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).
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).
Shattuck Labs Inc. has reported that its IND from the U.S. FDA for SL-325 for the treatment of inflammatory bowel disease is now in effect. The company expects to commence a phase I trial in healthy volunteers in the third quarter of this year.
One of the major obstacles to treating neurological disorders such as Alzheimer’s disease is the blood-brain barrier: drugs that are injected into the circulation usually do not enter the brain effectively. Researchers at Denali Therapeutics Inc., Biogen Inc. and the University of Minnesota have devised a vehicle for transporting antibodies against amyloid-β that can bypass the blood-brain barrier by binding to the transferrin receptor, which is expressed much more abundantly in capillaries than in arteries.
“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.”
Mabylon AG has raised a total of CHF30 million (US$37 million) to advance its pipeline and support its work using human-derived, multi-specific antibodies for the treatment of allergies. The funding combines equity investment and a convertible loan.
Casi Pharmaceuticals Inc. announced the U.S. FDA has cleared its IND application for CID-103, a monoclonal antibody targeting CD-38 for the prevention of antibody-mediated rejection (AMR) of kidney allografts. The company plans to initiate a phase I study in adults with active and chronic active renal allograft AMR.
GSK plc scientists have presented findings from studies on the therapeutic potential of GSK-5862611, an anti-Sortilin antibody, in addressing neurodegenerative disease mechanisms linked to the TDP43 G298S mutation.
Immunitas Therapeutics Inc. has revealed preclinical data supporting development of its potentially first-in-class, fully human anti-CD161 antibody, IMT-380. CD161-expressing T-cell subsets have been implicated in autoimmune diseases due to their production of inflammatory cytokines and presence in inflamed tissues.
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