Potential COVID-19 vaccine from China shows promise in animal tests

A potential COVID-19 vaccine being developed by Chinese researchers showed promise in trials in monkeys, triggering antibodies and raising no safety issues, researchers said, and a human trial with more than 1,000 participants is under way.
The vaccine candidate, called BBIBP-CorV, induced high-level neutralising antibodies that can block the virus from infecting cells in monkeys, rats, guinea pigs and rabbits, researchers said in a paper published in online by the medical journal Cell on Saturday.

“These results support the further evaluation of BBIBP-CorV in a clinical trial,” researchers said in the paper.
BBIBP-CorV, developed by Beijing Institute of Biological Products affiliated to state-owned China National Pharmaceutical Group (Sinopharm), is among five candidates China is testing in humans.

More than 100 potential COVID-19 vaccines are in various stages of development around the world. Among front runners currently in human trials are being developed by AstraZeneca, Pfizer, BioNtech, Johnson & Johnson, Merck, Moderna, Sanofi and China’s CanSino Biologics.
As well as appearing safe and able to generate an immune response in animals, BBIBP-CorV did not appear to trigger antibodies that could boost the infection – a phenomenon known as antibody-dependent enhancement (ADE)- the researchers said, although this does not necessarily guarantee ADE won’t occur in human tests.
Apart from BBIBP-CorV, Sinopharm, which has invested 1 billion yuan ($141.40 million) in vaccine projects, is testing in humans another vaccine candidate developed by its Wuhan-based unit. The two shots have been given to more than 2,000 people in clinical trials.
https://www.reuters.com/article/us-health-coronavirus-vaccine/potential-covid-19-vaccine-from-china-shows-promise-in-animal-tests-idUSKBN23H15J

Alnylam’s shares dip as analyst backs rival after rare disease data reveal

Alnylam has revealed the data that forms the basis of its filings for its latest potential rare disease drug lumasiran, but shares dipped after an analyst suggested it could be outperformed by a contender from rival biotech Dicerna.
The RNA therapeutics specialist announced the phase 3 data from the ILLUMINATE-A study of lumasiran, which is in development for the ultra-rare condition primary hyperoxaluria type 1 (PH1). 
Lumasiran is the first drug shown to help patients with the ultra-rare disease clear a toxic substance called oxalate from their kidneys and other vital organs and – if approved – would become Alnylam’s third product based on its RNA interference platform. 
It is already under review with the FDA and regulators in Europe for PH1, which is caused by a mutation in a gene called AGXT that leads to a deficiency in the AGT enzyme responsible for preventing the build-up of oxalate. 
In its absence, the substance is deposited in the kidneys, urinary tract and other organs causing tissue damage and – if untreated – can progress to end-stage renal disease that may require dialysis or a kidney transplant. Lumasiran switches off production of a precursor to oxalate. 
The latest clinical data was presented at a virtual session of the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA). 
In the 39-patient ILLUMINATE-A study, lumasiran met the primary efficacy endpoint of 24-hour urinary oxalate reduction from month three to month six relative to placebo and all tested secondary endpoints. 
In 26 PH1 patients aged six years and older treated with lumasiran, there was a 65.4% mean reduction in urinary oxalate relative to baseline, with a mean treatment difference of 53.5% relative to the 13 patients in the trial’s placebo arm. 
The mean maximal reduction with lumasiran was 76%, similar to results of 75-76% seen in phase 1/2 and phase 2 open label extension studies using a different assay method. 
Lumasiran also showed a 62.5% mean reduction in 24-hour urinary oxalate:creatinine ratio – an alternative measure of urinary oxalate excretion – relative to baseline, with a mean treatment difference of 51.8% relative to placebo. 
Safety-wise there were no deaths and no severe or serious adverse events reported and adverse events were reported in 22 out of 26 of lumasiran patients versus nine out of 13 placebo patients. 
However shares in Alnylam were down more than 3% on the Nasdaq following the announcement after RBC Capital analyst Luca Issi told investors that a rival from Dicerna Pharma may outperform it if approved. 
Dicerna’s drug has a more patient-friendly fixed dosing approach and could have a broader label tackling all PH subtypes. It may also capitalise on Alnylam’s “heavy lifting” on disease awareness, said Issi. 

Alnylam’s shares dip as analyst backs rival after rare disease data reveal

Substance use up amid pandemic

Some people with substance use disorders have increased their usage during the pandemic, according to a survey released Tuesday.
A survey of more than 1,000 people conducted by the Addiction Policy Forum found that 20 percent said they or a family member have increased substance use since COVID-19 began.
Four percent reported overdoses, and 1 percent of those were fatal, according to the survey.

“We are concerned that the progress we have made over the last several years to address overdoses and the opioid epidemic, that we might have lost ground during the pandemic shutdown,” said Jessica Hulsey, co-author of the report and president of the Addiction Policy Forum, an advocacy group for people with substance use disorders.
“We need to make sure that we are doubling down efforts to make sure that the colliding epidemics of coronavirus and the opioid epidemic doesn’t mean more loss of life in communities that are hit hard by both.”
Drug overdose deaths declined in 2018 for the first time in nearly two decades, driven by drops in deaths from prescription opioids.
Still, nearly 68,000 people died of drug overdoses in 2018, the most recent data available. Overdose deaths from synthetic narcotics, mainly fentanyl, and cocaine and meth continue to increase. Overall, 20 million people in the U.S. are estimated to be addicted to substances.
Experts have worried that the stress of the pandemic and social distancing requirements could increase that number and put people with substance use disorders at risk for relapses.
Respondents to the survey were most concerned about the lack of access to in-person support groups and 12 step meetings due to social distancing requirements.

In the earlier days of the pandemic, the Centers for Disease Control and Prevention (CDC) and other public health agencies had urged states and localities to limit in-person gatherings and discretionary travel as much as possible.
While some meetings have taken place virtually, it might not work for everyone, Hulsey said.
In all, 14 percent said they have been unable to access needed services during the pandemic. The web-based survey was conducted between April 27 and May 8 and is not representative of the broader population. The survey is a “rapid assessment” of the impact of COVID-19 on people with substance use disorders and is intended to inform additional research, the report states.
“In the future, I do think we need to readdress what are essential services and what isn’t,” Hulsey said.

“Addiction is a chronic health condition and some of the long-term support that individuals need to stay healthy and well need to be met even during a crisis like Covid-19.”
A recent analysis from the Well Being Trust estimated that 75,000 more people will die from drug or alcohol misuse and suicide if the U.S. Does not significantly invest in solutions to help “heal the nation’s isolation, pain and suffering” caused by COVID-19.
The Addiction Policy Forum and 47 other groups are asking Congressional leaders to appropriate millions of dollars in funding to help mitigate the impact of the pandemic on people with substance use disorders.
https://thehill.com/policy/healthcare/501923-substance-use-up-amid-pandemic-survey

Indian firm Panacea says aiming to make COVID-19 vaccine

Indian biotech firm Panacea Biotec Ltd said on Wednesday it would partner with U.S.-based Refana Inc to make a potential vaccine for COVID-19.
The collaboration aims to make more than 500 million doses of the vaccine candidate, with over 40 million doses expected to be available early next year, Panacea said in a statement to stock exchanges.
https://www.reuters.com/article/us-health-coronavirus-india-vaccine/indian-firm-panacea-says-aiming-to-make-covid-19-vaccine-idUSKBN23H0LL

Japan’s Fujifilm to spend $928 million to double capacity of Danish drug facility

Fujifilm Holdings Corp (4901.T) will spend $928 million to double capacity at a drug manufacturing facility in Denmark, which it has pledged to use in producing COVID-19 treatments, as the Japanese company steps up its pivot towards healthcare.
The investment in Fujifilm Diosynth Biotechnologies will expand production lines for bulk drug substances and cultivate cells for producing viral vaccines, Fujifilm announced on Tuesday. It bought the facility in Hillerod, Denmark, in August from Biogen Inc (BIIB.O) for about $890 million.
The investment expands Fujifilm’s presence as a global contract development and manufacturing organisation (CDMO), which supplies other companies in the pharma industry. Fujifilm started to diversify from cameras and office equipment and into healthcare more than a decade ago.

Fujifilm previously announced that the Denmark site would offer future manufacturing capacity to the COVID-19 Therapeutics Accelerator to speed-up the response to the global pandemic.
It is an initiative launched by the Bill & Melinda Gates Foundation and two other large charities, aimed at accelerating drug development and identifying a promising COVID-19 therapeutic candidate based on efficacy and safety data demonstrated in clinical trials.
Fujifilm’s pharma arm is testing its own anti-flu drug Avigan as a treatment for COVID-19.

The company aims to achieve 100 billion yen ($928.68 million) in sales in its bio-CDMO business by the fiscal year ending March 2022.
https://www.reuters.com/article/us-fujifilm-investment-denmark/japans-fujifilm-to-spend-928-million-to-double-capacity-of-danish-drug-facility-idUSKBN23H0C3

Temasek-backed Tychan to start human trials next week for COVID-19 treatment

Singapore’s Tychan, a biotechnology firm backed by state investor Temasek Holdings, said it will begin human clinical trials next week for a potential monoclonal antibody treatment for COVID-19.
The first phase of the trial to be conducted on 23 healthy volunteers will take about six weeks to evaluate the safety and tolerability of TY027 – a monoclonal antibody that specifically targets SARS-CoV-2, the virus that causes COVID-19.
Antibodies are generated in the body to fight off infection. Monoclonal antibodies mimic natural antibodies and can be isolated and manufactured in large quantities to treat diseases in patients.

Many scientists and researchers believe antibody-based therapies hold great promise for treating people already infected with the disease.
“We will continue with the fast pace of development as we are conscious that a day saved is a day less of misery,” said Teo Ming Kian, chairman of Tychan. He added that the company reached human trials in four months, when it would usually take 12-18 months.
TY027 is being explored for the treatment of patients with COVID-19 to slow the progression of the disease and accelerate recovery, as well as for its potential to provide temporary protection against infection with SARS-CoV-2.

After passing key milestones in the first phase trial, Tychan will seek approval from the Singapore regulator to expand TY027 to a larger population of COVID-19 volunteer patients to establish its efficacy.
Temasek Holdings is the founding investor of Tychan, which has previously developed therapeutic treatments for zika and yellow fever.
https://www.reuters.com/article/us-health-coronavirus-singapore-treatmen/temasek-backed-tychan-to-start-human-trials-next-week-for-covid-19-treatment-idUSKBN23H0M8

U.S. student’s app offers roadmap to Singapore contact tracing tech

Singapore kicked off a global rush to develop contact tracing apps for the novel coronavirus when the city-state launched an apparently new system in March.

But the project actually drew inspiration from a 2014 U.S. high school project that won an international prize but found no backers – until now.
It all started when Rohan Suri created an app at Thomas Jefferson High School in Alexandria, Virginia, to tell his mom to leave home for the bus stop when he was seven minutes away. As the Ebola epidemic ravaged western Africa at the time, Suri and schoolmate Claire Scoggins connected the dots between tracking apps and contact tracers who ask patients whom they may have spread viruses to.
“I got really interested in basically automating a lot of these contact tracing efforts,” Suri said, noting a staff shortage in remote parts of Africa during the Ebola epidemic.
When Suri and Scoggins developed a prototype called kTrace, they appealed to medical aid organizations and the U.S. government to bring it to the frontlines. But they found no takers, even after winning third place for systems software at the 2015 International Science and Engineering Fair.

The app languished until Suri, now a 21-year-old junior at Stanford University, got an email on Jan. 24 from Jason Bay, a Stanford alum and senior director at Singapore’s Government Technology Agency (GovTech).
“My mom had texted me saying, ‘You’ve got to look at this virus in Wuhan and do something about it,’” Suri said, referring to the city in China where the coronavirus outbreak began. “I didn’t take it seriously, though, and week later the Singapore government is reaching out.”
Bay’s team had been looking for technology to help curb the coronavirus and came across kTrace online. Suri spent February and March volunteering on GovTech’s TraceTogether app alongside fellow Stanford students Nikhil Cheerla and Daniel Lee.
They said they gave Singapore a roadmap by sharing kTrace’s code and providing advice in virtual meetings on stronger privacy protections. They also collected 13 phones to help test Bluetooth technology.
Singapore was “just looking around for any way to speed up the development process and we fit in,” Cheerla said.

The agency said it contacted Suri “to understand his experiences and considerations in designing kTrace for Android.” But Suri “did not commit code to TraceTogether, nor did (GovTech) use kTrace in the development of TraceTogether,” it added.

NEW PROJECT

University scientists Kate Farrahi and Manuel Cebrian said their studies as early as 2011 were the first to show Bluetooth readings could aid contact tracing. They did not develop an app, however, and Suri had not seen their work in high school.
But since Singapore’s app launched, several dozen governments, including Australia, Britain and U.S. states such as North Dakota, have spent millions of dollars among them to develop separate tracing apps. Government health authorities administer and promote the apps and link them to their testing systems.
Many other governments are monitoring progress in Singapore, where about 25% of the country’s 5.6 million residents have downloaded TraceTogether.
Contact tracing apps largely use anonymous Bluetooth radio exchanges to automatically log nearby users. The technology aims to slow viruses by identifying secondhand infections more quickly than through interviews.

But privacy concerns are a hurdle, and the technology does not work well on iPhones. A fix Apple Inc introduced in partnership with Alphabet Inc’s Google last month limits the personal data contact tracing apps can collect, which authorities say reduces their effectiveness.
Singapore has adopted a costly solution: Giving residents small tracing gadgets, possibly worn on a lanyard, that do not require smartphones.
Suri said he, too, had developed a wearable device in high school because Ebola infections were highest in countries with low smartphone ownership.
Suri is now focusing on a third app called Zero, aimed at U.S. cities.
The day after TraceTogether launched, a friend who knew about Suri’s involvement introduced him to a handful of New York entrepreneurs and venture capitalists seeking to bring similar technology to the United States.
They ended up co-founding Zero, which aims to attract users by bundling contact tracing technology with a safety-rating tool for shops and restaurants based on measures such as occupancy limits and mask rules.
“You need a strategy that goes hyperlocal, and that’s what Zero is doing,” Suri said.
For example, a shopper would check Zero for safety ratings before deciding where to go. Shops could promote special hours through the app for customers who wear masks.
Zero launched for iPhones last week, with its first business listings coming soon in New Rochelle, New York. Contact tracing will be added when cities agree to become partners.
https://www.reuters.com/article/us-health-coronavirus-apps-tracing/u-s-students-app-offers-roadmap-to-singapore-contact-tracing-tech-idUSKBN23H0I1