Alpheus Medical announces positive phase 1/2 trial results for the treatment of recurrent high-grade gliomas
- Alpheus Medical's Phase 1/2 trial showed doubled median overall survival and tripled progression-free survival in recurrent high-grade gliomas.
- The sonodynamic therapy (SDT) platform uses low-intensity diffuse ultrasound and oral 5-aminolevulinic acid to target cancer cells.
- The trial reported no treatment-related deaths or serious adverse events, highlighting a strong safety profile.
- Plans are underway to initiate a randomized, controlled trial across multiple U.S. centers in 2025.
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IN8bio reports continued durable remissions in phase 1 trial of INB-200
- 50% of patients receiving repeated doses of INB-200 remained in remission beyond the expected median overall survival.
- Biopsy results confirmed the presence of gamma-delta T cells in the brain tumor microenvironment.
- No treatment-related serious adverse events were reported, indicating a well-tolerated safety profile.
- The trial suggests potential immune system benefits and improved progression-free survival for glioblastoma patients.
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HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals complete first-in-human study for Parkinson's therapy
- HL192 (ATH-399A) was well tolerated with no major safety issues in 76 participants.
- The Phase 1 study met its primary endpoints of safety and tolerability across 5 dose groups.
- The study included single ascending dose, multiple ascending dose, and food effect components.
- Next steps involve initiating a clinical trial in Parkinson's patients to further evaluate safety.
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J INTS BIO and MD Anderson collaborate on brain tumor treatment 'JIN-001'
- J INTS BIO and MD Anderson Cancer Center are collaborating on 'JIN-001', a treatment targeting glioblastoma (GBM) cells.
- JIN-001 enhances the efficacy of radiation and chemotherapy by crossing the blood-brain barrier, a significant challenge in brain tumor treatment.
- The treatment showed promising results in combination with standard therapies, suppressing tumor growth and inducing apoptosis.
- J INTS BIO plans to accelerate preclinical trials and explore commercialization through global partnerships.
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Alnylam's sNDA for vutrisiran accepted by FDA for ATTR amyloidosis with cardiomyopathy
- The FDA has accepted Alnylam's supplemental New Drug Application (sNDA) for vutrisiran, targeting ATTR amyloidosis with cardiomyopathy.
- A Priority Review Voucher was used, setting the FDA action date for March 23, 2025.
- The application is based on positive results from the HELIOS-B Phase 3 study, showing improved cardiovascular outcomes and quality of life.
- If approved, vutrisiran would be the first U.S. therapeutic for both polyneuropathy and cardiomyopathy manifestations of ATTR amyloidosis.
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