Genetic Technologies Updates on COVID Severity Risk Test, Expansion

 Molecular diagnostics company Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”), provides the following update to the market on further development on the COVID-19 serious disease risk Polygenic Risk Score Test (COVID-19 PRS Test) and expansion of the Company’s offering to include Germline Testing division.

Key Highlights

• Total COVID-19 positive patient data analyzed exceeds 5,500 following inclusion of further 4,000 patients’ data
  º Predictive capabilities improved 100% over age and sex alone1
  º Analysis confirms that the test is well calibrated2
  º Further datasets will continue to enhance the accuracy and consistency of the algorithm

• Anticipate submission for regulatory clearance via Centers for Medicare and Medicaid Services/Clinical Laboratory Improvement Amendments (CMS/CLIA) by the end of Q1 CY21 following final validation process of expanded dataset

• In active conversations on commercialization opportunities in conjunction with CLIA regulatory submission and clearance

• Additionally, as previously announced, the Company has commenced with equipment calibration along with specialized inhouse training of the scientific team to establish the Germline Testing division for hereditary cancer risk with initial focus on:
  º BRCA testing to be offered in conjunction with GeneType for Breast Cancer, and
  º Lynch Syndrome testing to be offered in conjunction with GeneType for Colorectal Cancer

The Company will provide an update on further advancements to its diagnostic tests and hold an investor webinar to discuss the quarterly update, on Thursday, January 28, 2021 at 11:30 AEDT.

To participate on the quarterly investor webinar, please register at: https://us02web.zoom.us/webinar/register/WN_gy5DGFNMSKiAYfYeV0Ygpg

https://finance.yahoo.com/news/genetic-technologies-provides-covid-19-120000548.html

India's vaccine diplomacy in south Asia pushes back on China

 India will give millions of doses of COVID-19 vaccine to South Asian countries in the next few weeks, government sources said on Thursday, drawing praise from its neighbours and pushing back against China’s dominating presence in the region.

Free shipments of AstraZeneca’s vaccine manufactured by the Serum Institute of India, the world’s biggest producer of vaccines, have begun arriving in the Maldives, Bhutan, Bangladesh and Nepal.

Myanmar and the Seychelles are next in line to get free consignments as India uses its strength as one of the world’s biggest makers of generic drugs to build friendships.

“The government of India has shown goodwill by providing the vaccine in grant. This is at the people’s level, it is the public who are suffering the most from COVID-19,” said Nepal’s Minister for Health and Population Hridayesh Tripathi.

The gesture comes at a time that India’s ties with Nepal have been strained by a territorial dispute and Indian concern over China’s expanding political and economic influence in the Himalayan nation sandwiched between the Asian giants.

China, which had promised Nepal help to deal with the pandemic, is awaiting Nepali clearance for its Sinopharm shots.

“We’ve asked them to submit more documents and information before we give them the approval,” said Santosh K.C., spokesman for Nepal’s department of drug administration.

CHINESE RIVALRY

Bangladesh was supposed to get 110,000 doses of vaccine free from Chinese firm Sinovac Biotech, but Bangladesh refused to contribute towards the development cost of the vaccine leading to deadlock.

Bangladesh has instead turned to India for urgent supplies and on Thursday was due to receive 2 million shots of the AstraZeneca vaccine as a gift from India.

“India is making the AstraZeneca vaccine which makes all the difference. It can be stored and transported at normal refrigerated temperatures and countries like Bangladesh have that facility,” a Bangladesh health official said.

Meanwhile India’s arch-rival Pakistan on Thursday thanked China, its close strategic ally, for a pledge to provide half a million doses of the vaccine free of charge by the end of the month.

India for years has struggled to match the pace of Chinese investment in countries such as Sri Lanka, Nepal and the Maldives, where China is building ports, roads and power stations as part of its Belt and Road Initiative.

But the demand for vaccines in these countries desperate to revive their tourism-dependent economies has offered Prime Minister Narendra Modi’s government a way to claw back ground, diplomats say.

India is considering giving away anything from 12 million to 20 million shots to its neighbours in the first wave of assistance over the next three to four weeks, one government source said.

India is also helping with the training of health workers in some of these countries and the setting up of the infrastructure to administer the shots, the source said.

“It’s a well-crafted, calibrated series of actions you are seeing, they confirm the validity of our ‘neighbourhood first’ policy,” said a former Indian ambassador, Rajiv Bhatia.

“It plays to our strengths in science and pharma, and this is our moment to shine.”

https://www.reuters.com/article/us-health-coronavirus-india-diplomacy/indias-vaccine-diplomacy-in-south-asia-pushes-back-against-china-idUSKBN29Q0ZX

Drugmakers begin testing COVID-19 vaccines in children

 Pfizer, Moderna and AstraZeneca, along with its partner the University of Oxford in England, have all begun clinical trials testing their COVID-19 vaccines in children, Bloomberg reported. 

Pfizer and Moderna say they could have data from their trials by summer. AstraZeneca and the University of Oxford are planning to start testing their vaccine in children 12 to 18 year old next month, according to Bloomberg. 

Johnson & Johnson expects trials for children to start four to six weeks after it gets results from its adult trials, expected in early February. 

Pfizer's adolescent trial has finished enrollment and will test the vaccine in 2,000 volunteers ages 12 to 15, Bloomberg reported. The trial will be at Louisiana State University Health Shreveport. 

Moderna began giving its vaccine to children in December and plans to have initial data in time for possible approval before the 2021 school year, according to Bloomberg. The drugmaker will test its vaccine in 3,000 children ages 12 to 18. 

Moncef Slaoui, formerly the head of Operation Warp Speed, the government's initiative to speed COVID-19 drug and vaccine development and distribution, told Bloomberg that Moderna has struggled with enrollment in its adolescent trial. It took four weeks to recruit 800 children, he said. 

A Moderna spokesperson told Bloomberg that enrollment was lower over the holiday season, and they expect it to pick up soon. They're on track to have data around the middle of the year, the spokesperson added. 

The University of Oxford plans to recruit about 120 children in both the 12-to-18 and 6-to-11 age groups, according to Bloomberg. AstraZeneca will run a larger trial in the U.S. 

"The main rationale for vaccinating children, given that they’re relatively unaffected, would be to try and have an impact on transmission of the virus," Andrew Pollard, lead investigator on the University of Oxford trials, told Bloomberg. 

Children over the age of 12 will receive the same vaccine dosage as adults in Pfizer, Moderna and the University of Oxford's trials. 

https://www.beckershospitalreview.com/pharmacy/drugmakers-begin-testing-covid-19-vaccines-in-children.html

Patients push to get COVID-19 antibody drugs

 Many COVID-19 patients have had to advocate for themselves to get access to antibody drugs from Eli Lilly and Regeneron, according to a report from Kaiser Health News. 

More than 550,000 doses of the drugs have been delivered to healthcare facilities around the country, but only about 30 percent have been given to patients, HHS officials told Kaiser Health News. 

"The bottleneck here in the funnel is administration, not availability of the product," Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, told Kaiser Health News. 

Gary Herritz, a COVID-19 patient who was at high risk for serious illness because he previously had a liver transplant, told Kaiser Health News he only knew of the antibody drugs after reading about them on Twitter. It took him two days of making phone calls to get an appointment to receive the treatment. 

Some hospitals have refused to offer the drugs because physicians are skeptical about research from clinical trials. The studies only included a few hundred people, and the results were limited, Kaiser Health News reported. 

Some facilities have struggled to find a space that separates COVID-19 from other patients to give the drugs, which are administered through IV. 

Many patients are also unaware of the drugs and haven't been offered the option, according to Kaiser Health News. The drugs are most effective within 10 days of a positive COVID-19 diagnosis, so the window of treatment is short.

HHS has partnered with hospitals in California, Arizona and Nevada to set up infusion centers that can treat dozens of patients daily, Kaiser Health News reported. 

U.S. Surgeon General Jerome Adams, MD, urged providers to prescribe the drugs more frequently to eligible COVID-19 patients. 

"I want my colleagues to hear me. You need to think about and be willing to prescribe these medications much more frequently as a way to protect your patients, preserve your hospital capacity and to support your exhausted colleagues," he said, according to CNBC. 

HHS launched Jan. 13 an online locator that tracks facilities that have received the antibody drugs. States and territories must opt in to share information from their facilities, and HHS has encouraged all to participate.

https://www.beckershospitalreview.com/pharmacy/patients-push-to-get-covid-19-antibody-drugs.html

HCA to Invest in U.S.-Based Mask Production

 HCA Healthcare Inc. said it would invest in a new venture to manufacture personal-protective equipment after its spending on such materials jumped last year.

The Nashville-based operator of hospitals, physician clinics and other health-care providers said Thursday it would work with a business called A Plus International Inc. to make surgical and procedure masks from a factory in Asheville, N.C.

Some healthcare providers and other companies struggled at times last year to ensure they had enough masks, gloves and other protective equipment on hand for workers as the coronavirus spread. Distributors like Fastenal Co. and W.W. Grainger Inc. saw jumps in demand for such items.

"The recent surge in demand for PPE due to the pandemic has underscored how dependent we have been on supplies from overseas and the importance of working to diversify our supply chain," said Dr. Jonathan Perlin, HCA's chief medical officer.

Last year, the company's spending on such equipment rose by more than $196 million compared with 2019.

HCA didn't say in a statement how much it would invest in the venture but said its funding comes through an entity designed to support healthcare-related businesses in the western part of North Carolina.

Production is expected to begin in the early part of this year. HealthTrust, which works on purchasing for health companies, will co-manage the new joint venture and serve as the distribution arm for the business for organizations in the U.S.

A Plus International makes products like baby blankets, surgical towels, masks, beard protector and gowns, according to its website.

https://www.marketscreener.com/quote/stock/HCA-HEALTHCARE-INC-7534808/news/HCA-Strikes-Deal-to-Invest-in-U-S-Based-Mask-Production-32246169/

Fire at India's Serum Institute kills 5, AstraZeneca vax output unaffected

* Fire kills five, government says

* Blaze brought under control, electrical fault possible cause

* New product launches could be affected, says CEO

A big fire on Thursday at the Serum Institute of India killed five people, a government official told reporters, but the world's biggest vaccine maker said it would not affect production of the AstraZeneca coronavirus shot.

Videos and pictures from Reuters partner ANI showed black smoke billowing from a multi-story building in SII's massive headquarters complex in the city of Pune in Maharashtra state.

"We have learnt that there has unfortunately been some loss of life at the incident," SII Chief Executive Adar Poonawalla said on Twitter. "We are deeply saddened and offer our deepest condolences to the family members of the departed."

Pune Mayor Murlidhar Mohol said four people had been evacuated but five others had died. The Maharashtra state government said the fire could have been caused by an electrical fault during construction work.

SII has licensed the shot developed by Oxford University and AstraZeneca, and was also planning to start stockpiling up to 50 million doses a month of a vaccine candidate developed by Novavax Inc from around April.

Many low- and middle-income countries, from Bangladesh to Brazil, are depending on SII delivering the AstraZeneca vaccine, branded COVISHIELD by the Indian company.

"I would like to reassure all governments & the public that there would be no loss of COVISHIELD production due to multiple production buildings that I had kept in reserve to deal with such contingencies," Poonawalla said.

Poonawalla, whose family owns SII, was quoted as saying by broadcaster CNBC-TV18 that the fire would mean delays in launching new products and revenue losses of more than 10 billion rupees ($137 million). Equipment worth millions of dollars has been damaged, he said.

SII is producing around 50 million doses of the AstraZeneca vaccine a month at other facilities in the complex, with plans to increase that to as much as 100 million doses soon.

The AstraZeneca vaccine is already in use in India and has been shipped to countries such as Bangladesh, Nepal, the Maldives and Bhutan.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Fire-at-India-s-Serum-Institute-kills-5-AstraZeneca-vaccine-output-unaffected-32243760/

INmune Bio: XPro1595 Cuts Biomarkers in Alzheimer’s Phase 1b Trial

 Interim data show CSF biomarkers of neurodegeneration and synaptic dysfunction as well as neuroimaging biomarkers improved after three months of therapy with XPro1595

Data support initiation of blinded randomized Phase 2 study before year end

Company to host Key Opinion Leader Webinar Today, January 21, at 8:00am ET

To register and access the live webinar click here

Date: January 21, 2021
Time: 8:00 AM Eastern Time

https://www.globenewswire.com/news-release/2021/01/21/2162007/0/en/INmune-Bio-Inc-Announces-XPro1595-Found-to-Decrease-Neuroinflammation-and-Neurodegeneration-Biomarkers-in-Patients-with-Alzheimer-s-Disease-in-Phase-1b-Trial.html