axelvento
4 days 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
2 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
2 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
3 weeks 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
3 weeks 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.
axelvento
4 weeks ago
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
4 weeks ago
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
1 month ago
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
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