iBio Expands Tech Stack with EngageTx™; Adds TROP-2 Bispecific to Development Pipeline

BRYAN, Texas and SAN DIEGO, June 06, 2023 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA:IBIO) (“iBio” or the “Company”) today announced the expansion of its AI-powered technology stack with the launch of EngageTx, a proprietary T-cell engager antibody panel designed for developing bispecific antibodies for immuno-oncology applications. Through comprehensive screening and optimization techniques, iBio has identified highly potent, fully human TROP-2 (Trophoblast Cell Surface Antigen 2) monoclonal antibodies, which have been formatted into bispecific TROP-2 x CD3 molecules using EngageTx.

EngageTx comprises a robust array of CD3-binding antibodies, designed to be paired with tumor-targeting antibodies, such as TROP-2. This combination yielded a potent bispecific molecule that effectively mobilizes T-cells to unleash their anti-cancer capabilities against malignant cells. While iBio discovered the panel earlier this year, the Company is now deploying it internally, as well as offering it for use in potential future commercial partnerships.

“By strategically employing bispecific antibodies targeting TROP-2, we aim to stimulate the immune system for treating TROP-2-positive cancers, offering potential advantages over existing therapies,” said iBio’s Interim Chief Executive Officer and Chief Scientific Officer, Martin Brenner, DVM, Ph.D. “The generation of a highly potent TROP-2 bispecific with reduced cytokine release offers validation of our technology and its differentiated capabilities. We look forward to harnessing EngageTx to enrich our pipeline and offering this tremendous potential resource to prospective partners.”

TROP-2 is highly expressed in multiple solid tumors, including breast, lung, colorectal, and pancreatic cancers and is closely linked to metastasis and tumor growth. TROP-2 antibody drug conjugates have been developed to deliver toxic payloads to these cancer cells but could risk harming healthy cells and cause adverse effects. The Company’s bispecific approach has the potential to increase the therapeutic window, while promoting a robust and long-lasting anti-tumor response. Combining the bispecific TROP-2 approach with immunotherapies like checkpoint inhibitors can potentially lead to improved clinical outcomes.

“Developing bispecifics is notoriously challenging,” said Matt Greving, Ph.D., VP & Head of Machine Learning & Platform Technologies at iBio. “EngageTx is an important addition to iBio's tech stack and demonstrates the power of our patented, AI-guided epitope engineering and StableHu™ antibody optimizer technologies, which were used to build EngageTx.”

Features of the EngageTx panel include:

• Broad range of T-cell activity for optimized pairing with diverse tumor antigen arms;
• Reduced cytokine release for potentially expanded therapeutic window; and
• Human-primate cross reactivity to facilitate molecule de-risking in safety studies.
  

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 use of EngageTx in potential future commercial partnerships, strategically employing bispecific antibodies targeting TROP-2 to stimulate the immune system for treating TROP-2-positive cancers, offering potential advantages over existing therapies, harnessing EngageTx to enrich our pipeline and offering this tremendous potential resource to prospective partners, the Company’s bispecific approach having the potential to increase the therapeutic window, while promoting a robust and long-lasting anti-tumor response, and combining the bispecific TROP-2 approach with immunotherapies like checkpoint inhibitors leading to improved clinical outcomes. 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 use EngageTx in potential future commercial partnerships, derive the advantages and results anticipated from bispecific antibodies targeting TROP-2, 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:

Investor Relations
Stephen Kilmer
(646) 274-3580
skilmer@ibioinc.com

Media Relations
Susan Thomas
(619) 540-9195
susan.thomas@ibioinc.com

Released June 6, 2023