Oncolys Biopharma Inc.’s lead compound Telomelysin (suratadenoturev, OBP-301) met the primary endpoint of exceeding the predefined threshold of local complete response, confirming clinical benefit in a phase II study in locally advanced esophageal cancer combined with radiation.
With Deciphera Pharmaceuticals Inc.’s positive top-line data in hand from the pivotal phase III study called Motion, Wall Street speculation turned to the comparative safety and regulatory odds for vimseltinib (which analysts often refer to as “vim”) in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery.
Lianbio Co. Ltd. announced mixed phase III top-line results on Oct. 30 for its in-licensed Demodex blepharitis treatment called TP-03, with the U.S. FDA-approved eyedrop hitting just one co-primary endpoint in the Libra trial on Chinese patients.
This summer’s phase III news from Qilu Pharmaceutical Co. Ltd. with iruplinalkib – an oral inhibitor of ALK and ROS1 tyrosine kinase – reinforced an ongoing interest in the pair of oncology targets, where a handful of developers remain busy. Most notably of late is Nuvalent Inc., which rolled out stock-boosting data Oct. 4.
Chimeric Therapeutics Ltd.‘s chlorotoxin (CLTX) CAR T therapy, CHM-1101, which is derived from scorpion toxin, saw a disease control rate of 55%, exceeding the historical disease control rates of 20% to 37% in heavily pre-treated patients with glioblastoma.
A six-week treatment regimen of Paradigm Biopharmaceuticals Ltd.’s Zilosul (injectable pentosan polysulfate/iPPS) resulted in improvement of both the symptoms of osteoarthritis and preserved or regenerated joint tissues in the knee, according to phase II trial results.
Abbisko Therapeutics Co. Ltd. announced positive first-in-human data for its highly selective fibroblast growth factor receptor (FGFR) 4 inhibitor, irpagratinib (ABSK-011), for treating advanced hepatocellular carcinoma with FGF19 overexpression, which is seen in roughly 30% of liver cancers.
Precision cancer biotech Abion Inc. announced a positive interim phase II readout for ABN-401, its novel c-mesenchymal-epithelial transition (c-MET)-targeting tyrosine kinase inhibitor (TKI) for advanced non-small-cell lung cancer (NSCLC), lighting a runway to its next trial as a combination regimen.
January-August 2023 saw clinical trial data up 1.22% compared to the same time period last year. In the first eight months of this year, BioWorld reported on 2,314 drugs in phase I-III, compared to 2,286 in the same timeframe in 2022. The number of trial updates is down 13.24% from the 2,667 in 2021 and down from 2020’s 2,363, but up 20.46% from 2019’s 1,921.
Positive top-line data from the phase IIb study of BNC-210 to treat post-traumatic stress disorder (PTSD) supercharged Bionomics Ltd.’s stock. Shares (NASDAQ:BNOX) closed trading a dramatic 243.8% higher at $3.37 each on Sept. 28. The oral, selective negative allosteric modulator of the alpha7 nicotinic acetylcholine receptor stumbled last December in a phase II trial for treating social anxiety disorder but now has regained momentum.
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