GSK says RSV vaccine shows 94% efficacy in severe disease

 GSK’s vaccine against respiratory syncytial virus (RSV) is one of the top prospects in its pipeline, but also one with considerable competition, so needs strong data to support the programme. Thankfully for the company, it seems to be so.

This morning, GSK revealed the results from its pivotal AReSVi-006 trial of the RSV shot – called RSVPreF3 OA – having said earlier this year that the study was positive. Now, more details of the data have been revealed, and are described as “exceptional” by the company’s chief scientific officer, Tony Wood.

Top of the list is an overall protective efficacy against RSV lower respiratory tract disease of 82.6% in the study, which involved adults aged 60 years and above, meeting the study’s main objective.

Secondary endpoints are also very positive, including a 94.1% reduction in severe RSV disease – a level that was observed across the study, including in people with underlying health conditions making them vulnerable to RSV, as well as the elderly (70-plus) age bracket.

Wood said this morning that the efficacy means RSVPreF3 OA “has the potential to help reduce the significant global burden of RSV-associated disease in older adults, including those at the greatest risk of severe outcomes due to their age or underlying comorbidities.”

There’s no disguising that the data – due to be presented at IDWeek 2022, which runs from 12 to 23 October in Washington DC – are a big relief for GSK, which was rocked earlier this year when it as forced to abandon trials of the vaccine in pregnant women due to a safety signal.

The adult population is a much bigger market for a potential RSV vaccine, however, and accounts for the bulk of GSK’s predictions of $4 billion in peak sales for the jab, which would make it a stellar addition to the company’s vaccine portfolio headed by shingles vaccine Shingrix.

The level of efficacy seen in AReSVi-006 also means that the bar has been set high for GSK’s competitors in the category, which include Pfizer, Johnson & Johnson, Bavarian Nordic, and Moderna.

In August, closest rival Pfizer said interim results from the phase 3 RENOIR study of its RSVpreF shot revealed a vaccine efficacy of 85.7% in participants with more severe disease. That suggests GSK’s shot may have a slight edge, although that could change with the final results of Pfizer’s study and as the data from both studies is subjected to scrutiny.

The two companies say their shots show high efficacy against both the A and B strains of RSV, which remains one of the few major infectious diseases without a vaccine available. The two vaccines are heading for regulatory filings shortly, with approvals due around the same time in 2023.

J&J meanwhile started its phase 3 EVERGREEN trial last year and is anticipating results in 2023, while candidates from Bavarian Nordic and Moderna have also reached the final stage of clinical testing.

Assuming the data are similar overall, it’s possible there won’t be one winner in the category, with GSK, Pfizer, and other potential players splitting the market based on their own respective marketing strengths and subgroup data from the studies.

RSV is also a very big pie to share, given the massive size of the older adult population – even split into those with underlying health conditions – and the seriousness of RSV, with around 360,000 hospitalisations and more than 24,000 deaths worldwide each year.

https://pharmaphorum.com/news/gsk-says-rsv-vaccine-shows-94-efficacy-in-severe-disease/

Pacira guides below views in Q3 preannouncement

 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited revenues of $167.5 million for the third quarter of 2022, compared with $127.7 million for the third quarter of 2021. The company’s revenues include net product sales of EXPAREL® (bupivacaine liposome injectable suspension), ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), and the iovera° system. The company began recognizing sales of ZILRETTA in November 2021 after completing its acquisition of Flexion Therapeutics, Inc.

https://finance.yahoo.com/news/pacira-biosciences-reports-preliminary-third-120000911.html

Relmada depression med fails in Phase 3

 Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that its RELIANCE III study (REL-1017-303), evaluating REL-1017 in the monotherapy setting for Major Depressive Disorder (MDD), did not achieve its primary endpoint, which was a statistically significant improvement in depression symptoms compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) on Day 28. In the study, the REL-1017 treatment arm showed a MADRS reduction of 14.8 points at Day 28 versus 13.9 points for the placebo arm, a higher than expected placebo response.  Paradoxical results were observed in certain study sites, where placebo dramatically outperformed REL-1017. Relmada is investigating the nature of these results.

https://finance.yahoo.com/news/relmada-therapeutics-announces-top-line-110000380.html

Novavax Covid-flu combo Induced Antibody and T-Cell Responses against both

 

• Trial is the first of its kind to evaluate a combined COVID-19 and influenza vaccine

• Dose insights from Phase 1/2 trial will inform Phase 2 confirmation trial to begin in late 2022

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced positive results from the Phase 1/2 clinical trial of its COVID-19-Influenza Combination (CIC) vaccine candidate. Data demonstrated the CIC vaccine's ability to generate immune responses, including both antibody and polyfunctional CD4+ T-cell (lymphocytes that help coordinate the immune response) responses against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and homologous and heterologous influenza strains. The CIC combines Novavax' COVID-19 vaccine (NVX-CoV2373) and its quadrivalent influenza vaccine candidate.

The CIC vaccine formulations demonstrated induction of polyfunctional CD4+ T-cell responses against both SARS-CoV-2 and homologous and heterologous influenza strains at levels comparable to stand-alone NVX-CoV2373 and quadrivalent influenza vaccine candidate reference formulations. NVX-CoV2373 has previously been shown to induce functional SARS-CoV-2–specific CD4+ and CD8+ T-cell responses, and Novavax' quadrivalent influenza vaccine candidate has previously been shown to induce cross-reactive polyfunctional CD4+ T-cell responses. T-cell responses are thought to play an important role in the immune system's control of SARS-CoV-2 and influenza virus infections (e.g., by limiting disease severity and clearing infection), and in increasing the breadth of immunity.

The CIC vaccine formulations generated robust antibody responses against both SARS-CoV-2 and influenza antigens, and antibody responses were modelled using a Design of Experiments (DoE) approach to help optimize future dose selection.

The safety and tolerability profile of the CIC vaccine was consistent with the stand-alone NVX-CoV2373 prototype vaccine and quadrivalent influenza vaccine candidate reference formulations in the trial. The CIC vaccine was found to be generally well tolerated. Serious adverse events were rare, and none were assessed as being related to the vaccine.

https://finance.yahoo.com/news/novavax-covid-19-influenza-combination-123000496.html

More Harm Reduction, Less Abstinence-Only in COVID Messaging

 More attention to harm reduction -- rather than totally abstaining from risky behaviors -- would improve messaging on the COVID-19 pandemic, Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, said Wednesday.

"A lot of COVID-19 was abstinence-only" when it came to behavior, Adalja said during an online briefing sponsored by the Alliance for Health Policy on lessons to be learned from the HIV epidemic. "And it's not surprising that it failed. It's not surprising that most people lied about their activities. Because we know that abstinence-only doesn't work in any situation."

"For so long during the COVID-19 pandemic, that's what the actual official government policy was, even though many of us were saying, 'Harm reduction. Risk calculation. Just give people tools and they'll actually modify their behavior,' and I think that would have avoided some of the politicization that happened," he said. "If we would have had a harm reduction approach rather than the shaming and all of that that went on ... It all [involves] some COVID risk and that was just something that got ignored and hopefully now we're getting to that point."

"Always have the subject matter experts leading this," added Adalja. "When you have politicians involved, it's going to become political, just by definition, because when they view a public health emergency as a way to get a 'one up' on the other party, or they think about the rate of boosters or the low rate of boosters as a win or a loss for them rather than actually thinking about the infectious disease issue.

Both parties are "completely guilty" of politicizing these issues, and "for two different administrations during COVID-19, they don't actually think about what's going on on the ground," he continued. "What's the public health emergency? What do we need to fix here? They think, 'this is going to be good for my polling,' or 'this is my vision.' They shouldn't even be asking polling questions about disease because that's not something that should be in their purview."

Public health agencies, including the CDC, should be somewhat separate from government because "there just needs to be some insulation so that it's not sucked into the vortex of the day-to-day getting a 'one up' on your political opponent," he said.

Caring for HIV patients has become a non-partisan issue, but it didn't start out that way, according to Lindsey Dawson, MPP, associate director of HIV policy at the Kaiser Family Foundation. "HIV is still stigmatized, but there was a time of even deeper stigma. We had a sitting president that didn't mention HIV/AIDS until 1985," she said, referring to former President Reagan. "And that bipartisanship took a lot of coalition-building. It wasn't a given, and advocates made inroads in the agencies. So advocates were deeply involved in evolving policy at the FDA, changing regulatory pathways, and at NIH, having conversations about what clinical trials should look like. And similar conversations were happening on [Capitol] Hill. And so that bipartisanship was fought for."

Dawson said she agreed with Adalja that public health needed to be de-politicized. "We need to have a de-politicized, science-based approach to these conversations with leadership, and that's because the second you say something that is partisan or based in politics, there's going to be fear associated with it. And it's hard to do something when you're coming from a place of fear and threat. But if you're coming from a place of knowledge base and a science base, it might be easier to make political decisions. And I realize that that's easier said than done."

Another thing to consider in terms of distrusting public health messages is the mistrust in the medical community by people of color "based on the harm that has been done" to those communities by medical professionals, said Antoinette Jones, national field organizer for the Positive Women's Network, a group for women diagnosed with HIV. "That feeling is so embedded in the DNA of Black and brown people that it probably would never go away," she said.

"So the way to engage people who are living with HIV is going to look different than people who are not living with HIV, because people who are living with HIV have had more of a hands-on and a witnessing approach to seeing the progression of the HIV virus. So of course they are going to be a lot more trusting and eager to receive the COVID-19 vaccine and even the monkeypox vaccine because we are very, very much closer to science than the rest of our community who is not living with the virus," she continued.

"In order to not see the same things happen that we have seen in an HIV epidemic, we want to definitely do a [harm reduction] approach, but increased hands-on community support is important," Jones said. "Providing resources and education is important, especially when it comes to research and sharing back the research to the community that they have been involved in. And then also access is really important -- making sure that folks are able to get to these testing locations or these vaccine sites in order to increase those numbers ... as well as prevent further cases."

With the development of tools to combat HIV such as pre-exposure prophylaxis (PrEP) and antiretroviral treatment, "I think that HIV kind of became a paradigm for how science can solve a problem, but how it won't go all the way without actual implementation of those tools," Adalja said.

"And I think when you look at COVID, think about the way that the HIV response evolved, the tools that were brought to bear, and how this became a much more manageable infection," he added. "And I think it only happened because there was a concerted effort to actually treat HIV as the big health security risk that it was."

https://www.medpagetoday.com/infectiousdisease/covid19/101195

Science is on The Side of Life

 Georgia Democratic gubernatorial candidate Stacey Abrams said recently there is "no such thing" as a fetal heartbeat at six weeks gestation. Abrams made this outrageous claim in a speech in Atlanta, saying, "it is a manufactured sound designed to convince people that men have the right to take control of a woman's body." Abrams has also suggested that Georgia's heartbeat law shouldn't be referred to as a "heartbeat law" because "that's medically false, biologically a lie."

As an OB/GYN who cared for women and their babies for almost 30 years, I have been unable to get these disgraceful comments out of my mind. I have personally been in the room when women first heard the beautiful sound of their baby's heartbeat. It is truly a magical moment and you don't need to be a medical doctor to be able to say that. Millions of women who have experienced the wonder of pregnancy would agree with me. Over the course of nearly three decades, I delivered more than 3,000 children in North Texas. I have spent hours listening to newborns' miraculous cries. In the brief silence between those incredible shouts, I heard the hums and alerts of the remarkable medical technologies which monitored the mother and child—and had tracked their health for months prior to delivery.

Thousands of doctors across the country have spent long years in medical school and residency studying medicine to care for the most vulnerable among us. When I took the Hippocratic Oath to help mothers welcome their precious children into the world, I never wasted time considering anything other than the mother or child's best interest. The idea that we could somehow "manufacture" a sound to limit women and their families is egregiously false. In both my career as a medical doctor and my time as a member of Congress, my work has centered around my belief in protecting and optimizing human life, liberty, and pursuit of happiness. These unalienable rights are afforded to all Americans, enshrined by the Declaration of Independence, protected by our government and its public servants, and bolstered by hard-working men and women in every industry—particularly those in health care who sacrifice so much every day for the healing of others.

The reality is this: Abrams is trying to spread blatantly false information to back up her radical pro-abortion agenda. She has made clear that pro-abortion Democrats will stop at nothing to impose abortion on demand. These disingenuous comments are an attempt to dehumanize the baby in the womb. You might ask, "Why would they be doing this?" The answer is clear: life is winning, and they are grasping at straws.

June 24, 2022, marked a turn in the tide of the abortion fight in America when the 40-year precedent of Roe v. Wade was overturned. But even before the final decision came down, intimidation tactics were used when a leaked first-draft opinion in the Dobbs v. Jackson Women's Health Organization case authored by Justice Samuel Alito, writing for a majority, was published in early May. The publishing of this opinion was an unprecedented attack on the integrity of the Supreme Court. The Justices were not intimidated, however, and the Court sent the battle for life back to the states.

Unlike when Roe was first decided in 1973 and ultrasound technology was in its infancy, we now can see the distinctly human qualities of babies in the womb. People like Ms. Abrams would like to pretend these are "clumps of cells" or "manufactured sounds." They are not. Science has finally caught up with the lie of abortion, and science is on the side of life.

Congressman Michael Burgess, M.D. (OB/GYN), a Republican, represents Texas' 26th Congressional District.

https://www.newsweek.com/science-side-life-opinion-1750924

Alarming failures in the detection of pancreatic cancer

 Pancreatic cancer tumours are being missed on CT and MRI scans, narrowing the window for life-saving curative surgery, research presented today at UEG Week 2022 has revealed.1

The study analysed post-imaging pancreatic cancer (PIPC) cases, where a patient undergoes imaging that fails to diagnose pancreatic cancer but is then later diagnosed with the disease.

Results revealed over a third (36%) of PIPC cases were potentially avoidable, demonstrating a poor detection rate for a cancer that has alarming patient outcomes.

UK researchers studied the records of 600 patients diagnosed with pancreatic cancer between 2016 and 2021. Of those, 46 (7.7%) patients failed to have their cancer diagnosed through their first scan, but then received a pancreatic cancer diagnosis between 3 and 18 months later.

CT and MRI images were independently reviewed by radiologists to develop an algorithm to categorise the missed cases and identify the most likely explanation for why they were missed.

Dr Nosheen Umar, the lead author of the study, from the University of Birmingham, UK, commented, “There is often only a very short period for curative surgery in pancreatic cancer meaning it is vital that patients are diagnosed with the disease as early as possible to give them the best chance of survival. The study found that evidence of pancreatic cancer was initially missed in over a third of patients with post imaging pancreatic cancers, which is a huge window of lost opportunity.”

In almost half (48%) of PIPC patients examined, there were signs of cancer that had been missed when scans were reviewed by a specialist hepatobiliary radiologist. In 28% of PIPC patients, imaging signs associated with pancreatic cancer, such as dilated bile or pancreatic ducts, were not recognised and investigated further.

“We hope this study will raise awareness of the issue of post imaging pancreatic cancer and common reasons why pancreatic cancer can be initially missed”, explained Dr Umar. “This will help to standardise future studies of this issue and guide quality improvements efforts, so we can increase the likelihood of an early diagnosis of pancreatic cancer, increase the chances of patient survival and, ultimately, save lives.”

Responsible for 95,000 deaths in the EU every year, pancreatic cancer has the lowest survival rate of all cancers in Europe and life expectancy at the time of diagnosis is just 4.6 months.2 By 2035, the number of cases of pancreatic cancer is predicted to rise by almost 40%.3

Many patients are diagnosed at a late stage because the disease often presents vague early symptoms, making early recognition challenging. Symptoms can include jaundice, abdominal and back pain, unexplained weight loss and nausea.4 The complex nature of the disease also makes screening for early diagnosis challenging to implement.

https://www.eurekalert.org/news-releases/966798