Elicio Therapeutics Announces Preliminary Disease-Free Survival analysis from the Ongoing AMPLIFY-7P Phase 1a Study of ELI-002 7P
27 Giugno 2024 - 10:01PM
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 new preliminary data from the ongoing AMPLIFY-7P
Phase 1a study of its off-the-shelf investigational therapeutic
cancer vaccine candidate, ELI-002 7P. The preliminary data showed
patients receiving ELI-002 7P at the Phase 2 dose of 4.9mg
AMP-peptide were yet to reach the median disease-free survival
(“DFS”) endpoint as of the May 24, 2024 data cutoff date.
The AMPLIFY-7P study is evaluating the 7-peptide
formulation, ELI-002 7P, in patients with mKRAS-driven solid tumors
following standard locoregional treatment. Data were based on the
May 24, 2024 data cutoff date of 14 patients with minimal residual
disease who enrolled in the Phase 1 cohort of the AMPLIFY-7P study,
with a median follow up for the DFS endpoint of 29.1 weeks:
- The median DFS has not yet been
reached (n=14).
- The median disease-free survival
(“mDFS”) has not been reached in patients receiving the 4.9mg
AMP-peptide dose (n=8) vs. 12.6 weeks for patients receiving the
1.4mg AMP-peptide dose (n=6).
- Patients achieving a reduction in
their tumor biomarker levels had no progression events vs. mDFS of
11.0 weeks for patients whose tumor biomarker did not respond to
ELI-002 7P.
- Patients with an above median T cell
response to ELI-002 have had no progression events.
Christopher Haqq, M.D., Ph.D., Elicio’s Executive
Vice President, Head of Research and Development, and Chief Medical
Officer, added, “We are encouraged to see patients who received the
7-peptide version of ELI-002 at the Phase 2 dose continuing to do
well at this early timepoint of the Phase 1 trial. Furthermore, the
DFS data from the entire 14-patient cohort correlate strong T cell
response after receiving ELI-002 with reductions in their tumor
biomarker levels and reduced risk of progression or death. These
findings replicate the results in the AMPLIFY-2P trial of similar
patients published in Nature Medicine. We look forward to providing
additional clinical data updates from the AMPLIFY Phase 1 trials
expected later in 2024 and the randomized Phase 2 interim analysis
expected in first quarter of 2025.”
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, 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 initiation of
Elicio’s planned clinical trials; the timing of the availability of
data from Elicio’s clinical trials, including additional clinical
data updates from the AMPLIFY Phase 1 trials anticipated later in
2024 and the randomized Phase 2 interim analysis anticipated in the
first quarter of 2025; and Elicio’s plans to research, develop and
commercialize its current and future product candidates.
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, 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 ContactBrian PiekosElicio
TherapeuticsIR@elicio.com857-209-0153
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