.@TheBHF The World Council for Health urgently requests a full statement from The British Heart Foundation. Were the harms of these injections known and covered up?
The #vaccine rollout must be stopped pending an urgent investigation@iCharmaine #mRNA @ABridgen @JamesfWells t.co/3cGuFPcCTa— Dr Tess Lawrie (@lawrie_dr) December 14, 2022
BBC article today:
Researchers say they have successfully completed a trial of a personalised cancer vaccine that uses the same messenger-RNA technology as Covid jabs.
The experimental vaccine, made by Moderna and MSD, is designed to prime the immune system to seek and destroy cancerous cells.Doctors hope work such as this could lead to revolutionary new ways to fight skin, bowel and other types of cancer.
Moderna and MSD called it “a new paradigm” moment. Other pharmaceutical companies are looking to run similar studies.
But this is the first phase-IIb randomised clinical trial to test the investigational mRNA vaccine in patients.
www.bbc.com/news/health-63959843
CNN ARTICLE TODAY:
An experimental personalized mRNA vaccine in combination with the immunotherapy Keytruda reduced the risk of recurrence or death from melanoma in patients who had already had surgery, Moderna and Merck said Tuesday.
The randomized trial included 157 patients with stage 3 or stage 4 melanoma who had already had surgery. Some patients received nine doses of the experimental cancer vaccine made by Moderna and the immunotherapy made by Merck every three weeks for about a year, and some received only the immunotherapy. Treatment with the experimental vaccine in combination with the immunotherapy reduced the risk of cancer recurrence or death by 44% compared with the immunotherapy alone, the companies said.
The preliminary results of a Phase 2b trial were shared in a news release and have not been peer-reviewed or published. The companies said they will publish the full data in the future and share results at an upcoming conference.
www.cnn.com/2022/12/13/health/mrna-cancer-vaccine-study/index.html
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Tesla Inc Chief Executive Officer Elon Musk on July 2 announced on the microblogging site Twitter that the electric carmaker is building “RNA microfactories” for coronavirus vaccine developer CureVac in Germany.
CureVac, an unlisted German company, has said it is developing transportable, automated mRNA production units that it calls printers. They will be designed to be shipped to remote locations, where they can churn out its vaccine candidate and other mRNA-based therapies depending on the recipe fed into the machine.
But for the immediate pandemic use – should its vaccine candidate win market approval – it has production sites with regulatory approval in Germany with a capacity to produce hundreds of millions of doses.
January 20, 2022:
A technician in full body protective gear adjusting a machine for making mRNA vaccines.
The coronavirus pandemic has thrown a spotlight on messenger RNA (mRNA)—the molecule that carries a cell’s instructions for making proteins. Hundreds of millions of people worldwide have received mRNA vaccines that provide powerful protection against severe COVID-19 caused by infection with SARS-CoV-2.
As stunningly successful as the mRNA COVID-19 vaccines have been, researchers have long hoped to use mRNA vaccines for a very different purpose—to treat cancer. mRNA-based cancer treatment vaccines have been tested in small trials for nearly a decade, with some promising early results.
In fact, scientists at both Pfizer-BioNTech and Moderna drew on their experience developing mRNA cancer vaccines to create their coronavirus vaccines. Now, some investigators believe the success of the mRNA COVID-19 vaccines could help accelerate clinical research on mRNA vaccines to treat cancer.
“There’s a lot of enthusiasm around mRNA right now,” said Patrick Ott, M.D., Ph.D., who directs the Center for Personal Cancer Vaccines at the Dana-Farber Cancer Institute. “The funding and resources that are flowing into mRNA vaccine research will help the cancer vaccine field.”
www.cancer.gov/news-events/cancer-currents-blog/2022/mrna-vaccines-to-treat-cancer
Moderna says personalized mRNA cancer vaccine is effective for advanced melanoma
The company said that in a phase 2 clinical trial, the vaccine, when combined with immunotherapy drug Keytruda, reduced the risk of recurrence by 44%.
Moderna’s stock soared Tuesday after the Covid-19 vaccine maker detailed progress in developing a preventive shot for a deadly form of skin cancer.
The company said a possible melanoma vaccine it is studying with pharmaceutical giant Merck fared well in a small study of patients who had the cancer surgically removed.
The drugmakers said a combination of the vaccine and Merck’s immunotherapy Keytruda led to a statistically significant improvement in survival before the cancer returned in patients with advanced melanoma.
“We are very excited, we are moving very quickly with Merck onto phase 3 for this study,” Moderna CEO Stephane Bancel told CNBC Tuesday morning.
Phase 3 is generally the largest and most expensive stage of clinical research before regulators review a potential drug for approval.
Moderna developed one of the most popular vaccines used to protect patients against Covid, and the drugmaker brought in more than $3 billion from its Spikevax in this year’s third quarter.
Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with KEYTRUDA®, Merck’s anti-PD-1 therapy, demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival (RFS) versus KEYTRUDA alone for the adjuvant treatment of patients with stage III/IV melanoma following complete resection. Adjuvant treatment with mRNA-4157/V940 in combination with KEYTRUDA reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.31-1.08]; one-sided p-value=0.0266) compared with KEYTRUDA alone.
“Today’s results are highly encouraging for the field of cancer treatment. mRNA has been transformative for COVID-19, and now, for the first time ever, we have demonstrated the potential for mRNA to have an impact on outcomes in a randomized clinical trial in melanoma,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We will begin additional studies in melanoma and other forms of cancer with the goal of bringing truly individualized cancer treatments to patients. We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as with health authorities.”
“These positive findings represent an important milestone in our collaboration with Moderna,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “Over the last six years, our teams have worked closely together combining our respective expertise in mRNA and immuno-oncology with a focus on improving outcomes for patients with cancer. We look forward to advancing this program into the next phase of development.”
“The results of this randomized Phase 2b trial are exciting for the field. These data provide the first evidence that we can improve on the rates of recurrence-free survival achieved by PD-1 blockade in resected high-risk melanoma. These findings also provide the first randomized evidence that a personalized neoantigen approach may be beneficial in melanoma,” said Jeffrey S. Weber, MD, PhD, principal investigator of the study and Deputy Director of the Perlmutter Cancer Center at NYU Langone. Dr. Weber is a paid consultant for Merck and Moderna.
How mRNA Vaccines Help Fight Cancer Tumors, Too
June 15, 2021
Thanks to researchers in different fields who put in nearly two decades of past work on mRNA vaccine technology, people around the world are being immunized today from COVID-19 — and hopefully leading us out of this pandemic. Now, because of the increased focus on this versatile technology and that foundation of research, mRNA vaccines for other diseases have an even greater chance of making it to patients.
“The whole platform is very, very flexible,” said Norbert Pardi, PhD, a research assistant professor of Infectious Diseases in the Perelman School of Medicine. “You can use mRNA vaccines for many things.”
That includes cancer — which is just one of several areas outside of infectious diseases that researchers at Penn have been investigating.
Here’s a breakdown of how an mRNA-based vaccine could work to fight tumors, the challenges that need to be overcome, the technology’s roots in oncology, and where it’s headed.
Protection vs. Attack
There’s a key difference between how a vaccine would be used to treat cancers versus a vaccine that’s used for an infectious disease like COVID-19.
First, the mRNA vaccines for COVID-19 protect people from the virus. They’re prophylactic. But a cancer mRNA vaccine is an intervention (a treatment) given to patients with the hope that their immune systems would be activated in a way that would attack tumor cells.
Through their research, Pardi and others, including researchers whose work led to the development of the BioNTech and Moderna vaccines, Drew Weissman, MD, PhD, a professor of Infectious Diseases in the Perelman School of Medicine, and Katalin Karikó, PhD, an adjunct associate professor at Penn and a senior vice president at BioNTech, found that mRNA vaccines can not only prompt strong antibody responses to fight off invaders, like COVID-19, but also potent cytotoxic T cell responses.
That’s important because these T cells can kill cancer cells. They just need to be altered or motivated to do it. Think immunotherapy, like checkpoint inhibitors or chimeric antigen receptor (CAR) T cell therapy that engineers a patient’s own T cells to find and destroy cancer cells.
“A successful therapeutic cancer vaccine should induce strong T cell responses, particularly with CD8+ T cells, which have a known capacity to kill malignant cells,” said Pardi, who is currently leading studies to better understand mRNA vaccines to treat cancers, along with other diseases. Pardi was also a postdoctoral researcher in Weissman’s lab and a frequent collaborator with him and Karikó. “Therapeutic cancer vaccines would be given to cancer patients with the hope that those vaccine-induced cytotoxic T cells would clear tumor cells.”
www.pennmedicine.org/news/news-blog/2021/june/how-mrna-vaccines-help-fight-cancer-tumors-too
“At Penn Medicine, we are proud to pursue bold, paradigm-changing strategies to improve health and treat and cure disease – this ethos is a common trait among our faculty, staff, and students, and it is brought to life in the most inspiring ways,” said J. Larry Jameson, MD, PhD, executive vice president of the University of Pennsylvania for the Health System and dean of the Perelman School of Medicine.
Building an Interception Toolkit
Everyone has BRCA1 and BRCA2 genes, but some people are born with an error, or mutation, in one of these genes. Men and women with either of these inherited gene mutations are at increased risk for certain cancers, including breast, ovarian, prostate, and pancreatic cancers. Today, options for prevention of BRCA-related cancers are largely limited to surgical options such as the removal of healthy breasts and ovaries, both of which can bring significant side effects and tradeoffs. Other patients typically undergo close monitoring, but there are currently no reliable early detection methods for ovarian and pancreatic cancer.
The goal of interception, Domchek says, is to identify and deploy a toolkit of strategies that can be used much like HPV testing for cervical cancer screening and colonoscopies for colon cancer – both tests allow identification of pre-cancerous cells and opportunities to intervene before they develop into disease.
An interception plan for BRCA mutation carriers could potentially include a series of timed interventions designed to keep cancerous cells at bay. In the case of a 25-year-old woman who learns she has a BRCA mutation, for example, future initial care might include close monitoring – with, for instance, “liquid biopsies” – to detect even the most minute amounts of abnormal cells that are on the path to becoming cancer. At age 40, as the risk of cancer increases, her care team could administer a cancer vaccine, “setting back” the biological clock and stopping the growth of precancerous cells. At age 55, doctors could again intercept, perhaps with a drug from the class known as PARP inhibitors, which are already approved for both treatment and recurrence prevention of BRCA-related cancers. At age 70, another interception might be administered, such as preventive radiation or immunotherapy.
Nov. 21, 2022: mRNA revolutionized the race for a Covid-19 vaccine. Could cancer be next?
The unprecedented success of messenger RNA vaccines against the coronavirus is raising hopes that the technology could lead to new and better vaccines against a much older public health scourge: cancer.
In some ways, the challenge is similar: The aim of any vaccine is to focus the immune system’s response against a particular molecule, or antigen, whether that’s a piece of a virus or a protein that coats tumor cells. There’s one important difference, however: Cancer vaccines are generally treatments rather than preventative measures.
“The tumor cells are already there. And you have to build an army of immune cells which is big enough,” said Özlem Türeci, co-founder and chief medical officer of BioNTech, which has eight different cancer vaccines currently in clinical trials. “It’s a numbers game to conquer a tumor, which means you have to be able to induce very strong immune responses.”
Biotech companies are approaching this problem in two main ways: targeting antigens that are shared across patients and going after tailor-made targets. The former are “off-the-shelf” vaccines that could be used across patients, while the latter are bespoke vaccines.
The personalized approach starts by taking a sample of both a patient’s cancer cells and healthy tissue. Researchers then compare the DNA and RNA sequences of these healthy and cancerous samples to identify mutations they can target with a vaccine.
RELATED: The future of messenger RNA: Covid-19 vaccines are just the beginning
There are plenty of examples now in process, including a Phase 2 trial BioNTech started in October 2021 for colon cancer patients who’ve had their tumors surgically removed but still have cancer cells remaining, with bits of tumor DNA floating in their blood. The roughly 200-person randomized study is testing whether the vaccine improves disease-free survival compared with simply monitoring patients, which is the current standard.
h/t Digital mix guy