-- Announced Data and Safety Monitoring Board
Recommendation to Continue Phase 3 Registration Trial of Vicinium™
as Planned --
-- Entered Collaboration with National Cancer
Institute and AstraZeneca to Evaluate Vicinium in Combination with
Imfinzi™ (Durvalumab) in Patients with Non-Muscle Invasive Bladder
Cancer --
-- Management to Host Conference Call Today at
8:00 a.m. ET --
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:
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.
- Complete enrollment for Phase 3
registration clinical trial expected in first quarter of 2018
- Topline three-month data from Phase 3
registration clinical trial expected mid-2018; topline 12-month
data now expected in second quarter of 2019
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.
TPT Pipeline:
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.
Proxinium:
- Proxinium is a single protein
anti-EpCAM antibody fragment fused with ETA for the treatment of
late-stage, EpCAM-expressing, recurrent or metastatic 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).
- In prior Phase 1 and 2 clinical trials,
Proxinium demonstrated anti-tumor activity both injected as well as
un-injected tumors.
- At the appropriate time, the Company
plans to evaluate Proxinium in a Phase 1/2a clinical trial in
combination with a checkpoint inhibitor.
VB6-845d:
- VB6-845d is a systemically-administered
TPT utilizing a proprietary, highly potent, de-immunized plant
toxin, deBouganin, for the treatment of solid tumors.
- At the appropriate time, the Company
plans to file an investigational new drug (IND) application for
VB6-845d and initiate a Phase 1 trial.
Corporate:
- In May 2017, Eleven announced the
appointment of David Brooks, M.D., Ph.D., as Senior Vice President,
Clinical Development. Dr. Brooks is responsible for the execution
of Eleven’s ongoing and planned clinical trials.
Second Quarter 2017 Financial Results:
- Cash Position: Cash and cash
equivalents were $15.8 million as of June 30, 2017, compared to
$25.3 million as of December 31, 2016.
- Revenue: Eleven did not record
any revenue for the three months ended June 30, 2017, compared to
revenue of $0.3 million for the same period in 2016. This decrease
was due to the termination of Eleven’s collaboration agreement with
Thrombogenics N.V. in June 2016.
- R&D Expenses: Research and
development expenses were $2.9 million for the three months ended
June 30, 2017, compared to $3.3 million for the same period in
2016. This decrease was primarily due to a reduction in EBI-031
development expenses. Effective August 2016, F. Hoffmann-La Roche
Ltd and Hoffmann-La Roche Inc. (Roche) is responsible for
developing EBI-031 pursuant to Eleven’s license agreement with
Roche. This decrease was partially offset by increases in
Vicinium-related development expenses, which began in September
2016.
- G&A Expenses: General and
administrative expenses were $2.2 million for the three months
ended June 30, 2017, compared to $3.5 million for the same period
in 2016. This decrease was primarily due to a reduction in
professional fees.
- Net Loss: Net loss applicable to
common stockholders was $7.3 million, or $0.30 per share, for the
three months ended June 30, 2017, compared to net loss applicable
to common stockholders of $6.5 million, or $0.33 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:
- David Brooks, MD, PhD, SVP, Clinical
Development. “Development of Vicinium, an Intravesical Anti-EpCAM
Toxin Fusion Protein, in Phase 3 for Non-Muscle Invasive Bladder
Cancer.” 18th Future Directions in Urology Symposium (FDUS 18),
August 20-23, 2017 in Colorado Springs, Colorado.
- Gregory P. Adams, PhD, CSO. Keynote
Presentation: “Enabling Effective Immuno-Oncology.” CHI’s 5th
Annual Immunomodulatory Therapeutic Antibodies for Cancer, August
28-29, 2017 in Boston, Massachusetts.
Conference Call Information:
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.
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 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.
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 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.
ELEVEN BIOTHERAPEUTICS, INC. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in
thousands, except per share data)
Three Months Ended June
30, Six Months Ended June 30,
2017
2016
2017
2016
Total revenue $ - $ 277 $ 425 $ 506 Operating expenses:
Research and development 2,909 3,298 5,783 7,930 General and
administrative 2,241 3,471 4,454 5,618 (Gain) loss from change in
fair value of contingent consideration 2,200 -
3,700 - Total operating expenses
7,350 6,769 13,937
13,548 Loss from operations (7,350 ) (6,492 ) (13,512 )
(13,042 ) Other income (expense), net 34 1
135 (1,023 ) Net loss $ (7,316 ) $
(6,491 ) $ (13,377 ) $ (14,065 ) Net loss per share —basic and
diluted $ (0.30 ) $ (0.33 ) $ (0.54 ) $ (0.71 ) Weighted-average
number of common shares used in net loss per share —basic and
diluted 24,685 19,874 24,648
19,756
ELEVEN
BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE
SHEETS (unaudited) (in thousands)
June 30, December
31, 2017 2016 Assets Current
assets: Cash and cash equivalents $ 15,751 $ 25,342 Prepaid
expenses and other current assets 707 585
Total current assets 16,458 25,927 Property and equipment,
net 632 796 Restricted cash 10 10 Intangible assets 60,500 60,500
Goodwill 17,371 16,864 Other assets 77 -
Total assets $ 95,048 $ 104,097
Liabilities and stockholders' equity Current liabilities:
Accounts payable $ 1,245 $ 1,667 Accrued expenses 2,492 1,774
Deferred revenue - 425 Due to related party 118
114 Total current liabilities 3,855 3,980 Other
liabilities 148 - Warrant liability - 5 Deferred tax liability
16,335 16,335 Contingent consideration 48,800 45,100
Stockholders' equity: Common stock 25 25 Additional paid-in capital
162,564 161,963 Accumulated deficit (136,679 )
(123,311 ) Total stockholders' equity 25,910
38,677 Total liabilities and stockholders' equity $
95,048 $ 104,097
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version on businesswire.com: http://www.businesswire.com/news/home/20170814005384/en/
Stern Investor Relations, Inc.Hannah Deresiewicz,
212-362-1200hannahd@sternir.com
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