Biolojic Design Ltd. has reported preclinical data for its antibody-drug conjugate (ADC) BD-200, developed using an AI-guided antibody engineering platform named Multibody.
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.
Atara Biotherapeutics Inc.’s allogeneic T-cell immunotherapy, Ebvallo (tabelecleucel), for Epstein-Barr virus-positive post-transplant lymphoproliferative disease isn’t out of the running yet. Despite grim predictions in the wake of the U.S. FDA’s second complete response letter for the drug in January, Atara and partner Pierre Fabre Pharmaceuticals Inc. reached agreement with the regulator on a path for resubmitting the BLA.
Biosion Inc. recently presented preclinical data describing their B7H3/PD-L1 bispecific antibody-drug conjugate (ADC) BSI-737 for the treatment of cancer.
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.
Solve Therapeutics Inc. has prepared and tested new antibody-drug conjugates (ADCs) comprising a monoclonal antibody targeting trophoblast glycoprotein (TPBG; 5T4) covalently linked to cytotoxic drug and reported to be useful for the treatment of cancer.
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.
Signadori Bio SAS has successfully completed its seed extension financing round, bringing to €11.1 million (US$13 million) the total raised to support its development of a next-generation, off-the-shelf, in vivo-engineered, monocyte immunotherapy platform to treat solid tumors.
Tumors with strong immunosuppressive microenvironments such as microsatellite-stable colorectal cancer (MSS-CRC) remain unresponsive to immune checkpoint blockade therapy, with <20% of gastrointestinal tumors responding to therapy.
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