NextCure Presents Biomarker Data and Updated Clinical Results from Phase 1 Portion of its NC318 Clinical Trial at the 2020 Vi...
May 29 2020 - 8:05AM
NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical
company committed to discovering and developing novel,
first-in-class immunomedicines to treat cancer and other
immune-related diseases, today announced the presentation of
biomarker data and updated clinical results from the Phase 1
portion of its ongoing Phase 1/2 monotherapy trial with NC318 at
the 2020 Virtual American Society of Clinical Oncology (ASCO20)
Annual Meeting. NC318 is a monoclonal antibody targeting Siglec-15
(S15), a novel immunomodulatory protein that is expressed on highly
immunosuppressive cells called M2 macrophages and on tumor cells.
“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 Kevin N. Heller, M.D., NextCure’s chief medical
officer. “We expect to receive additional insight from the
Phase 2 portion of our ongoing trial, which will include additional
biomarker analyses.”
Biomarker Data and Updated Clinical Results
from the Phase 1 Portion of the NC318 Clinical TrialAs of
May 11, 2020, 49 patients had been dosed across seven dose cohorts
between 8 mg and 1,600 mg, administered every two weeks:
- 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.
About NC318 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. NextCure believes NC318 has the potential
to treat multiple cancer types.
About NextCure, Inc. NextCure is a
clinical-stage biopharmaceutical company committed to discovering
and developing novel, first-in-class immunomedicines to treat
cancer and other immune-related diseases. Through our proprietary
FIND-IO™ platform, we study various immune cells to discover and
understand targets and structural components of immune cells and
their functional impact in order to develop immunomedicines. Our
initial focus is to bring hope and new treatments to patients who
do not respond to current cancer therapies, patients whose cancer
progresses despite treatment and patients with cancer types not
adequately addressed by available therapies. www.nextcure.com
Forward-Looking StatementsThis
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 NextCure as of the date hereof.
Forward-looking statements include statements regarding NextCure’s
expectations, beliefs, intentions or strategies regarding the
future and can be identified by forward-looking words such as
“may,” “will,” “potential,” “expects,” “believes,” “intends,”
“hope,” “towards,” “forward,” “later” and similar expressions.
Examples of forward-looking statements in this press release
include, among others, statements about the results of NextCure’s
ongoing clinical study of NC318, NextCure’s expectations regarding
the potential benefits, activity, effectiveness and safety of
NC318, and NextCure’s plans, objectives and intentions with respect
to the discovery and development of immunomedicines.
Forward-looking statements involve substantial risks and
uncertainties that could cause actual results to differ materially
from those projected in any forward-looking statement. Such risks
and uncertainties include, among others: the impacts of the
COVID-19 pandemic on NextCure’s business, including NextCure’s
clinical trials, third parties on which NextCure relies and
NextCure’s operations; NextCure’s limited operating history and no
products approved for commercial sale; NextCure’s history of
significant losses; NextCure’s need to obtain additional financing;
risks related to clinical development, marketing approval and
commercialization; and the unproven approach to the discovery and
development of product candidates based on NextCure’s FIND-IO
platform. More detailed information on these and additional factors
that could affect NextCure’s actual results are described in
NextCure’s filings with the Securities and Exchange Commission (the
“SEC”), including NextCure’s most recent Form 10-K and subsequent
Form 10-Q. You should not place undue reliance on any
forward-looking statements. Forward-looking statements speak only
as of the date of this press release, and NextCure assumes no
obligation to update any forward-looking statements, even if
expectations change.
Investor Inquiries
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
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