Latest news with #clinicalTrials


Medscape
14 hours ago
- Health
- Medscape
Will Federal Cuts Affect mRNA Cancer Vaccine Research?
If you've ever administered or received a COVID-19 vaccine, chances are it was based on messenger RNA (mRNA) technology — a medical breakthrough decades in the making and finally achieved thanks to the coordinated effort and enormous funding mobilized by the pandemic. The promise of mRNA vaccines is immense, researchers said. Several vaccines, including for influenza and respiratory syncytial virus, have been approved or are in the approval pipeline. Now the same technology is being tested in hundreds of clinical trials for conditions that include not only infectious diseases but also many kinds of cancer. And with the mRNA therapeutics market expected to grow to $30 billion by 2030, research momentum is strong — for now. But recent cuts in federal research grants and the current administration's skepticism about mRNA vaccines have raised concerns that mRNA studies, including for cancer vaccines, could stall just as these treatments are starting to reach patients. The Promise of mRNA Medicine for Cancer Every gene in your body encodes an mRNA. It sends genetic information from the cell nucleus to the cytoplasm, where proteins are created to carry out the cell's work. The lab-made mRNA used in vaccines tells the cell to make proteins that activate the desired response. The COVID-19 vaccine expresses COVID-19 genes, for instance, so the immune system learns to recognize and fight the virus. In cancer cases, immune cells (T-cells) must be activated against a tumor. Checkpoint modulators allow the T-cell to penetrate the tumor and destroy it. The first of these immunologic drugs was approved in 2011, and since then, they have revolutionized treatment for '20% of all advanced, deadly cancers,' effectively turning them into chronic diseases, said Elizabeth Jaffee, MD, PhD, deputy director of the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore. But in the other 80% of cases, she said, the immune system fails to generate the T-cells needed because it doesn't recognize the tumor cells as abnormal. That's where mRNA could make a big impact. Researchers at Johns Hopkins and elsewhere have developed a personalized approach. First, they biopsy the tumor and sequence the sample's genome. Based on that, they design an mRNA vaccine, which is then injected into the patient to trigger T-cells that recognize the tumor as abnormal. With the help of a checkpoint modulator, the T-cells can then attack and destroy the tumor. The approach was tested at the Memorial Sloan Kettering Cancer Center, New York City, in an early clinical trial involving 16 patients with pancreatic cancer, which had a 5-year survival rate of 13%. Half of the participants received personalized mRNA vaccines, and the other half did not. '3 years later, the eight patients who got the vaccine appear to have disease-free survival,' Jaffee said. 'If we can push this vaccine method forward, we'll definitely have an effect on cancer.' Jaffee's team at Johns Hopkins is now conducting promising clinical trials on various gastrointestinal cancers — including colon cancer, gastric cancer, and a rare type of liver cancer. But Jaffee fears she could get an email saying her National Institutes of Health (NIH) grant will be cutoff within 24 hours. 'We'll have to tell the patients that day, 'Sorry, we no longer have the money to treat you.' That would be devastating.' She says her team stands to lose $20 million in NIH funding — a gap they can't replace with private grants. While the NIH hasn't officially pulled funding from mRNA research, scientists worry that it could be the next target in this year's wave of NIH cuts — concerns prompted in part by reports of funding cuts for vaccine hesitancy research and of NIH officials instructing scientists to scrub mRNA references from their grant applications. Robert F. Kennedy, Jr, 'has been a strong critic of mRNA, and under his leadership, there have been emails asking for names of scientists working on mRNA research,' said Jeff Coller, PhD, professor of RNA biology and therapeutics at Johns Hopkins. 'This has been a pattern over the last few months. So we're concerned, and the industry is concerned.' The Health and Human Services (HHS) Secretary has publicly expressed skepticism about vaccines, particularly the mRNA-based COVID-19 vaccines. In 2021, he described them as'the deadliest vaccine ever made.' That same year, the Children's Health Defense — a nonprofit organization that Kennedy founded and led before joining the Trump Administration — petitioned the US Food and Drug Administration (FDA) to rescind its authorization for the vaccines. Recently, the group has suggested a link between mRNA vaccines and cancer. Last week, the HHS canceled a nearly $600 million contract with mRNA vaccine maker Moderna for the development of its bird flu vaccine for humans. The FDA has not yet approved any cancer vaccines, but one for late-stage melanoma, currently in a phase 3 clinical trial, is getting closer. Some expect a successful trial will lead to FDA approval of the melanoma vaccine. But Drew Weissman, MD, PhD — who shared a Nobel Prize with Katalin Kariko, PhD, for the discoveries behind the COVID-19 vaccine — is less confident. As a vaccine researcher at the University of Pennsylvania, Philadelphia, leading a team of 80 scientists through dozens of trials, he worried that government skepticism could make FDA approval an uphill battle for his and others' mRNA research. Who Will Pay for Cancer Vaccines? The explosion in mRNA research has been funded by a mix of federal grants and private investment, with the government money aimed at basic research. The Defense Advanced Research Projects Agency had invested about $1 billion in mRNA research starting in 2012, said Andrew Geall, PhD, co-founder and chief development officer of Replicate Bioscience, an mRNA startup in San Diego. 'Most major pharmaceutical companies have made investments in mRNA technology,' said Geall. So have many venture capital firms. His own company, which was started in 2020, has received $53 million in private funding. This year, he said, Replicate Bioscience published phase 1 clinical trial data on its mRNA vaccine for rabies. Moderna, one of the two major makers of COVID-19 vaccines, has conducted clinical trials on mRNA treatments for solid tumors. BioNTech, which codeveloped the other leading COVID-19 vaccine with Pfizer, is working on melanoma research. And Roche and Genentech are supporting Memorial Sloan Kettering's research on pancreatic cancer. If NIH terminates mRNA grants, pharma companies and other US investors 'will probably pull back,' Geall said. That's because they rely on publicly funded research to share the costs — and risks — of their developments, he said. In fact, private investment is already slowing down, as companies hedge their bets against an expected cutoff of mRNA research funding, Geall said. 'If we need to do clinical trials, we're probably going to go abroad.' While most mRNA research is based in the United States, other countries are advancing studies of their own, poised to take the lead if the United States drops the ball. A recent poll showed that 75% of the US scientists will move abroad if their funding here is cutoff. Foreign regulators like the European Medicines Agency are gearing up to approve mRNA vaccines being developed in their countries. If scientists in other nations develop new mRNA vaccines before our scientists do, their people would likely have access to mRNA vaccines sooner than Americans. Whether any of this could delay US mRNA studies — and if so, for how long — remains unknown. After all, mRNA research is still happening in the United States, and with fruitful results. If federal support for mRNA studies is cutoff, the research won't stop — at least, not 'in Europe or China' or elsewhere, Weissman said. 'But it's going to stop in the US'


Medscape
a day ago
- Health
- Medscape
Skills Lab: Rethinking Surrogate Endpoints Approval
This transcript has been edited for clarity. Hello, everyone. This is Dr Bishal Gyawali, from Queens University, Kingston, Canada. Thank you for joining us in our Skills Lab video series. In the last lecture we discussed how progression-free survival (PFS) response rate and the surrogate endpoints are defined. We talked about the particularities with response rate and PFS, and in the adjuvant setting, with disease-free survival. Today we'll talk about surrogate endpoints and their role in regulatory approval. One question that people commonly ask is: What strength of surrogacy is required for drug approval? Are different strengths of surrogacy required for accelerated approval (or 'conditional' approval) vs regular approval (or 'full' approval)? We would expect that regular approval requires a higher bar of evidence as compared to accelerated approval. Unfortunately, there are no such published criteria, but based on the data we have seen, I think there are probably no unpublished criteria either. If we compare the response rates of drugs that have received accelerated approval vs regular approval, then we don't see much of a difference. Also, in one of these studies from 2002 to 2021, we saw that 30% of approvals were based on response rates from single-arm trials that received regular approval rather than next approval. You would believe that a response rate–based approval would usually be acceleratedor conditional approval so that the drug confirms clinical benefit in the future, but we found that in 30% of these cases, they received upfront, regular, full approval rather than accelerated approval. I call this upfront, premature, regular approval. If you look at the trends of the FDA approval, you'll notice in recent years that the number of approvals based onsurrogate endpoints is increasing, while simultaneously, the number of accelerated approvals is decreasing. At first, it does not make sense because accelerated approvals are supposed to be surrogate-based approvals. What this means is that nowadays we are approving more and more drugs on the basis of surrogate endpoints by giving them full or regular approval rather than accelerated approval, which I think is very concerning from a societal point of view. If we are giving upfront, regular approval, then we can never be sure that they confirm clinical benefit because they don't have a mandate to do such a confirmatory trial. Also, even if these drugs were to fail in subsequent trials, we can't withdraw them. Only accelerated approvals get withdrawn. I'll give you one example:the BOLERO-2 trial of everolimus in breast cancer. As you can see, the first graph is PFS, and there was a 6-month improvement in PFS, with a hazard ratio of 0.36, which led to the drug's approval. It was not accelerated approval; it was full approval. In just 2 years, the overall survival results were published. As you can see in the second graph, the overall survival was negative. Overall survival did not improve, but because it was a full approval, the drug was not withdrawn. I call this premature approval, and we should be asking why we are granting full approval based on surrogate data. One more example: Margetuximab in breast cancer was approved on the basis of PFS improvement. You can see how much PFS improvement there was. It was 5.8 vs 4.9 months, so it was just 0.9 months, or less than 1 month, of PFS improvement. This drug was given full approval, not accelerated approval like it was supposed to. You can look at the date. This drug was approved in December 2020, and just 9 months later, in September 2021, we received overall survival results from this trial. The drug failed to improve overall survival. If we had not given regular approval, then we would have withdrawn this drug, but because it was given premature full approval, the drug was not withdrawn. It took only 9 months to get overall survival data, so why did we not give accelerated approval? That is something we should be asking. We recently published a paper in JCO about why PFS should not be used as a primary endpoint for registration of anticancer drugs. We list several reasons why PFS fails to capture clinical benefit in these trials. I think we should at least agree that, if we're approving drugs based on surrogate endpoints, it should be accelerated or conditional approval and not full approval. The other common question is: If PFS did not lead to overall survival improvement, did it not improve quality of life? We tried to answer that question. First, of course, there is no reason for PFS to correlate with overall survival. As we discussed in the last lecture, nothing magical happens at 20% and not all progression events are the same. Some progression events are more symptomatic than others, therefore the quality-of-life effectis not always predictable. Quality-of-life impact is not only a function of how big the tumor is but also a function of drug toxicities. In recent years, we have seen that PFS has become the default primary endpoint. In the past decade or so, the frequency of trials using PFS at the primary endpoint has increased substantially and now exceeds the percentage of trials with overall survival as the primary endpoint. The strange thing about PFS is that we talk about correlation of PFS with overall survival and how we need to do correlation analysis to confirm that this is a valid surrogate as we saw with the case of bevacizumab in breast cancer, even after eight clinical trials were conducted, was PFS a good surrogate for overall survival in this setting? The answer was that we do not know. Maybe, maybe not. What I'm trying to say here is that, even after eight clinical trials of the same drug in the same setting, we are still unable to conclude definitively whether PFS is a goodsurrogate for overall survival. This means that it is far more expedient to just measure overall survival than to continue to do multiple trials and continue to guess whether PFS is a good surrogate for overall survival. Thank you very much. I'll see you in the next lecture, in which we will talk about physicians' and patients' understanding related to surrogate endpoints.


Medscape
a day ago
- Business
- Medscape
Metabolic Issues May Affect Liver Fibrosis in Hepatitis B
Patients with untreated chronic hepatitis B who had metabolic comorbidities were at a higher risk for advanced liver fibrosis and were less likely to see improvement with antiviral therapy than those without such comorbidities. METHODOLOGY: Researchers investigated the association between the presence of concurrent metabolic comorbidities and the severity of liver fibrosis in 3179 patients with untreated chronic hepatitis B (median age, 37 years; 72.2% men) using data from two tertiary clinics in the Netherlands and Canada and six global clinical trials. All patients underwent an initial liver biopsy, and 1307 of the patients enrolled in the clinical trials underwent a second biopsy 48-72 weeks after starting antiviral therapy. Biopsies were analyzed by experienced pathologists. Advanced fibrosis was defined as having METAVIR stages F3-F4, and nonadvanced fibrosis as having METAVIR stages F0-F2. Progression or regression of fibrosis was determined by an increase or decrease in fibrosis of at least one METAVIR stage from baseline, respectively. The presence of metabolic comorbidities (overweight, hypertension, diabetes, and dyslipidemia) was assessed using chart reviews and patient histories. TAKEAWAY: At baseline, metabolic comorbidities were present in 54.8% of patients, and advanced fibrosis was present in 24.4% of patients. The presence of metabolic comorbidities was independently associated with an increased risk for advanced fibrosis (adjusted odds ratio [aOR] for one comorbidity, 1.115; aOR for two or more comorbidities, 1.627; P = .006). = .006). The presence of metabolic comorbidities was also independently associated with reduced odds of regression from advanced to nonadvanced fibrosis after initiating antiviral therapy (aOR for one comorbidity, 0.79; aOR for two or more comorbidities, 0.26; P = .025). = .025). Progression to advanced fibrosis during antiviral therapy was observed in 9.8% of patients with one metabolic comorbidity and 14.3% of those with two or more metabolic comorbidities compared with 4.6% of those without metabolic comorbidities ( P = .001). IN PRACTICE: 'These findings provide solid support for the recently published World Health Organization HBV [hepatitis B virus] guideline, which underlines the importance of identifying and managing metabolic comorbidities in CHB [chronic hepatitis B] patients, as these comorbidities increase the risk of fibrosis progression and HCC [hepatocellular carcinoma] development,' the study authors wrote. SOURCE: The study, led by Lisa M. van Velsen, MD, Department of Gastroenterology & Hepatology, Erasmus Medical Center in Rotterdam, the Netherlands, was published online in Clinical Gastroenterology and Hepatology . LIMITATIONS: Information on hepatic steatosis was unavailable for the clinical trial patients. The presence of metabolic comorbidities was determined on the basis of a retrospective review of medical histories and medications, potentially leading to underdiagnosis of the conditions. Changes or development of metabolic comorbidities during follow-up could not be accounted for. DISCLOSURES: This study was sponsored by the Foundation for Liver and Gastrointestinal Research, and the data for the analyses were shared by Roche and Gilead Sciences. Several authors reported receiving research support or grants, consulting and/or speaking fees, honoraria, or contracts from pharmaceutical and biotechnology companies, including Roche and Gilead Sciences. One author reported being employed by Roche, and two authors reported being employed by Gilead Sciences.


The Guardian
2 days ago
- General
- The Guardian
A ‘war on children': as US changes Covid vaccine rules, parents of trial volunteers push back
As the Trump administration contemplates new clinical trials for Covid boosters and moves to restrict Covid vaccines for children and others, parents whose children participated in the clinical trials expressed anger and dismay. 'It's really devastating to see this evidence base officially ignored and discarded,' said Sophia Bessias, a parent in North Carolina whose two- and four-year-old kids were part of the Pfizer pediatric vaccine trial. 'It's infuriating. My kids contributed literal blood and tears to help demonstrate the safety of these vaccines,' Bessias said. 'As a parent and also a pediatrician, I think it's devastating that we might no longer have the option to protect kids against Covid,' said Katherine Matthias, a pediatrician in South Carolina and a cofounder of Protect Their Future, a children's health organization. Robert F Kennedy Jr, head of the US Department of Health and Human Services (HHS), has called for new trials using saline placebos for each of the routine childhood vaccines recommended by the Centers of Disease Control and Prevention (CDC), even though these vaccines have already been tested against placebos or against vaccines that were themselves tested against placebos. Marty Makary, the head of the US Food and Drug Administration (FDA), and Vinay Prasad, the FDA's vaccines chief, outlined a plan in a recent editorial to restrict Covid boosters for anyone under the age of 65 without certain health conditions. For everyone else between the ages of six months and 64 years old, each updated Covid vaccine would need to undergo another randomized controlled clinical trial, Makary and Prasad said. It's not clear when, how or whether this plan will be implemented officially. On Tuesday, top US health officials said on the social media site X that they would remove the recommendation for Covid vaccination from the childhood immunization schedule, and would also cease recommending it for pregnant people, who have much higher risks of illness, death and pregnancy complications with Covid. On Friday, the CDC appeared to contradict that announcement by keeping Covid vaccines as a routine immunization for children – though the agency now says health providers 'may' recommend the vaccine, instead of saying they 'should' recommend it. Changing recommendations could affect doctors' and parents' understanding of the safety and effectiveness of the vaccines. Vaccines recommended by the CDC are also covered by the federal Vaccines for Children program, and health insurers are required to cover the costs of routine vaccines. It's not clear if the wording change from 'should' to 'may' will affect that coverage. If insurance no longer covers the vaccines, pediatricians are less likely to keep many of the shots in stock, Matthias said, and pharmacies are limited by different state laws on which ages they may vaccinate – which means families who want the vaccines may not be able to find them. Matthias drove her children, then aged 15 months and 14 years old, two hours each way to a Moderna pediatric trial. They did six or seven visits, plus two visits to receive the actual vaccines after they learned they had received placebos. Child participants spent hours on each visit and endured blood draws, Covid swabs, regular symptom and temperature monitoring, and, of course, several shots. Each shot was followed by a week of daily journaling and side-effect reporting. Participants who got Covid, even months later, had blood draws to check their antibody responses. 'It was a pretty big commitment of our time and energy. But I did it because I wanted to be sure that my kids and all kids had access to vaccines,' Matthias said. Laura Labarre, a parent in Oregon, said the trials involved 'committing to something that felt important but larger than ourselves, because it ended up being a lot of work and a lot of logistics and a lot of effort'. She drove her two kids, then aged one and three, an hour and a half each way to a Pfizer trial, and searched for ways to keep them occupied for hours on end. When most people hear about new developments in pediatric medicine, such as new vaccines, they don't often consider the hard work of volunteers, some only a few months old, who made the trials possible, Labarre said. 'I don't think people consider the toll on the families who are the ones who bravely and nervously put their children up to be the first to try it out,' she said. When Nick Giglia got the call asking if he still wanted to enroll his one-year-old daughter in the Pfizer pediatric vaccine trial, he immediately said yes. For eight visits, extending over nearly a year, he would drive an hour each way to a trial in New Jersey. In all, his daughter received seven shots – three saline placebos, three vaccines and a booster. Sign up to This Week in Trumpland A deep dive into the policies, controversies and oddities surrounding the Trump administration after newsletter promotion 'It was very rigorous,' Giglia said of the study design. Now, he said, 'it's really difficult to hear people harping on the thoughts of there not being the placebo group. Well, it's news to me. My kid was in the placebo group,' he said. Parents who were eager to enroll in the original trials now wonder whether families would want to endure another round of placebo-controlled trials for updated vaccines. 'Finding the number of participants that they would need would be extremely difficult,' Matthias said. 'To think that they would subject anyone, let alone children, to potentially getting the placebo in a trial where we know that the control is already so beneficial for health, just seems highly unethical and really disturbing,' Labarre said. 'A new trial today would not add anything we don't already know,' Bessias said. 'It would feel like actually participating in a project of undermining the existing evidence, rather than contributing new evidence.' And the whole point of updating the vaccines is to counter new strains, Matthias said. Those vaccines would be out of date by the conclusion of a new study, which could take years. 'People should have the option' to get Covid vaccines, Matthias said. 'The people who don't want it don't have to get it.' When Matthias enrolled her kids in 2021, she felt as though they were in a limbo, and 'we were all just desperate to get our kids protected', she said. 'To kind of have that feeling coming back now – we worked so hard and we advocated so much to get our kids access and now it might just be taken away – is really upsetting.' While Covid mortality rates are highest among people over the age of 65, Covid is still the eighth leading cause of all deaths among children. Any child dying a preventable death is a tragedy, Bessias said. 'We have to take a step back and realize that absolute numbers matter, too. And we can really avoid a lot of hospitalizations and deaths and transmission and horrible experiences for families by reaching those younger children. It's baffling because that seems to be completely left out of these discussions.' Labarre feels 'profoundly enraged and betrayed' by the Trump administration's actions. Limiting access to the vaccine, especially while proposing cuts to Snap and Medicaid, feels like 'an additional audacious battlefront they've opened up in this sort of war on children', she said. 'It is destabilizing, frustrating and enraging to feel like my daughter, who wasn't even 18 months old, has done more for public health than some people who are now currently in charge of it,' Giglia said. 'It is very frustrating to hear that sacrifice that we volunteered to make for the country, and frankly, the world, belittled.' At the end of the trial, Giglia's daughter was given a stuffed teddy bear in a sweater that said 'Covid-19 vaccine study hero'. 'I don't care what anybody says. That's what she is,' Giglia said. 'I look forward to one day being able to tell my little girl all about how she helped save the world. And it's hard to hear that many people think that we did the exact opposite.'

News.com.au
2 days ago
- Business
- News.com.au
Health Check: Stuck in biotech's ‘death zone', Opthea and Patrys check in on the sat phone
Opthea and Patrys report they are still alive after failing to reach the summit, but the line's a bit crackly Renerve in Berkeley tie up for soft tissue repair Imugene furthers trial of 'off Broadway' asset With the Everest climbing season at its peak, the news from the 'death zone' is that the stricken Opthea is still alive. Can the company execute an organised descent? In a corporate update today, the eye disease drug developer said it was unable to clarify things until it had finished negotiating with its funders. So perhaps more of a non-update from camp four, although radio comms that high up can be patchy. But the company did announce that four of its eight board members would hang up their crampons. The departees are Dr Julia Haller, Dr Susan Orr, Quinton Oswald and Anshul Thakral. That leaves chairman Jeremy Levin, Kathy Connell, Lawrence Gozlan and Sujal Shah to battle on with depleted oxygen tanks. On March 24 the company reported the first of its two phase III eye disease trials failed to hit its primary endpoints. The second one fared no better and both have been abandoned in the blizzard. The studies focused on the hard-to-treat wet aged-related macular degeneration. Investors are asking how much of Opthea's residual cash of US$113 million ($176 million) will remain, if any. Under a development funding agreement (DFA), the company could be in hock to a cabal of investors for up to US$680 million. Opthea says it remains in 'active negotiations with its DFA investors … to explore possible options to deliver the best outcome for the company and its shareholders." Opthea shares were suspended on March 17 at 60 cents, for an illusory $738 million market cap. In reality, the shares potentially are worth nothing. The company promises a briefing when the DFA discussions are finalised. Stay tuned Meanwhile, Patrys' corporate update tomorrow should show whether the company has abandoned all attempts to reach the summit. Remember Patrys? The company was to launch a first-in-human phase I trial for its antibody cancer candidate, PAT-DX1. In October last year, the company said safety testing showed unacceptable margins of tolerance, so the program was canned. Patrys is forging ahead with a less favoured program, Pat-DX3 (not sure what happened with PAT-DX2). The company also intended to partner the DX-1 program. Patrys shares trade at a fraction of a cent, so are at base camp. Perhaps they can scale great heights again with the help of a decent Sherpa, er, partner. Renerve enrolls at Berkeley Nerve regeneration outfit Renerve has joined with the San Francisco based Berkeley Biologics to develop and commercialise two tissue-based products. Renerve recently started selling its FDA-cleared flagship product, the Nervalign Nerve Cuff, in the US. The company also has a nerve graft product. One initial product from the collaboration addresses the need for human dermal tissue (deeper layers of the skin often sourced from donors). The other provides amniotic tissue products, which are known for their regenerative and healing properties. 'These products have application in the medical procedures that Renerve seeks to address with its current and future Nervealign products,' Renerve says. 'Accordingly, their sale will be a natural extension of Renerve's current sales activities, using the same sales network and targeting the same surgeon and hospital customers.' The parties target the first product for a September quarter launch, with the second due on market before the year is out. Renerve will elaborate in an investor webinar scheduled for 11 am tomorrow. Imugene opens cancer site for 'off Broadway' program Immune-oncology drug developer Imugene has opened its first Australian trial site for a clinical study that hones in on a rare-ish subset of colorectal (bowel) cancer. That target is called mismatch repair-deficient/microsatellite instability high colorectal cancer, which accounts for 15% of all bowel tumours. The drug candidate is called PD1-Vaxx, which is all about inducing the body to produce polyclonal antibodies that block the PD-1 signalling pathway. This hopefully restores the immune system's ability to detect and destroy cancer cells. The trial is part of B-cell immunotherapy platform 'deprioritised' by Imugene, in favour of more show-stopping stuff such as Car-T therapies. But sometimes the off-Broadway stuff can prove the box office hit. The investigator-led phase II study is being carried out by Cancer Research UK Southampton Clinical Trials, the Royal Surrey Hospital NHS Foundation Trust and the Australasian Gastro-Intestinal Trial Group. The study's primary objective is the degree to which tumours reduce with PD1-Vaxx, pre surgery. Makes sense … Meanwhile, Imugene will seek shareholder consent to consolidate its stupendous 7.4 billion on issue, to around 200 million. Meanwhile, Inoviq (ASX:IIQ) shares this morning vaulted more than 30% after the company updated a US oncology powwow about its "breakthrough" ovarian cancer test results. As we noted already, Inoviq shares had moved already, but on 'old news' – fake news? – rather than today's 'new news'. The results were aired at the American Society of Clinical Oncology's get together in Chicago.