An international team of researchers has created two bat stem cell lines that reveal an unusual number of viral sequences in bat cells compared with those of other mammals. Writing in an article posted online Feb. 21, 2023, in Cell, the scientists suggested that the unusual amount of viral genetic material found in the bat stem cells could explain why these mammals are largely unaffected by most viral infections, despite being able to transmit them.
While still pending clearance in the U.S., Medtronic plc’s Minimed 780G advanced hybrid closed loop (AHCL) system continues to post strong results in clinical trials. Results of two studies presented at the 2023 Advanced Technologies & Treatments for Diabetes Conference in Berlin on Feb. 27 demonstrated that patients with type 1 diabetes (T1D) who used the device for one year maintained a 26.7% increase in time in range for adults and a 14% increase in time in range for children aged 7 to 17 compared to their baseline using multiple daily injections with a continuous glucose monitor (CGM).
Once-monthly subcutaneous injections of CSL Ltd.’s CSL-312 (garadacimab) significantly reduced the rate of hereditary angioedema (HAE) attacks compared to placebo, meeting both primary and secondary endpoints in the pivotal phase III Vanguard trial. Based on the trial results, CSL will file global regulatory submissions later in 2023.
Biocryst Pharmaceuticals Inc.’s unveiling of real-world data Feb. 24 with its approved Orladeyo (berotralstat) for prophylactic treatment of hereditary angioedema (HAE) brought more attention to the space, due to yield findings from would-be competitors in the near term.
Nektar Therapeutics Inc. President and CEO Howard Robin didn’t mince words during a call with investors after market close Feb. 23 to disclose top-line data from a phase II study testing rezpegaldesleukin (rezpeg) in systemic lupus erythematosus, which fell short of partner Eli Lilly and Co.’s criteria for advancing to phase III and raised uncertainty as to how the big pharma might proceed in other indications such as atopic dermatitis (AD).
Esophageal cancer is often referred to as the “silent killer” because few people show any symptoms until after the cancer has spread. If localized, five-year survival rate is 46%, but that drops to just 5% when malignancy has reached distant parts of the body.
The positive opinion Jan. 27 from the EMA’s Committee for Medicinal Products for Human Use regarding Reblozyl (luspatercept) from Bristol Myers Squibb Co. to treat adults with non‑transfusion-dependent beta-thalassemia marked an advance in the space, where several developers are jockeying for position. Reblozyl, a first-in-class erythroid maturation agent, was first approved in November 2019 in the hands of Celgene Corp., acquired by Princeton, N.J.-based BMS the same year.
The other shoe dropped in a good way for backers of Actinium Pharmaceuticals Inc. as the firm popped the lid off full data from the phase III study called Sierra testing Iomab-B in patients age 55 and older with active relapsed or refractory acute myeloid leukemia (r/r AML). Antibody radiation conjugate (ARC) Iomab-B met the primary endpoint of durable complete remission of six months following initial complete remission after bone-marrow transplant with a high degree of statistical significance.
Bridge Biotherapeutics Inc.’s small-molecule Pellino-1 inhibitor, BBT-401, failed to meet the primary efficacy endpoint in a phase II trial in ulcerative colitis (UC). The phase II mid-to-high dose cohort study included 38 patients with active UC enrolled at 37 clinical sites across the U.S., New Zealand, South Korea, Poland and Ukraine.
Ascletis Pharma Inc. presented subgroup data from a phase II trial showing its subcutaneous PD-L1 antibody envafolimab (ASC-22) was able to functionally cure chronic hepatitis B, according to hepatitis B surface antigen decline following 24-week treatment.
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