cleanerworldwehope
3 days ago
Scancell announces further positive data from the ongoing SCOPE trial of SCIB1 with double CPIs for Advanced
Melanoma
80% Progression Free Survival in 25 patients at 6 months
20% (5) patients have shown a complete response following treatment
Disease Control Rate of 84% and an Objective Response Rate of 72%
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, announces
today that 25 patients in cohort 1, receiving SCIB1 in combination with ipilimumab and nivolumab, have reached the
25-week landmark point of the SCOPE trial
it is possible that SCIB1 or iSCIB+ or any version they decide to move forward with could complete Phase 3 trials before the Moderna Combo mRNA-4157, primarily due to faster patient recruitment and a simpler manufacturing process. Here’s why:
1. Personalized mRNA-4157 Faces Recruitment & Manufacturing Challenges
Personalization Delays: Each mRNA-4157 vaccine is custom-made for individual patients, requiring tumor biopsy analysis, neoantigen sequencing, and vaccine synthesis Plus a cold storage place as identified by Heather Shaw —a process that can take weeks to months per patient.
Logistical Complexity: This customization adds significant cost, regulatory, and logistical hurdles, potentially slowing patient enrollment and extending trial timelines.
Phase 3 Trial Design: Moderna/Merck’s Phase 3 trial (V940-001, NCT05933577) is expected to enroll ~1,089 patients, but recruitment and manufacturing constraints could delay completion beyond 2027.
2. The Scancell SCIB1’s Off-the-Shelf Advantage
Faster Enrollment: SCIB1 is a ready-made, off-the-shelf DNA vaccine, meaning patients can be randomized and dosed immediately rather than waiting for personalized manufacturing.
Lower Costs & Scalability: DNA vaccines are cheaper and easier to produce at scale compared to mRNA-based personalized therapies.
SCIB1 + CPI Synergy: The SCOPE Phase 2 trial has already demonstrated superior efficacy over CPIs alone, positioning it well for an accelerated Phase 3 program.
Phase 2/3 Adaptive Design: Scancell has indicated plans for a Phase 2/3 registration trial with PFS as the primary endpoint. If efficacy is strong, an adaptive trial design could allow for earlier regulatory submission.
Conclusion: Could SCIB1 Finish Phase 3 First?
🔹 Yes, it’s possible—SCIB1’s simpler logistics and faster recruitment could help it outpace mRNA-4157 in trial completion.
🔹 Moderna’s mRNA-4157 trial faces patient recruitment bottlenecks, potentially extending timelines.
🔹 If SCIB1’s Phase 2/3 trial shows strong PFS and safety data, it could reach regulatory submission ahead of mRNA-4157, potentially securing a market advantage in the melanoma vaccine space.
Would you like an estimated timeline comparison for SCIB1 vs. mRNA-4157 Phase 3 completion? 🚀
axelvento
2 weeks ago
RFK Jr. says measles vaccine routinely causes deaths. That’s not true
When Robert F. Kennedy Jr. was confirmed as America’s secretary of health and human services, neutral observers might have asked themselves: Would it be possible for a lawyer who had questioned the safety of childhood vaccinations for two decades to look at the available data and reconsider his views?
Kennedy’s recent interviews with Fox News, along with an op-ed he published on that outlet’s website, have been enough to make many experts conclude the answer is “no.”
Parsing every claim about the measles vaccine that Kennedy has made would take a long time, so let’s focus on one: that the vaccine causes deaths every year. Researchers say that simply isn’t true, except potentially in a small number of people who are not supposed to receive it — those with compromised immune systems.
“There are adverse events from the vaccine,” Kennedy said in a March 11 interview with Fox’s Sean Hannity. “It does cause deaths every year. It causes — it causes all the illnesses that measles itself causes, encephalitis and blindness, et cetera. And so people ought to be able to make that choice for themselves.”
The Infectious Disease Society of America says there have been “no deaths related to the measles, mumps and rubella vaccine in healthy individuals.” (Since the 1970s, the measles vaccine has been given in a combination shot with mumps and rubella to minimize the number of injections kids get.)
Here is how we know that vaccines do not cause autism
“The MMR vaccine has never been found to cause a death in an immunocompetent individual,” Daniel Griffin, chief of the division of infectious diseases at Island Infectious Disease Medical in New York said, echoing that conclusion. “If you’ve got someone who has a compromised immune system, and someone doesn’t know any better and gives them an active vaccine, which is what you are not supposed to do, then, you know, that could result in a death.”
Measles is itself a killer. Before the measles vaccine was introduced in 1963, it was a near-certainty that children would be infected before the age of 15 — about three or four million cases occurred every year. Most children had no complications, but a little more than 1 in 1,000 would die after developing pneumonia or encephalitis. That equates to 400 or 500 deaths a year.
A 2024 study in the The Lancet estimated that measles vaccines prevented 93.7 million deaths globally between 1974 and 2024 — a number equivalent to a quarter of the U.S. population.
Measles isn’t a huge threat now. Public health experts worry that won’t remain the case because of low vaccination rates. Importantly, even though the measles vaccine is one of the most effective on the market, it will not protect every person vaccinated. Perhaps one person in 20, maybe less, will not have fully protective antibody levels. Having more unvaccinated people means more risk for everyone, including people with compromised immune systems and children too young to receive the shot. (Children are eligible for the shot at 1 year of age.)
All medical products come with risks. The measles vaccine includes a weakened virus, which means that scientists developed it by passing a measles virus through cell cultures and chicken embryos until it became less able to cause serious symptoms in people, but still able to spur immunity. It is, essentially, measles with dramatically less risk.
The shot still commonly causes a fever. Seizures caused by fever occur in 3 in 10,000 people who receive the shot. Clotting issues occur in roughly 3 in 100,000. Allergic reactions occur in perhaps 3 in a million.
Other side effects are even rarer than that. As Kennedy noted, the vaccine can cause encephalitis, although case counts appear vanishingly rare. There are also scattered case reports of patients developing optic neuritis, a condition that can cause blindness, but in most of these patients sight returned with time or treatment. Those cases are so rare it is difficult to even estimate the risk of them occurring — except to say that it is very, very low.
Kennedy’s assertion that the vaccine causes deaths every year likely comes from reports to the Vaccine Adverse Event Reporting System (VAERS), a government-run database that allows individuals or their doctors to submit reports of bad outcomes they think were caused by a vaccine. It is an important early warning system for vaccine side effects, but a flawed one, because there is no way of controlling for the fact that people sometimes think a bad outcome may have been caused by a vaccine when it was not. When there is press coverage of vaccines, reports of side effects tend to go up even though the number of children receiving the vaccines do not.
https://www.statnews.com/2025/03/14/rfk-jr-measles-vaccine-death-claims-scientists-disagree/
axelvento
2 weeks ago
Making a Mark: Local vaccine trial taking personal approach to treating kidney cancer
Researchers have partnered with Merck and Moderna on the study
NEW HAVEN, CT. (WFSB) - When it comes to treating and beating cancer, the same approach doesn’t always work for every patient.
That’s why a local vaccine trial is taking a personal approach, and the doctor behind it is making a mark with his research.
On the outside, it’s just another building in New Haven. But it’s what’s happening inside, where Dr. David Braun walks the halls, that sets it apart.
The Yale research lab is home to some of the smartest people, not just in Connecticut, but in the world, and they’re making groundbreaking progress on what’s called a personalized cancer vaccine, or PCV, for kidney cancer.
“It’s early days still and I always like to caution – but I think we certainly have reasons, we have tried to be really rigorous about it, reasons for initial excitement but the hard work still needs to be done to really prove this,” said Braun, who is a medical oncologist.
According to him, advanced kidney cancer is reasonably common with about 85,000 people diagnosed in the United States each year.
His trial focused on nine patients who received a PCV designed to target their cancer, and all of them had encouraging results.
“For those nine patients, we saw that the immune system really did steer towards their cancer – it did so in a really long-lasting way that immune response lasted years and I think very fortunately none of those nine patients had their cancer return,” Braun continued.
They’ve already launched a larger clinical trial of about 270 people that will continue over a few years.
While the process is incredibly scientific and complicated, the goal is simple.
“I think we have to make sure it’s done right because you want to make sure that this is really doing what you think it’s doing – it’s really helping people and that’s why it takes time, it just takes time to really understand that,” he said.
Dr. Braun says there is a lot to be excited about and that there are very few fields in medicine that are advancing as quickly as cancer treatments.
https://www.wfsb.com/2025/03/13/making-mark-local-vaccine-trial-taking-personal-approach-treating-kidney-cancer/
$MRNA
Vexari
2 weeks ago
If covid vaccines paved the way
For cancer vaccines
What will cancer vaccines
Pave the way for
Never ending
Cycle
Going from mRNA Covid vaccines to mRNA cancer vaccines is straightforward: same fridges, same protocol, same drug, just a different patient.
In the current trials, we do a biopsy of the patient, sequence the tissue, send it to the pharmaceutical company, and they design a personalized vaccine that’s bespoke to that patient’s cancer. That vaccine is not suitable for anyone else. It’s like science fiction.
Covid Vaccines Have Paved the Way for Cancer Vaccines
https://www.wired.com/story/wired-health-lennard-lee-cancer-vaccines/
axelvento
2 weeks ago
Scoop: White House pulls CDC director nomination
The White House is withdrawing the nomination of Dave Weldon to be the director of the Centers for Disease Control and Prevention (CDC), per a source close to Senate health committee and another source familiar.
Why it matters: The former Florida congressman was scheduled to appear before the committee this morning for a since-cancelled confirmation hearing. But his views questioning certain vaccines have garnered attention since he was nominated months ago and were sure to play a prominent role in questioning.
HHS Secretary Robert F. Kennedy Jr. himself said Weldon wasn't ready, per one of the sources.
Background: Weldon is an internal medicine doctor who served in the House of Representatives from 1995 through 2009. While in Congress, he was one of the sponsors of a bill that would have banned mercury from vaccines.
In a 2007 statement on a different bill he sponsored, Weldon wrote that "legitimate questions persist regarding the possible association between the mercury-based preservative, thimerosal, and the childhood epidemic of neurodevelopmental disorders (NDDs), including autism."
Thimerosal has been used as a preservative in vaccines, although it was taken out of childhood vaccines in 2001, per the CDC. Many studies have found no evidence of harm of thimerosal in low doses in vaccines.
Studies have also found no evidence of a connection between vaccines and autism.
Sen. Patty Murray (D-Wash.) said Weldon repeated debunked claims about vaccines in a meeting they had last month. She called on the administration to pick a nominee "who at bare minimum believes in basic science and will help lead CDC's important work to monitor and prevent deadly outbreaks."
axelvento
2 weeks ago
Going from mRNA Covid vaccines to mRNA cancer vaccines is straightforward: same fridges, same protocol, same drug, just a different patient.
In the current trials, we do a biopsy of the patient, sequence the tissue, send it to the pharmaceutical company, and they design a personalized vaccine that’s bespoke to that patient’s cancer. That vaccine is not suitable for anyone else. It’s like science fiction.
Covid Vaccines Have Paved the Way for Cancer Vaccines
https://www.wired.com/story/wired-health-lennard-lee-cancer-vaccines/
axelvento
2 weeks ago
Moderna’s mRNA-5671 (V941) encapsulates mRNA strands encoding KRAS mutations G12D, G12V, G13D, or G12C in LNPs for the treatment of nonsmall cell lung cancer, colorectal cancers, or pancreatic adenocarcinoma.
Nanoparticle Plus mRNA Attacks Pancreatic Liver Metastases in Mice
https://www.insideprecisionmedicine.com/topics/oncology/nanoparticle-plus-mrna-attacks-pancreatic-liver-metastases-in-mice/
This study demonstrates that reprogramming the immune-protective niche for metastatic pancreatic cancer can be achieved by the delivery of a STING agonist and mutant KRAS mRNA via ionizable LNPs, offering both prophylactic and therapeutic advantages.
https://pubs.acs.org/doi/10.1021/acsnano.4c14102
$MRNA
axelvento
2 weeks ago
Merck wins Gardasil litigation over cancer vaccine risks
On Tuesday, Merck & Co (NYSE:MRK) Inc. emerged victorious in a significant legal dispute concerning its Gardasil vaccine, which is designed to prevent cervical and other serious cancers. U.S. District Judge Kenneth Bell, presiding in Charlotte, North Carolina, dismissed more than 200 cases that were part of a consolidated multidistrict litigation.
The plaintiffs in the litigation had accused Merck (NSE:PROR) of failing to warn about potential side effects of Gardasil, specifically an increase in heart rate and ovarian issues. They contended that these warnings should have been included on the vaccine’s labels. However, Judge Bell determined that under federal law, Merck did not have the power to independently add warnings about such risks without more substantial evidence.
In his decision, Bell emphasized the importance of not deterring the use of vaccines that save lives with warnings that are not well-supported by evidence. He stated that federal law demands more than "speculative inferences" before imposing severe warnings on vaccines, which could potentially dissuade people from using them.
Merck responded to the ruling with approval, stating that they were "extremely pleased" with the outcome. The decision effectively resolves a large group of claims that had been brought against the pharmaceutical company regarding its Gardasil vaccine.
This ruling supports the position that vaccine manufacturers are not responsible for independently updating warnings on their products without the explicit direction of the Food and Drug Administration or a solid foundation of scientific proof. The dismissal of the cases underscores the legal protections in place for vaccine makers, especially when the allegations are not substantiated by robust scientific data.
axelvento
3 weeks ago
Moderna at TD Cowen Conference: Strategic Diversification Focus $$$$$$$$$$
On Wednesday, 05 March 2025, Moderna Inc. (NASDAQ: MRNA) participated in the TD Cowen 45th Annual Healthcare Conference. The discussion, led by Tyler Van Buren from TD Cowen and Steven Hoege, President of Moderna, highlighted the company’s strategic initiatives, including product diversification and cost reduction. While Moderna remains committed to its ambitious growth plans, it also acknowledged potential challenges, such as lower COVID vaccination rates and market uncertainties.
Key Takeaways
Moderna aims for 2025 vaccine sales between $1.5 billion and $2.5 billion.
The company targets cash breakeven by 2028 through diversification and cost management.
Moderna’s product pipeline includes vaccines for RSV, flu COVID combo, norovirus, and CMV.
The individualized neoantigen therapy (INT) program is a key focus in oncology.
Moderna is prepared to advance its bird flu vaccine program as needed.
Financial Results
Moderna reiterated its 2025 sales guidance of $1.5 billion to $2.5 billion, acknowledging potential headwinds.
The company aims to achieve cash breakeven by 2028 through product launches and cost reductions.
Cash investment is projected to decrease from $6.4 billion in 2024 to $5 billion in 2026.
Operational Updates
RSV Vaccine: Contracting discussions are ongoing, with label expansion under review for high-risk 18-59 year olds.
Flu COVID Combo Vaccine: No revenue expected in 2025, with a 2026 opportunity pending efficacy data.
Norovirus Vaccine: Data expected in 2026, with trials paused due to a Guillain Barre syndrome case.
INT Program: Phase 3 melanoma trial fully enrolled, with potential approval in 2027.
Bird Flu Vaccine: Phase 3 study in the U.S. under agreement, with a proactive approach to pandemic preparedness.
Future Outlook
Product Launches: Aiming to launch 10 products in three years, with three files under FDA review.
Cost Discipline: Continued cost reductions to balance investment and revenue by 2028.
Q&A Highlights
RSV Competition: Moderna aims to offer the broadest label and strong efficacy for its RSV vaccine.
Flu Season: Challenges include declining vaccine coverage and evolving influenza viruses.
Flu COVID Combo vs. Monotherapy: Two-thirds of the population prefer the combination vaccine, though monovalent products will remain significant.
Full transcript - TD Cowen 45th Annual Healthcare Conference:
https://www.investing.com/news/transcripts/moderna-at-td-cowen-conference-strategic-diversification-focus-93CH-3913103
axelvento
4 weeks ago
From Tumor Biology to Breakthrough Therapies: The Rise of Personalized Cancer Vaccines
Notably, in the KEYNOTE-942 trial (NCT03897881) led by Jeffrey S Weber, investigators observed improved relapse-free survival (RFS) with a combination of neoantigen vaccines and pembrolizumab (Keytruda; Merck & Co), marking a significant step forward in clinical translation.1,2 This phase 2b study evaluated the efficacy and safety of mRNA-4157 (V940; Moderna and Merck), an mRNA-based individualized neoantigen therapy, combined with pembrolizumab vs pembrolizumab monotherapy in patients with resected high-risk melanoma (stage IIIB-IV). The trial enrolled 157 patients across the US and Australia, randomized 2:1 to receive either the combination therapy or monotherapy.2
At a median follow-up of 24 months, the combination therapy improved RFS (HR 0.561, P=0.053), with 18-month RFS rates of 79% vs 62% in the monotherapy group. The combination therapy was associated with more grade 3 or higher treatment-related adverse events (AEs, 25% vs 18%), though no grade 4 to 5 events were attributed to mRNA-4157. Immune-mediated AE rates were similar between groups.2
Overall, the findings suggest that mRNA-4157 plus pembrolizumab enhances RFS with a manageable safety profile, supporting the potential role of mRNA-based neoantigen therapy in the adjuvant treatment of high-risk melanoma.2
With promising results such as those observed in the KEYNOTE-942 trial, Wu explained that pharmaceutical industry has begun to provide funding for larger studies investigating neoantigen vaccines in the adjuvant and neoadjuvant settings. For example, one study (NCT05933577) investigating melanoma (nearly finished) received funding from Merck and Moderna and enrolled 1089 patients. Another study (NCT06295809) investigating cutaneous squamous cell carcinoma in the adjuvant and neoadjuvant setting (will be commencing soon) also received funding from industry and has enrolled 1000 patients. Other studies include investigations into renal cell carcinoma (RCC, NCT06307431), bladder (NCT06305767), non-small cell lung cancer (NCT06077760), and resected pancreatic ductal adenocarcinoma (NCT05968326), all in the adjuvant setting with between 200 and approximately 900 patients enrolled.1
“Now we're getting—with support from industry—not 10 or 15 patient studies, but rather on the order of 200 and even more than 1000 patients,” Wu said. “I think in the time to come, we'll be able to really, truly look at the clinical impact of such vaccines.”
https://www.pharmacytimes.com/view/from-tumor-biology-to-breakthrough-therapies-the-rise-of-personalized-cancer-vaccines
axelvento
4 weeks ago
Yale doctor's use of ‘cancer vaccine' makes waves after early trials show promising results
The patients remained cancer-free for nearly three years, up until the study ended, Braun said. “We’re able to generate a long-lasting, anti-cancer immune response with the vaccine,” he said.
The next stage is a larger trial, in partnership with pharmaceutical companies Merck and Moderna, that will test the vaccine in combination with other treatments in 270 patients around the world. The first patient who enrolled in the new trial is being treated at Yale Cancer Center, Braun said.
https://www.nature.com/articles/s41586-024-08507-5
https://www.ctinsider.com/business/article/yale-cancer-vaccine-kidney-tumor-dna-research-20173018.php
axelvento
1 month ago
$BNTX Experimental vaccine for common cancer shows potential in clinical trial
Some pancreatic cancer patients showed immune response to mRNA vaccine
Vinod Balachandran, MD, principal investigator of the trial and senior study author at MSK, stated his optimism about the efficacy of this treatment.
"We find that with RNA vaccine technology, we can teach the immune system to recognize pancreatic cancer, and this immune response could potentially last for many years," he said.
"The ability to trigger a robust, long-lasting immune response is a requisite feature for any cancer vaccine."
https://www.foxnews.com/health/experimental-vaccine-common-cancer-shows-potential-clinical-trial
axelvento
1 month ago
Cancer Vaccines: https://finance.yahoo.com/news/cancer-vaccines-market-track-major-180000959.html
Leading cancer vaccine companies such as IO Biotech, Merck, Moderna, Candle Therapeutics, ISA Pharmaceuticals, PDS Biotechnology, PDC*line Pharma, LG Chem, AVEO Oncology, Archival Farma, and others are developing novel cancer vaccines that can be available in the cancer vaccines market in the coming years.
Some of the key cancer vaccines in the pipeline include IO102-IO103, mRNA-4157 (V940) + KEYTRUDA, CAN-2409, Nelipepimut-S + Cemiplimab, PDS0101 + Pembrolizumab, PDC*lung01, LB-LR1109, RUTI, and others.
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