Oxford/AstraZeneca’s nasal spray vaccine performed poorly in an early-stage study, squashing hopes for a quick advancement of the duo’s original formulation via an inoculation at SARS-CoV-2’s entryway.
A small study at one site in the UK revealed a bleak outlook for a nasal version of one of the top-administered Covid-19 vaccines in the world, behind breakouts Pfizer/BioNTech and Moderna. The Phase I study included 30 patients who hadn’t previously received a Covid-19 jab and 12 patients who tested the nasal vaccine as a booster.
The Oxford team, funded by AstraZeneca, went with the same vaccine as their injectable one, based on the ChAdOx1 adenovirus vector. They decided to go the same route as the original — first authorized in the UK in the final days of 2020, beset by dwindling demand and never approved in the US — because researchers wanted to “facilitate rapid rollout if the results were positive,” the university said in a statement.
Mucosal antibody responses were only observed in a “minority of participants,” which means very few given the already drastically small sample size. Intramuscular vaccination was stronger than the nasal one in terms of eliciting systemic immune responses, they also reported. One silver lining: No safety concerns emerged.
Despite the failure, the Oxford researchers think a simple nasal spray is more suited for a big rollout than that of a nebulizer device, which is required for delivery of the intranasal vaccine recently approved in China. The East Asian nation and India are the only two countries to have greenlit intranasal vaccines for the pandemic.
The Oxford vaccine comprises a weakened version of a common cold virus modified to the point that it can’t replicate in humans.
Sandy Douglas, chief investigator of the Phase I study at Oxford’s Jenner Institute, said flatly: “The nasal spray did not perform as well in this study as we had hoped.”
Douglas, in prepared remarks, said the results were “quite different” from the data out of CanSino Biologics’ nebulizer-delivered vaccine, which transforms the liquid into a mist, and goes “deep into the lungs.”
The Oxford investigator also said eyes will be fixated on the peer-reviewed publication of clinical trial data used to support the go-ahead for Bharat Biotech’s drops-in-the-nose vaccine.
But hurdles remain for nasal vaccines, thought by some experts — including Scripps director Eric Topol — to be the next place where big R&D investment needs to take place.
“One possibility is simply that the majority of the nasal spray vaccine ends up being swallowed and destroyed in the stomach — delivery to the lungs could avoid that,” Douglas continued.
Higher concentrations might be needed or substances that could help the vaccine adhere better inside the nose so that it’s not swallowed, the researchers said.
Outside the world’s most populated countries, the hunt for new vaccines continues nearly three full years into the pandemic.
For AstraZeneca, the Big Pharma’s future rests largely outside of Covid-19. Eyes are more focused on Enhertu, a drug that helped spur HER2-low as a new category of breast cancer, and its Sanofi-partnered respiratory syncytial virus antibody, nirsevimab, which was recently recommended by Europe’s advisors. An FDA decision awaits.
“The vaccine and Evusheld were important in the last two years,” Ruud Dobber, head of AstraZeneca’s biopharma unit, told the Wall Street Journal. “But there’s so much more.”
With household names like Botox and cancer treatment Keytruda, it’s no surprise that the global injectable drugs market is expected to top $1.2 trillion between 2022 and 2030. With a projected 9% compound annual growth rate (CAGR) in that same period, the market is quickly expanding to provide desperately needed treatments in areas like oncology and orphan disease to psychiatric disorders and immunodeficiencies.
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Many thanks to all those who turned up at the EUBIO event in London this week — the whole team is now basking in the positive feedback we got and the photos are giving me FOMO. Endpoints is looking to bring these in-person gatherings to many more corners of the world. Stay tuned.
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When it comes to the European Medicines Agency’s drug review committee, known as CHMP, any positive opinions it gives to a drug are all but certain to be approved across the EU. And the committee just doled out opinions to a batch of 10 drugs, including two with higher profiles.
The Committee for Medicinal Products for Human Use, aka CHMP, recommended seven brand-name drugs and three generic — for marketing authorization in the EU. And while the European Commission has to sign off before those drugs go to market, it’s rare that the commission bucks the committee’s choices.
Biohaven is looking for people living with obsessive compulsive disorder using TV, radio and digital ads to find patients for its ongoing obsessive compulsive disorder (OCD) trial.
Not unlike many pharma companies, Biohaven is seeking clinical trial participants for study — in its case, for an obsessive compulsive disorder drug candidate. However, unlike typical trial recruitment ads advising people to call this number or visit that website, the Biohaven campaign stars real OCD patients sharing their thoughts, worries and hopes.
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The biopharma industry reputation is sliding again — and alarmingly fast. The pharmaceuticals, biotechnology and life sciences category fell almost 3 points (2.9) between the first and second quarter of 2022, according to corporate reputation monitor RepTrak.
While a two- or three-point drop may not seem significant, RepTrak points out that its historical data “warns us that a 1-point drop often results in a 4-5% drop in support.”
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Making sure a pharma sponsor and the FDA are on the same page when it comes to a new drug development program, particularly around manufacturing, can be crucial to ensuring the drug gets a fair shake as the review process plays out.
One aspect of this dialogue is the agency may issue an information request (IR) via letter, email or fax — where FDA seeks a clarification to help its review.
But these IRs from CDER and CBER must be standardized, and adhere closely to what’s known as “Four-Part Harmony,” which is where reviewers are expected to communicate to sponsors: “(1) what was provided, (2) what is the issue or deficiency, (3) what is needed, and (4) why it is needed.”
Pfizer won’t be the only drugmaker to file an RSV vaccine with the FDA this year.
GSK — another frontrunner in the long race to develop a shot that can protect the elderly from respiratory syncytial virus infections — is out with what CSO Tony Wood calls “truly exceptional” Phase III results, opening the door to regulatory submissions in 2022.
The update marks a key and much-needed win for GSK’s RSV ambitions after an observation related to safety forced it to stop trials in pregnant women. It had hoped that by vaccinating pregnant women, it could immunize babies against the virus.
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Not two years after the family-owned Swiss pharma Helsinn engineered a $2.4 billion deal to get a piece of BridgeBio’s infigratinib — later approved as Truseltiq — it’s all coming to an abrupt end.
LianBio, the biotech player that holds the China license to the drug, flagged the news in an SEC disclosure — although it appears that BridgeBio has previously reported it in a September filing.
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Bivalent booster shots specific to currently circulating Omicron strains will soon be available to children as young as 5 years old.
The FDA has authorized Pfizer and BioNTech’s booster in children ages 5 through 11, the companies announced on Wednesday, as well as Moderna’s formulation in kids 6 through 17 years old. Both shots are specific to the Omicron BA.4/BA.5 subvariants, which account for more than 80% of cases in the US, according to Pfizer.
Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas
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