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 the completion of enrollment in the Phase 2
AMPLIFY-7P study (NCT05726864). The randomized Phase 2 study is
evaluating a 7-peptide formulation of ELI-002 (ELI-002 7P) in
patients with mutant KRAS (“mKRAS”)-driven pancreatic ductal
adenocarcinoma (“PDAC”) who are at high risk of relapse following
surgery. Elicio previously reported AMPLIFY-7P Phase 1a study
results demonstrating a favorable safety profile, robust T-cell
responses, antigen spreading and encouraging preliminary DFS data
in PDAC patients.
“We are pleased to announce the completion of enrollment in our
lead ELI-002 Phase 2 AMPLIFY-7P study. The speed of study
enrollment exceeded our expectations, reflecting high levels of
investigator and patient interest in an off-the-shelf monotherapy
treatment option for patients who completed neoadjuvant,
perioperative, or adjuvant chemotherapy,” said Christopher Haqq,
M.D., Ph.D., Elicio’s Executive Vice President, Head of Research
and Development and Chief Medical Officer. “We are now eagerly
looking forward to the pre-planned interim data analysis as we
continue working to bring this potentially transformative vaccine
to cancer patients.”
The Phase 2 AMPLIFY-7P study is a multicenter, open-label,
randomized trial designed to evaluate the safety, tolerability and
efficacy of ELI-002 7P. The trial enrolled a total of 135 PDAC
patients, who were randomized 2:1 to receive subcutaneous
injections of ELI-002 7P versus standard of care observation.
Patients randomized to observation are eligible to cross-over to
ELI-002 7P treatment in the event of confirmed disease progression.
All patients enrolled in the study had undergone successful (R0/R1)
resection of locoregional PDAC (Stages I, II, or III) harboring
KRAS mutations—including G12D, G12R, G12V, G12C, G12A, G12S or
G13D—and enrollment was agnostic of minimal residual disease
(“MRD”) status. These patients are known to remain at high risk of
disease recurrence.
The primary endpoint of the Phase 2 trial is DFS. Key secondary
and exploratory endpoints include serum tumor biomarker responses,
overall survival, and vaccine immunogenicity. The first patient to
enroll in the Phase 2 study was dosed in January 2024.
A formal interim Phase 2 analysis, including DFS, reviewed by
the study’s Independent Data Monitoring Committee, is on track for
the first half of 2025. Possible outcomes include: (1) successfully
achieving pre-specified criteria for reporting primary endpoint
analysis; (2) continuing to final DFS analysis, expected in the
second half of 2025; or (3) meeting pre-specified criteria for
futility. Results from the single-arm Phase 1a portion of
AMPLIFY-7P, including translational data highlighting the
relationship between vaccine immunogenicity and DFS, were recently
presented at the Society for Immunotherapy of Cancer (“SITC”) 2024
Annual Meeting.
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 Amphiphile (“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
Our 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 our 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
Our proprietary 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 on 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 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, we have 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, 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 the timing of the pre-planned formal interim Phase 2
AMPLIFY-7P data analysis in the first half of 2025 and the possible
outcomes following such analysis; 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
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