NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a
biotechnology company focused on discovering and developing
transformative therapeutics for patients, today announced the
presentation of preliminary data from the Phase 1 Part 1a
monotherapy dose escalation arm of the ongoing Phase 1/2 trial of
NGM707 in patients with advanced or metastatic solid tumors at the
European Society for Medical Oncology Immuno-Oncology (ESMO I-O)
Annual Congress, which is taking place December 7 – 9, 2022 in
Geneva, Switzerland. In the poster presentation titled,
“First-in-Human Study of NGM707, an ILT2/ILT4 Dual Antagonist
Antibody in Advanced or Metastatic Solid Tumors: Preliminary
Monotherapy Dose Escalation Data” (#174P), NGM707 was generally
well tolerated across all dose cohorts and demonstrated promising
early signals of anti-tumor activity. Of 24 response-evaluable
patients in the Part 1a arm, best overall responses as of November
23, 2022 are partial response in one patient, stable disease in six
patients and non-complete response/non-progressive disease in one
patient. Six patients had reduced target lesion size including a
maximum decrease in one patient of 70%. A copy of the presentation
presented at the ESMO I-O Annual Congress is available on NGM Bio’s
website
at https://www.ngmbio.com/discovery-engine/publications/.
The Phase 1 portion of the ongoing NGM707 trial includes a
monotherapy dose escalation arm (Part 1a) and a dose-finding arm in
combination with pembrolizumab (KEYTRUDA®) (Part 1b). The Phase 2
portion of the trial will include expansion cohorts of patients
treated with NGM707 in combination with KEYTRUDA (Part 2b) in
several advanced solid tumor types. The Part 1a arm enrolled
patients into escalating NGM707 dose cohorts (6 mg to 1800 mg)
administered intravenously every three weeks. Enrolled patients
received a median of four prior lines of therapy, and all had
metastatic disease. Primary objectives in the Phase 1 portion are
to assess safety and tolerability of NGM707 and to identify Phase 2
doses. Secondary/exploratory objectives include assessment of
PK/biomarker correlation, immunogenicity, and preliminary antitumor
activity per RECIST v1.1.
As of a November 23, 2022 data cut-off, 34 patients have been
enrolled in the monotherapy dose escalation. Of 24
response-evaluable patients (those completing at least one
on-treatment scan), best overall responses are partial response
(PR) in one patient, stable disease in six patients and
non-complete response/non-progressive disease in one patient. Six
of the 24 response-evaluable patients experienced target lesion
reduction. The patient experiencing the PR had a target lesion
decrease of 70%, along with a reduction and/or elimination of
non-target lesions. These responses were seen across five distinct
tumor types. Preliminary evidence of potential myeloid
reprogramming was observed in peripheral non-classical monocytes as
well as in tumor biopsies, with reduction of the M2 macrophage
marker CD163 observed post-treatment. Treatment-related adverse
events (TRAEs) occurred in 47% of patients, with 9% of patients
experiencing Grade ≥3 TRAEs. One dose-limiting toxicity of
pneumonitis (G5) in a patient with pulmonary metastasis was
observed at NGM707 600 mg. A maximum tolerated dose was not
reached.
As of November 23, 2022, four patients remain on NGM707
monotherapy treatment in the Part 1a arm, including the patient
experiencing the PR. Enrollment is ongoing in the Part 1b arm
evaluating NGM707 in combination with KEYTRUDA. NGM Bio anticipates
enrolling approximately 220 patients in the Phase 1/2 trial of
NGM707.
“NGM707 is designed to reprogram immune-suppressive ILT4- and
ILT2-expressing myeloid cells and ILT2-expressing lymphoid cells in
the tumor microenvironment into immune-stimulatory cells that will
promote anti-tumor activity. We’re pleased to present these initial
data demonstrating a favorable tolerability profile for NGM707 as
well as early, yet promising signals that this mechanistic approach
may translate to clinical benefit,” said Dan Kaplan, Ph.D., Head of
Translational Immuno-Oncology at NGM Bio. “We’re particularly
encouraged to see clinical benefit in certain patients in response
to monotherapy treatment with NGM707, and we look forward to
evaluating NGM707’s potential effect when combined with T cell
checkpoint inhibition in Part 1b of the study, which is now
underway.”
About NGM707
ILT2 and ILT4, inhibitory receptors with enriched expression on
myeloid cells in the tumor microenvironment, are myeloid
checkpoints that may enable certain tumors to evade immune
detection, thereby suppressing patients’ anti-tumor
responses. NGM707 is being developed with the goal of
improving patient immune response to tumors by inhibiting both ILT2
and ILT4. By inhibiting both ILT2 and ILT4, NGM707 may be able to
overcome the potential redundant role the two receptors play where
they are co-expressed in myeloid cells and reprogram those cells to
enhance T cell activity and proliferation. In addition, ILT2
blockade may drive further benefit through reducing suppression in
certain lymphoid cells capable of directly attacking tumor
cells.
About NGM Bio’s Oncology Portfolio
NGM Bio’s currently disclosed oncology product candidates are
all derived from the company’s in-house discovery engine and are
wholly owned by NGM Bio. These oncology programs include: NGM120, a
GFRAL antagonist antibody in a Phase 2 trial for the treatment of
metastatic pancreatic cancer; NGM707, an ILT2/ILT4 (LILRB1/LILRB2)
dual antagonist antibody in a Phase 1/2 trial for the treatment of
advanced or metastatic solid tumors; NGM831, an ILT3 (LILRB4)
antagonist antibody in a Phase 1 trial in advanced solid tumors;
and NGM438, a LAIR1 antagonist antibody in a Phase 1 trial in
advanced solid tumors.
Abbreviations (in Alphabetical Order)GFRAL=
Glial Cell-derived Neurotrophic Factor Receptor Alpha-like;
ILT2=Immunoglobulin-Like Transcript 2; ILT3=Immunoglobulin-Like
Transcript 3; ILT4=Immunoglobulin-Like Transcript 4; LAIR1=
LAIR1=Leukocyte-Associated Immunoglobulin-Like Receptor 1;
LILR=Leukocyte Immunoglobulin-Like Receptor [ILT2 = LILRB1,
ILT3=LILRB4, ILT4=LILRB2]; LIR=Leukocyte Immunoglobulin-Like
Receptor.
About NGM Bio
NGM Bio is focused on discovering and developing novel,
life-changing medicines for people whose health and lives have been
disrupted by disease. The company’s biology-centric drug discovery
approach aims
to seamlessly integrate interrogation of complex
disease-associated biology and protein engineering expertise to
unlock proprietary insights that are leveraged to generate
promising product candidates and enable their rapid advancement
into proof-of-concept studies. As explorers on the frontier of
life-changing science, NGM Bio aspires to operate one of the most
productive research and development engines in the
biopharmaceutical industry. All therapeutic candidates in the NGM
Bio pipeline have been generated by its in-house discovery engine,
always led by biology and motivated by unmet patient need. Today,
the company has seven programs in clinical
development, including four in Phase 2 or 2b
studies, including the recently completed NGM621 CATALINA
trial, across three therapeutic areas:
cancer, retinal diseases and liver and
metabolic diseases. Visit us at www.ngmbio.com for more
information.
KEYTRUDA® is a registered trademark of Merck Sharp &
Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ,
USA.
Forward Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Words such as
“will,” “may,” “potential,” “promising,” “plan,” “preliminary,”
“anticipates,” “aspires,” “aims,” “designed to” and similar
expressions (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to
identify forward-looking statements. These statements include those
related to: the potential proof-of-mechanism and anti-tumor
activity of NGM707, alone and in combination with KEYTRUDA; the
potential of NGM Bio’s immune-oncology product candidates, NGM707,
NGM831 and NGM438, to block myeloid checkpoints to reprogram
suppressive myeloid cells in the tumor microenvironment, including
NGM707’s potential to reprogram immune-suppressive ILT4- and
ILT2-expressing myeloid cells and ILT2-expressing lymphoid cells in
the tumor microenvironment into immune-stimulatory cells that will
promote anti-tumor activity; the potential effects of
blocking/inhibiting ILT and ILT4 together and separately; the
ability to enroll patients in the Phase 1/2 trial of NGM707; NGM
Bio’s aspiration to operate one of the most productive research and
development engines in the biopharmaceutical industry; and other
statements that are not historical fact. Because such statements
deal with future events and are based on NGM Bio’s current
expectations, they are subject to various risks and uncertainties,
and actual results, performance or achievements of NGM Bio could
differ materially from those described in or implied by the
statements in this press release. These forward-looking statements
are subject to risks and uncertainties, including, without
limitation, the risk that results obtained in preclinical or
clinical trials to date with NGM707 may not be indicative of
results obtained in ongoing or future trials and that NGM Bio’s
product candidates may otherwise not be tolerable and effective
treatments in their planned indications; risks and uncertainties
associated with the costly and time-consuming pharmaceutical
product development process and the uncertainty of clinical
success, including risks related to failure or delays in
successfully initiating, enrolling, reporting data from or
completing clinical studies, as well as the ongoing COVID-19
pandemic, which has adversely affected, and could materially and
adversely affect in the future, NGM Bio’s business and operations,
including NGM Bio’s ability to timely supply, initiate, enroll and
complete its ongoing and future clinical trials; the time-consuming
and uncertain regulatory approval process; NGM Bio’s reliance on
third-party manufacturers for its product candidates and the risks
inherent in manufacturing and testing pharmaceutical products; the
sufficiency of NGM Bio’s cash resources and NGM Bio’s need for
additional capital; and other risks and uncertainties affecting NGM
Bio and its development programs, including those discussed in the
section titled “Risk Factors” in NGM Bio’s quarterly report on Form
10-Q for the quarter ended September 30, 2022 filed with the United
States Securities and Exchange Commission (SEC) on November 3, 2022
and future filings and reports that NGM Bio makes from time to time
with the SEC. Except as required by law, NGM Bio assumes no
obligation to update these forward-looking statements, or to update
the reasons if actual results differ materially from those
anticipated in the forward-looking statements.
Investor Contact: Brian
Schoelkopfir@ngmbio.com
Media Contact:media@ngmbio.com
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