Les Laboratoires Servier SAS is touting its phase III win with vorasidenib as the first major advance in decades for low-grade glioma, with the trial called Indigo scoring statistical significance on two measures against residual or recurrent isocitrate dehydrogenase-mutant disease. The Suresnes, France-based firm said Indigo met the primary endpoint of progression-free survival (PFS) and the key secondary endpoint of time to next intervention (TTNI). The results of the prespecified interim analysis proved not only statistically significant but also clinically meaningful in PFS and TTNI.
China’s NMPA approved Shanghai Shengdi Pharmaceutical Co. Ltd.’s adebrelimab (SHR-1316) for first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy. The approval in mainland China makes adebrelimab the third domestic PD-L1 monoclonal antibody to make it to the domestic market. Shanghai Shengdi is a subsidiary of Jiangsu Hengrui Medicine Co. Ltd.
Pfizer Inc.’s appetite for acquisitions shows no signs of abating as it announced this morning its plan to acquire biotech Seagen Inc. for a whopping $43 billion in a move that will double the size of its early stage oncology pipeline. Under the deal, unanimously approved by the boards of directors of both firms, Pfizer will pay Seagen $229 per share. Bothell, Wash.-based Seagen expects to amass $2.2 billion in revenue in 2023, representing 12% year-on-year-growth, royalties and collaboration and license agreements from its four, FDA-approved products for the treatment of solid tumors and hematologic malignancies, antibody-drug conjugate drugs Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin) and Tivdak (tisotumab vedotin), and tyrosin kinase inhibitor Tukysa (tucatinib).
A deficiency in fumarate metabolism could be behind a new mechanism of inflammation mediated by mitochondrial DNA and RNA. Two independent and simultaneous studies described how the accumulation of fumarate in the mitochondria released the genetic material of this organelle through vesicles, activating an inflammatory signaling pathway.
Zhejiang Medicine Co. Ltd.’s subsidiary, Novocodex Biopharmaceuticals Inc., reported positive phase III study results for its humanized anti-HER2 monoclonal antibody-drug conjugate, ARX-788, in the treatment of patients with HER2-positive locally advanced or metastatic breast cancer in China.
Top-line results of a phase II study of RXC-004, a porcupine inhibitor for treating certain Wnt ligand-dependent cancers, are not good enough to continue development as a monotherapy for biliary tract cancer, according to Redx Pharma plc. Despite the monotherapy arm not hitting progression-free survival at six months, the Porcupine2 study continues with its other treatment arm, this one using Keytruda (pembrolizumab, Merck & Co. Inc.). Data from that arm are set to come in the second half of 2023.
Whether as primary tumors or metastases, brain tumors remain stubbornly intractable to the progress that has occurred in many other tumor types. As Igor Vivanco, who is a senior lecturer in the Institute of Pharmaceutical Science at King’s College London, noted in his talk at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) meeting in Paris this week, the last win in glioblastoma was the addition of temozolomide to the radiotherapy standard of care in 2005. And temozolomide’s benefit is measured in months, not years.
Findings published in Nature showing that dual blockage of PD-L1 and CD47 can boost the therapeutic effects of oxaliplatin chemotherapy as well as the FOLFOX regimen – in a CT-26 mice tumor model, anyway – served to highlight CD47, a target that has spurred added efforts of late.
Immorna Biotechnology Co. Ltd. raised nearly $100 million in series A+ and A++ financing rounds to speed up the clinical development and commercialization of its RNA-based therapeutics. Founded in 2019, Immorna develops therapeutics and vaccines based on its RNA platforms, including conventional, self-replicating and circular RNA.
Abbisko Therapeutics Co. Ltd. and Allist Pharmaceuticals Co. Ltd. signed an exclusive licensing deal that gives Allist rights to develop, manufacture and commercialize Abbisko’s ABK-3376, an EGFR tyrosine kinase inhibitor for $188 million plus royalties.