Clinical Trial News

Ipsen announced final CABINET Phase III trial data showing Cabometyx® (cabozantinib) significantly reduced disease progression or death risk in advanced pancreatic and extra-pancreatic neuroendocrine tumors (NETs) versus placebo, presented at ESMO 2024 and published in NEJM. Ipsen has submitted an extension of indication Marketing Authorization to the European Medicines Agency.

Clene Inc. secured an in-person meeting with senior FDA leadership to discuss CNM-Au8 for ALS, presenting biomarker, clinical endpoint, and survival data. The company has over 700 patient-years of safety data for CNM-Au8 with no significant concerns.

China's NMPA grants GSK's Blenrep breakthrough therapy designation for relapsed or refractory multiple myeloma treatment, based on Phase III DREAMM-7 trial results showing significant PFS improvements.

Velsera's tumor profiling tech supports Illumina's FDA-approved TruSight™ Oncology Comprehensive IVD, enhancing personalized cancer treatment.

Mizuho maintains Neutral rating on Apellis Pharmaceuticals with $42.00 price target, as EMA's CHMP to review pegcetacoplan approval. Despite 39% stock decline YTD, caution advised due to 10% approval probability. Apellis's Phase 3 VALIANT trial success and Q2 2024 revenue growth highlight potential, though profitability remains uncertain.

HighField Biopharmaceuticals presented positive safety and efficacy findings from its Phase 1 study of HF1K16 (K16), targeting myeloid-derived suppressor cells (MDSCs), at the ESMO Congress 2024. The study showed significant immune modulation and efficacy, with several R/R glioma patients surviving over 2 years.

Bio-Path Holdings announces publication in 'Biomedicines' on BP1003's broad anti-tumor effect in solid tumors like breast, ovarian, and pancreatic cancer. BP1003 targets STAT3 mRNA, enhancing stability and cellular uptake, potentially improving chemotherapy efficacy in various cancers.

Dose 1 of PBFT02 in upliFT-D trial for FTD-GRN achieved robust CSF progranulin levels, sustained up to 12 months, and was well-tolerated with revised immunosuppression. Updated data to be presented at ISFTD2024.

TNG462, a PRMT5 inhibitor by Tango Therapeutics, is in Ph. I/II trial for MTAP-deleted solid tumors, designed to bind with MTA in these tumors, causing synthetic lethality. A CNS-permeable analogue, TNG908, is also being tested for MTAP-deleted glioblastoma.

Roche’s Tecentriq Hybreza, a subcutaneous PD-L1 inhibitor, approved by the FDA for multiple cancer types, offering a 7-minute injection compared to 30-60 min IV infusion. The SC formulation, combining Tecentriq with Halozyme’s Enhanze technology, is the first and only SC anti-PD-L1 immunotherapy in the US, applicable to all adult indications of IV Tecentriq. Phase 1b/3 study results showed comparable efficacy and safety profiles, with 71% of patients preferring Tecentriq Hybreza for its quicker administration and reduced clinic time.