NextCure Presents Biomarker Data and Updated Clinical Results from Phase 1 Portion of its NC318 Clinical Trial at the 2020 Virtual American Society of Clinical Oncology Annual Meeting
“Because this is a trial in progress with limited samples, we cannot draw definitive conclusions, but we believe these early biomarker data provide additional evidence of NC318 activity,” said
Biomarker Data and Updated Clinical Results from the Phase 1 Portion of the NC318 Clinical Trial
- The early biomarker data suggest collectively the potential of NC318 to block S15-mediated immune suppression, as indicated by:
- Increase of regulatory T cells in peripheral blood in the highest dose cohorts;
- Increase of PD-1 expression on circulating CD4+ T cells while on treatment;
- Expansion of peripheral T cell receptor clones while on treatment; and
- Presence of proliferating CD8 T cells systemically and increase of proliferating lymphocytes within the tumor microenvironment while on treatment.
- S15 and PD-L1 expression from tumor biopsies were assessed at baseline for 15 subjects. On treatment biopsies were obtained for 9 of the 15 subjects, and relative to baseline assessments, changes in S15 or PD-L1 expression were observed while on treatment with NC318 in 7 of the 9 paired biopsies.
- As previously reported at the
Society for Immunotherapy of Cancer(SITC) annual meeting in November 2019:
- The most common tumor types enrolled included: non-small cell lung cancer (NSCLC) (13 patients), ovarian cancer (7 patients), melanoma (7 patients), breast cancer (4 patients) and colorectal cancer (3 patients).
- All of the patients enrolled were heavily pre-treated with a median of three prior therapies.
- All 13 NSCLC patients were PD-1 refractory, with a median of four prior therapies.
- As of
May 11, 2020, two NSCLC subjects from the Phase 1 portion of the clinical trial remain on study: a complete response and a partial response for 82 and 54 weeks, respectively. In addition, 10 subjects, including 3 NSCLC, had durable stable disease for at least 24 weeks, and progressed subsequently. All responses were based on investigator tumor assessments per RECIST v1.1.
- Immune-related adverse events and treatment-related adverse events continued to be observed at a frequency consistent with what has been previously reported (e.g., treatment-related adverse events occurring in more than 5% of subjects were diarrhea, infusion reactions, fatigue, headaches, pruritis, and elevations in lipase and amylase). There were no new safety signals.
The poster presented at ASCO20 further detailing these data is available on NextCure’s website within the “Events and Presentations” section at http://ir.nextcure.com/events-and-presentations.
NC318 is a first-in-class immunomedicine against S15, a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15.
This press release contains forward-looking statements, including statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations, forecasts, assumptions and other information available to
Timothy Mayer, Ph.D. NextCure, Inc.Chief Operating Officer (240) 762-6486 IR@nextcure.com Media Inquiries Shai Biran, Ph.D. MacDougall (781) 235-3060 NextCure@macbiocom.com