Shanghai Henlius Biotech Inc.’s HLX-48 for injection has received approval from the Human Research Ethics Committee (HREC) in Australia and been acknowledged by the Therapeutic Goods Administration (TGA). The first-in-human phase I study in Australia will evaluate HLX-48 in patients with advanced or metastatic solid tumors.
Fractyl Health Inc. has received clinical trial application authorization in the Netherlands to initiate a first-in-human phase I/II study of RJVA-001, the first clinical candidate from the company’s Rejuva Smart GLP-1 gene therapy platform.
Harbour Biomed has gained IND clearance from the FDA for HBM-7004, enabling the initiation of a first-in-human phase I trial in subjects with advanced solid tumors.
Arrivent Biopharma Inc. has obtained IND clearance from the FDA for ARR-002 (AV-P138-ADC), an antibody-drug conjugate (ADC) with an initial focus in ovarian and endometrial cancers and broader therapeutic potential across solid tumors. A phase I trial is expected to open in the second half of the year.
Beijing Innocare Pharma Tech Co. Ltd. has received IND approval from China’s National Medical Products Administration (NMPA) for ICP-B208, an antibody-drug conjugate targeting CDH17, which is highly expressed in gastrointestinal cancers, including colorectal, gastric and biliary tract cancers and pancreatic ductal adenocarcinoma.
Simcere Zaiming Pharmaceutical Co. Ltd.’s SIM-0613 for injection has received clinical trial approval from China’s National Medical Products Administration (NMPA), enabling initiation of a clinical trial for advanced solid tumors.
Laguna Biotherapeutics Inc. has obtained IND clearance from the FDA for its cancer immunotherapeutic LGNA-100 (QUAIL-100). The planned first-in-human phase I study will evaluate LGNA-100 in pediatric and young adult participants with high-risk acute leukemias and myelodysplastic syndromes following αβ-depleted hematopoietic stem cell transplantation (HSCT) to prevent leukemic relapse.
Taiho Oncology Inc., Taiho Pharmaceutical Co. Ltd. and Araris Biotech AG have announced completion by the FDA of the IND review period for ARC-02, enabling initiation of a phase I trial by Taiho Oncology.
Naturecell Co. Ltd.’s U.S. subsidiary, Naturecell America, has received IND clearance from the FDA for Astrostem-AU, an autologous adipose-derived mesenchymal stem cell therapy for adults with autism spectrum disorder (ASD).
RSS
