Elicio Therapeutics (Nasdaq: ELTX), a clinical-stage biotechnology
company developing a pipeline of novel immunotherapies for the
treatment of cancer, today announced positive interim clinical data
from the ongoing Phase 1 (AMPLIFY-201) study of its lead asset,
ELI-002, an investigational therapeutic cancer immunotherapy. This
study evaluated ELI-002 2P, a 2-peptide formulation designed to
treat cancers driven by G12D and G12R mutations in KRAS. ELI-002
was studied as a monotherapy in patients with mutant KRAS-driven
tumors who are at high risk for relapse due to detection of minimal
residual disease (MRD) following standard surgery and chemotherapy
(NCT04853017). The data will be presented in a poster discussion
session at the 2023 American Society of Clinical Oncology (ASCO)
Annual Meeting, a hybrid event taking place online and at McCormick
Place in Chicago from June 2-6, 2023.
ELI-002 2P was well-tolerated, with no dose
limiting toxicity or cytokine release syndrome across 5 cohorts
that evaluated ascending doses from 0.1 to 10.0 mg of the adjuvant
Amph-CpG. Responses were observed at all dose levels, with a high
proportion of patients having tumor biomarker reduction including a
subset with clearance. Robust mKRAS-specific T cell responses were
induced in 87% of patients with an average of a 56-fold [range
2-423-fold] increase directly ex vivo.
“mKRAS-specific T cells have been shown to
mediate anti-tumor efficacy, which prompted us to assess ELI-002 in
high relapse-risk patients where tumor biomarkers can provide an
early efficacy signal,” said Eileen M. O’Reilly, M.D., Winthrop
Rockefeller Endowed Chair of Medical Oncology; Co-Director, Medical
Initiatives, David M. Rubenstein Center for Pancreatic Cancer
Research; Section Head, Hepatopancreaticobilary &
Neuroendocrine Cancers, Memorial Sloan Kettering Cancer Center
(MSK). “We are encouraged by the findings which showed that ELI-002
was well-tolerated. The trial enabled patients to enroll with
minimal disease which reduces the chances of an immunosuppressive
tumor environment and increases the ratio of T cells to target
tumor cells.”
Christopher Haqq, M.D., Ph.D., Elicio’s
Executive Vice President, Head of Research and Development, and
Chief Medical Officer, said, “ELI-002 is designed with our
proprietary AMP technology, which allows for smart delivery to the
lymph nodes, the ‘brain center’ of the immune system. The immune
responses observed were robust and durable in addition to being
able to carry out multiple anti-tumor functions. These data
validate the clinical activity of ELI-002 with two peptides and
support our bridge to the 7-peptide formulation of ELI-002,
designed to stimulate an immune response against the seven most
common KRAS mutations present in 25% of solid cancer patients. We
are grateful to the patients, caregivers, physicians and study
staff for their contribution to this study.”
Presentation summary:
Title: AMPLIFY-201, a first-in-human
safety and efficacy trial of adjuvant ELI-002 2P immunotherapy for
patients with high-relapse risk with KRAS G12D- or G12R-mutated
pancreatic and colorectal cancer.Abstract
#: 2528Presenter: Eileen
O’Reilly, M.D., Winthrop Rockefeller Endowed Chair of Medical
Oncology; Co-Director, Medical Initiatives, David M. Rubenstein
Center for Pancreatic Cancer Research; Section Head,
Hepatopancreaticobilary & Neuroendocrine Cancers, Memorial
Sloan Kettering Cancer Center (MSK)
Study Design
- AMPLIFY-201 is a multicenter Phase 1 trial assessing the
safety, immunogenicity and antitumor activity of ELI-002 2P as a
monotherapy in patients with mutant KRAS-driven tumors who are at
high risk for relapse due to detection of MRD following standard
surgery and chemotherapy.
- ELI-002 2P is comprised of two AMP-modified mutant KRAS peptide
antigens (Amph-mKRAS G12D and Amph-mKRAS G12R) and an AMP TLR-9
agonistic DNA adjuvant (Amph-CpG-7909).
- There were five cohorts of patients who received a 1.4 mg fixed
dose of the two mutant KRAS peptide antigens and different doses of
Amph-CpG-7909 (0.1 mg, 0.5 mg, 2.5 mg, 5.0 mg or 10.0 mg).
Study Results
- ELI-002 2P was very well-tolerated with no Grade ≥3 related
adverse events (AEs), no cytokine release syndrome and no dose
limiting toxicities.
- A high proportion of ELI-002 2P patients had tumor biomarker
reduction (77%) with a subset achieving clearance (32%).
- Notable mKRAS-specific T cell responses were induced with an
average of a 56-fold [range 2-423-fold] increase directly ex vivo.
The T cell infiltration was 10 to 29-fold higher than the
literature in pancreatic tumors.
- The recommended Phase 2 dose (RP2D) is 10 mg of
Amph-CpG-7909.
Mutant KRAS drives 25% of solid human cancers
with an overall poor prognosis and high relapse risk and limited
therapeutic options. In the Phase 1 AMPLIFY-201 study, ELI-002
targets two of the KRAS mutations, G12R and G12D, the most commonly
occurring variants in pancreatic, colorectal, non-small cell lung,
ovarian, biliary and gallbladder cancers. The proprietary AMP
technology allows for ELI-002 to “educate” T cells to recognize the
G12R and G12D KRAS mutations, which allows them to then target
these cancers for elimination. Most other mKRAS-targeted
therapeutics in development — particularly small molecule
mKRAS inhibitors — are only able to target one or two KRAS
mutations. Elicio has developed a broad spectrum 7-peptide
formulation of ELI-002 currently being assessed in a Phase 1/2
study (NCT05726864).
About ELI-002
ELI-002 is a structurally novel investigational
AMP therapeutic immunotherapy targeting mutant KRAS-driven cancers.
KRAS mutations are among the most prevalent human cancers. The
seven KRAS driver mutations targeted by the ELI-002 7P formulation
are present in 25% of all solid tumors. In particular, 93% of
pancreatic ductal adenocarcinoma and 52% of colorectal cancers,
those most prevalent in the AMPLIFY-201 study, are positive for
KRAS mutations. In addition, 27% of non-small cell lung cancers are
positive for KRAS mutations. ELI-002 is comprised of AMP-modified
mutant KRAS peptide antigens and ELI-004, an AMP-modified
immune-stimulatory oligonucleotide CpG adjuvant. The AMP mKRAS
peptides and AMP CpG are targeted to the lymph node where they can
potentially enhance the action of key immune cells.
ELI-002 2P is currently being studied in a Phase
1 trial (AMPLIFY-201) in patients with high relapse risk
mKRAS-driven solid tumors, following surgery and chemotherapy. A
new formulation, ELI-002 7P, is currently being studied in
AMPLIFY-7P, a Phase 1/2 trial in patients with high relapse risk
mKRAS-driven solid tumors. The ELI-002 7P formulation is designed
to provide immune response coverage against seven of the most
common KRAS mutations, thereby increasing the potential patient
population for ELI-002 and potentially reducing the chance of
bypass resistance mechanisms.
About the Amphiphile
Platform
Our proprietary Amphiphile, or AMP, platform
delivers investigational immunotherapeutics directly to the “brain
center” of the immune system — the lymph nodes. We believe
this site-specific delivery of disease-specific antigens, adjuvants
and other immunomodulators may efficiently educate, activate and
amplify critical immune cells, potentially resulting in induction
and persistence of potent adaptive immunity required to treat many
diseases. In preclinical models, we have observed lymph
node-specific engagement driving therapeutic immune responses of
increased magnitude, function and durability. We believe our AMP
lymph node-targeted approach will produce superior clinical
benefits compared to immunotherapies that do not engage the lymph
nodes based upon preclinical studies.
Our AMP platform, originally developed at the
Massachusetts Institute of Technology, or MIT, has broad potential
in the cancer space to advance a number of development initiatives
through internal activities, in-licensing arrangements or
development collaborations and partnerships.
The Amphiphile platform has been shown to
deliver immunotherapeutics directly to the lymph nodes by latching
on to the protein albumin, found in the bloodstream, as it travels
to lymphatic tissue. In preclinical models, we have observed lymph
node-specific engagement driving immune responses of increased
magnitude, function and durability.
About Elicio Therapeutics
Elicio Therapeutics is a clinical-stage
biotechnology company developing a pipeline of novel
immunotherapies for the treatment of cancer. By combining expertise
in immunology and immunotherapy, Elicio is engineering
investigational Amphiphile (AMP) immunotherapies intended to
precisely target and fully engage the lymph nodes, the site in our
bodies where the immune response is orchestrated. Elicio is
engineering lymph node-targeted AMPlifiers, immunomodulators,
adjuvants and vaccines for an array of aggressive cancers.
Elicio began dosing subjects in AMPLIFY-201, its
Phase 1 clinical trial in solid tumor subjects for its lead AMP
immunotherapy, ELI-002 2P, targeting mKRAS-driven cancers, in
October 2021 and began dosing subjects with the new formulation,
ELI-002 7P, in April 2023. The AMP platform emerged from the
laboratories of Darrell Irvine, Howard Hughes Investigator and
Professor of Biomedical Engineering in the Koch Institute of
Integrative Cancer Research at MIT.
Cautionary Statement Regarding
Forward-Looking Statements
Certain statements contained in this
communication regarding matters that are not historical facts, are
forward-looking statements within the meaning of Section 21E of the
Securities and Exchange Act of 1934, as amended, and the Private
Securities Litigation Reform Act of 1995, known as the PSLRA. These
include statements regarding Elicio’s planned clinical programs,
including planned clinical trials and the potential of Elicio’s
product candidates. No forward-looking statement can be guaranteed,
and actual results may differ materially from those projected.
Angion and Elicio undertake no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise, except to the extent required by law.
We use words such as “anticipates,” “believes,” “plans,” “expects,”
“projects,” “future,” “intends,” “may,” “will,” “should,” “could,”
“estimates,” “predicts,” “potential,” “continue,” “guidance,” and
similar expressions to identify these forward-looking statements
that are intended to be covered by the safe-harbor provisions of
the PSLRA. Such forward-looking statements are based on our
expectations and involve risks and uncertainties; consequently,
actual results may differ materially from those expressed or
implied in the statements due to a number of factors, including,
but not limited to: Elicio’s plans to develop and commercialize its
product candidates, including ELI-002; the timing of initiation of
Elicio’s planned clinical trials; the timing of the availability of
data from Elicio’s clinical trials; the timing of any planned
investigational new drug application or new drug application;
Elicio’s plans to research, develop and commercialize its current
and future product candidates; Elicio’s ability to successfully
collaborate with existing collaborators or enter into new
collaborations, and to fulfill its obligations under any such
collaboration agreements; the clinical utility, potential benefits
and market acceptance of Elicio’s product candidates; Elicio’s
commercialization, marketing and manufacturing capabilities and
strategy; Elicio’s ability to identify additional products or
product candidates with significant commercial potential;
developments and projections relating to Elicio’s competitors and
our industry; the impact of government laws and regulations;
Elicio’s ability to protect its intellectual property position; and
Elicio’s estimates regarding future revenue, expenses, capital
requirements and need for additional financing following the
proposed transaction.
New factors emerge from time to time, and it is
not possible for us to predict all such factors, nor can we assess
the impact of each such factor on the business or the extent to
which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any
forward-looking statements. These risks, as well as other risks
associated with the merger, are more fully discussed in the proxy
statement/prospectus/information that is included in the
registration statement on Form S-4 (File No. 333-269741) that was
filed with the SEC and Elicio’s periodic reports and other
documents filed from time to time with the SEC. Forward-looking
statements included in this release are based on information
available to Elicio as of the date of this release. Elicio does not
undertake any obligation to update such forward-looking statements
to reflect events or circumstances after the date of this release,
except to the extent required by law.
Media Contact
Gloria GasaaturaLifeSci
Communicationsggasaatura@lifescicomms.com 646-970-4688
Investor Relations Contact
Heather DiVecchiaElicio
TherapeuticsIR@elicio.com 857-209-0153
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