We will now have to wait until 2022 to find out whether Sanofi and GlaxoSmithKline have an effective recombinant vaccine against Covid-19.
The two pharma giants revealed that their Phase III trial isn’t quite ready for a readout. Meanwhile, they seem to have more hope in the booster application of their candidate, touting positive preliminary data suggesting that it spurred an increase in neutralizing antibodies in all patients — whether they received mRNA or adenovirus-based shots as the primary vaccines.
They had originally expected data early enough for regulatory clearance by the end of 2021.
At the last review, though, the independent data safety monitoring board recommended that the trial continue into early 2020 to accrue more data. And Sanofi and GSK suggest that proving efficacy will be tough, since regulatory authorities require Phase III efficacy to be demonstrated in ‘naive’ populations that have never been infected before.
Most of the participants in their trial were recruited in Q3 this year, they noted — when the Delta variant drove a surge in new infections — meaning more events are needed in the trial to support an analysis.
‘While pursuing a phase 3 trial is a challenge in a quickly shifting pandemic environment, we look forward to seeing the results to support submissions of our booster vaccine as quickly as possible,’ Sanofi EVP Thomas Triomphe said in a statement.
This isn’t the first delay Sanofi and GSK have run into as they tried to bring a new vaccine to market using a traditional technology. The closely watched program had been pushed back once already late last year after it failed to kick up a sufficient immune response in older adults. The current Phase III trial (which involves sites in multiple countries, including the US, France and the UK) is testing a new, updated version of the vaccine.
For the extension — which Sanofi and GSK call the most comprehensive heterologous booster trial conducted to date — investigators tracked down recipients of the four most widely approved Covid-19 vaccines, including Moderna, Pfizer/BioNTech, AstraZeneca/Oxford and J&J, and gave them the adjuvanted protein-based vaccine.
They found that neutralizing antibodies increased across all cohorts and all age groups, in a 9- to 43-fold range (although they didn’t break down the numbers), with a good safety and tolerability profile.
‘The initial booster data are promising, and we await the phase III results to determine the next steps on making protein-based adjuvanted COVID-19 vaccines available,’ said Roger Connor, president of GSK Vaccines.
Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
A nurse administers a COVID-19 booster shot to Joe Rigdon at a vaccination site in Eastmonte Park, Altamonte Springs. (Photo by Paul Hennessy/SOPA Images/LightRocket via Getty Images)
When Laura Burns went to get her first Covid-19 shot last January, no one had warned her that the vaccines might not work for her.
Burns, the recipient of a double-lung transplant in 2016, knew to be careful about the medicines she took. She consulted with her transplant team when the Pfizer and Moderna shots were authorized and only signed up after being told the vaccines would likely be safe for her, which they were.
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Jay Bradner, President, Novartis Institutes for BioMedical Research
John Carroll: Well, hello everybody. This is John Carroll. I’m the editor of Endpoints News, the editor and founder of Endpoints News. I’m here with Jay Bradner, the president of the Novartis Institutes for BioMedical Research. Jay, we’re going to be talking about ASH in just a second, but you’ve just recently celebrated your sixth anniversary as president of NIBR. And I’m curious, it’s such a significant amount of time for anybody to spend in one career phase. And looking back over the last six years, is everything fundamentally different about the research process and the translational arena that you’re in?
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Albert Bourla (Evan Vucci, AP Images)
After a post-marketing trial for Pfizer’s Xeljanz turned concerning safety results at the beginning of the year, thwarting the whole JAK class, the FDA is finally rolling out some new approvals — but with added warnings and a key label change.
Both Xeljanz and AbbVie’s Rinvoq got cleared for new indications on Tuesday, but on one condition: They can only be taken after a patient has failed on one or more tumor necrosis factor (TNF) blockers, like Humira or Enbrel.
Harpreet Singh, Immatics CEO (Credit: Allogeneic Cell Therapies Summit)
Just a few weeks after offering a positive readout on its first early clinical-stage offering, the transatlantic biotech Immatics is back with news that the research crowd around Rupert Vessey at Bristol Myers Squibb has anted up $150 million in cash to get on at the ground floor with one of their still-preclinical efforts.
This time the news is centered on IMA401, Immatics’ most advanced bispecific, which uses one binder to latch on to MAGEA4/8 while another is used to whip up T cell activity against tumor cells where that’s a common antigen. For now, that’s still a preclinical effort, with the first human trial set to launch in the first half of next year.
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CVS Health is adding clinical trial services inside some of its retail locations with HealthHubs and in the future at CVS primary care centers (via CVS Health)
During the Covid-19 pandemic, local pharmacies were not only key purveyors of prescriptions and hand sanitizer, but also important testing and vaccine delivery locations. Next up? Clinical trial sites. That’s according to a recent PwC Health report that lays out the case for both pharma and pharmacies — and why it’s more probable than ever.
Figuring out how to scale decentralized trials is necessary, made clear by the pandemic, said Greg Rotz, PwC’s pharma and life sciences leader in the US. The good news from his perspective is both pharma companies and retailers are investing in business models and infrastructure to make it happen.
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Aamir Malik, Pfizer chief business innovation officer
Pfizer made a big splash in the M&A space Monday, announcing a $6.7 billion buyout of Arena Pharmaceuticals to chase Bristol Myers Squibb in the S1P race. But company execs suggested the company isn’t finished bringing on new assets.
In an investor call outlining the Arena acquisition, chief business innovation officer Aamir Malik took a moment to discuss Pfizer’s growth plans going forward. The strategy was made up of three pillars: advancing the internal pipeline, continuing to pursue outside opportunities and exploring the combination of technology and data to ‘accelerate’ growth.
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The drastic difference in efficacy for Merck’s Covid-19 pill between interim and final analyses — from a 50% relative reduction in hospitalizations and deaths at the interim to just 30% in the final results — had some worrying that the Pfizer pill’s early success for adults at high risk of hospitalization might also be more muted in the final results.
But that wasn’t the case early Tuesday as Pfizer said that final data available from the more than 2,200 high-risk patients enrolled in its trial confirmed prior results showing Paxlovid reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo. The company added:
Tillman Gerngross, Adagio CEO
Since the pandemic began in the spring of 2020, Tillman Gerngross has raised more than half a billion dollars for his startup Adagio and their promise to develop a so-called broadly neutralizing coronavirus antibody that could snare any variant.
When Omicron broke out over Thanksgiving, bringing a strain that threatened to evade widely-used antibody treatments from Eli Lilly and Regeneron, Adagio’s $ADGI soared 34% as Gerngross’ predictions appeared to come true. Early computational analyses suggested Adagio’s antibody, ADG20, currently in pivotal trials, should retain full efficacy against the variant.
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