NextCure Inc (NASDAQ: NXTC) shares, which posted a stellar gain of about 250% on Nov. 5, are falling back down from those stratospheric levels following an updated data readout at the 34th annual meeting of Society for Immunotherapy of Cancer, or SITC.
The Beltsville, Maryland-based clinical-stage biopharma said it presented updated Phase 1 data from its ongoing trial of NC318 and has initiated the Phase 2 portion of the trial.
NC318 is a monoclonal antibody targeting Siglec-15, or S15, an immunomodulatory protein that is expressed on highly immunosuppressive cells called M2 macrophages and on tumor cells.
As of Nov. 9, about 49 patients were dosed across seven cohorts, with doses ranging from 8 mg to 1,600 mg, administered every two weeks.
The most common tumor types enrolled were non-small cell lung cancer, or NSCLC; ovarian cancer; melanoma; breast cancer; and colorectal cancer patients, and most patients were heavily pretreated, the company said.
Durable responses were observed in patients, with one complete response; one partial response and four stable diseases in NSCLC; and 14 stable diseases overall, according to NextCure.
Data showed that NC318 was well-tolerated, and the only dose-limiting toxicity was grade 3 pneumonitis in the 1,600 mg cohort, the company said.
Treatment-related adverse events were easily manageable, or mild or moderate, except for one grade 3 case of episcleritis/uveitis and two cases of grade 3 pneumonitis, NextCure said.
Why It's Important
NC318 has demonstrated the potential to block S15-mediated immune suppression among a patient population unlikely to respond to PD-1/PD-L1-directed therapies such as Merck & Co., Inc.'s (NYSE: MRK) Keytruda, according to NextCure.
"The tolerability and initial anti-tumor activity with NC318 reinforces our belief that NC318 has the potential to be a new therapy for patients with solid tumors and low levels of PD-L1 expression or who do not respond to current anti-PD-1/PD-L1 treatments," CEO Michael Richman said in a statement.
NextCure expects to report initial data from the Phase 2 portion of the trial by the end of 2020.
NextCure shares jumped about 250% Nov. 5 in the wake of the IPO lockup period expiration and in anticipation of a positive clinical readout at the SITC, although the stock gave back about 10% of the gains over the next three sessions.
With the data readout now behind NextCure, the shares are moving lower in a typical "buy-the-rumor, sell-the-news" move.
The stock was down 50.65% at $40.91 at the time of publication Monday.