Nov. 2 Quick Takes: Early efficacy signal for IDRx’s GIST therapy

Multi-mutation-selective c-KIT inhibitor IDRX-42 from well-funded start-up IDRx Inc. has shown signs of clinical efficacy as monotherapy in the Phase I StrateGIST study to treat gastrointestinal stromal tumors. Among 28 evaluable patients in a second-line or later setting, four (14.3%) had partial responses to the therapy. Adding 15 patients with stable disease for at least 16 weeks, the company reported a clinical benefit rate of 67.9%. IDRX-42 targets c-KIT resistance mutations including in exons 9, 11, 13 and 17. Alexis Borisy and Ben Auspitz launched the biotech last year with a $122 million series A round and a goal to develop therapies and combinations addressing cancer resistance.

Eli Lilly and Co. (NYSE:LLY) disclosed in its earnings call that FDA’s approval decision on Alzheimer’s disease candidate donanemab will be delayed into 1Q24; the pharma did not say why. In a handful of other neuroscience updates, Lilly said it intended to start a phased commercial launch of its plasma p-tau217 laboratory-developed test by the end of the year. The pharma has been using the test to identify individuals with presymptomatic Alzheimer’s disease for enrollment in its TRAILBLAZER-ALZ 3 prevention trial of donanemab. During the call, Lilly said that study now has “a sufficient number of qualifying presymptomatic participants” and should report out “within three years.” Donanemab is under review to treat early symptomatic Alzheimer’s disease, but Lilly’s subgroup analyses raised questions about whether the anti-amyloid mAb is effective in all early-stage patients or just those with low levels of tau pathology...