Tagged News
Porton Advanced Accelerates Development of Innovative Cell Therapies for Solid Tumors with Key Partnerships
• Porton Advanced's CDMO services have enabled Tasly Pharmaceutical's dual-targeting CAR-T therapy for recurrent glioblastoma to receive IND approval from China's NMPA, demonstrating the effectiveness of their end-to-end manufacturing platform.
• The company has established a new partnership with Hualong Biological to accelerate the development of Multi-Activated T Cell (MATC) therapy for solid tumors, leveraging Porton's regulatory expertise and manufacturing capabilities.
• With 18 global IND approvals and specialized platforms for plasmids, viral vectors, and cell therapies, Porton Advanced is positioning itself as a leading CDMO in the advanced therapy medicinal products (ATMPs) sector.
Dual-Modal Approach Combining OCT and Raman Spectroscopy Achieves 97% Accuracy in Skin Cancer Detection
• A novel dual-modal approach combining optical coherence tomography (OCT) and Raman spectroscopy has demonstrated 96.9% accuracy in differentiating melanoma from benign lesions when paired with machine learning algorithms.
• Early melanoma detection significantly impacts patient outcomes, with 5-year survival rates dropping from 99% in early-stage cases to just 35% when the cancer metastasizes to distant organs.
• This non-invasive diagnostic technique could potentially reduce reliance on painful biopsies while providing clinicians with more objective and rapid diagnostic capabilities for skin cancer.
FDA Approves Theratechnologies' EGRIFTA SV Prior Approval Supplement and Alpha Tau's Trial for Recurrent Glioblastoma
• Theratechnologies has received FDA approval for a Prior Approval Supplement (PAS) for EGRIFTA SV, paving the way for its replacement with the new EGRIFTA WR formulation while ensuring continued distribution of EGRIFTA SV.
• Alpha Tau has secured FDA approval to initiate a clinical trial evaluating its Alpha DaRT technology for patients with recurrent glioblastoma, representing a potential new treatment approach for this aggressive brain cancer.
• Both regulatory milestones highlight ongoing innovation in specialized therapeutic areas, with Theratechnologies focusing on metabolic conditions and Alpha Tau advancing novel radiation technology for difficult-to-treat cancers.
Reunion Neuroscience to Launch REKINDLE Phase 2 Trial for Adjustment Disorder in Cancer Patients Using Psychedelic Therapy
• Reunion Neuroscience has unveiled plans for REKINDLE, a Phase 2 clinical trial evaluating RE104, a novel psychedelic therapeutic, for adjustment disorder (AjD) in patients with cancer and other serious medical illnesses.
• AjD affects approximately 500,000 Americans annually following medical diagnoses, with no FDA-approved treatments currently available despite its significant impact on treatment outcomes and quality of life.
• RE104, a proprietary prodrug of 4-OH-DiPT, offers a shorter psychedelic experience (3-4 hours) compared to psilocybin while maintaining similar therapeutic potential, with trial initiation expected mid-2025.
Related Clinical Trials:
Reunion Neuroscience Inc
Posted 6/14/2024
PharmaMar Expands Global Reach of Zepzelca with Argentina Approval and Merck Partnership for Japan
• PharmaMar and partner Adium Pharma have secured conditional marketing approval for Zepzelca (lurbinectedin) in Argentina for treating metastatic small cell lung cancer, extending the drug's availability to 18 territories globally.
• The company has simultaneously formed an exclusive license agreement with Merck for Zepzelca's development and commercialization in Japan, receiving an initial payment of €22 million with potential for €31 million more in milestone payments.
• These strategic moves strengthen PharmaMar's position in the oncology market while providing new treatment options for patients with an aggressive form of lung cancer across multiple regions.
Study Reveals Chemotherapy Causes Greater Long-Term Physical Health Decline in Breast Cancer Survivors Than Endocrine Therapy
• A new study published in JAMA Network Open found that breast cancer patients treated with chemotherapy experienced significant long-term physical health declines compared to those receiving endocrine therapy alone.
• Patients who received endocrine therapy maintained physical health profiles similar to women who never had breast cancer, while chemotherapy led to greater declines in mobility, pain levels, and fatigue.
• Researchers emphasize the need for personalized treatment approaches and suggest incorporating physical therapy into care plans to mitigate long-term effects of chemotherapy.
MR-LINAC Technology Advances Precision Radiation Therapy Across Multiple Cancer Types
• MR-LINAC technology enables adaptive radiation treatment planning with real-time imaging, allowing clinicians to customize radiation delivery based on daily changes in patient anatomy and tumor position.
• The technology has shown promising early results in reducing toxicity rates in pancreatic and prostate cancers by precisely targeting tumors while sparing nearby sensitive organs.
• Despite longer treatment sessions and potential claustrophobia issues, MR-LINAC offers significant advantages for treating cancers near sensitive organs, with ongoing research exploring novel MR contrast agents and biology-adaptive radiation approaches.
Related Clinical Trials:
NCT04075305Recruiting
UMC Utrecht
Posted 2/1/2019
Early Rituximab Treatment Shows Significant Benefits for Advanced-Stage, Low Tumor Burden Follicular Lymphoma
• Recent phase III JCOG1411/FLORA trial demonstrates that early rituximab administration significantly delays disease progression to high tumor burden follicular lymphoma and postpones the need for cytotoxic chemotherapy compared to watchful waiting.
• Long-term 15-year follow-up data from a separate phase III trial confirms the durability of rituximab's benefits, with 65% of patients in the rituximab maintenance group avoiding new treatments compared to just 34% in the watchful waiting group.
• Despite clear benefits in delaying disease progression, both studies found no significant differences in overall survival between early rituximab treatment and watchful waiting approaches, prompting ongoing debate about optimal timing of intervention.
Related Clinical Trials:
University College, London
Posted 9/1/2004
USDA Approves First Autologous Immunotherapy for Canine Osteosarcoma
• ELIAS Cancer Immunotherapy (ECI) has received full approval from the USDA Center for Veterinary Biologics as the first autologous prescription product for treating canine osteosarcoma.
• The innovative treatment works by conditioning the dog's immune system to recognize cancer cells, then delivering activated killer T cells that target and attack those specific cancer cells.
• ECI is available at 100 authorized treatment centers across the United States, with the treatment process requiring cancer tissue collection prior to surgery for manufacturing the personalized therapy.
Ascelia Pharma Advances Orviglance NDA Following Positive FDA Meeting, Submission Planned for Mid-2025
• Ascelia Pharma has received positive guidance from the FDA regarding its New Drug Application for Orviglance, a novel contrast agent for MRI liver imaging in patients with impaired kidney function.
• The company's Phase 3 SPARKLE study met its primary endpoint with statistical significance (p<0.001), demonstrating Orviglance's ability to improve visualization of focal liver lesions in the target patient population.
• Following successful completion of nine clinical studies involving 286 participants, Ascelia plans to submit the Orviglance NDA by mid-2025, likely in early August, with a cash runway extending through at least the end of 2025.