Kazia Therapeutics Ltd. stopped its two-part paxalisib plus radiotherapy phase I trial early based on positive safety and promising clinical responses in patients with phosphoinositide 3-kinase pathway mutation brain metastases from solid tumors. The company plans to meet with the U.S. FDA to discuss a pivotal registrational trial.
Global interest in radiopharmaceuticals is soaring, and the global radiopharma market is expected to grow 10% over the next decade to $13.67 billion by 2032, according to a new report by Precedence Research.
San Francisco-based Xyphos Biosciences Inc. is pooling technology platforms with Boston’s Kelonia Therapeutics Inc. in a novel immuno-oncology (I-O) drug discovery deal that could fetch more than $800 million. Xyphos and Kelonia will collaborate to develop a maximum of two in vivo CAR T-cell therapy programs, utilizing both Kelonia’s in vivo gene placement system called iGPS and Xyphos’ Accel technology platform.
Ono Pharmaceutical Co. Ltd. inked deals with Shattuck Labs Inc. and Numab Therapeutics AG aimed at bolstering its pipeline in oncology and autoimmune and inflammatory diseases. Ono struck a drug discovery collaboration and option agreement with Shattuck Labs to generate bifunctional fusion proteins for pathways involved in autoimmune and inflammatory diseases. It also signed a global research, development and commercialization deal with Numab for its NM-49, a multispecific antibody designed to activate tumor-associated macrophage phagocytosis for treating cancers.
Hong Kong’s Hutchmed (China) Ltd. reported mixed phase III results of fruquintinib as a second-line combination therapy for advanced gastric cancer on Feb. 6, with the oral vascular endothelial growth factor receptor inhibitor hitting just one co-primary endpoint.
The U.S. FDA has accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan (dato-dxd) to treat adults with locally advanced or metastatic nonsquamous non-small-cell lung cancer who have received prior systemic therapy.
Taipei-based precision oncology firm Anbogen Therapeutics Inc. drew $12.5 million in a series A funding round to propel two major clinical assets in its cancer pipeline.
Biontech SE and Duality Biologics Co. Ltd. have progressed BNT-323/DB-1303 to pivotal phase III trials, beginning in China in patients with hormone receptor-positive and HER2-low metastatic breast cancer.
As gene therapies gain unprecedented traction into 2024, preclinical-stage South Korean biotech Genecraft Inc. said it raised ₩10 billion (US$7.48 million) in a series A financing to further R&D for its therapy against lung cancer.
Axelia Oncology Pty Ltd. was spun out of Ena Respiratory Pty. Ltd., which developed a series of synthetic Toll-like receptor (TLR) 2/6 agonists for nasal delivery to treat respiratory infections, including influenza and SARS-CoV-2. Although the pegylated TLR 2/6 agonist, INNA-051, was initially focused on antiviral activity, the company discovered that it also worked in oncology models, and Axelia was spun out to focus on oncology, CEO Phil Kearney told BioWorld.