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These are some of the coronavirus vaccine candidates

These are some of the coronavirus vaccine candidates

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coronavirus vaccine candidate covid 19 vaccine candidate

There’s a long list of coronavirus vaccine candidates in development right now, but it’s too early to say which will enter production. Investors have been quick to jump on any public companies that have COVID-19 vaccine candidates in development, although it’s still very early in the process.

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Here are some of the coronavirus vaccine candidates

The World Health Organization is keeping a list of coronavirus vaccine candidates in development here. Toward the top of the list, you'll see the RNA COVID-19 vaccine candidate from Moderna and the National Institute of Allergy and Infectious Diseases.

Also on the list are Sinovac's effort, the non-replicating viral vector candidate from the University of Oxford, Inovio Pharmaceuticals' DNA vaccine, and the RNA vaccine candidate in development by Pfizer with BioNTech and Fosun Pharma. The Wuhan Institute of Biological Products is also working on a coronavirus vaccine candidate with Sinopharm, and the Beijing Institute of Biological Products is also working on one with Sinopharm.

Other companies listed on the list of COVID-19 vaccine candidates are Janssen Pharmaceutical, Altimmune, GeoVax and BravoVax, Valo Therapeutics, Sanofi Pasteur and GlaxoSmithKline, and Novavax.

The WHO's list of coronavirus vaccine candidates is five pages long, illustrating just how much effort is being put into finding a vaccine for the deadly virus.

Types of vaccines

Researchers are looking into four different approaches for creating a vaccine. The process usually takes years, but they are combining trial phases and taking other steps to shorten the process due to the severity of the pandemic right now. Over 100 different teams of scientists around the world are trying their hand at developing a vaccine for the coronavirus, which has sickened nearly 5 million people and taken about 325,000 lives.

Nature explained what questions scientists must ask as they test each coronavirus vaccine candidate. The most obvious question is about what kind of immune response the vaccine will cause and whether it effectively prevents COVID-19. Another question is whether each vaccine is safe, while another is how to know if it will actually work.

Finally, researchers must determine that if immunity does develop from any vaccine, how long will it last?

Here's what's happening now in the COVID-19 vaccine candidate effort

The U.S. Department of Health is providing up to $1.2 billion to speed up the development of AstraZeneca's coronavirus vaccine candidate. The money will also secure 300 million doses of the vaccine for the U.S. The vaccine candidate is being developed by the University of Oxford and licensed to AstraZeneca.

The deal allows for a late-stage Phase 3 clinical trial of the vaccine involving 30,000 people in the U.S. AstraZeneca said it has secured agreements for at least 400 million doses of the vaccine and arranged manufacturing for 1 billion doses. Deliveries of the vaccine are set to start in September, according to Reuters. The U.S. government also has deals with Johnson & Johnson, Moderna and Sanofi.

In other parts of the world, preparations are also being made to manufacture vaccines. The Serum Institute of India is the biggest vaccine maker by volume, and it has set aside one of its facilities to produce up to 400 million doses of Oxford's vaccine per year.

Next steps

About 100 different coronavirus vaccine candidates are in the works, so it will be some time before researchers know which candidate will be the best one to put into mass production. At lease six of those COVID-19 vaccine candidates are now being tested for safety in humans. The next step will be to determine which vaccines actually do what they're supposed to do, which is prevent infection with the novel coronavirus.

Nature explained that the vaccine trials involve giving thousands or tens of thousands of people the vaccine candidate or a placebo and then watching over months or years whether there is a difference in the number of people who get infected between the two groups. The trials are also focused on ensuring that the vaccines are safe.

Due to the COVID-19 pandemic, officials are speeding up the rate of vaccine development because it's thy only way to fully protect the world's population. Despite the fact that millions of people have been infected, many still haven't been exposed to it, so the human race is a long way from herd immunity.

Which coronavirus vaccine candidates to test first

The World Health Organization is planning a trial to test multiple COVID-19 vaccine candidates in a single study. Such an undertaking has never been attempted before, and vaccines have never been tested in such a short timeframe. The WHO's study will allow for more vaccine candidates to be added to the trial on a regular basis. Candidates that don't appear to work can be easily dropped from the trials.

As far as which coronavirus vaccine candidates will be tested first, researchers will look at production capacity and the amount of immune response generated in early trials and animal studies. Nature notes that some of the types of vaccines that are being developed, like RNA vaccines, which Bill Gates is excited about, haven't been tested widely in humans. The RNA method also hasn't been used in any vaccine that has previously won approval by regulators.

One other issue with testing multiple vaccine candidates is figuring out how each of them compares to each other. The WHO's trial could allow vaccines to be compared to each other, but some developers might not want to do it because such a trial could impact their vaccine's commercial prospects.

Another way to accelerate coronavirus vaccine candidates

Mass-scale trials will play an important role in the development of each coronavirus vaccine candidate, but there is a possibility that regulators could approve emergency deployment of them. Nature said one possibility is to look for signs in early-state trials that a vaccine candidate works in hundreds of patients and then seek approval from regulators to administer the vaccine to high-risk groups like healthcare workers.

The U.S. Food and Drug Administration can grant such emergency deployment measures while more data is being collected to license a particular vaccine. So far, no vaccine has ever been given out under emergency provisions. If the coronavirus vaccine does follow that path, regulators will want to be sure that it's safe before issuing emergency approval.

Believe it or not, some are advocating a more radical approach to getting COVID-19 vaccine candidates approved faster. This would involve intentionally infecting volunteers who are young and healthy, which would mean that study administrators wouldn't need to wait and see if trial participants become infected naturally. This process is already being used for diseases like dengue fever and malaria. However, without an effective treatment, such a process would be extremely risky because there would be no way to know which young, healthy volunteers will develop life-threatening symptoms from the disease.

The post These are some of the coronavirus vaccine candidates appeared first on ValueWalk.

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Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

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To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

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Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

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Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


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Another country is getting ready to launch a visa for digital nomads

Early reports are saying Japan will soon have a digital nomad visa for high-earning foreigners.

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Over the last decade, the explosion of remote work that came as a result of improved technology and the pandemic has allowed an increasing number of people to become digital nomads. 

When looked at more broadly as anyone not required to come into a fixed office but instead moves between different locations such as the home and the coffee shop, the latest estimate shows that there were more than 35 million such workers in the world by the end of 2023 while over half of those come from the United States.

Related: There is a new list of cities that are best for digital nomads

While remote work has also allowed many to move to cheaper places and travel around the world while still bringing in income, working outside of one's home country requires either dual citizenship or work authorization — the global shift toward remote work has pushed many countries to launch specific digital nomad visas to boost their economies and bring in new residents.

Japan is a very popular destination for U.S. tourists. 

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This popular vacation destination will soon have a nomad visa

Spain, Portugal, Indonesia, Malaysia, Costa Rica, Brazil, Latvia and Malta are some of the countries currently offering specific visas for foreigners who want to live there while bringing in income from abroad.

More Travel:

With the exception of a few, Asian countries generally have stricter immigration laws and were much slower to launch these types of visas that some of the countries with weaker economies had as far back as 2015. As first reported by the Japan Times, the country's Immigration Services Agency ended up making the leap toward a visa for those who can earn more than ¥10 million ($68,300 USD) with income from another country.

The Japanese government has not yet worked out the specifics of how long the visa will be valid for or how much it will cost — public comment on the proposal is being accepted throughout next week. 

That said, early reports say the visa will be shorter than the typical digital nomad option that allows foreigners to live in a country for several years. The visa will reportedly be valid for six months or slightly longer but still no more than a year — along with the ability to work, this allows some to stay beyond the 90-day tourist period typically afforded to those from countries with visa-free agreements.

'Not be given a residence card of residence certificate'

While one will be able to reapply for the visa after the time runs out, this can only be done by exiting the country and being away for six months before coming back again — becoming a permanent resident on the pathway to citizenship is an entirely different process with much more strict requirements.

"Those living in Japan with the digital nomad visa will not be given a residence card or a residence certificate, which provide access to certain government benefits," reports the news outlet. "The visa cannot be renewed and must be reapplied for, with this only possible six months after leaving the countr

The visa will reportedly start in March and also allow holders to bring their spouses and families with them. To start using the visa, holders will also need to purchase private health insurance from their home country while taxes on any money one earns will also need to be paid through one's home country.

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