iBio Reports Triple Milestone: In Vivo Proof-of-Concept for Three Programs, a Transformative Step in Advancing its Immuno-Oncology Pre-Clinical Pipeline Towards Clinical Development
14 Agosto 2023 - 10:15PM
iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”), an AI-driven
innovator of precision antibody immunotherapies, today announced
positive pre-clinical in vivo data for three immuno-oncology
candidates, anti-EGFRvIII, CCR8 and a bispecific TROP-2 x CD3,
advancing these programs to clinical candidate selection stage.
The anti-EGFRvIII antibody was specially
engineered to enhance its ability to attack cancer cells and has
proven effective in a mouse model for head and neck cancer. In
preclinical studies, iBio’s anti-EGFRvIII antibody demonstrated a
43 percent reduction in tumor growth compared to untreated animals.
iBio developed the antibody using its patented AI epitope steering
technology. This innovative approach allows iBio to target a
specific variant of the Epidermal Growth Factor Receptor (EGFR)
found in tumors without affecting the normal version of the
receptor present in healthy tissue. By focusing solely on the
tumor-specific variant, iBio aims to reduce potential side
effects.
In addition to the anti-EGFR program, iBio’s
CCR8 antibody has proven effective in a mouse model for colon
cancer. Preclinical studies show the anti-CCR8 molecule inhibited
tumor growth and achieved a 22 percent reduction in tumor size
compared to its pre-treatment dimensions. Using its patented AI
epitope steering platform, iBio specifically engineered the
anti-CCR8 molecule to enhance its ability to attack cancer cells
without affecting its close relative, CCR4, even though their
binding regions are highly similar. This selective targeting
demonstrates the power of iBio's epitope steering platform and is
believed to minimize potential side effects.
In a recent study involving a humanized mouse
model of squamous cell carcinoma, iBio’s TROP-2 x CD3 bi-specific
antibody demonstrated a significant 36 percent reduction in tumor
size within just 14 days after tumor implantation, and after only a
single dose. iBio's TROP-2 x CD3 was engineered using its
proprietary EngageTx™ T-cell engager antibody platform, which
represents a cutting-edge approach to developing next-generation
bispecific antibodies for immuno-oncology applications. TROP-2 x
CD3 is a bispecific antibody targeting an overexpressed cell
surface protein in multiple solid tumors, including breast, lung,
colorectal, and pancreatic cancers. iBio is currently exploring
whether the molecule also shows efficacy in other solid tumors.
Dillon Phan, PhD, iBio’s VP and Head of Early
R&D, commented, “The swift and concurrent achievement of in
vivo proof-of-concept for three of our pre-clinical programs
showcases the power of our AI-enabled technology and the relentless
dedication and focus of our drug discovery team. The development of
bispecific antibodies, such as TROP-2 x CD3, is particularly
challenging, so we are especially pleased with the recent addition
of the T-cell engager platform, EngageTx, to our tech stack, which
has enabled the discovery and advancement of this candidate so
quickly. We are excited about the potential to further develop and
initiate IND-enabling studies for all three molecules to support
the continued advancement of iBio’s therapeutic pre-clinical
pipeline.”
About iBio, Inc.
iBio develops next-generation biopharmaceuticals
using computational biology and 3D-modeling of subdominant and
conformational epitopes, prospectively enabling the discovery of
new antibody treatments for hard-to-target cancers and other
diseases. iBio’s mission is to decrease drug failures, shorten drug
development timelines, and open up new frontiers against the most
promising targets. For more information, visit www.ibioinc.com.
FORWARD-LOOKING STATEMENTS
Certain statements in this press release
constitute "forward-looking statements" within the meaning of the
federal securities laws. Words such as "may," "might," "will,"
"should," "believe," "expect," "anticipate," "estimate,"
"continue," "predict," "forecast," "project," "plan," "intend" or
similar expressions, or statements regarding intent, belief, or
current expectations, are forward-looking statements. These
forward-looking statements are based upon current estimates and
assumptions and include statements regarding the Company’s
anti-EGFRvIII antibody reducing potential side effects by focusing
solely on the tumor-specific variant and the potential to further
develop and initiate IND-enabling studies for all three molecules
to support the continued advancement of the Company’s therapeutic
pre-clinical pipeline. While the Company believes these
forward-looking statements are reasonable, undue reliance should
not be placed on any such forward-looking statements, which are
based on information available to us on the date of this release.
These forward-looking statements are subject to various risks and
uncertainties, many of which are difficult to predict that could
cause actual results to differ materially from current expectations
and assumptions from those set forth or implied by any
forward-looking statements. Important factors that could cause
actual results to differ materially from current expectations
include, among others, the Company’s ability to generate successful
results from the molecules, including reducing side effects,
continue to execute its growth strategy; its ability to obtain
regulatory approvals for commercialization of its product
candidates, or to comply with ongoing regulatory requirements;
regulatory limitations relating to its ability to promote or
commercialize its product candidates for specific indications;
acceptance of its product candidates in the marketplace and the
successful development, marketing or sale of products; its ability
to maintain its license agreements; the continued maintenance and
growth of its patent estate; its ability to obtain or maintain the
capital or grants necessary to fund its research and development
activities and whether the Company will incur unforeseen expenses
or liabilities or other market factors; successful compliance with
governmental regulations applicable to its manufacturing facility;
competition; its ability to retain its key employees or maintain
its NYSE American listing; and the other factors discussed in the
Company’s filings with the SEC including the Company’s Annual
Report on Form 10-K for the year ended June 30, 2022 and the
Company’s subsequent filings with the SEC on Forms 10-Q and 8-K.
The information in this release is provided only as of the date of
this release, and the Company undertakes no obligation to update
any forward-looking statements contained in this release on account
of new information, future events, or otherwise, except as required
by law.
Contacts:
Stephen KilmeriBio, Inc.Investor Relations(646)
274-3580skilmer@ibioinc.com
Susan ThomasiBio, Inc.Media Relations(619)
540-9195Sthomas@ibioinc.com
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