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Covid-19 roundup: Boehringer pulls a drug out of the pipeline for a PhII Covid-19 trial; Novavax delays PhIII trial in US, with PhII data coming Friday;

Covid-19 roundup: Boehringer pulls a drug out of the pipeline for a PhII Covid-19 trial; Novavax delays PhIII trial in US, with PhII data coming Friday;

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With big questions still hanging over the fate of the vaccines and drugs now in late-stage development for Covid-19, Boehringer Ingelheim is pulling one of its early-stage drugs into a Phase II trial to see if it can help some of the most severely afflicted patients.

Put through a safety study last year, researchers have been intrigued by the potential of BI 764198 — a TRPC6 inhibitor — as a treatment for acute respiratory distress syndrome (ARDS), which can cause immense damage and death for patients exposed to the virus.

Clive Wood

As the pandemic hit, “we started to ask, what are the mechanisms we have in the pipeline, what might help these patients?” says Clive Wood, head of discovery research at Boehringer. That led them to a drug in development for chronic kidney disease, which shares a pathway that could have an impact on the virus.

“We are far from having a clear path to having a clear path to the end of this situation,” says Wood, and that makes it important to recruit 90 patients for the Phase II, with the ability to pivot into a late-stage registration study if it works out.

Even if it doesn’t work out in time for Covid-19, Boehringer’s researchers expect that success could pave the way to other uses in the future. Right now, the only thing they know for certain is they need to see if it works. — John Carroll

Manufacturing delay pushes back the launch of a PhIII at Novavax

Though Novavax $NVAX is near the forefront of the Covid-19 vaccine race, it will be starting its Phase III trial later than anticipated.

The company said Tuesday that its late-stage study in the US has been pushed back to the end of November after delays in upscaling its manufacturing processes. That’s about one month after previously reported timelines.

Meanwhile, trial data from a separate Phase III being conducted in the UK are likely coming sometime “early” in the first quarter, Novavax said, adding that the results from this study “are expected to serve as the basis for global licensure.” Novavax did not elaborate on what that meant nor how they plan to apply for such “licensure” in the US.

Additionally, new Phase II data from the company’s ongoing Phase I/II trial are expected to come Friday. Investors mostly greeted the news warmly, as the company’s shares rose about 3% in Tuesday trading.

While there haven’t been any Covid-19 vaccine approvals or EUAs thus far, there have been a few for treatments. The FDA recently granted approval for Gilead’s remdesivir, marketed as Veklury, in hospitalized patients older than 12. That followed an EUA for the therapy, as well as EUAs for hydroxychloroquine and convalescent plasma. Regulators have since revoked the former’s authorization.

Novavax received a $1.6 billion Warp Speed contract in July and began its UK Phase III study in late September. The biotech is testing a two-shot regimen of its lower, 5 µg dose of protein antigen currently in Phase II, plus a 50 µg Matrix‑M adjuvant. The shots are being administered 21 days apart.

Pfizer currently leads Endpoints News’ Covid-19 vaccine race tracker, with Novavax coming in 8th. — Max Gelman

CBER director promises ‘safe and effective’ vaccine in op-ed

In an effort to shore up trust in the FDA’s ability to authorize a safe and effective vaccine, CBER director Peter Marks broke down the EUA process in a USA Today op-ed. 

“We hope to ensure public confidence in COVID-19 vaccines by being transparent about FDA’s decision-making process,” he wrote. “Whether a vaccine is made available through an EUA or through a traditional approval, FDA will ensure that it is safe and effective.”

Peter Marks

In the roughly 1,000-word piece, Marks promised that an EUA decision will not be rushed. And he explained that the FDA’s minimum recommendation of 50% efficacy is just that — a minimum.

“Of course, it is hoped that the vaccines will prevent a much higher percentage of cases, but the 50% figure establishes the minimum efficacy of a COVID-19 vaccine that FDA could find acceptable,” he said.

The director also mentioned that considerations for an EUA may be different, depending on how a product will be used. For example, if a drug is intended for hospitalized patients who have no other treatment, “the potential benefits may outweigh the risks even if there is uncertainty about effectiveness and there are real, but acceptable, safety concerns,” Marks wrote.

In June, the FDA yanked an EUA for hydroxychloroquine as a Covid-19 treatment, after determining the drug is “unlikely to be effective.” And in September, a panel of experts convened by the NIH concluded that there is a lack of data supporting the safety and efficacy of another coronavirus treatment granted an EUA: convalescent plasma.

In the op-ed, Marks said that wouldn’t be the case for a vaccine:

For a COVID-19 vaccine that could be administered to millions of individuals, including healthy people, FDA will only issue an EUA if a vaccine has demonstrated clear and compelling efficacy in a large well-designed phase 3 clinical trial, much like would be required for a BLA. 

Normally, drug makers take months to analyze data before submitting a BLA, which can be tens of thousands of pages long, according to Marks. “But these are not ‘normal’ times,” he said. “In the United States, we have seen many hundreds of people die every day from COVID-19.”

“With high uptake, COVID-19 vaccines have the potential to save many lives in the United States that may otherwise be lost. And saving as many lives as is possible must be the goal that we strive to achieve together,” he wrote. — Nicole DeFeudis

Sanofi and GSK pledge 200 million vaccine doses

Sanofi and GSK have agreed to give 200 million doses of their vaccine candidate to the COVAX Facility, which is part of a program set up by CEPI, the WHO and Gavi to equitably distribute vaccines around the world.

The idea behind COVAX is to give all participating countries equal access to vaccines, regardless of income level. As of Oct. 14, more than 180 countries had signed agreements to the COVAX Facility, including France and the UK. China joined earlier this month, pledging to make its vaccines a “global public good.” One country notably off the list is the United States.

The Trump administration has refused to join the program. The US has placed an initial $1.95 billion order for 100 million doses of Pfizer’s candidate, with the option to acquire up to 500 million more down the road. And it placed a $1.5 billion order with Moderna for 100 million doses, with an option for another 400 million later. One White House spokesman said the country won’t be “constrained by multilateral organizations influenced by the corrupt World Health Organization and China,” according to a Bloomberg report.

COVAX is hoping to have 2 billion doses available by the end of 2021, “which should be enough to protect high risk and vulnerable people, as well as frontline healthcare workers,” the GAVI website states.

Thomas Triomphe

Sanofi and GSK entered their adjuvanted recombinant protein-based candidate in a Phase I/II study on Sept. 3, and anticipate the first cut of data in early December. The companies are hoping the results support the launch a pivotal Phase III trial before the end of the year. If all goes according to plan, they think a request for approval could come in the first half of 2021.

“The commitment we are announcing today for the COVAX Facility can help us together stand a better chance of bringing the pandemic under control,” Sanofi Pasteur executive VP and global head Thomas Triomphe said in a statement. “This moment also reflects our long-term commitment to global health and ensures our COVID-19 vaccines are affordable and accessible to those most at risk, everywhere in the world.” — Nicole DeFeudis

Vaccinologist Paul Offit calls for more efficacy data 

In the next couple months, drug makers will likely submit EUA applications for Covid-19 vaccines, renowned vaccinologist Paul Offit predicts.

This could come at the beginning of a “twindemic” — parallel flu and coronavirus outbreaks, he added. The question is, what will be required for emergency authorization?

“Permission is being given to vaccinate 150 million Americans essentially, which is obviously something we’ve never dealt with before,” Offit, director of the Children’s Hospital of Philadelphia’s Vaccine Education Center and inventor of the rotavirus vaccine, said in a JAMA Network interview.

Paul Offit

“How much uncertainty are we willing to live with knowing that we’re facing a virus that’s brought us to our knees?” he asked later.

Offit said he’s concerned the public will see emergency authorization as “flimsy,” or based on a lack of evidence, after what happened with hydroxychloroquine and the “convalescent plasma fiasco.”

“I think where the rubber’s going to meet the road here is how we handle these interim analyses,” he said in the interview.

Pfizer and BioNTech, currently in the lead for an EUA, announced in their trial protocol that their first interim analysis would occur when 32 participants are infected. Moderna will hold its first interim analysis at 53 events. And AstraZeneca is planning to conduct an analysis when 75 patients get sick. Researchers would then compare how many infections occurred in the vaccine arm, versus the placebo arm.

“I’d like to think that we’re going to be really loathe to approve this or to recommend approval through emergency use authorization with just 34 or 60 participants getting sick,” Offit said.

In NIH ACTIV trials, statisticians wanted to see 147 infections if the vaccine was administered in a 2:1 ratio to placebo, or 160 infections in a 1:1 scenario, Offit said. “That’s where I’m coming from,” he added.

“If dreams could come true, all I ask is this: Let’s have at least 150 participants that got sick,” Offit said. “That’s all I ask.” — Nicole DeFeudis

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EUR/AUD bearish breakdown supported by additional China fiscal stimulus and AU inflation

Weak PMI readings from the Eurozone, an increase in China’s budget deficit ratio, and renewed inflationary pressures in Australia may trigger a persistent…

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October 24, 2023

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  • Weak PMI readings from the Eurozone, an increase in China’s budget deficit ratio, and renewed inflationary pressures in Australia may trigger a persistent bearish sentiment loop in EUR/AUD.
  • Watch the key short-term resistance at 1.6700 for EUR/AUD.
  • A break below 1.6250 key medium-term support on the EUR/AUD may trigger a multi-week bearish impulsive down move.

The Euro (EUR) tumbled overnight throughout the US session as it erased its prior gains against the US dollar recorded on Monday, 23 October; the EUR/USD shed -104 pips from yesterday’s intraday high of 1.0695 to close the US session at 1.0591, its weakest performance in the past seven sessions.

Yesterday’s resurgence of the USD dollar strength has been attributed to a robust set of October flash manufacturing and services PMI data from the US in contrast with weak readings seen in the UK and Eurozone that represented stagflation risks.

Interestingly, the Aussie dollar (AUD) has outperformed the US dollar where the AUD/USD managed to squeeze out a minor daily gain of 21 pips by the close of yesterday’s US session. The resilient movement of the AUD/USD has been impacted by positive news flow out from China, Australia’s key trading partner.

China’s national legislature has just approved a budgetary plan to raise the fiscal deficit ratio for 2023 to around 3.8% of its GDP which was above the initial 3% set in March and set to issue additional sovereign debt worth 1 trillion yuan in Q4. This latest round of additional fiscal stimulus suggests that China’s top policymakers are expanding their initial targeted measures to address the ongoing severe liquidity crunch in the domestic property market as well as to reverse the persistent weak sentiment inherent in the stock market.

In addition, the latest set of Australia’s inflation data surpassed expectations has also reinforced another layer of positive feedback loop in the Aussie dollar which in turn may put Australia’s central bank, RBA on a “hawkish guard” against cutting its policy cash rate too soon.

The less lagging monthly CPI Indicator has risen to an annualized rate of 5.6% in September, above consensus estimates of 5.4%, and surpassed August’s reading of 5.2% which has translated into a second consecutive month of uptick in inflationary growth.

In the lens of technical analysis, a potential bearish configuration setup has emerged in the EUR/AUD cross pair from a short to medium-term perspective.

Major uptrend phase of EUR/AUD is weakening

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Fig 1: EUR/AUD medium-term trend as of 25 Oct 2023 (Source: TradingView, click to enlarge chart)

Even though the price actions of the EUR/AUD have been oscillating within a major ascending channel since its 25 August 2023 low of 1.4285 and traded above the key 200-day moving average so far, the momentum of this up movement is showing signs of bullish exhaustion.

Yesterday (24 October) price action ended with a daily bearish reversal “Marubozu” candlestick coupled with the daily RSI momentum indicator that retreated right at a significant parallel resistance in place since March 2023 at the 65 level which suggests a revival of medium-term bearish momentum.

EUR/AUD bears are now attacking the minor ascending support

Fig 2: EUR/AUD minor short-term trend as of 25 Oct 2023 (Source: TradingView, click to enlarge chart)

The EUR/AUD has now staged a bearish price action follow-through via the breakdown of its minor ascending support from its 29 September 2023 low after a momentum bearish breakdown that was flashed earlier yesterday (24 October) during the European session as seen from the 4-hour RSI momentum indicator.

Watch the 1.6700 key short-term pivotal resistance (also the 50-day moving average) for a further potential slide toward the intermediate supports of 1.6460 and 1.6320 in the first step.

On the other hand, a clearance above 1.6700 invalidates the bearish tone to see the next intermediate resistance coming in at 1.6890.

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GigXR partners with NUS Medicine to deliver holographic clinical scenarios for gastroenterology training

GigXR, Inc., a global provider of holographic healthcare training, announced today its partnership with the Yong Loo Lin School of Medicine, National University…

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October 24, 2023

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GigXR, Inc., a global provider of holographic healthcare training, announced today its partnership with the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine), one of the world’s leading medical schools, to introduce a new gastrointestinal module for the award-winning HoloScenarios application. Created to better prepare medical and nursing students in diagnosing and treating acute gastrointestinal diseases, HoloScenarios: Gastrointestinal delivers evidence-based, robust clinical simulations that present hyperrealistic holographic simulated patients and medical equipment to be used in any physical learning environment, accessed anywhere in the world.

Credit: Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine), and GigXR

GigXR, Inc., a global provider of holographic healthcare training, announced today its partnership with the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine), one of the world’s leading medical schools, to introduce a new gastrointestinal module for the award-winning HoloScenarios application. Created to better prepare medical and nursing students in diagnosing and treating acute gastrointestinal diseases, HoloScenarios: Gastrointestinal delivers evidence-based, robust clinical simulations that present hyperrealistic holographic simulated patients and medical equipment to be used in any physical learning environment, accessed anywhere in the world.

Going beyond linear step-based training traditionally seen with virtual reality (VR), HoloScenarios: Gastrointestinal uses mixed reality (MR) to simulate the entire patient journey, while including branching logic to catalyze variance in learning experiences. From taking basic medical history to performing invasive testing and emergency procedures, the new module empowers learners to master vital medical decision-making and manual skills as they would see them in real-life clinical scenarios and patient care.

HoloScenarios: Gastrointestinal is created in collaboration with renowned medical professionals and educators from NUS Medicine who specialize in the fields of Gastrointestinal (GI) Surgery and holographic medical training. The module is delivered by the Gig Immersive Learning Platform, the enterprise-scale platform enabling the creation, curation, and sharing of immersive training applications and modules made by the world’s preeminent healthcare institutions and MR developers.

“Gastrointestinal pathologies can be complex and challenging to diagnose. This module will allow learners to form a deeper understanding and appreciation of the gastrointestinal tract, especially the three-dimensional understanding of anatomy and body functions,” said Associate Professor Alfred Kow Wei Chieh from the school’s Department of Surgery and Assistant Dean (Education) at NUS Medicine. “We believe mixed reality is the next evolution in healthcare training, and collaborating with immersive platform innovators like GigXR helps us to bring this vital content to more learners globally and, ultimately, improve patient care.”

With international medical and surgical credentials that include MBBS (S’pore), M Med (Surg), FRCSEd (Gen Surg), FAMS, and FACS, Associate Professor Kow has trained thousands of healthcare professionals and advanced surgical fellows. He received the 2023 REAL Advancing in Liver Transplantation Award for his contributions to global liver transplantation education and is a founding member of The Holomedicine® Association.

“GigXR has one of the most advanced and comprehensive platforms in mixed reality, especially in medical training, and enables the exchange of developments, innovation, and expertise with a wider community across Asia and beyond,” added Associate Professor Kow. He is also the Head and Senior Consultant of the Division of Hepatobiliary & Pancreatic Surgery, Department of Surgery, at Singapore’s National University Hospital (NUH), the teaching hospital of NUS Medicine.

The new module also delivers enhanced realism in training learners to more accurately diagnose and treat acute gastrointestinal diseases. Whereas VR has been widely used in gastroenterology training for linear step-based skills, such as in endoscopic procedures, it is limited in its ability to simulate fully realized clinical scenarios. Holographic patient simulation in MR merges hyper-realistic holograms in physical learning spaces that accurately reflect the clinical environment and tools with which learners will care for real patients.

With HoloScenarios: Gastrointestinal, learners can interact with the holographic simulated patients, holographic medical equipment, instructors, and each other. This allows them to master both technical and soft skills, such as patient empathy and team communication, in hyper-realistic, safe-to-fail environments that reduce cognitive load. If the holographic patient displays the need for further care, such as a definitive surgery, learners can discuss a definitive treatment plan.

To gain a deeper evaluation of outward symptoms, co-located learners can safely walk around the patient hologram that is displayed on top of their real-world surroundings. Whereas VR locks learners into a virtual “box,” MR enables clear visibility and awareness of physical surroundings. This allows learners to move freely without fear of physical collisions and safety so they can fully focus on learning key gastrointestinal treatment, diagnostic, and communication skills with peers and instructors.

“In healthcare, educators are not only trying to help learners master and retain vital knowledge, but recall and apply it when a patient’s life may be at risk,” said Dr. Gao Yujia, MBBS (S’Pore), MRCS, FRCSEd, Consultant and Assistant Group Chief Technology Officer at Singapore’s National University Health System, and Vice Chairman of The Holomedicine® Association. “With HoloScenarios: Gastrointestinal, learners will have the ability to not only visualize the presentation of a given disease in 3D but better understand how to apply key learnings in the clinical context and within team environments.” Dr Gao is also the Director of Undergraduate Medical Education for Surgery at NUS Medicine.

With scenarios across gastrointestinal pathologies that include gastrointestinal bleeding, intestinal obstruction, and chronic liver failure, learners can master complex and potentially critical situations. They can learn, for example, how to stabilize patients who are dehydrated, bleeding, or septic, as well as the types of diagnostic procedures that may then be required to get a definitive diagnosis. Using mixed reality headsets or any Android, iOS smartphone or tablet, learners can access HoloScenearios: Gastrointestinal from anywhere for remotely distributed, yet highly immersive simulation.

“Immersive technology has accelerated the sharing of expertise for teaching, training, and simulation. Mixed reality, with its natural propensity to facilitate hyperrealistic, safe, and collaborative learning, continues to accelerate both the quality and scale of training outcomes,” said Jared Mermey, CEO of GigXR. “We are immensely proud to partner with NUS Medicine which has been at the forefront of adopting mixed reality in both clinical and educational use cases. By bringing their esteemed expertise onto our platform with the co-creation of HoloScenarios’ newest module, we believe clinical breakthroughs in diagnosing and treating gastrointestinal diseases will take a giant leap forward.”

Designed specifically for pedagogy, the Gig Immersive Learning Platform is trusted by over 70 enterprise-scale healthcare institutions across four continents to build full immersive curricula utilizing a robust content catalog – all of which is managed from a single dashboard. Third-party content developed by leading 3D medical partners, including DICOM Director, 3D4Medical by Elsevier, and ANIMA RES, seamlessly integrates with the platform to provide complementary, in-depth anatomy applications that empower learners with a broader physical context for the pathologies that they study.

“The Gig Immersive Learning Platform has quickly become the premier educational, social network for sharing healthcare training expertise in the immersive format, spanning global healthcare institutions and the Department of Defense to content developers and enterprises large and small,” said David King Lassman, Founder of GigXR. “HoloScenarios: Gastrointestinal marks the latest milestone in our rapidly expanding catalog, which now boasts a dozen different licensable training modules that span holographic simulated patients, clinical scenarios, anatomy, pathophysiology, and 3D medical imaging.”

NUS joins the University of Cambridge and Cambridge University Hospitals (CUH) NHS Foundation Trust, University of Michigan, and Morlen Health, a subsidiary of Northwest Permanente, P.C., as the world-class institutions partnering with GigXR to co-create holographic healthcare training. These simulations include modules centered around Respiratory diseases, Basic Life Support, Advanced Cardiac Life Support, Neurology scenarios, and now, with NUS, Gastrointestinal diseases.

GigXR and NUS Medicine plan to launch HoloScenarios: Gastro in Spring 2024. For more information on GigXR, visit GigXR.com or email sales@gigxr.com. For more information on NUS, visit nus.edu.sg.

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UC Riverside physicist awarded National Medal of Science

RIVERSIDE, Calif. — Physicist Barry C. Barish, a distinguished professor of physics and astronomy at UC Riverside, was awarded the National Medal…

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October 24, 2023

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RIVERSIDE, Calif. — Physicist Barry C. Barish, a distinguished professor of physics and astronomy at UC Riverside, was awarded the National Medal of Science by President Joe Biden at a ceremony held at the White House today. Established in 1959 by the U.S. Congress, the National Medal of Science is the highest recognition the nation can bestow on scientists and engineers.

Credit: Stan Lim, UC Riverside.

RIVERSIDE, Calif. — Physicist Barry C. Barish, a distinguished professor of physics and astronomy at UC Riverside, was awarded the National Medal of Science by President Joe Biden at a ceremony held at the White House today. Established in 1959 by the U.S. Congress, the National Medal of Science is the highest recognition the nation can bestow on scientists and engineers.

The President’s National Medal of Science is given to individuals “deserving of special recognition by reason of their outstanding contributions in biology, computer sciences, education sciences, engineering, geosciences, mathematical and physical sciences, and social, behavioral, and economic sciences, in service to the Nation.” It is administered by National Science Foundation.

Barish was recognized for “exemplary service to science, including groundbreaking research on sub-atomic particles. His leadership of the Laser Interferometer Gravitational-Wave Observatory led to the first detection of gravitational waves from merging black holes, confirming a key part of Einstein’s Theory of Relativity. He has broadened our understanding of the universe and our Nation’s sense of wonder and discovery.”

“UCR congratulates Prof. Barish on receiving the National Medal of Science,” said UCR Chancellor Kim A. Wilcox. “The distinguished names of previous winners make this recognition very exceptional. Prof. Barish is a strong inspiration for our students, researchers, and faculty. UCR continues to benefit from his extraordinary achievements.”

Barish won the 2017 Nobel Prize in physics for the discovery of gravitational waves. He joined the UCR faculty in 2018. He earned his bachelor’s degree in physics in 1957 and his doctorate in experimental particle physics in 1962, both from from UC Berkeley. He joined Caltech as a postdoc in 1963, became a professor in 1966, and was appointed Linde Professor of Physics in 1991. He led the Laser Interferometer Gravitational-wave Observatory, or LIGO, effort from its inception through the final design stages, and in subsequent discoveries. In 1997, he created the LIGO Scientific Collaboration, which enables more than 1,000 collaborators worldwide to participate in LIGO.

Barish has served on many committees, including co-chairing the subpanel of the High Energy Physics Advisory Panel that developed a long-range plan for U.S. high-energy physics in 2001. He chaired the Commission of Particles and Fields and the U.S. Liaison Committee to the International Union of Pure and Applied Physics.

He is the recipient of the Fudan-Zhongzhi Science Award (China), Princess of Asturias Prize for Science and Technology (Spain), Giuseppe and Vanna Cocconi Prize from the European Physical Society, the Enrico Fermi Prize from the Italian Physical Society, and the Klopsteg Award from the American Association of Physics Teachers. He is a member of the National Academy of Sciences, which awarded him the Henry Draper Medal. From 2003 to 2010, he served as a presidential appointee to the National Science Board.

He is an elected member of the American Academy of Arts and Sciences and a fellow of both the American Association for the Advancement of Science and of the American Physical Society, where he also served as president. He has received honorary doctorates from the University of Bologna, University of Florida, University of Glasgow, and Universitat de València in Spain. He has been inducted as honorary academician into the Royal Academy of European Doctors, based in Spain. He was elected a foreign member of the Royal Society in 2019. Last year, he won the Copernicus Prize, bestowed by the government of Poland. Earlier this year, he was elected a corresponding member of the Royal Academy of Sciences and Arts of Barcelona. 

The University of California, Riverside is a doctoral research university, a living laboratory for groundbreaking exploration of issues critical to Inland Southern California, the state and communities around the world. Reflecting California’s diverse culture, UCR’s enrollment is more than 26,000 students. The campus opened a medical school in 2013 and has reached the heart of the Coachella Valley by way of the UCR Palm Desert Center. The campus has an annual impact of more than $2.7 billion on the U.S. economy. To learn more, visit www.ucr.edu.

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