Positive data from Novo Nordisk A/S’s pivotal phase IIIa study of once-weekly and once-monthly doses of its hemophilia treatment, Mim8, are prompting the company to say it will submit the first regulatory approval request toward the end of this year. It could challenge Roche Holding AG’s Hemlibra (emicizumab), a bispecific factor IXa- and factor X-directed antibody for hemophilia A, that was approved in 2017 by the U.S. FDA.
Citing a high rate of patients leaving the study, Merck & Co. Inc. has discontinued the anti-TIGIT antibody vibostolimab and the anti-PD-1 Keytruda (pembrolizumab) portion of it phase III Keyvibe-10 trial as an adjuvant treatment for those with resected high-risk melanoma.
Eluminex Biosciences Ltd. has presented results from preclinical studies of EB-105, a humanized trispecific antibody targeting IL-6 receptor (IL-6R), vascular endothelial growth factors (VEGFs) and angiopoietin-2 (Ang-2) for the treatment of diabetic macular edema.
The bifunctional antibody approach continues to pay off for Zenas Biopharma Inc., which banked an upsized $200 million series C preferred stock financing led by SR One along with NEA, Norwest Venture Partners and Delos Capital. Enavate Sciences and Longitude Capital participated significantly as well.
“A white space opportunity.” That’s how Enlaza Therapeutics Inc. co-founder and CEO Sergio Duron described to BioWorld the company’s efforts to develop the first covalent biologics, an endeavor that has gained the backing of an impressive group of investors in a recently closed $100 million series A round.
Eluminex Biosciences Ltd. announced the FDA’s acceptance of their IND application for EB-105, a trispecific fusion antibody targeting vascular endothelial growth factor A (VEGF-A, and isomers), VEGF-B, placental growth factor (PlGF), angiopoietin-2 (Ang-2) and interleukin-6 receptor (IL-6R) for the treatment of diabetic macular edema (DME).
“A white space opportunity.” That’s how Enlaza Therapeutics Inc. co-founder and CEO Sergio Duron described to BioWorld the company’s efforts to develop the first covalent biologics, an endeavor that has gained the backing of an impressive group of investors in a recently closed $100 million series A round.
Biolojic Design Ltd. announced that Nektar Therapeutics Inc. has exercised its license option to develop a program resulting from the companies’ 2021 research collaboration, established to design and test agonistic antibodies targeting tumor necrosis factor receptor type II (TNFR2).
China’s National Medical Products Administration has cleared Immuneonco Biopharmaceuticals Co. Ltd.’s’ IMM-01 (timdarpacept) to enter a pivotal phase III trial in combination with Beigene Co. Ltd.’s PD-1 inhibitor, tislelizumab, in relapsed or refractory classical Hodgkin lymphoma patients who relapsed or progressed after treatment with PD-1 inhibitors.
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