On May 4, 2017 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported financial results for the quarter ended March 31, 2017, and provided a corporate update (Press release, Eleven Biotherapeutics, MAY 4, 2017, View Source [SID1234518830]). Schedule your 30 min Free 1stOncology Demo! "During our first quarter of 2017, we made meaningful progress, advancing our Phase 3 registration clinical trial of Vicinium and continuing development efforts with Proxinium and VB6-845d," said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. "Importantly, we also presented new preclinical data supporting the potential of our locally- and systemically-administered drug candidates not just as monotherapies, but also in combination with immuno-oncology products, including checkpoint inhibitors. These results accord with our clinical development strategies, and we look forward to further exploring TPTs as new medicines with the potential to offer considerable improvements over existing options."
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First Quarter and Recent Business Highlights and Anticipated Upcoming Milestones:
Vicinium: Vicinium is a single protein anti-epithelial cell adhesion molecule (anti-EpCAM) antibody fragment fused with Pseudomonas Exotoxin A (ETA) that is designed to specifically target and deliver a potent anti-cancer payload directly into tumor cells. Vicinium is currently in a Phase 3 registration clinical trial for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC) in subjects who have previously received two courses of Bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive.
Complete enrollment for Phase 3 registration clinical trial expected in second half of 2017
Topline data from Phase 3 registration clinical trial expected in 2018
Proxinium: Proxinium is a single protein anti-EpCAM antibody fragment fused with ETA for the treatment of late-stage squamous cell carcinoma of the head and neck (SCCHN). Proxinium has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and Fast Track designation from the FDA. Proxinium has demonstrated anti-tumor activity in prior Phase 1 and 2 clinical trials.
Initiation of Phase 1/2a clinical trial evaluating Proxinium in combination with a checkpoint inhibitor expected in second half of 2017
At the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April, Eleven presented new preclinical results with VB4-845, the active pharmaceutical ingredient used to formulate both Vicinium and Proxinium. Data suggest that VB4-845 induces the expression of HMGB1 in tumor treated cells; HMGB1 is one of three damage-associated molecular patterns (DAMPs) indicative of immunogenic cell death (ICD). Eleven has previously disclosed observations of the other two DAMPs markers – cell surface expression of calreticulin and extracellular release of ATP – following treatment with VB4-845. Together, these results suggest that product candidates formulated with VB4-845 are capable of driving host anti-tumor immune responses that can potentiate the activity of immuno-oncology agents.
As part of the same poster presentation, Eleven shared data from a preclinical model in patient-derived xenograft tumor-bearing mice reconstituted with a human immune system, which was used to assess the combination of intratumoral injection of VB4-845 with the anti-PD1 antibody, nivolumab. Treatment with VB4-845 alone suppressed the growth of injected tumors, while monotherapy nivolumab had little effect. In contralateral, non-injected tumors, responses from mice treated with both VB4-845 and nivolumab were more pronounced than responses in mice treated with either product as a monotherapy. Based on these results, Eleven believes that VB4-845 killing of tumor cells could facilitate and augment checkpoint inhibitor anti-tumor activity.
Systemically-administered TPT Pipeline: Eleven’s initial systemically-administered TPTs leverage a proprietary, highly potent, de-immunized, plant toxin, deBouganin. DeBouganin has picomolar killing of cancer cells and may be effective against cancer stem cells. In preclinical studies, deBouganin demonstrated the ability to avoid multi-drug resistance mechanisms that can decrease the efficacy of small molecule payloads. Based on these results, Eleven believes that deBouganin-based therapies may be effective against a wide spectrum of cancers.
Investigational New Drug Application (IND) submission for VB6-845d planned for first quarter of 2018
At the AACR (Free AACR Whitepaper) Annual Meeting, Eleven presented preclinical data suggesting that its deBouganin payload is capable of effectively killing tumor cells that are resistant to treatment with antibody drug conjugates (ADCs) composed of DM-1 and MMAE payloads when conjugated to the same monoclonal antibody, trastuzumab. The Company believes this is due, in part, to deBouganin’s lack of sensitivity to both the multidrug resistance pumps and the changes in phosphorylation status of proteins involved in cell proliferation and survival that allow some cancers to escape the action of anti-mitotic ADCs.
Corporate: Eleven further expanded its internal clinical development team with two key hires: Gary Conboy as Executive Director, Clinical Sciences and Mary Rohrer as Associate Director, Clinical Operations.
First Quarter 2017 Financial Results:
Cash Position: Cash and cash equivalents were $20.3 million as of March 31, 2017, compared to $25.3 million as of December 31, 2016.
Revenue: Revenue was $0.4 million for the three months ended March 31, 2017, compared to $0.2 million for the same period in 2016. This increase was due to revenue recognized from the License Agreement (License Agreement) with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche).
R&D Expenses: Research and development expenses were $2.9 million for the three months ended March 31, 2017, compared to $4.6 million for the same period in 2016. The decrease was due primarily to a reduction in isunakinra and EBI-031 related development expenses, partially offset by an increase in Vicinium related development expenses.
G&A Expenses: General and administrative expenses were $2.2 million for the three months ended March 31, 2017, compared to $2.1 million for the same period in 2016.
Net Loss: Net loss was $6.1 million, or $0.25 per share, for the three months ended March 31, 2017, compared to net loss of $7.6 million, or $0.39 per share, for the same period in 2016.
Financial Guidance: Based on current operating plans, Eleven expects to have cash to fund research and development programs and operations into early 2018.
Upcoming Events and Presentations:
American Urological Association 2017 Annual Meeting, May 12-16, 2017 in Boston, Massachusetts