Chinese producers agree to supply more than half a billion vaccines to COVAX

 The GAVI alliance said on Monday it had signed two advance purchase agreements with Chinese drugmakers Sinopharm and Sinovac to provide up to 550 million COVID-19 vaccines to the COVAX programme.

The new deals include up to 170 million doses of the Sinopharm shot and up to 380 million doses of the Sinovac vaccine, through to the middle of 2022, the statement said. Sinovac confirmed the agreement in a statement.

"The agreements, which come at a time when the Delta variant is posing a rising risk to health systems, will begin to make 110 million doses immediately available to participants of the COVAX Facility, with options for additional doses," GAVI said in a statement.

COVAX, which distributes vaccines to poorer countries, has struggled to meet its early commitments amid Indian export disruptions, forcing many countries to freeze their inoculation programmes in their early phases.

However, its latest supply forecast shows that the programme is on track to deliver more than 2 billion doses by early 2022.

https://finance.yahoo.com/news/1-chinese-producers-agree-supply-101242955.html

Thailand To Mix Sinovac, AstraZeneca Jabs To Boost Protection Against Delta

 Thailand's immunisation strategy against the coronavirus will see a shot of AstraZeneca's viral vector vaccine administered after one dose of Sinovac's vaccine, its health minister said on Monday.

The plan, if implemented, would be the first publicly announced mix and match of a Chinese vaccine and a Western-developed shot.

The move aims to increase protection against highly transmissible variants, Anutin Charnvirakul told reporters.

"This is to improve protection against the Delta variant and build high level of immunity against the disease," Health Minister Anutin said, referring to the variant first detected in Indonesia.

Thailand and neighbours like Indonesia have reported breakthrough infections among medical and frontline workers inoculated with Sinovac's inactivated virus vaccine.

The majority of Thailand's medical and frontline workers were given Sinovac's shots after February with the viral vector vaccine from AstraZeneca AZN.L arriving in June.

https://www.ndtv.com/world-news/covid-19-thailand-to-mix-sinovac-astrazeneca-jabs-to-boost-protection-against-delta-variant-2484698

Pfizer, Israel agree: New COVID vaccines coming August 1

 A new shipment of Pfizer vaccines will be delivered on August 1 instead of September, Prime Minister Naftali Bennett announced Sunday.

All the current supply of vaccines Israel possesses is due to expire on July 31. As a result, individuals under 18 were not supposed to be able to receive a first shot until new vaccines arrived, being that three weeks must elapse between the first and second shots.

Israel currently has some 200,000 doses of Moderna, which are only authorized for adults.

However, thanks to the new deal, the vaccination campaign will continue.

“We have been working on the issue of vaccines for several weeks,” Bennett said. “This morning, I am pleased to announce that after a series of discussions with Pfizer CEO Albert Bourla, we closed a deal last night to move up the next vaccination delivery to August 1.”

“There are vaccines for everyone,” he said, and all those who have not been inoculated should do so.

Some 200,000 doses of vaccines are expected to be delivered on August 1.

Last week, Israel announced it had agreed on a vaccine-exchange deal with South Korea. Under the terms of the deal, Israel delivered some 700,000 doses to South Korea, which it will return when it receives its next vaccine delivery.

Immunocompromised patients will be able to receive a third shot of the Pfizer vaccine starting immediately, Health Minister Nitzan Horowitz said Sunday. The healthcare providers will determine who is eligible, he told KAN News. People with specific conditions, for example, who have had an organ transplant, will be eligible, he said.

In the meantime, Israel continues to register a higher number of daily cases. At the beginning of June, some 10-20 people were found to be new virus carriers every day. Currently, several hundred are testing positive on a daily basis.

Most days last week, Israel registered more than 500 cases. On Saturday, 261 new virus carriers were identified, but with a significantly lower number of tests, about 50,000. Previously, there were more than 70,000 each day.

As of 6 p.m. on Sunday, another 263 new virus carriers had been identified out of about 29,000 tests that were processed.

The number of active cases, which had dropped to fewer than 200 just a few weeks ago, currently stands at almost 4,000, marking a slight decline since the day before, the first decrease in several weeks.

At the same time, the increase in serious morbidity has remained low. As of Sunday night, there were 47 patients in serious condition. In April, with a similar number of active cases, there were more than 260.

At the coronavirus cabinet meeting last Wednesday, the ministers said the number of patients in serious condition would be the central parameter to determine the country’s strategy.

The cabinet is due to meet again on Tuesday to discuss possible new measures against the current outbreak.

The Health Ministry is going to discuss an outline to introduce a new form of “green pass” system for big gatherings, Health Ministry Director-General Nachman Ash told Channel 12 on Sunday, when his appointment was approved by the government.

According to the outline, participants would be required to undergo a rapid test. However, many logistical challenges remain, including how to deploy enough testing stations, how to enforce the system and who would pay for the tests.

“A wedding in September? I think it is a very precarious situation,” Ash said. “I don’t know if I would recommend it.”

He said he did not know what will happen in two months, adding that if the morbidity continues at this level, Israel could have a very high number of cases, even though probably not as many as in the past.

It is important to stop the current outbreak long before the number of serious patients overwhelms the health system, Ash said. The Health Ministry is considering what measures might be needed to reopen the school year safely, he said, denying that he was causing unnecessary panic.

Earlier in the day, Prof. Eran Segal, a computational biologist at the Weizmann Institute of Science in Rehovot who is an adviser to the government, said he did not believe Israel would reach the same number of serious patients it registered at the peak of the pandemic, which was about 1,200.

“Why do I think we are not going back to some 1,000 seriously ill patients in the hospitals?” he tweeted. “Because all it takes to return to the pre-Delta decline [in cases] is an additional number of individuals vaccinated or recovered. How many? It is not clear, maybe 500,000, maybe more.”

Before the contagious Delta variant spread in Israel, many experts thought the country had reached some form of herd immunity because the outbreaks were very limited for several months.

However, the rate of a population immune from the virus through inoculation or previous infection required to reach herd immunity increases as the ability of the virus to infect increases, as in the case of the Delta variant.

“Another 200,000 have been vaccinated in the last two weeks, and if some more among the 1.1 million we have not yet vaccinated get jabbed, that may be enough,” Segal wrote. “If not, the increase in new cases will continue. But this time, because of the vaccines, there will have to be many more cases than before to reach the same amount of seriously ill patients. According to our model, maybe even 500,000, which in itself will lead to many people recovering, who will help start a new decline [in cases].

In the UK, where the Delta variant is raging, there are eight to 10 times fewer people who succumbed to the virus, and three or four times fewer hospitalized patients, compared with the period before vaccinations started, Segal wrote.

https://www.jpost.com/breaking-news/coronavirus-in-israel-immunocompromised-can-get-jab-today-health-min-673464

Biocryst ORLADEYO Reduced HAE Attack Rate by 80% from Baseline

  BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that hereditary angioedema (HAE) patients who were randomized to receive 150 mg of oral, once-daily ORLADEYO® (berotralstat) at the start of the APeX-2 trial had an 80 percent average reduction in their mean attack rate per month during weeks 25-96 of the trial, compared to baseline. Median attack rates also decreased from 2.7 attacks/month at baseline to 0.0 attacks per month in 16 of 17 months through the same period.

ORLADEYO was generally well-tolerated during the treatment period with fewer drug-related adverse events reported in part 3 (weeks 49-96) as compared to part 1 (weeks 0-24) and part 2 (weeks 25-48). Eighty-one percent of the patients who entered part 3 completed the trial.

“The long-term data we now see from two years of therapy in the clinical program reinforces the substantial, sustained reduction in HAE attacks patients experienced with ORLADEYO. These results are consistent with the experience many patients are having in the real world since we launched ORLADEYO, which is a key driver for the strong patient demand we are seeing as patients switch from injectable prophylactic agents and injectable acute-only therapies to oral, once-daily ORLADEYO for control of their HAE attacks,” said Dr. William Sheridan, chief medical officer of BioCryst.

The data are scheduled to be presented in an oral presentation on Monday, July 12, 2021 at 2:15pm CET at the EAACI Hybrid Congress 2021.

https://finance.yahoo.com/news/biocryst-reports-96-week-data-140000408.html

Galapagos’ filgotinib leads to rapid symptom improvement for ulcerative colitis

 A post-hoc analysis from a Phase III clinical programme evaluating Galapagos’ filgotinib showed significant symptom improvements for patients with ulcerative colitis (UC).

The new data, presented at the European Crohn’s and Colitis Organisation (ECCO) annual congress, showed significant improvements in patient-reported outcomes of stool frequency and rectal bleeding – observed as early as the first weeks of filgotinib 200mg daily therapy versus placebo.

According to Galapagos, these findings were observed in both biologic-naïve and biologic-experienced UC patients.

A further post-hoc analysis of the SELECTION maintenance study suggested the proportion of patients who were steroid-free at different timepoints before achieving remission at week 58.

The data suggested that filgotinib 200mg reduced and eliminated corticosteroid (CS) use versus placebo at week 58 in patients with moderately to severely active UC.

A significantly higher proportion of patients who demonstrated CS-free remission at week 58 with filgotinib 200mg daily had been CS-free in the previous six months in comparison to placebo.

In addition, safety analysis from the SELECTION programme – combining induction, maintenance and the long-term extension study data – showed results consistent with the original induction and maintenance trials, where filgotinib was well tolerated in patients with moderately to severely active UC.

“Listening to the needs of patients living with moderately and severely active UC, and the healthcare professionals treating them, helps us understand the importance of finding treatments that address both clinical symptoms and patient reported outcomes,” said Walid Abi-Saab, chief medical officer of Galapagos.

“[This] new data from SELECTION and the long-term extension study suggest that patients with moderately to severely active UC have experienced rapid response, sustained steroid-free remission and long-term tolerability when taking filgotinib 200mg versus those on a placebo,” he added.

https://www.pharmatimes.com/news/galapagos_filgotinib_leads_to_rapid_symptom_improvement_for_ulcerative_colitis_patients_1373026

Biotech week ahead, July 12

 Biopharma stocks closed the holiday-shortened week lower amid a lack of any significant news flow.

On the drug approval front, Provention Bio, Inc. PRVB 3.85% faced a setback, as its diabetes drug failed to get the FDA nod. The stock shed over 20% in reaction to the adverse outcome. Expectedly, the review period for ChemoCentryx, Inc.'s CCXI 11.06% avacopan as a treatment option for small blood vessel damage was extended. The stock reacted positively to the outcome.

Alector, Inc. ALEC 5.67% was among the biggest gainers of the week, buoyed by an immuno-neurology deal it struck with GlaxoSmithKline plc GSK 0.45%.

Biogen, Inc. 

BIIB 2.95% was under the scanner as the FDA narrowed the Aduhelm label and also called for an investigation into the interactions between FDA staffers and the company in the run-up to the approval.

Here are the key catalytic events that can impact trading in biotech stocks in the unfolding week:

Conferences

European Academy of Allergy and Clinical Immunology, or EAACI, Annual Congress 2021, to be held virtually: July 10-16
Ladenburg Thalmann Annual Healthcare Conference: July 13-14
William Blair Biotech Focus Conference 2021: July 14-15

Adcom Calendar

FDA's Cardiovascular and Renal Drugs Advisory Committee is scheduled to meet July 15 to discuss the NDA for FibroGen, Inc.'s FGEN 0.23% roxadustat for the treatment of anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis. FibroGen is partnering with AstraZeneca PLC AZN 0.62% for Roxadustat. Roxadustat is already approved in Japan and China.

Clinical Readouts/Presentations

KalVista Pharmaceuticals, Inc. KALV 0.17% will present at the EAACI Congress results of a phase 2 study of KVD900 as a treatment option for patients with hereditary angioedema. The presentation is scheduled for Monday.

AVEO Oncology AVEO 5.69% will host a key opinion leader webinar focusing on Fotivda, its oral, once-daily, differentiated vascular endothelial growth factor receptor tyrosine kinase inhibitor, for the treatment of adult patients with relapsed or refractory renal cell carcinoma following two or more prior systemic therapies. The event is scheduled for Friday afternoon.

Earnings

AngioDynamics, Inc. ANGO 2.89% (Tuesday, before the market open)

IPOs

IPO Pricing

Utah-based Sera Prognostics, Inc. is proposing to offer 4.69 million shares of its Class A common stock in an initial public offering at an estimated price range of $15-$17 apiece. Sera is a women's health diagnostic company utilizing its proprietary proteomics and bioinformatics platform to discover clinically meaningful and economically impactful biomarker tests, with an initial focus on improving pregnancy outcomes. The company has applied to list the shares on the Nasdaq under the ticker symbol SERA.

Sight Sciences, Inc., a medical device company that focuses on development of proprietary devices that target the underlying causes of eye diseases, has filed for offering 6.98 million shares in an IPO. The California-based company expects to price the offering between $20 and $23 per share. The company has applied for listing its shares on the Nasdaq under the ticker symbol SGHT.

IPO Quiet Period Expiry

Molecular Partners AG MOLN 0.37%
Verve Therapeutics, Inc. VERV 0.54%
Lyell Immunopharma, Inc. LYEL 4.13%
Ambrx Biopharma Inc. AMAM 0.78%
Century Therapeutics, Inc. IPSC 4.27%
Codex DNA, Inc. DNAY 0.99%
Cyteir Therapeutics, Inc. CYT 3.62%
Atai Life Sciences N.V. ATAI 4.62%

https://www.benzinga.com/general/biotech/21/07/21921197/the-week-ahead-in-biotech-adcom-test-awaits-fibrogen-data-readouts-ipos-in-the-mix

COVID Test as Easy as Breathing

 In May, musicians from dozens of countries descended on Rotterdam, the Netherlands, for the Eurovision Song Contest. Over the course of the competition, the performers — clad in sequined dresses, ornate crowns or, in one case, an enormous pair of angel wings — belted and battled it out for their chance at the title.

But before they were even allowed onstage, they had to pass another test: a breath test.

When they arrived at the venue, the musicians were asked to exhale into a water-bottle-sized device called the SpiroNose, which analyzed the chemical compounds in their breath to detect signatures of a coronavirus infection. If the results came back negative, the performers were cleared to compete.

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The SpiroNose, made by the Dutch company Breathomix, is just one of many breath-based COVID-19 tests under development across the world. In May, Singapore’s health agency granted provisional authorization to two such tests, made by the domestic companies Breathonix and Silver Factory Technology. And researchers at Ohio State University say they have applied to the U.S. Food and Drug Administration for an emergency authorization of their COVID-19 breathalyzer.

“It’s clear now, I think, that you can detect this disease with a breath test,” said Paul Thomas, a chemist at Loughborough University in England. “This isn’t science fiction.”

Scientists have long been interested in creating portable devices that can quickly and painlessly screen a person for disease simply by taking a whiff of their breath. But delivering on this dream has proved to be a challenge. Different diseases may cause similar breath changes. Diet can affect the chemicals someone exhales, as can smoking and alcohol consumption, potentially complicating disease detection.

Still, scientists say, advances in sensor technology and machine learning, combined with new research and investment spurred by the pandemic, mean that the moment for disease-detecting breathalyzers may have finally arrived.

I’ve been working in the area of breath research for almost 20 years now,” said Cristina Davis, an engineer at the University of California, Davis. “And during that time, we’ve seen it progress from a nascent stage to really being something that I think is close to being deployed.”

The Biology of Breath

Human breath is complex. Whenever we exhale, we release hundreds of gases known as volatile organic compounds, or VOCs — byproducts of respiration, digestion, cellular metabolism and other physiological processes. Disease can disrupt these processes, altering the mix of VOCs that the body emits.

People with diabetes, for instance, may have breath that smells fruity or sweet. The odor is caused by ketones, chemicals produced when the body begins to burn fat instead of glucose for energy, a metabolic state known as ketosis.

“The idea that exhaled breath could hold diagnostic potential has been around for some time,” Davis said. “There are reports in ancient Greek and also ancient Chinese medical training texts that reference a physician’s use of smell as a way to help guide their clinical practice.”

Modern technologies can detect more subtle chemical changes, and machine-learning algorithms can identify patterns in breath samples from people with certain diseases. In recent years, scientists have used these methods to identify unique “breathprints” for lung cancer, liver disease, tuberculosis, asthma, inflammatory bowel disease and other conditions. (Davis and her colleagues have even used VOC profiles to distinguish among cells that had been infected with different strains of flu.)

Before COVID hit, Breathomix had been developing an electronic nose to detect several other respiratory diseases.

“We train our system, ‘OK, this is how asthma smells, this how lung cancer smells,” said Rianne de Vries, the company’s chief technology and scientific officer. “So it’s building a big database and finding patterns in big data.”

Last year, the company — and many other researchers in the field — pivoted and began trying to identify a breathprint for COVID-19. During the virus’ initial surge in the spring of 2020, for instance, researchers in Britain and Germany collected breath samples from 98 people who showed up at hospitals with respiratory symptoms. (Participants were asked to exhale into a disposable tube; the researchers then used a syringe to extract a sample of their breath.)

Thirty-one of the patients turned out to have COVID, while the remainder had a variety of diagnoses, including asthma, bacterial pneumonia or heart failure, the researchers reported. The breath samples from people with COVID-19 had higher levels of aldehydes, compounds produced when cells or tissues are damaged by inflammation, and ketones, which fits with research suggesting that the virus may damage the pancreas and cause ketosis.

The COVID patients also had lower levels of methanol, which could be a sign that the virus had inflamed the gastrointestinal system or killed the methanol-producing bacteria that live there. Those breath changes combined “give us a COVID-19 signal,” said Thomas, a co-author of the study.

Waiting to Exhale

Several other studies have also detected unique chemical patterns in the breath of patients with COVID-19, and some devices claim impressive results. In one study of the SpiroNose, which included 4,510 participants, a team of Dutch researchers reported that the device correctly identified at least 98% of people who were infected with the virus, even in a group of asymptomatic participants. (The study, which included researchers from Breathomix, has not yet been peer-reviewed.)

But the SpiroNose had a relatively high rate of false positives, the study found. Because of this problem, the device does not provide consumers with a definitive diagnosis; the results either come back negative or inconclusive, in which case a standard polymerase chain reaction test is administered.

Dozens of testing sites in the Netherlands are now using the machine, de Vries said, but there have been some hiccups. In May, Science reported that Amsterdam’s public health authorities suspended use of the SpiroNose after 25 false negatives. Officials later determined that user error was largely responsible, and SpiroNose screening has resumed, de Vries said.

Other groups are working on their own breathalyzers. Researchers at the Children’s Hospital of Philadelphia, who have identified a breathprint of COVID in children, are now trying to identify breath markers of a rare but dangerous complication of the disease, known as multisystem inflammatory syndrome in children (MIS-C).

“The clinicians on the front line, they’re really struggling with which children we need to worry most about,” said Dr. Audrey Odom John, an infectious disease specialist at Children’s Hospital of Philadelphia, who is leading the research.

In addition to studying the VOCs emitted by COVID patients, Davis and her colleagues are analyzing what is known as exhaled breath condensate, a concentrated solution of the tiny droplets of fluid, or aerosols, that are present in breath. These aerosols contain all sorts of complex biological molecules, including proteins, peptides, antibodies and inflammatory markers.

They hope to find biomarkers to help doctors predict which COVID-19 patients are most likely to become severely ill.

“I think that that will be a part of a clinical arsenal, where clinicians cannot only do rapid diagnostics, but then they could try to understand what’s the trajectory for that particular patient,” she said.

Other teams are working to create breath tests that look for the virus itself. Researchers at Washington University in St. Louis, for instance, are developing a biosensor that is coated in tiny antibody fragments, or nanobodies, that bind to SARS-CoV-2. If someone is exhaling viral particles, they should attach to the nanobodies, activating the sensor.

Passing the Smell Test

Interest in the technology is fierce. Perena Gouma, a materials scientist at Ohio State who has applied for FDA authorization for her COVID-19 breathalyzer, said she has already heard from colleges, theaters, sports leagues, travel authorities and others who want to get their hands on the device.

“I don’t think that there has been anyone who has been affected by this pandemic that hasn’t been excited about the prospect of having a breath test,” she said.

But the approach still needs to be validated in larger studies, and basic scientific questions remain unanswered.

“If we take a blood test for example, it’s well established that there is a normal range for, let’s say, hemoglobin levels or white blood cell count,” said Oliver Gould, an analytical chemist at the University of the West of England. “So, of course, then it’s very easy to see when something is abnormal.”

Those reference ranges do not yet exist for breath, he noted.

Researchers said that they do not expect breath-based tests to completely replace other diagnostic tests.

“Do I think that a breathalyzer is going to be used in your pediatrician’s office? Probably not,” John said. “Where I really see breath testing being useful is where you need to screen a whole bunch of people quickly. Could you screen every child in a school on a Monday? Could you do it before people enter a mall or a bounce house?”

And once the technology has been developed and validated, it could theoretically be used to screen for a wide variety of different diseases.

“The thing about a breath test is, if you have the technology in place, you can learn the signal for a new disease very fast,” Thomas said.

So the research being done now could pay long-term dividends.

“We’re developing the tools necessary to hopefully help us in the fight for the next disease,” said Edward DeMauro, an engineer at Rutgers University who is working on a COVID breathalyzer. “There is a very big value in, even if the pandemic’s over, not sitting back. That’s not the time to catch our breath.”

https://news.yahoo.com/covid-test-easy-breathing-162334378.html