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

– AI-powered technology enables rapid, simultaneous progress of antibodies against challenging targets –

BRYAN, Texas and SAN DIEGO, Aug. 14, 2023 (GLOBE NEWSWIRE) -- 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 Kilmer
iBio, Inc.
Investor Relations
(646) 274-3580
skilmer@ibioinc.com

Susan Thomas
iBio, Inc.
Media Relations
(619) 540-9195
Sthomas@ibioinc.com

Released August 14, 2023