axelvento
5日前
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
6日前
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週前
$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
2週前
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.
axelvento
2週前
Moderna Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides Business Updates
Cash Position: Cash, cash equivalents and investments as of December 31, 2024, were $9.5 billion, compared to $9.2 billion as of September 30, 2024. The increase during the quarter was primarily attributable to the timing of accounts receivable collections.
https://investors.modernatx.com/news/news-details/2025/Moderna-Reports-Fourth-Quarter-and-Fiscal-Year-2024-Financial-Results-and-Provides-Business-Updates/default.aspx
jondoeuk
3週前
The vaccine targets five antigens VHL, PBRM1, BAP1, KDM5C, PIK3CA.
From the paper: ''All patients generated T?cell immune responses against the PCV antigens, including to RCC driver mutations in VHL, PBRM1, BAP1, KDM5C and PIK3CA.'' https://www.nature.com/articles/s41586-024-08507-5
MRNA's vaccine targets up to 34 patient-specific neoantigens.
DCVax-L in combination with poly-iclc can certainly fix those highly mutated genes.
There is a reason why NWBO has never disclosed or talked about this trial. NWBO's -L isn't a gene therapy either.
Can you imagine the magnitude of efficacy that the latest version of DCVax-L in combination with keytruda can bring after dendritic cells present hundreds of tumor-associated antigens to immune system?
Again, there is a reason why NWBO has never disclosed or talked about this trial. Also, if a mutation is never transcribed, translated and processed, it cannot stimulate an immune response from T-cells. Looking at the data from Dr Rosenberg's group at the US NCI, as well as others, only approximately 1-6% of the mutations are actually transcribed, translated and processed, presented on the surface and can be recognised by the patient's own T-cells using current methods https://www.cell.com/cancer-cell/fulltext/S1535-6108(20)30374-3 https://aacrjournals.org/cancerdiscovery/article/9/8/1022/41919/Unique-Neoantigens-Arise-from-Somatic-Mutations-in https://ascopubs.org/doi/10.1200/JCO.21.02170
axelvento
3週前
CAR-macrophage therapy for HER2-overexpressing advanced solid tumors: a phase 1 trial
Chimeric antigen receptor (CAR) macrophages (CAR-Ms) mediate antitumor immunity via phagocytosis, cytokine release, activation of the tumor microenvironment and antigen presentation. We report results from a non-prespecified interim analysis of a first-in-human, phase 1 clinical trial of CT-0508, an anti-human epidermal growth factor receptor 2 (HER2) CAR-M in patients with advanced HER2-overexpressing tumors. Fourteen patients were treated across two different regimens. Patients with breast cancer and gastroesophageal cancer were primarily enrolled and had to have demonstrated overexpression of HER2 according to the American Society of Clinical Oncology/College of American Pathologists guidelines (HER2 immunohistochemistry 3+ or immunohistochemistry 2+/in situ hybridization-amplified). No lymphodepletion chemotherapy was used before infusion. The primary endpoints were safety and CAR-M manufacturability. Secondary endpoints included cellular kinetics and efficacy using objective response rate, overall survival, progression-free survival and duration of response. No dose-limiting toxicities, severe cytokine release syndrome (≥grade 3) or immune effector cell-associated neurotoxicity syndrome were observed; 44% (n?=?4 of 9, 95% confidence interval?=?14–79%) of HER2 3+ tumors achieved stable disease as best overall response 8 weeks after treatment. No meaningful activity was observed in the HER2 2+ population (n?=?5). Correlative analyses of serial biopsies confirmed that CT-0508 traffics to and remodels the tumor microenvironment, resulting in expansion of CD8+ T cells. These findings demonstrate the preliminary safety, tolerability and manufacturing feasibility of CT-0508 for HER2+ tumors. ClinicalTrials.gov registration: NCT04660929.
https://www.nature.com/articles/s41591-025-03495-z
Carisma and Moderna Expand Collaboration to Develop Two In Vivo CAR-M Therapies for Autoimmune Diseases
https://ir.carismatx.com/news-releases/news-release-details/carisma-and-moderna-expand-collaboration-develop-two-vivo-car-m
axelvento
4週前
Work finishes on Moderna Innovation and Technology Centre in Oxfordshire
Construction is now complete on the Moderna Innovation and Technology Centre (MITC), the pharma firm’s new research, development and manufacturing facility at Harwell Campus in Oxfordshire.
Subject to licensure, the first product manufactured at scale at the centre is expected to be a Covid-19 vaccine to support the NHS vaccination programme.
In the event of a pandemic, the site will have the capacity to produce a minimum of 250 million vaccine doses per year.
The MITC also features labs and office spaces to support high-priority pre-clinical and clinical-stage assays.
Its biomarker, bioanalytical, and molecular assay laboratories will process samples from Moderna’s clinical trials to assess the safety and effectiveness of potential therapeutics and vaccines.
Stephen Hoge, MD president of Moderna, said: “We’re immensely proud of our new manufacturing facility and clinical laboratories in Oxfordshire and the significant and ongoing investment into R&D across the UK.
“By investing heavily across clinical trials and research, we aim to drive breakthroughs that could improve patient outcomes, support the UK healthcare ecosystem and ultimately shape the future of medicine.”
Moderna has launched 23 clinical trials in the UK across 110 sites since 2021, involving more than 12,700 people.
It has an ongoing 10-year strategic partnership with the UK government, managed by the UK Health Security Agency (UKHSA).
Prof Dame Jenny Harries, chief executive of the UKHSA, added: “The Covid-19 pandemic demonstrated how government can and must work closely with industry to respond to emerging health threats.
“Our partnership with Moderna exemplifies these opportunities and will support the UK’s ambitions towards the 100 Days Mission, help put the UK at the forefront of new technologies and drive economic growth.
"The completion of construction of this impressive facility marks a real milestone and doing so in less than two years is a remarkable achievement.
“Once regulated, it will help ensure the NHS has rapid access to mRNA vaccines if needed in a future pandemic, as well as open doors to new vaccine products.”
The event at Harwell coincided with the first meeting of the new government’s joint oversight committee, co-chaired by Georgia Gould MP, parliamentary secretary at the cabinet office, and Moderna President, Stephen Hoge.
The committee discussed the progress of their partnership and toured the facility, which is expected to be fully operational later this year.
https://thebusinessmagazine.co.uk/technology-innovation/work-finishes-on-moderna-innovation-and-technology-centre-in-oxfordshire/
axelvento
1月前
When Donald Trump unveiled a $500bn plan to spearhead a cancer vaccine, many greeted it as another of his grandiose proposals.
But not Anna Bochenski.
The 53-year-old New Yorker is one of the few people in the world who knows how life-changing the shots can be.
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The administrative worker was told she had just months to live in January 2021 after her aggressive breast cancer returned and stopped responding to treatment.
After a six-year battle with the disease, which included numerous surgeries and 32 brutal rounds of radiation, the cancer had spread to her ribs and spine, where it had become virtually incurable, known as 'metastatic'.
As a last resort, she was enrolled in a clinical trial for an experimental cancer vaccine developed at the famous Mount Sinai hospital in Manhattan.
The vaccine works by melting away the primary tumor and teaches the body to hunt and kill the cells that have spread elsewhere. Within weeks, the tumors in her back and a tennis ball-sized tumor under her armpit disappeared, while a third in her chest shrunk.
Speaking to DailyMail.com this month, almost exactly four years after the vaccine, she said: 'It saved my life. At that time, there was nothing I could do. There was nothing that could treat my cancer.'
Hundreds of experimental cancer vaccines are in production around the world, but President Trump's newly announced artificial intelligence project could be the catalyst that finally brings these shots to the public.
https://www.dailymail.co.uk/health/article-14322495/cancer-vaccine-donald-trump-mrna-cure-tumors.html
axelvento
1月前
Fetterman: RFK Jr.’s nomination in trouble after rocky hearing
Sen. John Fetterman (D-Pa.), who was thought to be open to voting for Robert F. Kennedy Jr.’s nomination to head the Department of Health and Human Services, now says the nominee is in serious trouble after his rocky confirmation hearing.
“I don’t think it went well for him today. I don’t think that was a good one,” he said after Kennedy sparred with Democrats on the Senate Finance Committee over his past statements and stance on vaccines.
Fetterman said after the bruising hearing that he thinks Kennedy’s nomination may be “moot.”
“It’s moot,” he said when asked if he’s still open to voting for Kennedy. “I’m not really sure how much support’s going to emerge after that.”
The Pennsylvania Democrat noted that he’s met with Kennedy twice already.
“I think we can all agree that was really a difficult performance,” he said. “I’m not sure he’ll even make it out of the committee.”
Sen. Michael Bennet (D-Colo.), one of the Democrats who grilled Kennedy at his hearing Wednesday, asked him pointedly about his comments on a podcast that exposure to pesticides could be causing more children to identify as transgender.
Kennedy acknowledged under Bennet’s cross-examination that he “probably did say” that Lyme Disease was a militarily-engineered bioweapon.
Sen. Ron Wyden (D-Ore.), meanwhile, tried to pin down Kennedy on his past views and statements on vaccines in a combative back-and-forth.
“You have a history of trying to take vaccines away from people,” Wyden told him.
RFJ, Jr.’s nomination will be voted on by the Senate Finance Committee, but before that happens, he will appear before the Senate Health, Education, Labor and Pensions Committee for a second round of questioning Thursday.
Sen. Susan Collins (R-Maine), a member of the HELP Committee and a key Senate swing vote, said it’s “premature” for her to say how she will vote.
“I do not make decisions on nominees prior to the public hearings,” she said.
“It’s totally premature to make a decision prior to the [public hearing,]” she added.
https://thehill.com/homenews/senate/5114271-fetterman-rfk-jr-nomination-hearing/
axelvento
1月前
As the Senate committee hearings over Robert F. Kennedy Jr.’s nomination to serve as secretary of Health and Human Services kick off Wednesday, opposition to his bid is mounting.
"All we need is a handful of senators," says Dr. Rob Davidson, executive director of Committee to Protect Health Care, a progressive advocacy group that reports gathering more than 18,000 signatures from physicians (though the list hasn't been made public). "They should look at his record and it will absolutely confirm that he is a danger."
let's see what will happen
https://www.npr.org/sections/shots-health-news/2025/01/28/nx-s1-5274744/rfk-confirmation-vaccines-health-secretary
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