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The 10-year update to Medtronic plc’s ENGAGE registry for its Endurant abdominal aortic aneurysm (AAA) stent graft system demonstrated high degrees of protection from aneurysm and sac regression in a real-world setting. The results were presented at the 2023 Charing Cross Symposium in London on April 26.
The long-anticipated top-line phase IIa study results for Morphic Therapeutic Inc.’s oral alpha 4 beta 7 integrin inhibitor, MORF-057, have surpassed even the company’s own expectations, with a significant decline in disease activity seen in moderate to severe ulcerative colitis (UC) patients combined with a safety profile consistent with phase I findings.
Shanghai Junshi Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody toripalimab showed positive interim event-free survival (EFS) results in a phase III study to treat patients with resectable non-small-cell lung cancer (NSCLC). This is the world’s first phase III trial that shows perioperative treatment with an anti-PD-1 monoclonal antibody significantly extends EFS of patients with resectable NSCLC, according to Shanghai-based Junshi Biosciences.
The data are early and from only seven evaluable patients, but results from In8bio Inc.’s phase I study of gamma-delta T-cell therapy INB-100 in leukemia patients who have undergone haploidentical hematopoietic stem cell transplant, presented at the European Society for Blood and Marrow Transplantation meeting, were compelling enough to drive the company’s shares (NASDAQ:INAB) up 183% April 24.
Shanghai Junshi Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody toripalimab showed positive interim event-free survival (EFS) results in a phase III study to treat patients with resectable non-small-cell lung cancer (NSCLC). This is the world’s first phase III trial that shows perioperative treatment with an anti-PD-1 monoclonal antibody significantly extends EFS of patients with resectable NSCLC, according to Shanghai-based Junshi Biosciences.
Moderna Inc.’s mixed results in mid-February from a trial with its mRNA influenza vaccine served to emphasize the need for a more comprehensive preventer of the still problematic-for-many seasonal bug – a space where Vir Biotechnology Inc. has been busy and is slated to report closely watched phase II data from the study called Peninsula in late spring or early summer of this year.
The U.S. FDA’s green light April 17 for Abbvie Inc. to expand the label of Qulipta (atogepant) – the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist for migraine, with language that includes prevention of such headaches chronically in adults – provided a welcome addition to the arsenal, but sufferers are still waiting for an improved remedy. Vaxxinity Inc. just might have it. And with a vaccine, no less.
As investors await phase II/III data from Gritstone Bio Inc.’s closely watched trial with Granite, an individualized neoantigen vaccine for microsatellite-stable colorectal cancer, Wall Street was busy handicapping odds for firm’s new approach, given the struggles by personalized methods generally.
Final phase II data showing improved survival rates in cervical cancer is giving Nykode Therapeutics ASA even more confidence in taking vaccine candidate VB10.16 further into oncology. The company had been considering targeting head and neck cancer for months. Now, with these new data, it said it’s fully behind focusing on PD-L1 patients with up to one prior line of systemic therapy.
Immuneering Corp.’s positive pharmacokinetic, pharmacodynamic and safety phase I data with universal RAS inhibitor IMM-1-104 let the company move up the timeline for a recommended phase II dose from previous guidance of mid-2024 to early next year.
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