A Phase 2 Study of Anti-Siglec-15 Antibody, NC318, in Combination with Pembrolizumab (NCT04699123) Demonstrates Clinical Activity in Patients with Advanced PD-1 Axis Inhibitor Refractory NSCLC
September 12 2023 - 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 Phase
2 clinical data by collaborators at the Yale Cancer Center
demonstrating clinical benefit in patients with advanced, PD-1 axis
inhibitor refractory non-small cell lung cancer (NSCLC) treated
with a combination regimen of NC318, a Siglec-15 (S15) monoclonal
antibody (mAb), and pembrolizumab, an anti-PD-1 antibody.
NC318 is a humanized IgG1 mAb against S15 that blocks
interactions of S15 with myeloid cells and T lymphocytes within the
tumor microenvironment, relieving immune inhibitory signaling. In
an earlier monotherapy study from NextCure, NC318 demonstrated
single agent activity in a Phase 1/2 dose escalation trial
(NCT03665285) for patients with advanced solid tumors (Tolcher et
al, SITC 2019).
The ongoing NCT04699123 study is a randomized trial designed to
assess the safety and efficacy of NC318 alone or in combination
with pembrolizumab. The combination portion of the study is
assessing efficacy in NSCLC subjects who have experienced disease
progression on, or after, PD-1 axis inhibitor therapy. Key findings
from the trial include:
- Efficacy data demonstrate that the combination of NC318 and
pembrolizumab is active in advanced PD-1 axis inhibitor refractory
NSCLC: 28% of patients (5/18) had durable clinical benefit (partial
response or stable disease lasting greater than 6 months by RECIST
and/or irRC) with three of these being confirmed responses.
- To date, both monotherapy and combination arms have been well
tolerated, with six Grade 3 treatment-related adverse events
(TRAEs) [transverse myelitis (1), infusion reactions (3), rash (1)
and pneumonitis (1)] and four Grade 2 TRAEs [infusion reactions
(2), pericarditis (1) and psoriasis (1)] between both arms.
- NC318 infusion reactions were seen in seven patients (three
Grade 3, four Grade 2), six receiving the combination and one NC318
alone. No additional infusion reactions occurred once NC318
infusion time was increased from 30 to 60 minutes.
- All confirmed responses were in patients with PD-L1 negative
tumors, and benefits were seen in patients with both PD-L1 positive
and negative tumors.
- Additional biomarker and pharmacodynamic studies are
ongoing.
“Based on these early encouraging results, Yale is continuing to
enroll patients to gain further evidence of clinical activity of
NC318,” said Solomon Langermann, Ph.D., NextCure’s chief scientific
officer. “We look forward to continuing our collaboration with Drs.
Herbst and Gettinger and the Yale Cancer Center.
“We are excited that this investigator-initiated trial, part of
our NCI Lung SPORE (Specialized Program of Research Excellence), is
providing new insights into the mechanisms and treatment of immune
therapy resistance. We look forward to reporting more data in the
future,” said Roy Herbst, M.D., Ensign Professor of Medicine
(Medical Oncology) and Professor of Pharmacology; Deputy Director,
Yale Cancer Center; Chief of Medical Oncology, Yale Cancer Center
and Smilow Cancer Hospital; Assistant Dean for Translational
Research, Yale School of Medicine; Director, Center for Thoracic
Cancers, Yale Cancer Center and Smilow Cancer Hospital.
Details of the presentation are as follows:
Title: A Phase 2 study of NC318 alone or in
combination with pembrolizumab in patients with advanced
NSCLCPresenter: Roy Herbst, MDPresentation
No: MA15.07Session Title: Bringing New
Discoveries into Early Phase Clinical TrialsSession
Time: September 12, 2023, 10:45AM - 11:45AM SGT
NextCure has maintained a longstanding relationship with
clinician scientists at Yale University stretching back to the
company’s founding. NextCure’s scientific founder Dr. Lieping Chen,
a leader in immunology and medical oncology, is the United
Technologies Corporation Professor in Cancer Research and Professor
of Immunobiology, Dermatology and Medicine (Medical Oncology) at
Yale University. The immunosuppressive properties of S15 were
discovered by Dr. Chen at Yale University. NextCure has exclusively
licensed technologies relating to S15 from Yale University, and has
since collaborated with Yale University to continue development of
NC318, as well as other immuno-oncology candidates, through
sponsored research and clinical trial agreements.
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 disease in order to develop
immunomedicines. Our 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. http://www.nextcure.com
Cautionary Statement Regarding Forward-Looking
StatementsStatements made in this press release that are
not historical facts are forward-looking statements. Words such as
“expects,” “believes,” “intends,” “hope,” “forward” and similar
expressions are intended to identify forward-looking statements.
Examples of forward-looking statements in this press release
include, among others, statements about NextCure’s plans,
objectives, and intentions with respect to the discovery of
immunomedicine targets and 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: our limited
operating history and no products approved for commercial sale; our
history of significant losses; our need to obtain additional
financing; risks related to clinical development, including that
early clinical data may not be confirmed by later clinical results;
risks that pre-clinical research may not be confirmed in clinical
trials; risks related to marketing approval and commercialization;
and the unproven approach to the discovery and development of
product candidates based on our 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. NextCure assumes no
obligation to update any forward-looking statements, even if
expectations change.
Investor InquiriesTimothy Mayer, Ph.D.NextCure,
Inc.Chief Operating Officer(240) 762-6486IR@nextcure.com
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