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Eleven Biotherapeutics

www.elevenbio.com
Cambridge, MA, United States
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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 that its Phase 3 registration trial of Vicinium in non-muscle invasive bladder cancer (NMIBC) has exceeded 50% enrollment and that the independent Data and Safety Monitoring Board (DSMB) for the trial has recommended that the trial continue as planned. The DSMB reviewed available data to assess the risk/benefit to patients on drug and recommended that the trial continue without modification. “We are very pleased that the DSMB recommended we continue enrolling our Phase 3 trial after their review of available safety and efficacy data,” said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. “Patients with Bacillus Calmette-Guérin (BCG) unresponsive NMIBC have limited therapeutic options and frequently require cystectomies to prevent disease progression. Bladder removal, however, is a serious and life-altering surgery associated with significant morbidity and mortality. Vicinium may offer patients a positive non-surgical risk/benefit profile versus the standard of care. We look forward to advancing our trial as we continue to gain important information about the activity of Vicinium in patients with NMIBC.” “Urologists are looking for new treatment options for their patients with NMIBC once they stop responding to BCG. Their patients want alternatives to cystectomy. However, the NMIBC treatment landscape has not seen meaningful advances in forty years,” commented Arthur DeCillis, Chief Medical Officer of Eleven Biotherapeutics. “With this positive step behind us, we look forward to continuing our Phase 3 registration trial and to reporting topline 3-month data in the second quarter of next year.” 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. The ongoing Phase 3 registration trial is a single-arm study evaluating Vicinium in patients with high-grade NMIBC, who have previously received two courses of BCG and whose disease is now BCG-unresponsive. Eleven Biotherapeutics plans to enroll 134 patients, at over 70 centers in the United States and Canada. The trial’s primary endpoint is the complete response rate in patients with carcinoma-in-situ (CIS). Secondary endpoints include time to disease recurrence and event free survival. The Company expects to complete patient enrollment in the second half of 2017 and to report 3-month data in the second quarter of 2018. 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 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 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.


News Article | August 14, 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 June 30, 2017, and provided a corporate update. “The second quarter was a very productive one for Eleven Bio. We significantly advanced our clinical development program for our lead candidate Vicinium™. Our independent Data Safety Monitoring Board (DSMB) had previously only reviewed safety data from our Phase 3 registration trial, but in June they undertook their first review of preliminary efficacy in conjunction with safety data, and recommended that the trial continue without modification. Patients with Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) have limited therapeutic options and frequently require cystectomies to prevent disease progression. Bladder removal, however, is a serious and life-altering surgery associated with significant morbidity and mortality. We consider the results of the DSMB’s review to be a very significant step, as they suggest that Vicinium may offer patients a positive non-surgical benefit/risk profile versus the standard of care,” said Stephen Hurly, President and Chief Executive Officer of Eleven Biotherapeutics. “We were also very excited to announce that we entered into a collaboration with the National Cancer Institute (NCI) to evaluate Vicinium’s potential in combination with AstraZeneca’s immune checkpoint inhibitor, Imfinzi. One of the key differentiating attributes of our TPT platform is its dual mechanism of action. TPTs directly kill cancer cells via protein synthesis inhibition after targeted internalization, resulting in immunogenic cell death, which we believe sparks a second mechanism of anti-tumor activity via the patient’s own immune system. Together, our achievements this quarter represent important progress toward both our Vicinium monotherapy strategy and our combination strategy for our TPT platform more broadly. We look forward to announcing topline three-month complete response rate data from our Phase 3 registration trial next year.” Second Quarter and Recent Business Highlights and Anticipated Upcoming Milestones: Vicinium is based on Eleven’s TPT technology. TPTs are fully biologic, single protein molecules that selectively bind to cell surface markers that are over-expressed on cancer cells. The TPTs are then internalized by cancer cells, and once inside, release highly cytotoxic payloads to selectively kill the cell while sparing non-targeted healthy cells. TPTs are specifically designed to improve upon and overcome the challenges of existing antibody drug conjugates (ADCs) by directly killing cancer cells, promoting systemic anti-tumor immune responses and delivering better tumor penetration with an improved payload that is capable of killing both dividing and non-dividing cancer cells. TPTs are designed to be stable by using a single protein structure that Eleven believes will improve safety and tolerability. At the American Association for Cancer Research Annual Meeting in April 2017, Eleven presented new preclinical data demonstrating that cancer cells treated with VB4-845, the active pharmaceutical ingredient used to formulate Vicinium, induced the expression of HMGB1. HMGB1 is one of the three damage-associated molecular patterns (DAMPs) indicative of immunogenic cell death, which is recognized by immunologists to actively engage the host immune system and promote anti-tumor immune responses. This is especially meaningful because it builds on prior research in which Eleven observed the two other DAMPs markers – cell surface expression of calreticulin and extracellular release of ATP – following treatment with VB4-845. The induction of the three DAMPs that comprise the hallmark of immunogenic cell death suggests that TPTs are capable of inducing host anti-tumor immune responses, which can promote the function of immuno-oncology agents like checkpoint inhibitors. This supports the hypothesis that 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. Vicinium is a single protein TPT 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 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. Vicinium is currently in a Phase 3 registration trial for the treatment of high-grade NMIBC in subjects who have previously received a minimum of two courses of BCG and whose disease is now BCG-unresponsive. In June 2017, Eleven announced that its ongoing Phase 3 registration trial of Vicinium exceeded 50% enrollment. Eleven also announced that the DSMB for the trial reviewed available data to assess the risk/benefit to patients on drug, and recommended that the trial continue without modification. The ongoing Phase 3 registration trial is a single-arm study evaluating Vicinium in patients with high-grade NMIBC, who have previously received a minimum of two courses of BCG and whose disease is now BCG-unresponsive. Eleven plans to enroll 134 patients at over 70 centers in the United States and Canada. The trial’s primary endpoints are the complete response rate and duration of response in patients with carcinoma-in-situ (CIS). Secondary endpoints include time to disease recurrence and event-free survival. Also in June 2017, Eleven announced the signing of a Cooperative Research and Development Agreement (CRADA) with the NCI for the development of Vicinium in combination with AstraZeneca’s immune checkpoint inhibitor, Imfinzi, for the treatment of NMIBC. Under the terms of the CRADA, the NCI will conduct a Phase 1 clinical trial in patients with high-grade NMIBC to evaluate the safety, efficacy and biological correlates of Vicinium in combination with Imfinzi. Patients will be evaluated for safety and efficacy throughout the study. A broad biomarker program will provide information regarding Vicinium’s ability to drive host anti-tumor immune responses. This will not only allow Eleven to assess the ability of Vicinium to work synergistically with Imfinzi, but will also help guide the identification of other immuno-oncology pathways and drugs that could be attractive candidates for combination studies with Vicinium and other TPTs. The decision to evaluate Vicinium in combination with Imfinzi is based on preclinical data, which suggest that Eleven’s TPTs induce a host immune cell-mediated anti-tumor response, and thus may have synergy with checkpoint inhibitors and other immuno-oncology compounds. Eleven’s pipeline includes additional locally delivered product candidates, as well as a systemic platform. Given Eleven’s enthusiasm for quickly driving the development of Vicinium forward, the Company is focusing its resources on the continued advancement of its Phase 3 registration trial at this time and temporarily holding the development of its earlier-stage product candidates, Proxinium and VB6-845d. The Company looks forward to moving these forward at the appropriate time. Eleven Biotherapeutics’ management team will host a conference call and audio webcast today at 8:00 a.m. ET to discuss the second 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 63779857. 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 targeted protein therapeutics (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 therapeutic options. 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 resistant 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. 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 (License Agreement) with F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc., 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 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: 2011-07-29

Featured herein are non-naturally occurring cytokine domains that can be used, inter alia, to modulate cellular signalling responsive to interleukin-1 receptor I (IL-1 RI), 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: 2012-07-27

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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