stage, or Phase III, trials to test efficacy.
The trial will test two vaccine strains and a placebo. Two doses three weeks apart will be administered and volunteers followed for a year, said Nawal Alkaabi, head of the UAE’s COVID-19 Clinical Management Committee.
Around 15,000 volunteers over three to six months will be recruited, initially in Abu Dhabi. They will be 18 to 60 years of age with no serious underlying medical issues and without previous COVID-19 infection, Alkaabi said.
Sinopharm chose the United Arab Emirates because around 200 different nationalities reside there and it has a focus on medical research and fighting the pandemic, Koshy said.
The UAE says it has conducted more than 4 million coronavirus infection tests on a population of around 9.6 million. It has recorded almost 56,000 cases of infection and 335 deaths.
Sinopharm secured approval for the trial in late June. The experimental vaccine passed Phases I and II of clinical trials with 100% of volunteers generating antibodies after two doses in 28 days, an Abu Dhabi government statement said.
China has been looking overseas to trial potential vaccines because of a lack of new patients at home. China’s Sinovac Biotech (SVA.O) is conducting Phase III trials of a vaccine in Brazil.
Sinopharm and G42 would not have access to patient data in the trial which would be conducted in Abu Dhabi state hospitals, G42 Healthcare research director Walid Zaher said, adding the UAE intended to manufacture any resulting successful vaccine.
G42 is an Abu Dhabi-based artificial intelligence firm that has partnered with Chinese genomics company BGI to build a COVID-19 testing laboratory in the emirate and with Israeli contractors to develop technologies to help fight the disease.
Koshy said the company was privately owned but declined to say by whom.
Like other Gulf states the UAE has developed close ties with China, seeking capital and technology to diversify its economy away from hydrocarbon revenues.
However, key ally the United States has warned Gulf states to proceed with caution and to consider their relationship with Washington.

Americans on COVID-19 jobless benefits spent more than when working – study

Americans who received enhanced unemployment benefits due to the coronavirus pandemic spent more than when they were working, a study released on Thursday said, adding to concerns about a steep fall in spending when the emergency benefits expire.
The $600 weekly supplement added to jobless benefits as part of the CARES Act helped unemployed households spend 10% more after receiving benefits than they did before the pandemic, according to research by the JPMorgan Chase Institute.
Researchers analyzed transactions for 61,000 households that received unemployment benefits between March and May. Spending dropped for all households as the virus spread and led to business shutdowns, but then rose when households began receiving jobless benefits, the study found.
That contrasts with a typical recession, when households receiving unemployment benefits usually cut spending by 7% because regular jobless benefits amount to only a fraction of a person’s prior earnings, the research found.
The analysis highlighted how the additional unemployment benefits are helping to prop up the U.S. economy and consumer spending after the pandemic led to a surge in joblessness across the country.
More than 30 million Americans are estimated to be receiving unemployment benefits – and they could be pushed off an income cliff when the supplemental benefits, which are due to expire at the end of July, are withdrawn.
“Our estimates suggest that expiration will result in large spending cuts, with potentially negative effects on both households and macroeconomic activity,” the researchers wrote.
The data also reflected the financial pain faced by households that encountered big delays in collecting benefits after states across the country were overwhelmed by applications.
Households that had to wait several weeks for their first unemployment check to arrive cut spending by about 20%, the study found. Spending recovered after the checks arrived.

Tiziana submits patent application for expanded use of foralumab

July 16, 2020

Tiziana Life Sciences (NASDAQ:TLSA) has submitted a patent application on potential use of Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), to improve success of CAR-T therapy for cancer and other human diseases.
The patent application conveys inventions related to improving CAR-T expansion and/or survival using anti-CD-3 mAbs administered either alone or in combination with other co-stimulatory molecules.
Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of regulatory T-cells.

AstraZeneca Brilinta reduced new stroke events in late-stage study

July 16, 2020

Following up on its initial announcement in January, AstraZeneca (NYSE:AZN) reports detailed results from a Phase 3 clinical trial, THALES, evaluating blood thinner Brilinta (ticagrelor), administered with aspirin, for preventing new stroke events in patients with acute ischemic stroke or transient ischemic attack. The data were just published in The New England Journal of Medicine.
90 mg of Brilinta taken twice daily with daily aspirin for 30 days reduced the rate of the primary composite endpoint of stroke and death by 17% (hazard ratio = 0.83) compared to aspirin alone, a statistically significant result.
The company’s supplemental marketing application for this indication is currently under FDA review with an action date next quarter.
Shares down 3% premarket on modest volume after yesterday’s 7% jump ahead of expected data on COVID-19 vaccine candidate AZD1222.

Johnson & Johnson EPS beats by $0.16, beats on revenue

Johnson & Johnson (NYSE:JNJ): Q2 Non-GAAP EPS of $1.67 beats by $0.16; GAAP EPS of $1.36 beats by $0.18.
Revenue of $18.34B (-10.8% Y/Y) beats by $610M.
Consumer Health revenue of $3.3B vs. consensus of $3.54B

Johnson & Johnson Q2 2020 Earnings Preview

Johnson & Johnson (NYSE:JNJ) is scheduled to announce Q2 earnings results on Thursday, July 16th, before market open.
The consensus EPS Estimate is $1.51 (-41.5% Y/Y) and the consensus Revenue Estimate is $17.73B (-13.8% Y/Y).
Over the last 2 years, JNJ has beaten EPS estimates 100% of the time and has beaten revenue estimates 88% of the time.
Over the last 3 months, EPS estimates have seen 2 upward revisions and 13 downward. Revenue estimates have seen 1 upward revision and 12 downward.
Q2 consumer division revenue of $3.54B.