Unsure whether to get a COVID-19 jab? Ask Vira!

 With COVID-19 vaccine hesitance an increasing concern in the US, researchers at Johns Hopkins have developed a chatbot – called Vira – that aims to explode myths about vaccination.

Worried that COVID-19 vaccines have serious side effects that are being covered up, or vaccines are being used to track the population? Or just uncertain whether you should be vaccinated as en expectant mother, or if you can choose which vaccine you receive?

Vira – short for short for Vaccine Information Resource Assistant – is available to answer those questions and provide credible information that can support behaviour changes, according to its developers, from the International Vaccine Access Center (IVAC) at the Johns Hopkins Bloomberg School of Public Health.

The chatbot has been launched as the US government missed its target of administering at least one dose of COVID-19 to 70% of adults in the country by the 4 July holiday.

The number of vaccinations being delivered every day in the US has fallen from a peak of 3.4 million in April, and is now running at around 600,000 per day. Some areas of the country have vaccination rates of 70%-80%, but in others – such as Mississippi and Alabama – take-up is as low as 30%.

The chatbot – available at VaxChat.org via mobile or desktop – is particularly aimed at young people, as vaccination is lagging in young adults across the US, said Johns Hopkins. It is designed to “support and meet young people where they are with simple answers to common COVID-19 vaccine questions.”

Vira’s knowledge base comes from Johns Hopkins vaccine scientists and was developed with support from its COVID-19 Training Initiative, with funding from Bloomberg Philanthropies.

The system was developed using IBM software and is adaptive, learning by listening to questions and feedback and can be used to help scientists respond to emerging questions about COVID-19 jabs

“Vira can help health workers or anyone who seeks help fielding questions from family and friends about the COVID-19 vaccines,” said its developers, who note that it contains over 150 distinct concerns which were expressed by real world users during development and testing.

“We envision developing similar chatbots to help individuals make more informed decisions about various topics such as quitting smoking, donating blood, voting and more,” they add.

https://pharmaphorum.com/news/unsure-whether-to-get-a-covid-19-jab-just-ask-vira/

Novartis to make Leqvio for U.S. in Austria to overcome FDA delay

 Novartis will manufacture anti-cholesterol drug Leqvio at its own plant in Austria to supply the United States as it seeks U.S. approval that has been delayed by regulatory concerns over a contractor's Italian facility.

Leqvio, which cost Novartis $10 billion in a 2019 acquisition, has been approved in Europe but U.S. clearance stalled after the Food and Drug Administration (FDA) questioned "unresolved facility inspection-related conditions" at the Italian plant of Novartis supplier Corden Pharma.

Novartis said in a statement on Tuesday that it has issued a resubmission to the FDA's so-called "complete response letter" in which it listed "its own site in Schaftenau, Austria, as the manufacturing location for the final finished product".

The medicine's generic name is inclisiran.

"We are manufacturing inclisiran at Schaftenau and with Corden," a spokesperson for Basel-based Novartis said. "Corden continues to supply our markets outside the U.S. and Schaftenau will supply the U.S."

Novartis Chief Executive Vas Narasimhan has said that Leqvio, bought from The Medicines Co. to augment its heart-drug portfolio, could become one of the Swiss drugmaker's biggest sellers ever.

Narasimhan had previously said the FDA's final sign-off for Leqvio was out of the company's control.

Novartis, which reiterated that any issues with Corden's plant had nothing to do with Leqvio's efficacy or safety, added that the transfer of manufacturing to Austria had been planned and began in 2020, before the FDA raised concerns.

The U.S. delay for Leqvio has weighed on Novartis's sales growth, which was already being crimped by the pandemic. And a big study of the drug in Britain has been pushed back as COVID-19 disrupted the clinical trial.

https://finance.yahoo.com/news/2-novartis-leqvio-u-austria-084234788.html

Olympics-No spectators at marathons and race walks, Games at risk of more curbs

 World Athletics said on Tuesday that it was surprised by the "seemingly inconsistent" decision to ask spectators to stay away from the marathon and race walk at the Tokyo Olympics, outdoor events that are hugely popular in Japan.

Organisers had earlier asked the public not to gather on the streets for the events to reduce the risk of infection amid the COVID-19 pandemic, after a technical working group meeting with Hokkaido prefectural and Sapporo city authorities and police.

The decision is a blow to fans in a country where the marathon has gained in popularity in recent years, after Naoko Takahashi and Mizuki Noguchi won gold in the women's event in 2000 and 2004 respectively.

"World Athletics is surprised by this new decision about our events in Sapporo, which is seemingly inconsistent with the decision to allow up to 10,000 spectators in venues in Tokyo, many of which are indoor venues," the athletics governing body said in a statement.

"We'll discuss this decision as soon as possible as it would be a great shame not to have spectators for the race walk and marathon in Sapporo given the popularity of both disciplines in Japan and the fact they are being held outdoors."

The race walks will be held on Aug. 5-6 and the marathon races on Aug. 7.

Japan is also considering barring all but VIP spectators from the Games' opening ceremony, a newspaper said, another downgrade for the Olympics that have had their pomp and spectacle tarnished by the novel coronavirus.

Once promoted as an extravaganza to showcase Japan to the world, the Games appear in danger of taking place largely without spectators in a country closed to visitors from abroad because of the pandemic and with areas around Tokyo still under restrictions.

The Games, already delayed a year, are set to open on July 23 despite concern that an influx of thousands of people from around the world could trigger new waves of infections.

Plans for the opening ceremony remain under wraps but the Asahi newspaper, ahead of talks with the International Olympic Committee and other organisers, reported that the government would slash the number of VIPs, such as sponsors' guests and diplomats, at the ceremony from an initial estimate of about 10,000.

During the Games, events at large venues and those after 9 p.m. would also be held without spectators, the paper said, citing multiple unidentified government sources.

Organisers have already banned overseas spectators and set a cap on domestic spectators at 50% of capacity, up to 10,000 people.

With the public nervous about new clusters of infections, medical experts have said no spectators would be the least risky option.

The question of spectators is due to be decided at five-way talks also expected on Thursday that will include the Tokyo governor and IOC President Thomas Bach, who arrives in Japan that day.

The government looks likely to decide on Thursday to extend a state of quasi-emergency in Tokyo and three nearby prefectures beyond an original end-date of July 11, government sources have said.

Kyodo News reported that the extension would likely last a month, meaning the curbs will be in place throughout the Olympics, which close with a ceremony on Aug. 8.

TORCH RELAY

When the Games were postponed last year, Japanese officials said they hoped they would be held in 2021 as a symbol of "victory" by humankind over the virus.

With that celebration on hold as countries around the world grapple with new outbreaks, they now say the Games will help bring together a divided world.

In another blow, the Olympic torch relay, set to reach Tokyo on Friday and parade through the city until the opening ceremony, will be moved off public roads.

Instead, torch-lighting ceremonies without spectators will be held, the Yomiuri newspaper reported.

When Japan was awarded the Games in 2013, they were expected to be a celebration of recovery from a deadly earthquake, tsunami nuclear accident in 2011.

In 2015, then-prime minister Shinzo Abe promised visitors would be able to use self-driving cars to run around Tokyo and a start-up backed by Toyota Motor Corp said in 2017 it aimed to light the Olympic flame with its flying car.

The coronavirus has brought everyone down to earth.

Asked about spectators, top government spokesman Katsunobu Kato told a news conference that Prime Minister Yoshihide Suga has said holding the Games without spectators was a possibility.

Suga was keen to have fans in the stadiums, the Asahi said, but added some ruling party members wanted a ban, especially after the ruling coalition failed to win a majority in an election for the Tokyo's assembly on Sunday, partly due to dissatisfaction with the government's COVID-19 response.

That poll is seen as a bellwether for a general election later this year.

Japan has not had the explosive COVID-19 outbreaks seen elsewhere but has seen more than 800,000 cases and more than 14,800 deaths. A slow rollout has meant only a quarter of its population has had at least one vaccination.

https://news.trust.org/item/20210706171557-4gvzh/

Opiant: Positive Top-line Results of Confirmatory Study for Novel Opioid Overdose Treatment

 Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT) today announced positive top-line results from its confirmatory pharmacokinetic (“PK”) study for OPNT003, nasal nalmefene, for opioid overdose.

The study was conducted in 68 healthy subjects and compared OPNT003, nalmefene hydrochloride nasal spray, 3 mg, (“nasal nalmefene”), with an intramuscular nalmefene hydrochloride injection, 1 mg, which was the comparator previously agreed upon with the U.S. Food and Drug Administration (“FDA”). According to an initial analysis, the top-line data demonstrated that nasal nalmefene achieved significantly higher plasma concentrations compared to an intramuscular injection (p<0.0001). The time for nasal nalmefene to achieve maximum plasma concentrations (Tmax) was consistent with data from the previously completed pilot study (~15 minutes). The maximum plasma concentration (Cmax) was higher than observed in the pilot study, and the plasma half-life of nasal nalmefene (~11 hours) was consistent with reported values following other routes (oral and parenteral) of administration. Naloxone, currently the only FDA-approved treatment for opioid overdose, has a half-life of approximately 2 hours.

“We are very pleased with the results of this confirmatory PK study. Importantly, the data are consistent with the findings of our initial pilot study,” said Roger Crystal, M.D., CEO and President, of Opiant. “In the United States, where we’ve seen the opioid epidemic worsen during COVID-19, the nationwide spread of potent illicit synthetic opioids, such as fentanyl, which is 50 times stronger than heroin, with a half-life more than seven hours1, is driving significant numbers of opioid overdose deaths. A rescue agent with a rapid onset and a long half-life, is critical to saving lives from overdose. We now look forward to the PD data later in the year.”

https://finance.yahoo.com/news/opiant-pharmaceuticals-announces-positive-top-200100142.html

Agenus: Bristol Myers Squibb licensing deal has up to $1.3B in milestone payments

 Shares of Agenus Inc. AGEN, -1.99% were up 2.0% in premarket trading on Tuesday after the company said a licensing deal with Bristol Myers Squibb Co. BMY, -0.83% had closed. As part of the agreement, Bristol plans to study an experimental Agenus immuno-oncology drug as a treatment for non-small cell lung cancer. Bristol will pay Agenus $200 million upfront, with up to $1.3 billion in possible milestones payments. Agenus' stock has gained 73.6% so far this year, while the broader S&P 500 SPX, -0.37% is up 15.8.%.

https://www.marketwatch.com/story/agenus-says-its-bristol-myers-squibb-licensing-deal-has-up-to-13-billion-in-milestone-payments-2021-07-06

ALX Oncology: ALX148 Shows ORR of 72% In Patients With HER2 Positive Stomach Cancer

 

• ALX Oncology Holdings Inc (NASDAQ: ALXO) announced updated data from its ongoing ASPEN-01 Phase 1b trial evaluating ALX148 in combination with trastuzumab and chemotherapy to treat gastric or gastroesophageal junction cancer (GC).

• The new data were shared at the World Congress on Gastrointestinal Cancer.

• Data showed that ALX148, combined with trastuzumab and chemotherapy, is highly active and well-tolerated in patients with second-line or greater HER2 positive GC.

• As of the data cut-off of May 3, 2021, ALX148 demonstrated a favorable initial confirmed objective response rate (ORR) of 72% and estimated overall survival (OS) at 12 months of 76%.

• These results compare favorably to randomized historical control studies; RAINBOW reported an ORR of 28% and OS at 12 months of 40%, and DESTINY-01 reported an ORR of 41% and OS at 12 months of 52%.

• Preliminary data suggest that ALX148 can be combined with trastuzumab, ramucirumab, and paclitaxel with no maximum tolerated dose reached.

• The maximum administered dose of ALX148 in combination was 15 mg/kg once weekly.

• ALX Oncology hosted a conference call today at 8:30 a.m. E.T.

https://finance.yahoo.com/news/alx-oncology-shares-jump-alx148-131535993.html

Sanofi expects Covid vaccine to be ready by December

 French pharmaceutical giant Sanofi says its much-awaited Covid-19 vaccine should be available by December – news the government hopes will convince sceptics to get themselves vaccinated. 

Made in partnership with Britain’s Glaxo GSK, the vaccine uses recombinant proteins to trigger an immune response – the same technology that is used in one of Sanofi’s seasonal flu vaccines.

"This is the technology that was the most efficient a year ago, before messenger RNA,” Sanofi France chairman Olivier Bogillot told France Inter on Monday, adding the method had been “proven for a few years now”.

Messenger RNA (mRNA) is the pioneering technology used in leading global Covid-19 vaccines made by Pfizer and Moderna.

Sanofi has begun pivotal phase three trials on its vaccine, which uses a adjuvant – a substance that helps boost the immune response. Phase two trials showed a high antibody responses in all adult age groups.

French minister for industry, Agnès Pannier-Runacher, said the vaccine could be the key to convincing millions of French people who are still reluctant to get themselves vaccinated.

“There is strong support for a French-made vaccine … it’s psychological. I can't explain it, but it’s true,” she told France Info radio.

“If this vaccine can contribute to getting French people vaccinated, then so much the better.”

Cheaper, easier to store

Just over 24 million people – or 36 percent of the population – have been fully vaccinated in France.

The Sanofi-GSK vaccine, which is cheaper and easier to store than its rivals, will require two initial doses followed by a booster shot.

Despite its late arrival on the market – four vaccines have been approved by the European Medicines Agency – Bogillot said the vaccine would still be useful both in France and around the world.

"We will have to achieve a very high level of collective immunity with the arrival of the variants” he said.

“Today, only 20 percent of the world's population is vaccinated.”

Rival technology

The mRNA technology used by Pfizer and Moderna has never been used in an approved vaccine. It works by teaching the body to make harmless pieces of Covid-19’s so-called “spike protein”, which then triggers the production of antibodies.

Vaccines made by Johnson & Johnson and AstraZeneca, meanwhile, are viral vectors, which use a harmless version of another virus as a delivery system. 

Viral vector technology has been effectively used to combat Ebola, Zika, HIV and several other viruses.

Although the vaccines are scientifically different, experts say they should all contribute towards herd immunity.

https://www.rfi.fr/en/france/20210705-france-s-sanofi-expects-covid-vaccine-to-be-ready-by-december