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).
CSPC Pharmaceutical Group Ltd.’s SYS-6051 has gained clinical trial clearance from China’s National Medical Products Administration (NMPA) for advanced solid tumors. SYS-6051 is a human tissue factor-targeted antibody-drug conjugate that binds to tissue factor expressed on the surface of tumor cells.
Mabwell (Shanghai) Bioscience Co. Ltd.’s has announced IND acceptance by China’s National Medical Products Administration (NMPA) for the company’s LILRB4/CD3 T-cell engager bispecific antibody 6MW5311. The drug candidate is being developed for hematologic malignancies, specifically acute myeloid leukemia (AML), chronic myelomonocytic leukemia and multiple myeloma.
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