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 preliminary data from the ongoing AMPLIFY-7P Phase
1a study of its off-the-shelf investigational therapeutic cancer
vaccine candidate, ELI-002 7P, in a poster presentation at the
American Society of Clinical Oncology (“ASCO”) Annual Meeting,
being held May 31-June 4, 2024, in Chicago, IL. The preliminary
data showed ELI-002 7P was well tolerated with T cell responses
correlating with a reduction in tumor biomarkers at the recommended
Phase 2 dose (“RP2D”).
The AMPLIFY-7P study is evaluating the 7-peptide formulation of
Elicio’s cancer vaccine candidate, ELI-002 7P, in patients with
mKRAS-driven solid tumors that are positive for minimal residual
disease following standard locoregional treatment. ELI-002 7P was
developed with Elicio’s proprietary lymph node-targeting Amphiphile
(“AMP”) technology designed to stimulate an immune response against
the seven KRAS mutations (G12D, G12R, G12V, G12A, G12C, G12S and
G13D) that drive 25% of all solid tumors.
“KRAS mutated cancers are difficult to target in part due to the
number of diverse mutations and bypass resistance mechanisms. We
are encouraged by the first data from the ongoing AMPLIFY-7P trial,
which demonstrate ELI-002 7P has a favorable safety profile and
early antitumor effects that correlate with induction of T cells
specific for multiple KRAS mutations potentially providing broader
coverage for patients,” said Craig E. Devoe, M.D., MHCM., Chief,
Division of Medical Oncology & Hematology, R.J. Zuckerberg
Cancer Center, and Scientific Investigator, Northwell Health.
Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice
President, Head of Research and Development, and Chief Medical
Officer, added, “These early immunogenicity and biomarker response
data from ELI-002 7P continue to provide encouraging results
showing that our lymph node-targeted approach generates a robust
and differentiated T cell response that strongly correlates with
tumor biomarker reductions. Across two trials, ELI-002 has
demonstrated an ability to generate a robust T cell response
against all mKRAS mutations of enrolled patients as well as T cell
responses against non-immunizing personalized tumor neoantigens.
ELI-002’s broader KRAS mutation coverage and higher T cell
responses with the 7-peptide vaccine at the Phase 2 dose holds
promise for the high unmet need of patients with KRAS-mutated
tumors.”
Presentation Details
ASCO 2024 Abstract Title: AMPLIFY-7P, a
first-in-human safety and efficacy trial of adjuvant mKRAS-specific
lymph node targeted amphiphile ELI-002 7P vaccine in patients with
minimal residual disease–positive pancreatic and colorectal
cancerAbstract Number: 2636Session Type
and Title: Poster Session – Developmental
Therapeutics—ImmunotherapySession Date and Time:
June 1, 2024, 9:00 AM-12:00 PM CDT (10:00 AM-1:00 PM
ET)Presenter: Craig E. Devoe, M.D., MHCM., Chief,
Division of Medical Oncology & Hematology, R.J Zuckerberg
Cancer Center, and Scientific Investigator, Northwell Health
- At data cutoff December 18, 2023, polyfunctional mKRAS-specific
T cells were observed in 100% (n = 11/11) of evaluable
patients.
- Both CD8+ and CD4+ responses were induced in 66.7% (4/6) of
evaluable patients, at the RP2D 4.9 mg dose level, with higher
median fold-change from baseline.
- Biomarker reductions were observed in 2/5 (40%) at the 1.4 mg
AMP-Peptides 7P dose level and in 5/7 (71%) at the RP2D 4.9 mg dose
level in patients with reductions/clearance observed for all the
common G12 (G12D, G12V, G12R) and G13 (D) KRAS mutations enrolled
in the study to date.
- Minimum residual disease clearance was observed in one (1) G12V
pancreatic (PDAC) patient at 4.9 mg.
- Antigen-spreading was observed with increased T cell responses
targeting non-immunizing, personalized tumor neoantigens observed
in 7/10 (70%) evaluable patients, 6/6 (100%) evaluable patients
treated at the 4.9 mg RP2D dose level.
- There were no dose-limiting toxicities, no treatment-related
serious adverse events or cytokine release syndrome.
- The recommended Phase 2 dose (RP2D) is 10.0 mg AMP-CpG-7909
with 4.9 mg AMP-Peptides 7P.
About ELI-002 Our lead product candidate,
ELI-002, is a structurally novel investigational Amphiphile (“AMP”)
cancer vaccine that targets cancers that are driven by mutations in
the mKRAS-gene—a prevalent driver of many human cancers. ELI-002 is
comprised of two powerful components that are built with our AMP
technology consisting of AMP-modified mutant KRAS peptide antigens
and an AMP-modified CpG adjuvant that is available as an
off-the-shelf subcutaneous administration.
ELI-002 2P (2 peptide formulation) is currently being studied in
an ongoing 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 Elicio Therapeutics Elicio
Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology
company advancing a pipeline of novel lymph node-targeted
immunotherapies for the treatment of some of the most aggressive
cancers. By combining expertise in immunology and immunotherapy,
Elicio is harnessing the natural power of the immune system with
the AMP technology, which allows for therapeutic payloads to be
delivered directly to the lymph nodes, with the goal of enhancing
the immune system’s cancer-fighting capabilities. By targeting
cancer immunotherapies to the core of the immune response, AMP aims
to optimize the lymph nodes’ natural ability to educate, activate
and amplify cancer-specific T cells, which are essential for
recognizing and eliminating tumor cells. Engineered to synchronize
immunity in these highly potent sites, AMP is built to enhance the
magnitude, potency, quality and durability of the immune response
to drive antitumor activity. The Company’s R&D pipeline
includes off-the-shelf therapeutic cancer vaccines ELI-002,
(targeting mKRAS-driven cancers) as well as ELI-007 and ELI-008
(targeting BRAF-driven cancers and p53 hotspot mutations,
respectively). For more information, please visit
www.elicio.com.
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, including the promise of ELI-002 7P for the
high unmet need of patients with KRAS-mutated tumors, 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
financial condition, including its 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; 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; Elicio’s
ability to advance ELI-002 outside of PDAC monotherapy and Elicio’s
pipeline programs; 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.
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
our Annual Report on Form 10-K filed with the SEC on March 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.
Media ContactKristin PolitiLifeSci
Communicationskpoliti@lifescicomms.com646-876-4783
Investor Relations ContactHeather
DiVecchiaElicio TherapeuticsIR@elicio.com857-209-0153
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