Thinly traded NextCure (NASDAQ:NXTC) is down 53% premarket on modest volume on the heels of updated results from the first part of its Phase 1/2 clinical trial evaluating NC318, a Siglec-15 (S15)-targeting monoclonal antibody, in patients with solid tumors. The data were presented at the SITC Annual Meeting in Maryland.
Seven dose cohorts (8 mg – 1,600 mg every two weeks) were assessed, predominantly in patients with non-small cell lung cancer (n=13), ovarian cancer (n=7), melanoma (n=7), breast cancer (n=4) and colorectal cancer (n=3). All NSCLC patients failed to respond to PD-1 inhibitor treatment (median of four prior lines of therapy).
Durable responses were observed, including one complete response (ongoing at week 55), one partial response (ongoing at week 28), four NSCLC patients with stable cancer (ongoing at weeks 16 – 40) and 14 participants overall with stable cancer (ongoing at weeks 16 – 42).
On the safety front, 15 patients remain on study implying a discontinuation rate as high as 44% (n=15/34). Most treatment-emergent adverse events (TEAEs) were mild/moderate. There were three serious TEAEs, one case of episcleritis/uveitis and two cases of pneumonitis.
The company has initiated the Phase 2 portion which will evaluate 400 mg administered every two weeks in ~100 patients with NSCLC, ovarian, head and neck and triple-negative breast cancers. The primary endpoints are safety and tolerability. Secondary endpoints include efficacy measures. Preliminary data should be available by late Q4 2020.
Shares tripled last week ahead the data.
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