Moderna

Precision medicine uses genetic, environmental, and lifestyle data to tailor treatments, with AI, CRISPR-Cas9, and mRNA as key trends. AI accelerates genomic analysis and drug discovery, CRISPR-Cas9 offers precise gene editing, and mRNA vaccines expand beyond COVID-19, driving personalized healthcare.

Lack of funding and understanding of long COVID's mechanisms hinder drug development, frustrating patients and researchers. Despite initial positive results with Ampligen, Aim ImmunoTech faced funding challenges. The NIH's RECOVER initiative focuses on observational studies rather than new compounds, and private investors avoid long COVID due to perceived risk. Small biotech companies struggle to sustain research efforts, with some shifting focus or shutting down. Public-private partnerships and increased federal funding are suggested as solutions to advance long COVID treatment research.

AllClinicalTrials.com unifies US clinical trial data, simplifying access for patients and researchers. Features include a pre-screener survey, advanced search filters, and real-time notifications for new trials. Successfully supported Moderna's Phase 3 COVID-19 vaccine trial recruitment.

Moderna's mResvia RSV vaccine uptake slower than expected, facing challenges from GSK and Pfizer. Moderna executives acknowledge initial optimism and difficulties in contracting and CDC approval.

Moderna revised its break-even forecast from 2026 to 2028, leading to significant R&D cuts and a downgrade in stock ratings by firms like Jefferies and J.P. Morgan. The company plans to focus on 10 pipeline candidates, halting development of five programs, and expects a compounded annual growth rate of over 25% from 2026 to 2028.

Gene therapy tools enabling in vivo CAR T generation offer potential to make CAR T therapies faster, better, and cheaper, bypassing ex vivo limitations. Companies like Interius and Umoja are pioneering this approach with engineered lentiviral vectors and lipid nanoparticles, targeting immune cells directly in the body. This shift could blur the lines between cell and gene therapies, with initial trials in cancer and autoimmune diseases expected to yield significant insights by 2026.

Interim Phase I data of mRNA-4359 immunotherapy shows promise in advanced solid cancers, with 8/16 patients showing no tumor growth. The therapy activates immune response and is well-tolerated, supporting further research.

COVID-19 accelerated mRNA vaccine development, leading to record profits and FDA approval of mRNA vaccines. Moderna and Pfizer/BioNTech are expanding their mRNA pipelines into other diseases, with Moderna's RSV vaccine recently approved. The mRNA therapeutics market is projected to reach $68 billion by 2030. mRNA technology is favored for its rapid development potential compared to traditional vaccines. Five mRNA vaccine candidates, including Pfizer/BioNTech's influenza vaccine and Moderna's combination COVID-19/influenza vaccine, are highlighted as near-future prospects.

Surgeon General Joseph Ladapo advises against mRNA COVID-19 vaccines, questioning their efficacy against current strains. Despite this, many residents in The Villages are receiving the latest vaccine and flu shots. Ladapo's guidance on COVID-19 boosters for the 2024-2025 season highlights concerns over lack of human trial data and protection against dominant strains.