Shares of Sensei Biotherapeutics Inc. (NASADQ:SNSE) fell 16% to $9.10 on June 29 after an announcement by President and CEO John Celebi that the antigen display technology used in its prior lead candidate, SNS-301, "is suboptimal for use in an active cancer vaccine." A phase I/II trial evaluating it will be discontinued, he said. Now, work on a next-generation vaccine, SNS-401-NG, and the monoclonal antibody SNS-VISTA will take precedence in a portfolio reprioritization at the company, with IND-enabling studies for the anti-VISTA program planned to start by the end of 2021 and for the next-gen vaccine in second half of 2022.
Diamedica Therapeutics Inc.’s chief medical officer, Harry Alcorn, said that “due to the complexity [of diabetic kidney disease (DKD)], there's not a clear answer” as to why such patients did less well in the company’s Redux phase II trial with DM-199 (recombinant human tissue kallikrein 1 [KLK1]). “But I wouldn't say that there wasn't a response in the DKD group,” he said, citing upside in 30% of subjects.
While stakeholders have concerns about the costs of registries for medical devices, they are still generally seen as less expensive and simpler to administer than randomized, controlled clinical trials (RCTs). A new journal article compares the quality of the data from a registry and the data generated by a clinical trial, and despite an interest in ascertaining whether registry data provided similar data quality, the authors concluded that registry data is still more useful as a means of supporting, rather than supplanting, the RCT.
Top-line data from a phase II trial of Italfarmaco SpA's givinostat in men with Becker muscular dystrophy found it failed to affect a significant change in total muscle fibrosis vs. placebo, the study's primary endpoint. But whether the outcome reflected a shortcoming of the drug or a function of the rare condition's clinical profile remained uncertain, with the company placing its bets on the latter.
CEO John Leonard said Intellia Therapeutics Inc. plans “to share information on a cohort-by-cohort basis, so we get a consistent readout” and, as the year goes on, longer-term follow-up findings will emerge from the phase I trial with the company’s lead in vivo genome editing candidate, NTLA-2001.
A new study from researchers at the Washington University School of Medicine In St. Louis demonstrated evidence of a long-lasting immune response, possibly one that could last for years, from receiving Pfizer Inc.’s mRNA COVID-19 vaccine.
LONDON – New data have arrived to allay concerns about shortages of COVID-19 vaccines disrupting dosing schedules, and also answering the question of whether third – booster – doses will restore waning immunity and be effective against viral variants.
Swiss biotech Polyphor AG is facing an uncertain future after a pivotal phase III study of the company’s balixafortide in HER2-negative breast cancer showed the drug did not improve response rates compared with standard therapy alone.
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