Cambridge, MA, United States

Eleven Biotherapeutics

www.elevenbio.com
Cambridge, MA, United States

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On Wednesday, shares in Zug, Switzerland headquartered Auris Medical Holding AG recorded a trading volume of 114,073 shares. The stock ended flat at $0.66. The Company's shares are trading below their 50-day moving average by 16.46%. Furthermore, shares of Auris Medical, which focuses on the development of novel products for the treatment of inner ear disorders, have a Relative Strength Index (RSI) of 29.74. On May 09th, 2017, Auris Medical announced key results from AMPACT1 (AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1), the open-label extension study of the Phase 3 TACTT2 clinical trial. The study provides additional confirmation on the long-term safety of Keyzilen® and suggests the potential for further therapeutic benefits from repeated treatment. Access our complete research report on EARS for free at: Cambridge, Massachusetts-based Eleven Biotherapeutics Inc.'s stock finished yesterday's session 7.32% lower at $1.52. A total volume of 422,851 shares was traded, which was above their three months average volume of 419,820 shares. The Company's shares are trading below their 50-day moving average by 21.64%. Furthermore, shares of Eleven Biotherapeutics, which focuses on the design and development of targeted protein therapeutics, have an RSI of 24.34. On May 04th, 2017, Eleven Biotherapeutics reported financial results for the quarter ended March 31st, 2017. Revenue was $0.4 million for Q1 2017; net loss was $6.1 million; R&D expenses were $2.9 million; general and administrative expenses were $2.2 million; and cash and cash equivalents were $20.3 million. In addition, the Company expects to have cash to fund research and development programs and operations into early 2018, based on current operating plans. The complimentary research report on EBIO can be downloaded at: At the close of trading on Wednesday, shares in Lexington, Massachusetts headquartered Inotek Pharmaceuticals Corp. saw a decline of 5.41%, ending the day at $1.75. The stock recorded a trading volume of 318,300 shares. The Company's shares have advanced 7.69% in the previous three months. The stock is trading 6.27% below its 50-day moving average. Moreover, shares of Inotek Pharma, which focuses on the discovery, development, and commercialization of therapies for glaucoma and other diseases of the eye in the US, have an RSI of 44.67. On May 10th, 2017, Inotek Pharma reported financial results and operational highlights for the quarter ended March 31st, 2017. R&D expenses were $7.1 million for Q1 2017; general and administrative expenses were $2.9 million; loss from operations was $10.0 million; and net loss was $10.7 million. The Company also reported cash and cash equivalents and short-term investments of $114.7 million as of March 31st, 2017. Register for free on Stock-Callers.com and get access to the latest PDF format report on ITEK at: Radnor, Pennsylvania-based Marinus Pharmaceuticals Inc.'s shares ended the day 3.85% lower at $1.25 with a total trading volume of 208,878 shares. The stock has gained 23.76% on an YTD basis. The Company's shares are trading 8.90% below their 200-day moving average. Additionally, shares of Marinus Pharma, which focuses on developing and commercializing therapeutics to treat epilepsy and neuropsychiatric disorders, have an RSI of 36.40. On May 01st, 2017, Marinus Pharmaceuticals reported its financial results for the quarter ended March 31st, 2017. R&D expenses for Q1 2017 decreased to $3.6 million; general and administrative expenses increased to $1.8 million; and cash used in operating activities increased to $6.8 million. Additionally, the Company had cash, cash equivalents, and investments of $24.8 million at March 31st, 2017. Download your free research report on MRNS at: Stock Callers (SC) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. SC has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. SC has not been compensated; directly or indirectly; for producing or publishing this document. 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News Article | May 4, 2017
Site: www.businesswire.com

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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, today reported financial results for the quarter ended March 31, 2017, and provided a corporate update. “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.” 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. 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. At the American Association of Cancer Research (AACR) 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. At the AACR 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. Eleven Biotherapeutics’ management team will host a conference call and audio webcast today at 8:00 a.m. ET to discuss the first quarter 2017 financial results and provide a corporate update. To access the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) at least five minutes prior to the start time and refer to conference ID 12752483. An audio webcast of the call will also be available on the Investors & Media section of the Company’s website, www.elevenbio.com. An archived webcast will be available on the Company’s website approximately two hours after the event and will be available for 30 days. 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 ADC 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 immuno-oncology drugs such as checkpoint inhibitors. For more information please refer to the Company’s website at www.elevenbio.com. 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 occurrence of any event change or other circumstances that could give rise to the termination of the License Agreement, the uncertainties inherent in receiving future payments pursuant to the License Agreement, the uncertainties inherent in the initiation and conduct of 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 clinical trials, availability and timing of data from clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical studies will be indicative of the results of future studies, the adequacy of any clinical models, expectations regarding regulatory approvals, our ability to obtain, maintain and protect our intellectual property for our technology and products, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the financial performance of the Company, other matters that could affect the availability or commercial potential of the Company’s product candidates 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.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 4, 2017 to report its first quarter 2017 financial results and provide a corporate update. To access the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) at least five minutes prior to the start time and refer to conference ID 12752483. An audio webcast of the call will also be available on the Investors & Media section of the company's website, www.elevenbio.com. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 30 days. Eleven Biotherapeutics, Inc. is a late-stage clinical oncology company advancing a broad pipeline of novel product candidates based upon the Company's TPTs 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.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--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, today announced the signing of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) on the development of Eleven’s targeted therapeutic, ViciniumTM in combination with AstraZeneca’s immune checkpoint inhibitor, ImfinziTM (durvalumab), for the treatment of non-muscle invasive bladder cancer (NMIBC). “Despite current therapies and surgical regimens, there remains a large unmet need for patients with recurring or progressing NMIBC that is no longer responding to Bacillus Calmette-Guérin (BCG),” said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. “While we remain internally focused on advancing our Phase 3 registration trial of Vicinium as a monotherapy, preclinical data suggests that Vicinium also has the ability to potentiate the activity of immuno-oncology agents. We are pleased to enter into this collaboration with the National Cancer Institute and AstraZeneca, which broadens the scope of our ongoing clinical program and enables us to evaluate Vicinium together with Imfinzi, a PD-L1 checkpoint inhibitor. We look forward to generating additional data, as we continue to advance Vicinium and work expeditiously to bring it forward as a new treatment option for patients with NMIBC.” Vicinium, like Eleven’s other TPTs, is a single protein molecule composed of an antibody fragment genetically fused to a potent cytotoxic payload. Vicinium selectively binds to epithelial cell adhesion molecules (EpCAM), a cell surface marker that is highly expressed on many cancers, including high grade NMIBC, but that is present at minimal to no levels on healthy bladder tissue. After binding to EpCAM on the surface of the tumor cell, Vicinium is internalized into the cell where its potent cytotoxic cell killing payload, Pseudomonas Exotoxin A (ETA), is released, disrupting protein synthesis and leading to cell death. At the American Association for Cancer Research Annual Meeting in April 2017, new preclinical data were presented demonstrating that cancer cells treated with VB4-845, the active pharmaceutical ingredient used to formulate Vicinium, undergo immunogenic cell death (ICD). ICD is known to stimulate host immune responses against cancer. This supports the hypothesis that Eleven’s TPTs not only directly kill tumor cells, but also induce a host immune cell-mediated anti-tumor response. This suggests that they are differentiated from existing treatments, and that they may have synergy with checkpoint inhibitors and other immuno-oncology compounds. Under the terms of the CRADA, the NCI, led by principal investigator Dr. Piyush Agarwal of the NCI Center for Cancer Research, Urologic Oncology Branch, will conduct a Phase 1 clinical trial in patients with high-grade NMIBC to evaluate the safety, efficacy, and biological correlates of the Vicinium and durvalumab combination therapeutic strategy. Patients will be evaluated for response and recurrence throughout the study. For referrals, please contact Sonia Bellfield, Research Nurse, at 301-435-6255. Vicinium is currently in a Phase 3 registration trial for the treatment of high-grade NMIBC. Eleven expects to complete patient enrollment in the second half of 2017, and to report topline 3-month data in the second quarter of 2018. Imfinzi, in development by AstraZeneca and its biologic research arm, MedImmune, is a human monoclonal antibody directed against programmed death ligand-1 (PD-L1), that has accelerated approval by the FDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, regardless of PD-L1 status. Vicinium is a single protein anti-epithelial cell adhesion molecule (anti-EpCAM) fusion protein fused with Pseudomonas Exotoxin A (ETA) 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. Eleven Biotherapeutics intends to enroll 134 subjects in the trial, including 77 subjects with carcinoma in situ (CIS), at over 70 centers in the United States and Canada. Primary and secondary endpoints include complete response (CR) rate in CIS subjects, time to disease recurrence and event free survival. Imfinzi (durvalumab, previously known as MEDI4736) is a human monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1 and CD80. Durvalumab is also being tested in the 1st-line treatment of patients with unresectable and metastatic bladder cancer as a monotherapy and in combination with tremelimumab, a checkpoint inhibitor that targets CTLA-4, as part of the DANUBE Phase III trial, which had the last patient commenced dosing during the first quarter of 2017 (global trial, excluding China). Additional clinical trials are ongoing to investigate durvalumab as monotherapy or in combination in multiple solid tumours and blood cancers. 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 to achieve focused tumor cell killing. The Company believes its TPT approach offers significant advantages in treating cancer over existing ADC 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 immuno-oncology drugs such as checkpoint inhibitors. For more information please refer to the Company’s website at www.elevenbio.com. 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 occurrence of any event change or other circumstances that could give rise to the termination of the License Agreement, the uncertainties inherent in receiving future payments pursuant to the License Agreement, the uncertainties inherent in the initiation and conduct of 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 clinical trials, availability and timing of data from clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical studies will be indicative of the results of future studies, the adequacy of any clinical models, expectations regarding regulatory approvals, our ability to obtain, maintain and protect our intellectual property for our technology and products, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the financial performance of the Company, other matters that could affect the availability or commercial potential of the Company’s product candidates 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.


Patent
Eleven Biotherapeutics | Date: 2014-03-13

Featured herein are vehicle formulations and formulations containing a chimeric cytokine designed for e.g., ocular delivery.


Patent
Eleven Biotherapeutics | Date: 2014-08-15

Featured herein are non-naturally occuring cytokine domains that can be used, inter alia, to modulate cellular signalling responsive to interleukin-1 receptor I (IL-1RI), to treat disorders, and to detect and/or bind to cellular receptors, as well as other agents. Exemplary cytokine domains can contain amino acid residues from at least two parental cytokines domains, for example, receptor binding features, surface features, strands, and loops from at least two parental cytokines domains.


Patent
Eleven Biotherapeutics | Date: 2012-11-18

The invention provides methods and materials for making and using variant serum albumin amino acid sequences which exhibit improved properties compared to wild type serum albumin sequences. The invention further provides methods and materials for making and using fusion proteins in which the variant serum albumin amino acid sequences are fused to a therapeutic or diagnostic agent, such as a therapeutic protein, or a functional fragment or variant thereof that maintains activity, and exhibits improved properties.


Patent
Eleven Biotherapeutics | Date: 2014-10-07

IL-6 antagonists are provided that are specific for binding to site II of IL-6. Methods of using such inhibitors to treat IL-6 related diseases, e.g., disease of the eye such as diabetic macular edema are disclosed.


Patent
Eleven Biotherapeutics | Date: 2014-05-02

The invention relates to methods of identifying albumin variants having improved pharmacokinetics, albumin variants having improved pharmacokinetics, and therapeutic uses of albumin variants having improved pharmacokinetics.


Patent
Eleven Biotherapeutics | Date: 2012-07-27

The present invention provides methods and compositions for the preparation and delivery of chimeric cytokine proteins, including cell cultures, methods of purification and purified compositions.

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