SK Bioscience Co. Ltd. of Seongnam-si, South Korea, gained the World Health Organization’s (WHO) prequalification certification for typhoid conjugate vaccine, Skytyphoid (NBP-618), on Feb. 23. Skytyphoid conjugates a polysaccharide of typhoid bacteria, which serves as an antigen, to a diphtheria toxin protein called diphtheria toxoid that acts as a carrier.
With the number of people with dementia in Australia expected to nearly double by 2054, the federal government is funding a new AU$50 million (US$32.76 million) biomedical and med-tech incubator program to develop new therapies, medical devices and digital health technologies to address dementia and cognitive decline.
Korean neurodegenerative disease-focused Aribio Co. Ltd. gained the U.K.’s regulatory clearance to start the phase III Polaris-AD trial on AR-1001 (mirodenafil), an investigative therapy for early Alzheimer’s disease (AD). The U.K.’s Medicines and Healthcare products Regulatory Agency gave notice of acceptance to Seoul, South Korea- and San Diego-based Aribio for the clinical study on Feb. 21 after “confirming a favorable ethical opinion,” Aribio said. AR-1001 is an oral phosphodiesterase-5 inhibitor under development to treat early AD.
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.
In a surprise reveal that propelled stocks by 25%, Alteogen Inc., of Daejeon, South Korea, named MSD International Business GmbH as its counterpart in a near-$4 billion technology transfer agreement inked in 2020, while upping terms of the deal.
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.
CSL Ltd. will review the data further to see if there is a path forward for CSL-112 (human apolipoprotein A-I) after the phase III AEGIS-II trial failed to meet the primary efficacy endpoint in reducing the risk of major adverse cardiovascular events in patients following an acute heart attack.
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.
South Korean biopharmaceutical firm GNT Pharma Co. Ltd. on Feb. 13 reported positive findings from a domestic phase III trial of its neuroprotectant therapy, nelonemdaz (NEU-2000), for patients with acute ischemic stroke.