NextCure Presents Updated Clinical Data from NC318 Phase 1/2 Clinical Trial at the 34th Annual Meeting of Society for Immuno...
November 09 2019 - 5:05PM
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 that updated clinical
results from the Phase 1 portion of its ongoing trial with NC318, a
monoclonal antibody targeting Siglec-15 (S15), were presented at
the SITC annual meeting. S15 is a novel immunomodulatory protein
that is expressed on highly immunosuppressive cells called M2
macrophages and on tumor cells. In addition, NextCure announced the
initiation of the Phase 2 portion of its ongoing Phase 1/2 clinical
trial of NC318.
Updated Results from the Phase 1 Portion of
the Phase 1/2 TrialAs of November 9, 2019, 49 patients had
been dosed across seven dose cohorts between 8 mg and 1,600 mg,
administered every two weeks:
- The most common tumor types enrolled included: non-small cell
lung cancer (NSCLC) (13 patients), ovarian cancer (seven patients),
melanoma (seven patients), breast cancer (four patients) and
colorectal cancer (three 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.
- Data show that NC318 was well tolerated, and the only
dose-limiting toxicity was a grade 3 pneumonitis in the 1,600 mg
cohort.
- Treatment-related adverse events occurring in more than 5% of
subjects were diarrhea, infusion reactions, fatigue, headaches,
pruritis and elevations in lipase and amylase.
- Most treatment-related adverse events were easily manageable,
asymptomatic or mild or moderate, except for one grade 3
episcleritis/uveitis and two cases of grade 3 pneumonitis.
- Immune-related adverse events such as vitiligo, uveitis and
pneumonitis were observed.
- Data from the trial indicate activity in multiple tumor types
including durable stable disease in patients with NSCLC,
endometrial cell cancer, ovarian cancer, squamous cell carcinoma,
Merkel cell cancer and head and neck cancer (ongoing for 16 to 55
weeks as of November 9, 2019).
- Durable responses were observed in patients who received NC318,
including one complete response (ongoing at 55 weeks), one partial
response (ongoing at 28 weeks) and four stable diseases in NSCLC
(ongoing for 16 to 40 weeks) and 14 stable diseases overall
(ongoing for 16 to 42 weeks).
- 15 patients remain on study in the Phase 1 portion of the
trial, including seven patients with NSCLC.
- All responses were based on investigator tumor assessments per
RECIST v1.1.
“NC318 has been well tolerated in the Phase 1
trial, and the only dose-limiting toxicity was a grade 3
pneumonitis in the 1,600 mg cohort,” said Kevin N. Heller, M.D.,
NextCure’s chief medical officer. “It is encouraging to see
single-agent activity among NSCLC patients refractory to PD-1
therapies, including a durable complete response and a durable
partial response. Given what appears to be the non-overlapping
expression of PD-L1 and S15, the results to date support the
potential of NC318 to block S15-mediated immune suppression among a
patient population unlikely to respond to PD-1/PD-L1-directed
therapies.”
“There is a real need for new treatment options for
patients who do not respond to current therapies. 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,” said Michael
Richman, NextCure’s president and chief executive officer. “In
addition, the initiation of the Phase 2 portion of the trial is an
important milestone for the NC318 program and reflects NextCure’s
continued commitment to developing novel medicines to improve the
lives of patients with cancer. We look forward to reporting initial
data from the Phase 2 portion of the trial by the end of 2020.
These findings also revalidate the importance of the approach of
our FIND-IOTM discovery platform in identifying targets like S15
that can impact immune function.”
Slides from the SITC presentation will be posted on
NextCure’s website on the “Events and Presentations” tab at
http://ir.nextcure.com/events-and-presentations.
Design of NC318 Phase 1/2 Clinical
TrialThe Phase 1 component of the open-label, multicenter
Phase 1/2 clinical trial is designed to assess the safety and
tolerability of NC318, to define the maximum tolerable dose and/or
pharmacologically active dose and to assess preliminary efficacy in
patients with advanced or metastatic solid tumors. NC318 is being
administered on day one of each 14-day cycle in sequential dose
cohorts at increasing dose levels until the maximum tolerated dose
is identified.
The Phase 2 component of the Phase 1/2 clinical
trial is designed as a single-arm trial to evaluate the efficacy of
NC318 at a 400 mg dose administered every two weeks. NextCure
expects to enroll approximately 100 patients with NSCLC, ovarian
cancer, head and neck cancer and triple-negative breast cancer. The
primary endpoints are safety and tolerability, and secondary
endpoints include response rate, progression-free survival,
duration of response and overall survival. Additional doses and
dose administration schedules may be considered. The company
expects to report initial data from the Phase 2 portion of the
trial by the end of 2020.
Phase 2 Combination TrialIn the
first half of 2020, the Company intends to initiate a Phase 2
clinical trial to evaluate NC318 in combination with standard of
care chemotherapies in patients with advanced or metastatic solid
tumors. This open-label trial will be designed to assess the safety
and tolerability of NC318 in combination with at least two
different chemotherapy regimens and to define the maximum tolerable
dose of NC318 when administered with each chemotherapy. The trial
will also be designed to assess preliminary efficacy of each
combination in specific tumor types in a manner that can
potentially support the use of such combinations in first-line
therapies of advanced or metastatic solid tumors.
Event and Webcast NextCure will
host an event at the SITC conference to discuss these results in
more detail with Dr. Kevin Heller today, November 9, 2019 at 6:30
pm ET. During the event, Dr. Heller will provide a review of the
data presented at SITC by Dr. Anthony Tolcher and be available for
a Q&A session. This event will be webcast live and archived for
90 days and may be accessed from the Investors section of the
NextCure website at www.nextcure.com.
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 pace and expected
timing and 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: 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 Form 10-Q filed with
the SEC on August 12, 2019. 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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