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 publication of promising preclinical data
in Cancer Immunology Research, a journal of the American
Association for Cancer Research (“AACR”). These preclinical data
demonstrate that Elicio’s proprietary “AMP” lymph node-targeting
immunotherapy platform, carrying cognate peptide and adjuvant
cargos, boosted T cell receptor-modified T cell therapies (“TCR-T
cells”) enhancing anti-tumor function and eradicating solid tumors.
“Optimization of TCR-T cell therapy could potentially have
wide-ranging therapeutic benefits in many previously intractable
solid tumors,” said Peter DeMuth, Ph.D., Chief Scientific Officer
at Elicio Therapeutics. “In this study, we’ve demonstrated that
boosting TCR-T cell therapy directly in the lymph nodes with AMP
immunotherapy resulted in durable anti-tumor T cell responses and
tumor eradication. The AMP treatment uniquely promoted potent
mechanisms for immune activation in lymph nodes to invigorate both
adoptive and endogenous anti-tumor T cell immunity. Simple
application to a variety of cancer targets including mKRAS, HPV E7
and NY-ESO-1 could elevate existing TCR-T cell therapies to
generate powerful new combinations for hard-to-treat solid
tumors.”
Previous Elicio studies have demonstrated that AMP immunotherapy
promoted specific trafficking and retention of payloads into lymph
nodes, yielding enhanced T cell numbers, persistence and functional
quality. Preliminary Phase 1 data from the ongoing study of
Elicio’s lead asset, ELI-002, an mKRAS-specific AMP vaccine,
demonstrated significant T cell responses including both CD4+ and
CD8+ when administered as an adjuvant monotherapy in patients with
pancreatic and colorectal cancers. The strength of the T cell
response induced by ELI-002 was further correlated to significant
improvements in tumor biomarker response, and reduced risk of
progression and death indicating an association between the ELI-002
mechanism of action and clinical outcome.
Robert Connelly, Chief Executive Officer at Elicio Therapeutics,
added, “This study adds to our growing body of preclinical and
clinical evidence demonstrating the importance of the lymph nodes
and the robust efficacy that our AMP immunotherapy strategy can
potentially achieve for patients with solid tumors, both as a
monotherapy and in combination with other strategies. The AMP
platform provides attractive potential for broad and rapid
application to clinical and developmental TCR-T cell programs. We
look forward to finding the right partner to advance this promising
combination into the clinic for patients with solid tumors.”
Key Study Findings:
- AMP immunotherapy in combination with TCR-T cell therapy led to
complete eradication and durable responses against established
murine solid tumors refractory to TCR-T cell monotherapy.
- AMP immunotherapy led to enhanced lymph node delivery and
correlated with pro-inflammatory lymph node transcriptional
reprogramming and increased antigen-presenting cell maturation,
resulting in TCR-T cell expansion and functional enhancement.
- Enhanced anti-tumor efficacy was correlated with simultaneous
in vivo invigoration of adoptively transferred TCR-T cells and in
situ expansion of the endogenous anti-tumor T cell repertoire.
- AMP immunotherapy enhanced the infiltration and function of
TCR-T cells in the tumor microenvironment and led to epitope
spreading against diverse tumor targets.
- Long-term protection against tumor recurrence in AMP-treated
mice was associated with antigen spreading to additional
tumor-associated antigens not targeted by the treatment.
- In vitro evaluation of AMP peptides with matched human TCR-T
cells targeting NY-ESO-1, mutant KRAS and HPV16 E7 illustrated the
clinical potential of AMP to enhance human TCR-T cell
proliferation, activation and anti-tumor activity.
About the Amphiphile PlatformOur proprietary
Amphiphile (“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 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
available as an off-the-shelf subcutaneous administration. 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 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 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 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
StatementsCertain 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 potential of the AMP platform’s
application to clinical and developmental TCR-T cell programs, 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 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
Elicio to predict all such factors, nor can Elicio assess the
impact of each such factor on Elicio’s 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
Elicio’s 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 ContactKristin PolitiLifeSci
Communicationskpoliti@lifescicomms.com646-876-4783
Investor Relations ContactHeather
DiVecchiaElicio
TherapeuticsIR@elicio.com 857-209-0153
Elicio Therapeutics (NASDAQ:ELTX)
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