$NXTC got hammered on Monday after reporting disappointing data over the weekend. While the stock closed down 52%, it could have been a lot worse and the stock did bounce on the day. This signals that buyers were stepping in.
Here's what happened:
Thinly traded NextCure (NASDAQ:NXTC) closed down 52% 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.
NextCure, Inc., a biopharmaceutical company, engages in discovering and developing immunomedicines to treat cancer and other immune-related diseases by restoring normal immune function. Its lead product candidate is NC318, which is in Phase I/II clinical trials for the treatment of advanced or metastatic solid tumors. The company is also developing NC410, is a novel immunomedicine designed to block immune suppression for the treatment of ovarian cancer, non-small cell lung cancer, and renal cancer. Its discovery and research programs include an antibody in preclinical evaluation of other potential novel immunomodulatory molecules that targets a novel member of the B7-family of immunomodulatory proteins; and an antibody in preclinical development targeting an immune modulator that is expressed in inflamed tissue and the tumor microenvironment in various tumor types. NextCure, Inc. has a license agreement with Yale University; and a research and development collaboration with Eli Lilly and Company. The company was founded in 2015 and is based in Beltsville, Maryland.
As always, trade with caution and use protective stops.
Good luck to all!
Here's what happened:
Thinly traded NextCure (NASDAQ:NXTC) closed down 52% 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.
NextCure, Inc., a biopharmaceutical company, engages in discovering and developing immunomedicines to treat cancer and other immune-related diseases by restoring normal immune function. Its lead product candidate is NC318, which is in Phase I/II clinical trials for the treatment of advanced or metastatic solid tumors. The company is also developing NC410, is a novel immunomedicine designed to block immune suppression for the treatment of ovarian cancer, non-small cell lung cancer, and renal cancer. Its discovery and research programs include an antibody in preclinical evaluation of other potential novel immunomodulatory molecules that targets a novel member of the B7-family of immunomodulatory proteins; and an antibody in preclinical development targeting an immune modulator that is expressed in inflamed tissue and the tumor microenvironment in various tumor types. NextCure, Inc. has a license agreement with Yale University; and a research and development collaboration with Eli Lilly and Company. The company was founded in 2015 and is based in Beltsville, Maryland.
As always, trade with caution and use protective stops.
Good luck to all!
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