-Viventia's Lead Product Candidate, ViciniumTM, being developed for high-grade non-muscle invasive bladder cancer, with topline Phase 3 data expected in 1H 2018-
-ProxiniumTM being developed for late-stage squamous cell carcinoma of the head and neck with Phase 2 initiation planned for early 2017-
-Stephen Hurly to Serve as President and Chief Executive Officer of Combined Company-
-Company to Host Conference Call and Webcast Today
The acquisition creates a
Eleven's pipeline now includes Viventia's lead product candidates Vicinium and Proxinium. Vicinium is in a Phase 3 clinical trial for high grade non-muscle invasive bladder cancer (NMIBC), with topline data expected in the first half of 2018. To date, Vicinium has been evaluated in more than 100 patients. In a Phase 2 clinical trial, Vicinium demonstrated a complete response rate of 40% at three months with no drug-related serious adverse events observed in the trial.
Proxinium is expected to enter Phase 2 development in early 2017 for the
treatment of late-stage squamous cell carcinoma of the head and neck. In
previous clinical trials, Proxinium was generally safe and
well-tolerated and showed signs of anti-tumor activity. Proxinium has
received Orphan Drug Designation from the
Eleven's pipeline now also includes Viventia's earlier stage pipeline of next generation TPT candidates that are designed and optimized for systemic administration for the potential treatment of a broader spectrum of cancer types.
"We are excited to join with Eleven to create a company with extensive
experience in engineering and developing novel protein therapeutics for
local delivery that we believe may maximize efficacy and reduce
toxicity. Our TPTs combine specific tumor targeting with a protein based
tumor killing payload, and will be developed to serve cancer patients in
areas of high unmet need. Together we have a strong Board of Directors,
management team, product pipeline and technology platform, and the
capital needed to support the Company's development plans into 2018,"
said Stephen Hurly, Chief Executive Officer of
"As previously announced, Eleven performed an extensive review of our strategic alternatives, and our Board of Directors believes that the acquisition of Viventia offers Eleven shareholders a compelling opportunity for enhancing long-term value," said Abbie Celniker, Ph.D., former President and Chief Executive Officer of Eleven Biotherapeutics and current member of Eleven's Board of Directors. "Our combined company will continue to support Roche as they develop EBI-031, and will benefit from the capital contributed by this partnership, which provides the necessary funding to enable further development of Vicinium and Proxinium."
About Targeted Protein Therapeutics (TPTs)
Viventia's drug development is currently focused on locally administered targeted protein therapeutics (TPTs) for the treatment of cancer. Viventia's TPTs are expressed as a single fusion protein with a differentiated payload mechanism, eliminating the need for payload conjugation and multi-step manufacturing. We believe TPTs have a dual action of both directly killing the cancer cell and enhancing the local immune response.
License Agreement with Roche
Viventia Acquisition Details
Under the share purchase agreement, Eleven purchased all of the outstanding capital stock of Viventia in exchange for the issuance of 4,031,431 newly issued shares of Eleven common stock, which represented approximately 19.9% of the voting power of Eleven as of immediately prior to the issuance of such shares, and the agreement by Eleven to pay to the selling shareholders certain post-closing contingent cash payments upon the achievement of specified milestones and based upon net sales related to Viventia's lead product candidate, Vicinium.
The acquisition was approved by the boards of directors of both companies.
Management and Organization
In connection with the acquisition, Eleven's Board of Directors elected
Stephen Hurly and
Conference Call and Webcast
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.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
The standard immunotherapy drug for bladder cancer is the Bacillus
Calmette-Guérin (BCG) vaccine which was approved by the
For more information please visit www.mybladdercancer.com.
About Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Squamous cell carcinoma is the most frequent malignant tumor of the head and neck region. Head and neck cancer is the seventh most common cancer in the world. Head and neck cancers are strongly associated with certain environmental and lifestyle risk factors.
Existing treatment options for squamous cell carcinoma of the head and neck include surgery, drug agents, radiation or combination therapy. There is no treatment option for patients who progress after receiving these treatments.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about benefits of
the Acquisition, future management of the Company, Viventia's business,
the Company's strategy, future operations, advancement or maturation of
its product candidates and product pipeline, clinical development of the
Company's product candidates, including expectations regarding timing of
regulatory submissions and initiation of clinical trials, regulatory
requirements for initiation of clinical trials and registration of
product candidates, the sufficiency of its cash resources 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,
availability and timing of data from clinical trials, whether results of
early clinical trials or preclinical studies will be indicative of the
results of future trials, the adequacy of any clinical models,
uncertainties associated with regulatory review of clinical trials and
applications for marketing approvals and other factors discussed in the
"Risk Factors" section of the Company's report on Form 10-Q for the
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