PERTH, Australia – After hitting a few setbacks in recent months, regenerative medicine company Mesoblast Ltd. believes it finally has a path to market with its allogeneic mesenchymal precursor cell therapy, rexlemestrocel-L, in chronic low back pain.
Nearly five months after its tau-directed antibody, semorinemab, failed to demonstrate efficacy in a phase II trial in Alzheimer’s disease, AC Immune SA is back with positive data on a different approach with its anti-phospho-tau vaccine candidate, ACI-35.030.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Acer, Actinium, Almirall, Artios, Athenex, Benevolentai, Kite, Mesoblast, Olatec, Outlook, Urovant.
Panbela Therapeutics Inc. hit a speed bump with its phase I trial in the ever-challenging indication of pancreatic cancer (PC), as an independent data safety monitoring board (DSMB) recommended that dosing be held for patients until more safety information is available about polyamine analog SBP-101.
Janssen Pharmaceutica NV and Exelixis Inc. are among the many companies releasing new data ahead of the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), which runs Feb. 11-13.
DUBLIN – After a COVID-19-induced delay that set it back most of last year, Interna Technologies BV has moved its first microRNA-based drug development program into the clinic and has also unveiled €18.5 million (US$22.4 million) in a series B funding round, which it completed in two stages.
New interim phase II data in advanced non-small-cell lung cancer (NSCLC) has shown that a combination of Heat Biologics Inc.'s cell therapy candidate, HS-110 (viagenpumatucel-L), and Bristol Myers Squibb Co.'s Opdivo (nivolumab) helped extend overall survival for both checkpoint inhibitor-naïve patients and those who had been treated with a checkpoint inhibitor but whose disease had later progressed.
Kalvista Pharmaceuticals Inc.’s chief development officer, Christopher Yea, said the across-the-board positive phase II top-line data with KVD-900 for on-demand use against hereditary angioedema (HAE) attacks will open “a very flexible discussion with regulators” regarding the design and endpoints of the phase III study to come with the oral kallikrein inhibitor. Shares of the Cambridge, Mass.-based firm (NASDAQ:KALV) closed at $33.50, up $17.89, or 115%, after reaching a high of $45, as Wall Street digested the findings.
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