Evelo Biosciences Presents New Preclinical Data for Extracellular Vesicle Anti-inflammatory Product Candidate EDP2939 at the ...
May 13 2021 - 7:00AM
Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage
biotechnology company developing a new modality of orally delivered
medicines, today presented preclinical data for its extracellular
vesicle (EV) product candidate, EDP2939, for the treatment of
inflammatory diseases, at Virtual IMMUNOLOGY2021, the 104th Annual
Meeting of the American Association of Immunologists (AAI). The
poster presentation showed that EDP2939, which is gut-restricted
after oral administration, gave broad-based resolution of
inflammation in preclinical mouse models, with no apparent safety
or tolerability concerns.
“Evelo has demonstrated preclinically and clinically the
therapeutic potential of products that engage the small intestinal
axis, SINTAX™,” said Mark Bodmer, Ph.D., Chief Scientific Officer
of Evelo. “Our research and development teams continue to explore
ways to optimize our product candidates through new forms and
formulations, including our preclinical work with oral EVs. We are
pleased to share new data for our first anti-inflammatory EV
product candidate, EDP2939, which demonstrated potent systemic
anti-inflammatory activity after oral administration in mouse
models. These results support the potential of EVs as the next
generation of Evelo’s SINTAX medicines and a foundation for our
next phase of growth. We look forward to initiating the clinical
development of EDP2939 in 2022.”
EDP2939: Orally Delivered EV for Inflammatory
DiseasesIn the preclinical study presented at AAI, mice
undergoing a delayed-type hypersensitivity (DTH) reaction against
keyhole limpet hemagglutinin (KLH) were treated with EDP2939,
EDP2939 in combination with different antibodies, or with placebo.
These data suggest that EDP2939 requires the stimulation of both
the TLR2 receptor and the IL-10 receptor, in addition to lymphocyte
homing to the intestinal lymphoid tissue. Also, in-vitro, EDP2939
induces TLR2-dependent release of IL-10. Fluorescent
biodistribution analysis showed that EDP2939 was not detected
outside the gastrointestinal tract. The data suggest that treatment
with EDP2939 resulted in broad-based resolution of inflammation and
the establishment of immune homeostasis, with no apparent adverse
safety or tolerability effects preclinically, providing key
insights into the pharmacologic effects, mechanism of action, and
biodistribution of EDP2939.
EDP2939 is now in preclinical development for the treatment of
inflammatory diseases; initiation of clinical development is
anticipated in 2022.
About Extracellular VesiclesSome bacteria
produce EVs that share molecular content with the parent bacterium,
in particles that are roughly one-one thousandth the volume and are
not capable of self-replicating. EVs enable bacterial
communication and survival during stress, host-immune modulation,
material exchange and cell-cell interactions. The
significantly smaller size of EVs compared to microbes enables
improved distribution and target engagement.
About EDP2939 EDP2939 is an investigational
orally delivered and gut-restricted bacterial extracellular vesicle
being developed for the treatment of inflammatory diseases. It
is derived from a single gram-negative bacterial strain of
Prevotellaceae, selected for its anti-inflammatory pharmacological
properties. Preclinically, EDP2939 had anti-inflammatory activity
in murine models of Th1 and Th17 inflammation.
About Evelo BiosciencesEvelo Biosciences is a
clinical stage biotechnology company developing orally delivered
medicines that act on SINTAX™, the small intestinal axis, to have
systemic therapeutic effects. SINTAX plays a central role in
governing the immune, metabolic, and neurological systems. Evelo
currently has four product candidates in development: EDP1815,
EDP1867, and EDP2939 for the treatment of inflammatory diseases and
EDP1908 for the treatment of cancer. Evelo is advancing additional
product candidates in other disease areas.
For more information, please
visit www.evelobio.com and engage with Evelo
on LinkedIn.
Forward Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including statements concerning the development of EDP2939, the
promise and potential impact of EDP2939, and the timing of and
plans for clinical trials of EDP2939.
These forward-looking statements are based on management's
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: the impact of the COVID-19 pandemic on our operations,
including our preclinical studies and clinical trials, and the
continuity of our business; we have incurred significant losses,
are not currently profitable and may never become profitable; our
need for additional funding; our limited operating history; our
unproven approach to therapeutic intervention; the lengthy,
expensive, and uncertain process of clinical drug development,
including potential delays in regulatory approval; our reliance on
third parties and collaborators to expand our microbial library,
conduct our clinical trials, manufacture our product candidates,
and develop and commercialize our product candidates, if approved;
our lack of experience in manufacturing, selling, marketing, and
distributing our product candidates; failure to compete
successfully against other drug companies; protection of our
proprietary technology and the confidentiality of our trade
secrets; potential lawsuits for, or claims of, infringement of
third-party intellectual property or challenges to the ownership of
our intellectual property; our patents being found invalid or
unenforceable; risks associated with international operations; our
ability to retain key personnel and to manage our growth; the
potential volatility of our common stock; our management and
principal stockholders have the ability to control or significantly
influence our business; costs and resources of operating as a
public company; unfavorable or no analyst research or reports; and
securities class action litigation against us.
These and other important factors discussed under the caption
"Risk Factors" in our Quarterly Report on Form 10-Q for the three
months ended March 31, 2021 and our other reports filed with the
SEC could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management's
estimates as of the date of this press release. While we may elect
to update such forward-looking statements at some point in the
future, except as required by law, we disclaim any obligation to do
so, even if subsequent events cause our views to change. These
forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
ContactJessica Cotrone,
978-760-5622jcotrone@evelobio.com
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