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,
presented updated results from the Phase 1 AMPLIFY-201 clinical
trial (NCT04853017) of ELI-002, an Amphiphile (“AMP”) cancer
vaccine that targets KRAS-mutant tumors, at the ESMO
Immuno-Oncology Congress 2024 in Geneva, Switzerland. ELI-002 was
evaluated in individuals with mutant KRAS (“mKRAS”)-driven
colorectal or pancreatic cancer with residual circulating tumor DNA
and/or serum tumor biomarkers, who remain at high risk of disease
recurrence following standard locoregional treatment. The updated
clinical results, featured in an oral presentation by Shubham Pant,
M.D., MBBS, of the University of Texas, MD Anderson Cancer Center,
build upon earlier results published in Nature Medicine. With a
median study follow-up of 19.7 months, ELI-002 continues to show a
favorable safety profile, the ability to elicit mKRAS-specific T
cell responses in most patients, and encouraging efficacy data with
respect to mRFS and mOS.
Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice
President, Head of Research and Development and Chief Medical
Officer, added, “With longer follow-up from AMPLIFY-201, we are
encouraged that individuals who received ELI-002 are continuing to
do well, exceeding expectations based on historical cohorts of
similar populations with KRAS-mutant pancreatic and colorectal
cancers. Furthermore, these data show a strong correlation between
T cell response, tumor biomarker reductions, and reduced risk of
progression or death—which was also observed in the Phase 1 portion
of our AMPLIFY-7P trial. As we continue working to bring this
potentially transformative off-the-shelf vaccine to cancer
patients, we look forward to the interim analysis of the randomized
Phase 2 portion of AMPLIFY-7P, expected in the first half of
2025.”
AMPLIFY-201 is a multicenter, open-label, dose-ranging Phase 1
study designed to evaluate the safety and tolerability of the
ELI-002 two-peptide formulation (ELI-002 2P). The trial enrolled a
total of 25 individuals—including 20 with pancreatic ductal
adenocarcinoma (“PDAC”) and five with colorectal cancer (“CRC”). To
qualify for enrollment, all study patients underwent successful
(R0/R1) surgical resection of tumors harboring two common KRAS
mutations (G12D and G12R) but remained at high risk of relapse
based on positive minimal residual disease (MRD) status. A
seven-peptide formulation of ELI-002 (ELI-002 7P), designed to
target additional KRAS mutations (G12D, G12R, G12V, G12C, G12A,
G12S and G13D), is currently being evaluated in a fully-enrolled,
randomized Phase 2 study (NCT05726864), which an interim analysis
is expected in H1 2025.
The presentation featured updated mRFS and mOS data (data cutoff
September 24, 2024) as well as previously-presented safety,
immunogenicity and biomarker response data (data cutoff September
6, 2023) from 25 evaluable individuals who received doses of
ELI-002 2P ranging from 0.1 mg to 10.0 mg. Key observations
include:
- A 16.3-month mRFS and 28.9-month mOS
for the full study cohort (n=25)
- mRFS has not yet been reached in
patients with above-median T cell responses (n=13); patients who
achieved below-median T cell responses (n=12) achieved a 4.0-month
mRFS (HR=0.226; p=0.0184)
- Similar mRFS was observed between
the PDAC subgroup (15.3 months; n=20), the CRC subgroup (16.3
months; n=5) and the full study cohort (16.3 months; n=25)
- 28.9-month mOS was identical for the
PDAC subgroup and the full study cohort, comparing favorably to a
historical PDAC control group (Groot et al., 2019. Clin Cancer Res
25:4973); mOS was not reached in the CRC subgroup (n=5)
- Ex vivo expansion of mKRAS-specific
T cells with concomitant tumor biomarker reductions in most
patients
- ELI-002 2P was well-tolerated, with no Grade 3/4
treatment-emergent adverse events, dose-limiting toxicities or
cases of cytokine release syndrome observed
About Elicio Therapeutics
Elicio Therapeutics, Inc. (Nasdaq: ELTX)
is a clinical-stage biotechnology company advancing novel
immunotherapies to prevent the recurrence of high-prevalence
cancers, including mKRAS-positive pancreatic and colorectal
cancers. Elicio intends to build on recent clinical successes in
the personalized cancer vaccine space to develop effective,
off-the-shelf vaccines. Elicio’s AMP technology aims to enhance the
education, activation, and amplification of cancer-specific T
cells relative to conventional vaccination strategies, with the
goal of promoting durable cancer immunosurveillance in
patients. Elicio’s ELI-002 lead program is an off-the-shelf
vaccine candidate targeting the most common KRAS mutations, which
drive approximately 25% of all solid tumors. ELI-002 is being
studied in an ongoing, randomized clinical trial in patients with
mKRAS-positive pancreatic cancer who completed standard therapy but
remain at high risk of relapse. Elicio’s pipeline includes
additional off-the-shelf therapeutic cancer vaccines, including
ELI-007 and ELI-008, that target BRAF-driven cancers and p53
hotspot mutations, respectively. For more information, please
visit www.elicio.com.
About ELI-002
Elicio’s lead product candidate, ELI-002, is a structurally
novel investigational AMP cancer vaccine that targets cancers that
are driven by mutations in the KRAS-gene—a prevalent driver of many
human cancers. ELI-002 is comprised of two powerful components that
are built with Elicio’s AMP technology consisting of AMP-modified
mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG
oligodeoxynucleotide adjuvant that is available as an off-the-shelf
subcutaneous administration.
ELI-002 2P (2-peptide formulation) has been studied in the Phase
1 (AMPLIFY-201) trial in patients with high relapse risk
mKRAS-driven solid tumors, following surgery and chemotherapy
(NCT04853017). ELI-002 7P (7-peptide formulation) is currently
being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with
mKRAS-driven pancreatic cancer (NCT05726864). The ELI-002 7P
formulation is designed to provide immune response coverage against
seven of the most common KRAS mutations present in 25% of all solid
tumors, thereby increasing the potential patient population for
ELI-002.
About the Amphiphile Platform
Elicio’s proprietary AMP platform delivers investigational
immunotherapeutics directly to the “brain center” of the immune
system – the lymph nodes. Elicio believes 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, Elicio observed lymph
node-specific engagement driving therapeutic immune responses of
increased magnitude, function and durability. Elicio believes its
AMP lymph node-targeted approach will produce superior clinical
benefits compared to immunotherapies that do not engage the lymph
nodes based on preclinical studies.
Elicio’s 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 AMP platform has been shown to deliver immunotherapeutics
directly to the lymph nodes by latching on to the protein albumin,
found in the local injection site, as it travels to lymphatic
tissue. In preclinical models, Elicio observed lymph node-specific
engagement driving immune responses of increased magnitude,
function and durability.
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 medical meetings, 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 financial condition, including its
anticipated cash runway and ability to obtain the funding necessary
to advance the development of ELI-002 and any other future product
candidates, and Elicio’s ability to continue as a going concern;
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, including interim analysis of the
randomized Phase 2 portion of the AMPLIFY-7P trial, expected in the
first half of 2025; 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; and Elicio’s estimates regarding future revenue,
expenses, capital requirements and need for additional
financing.
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 Annual Report on Form
10-K filed with the SEC on March 29, 2024, as amended on April 29,
2024, under the heading “Risk Factors”, and any subsequent 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.
Investor Relations Contact
Carlo Tanzi, Ph.D.ctanzi@kendallir.com
Elicio Therapeutics (NASDAQ:ELTX)
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