Personalized Skin Cancer Vaccine

Two major pharmaceutical companies are testing a personalized vaccine that might prevent the recurrence of a specific type of skin cancer. Moderna, one of the companies behind the COVID-19 vaccine, and Merck, an enterprise focused largely on oncology and preventative medicines, are teaming up to see if they can reduce the public’s risk of re-developing the deadliest form of skin cancer: melanoma.

The vaccine essentially combines two medical technologies: the mRNA vaccine and Merck’s Keytruda. As with the COVID-19 vaccine, mRNA shots don’t require an actual virus. Instead, they use a disease’s genetic code to “teach” the immune system to recognize and fight that particular illness. This makes it relatively easy and inexpensive for scientists to develop mRNA vaccines and edit them if a new form of the disease emerges. Keytruda, meanwhile, is a prescription medication that helps prevent melanoma from coming back after known cancer cells have been surgically removed.

Moderna and Merck are testing the feasibility of not only creating a two-in-one drug with both technologies but also customizing individual vaccines to suit their respective patients. Each vaccine is engineered to activate the patient’s immune system, which in turn deploys T cells (a type of white blood cell known to fight cancer) that go after the specific mutations of a patient’s tumor. Keytruda assists this effort by barring certain cell proteins from getting in the way of T cells’ intervention.

The experimental drug is currently in its second clinical trial out of three. The trial involves 157 participants with high-risk melanoma who just successfully underwent surgical removal. Some of the participants were given the personalized vaccine, while others were given Keytruda alone. Moderna and Merck will observe whether the participants’ melanoma returns over the span of approximately one year, with primary data expected at the end of this year.

If a vaccine preventing the recurrence of melanoma does in fact become commercially available, it could prevent more than 7,000 deaths per year in the US alone.

Source: https://www.extremetech.com/

Moderna Announces mRNA Vaccine Targeting Herpes and Cancer

Building on the momentum of its extraordinarily successful mRNA COVID-19 vaccine, biotechnology company Moderna has announced three new mRNA development targets. The company is now setting its vaccine sights on the herpes simplex virus, the varicella-zoster virus, and a novel cancer vaccine.  mRNA COVID-19 vaccines were demonstrating extraordinary safety and efficacyModerna has just announced a trio of new developmental targets. These three new mRNA vaccine targets sit alongside the company’s previously announced focuses on HIV, influenza, cytomegalovirus (CMV), and the Epstein-Barr virus (EBV).
The biggest newly announced target is a mRNA vaccine against the herpes simplex virus (HSV).  HSV-2 is the world’s most common sexually transmitted disease, with around 10 percent of people thought to be infected. Some researchers have also hypothesized the herpes virus may play a role in the onset of neurodegenerative diseases such as Alzheimer’s.

The second mRNA target announced by Moderna is aimed at the varicella-zoster virus (VSV). This is the virus that causes chicken pox and it is also a latent virus that can remain dormant for years after an initial infection. When VSV reactivates it causes a disease known as shinglesModerna’s targeting of shingles follows an announcement last month from Pfizer indicating it too will be looking at developing an mRNA vaccine for this common disease.

The final newly announced mRNA target is for a vaccine aimed at two antigens expressed by some cancer cells. The vaccine focuses on two antigens: Indoleamine 2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1). Both molecules are known to play a role in the growth of tumor cells. The goal of an mRNA vaccine for cancer would be to train the body’s immune cells to detect tumor cells expressing these specific antigens. The mRNA vaccine will initially be tested on advanced or metastatic skin cancer and a type of lung cancer called non-small cell lung carcinoma.

We are committed to addressing latent viruses with the goal of preventing the lifelong medical conditions that they cause with our mRNA vaccine programs,” said Stephane Bancel, CEO of Moderna. “With our HSV and VZV vaccine candidates, we also hope to improve the quality of life for those with symptomatic disease. With our new checkpoint cancer vaccine, we look forward to exploring if we can induce T cells specific to PD-L1 and IDO1 through vaccination. Our research teams are working on additional mRNA candidates, which we look forward to sharing in the future.

Source: https://www.accesswire.com/

HIV Vaccine Uses mRNA technology

An experimental HIV vaccine that uses the same technology as the COVID-19 mRNA vaccines from Moderna and Pfizer is showing promising results in both monkeys and mice. A press release from the National Institute of Allergy and Infectious Diseases (NIAID) explained that monkeys who received a multiple doses of the experimental vaccine had their chances of contracting an HIV-like virus lowered by 79%.

Scientists have spent decades struggling to create an HIV vaccine due to the speed at which the virus mutates and its remarkable ability to evade the immune system. Dr. Anthony Fauci, president of NIAID, leader of the United States’ battle against COVID-19, and a co-author of this HIV vaccine study published in Nature Medicine, expressed optimism about the progress made by the mRNA technology.

Despite nearly four decades of effort by the global research community, an effective vaccine to prevent HIV remains an elusive goal,” Fauci said. “This experimental mRNA vaccine combines several features that may overcome shortcomings of other experimental HIV vaccines and thus represents a promising approach.”

The trial involved a series of booster shots in macaques over the course of an entire year. The authors explained that not only did the trial yield a positive immune response, but also that “the vaccine was well tolerated with only mild adverse events after each inoculation,” with the most common side effect being loss of appetite.

Now the researchers are working on refining the process so less rounds of shots are needed, as they noted in Nature Medicine that “a vaccination regimen encompassing seven or more sequential immunizations would be difficult to implement in humans.” The study’s leader Dr. Paolo Lusso, said that if the team is successful at reducing the number of boosters in a safe and effective way, they will then move on to a phase 1 trial of the vaccine in adult humans.

Source: https://www.lgbtqnation.com/

Moderna says an omicron variant vaccine could be ready in early 2022

Modernas Chief Medical Officer Paul Burton said Sunday the vaccine maker could roll out a reformulated vaccine against the omicron coronavirus variant early next year. It’s not clear whether new formulations will be needed, or if current Covid vaccinations will provide protection against the new varianthat has begun to spread around the globe.

We should know about the ability of the current vaccine to provide protection in the next couple of weeks, but the remarkable thing about the MRNA vaccines, Moderna platform is that we can move very fast,” Burton said on BBC’s “Andrew Marr Show.”

The emergence of a new COVID-19 variant sparked a big rally in shares of Moderna on Monday as the company announced plans to combat the virus with more vaccines. Moderna jumped as much as 10% on Monday, extending its two-day rally to more than 30% amid budding fears of the Omicron variant.

https://www.cnbc.com/

How to Use mRNA Technology in Vaccines to Fight Cancer

Until recently, most of the world had never heard of mRNA vaccines. To combat COVID-19, the United States Food and Drug Administration issued emergency use authorization in December 2020 for mRNA vaccines developed by Pfizer-BioNTech and Moderna. While the pandemic brought mRNA vaccines into the limelight, melanoma patient Bobby Fentress had experience with mRNA technology nearly a year prior. mRNA vaccines hold promise for fighting infectious diseases beyond the SARS-CoV-2 virus, including fighting cancer. At age 68, Bobby was an early participant in a clinical trial intended to see whether a vaccine made with mRNA could destroy his cancer cells and prevent recurrence.

Bobby’s story began in 2019. He found an odd bump on his middle finger and assumed it was a wart. After his wife urged him to be seen by a dermatologist, he received a call that he would need a biopsy – which ultimately revealed that he had stage 2c melanoma. Several months later, Bobby had most of his middle finger amputated and was told that there was a 50% possibility that the cancer would reoccur.  That’s when Bobby decided to enroll in a clinical trial with HCA Healthcare’s Sarah Cannon Research Institute in Nashville, Tennessee. He received his first shots of a personalized mRNA vaccine created by Moderna in April 2020. These vaccines are developed from a patient’s specific tumor DNA. The DNA of the tumor is analyzed to determine the differences between the tumor and a patient’s own cells and which proteins might elicit the best immune response. The mRNA vaccine is then developed to instruct the body to make these proteins and stimulate an immune response. Patients such as Bobby then receive a series of these vaccine treatments.

Bobby finished his year of treatment earlier this spring. While it is too early to know if the therapy will work, Bobby’s oncologist, Dr. Meredith McKean, is optimistic.  Immunotherapy has been a game changer for melanoma. With mRNA, the hope is that personalized therapy would offer additional treatment benefit above our standard treatments that we offer for patients broadly. Even for patients like Bobby that had surgery, ten years ago we wouldn’t be able to give him anything but highly toxic therapy options. It’s refreshing to offer a clinical trial like this. While the trial is not yet complete, we have enough data to be hopeful. It’s a very encouraging area that I’m excited about as a provider,” says Dr McKean, associate director of the melanoma and skin cancer research program at Sarah Cannon Research Institute.

https://hcahealthcaretoday.com/

Moderna Starts Human Trials for its Revolutionary HIV Vaccine Today

Today, the biotech company Moderna will start human trials for its HIV vaccine. Its HIV vaccine will be the first of its kind to use messenger RNA (mRNA), an approach that Moderna used in its effective COVID-19 vaccine.

The clinical trials will end sometime around spring 2023, according to the National Institutes of Health’s trial registry. They will involve 56 HIV-negative participants aged 18 to 56. The participants will be given one or two forms of mRNA that cause the body to form defenses against HIV infection.

In the past, HIV vaccines used inactivated forms of the virus. However, previous trials showed that these forms didn’t produce any immune responses. In fact, researchers canceled one trial in Thailand during the 2000s after inactivated forms of the virus were found to actually increase people’s risk of catching HIV rather than preventing infections.

Instead, the Moderna trials will contain one of two different types of mRNA: mRNA-1644 and mRNA-1644v2. These get the body’s cells to develop a “protein spike” on their surfaces. These spikes are similar to those embedded by HIV on a cell’s surface when it begins to infect cells to reproduce. When the body recognizes the presence of the mRNA spike, it begins producing antibodies to protect against infection. The mRNA may also allow scientists to make tweaks to the vaccine more easily.

The mRNA platform makes it easy to develop vaccines against variants because it just requires an update to the coding sequences in the mRNA that code for the variant,” Rajesh Gandhi, MD, an infectious diseases physician at Massachusetts General Hospital and chair of the HIV Medicine Association, told the medical site Verywell. This is especially helpful for HIV since the virus is known for having mutated into at least 16 known variants.

Source: https://www.lgbtqnation.com/

Moderna to Trial HIV and Flu Vaccines With mRNA Technology

The astonishing success of COVID-19 vaccines may signal a breakthrough in disease prevention technologyModerna is developing influenza and HIV vaccines using mRNA technology, the backbone of its effective COVID-19 vaccine. The biotech company is expected to launch phase 1 trials for its mRNA flu and HIV vaccines this year. If successful, mRNA may offer a silver lining to the decades-long fight against HIV, influenza, and other autoimmune diseases. Traditional vaccines often introduce a weakened or inactive virus to one’s body. In contrast, mRNA technology uses genetic blueprints, which build proteins to train the immune system to fight off the virus. Since mRNA teaches the body to recognize a virus, it can be effective against multiple strains or variants as opposed to just one.

The mRNA platform makes it easy to develop vaccines against variants because it just requires an update to the coding sequences in the mRNA that code for the variant,”  said Rajesh Gandhi, MD, an infectious diseases physician at Massachusetts General Hospital and chair of HIV Medicine association.

Future mRNA vaccines have the potential to ward off multiple diseases with one shot, according to the Centers for Disease Control and Prevention (CDC).  Current mRNA vaccines, as demonstrated in their use against COVID-19, already appear to be less susceptible to new variants. “Based on its success in protecting against COVID-19, I am hopeful that mRNA technology will revolutionize our ability to develop vaccines against other pathogens, like HIV and influenza,” Gandhi says.

Moderna’s flu and HIV vaccines are still in early development stages, having yet to undergo their clinical trials. Still, if they prove successful, the mRNA-based treatment could dramatically change health care — both in expediting the route to immunity and by providing a solution to illnesses that have been around for decades. Scientists currently make annual alterations to the typical flu shot to keep up with the viruses in circulation. But a successful mRNA vaccine could provide a far more effective alternative.

An approved mRNA flu vaccine could be administered every other year rather than annually, explained virologist Andrew Pekosz, PhD. This is because mRNA accounts for variants and produces a stronger and longer-lasting immune response than that of the current flu vaccine, he says. The influenza vaccine is similar to the COVID-19 vaccine because the viruses have similar characteristics and necessary treatments, according to Pekosz.

However, a potential concern lies in the level of public immunity prior to receiving a vaccine. Since the flu has been around since the early 1900s, an mRNA vaccine could potentially boost older or less effective antibody responses rather than targeting current strains, Pekosz adds. “There’s no way to answer that question except to do some clinical trials, and see what the results tell us”.

Source: https://www.verywellhealth.com/

Moderna Is Testing new Vaccine Stored in Refrigerators, no More in Freezers

Moderna Inc said it had dosed the first participant in an early-stage study of a new COVID-19 vaccine candidate that could potentially be stored and shipped in refrigerators instead of freezers. The company said its new candidate could make it easier for distribution, especially in developing countries where supply chain issues could hamper vaccination drives.

The early-stage study will assess the safety and immunogenicity of the next-generation vaccine, designated as mRNA-1283, at three dose levels, and will be given to healthy adults either as a single dose or in two doses 28 days apart, the company said. Moderna also plans to evaluate the new vaccine, mRNA-1283, as a potential booster shot in future studies.

Last week, Moderna began dosing the first participants in a study testing COVID-19 booster vaccine candidates targeting the variant, known as B.1.351, that first emerged in South Africa.

The booster vaccine candidates, designated mRNA-1273.351, will be tested in a trial of both a variant-specific shot and a multivalent shot, according to the company’s announcement.

Janssen Vaccine could be Rolled Out in Europe by March 15

The European Medicines Agency (EMA) has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V. Janssen is a subsidiary of the giant pharma-company Johnson & Johnson.

EMA’s human medicines committee (CHMP) will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable. The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust.

Such a short time for evaluation is only possible because EMA has already reviewed some data during a rolling review. During this phase, EMA assessed quality data and data from laboratory studies which looked at how well the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2 (the virus that causes COVID-19). The Agency also looked at clinical safety data on the viral vector used in the vaccine.

EMA is now assessing additional data on the efficacy and safety of the vaccine as well as its quality. If EMA concludes that the benefits of the vaccine outweigh its risks, it will recommend granting a CMA. The European Commission will then issue a decision on whether to grant a CMA valid in all EU and EEA Member States within days.

This is the fourth CMA application for a COVID-19 vaccine since the start of the current pandemic. It comes after EMA’s evaluation of vaccines from BioNTech/Pfizer, Moderna and AstraZeneca. These vaccines are now authorised in the EU and are among the tools Member States are using to combat COVID-19.

Source: https://www.ema.europa.eu/

Katalin Kariko, RNA Hero, Future Nobel Prize

The development of the Pfizer-BioNTech coronavirus vaccine, the first approved jab in the West, is the crowning achievement of decades of work for Hungarian biochemist Katalin Kariko, who fled to the US from communist rule in the 1980s.

When trials found the Pfizer-BioNTech coronavirus vaccine to be safe and 95 percent effective in November, it was the crowning achievement of Katalin Kariko’s 40 years of research on the genetic code RNA (ribonucleic acid). Her first reaction was a sense of “redemption,” Kariko told The Daily Telegraph.

I was grabbing the air, I got so excited I was afraid that I might die or something,” she said from her home in Philadelphia. “When I am knocked down I know how to pick myself up, but I always enjoyed working… I imagined all of the diseases I could treat.”

Born in January 1955 in a Christian family in the town of Szolnok in central Hungary – a year before the doomed heroism of the uprising against the Soviet-backed communist regimeKariko grew up in nearby Kisujszellas on the Great Hungarian Plain, where her father was a butcher. Fascinated by science from a young age, Kariko began her career at the age of 23 at the University of Szeged’s Biological Research Centre, where she obtained her PhD.

It was there that she first developed her interest in RNA. But communist Hungary’s laboratories lacked resources, and in 1985 the university sacked her. Consequently, Kariko looked for work abroad, getting a job at Temple University in Philadelphia the same year. Hungarians were forbidden from taking money out of the country, so she sold the family car and hid the proceeds in her 2-year-old daughter’s teddy bear. “It was a one-way ticket,” she told Business Insider. “We didn’t know anybody.”

Not everything went as planned after Kariko’s escape from communism. At the end of the 1980s, the scientific community was focused on DNA, which was seen as the key to understanding how to develop treatments for diseases such as cancer. But Kariko’s main interest was RNA, the genetic code that gives cells instructions on how to make proteins.

At the time, research into RNA attracted criticism because the body’s immune system sees it as an intruder, meaning that it often provokes strong inflammatory reactions. In 1995, Kariko was about to be made a professor at the University of Pennsylvania, but instead she was consigned to the rank of researcher.

Usually, at that point, people just say goodbye and leave because it’s so horrible,” Kariko told medical publication Stat. She went through a cancer scare at the time, while her husband was stuck in Hungary trying to sort out visa issues. “I tried to imagine: Everything is here, and I just have to do better experiments,” she continued. Kariko was also on the receiving end of sexism, with colleagues asking her the name of her supervisor when she was running her own lab.

Kariko persisted in the face of these difficulties. “From outside, it seemed crazy, struggling, but I was happy in the lab,” she told Business Insider. “My husband always, even today, says, ‘This is entertainment for you.’ I don’t say that I go to work. It is like play.” Thanks to Kariko’s position at the University of Pennsylvania, she was able to send her daughter Susan Francia there for a quarter of the tuition costs. Francia won gold on the US rowing team in the 2008 and 2012 Olympics.

It was a serendipitous meeting in front of a photocopier in 1997 that turbocharged Kariko’s career. She met immunologist Drew Weissman, who was working on an HIV vaccine. They decided to collaborate to develop a way of allowing synthetic RNA to go unrecognised by the body’s immune system – an endeavour that succeeded to widespread acclaim in 2005. The duo continued their research and succeeded in placing RNA in lipid nanoparticles, a coating that prevents them from degrading too quickly and facilitates their entry into cells.

The researchers behind the Pfizer-BioNTech and Moderna jabs used these techniques to develop their vaccines.

Source: https://www.france24.com/