Iovance Biotherapeutics Inc. has received IND clearance from the FDA for IOV-5001, a next-generation interleukin-12 (IL-12)-tethered tumor-infiltrating lymphocyte (TIL) therapy.
Laverock Therapeutics Ltd. has been awarded two new grants totaling in excess of £2.2 million (US$3 million) to support the next generation of its gene-control platform development, and expansion into additional nononcology therapeutics areas.
Ichnos Glenmark Innovation Inc. has announced a new development candidate, ISB-2301, a potentially first-in-class, multispecific immune cell activator for the potential treatment of multiple solid tumor indications. ISB-2301 is a multispecific antibody that targets three tumor-associated antigens to trigger tumor cell death and engages both T and NK cells to activate the immune system. Leveraging the company’s BEAT technology, ISB-2301 is designed to induce potent antibody-dependent cellular cytotoxicity, checkpoint inhibition and a sustained type 1 immune response.
Mekanistic Therapeutics Inc. has obtained IND clearance from the FDA for MTX-531, the company’s lead oncology candidate. A phase I study will be conducted in patients with advanced solid tumors characterized by dysregulated EGFR and/or PI3K signaling, including head and neck and endometrial cancers. Dosing is expected to begin in the third quarter.
China’s National Medical Products Administration (NMPA) has granted clinical trial clearance to SYH-2095 tablets, a novel lysine acetyltransferase 6 (KAT6) inhibitor codeveloped by CSPC Pharmaceutical Group Ltd. and Hangzhou Innogate Pharma Co. Ltd. for the treatment of advanced malignant tumors. SYH-2095 received IND clearance in the U.S. last month.
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.
HEC Pharma Co. Ltd. recently presented HEC-201625, a small-molecule PD-L1 inhibitor for cancer immunotherapy that blocks the PD-1/PD-L1 signaling pathway. HEC-201625 was tested in vitro and in vivo in MC38 syngeneic murine model, as well as in xenograft A375 and NCI-H358 models.
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.
