Tagged News
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.
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.
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
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.
Theralase's Light-Activated Ruvidar Shows Promising Results in BCG-Unresponsive Bladder Cancer Clinical Trial
• Theralase's Phase II clinical trial for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) shows 62.5% complete response rate with its light-activated small molecule Ruvidar.
• The therapy demonstrates impressive durability with 45% of complete responders maintaining cancer-free status for at least 12 months, and some patients showing responses lasting over 7 years.
• Theralase plans to complete trial enrollment by mid-2025, submit regulatory applications to Health Canada and FDA in late 2026, with potential market approval by early 2027.
Evolving Treatment Landscape for EGFR-Mutant NSCLC: Managing Resistance and Optimizing Therapy Sequence
• Repeat biopsies at disease progression are crucial for identifying resistance mechanisms in EGFR-mutant NSCLC, with MET alterations present in approximately 25-30% of patients and histologic transformation remaining a significant challenge.
• The MARIPOSA-2 regimen (amivantamab plus chemotherapy), VEGF inhibitors, and emerging antibody-drug conjugates represent key treatment options for patients who progress after initial EGFR-targeted therapy.
• Despite significant advances in first-line treatment with 25% improvement in overall survival, managing resistance remains the primary challenge, driving ongoing clinical trials like SAVANNAH and ORCHARD to explore novel combinations.