Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).
Summit Therapeutics Inc.’s presentation for bispecific antibody ivonescimab in non-small-cell lung cancer could draw some extra attention at next month’s World Conference on Lung Cancer meeting thanks to promising overall survival data from partner Akeso Pharmaceuticals Inc.’s China study of the PD-1/VEGF candidate.
Beone Medicines Ltd. (formerly Beigene Ltd.) is selling its worldwide royalty rights on Imdelltra (tarlatamab) sales, excluding China, to Royalty Pharma for up to $950 million.
Generative AI drug discovery company Vantai Inc. could bring in more than $1 billion in a new collaboration with Halda Therapeutics Inc. Vantai already has collaborations with other companies, including Bristol Myers Squibb Co. (BMS), Janssen Pharmaceutica and Blueprint Medicines Corp.
Avixgen Co. Ltd., a subsidiary of Dx&Vx Co. Ltd., inked a $360 million license agreement with an unidentified U.S.-based biotechnology company, granting the latter rights to its advanced cell penetrating (ACP) peptide drug delivery platform.
With the trial sites now open for its CRISPR-edited T-cell receptor immunotherapy trial, Anocca AB has raised SEK440 million (US$46 million) to fund the phase I part of the multicenter study to completion. The company’s engineered T-cell receptor T-cell therapy (TCR-T) is first being tested against KRAS mutations in pancreatic cancer.
“Our mission is to apply our protein-protein interaction (PPI) big data-generation platform to create novel antibody therapeutics,” Proteina Co. Ltd. CEO Yoon Tae-young recently told BioWorld. “We have been working to build a proprietary technology platform for more than 15 years,” Yoon said, “and we take pride in the fact that we made our own technology platform, instead of running a company based on licensed-in technology.”
G2Gbio Inc. debuted on the Korea Exchange with a ₩52.2 billion (US$37.7 million) IPO Aug. 14. Nearly half of the funds raised will be used to expand Cheongju-si, South Korea-based G2Gbio’s manufacturing plants and help mass produce sustained-release injectable drug products such as GB-5001, its lead candidate in development as a once-monthly formulation of donepezil (Aricept; Eisai Co. Ltd.) for Alzheimer’s disease.
With a packed pipeline of drug candidates targeting multiple markers of cancer, Bayer AG signed on for a new project, this time going after the KRAS pathway with a global deal that could bring Kumquat Biosciences Inc. up to $1.3 billion in payments.
Experimental drugs that directly inhibit the NSD2 enzyme have shown potential as an effective strategy against hard-to-treat cancers, such as lung and pancreatic tumors driven by KRAS mutations. The therapeutic mechanism involves reversing a histone H3 methylation that promotes open chromatin and the expression of oncogenes.