Clinical Trials - August 6, 2024
Diamyd Medical announces positive interim analysis results
Diamyd Medical has announced a successful interim analysis (non-futility test) for its ongoing precision medicine Phase 3 DIAGNODE-3 trial. The interim analysis, reviewed by an independent Data Safety Monitoring Board (DSMB), resulted in a favorable recommendation to continue the trial without any modifications. “We are extremely pleased with the DSMB’s recommendation to continue the DIAGNODE-3 […]
Clinical Trials - July 5, 2024
Medivir presents promising results
Medivir has presented new data from its ongoing phase Ib/IIa study of fostroxacitabine bralpamide (fostrox) + Lenvima in advanced hepatocellular carcinoma (HCC) at the European Society of Medical Oncology, Gastrointestinal Cancers Cancers Congress in Munich, Germany. The data shows an overall response rate (ORR) of 24%, with a disease control rate (DCR) of 81%, while […]
Clinical Trials - July 4, 2024
Alligator Bioscience presents new data
Alligator Bioscience has announced positive 18-month follow-up data from the OPTIMIZE-1 Phase 2 study of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naïve pancreatic cancer […]
Clinical Trials - May 27, 2024
Alligator Bioscience to present positive Phase 2 data
Data presented at ASCO from the OPTIMIZE-1 study, of mitazalimab in combination with mFOLFIRINOX chemotherapy, showed that pharmacological analyses identified mitazalimab-induced expansion of CD4 effector T cells one week after first administration as a correlate of treatment outcomes. Alligator Bioscience has announced that two clinical abstracts on its lead drug candidate mitazalimab, a CD40 agonist, […]
Clinical Trials - May 24, 2024
Medivir’s licensee discontinues development of clinical program
Medivir’s licensee Tango Therapeutics has announced that the phase 1/2 clinical trial of TNG348, a novel USP1 inhibitor, is being terminated due to toxicity observed in the initial study cohorts. TNG348 is a novel USP1 (ubiquitin-specific protease 1) inhibitor, for the treatment of BRCA1/2-mutant and other homologous recombination deficiency (HRD)+ cancers, and has been developed […]
Clinical Trials - May 21, 2024
Henlius Biotech receives FDA IND Clearance for Phase 3 Initiation
Alligator Bioscience’s has announced that Shanghai Henlius Biotech has received Investigational New Drug (IND) clearance from the FDA to initiate a Phase 3 study to evaluate HLX22 in combination with trastuzumab and chemotherapy in 1st line HER2-positive advanced gastric cancer patients. HLX22 (AC101) is a monoclonal anti-HER2-antibody, which was out-licensed by Alligator to the South […]