New Study Shows TAF and Dolutegravir Superior for Second-Line HIV Treatment in Children
• The CHAPAS-4 trial found that tenofovir alafenamide (TAF) plus emtricitabine (FTC) suppressed HIV in 6% more children than standard backbone treatments while being more cost-effective.
• Dolutegravir (DTG) emerged as the superior anchor drug, achieving full viral suppression in 10% more children than lopinavir/ritonavir and atazanavir/ritonavir, while also being the least costly option.
• Children receiving newer drug combinations showed improved growth, bone health, and cholesterol levels, reinforcing WHO recommendations for DTG-based regimens as preferred second-line treatments.
Bulevirtide Shows Durable Response in Chronic Hepatitis Delta Virus After Treatment Cessation
• Final data from Gilead's Phase 3 MYR301 study reveals 36% of chronic HDV patients maintained virologic suppression for nearly two years after stopping bulevirtide treatment.
• Notably, 90% of patients who achieved undetectable HDV RNA for ≥96 weeks during treatment remained virus-free after discontinuation, with no relapses occurring in the second year of follow-up.
• The findings, presented at EASL Congress 2025, demonstrate bulevirtide's potential as the first effective monotherapy for chronic HDV that maintains benefits even after treatment ends.
Sylvester Comprehensive Cancer Center to Present Groundbreaking Research at ASCO 2025 Annual Meeting
• Researchers from Sylvester Comprehensive Cancer Center will deliver 9 oral presentations, 4 rapid oral presentations, and 51 poster presentations at the upcoming ASCO 2025 Annual Meeting, showcasing significant advances across multiple cancer types.
• Highlighted studies include the ADVANCE clinical trial examining novel multiple myeloma treatments, innovative virtual reality interventions for stem cell transplant patients, and groundbreaking research on alcohol-related cancer mortality in the US.
• The extensive research portfolio demonstrates Sylvester's leadership in developing cutting-edge cancer therapies, addressing health disparities, and improving supportive care for diverse patient populations.
RedHill's Opaganib Shows Promise for Weight Loss and Diabetes, Potentially Disrupting $100B Market
• New research published in Diabetes, Metabolic Syndrome and Obesity demonstrates opaganib's effectiveness in promoting weight loss and improving glucose tolerance in preclinical models, comparable to semaglutide.
• Opaganib, a first-in-class oral sphingosine kinase-2 inhibitor, offers a novel non-peptide approach that could avoid common GLP-1 inhibitor side effects while targeting multiple metabolic pathways.
• With existing human safety data from over 470 subjects across several clinical programs, opaganib may have a de-risked regulatory pathway as RedHill Biopharma positions it to compete in the rapidly growing obesity-diabetes market.
Sanofi Advances Respiratory Pipeline with Promising Amlitelimab Data in Heterogeneous Inflammatory Asthma
• Sanofi's amlitelimab demonstrated clinically meaningful efficacy in heterogeneous inflammatory asthma, showing over 70% reduction in exacerbations in patients with specific biomarkers at week 60 of the TIDE-Asthma phase 2 study.
• The company is expanding its respiratory portfolio with lunsekimig now targeting chronic rhinosinusitis and COPD alongside asthma, with phase 2 readouts anticipated in 2026.
• Itepekimab, developed in partnership with Regeneron, is broadening its clinical program beyond COPD into chronic rhinosinusitis, with phase 3 readouts in COPD expected in H2 2025.
ViiV Healthcare Showcases Long-Acting HIV Innovations and Pipeline Advances at CROI 2025
• Real-world data presented at CROI 2025 demonstrates zero HIV acquisitions and high persistence with Apretude (cabotegravir LA) for PrEP across diverse populations, reinforcing its effectiveness in HIV prevention.
• Long-term follow-up data from multiple studies confirms the sustained efficacy and safety of Cabenuva (cabotegravir + rilpivirine LA) as a complete treatment regimen for people living with HIV.
• Late-breaking phase IIb data reveals promising results for an investigational broadly neutralizing antibody (VH3810109) in combination with cabotegravir LA, potentially expanding long-acting treatment options.
PADCEV-KEYTRUDA Combination Shows Sustained Survival Benefit in Advanced Urothelial Cancer Trial
• Phase 3 EV-302 trial demonstrates PADCEV plus KEYTRUDA reduces mortality risk by 49% compared to chemotherapy in advanced urothelial cancer patients, with median overall survival of 33.8 months versus 15.9 months.
• The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk.
• Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.
RedHill and Bayer Launch Phase 2 Trial Combining Opaganib with Darolutamide for Advanced Prostate Cancer
• RedHill Biopharma initiates an 80-patient Phase 2 study testing opaganib in combination with Bayer's darolutamide for metastatic castrate-resistant prostate cancer, with financial backing from Bayer and Ramsay Hospital Research Foundation.
• The study will utilize a novel PCPro biomarker test to identify patients with poor prognosis who may benefit from the combination therapy, with the primary endpoint being 12-month radiographic progression-free survival.
• Prostate cancer affects approximately 1.5 million new patients annually worldwide, with the study targeting a significant unmet need in the $12 billion market for patients who develop resistance to standard treatments.
Health Disparities in HIV Care: New Study Reveals Critical Gaps and Strategies for Improving Access
• Despite effective antiretroviral therapy availability, only 66% of people with HIV received care and 57% achieved viral suppression in 2022, highlighting significant treatment gaps.
• Black/African American, Hispanic/Latinx, and transgender individuals face disproportionate HIV burden due to social determinants of health and structural barriers to care.
• Early initiation of antiretroviral therapy and simplified treatment regimens show improved outcomes, with single-tablet regimens leading to better viral suppression rates than multi-tablet options.
Bioxodes Advances BIOX-101 for Intracerebral Hemorrhage Treatment with New Funding and Clinical Milestones
• Bioxodes secured €2.7 million in Series A extension funding to advance BIOX-101, a novel therapy for intracerebral hemorrhage (ICH).
• The funding supports the completion of the BIRCH Phase 2a trial and preparations for a Phase 2b trial of BIOX-101 in ICH.
• Interim data from the BIRCH Phase 2a trial, evaluating BIOX-101 in ICH patients, is expected in Q1 2025.
• BIOX-101, derived from tick saliva, aims to reduce secondary brain injuries post-hemorrhagic stroke by preventing clot formation and neuroinflammation.
Global Biotechnology Market Projected to Reach USD 3.54 Trillion by 2033, Driven by Therapeutic Innovations
• The global biotechnology market is expected to grow from USD 1.68 trillion in 2024 to USD 3.54 trillion by 2033, representing a CAGR of 9.18%, according to Cervicorn Consulting.
• Red biotechnology, focused on medical applications, is projected to reach USD 649.31 billion by 2033, with monoclonal antibodies dominating the product segment.
• North America leads the global biotechnology market with the highest market share, while Asia Pacific is experiencing the fastest growth due to increasing investments and government support.
BriaCell's Bria-OTS Shows Promise in Metastatic Breast Cancer with Lung Metastasis Resolution
• BriaCell's Bria-OTS, a personalized off-the-shelf immunotherapy, demonstrated resolution of lung metastasis in a metastatic breast cancer patient after just two months of monotherapy.
• The Phase 1/2a dose escalation study (NCT06471673) evaluates Bria-OTS in patients with metastatic recurrent breast cancer who have failed at least two prior systemic therapies.
• The 78-year-old patient, who had hormone receptor-positive, HER2-negative breast cancer, experienced no toxicity related to the Bria-OTS treatment and remains in the study.
• BriaCell plans to expand the evaluation of Bria-OTS, including in combination with immune checkpoint inhibitors, to other cancers like prostate cancer, melanoma, and lung cancer.
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