Eleven Biotherapeutics to Present New Preclinical Data at the American Association for Cancer Research Annual Meeting 2017

Single-agent and Combination Data Support Clinical Development Plan

CAMBRIDGE, Mass.--()--Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based on its Targeting Protein Therapeutics (TPTs) platform, today announced that it will present preclinical data supporting the ongoing development of its locally- and systemically-administered drug candidates at the American Association for Cancer Research (AACR) Annual Meeting 2017, taking place April 1-5, 2017 in Washington D.C.

“The presentations at AACR speak to the potential of our locally- and systemically-administered TPTs to provide patients with new therapeutic options that offer improvements over existing antibody drug conjugates (ADCs), both in combination with existing checkpoint inhibitors and as single agents,” said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. “We are particularly excited by the preclinical data with VB4-845, the active pharmaceutical ingredient used to formulate Vicinium™ and Proxinium™. These results support prior findings regarding the compound’s dual mechanism of action, demonstrating that it activates an immunogenic cell death (ICD) pathway and promotes a local anti-tumor immune response. This, in turn, suggests that VB4-845 may improve the efficacy of existing checkpoint inhibitors. Looking ahead, we plan to use these data to guide our clinical strategy as we explore additional opportunities to develop our medicines for the treatment of cancer.”

Details of the poster presentations are as follows:

Title: VB4-845 tumor cell killing in a combination study with the anti-PD-1, nivolumab
Date & Time: Sunday, April 2, 2017 from 1:00 – 5:00 p.m. ET
Session Category: Immunology
Session Title: T-cell Immunity to Cancer: New Progress
Presenter: Dillon, R.L.
Abstract Number: 614
Location: Walter E. Washington Convention Center, Poster Section 26
Summary: This study evaluated the ability of VB4-845-mediated cell killing to elicit ICD and the effect of VB4-845-mediated cell killing when combined with the checkpoint inhibitor nivolumab in PDX tumor-bearing NOG mice. VB4-845 showed growth suppression of the injected tumor; growth inhibition of the contralateral, non-injected tumor was more pronounced with the addition of nivolumab. These data suggest that VB4-845 mediates tumor cell killing via an ICD pathway, and that the resulting cross-priming effect can enhance the anti-tumoral activity of immune checkpoint inhibitors.

Title: Trastuzumab and C6.5 diabody armed with deBougnanin overcome drug resistance to ADCs comprised of anti-microtubule agents
Date & Time: Sunday, April 2, 2017 from 1:00 – 5:00 p.m. ET
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody Technology
Presenter: Chooniedass, S.
Abstract Number: 79
Location: Walter E. Washington Convention Center, Poster Section 3
Summary: This study explored the differentiating mechanism of action of deBouganin, a de-immunized form of the ribosome inactivating protein bouganin. Data showed that treatment with chemotherapeutic agents or antibody drug conjugates comprised of small molecule compounds can lead to a subpopulation of drug-resistant tumor cells with cross-resistance to both similar agents, as well as to unrelated compounds, potentially leading to future treatment failures. In contrast, antibodies and antibody fragments armed with deBouganin can overcome these mechanisms of resistance and may therefore represent a more effective treatment option.

About Eleven Biotherapeutics

Eleven Biotherapeutics, Inc. is a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based upon the Company's TPT platform. The Company's TPTs incorporate a tumor-targeting antibody fragment and a protein cytotoxic payload into a single protein molecule in order to achieve focused tumor cell killing. The Company believes its TPT approach offers significant advantages in treating cancer over existing antibody drug conjugate technologies. The Company believes its TPTs provide effective tumor targeting with broader cancer cell-killing properties than are achievable with small molecule payloads that require tumor cell proliferation and face multi-drug resistance mechanisms. Additionally, the Company believes that its TPT's cancer cell-killing properties promote an anti-tumor immune response that will potentially combine well with immune oncology drugs such as checkpoint inhibitors. For more information please refer to the Company's website at www.elevenbio.com.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of pre-clinical studies and clinical trials, our ability to successfully develop our product candidates and complete our planned clinical programs, our ability to obtain marketing approvals for our product candidates, expectations regarding our ongoing pre-clinical studies and clinical trials, availability and timing of data from pre-clinical studies and clinical trials, whether interim results from a pre-clinical study or clinical trial will be predictive of the final results of the study or trial or results of early pre-clinical and clinical studies will be indicative of the results of future studies, the adequacy of any clinical models, expectations regarding regulatory approvals, and other factors discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

Contacts

Stern Investor Relations
Hannah Deresiewicz
hannahd@sternir.com

Contacts

Stern Investor Relations
Hannah Deresiewicz
hannahd@sternir.com