Nature Medicine Publishes Updated Preliminary Phase 1 Data From Elicio Therapeutic’s AMPLIFY-201 Phase 1 Solid Tumor Study of ELI-002
09 Januar 2024 - 12:00PM
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 data from the Phase 1
(AMPLIFY-201) study of ELI-002 2P in Nature Medicine. The paper,
“Lymph Node Targeted, mKRAS-specific Amphiphile Vaccine in
Pancreatic and Colorectal Cancer: The phase 1 AMPLIFY-201 Trial”,
details expanded and updated results originally presented at the
2023 American Society of Clinical Oncology (“ASCO”) Annual Meeting
and the 2023 AACR Special Conference on Pancreatic Cancer.
“When tumor DNA or protein persists or recurs after treatment,
patients with pancreatic and colorectal cancers are unfortunately
not left with many options and are often incurable,” said study
author Shubham Pant, M.D., Associate Professor of Gastrointestinal
Medical Oncology at The University of Texas MD Anderson Cancer
Center. “These are promising early findings from the AMPLIFY-201
study with follow up ongoing. Most patients reduced their tumor
biomarkers with some having complete clearance following treatment
with ELI-002.”
Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice
President, Head of Research and Development, and Chief Medical
Officer, added, “Our lymph node-targeted cancer vaccine candidate
induced direct ex vivo mKRAS-specific T cell responses in 84% of
patients, with 59% of patients demonstrating a response with two
key types of T cells – helper cells and killer cells. Past studies
have not seen this large a fraction of patients respond, this high
a magnitude of a response or the expansion of both key populations
of T cells. Importantly, these T cell responses were specific to
tumor-driver mutant KRAS neoantigens, correlated with reduced risk
of relapse and we saw a pool of memory T cells form that we believe
hold promise to confer long-term protection. We look forward to
progressing ELI-002 into a randomized phase 2 trial as a
monotherapy for patients with PDAC.”
Nature Medicine Publication Highlights
- The data is as of September 6, 2023, based on 25 patients with
solid tumors (20 pancreatic, 5 colorectal) who were positive for
minimal residual mKRAS disease after locoregional treatment.
- Direct ex vivo mKRAS-specific T cell responses were observed in
21/25 patients (84%; 59% both CD4+ and CD8+).
- Tumor biomarker responses were observed in 21/25 patients (84%)
and biomarker clearance in 6/25 patients, as determined by
tumor-informed circulating tumor DNA (24%; 3 pancreatic, 3
colorectal).
- At 8.5 months median follow-up the median RFS of the 25-patient
cohort was 16.33 months.
- Efficacy correlated with T cell response (≥ versus < median:
12.75-fold over baseline):
- Median tumor biomarker reduction was -76.0% compared to -10.2%
in above versus below median T cell responders, respectively
(p<0.0014).
- Median RFS was not reached compared to 4.01 months in above
versus below median T cell responders, respectively (HR 0.14, 95%
CI 0.03 to 0.63, p=0.0167).
- Patients with greater than median T cell response had an 86%
reduction in the risk of progression or death.
- The association of RFS with T cell response was not correlated
to baseline prognostic variables including tumor stage, recovery
from prior cytotoxic therapy as assessed by absolute neutrophil
count or immune system subsets such as %CD4+ or %CD8+ of CD3+
lymphocytes.
- RFS was shorter in patients who began treatment with a low
absolute lymphocyte count.
- No safety concerns were identified, and no dose limiting
toxicities and no ≥ grade 3 treatment related adverse events were
observed.
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 1/2 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 Amphiphile (“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
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
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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 initiate a randomized
phase 2 trial studying ELI-002 as a monotherapy in adjuvant PDAC
patients early in 2024; 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 the 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
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