Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics”
or “Elicio”), a clinical-stage biotechnology company developing a
pipeline of novel immunotherapies for the treatment of cancer,
today announced promising preliminary relapse-free survival
(RFS) data from the ongoing Phase 1 (AMPLIFY-201) study of its lead
asset, ELI-002. This study evaluated ELI-002 2P, a 2-peptide
formulation designed to treat cancers driven by G12D and G12R
mutations in KRAS, as a monotherapy in patients with mutant
KRAS-driven solid tumors. The data will be presented September 29th
from 4:40pm – 6:40pm ET at the AACR Special Conference on
Pancreatic Cancer in Boston, Massachusetts, taking place from
September 27-30, 2023.
“Patients with mutant KRAS cancers, particularly
pancreatic and colorectal cancers, have a poor prognosis with
limited treatment options when tumor DNA or protein biomarkers are
detected after standard surgery and chemotherapy. We are encouraged
by the early data showing ELI-002 induced T cells can positively
impact clinical endpoints including the risk of relapse and death
in this study,” 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).
Christopher Haqq, M.D., Ph.D., Elicio’s
Executive Vice President, Head of Research and Development, and
Chief Medical Officer, added, “These data provide further support
for ELI-002’s mechanism of action and the potential benefit of a
lymph node-targeted cancer vaccine. With the data presented here
and the data previously reported at ASCO 2023, we have shown
ELI-002’s induction of a potent mKRAS-specific T cell response,
including both CD4 and CD8 populations, correlated with tumor
biomarker responses, which the data suggest may lead to improved
clinical outcomes. We are encouraged by these early observations
and look forward to continuing to follow and report additional
clinical and biomarker data on the AMPLIFY-201 study. Additionally,
the AMPLIFY-7P study’s independent data monitoring committee
supported initiation of a randomized phase 2 trial studying ELI-002
7P as a monotherapy in adjuvant PDAC patients.”
Presentation Summary:
Title: T cell responses and
clinical outcomes in pancreatic and colorectal cancer patients with
Minimal Residual Disease in AMPLIFY-201, a phase 1 trial of a
first-in-class amphiphile lymph node targeted mutant KRAS
vaccineSession: Poster Session
CPresenter: 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 in patients with mutant KRAS-driven tumors who are at
high risk for relapse due to detection of MRD following standard
surgery and chemotherapy.
- The analysis involved patients with
resected PDAC (n=20) or CRC (n=5) tumors harboring KRAS G12D or
G12R who had MRD defined as elevated ctDNA and/or serum tumor
biomarker (CA19-9/CEA).
- Patients received up to six priming
doses and four booster doses separated by a 3-month rest period of
subcutaneous ELI-002 2P vaccine monotherapy comprised of
Amph-peptides (700 mcg each G12D/G12R), admixed with Amph-CpG-7909
at 0.1, 0.5, 2.5, 5.0 and 10.0 mg per cohort dose level.
- Primary endpoints included safety
and the recommended Phase 2 dose (RP2D) of Amph-CPG-7909, and the
secondary endpoint included biomarker reduction/clearance.
- Exploratory endpoints included RFS
using immune Response Evaluation Criteria in Solid Tumors (iRECIST)
and immunogenicity assessed by direct ex vivo Fluorospot
and intracellular cytokine staining of peripheral blood mononuclear
cells.
Preliminary Study Findings
- Direct ex vivo polyfunctional
mKRAS-specific T cell responses to ELI-002 2P were observed in
20/23 (87%; 50% induced both CD4+ and CD8+ T cells,
median 13-fold and mean 56-fold increase from baseline), with T
cell response in 9/9 (100%) patients treated at the highest two
dose levels including the 10 mg RP2D.
- The median RFS in evaluable pts
(n=22) was 16.3 months, and the median OS has not been
reached.
- Tumor biomarker response was
observed in 17/22 (77%), with clearance in 6/22 (27%).
- Clinical efficacy correlated with T
cell response:
- Median tumor biomarker
reduction/clearance was -86.9% vs -1.0% in above vs below median T
cell responders, respectively (p < 0.0017).
- At 7.6 months median follow-up, the
median RFS was not reached compared to 3.9 months in above versus
below median T cell responders (HR 0.14; 95% CI 0.03-0.61; p =
0.013).
- The association of RFS with T cell
response was not confounded by other baseline prognostic variables
(including tumor stage, recovery from prior cytotoxic therapy as
assessed by absolute neutrophil count or immune system subsets such
as %CD4+ or %CD8+ of CD3+ lymphocytes).
- No safety concerns were identified,
and there were no dose limiting toxicities and no ≥ Grade 3
treatment related adverse events.
About ELI-002ELI-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 (NCT04853017). 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 (NCT05726864). 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
PlatformOur 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 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 TherapeuticsElicio
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.
Cautionary Note on 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 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, the potential of Elicio’s
product candidates, the expected participation and presentation at
upcoming conferences, and other statements regarding management’s
intentions, plans, beliefs, expectations or forecasts for the
future, and, therefore, you are cautioned not to place undue
reliance on them. No forward-looking statement can be guaranteed,
and actual results may differ materially from those projected.
Elicio undertakes 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 the
availability of data from Elicio’s clinical trials; Elicio’s plans
to initiate a randomized phase 2 trial studying ELI-002 7P as a
monotherapy in adjuvant PDAC patients early in 2024; Elicio’s plans
to research, develop and commercialize its current and future
product candidates; Elicio’s ability to enter into new
collaborations, in-licensing arrangements or partnerships, and to
fulfill its obligations under any such 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; and developments and projections relating to
Elicio’s competitors and our industry.
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 are more fully discussed in
the current report on Form 8-K that was filed with the SEC on June
2, 2023 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 ContactGloria GasaaturaLifeSci
Communicationsggasaatura@lifescicomms.com646-970-4688
Investor Relations ContactHeather
DiVecchiaElicio TherapeuticsIR@elicio.com857-209-0153
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