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.
Harpoon Therapeutics Inc. provided updated interim monotherapy data from 71 patients in its phase I/II trial testing HPN-328 in small-cell lung cancer (SCLC) and other neuroendocrine tumor types in a poster at the European Society of Medical Oncology Congress (ESMO). Wall Street immediately began comparing the compound, which takes aim at delta-like ligand 3 (DLL3) with a similar prospect from Amgen Inc. that recently yielded promising results.
Medtronic plc got a jump on its cardiology competitors with big news ahead of the Transcatheter Cardiovascular Therapeutics (TCT) conference that starts on Oct 24 in San Francisco, with U.S. FDA approval of its Aurora extravascular implantable cardioverter-defibrillator (EV-ICD). The system delivers defibrillation and heart pacing without placing wires in the heart or vasculature. That puts it in direct competition with Boston Scientific Corp.’s Emblem S-ICD, currently the only player in the market.
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.
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.
Nkarta Inc. is looking to return to the heady heights it hit three years ago when its shares were going for around $70 each. The company is reinventing itself as a cancer fighter and branching out as an autoimmune specialist. Nkarta joins at least four other companies looking at expanding their cell therapies into other autoimmune indications.
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.
Investors awaiting the announcement of a partnering deal for RASP modulator reproxalap ahead of the drug’s Nov. 23 PDUFA date were in for a rude awakening, as Aldeyra Therapeutics Inc. disclosed that the U.S. FDA had raised issues with the NDA, putting its imminent approval in dry eye disease in doubt. The update, disclosed in an SEC filing, sent shares (NASDAQ:ALDX) sinking 66%, or $3.60, to close Oct. 16 at $1.83.
Omeros Corp.’s phase III stumble in the busy immunoglobulin A nephropathy (IgAN) space put a sizeable dent in the stock (NASDAQ:OMER) and caused the Seattle-based firm to end the experiment with narsoplimab. Shares closed Oct. 16 at $1.54, down 73 cents, or 32%, after Omeros reported the interim analysis outcome of the trial called Artemis-IgAN.