Tagged News
Dawn Health Secures €11.5 Million to Expand Pharma-Focused Digital Health Platform
• Copenhagen-based Dawn Health has raised €11.5 million from existing investors to scale its regulatory-grade digital health platform designed specifically for pharmaceutical companies.
• The platform, already utilized by industry leaders like Merck and Novartis, supports patients with conditions including oncology, multiple sclerosis, and rare pediatric diseases through AI-driven symptom tracking and clinical integration.
• This funding will accelerate Dawn Health's SaaS delivery model, product development, and international expansion as the company aims to become the global leader in pharmaceutical digital health solutions.
Panitumumab Plus FOLFOX Significantly Improves Survival in RAS/BRAF Wild-Type Locally Advanced Colon Cancer
• Exploratory findings from the FOxTROT trial reveal that adding panitumumab to neoadjuvant FOLFOX chemotherapy significantly reduced recurrence and improved survival in patients with RAS/BRAF wild-type locally advanced colon cancer.
• The combination therapy demonstrated impressive results with a 49% reduction in disease-free survival risk (HR, 0.51), 77% reduction in colon cancer death risk (HR, 0.23), and 64% improvement in overall survival (HR, 0.36) compared to FOLFOX alone.
• These results provide the first evidence that anti-EGFR therapy can improve long-term cancer control in locally advanced colon cancer, validating molecular selection for targeted therapy in non-metastatic disease.
UCLA Study: Advanced MRI and Focal Therapy Revolutionize Prostate Cancer Surveillance
• A groundbreaking UCLA study demonstrates that combining advanced MRI imaging with targeted focal therapy allows men with low to intermediate-risk prostate cancer to safely remain on active surveillance longer.
• The research found that 84% of men receiving focal therapy avoided radical treatments like surgery or radiation, compared to only 46% in the control group, significantly reducing overtreatment risks.
• MRI technology proved remarkably accurate, correctly predicting disease stability in 90-95% of low-risk cases and 70% of intermediate-risk cases, while reducing the need for invasive repeat biopsies.
Aptevo Advances APVO711: Novel Bispecific Antibody Combining PD-L1 Checkpoint Inhibition with CD40 Immune Activation
• Aptevo Therapeutics has announced progress on APVO711, a dual-mechanism bispecific antibody that simultaneously blocks PD-L1 and activates CD40, potentially overcoming resistance to standard checkpoint inhibitors.
• Preclinical studies demonstrate APVO711's ability to both block immune suppression and enhance T-cell priming, showing promise for treating a wide range of solid tumors resistant to current immunotherapies.
• The development of APVO711 showcases Aptevo's ADAPTIR platform capabilities while complementing their clinical-stage pipeline, which includes mipletamig for AML and ALG.APV-527 for solid tumors.
FDA's ODAC to Review Four Cancer Drugs in May Meeting
• The FDA has scheduled a two-day meeting of its Oncologic Drugs Advisory Committee (ODAC) in May to review four different cancer therapies.
• The ODAC meeting represents a significant regulatory milestone for the cancer drugs under review, potentially impacting their approval pathways and availability to patients.
• Following the oncology reviews, the FDA's Vaccines and Related Biological Products Advisory Committee will evaluate COVID-19 vaccine formulations for the 2025-2026 season.
Mana.bio Unveils AI-Driven Advances in RNA Delivery at ASGCT 2025
• Mana.bio presented three posters at ASGCT 2025 showcasing their machine learning platform for designing lipid nanoparticles with improved safety and tissue specificity for RNA therapeutics.
• The company demonstrated significant progress in developing precision RNA therapies targeting T-cells and lung tissue, addressing key challenges in extra-hepatic RNA delivery.
• By combining public and laboratory-generated data, Mana.bio's AI models can predict critical LNP attributes including physiochemical properties, tissue specificity, and in-vivo safety profiles.
FDA Advisory Committee Discusses Columvi Combination for Relapsed or Refractory DLBCL
• Genentech's Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin demonstrated a 41% reduction in risk of death for patients with relapsed or refractory diffuse large B-cell lymphoma in the Phase III STARGLO study.
• The FDA Oncologic Drugs Advisory Committee met to discuss the supplemental Biologics License Application for this combination therapy, focusing on the applicability of global trial results to U.S. patients.
• If approved, this first-of-its-kind bispecific antibody combination could provide a much-needed, off-the-shelf, fixed-duration treatment option for transplant-ineligible patients who currently face poor prognosis.
Related Clinical Trials:
Hoffmann-La Roche
Posted 2/23/2021
Targeted Radiopharmaceuticals Summit Returns to Europe and US as Industry Momentum Builds
• The 6th Targeted Radiopharmaceuticals Summit Europe will take place in Amsterdam on December 3-5, featuring 40+ speakers across pre-clinical and clinical tracks as radiopharmaceutical innovation accelerates.
• Major pharmaceutical companies including Novartis, Eli Lilly, AstraZeneca, and Bayer are driving industry growth through billion-dollar collaborations and clinical advancements in novel radiopharmaceutical targets.
• The 4th Targeted Radiopharmaceuticals Summit US returns to San Diego in July, bringing together 275+ global stakeholders to address key challenges in isotope supply, manufacturing, and clinical translation.
Hovione and Firstgene Partner to Develop Novel Gene Therapy for Liver Cancer
• Hovione and Firstgene Life Sciences have established a strategic collaboration to develop a tissue-specific gene therapy targeting hepatocellular carcinoma, the most common type of liver cancer and third leading cause of cancer-related deaths worldwide.
• The partnership leverages Hovione's proprietary virus-like particle platform technology, which enables highly specific delivery of genetic material to target tissues while minimizing off-target effects common in conventional gene therapies.
• This collaboration represents Xlife Sciences AG's strategic entry into the gene therapy market, expanding its portfolio into high-potential therapeutic areas while addressing a significant unmet medical need for the approximately 900,000 new HCC cases diagnosed annually.
JNJ-1900 Shows Promise in Phase 1 Trial for Advanced Pancreatic Cancer
• JNJ-1900 (NBTXR3) demonstrated favorable safety and feasibility in a Phase 1 trial involving 22 patients with locally advanced or borderline resectable pancreatic cancer.
• The trial showed encouraging efficacy with a median overall survival of 23 months from diagnosis, compared to 19.2 months with standard care in a historical review.
• Exploratory biomarker analyses revealed CA19-9 normalization in 59% of patients, associated with improved survival, and increased circulating tumor mutational burden in 40% of patients.