Company Announces Additional Key Primary and
Secondary Endpoints Further Supporting Vicinium® Treatment
Potential in High-Risk Non-Muscle Invasive Bladder Cancer
Company on Track to Report Updated 12-Month
Data from Phase 3 VISTA Trial of Vicinium in Mid-2019
Management to Host a Business Update Call on
March 4, 2019 at 8:00 a.m. EST
Sesen Bio (Nasdaq: SESN), a late-stage clinical company
developing targeted fusion protein therapeutics for the treatment
of patients with cancer, today reported operating results for the
fourth quarter and full year ended December 31, 2018. The Company
also reported new, preliminary analyses from the Company’s Phase 3
VISTA trial further demonstrating the activity of Vicinium
treatment in patients with high-risk non-muscle invasive bladder
cancer (NMIBC).
“2018 was a year of tremendous progress towards our goal of
bringing Vicinium to patients with BCG-unresponsive NMIBC, setting
us up for a transformational 2019,” said Dr. Thomas Cannell,
president and chief executive officer of Sesen Bio. “We are well
underway with our Phase 3 VISTA trial designed to support the full
approval of Vicinium for patients with NMIBC. The totality of the
efficacy and safety data generated to date in our Phase 3 VISTA
trial, and the compelling benefit-risk profile, give us confidence
in the approvability of Vicinium for this indication. Due to the
limited treatment options, once patients become BCG-unresponsive,
their choice is to either undergo a life-altering, complicated
surgery of complete bladder removal or live with a
highly-progressive cancer. We believe Vicinium can have a
substantial impact on how patients with NMIBC are treated,
translating into a significant commercial opportunity, as we
endeavor to achieve our mission of saving and renewing the lives of
patients with cancer.”
VISTA Trial Progress
- Positive Preliminary VISTA Trial
Data Reported in BCG-unresponsive NMIBC: In January, Sesen Bio
announced positive preliminary data from its ongoing Phase 3 VISTA
trial, a single-arm, multi-center clinical trial designed to
support the approval of Vicinium for the treatment of patients with
high-risk, BCG-unresponsive NMIBC. The trial completed enrollment
in the second quarter of 2018, with a total of 133 patients across
three cohorts based on histology and time to disease recurrence
after adequate BCG treatment. Cohort 1 enrolled 86 patients with
Carcinoma in situ with or without papillary disease that was
determined to be refractory or recurred within six months of their
last course of adequate BCG. Cohort 2 enrolled seven patients with
Carcinoma in situ with or without papillary disease that was
determined to be refractory or recurred after six months, but less
than 12 months, after their last course of adequate BCG. Cohort 3
enrolled 40 patients with high-risk papillary disease without
Carcinoma in situ that was determined to be refractory or recurred
within six months of their last course of adequate BCG. As of a
December 3, 2018 data cutoff data, preliminary efficacy data for
each of the trial cohorts were as follows:
Cohort 1 CRRs (n=86) Time point
EvaluablePatients
Complete Response Rate(95% Confidence
Interval)
3-months n=86 37% (27%-48%) 6-months
n=85 25% (16%-35%) 9-months
n=84 18% (10%-28%) 12-months
n=81 14% (7%-23%)
Patients with Carcinoma in situ with or
without papillary disease that was determined to be refractory or
recurred within six months of their last course of adequate BCG
Cohort 2 CRRs (n=7) Time point
EvaluablePatients
Complete Response Rate(95% Confidence Interval)
3-months n=7 57% (18%-90%) 6-months
n=7 57% (18%-90%) 9-months
n=7 43% (10%-82%) 12-months n=7
14% (0%-58%)
Patients with Carcinoma in situ with or
without papillary disease that was determined to be refractory or
recurred after six months, but less than 12 months, after their
last course of adequate BCG
Pooled Cohorts 1 and 2 CRRs (n=93) Time point
EvaluablePatients
Complete Response Rate(95% Confidence
Interval)
3-months n=93 39% (29%-49%) 6-months
n=92 27% (18%-37%) 9-months
n=91 20% (12%-29%) 12-months
n=88 14% (7%-23%)
Patients with Carcinoma in situ with or
without papillary disease that was determined to be refractory or
recurred less than 12 months, after their last course of adequate
BCG
Cohort 3 Recurrence-Free Rate (n=40)* Time
point
EvaluablePatients
Recurrence-Free Rate(95% Confidence
Interval)
3-months n=40 68% (51%-81%) 6-months
n=39 56% (40%-72%) 9-months
n=38 42% (26%-59%) 12-months
n=36 36% (21%-54%)
Patients with high-risk papillary disease
without Carcinoma in situ that was determined to be refractory or
recurred within six months of their last course of adequate BCG
*As of the December 3, 2018 data cut
off, but not previously reported in January 2019
- Additional Preliminary VISTA
Analyses Further Support Vicinium Treatment Potential for
NMIBC: Since the first preliminary data were reported in
January, Sesen Bio conducted additional analyses, including
duration of response in patients with Carcinoma in situ with or
without papillary disease, time to cystectomy across all patient
types with Carcinoma in situ or papillary disease, and time to
disease recurrence and recurrence-free rate in patients with
papillary disease without Carcinoma in situ as of an assessment
date of December 3, 2018. These additional preliminary data, in
addition to the data reported in January, support a growing body of
evidence demonstrating the anti-tumor activity of Vicinium.
- Duration of Response: In
addition to the complete response rate in Cohort 1, duration of
response in Cohort 1 is a primary endpoint measure. The median
duration of complete response for patients in Cohort 1 (n=86) is
227 days (95% CI, 127-516), using the Kaplan-Meier method.
Additional ad hoc analysis of pooled data for all patients with
Carcinoma in situ (Cohorts 1 and 2, n=93) shows that among patients
who achieved a complete response at 3 months, 69% had a complete
response of 6 months or longer after starting therapy.
- Time to Cystectomy: The U.S.
Food and Drug Administration (FDA) guidance states that the goal of
therapy in patients with BCG-unresponsive NMIBC is to avoid
cystectomy. Therefore, time to cystectomy is a key secondary
endpoint in the VISTA trial. Across all 133 patients treated with
Vicinium, patients are projected to be cystectomy-free for
approximately 519 days (95% CI, 361-523), or 18 months.
- Time to Disease Recurrence:
High-grade Ta or T1 NMIBC is associated with higher rates of
progression and recurrence. Therefore, time to disease recurrence
is a key secondary endpoint for patients with high-grade
papillary-only (Ta and T1) NMIBC. The median time to disease
recurrence for patients in Cohort 3 (n=40) is 270 days (95% CI,
169-452).
- Recurrence-free Rate: Sesen Bio
conducted an ad hoc analysis on disease recurrence, a standard
criterion to evaluate treatment response for patients with
high-grade papillary-only (Ta and T1) NMIBC. The analysis showed
that for patients in Cohort 3 (n=40), Vicinium treatment
demonstrated favorable efficacy with 56% (95% CI, 40%-72%) of
patients remaining recurrence-free at 6 months, and 36% (95% CI,
21%-54%) of patients remaining recurrence-free at 12 months.
- Vicinium Demonstrated to be
Well-tolerated in the VISTA Trial: As of the December 3, 2018
data cut off, in patients across all cohorts (n=133), 78% adverse
events were Grade 1 or 2. The most commonly reported
treatment-related adverse events were dysuria (13%), hematuria
(12%) and urinary tract infection (11%) – all of which are
consistent with the profile of bladder cancer patients and the use
of catheterization for treatment delivery. These adverse events
were determined to be manageable and reversible, and only five
patients discontinued treatment due to an adverse event. Serious
adverse events, regardless of treatment attribution, were reported
in 14% of patients. There were four treatment-related SAEs reported
in three patients including acute renal injury (Grade 3), pyrexia
(Grade 2), cholestatic hepatitis (Grade 4) and renal failure (Grade
5). No patient developed metastatic disease during the Phase 2
clinical trial for Vicinium or the Phase 3 VISTA trial (through the
December 3, 2018 data cut off).
- Updated VISTA Trial Data on Track to
be Reported in Mid-2019: The Phase 3 VISTA trial remains
ongoing and the company anticipates reporting updated primary and
secondary endpoint data from the VISTA trial in mid-2019. In August
2018, Vicinium was granted Fast Track Designation by the FDA for
the treatment of patients with high-risk NMIBC who have previously
received two courses of BCG and whose disease is now
BCG-unresponsive. In connection with this designation, the Company
is planning to further engage with the FDA in the first half of
2019 to discuss its intended registration strategy for Vicinium for
the treatment of high-risk NMIBC.
Additional Vicinium Progress
- Manufacturing Readiness Underway
with FUJIFILM: In October 2018, the Company entered into an
agreement for the manufacturing process and technology transfer of
Vicinium production with FUJIFILM Diosynth Biotechnologies U.S.A.,
Inc. (FUJIFILM). Preparations are underway for full-scale
GMP manufacturing at FUJIFILM in the second quarter of 2019 to
assess FUJIFILM’S ability to produce the bulk drug substance form
of Vicinium for commercial purposes if Sesen Bio receives
regulatory approval to market Vicinium for the treatment of
high-risk NMIBC.
- Continued Support of Vicinium
Combination Trial in NMIBC: Sesen Bio has continued support of
the National Cancer Institute’s ongoing clinical assessment of
Vicinium in combination with AstraZeneca’s immune checkpoint
inhibitor, durvalumab, for the treatment of patients with
high-risk, BCG-unresponsive NMIBC. Sesen Bio believes the Phase 1
trial is based on strong scientific rationale, as well as both
clinical and preclinical data, on combining Vicinium with a
checkpoint inhibitor. The Company expects biomarker data from this
Phase 1 trial to be reported in the second half of 2019.
Fourth Quarter and Full-Year 2018 Financial Results
- Cash Position: Cash and cash
equivalents were $50.4 million as of December 31, 2018, compared to
$14.7 million as of December 31, 2017.
- Revenue: No revenue was recorded
for the three months ended December 31, 2018, nor for the same
period in 2017. For the twelve months ended December 31, 2018,
Sesen Bio did not record any revenue, compared to $0.4 million in
revenue for the same period in 2017. This decrease was due to
revenue recognized in 2017 from the License Agreement with F.
Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc related to EBI-031
and all other IL-6 antagonist antibody technology, which was a part
of the Company’s prior technology platform before the Company
acquired Viventia Bio, Inc. in 2016.
- R&D Expenses: Research and
development (R&D) expenses for the fourth quarter of 2018 were
$4.7 million, compared to $3.1 million in R&D expenses for
the same period in 2017. For the twelve months ended December 31,
2018, research and development expenses were $14.1 million compared
to $12.5 million for the same period in 2017. The fourth
quarter and annual increases were both driven by expenses related
to the ongoing manufacturing process and technology transfer with
FUJIFILM which initiated in mid-2018.
- G&A Expenses: General and
administrative expenses for the fourth quarter of 2018 were $3.5
million compared to $2.0 million for the same period in 2017.
The increase was due primarily to higher staffing, and consulting
costs as well as higher legal and intellectual property related
costs in 2018. For the twelve months ended December 31, 2018,
general and administrative expenses were $11.6 million
and $8.1 million for the same period in 2017. The increase was
due primarily to an increase in professional fees, one-time
personnel-related expenses and increased market research consulting
costs.
- Net Loss: Net loss was $6.8
million, or $0.09 per share, for the fourth quarter of 2018 and
$33.7 million, or $0.55 per share, for the twelve months ended
December 31, 2018, compared to $6.5 million, or $0.22 per share,
for the fourth quarter of 2017 and $29.0 million, or $1.11 per
share, for the full year ended December 31, 2017.
- Financial Guidance: Based on its
current operating plans, Sesen Bio believes it will have capital
sufficient to fund its current operating plan into 2020.
Conference Call InformationTo participate in the
conference call, please dial (844) 831-3025 (domestic) or (315)
625-6887 (international) and refer to conference ID 2179668. The
webcast can be accessed in the Investor Relations section of the
company's website at www.sesenbio.com. The replay of the webcast
will be available in the investor section of the company’s website
at www.sesenbio.com for 60 days following the call.
About the VISTA Clinical TrialThe VISTA trial is an
open-label, multicenter, single-arm Phase 3 clinical trial
evaluating the efficacy and tolerability of Vicinium as a
monotherapy in patients with high-risk, bacillus Calmette-Guérin,
or BCG, unresponsive non-muscle invasive bladder cancer (NMIBC).
The primary endpoints of the trial are the complete response rate
and duration of complete response in patients with Carcinoma in
situ with or without papillary disease. Patients in the trial
receive locally administered Vicinium twice a week for six weeks,
followed by once-weekly treatment for another six weeks, then
treatment every other week for up to two years. Updated
twelve-month data for the VISTA trial are anticipated in mid-2019.
To learn more about the Phase 3 VISTA trial, please
visit www.clinicaltrials.gov and search the
identifier NCT02449239.
About Vicinium®Vicinium, a locally-administered
fusion protein, is Sesen Bio’s lead product candidate being
developed for the treatment of high-risk non-muscle invasive
bladder cancer (NMIBC). Vicinium is comprised of a recombinant
fusion protein that targets epithelial cell adhesion molecule
(EpCAM) antigens on the surface of tumor cells to deliver a potent
protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is
constructed with a stable, genetically engineered peptide tether to
ensure the payload remains attached until it is internalized by the
cancer cell, which is believed to decrease the risk of toxicity to
healthy tissues, thereby improving its safety. In prior clinical
trials conducted by Sesen Bio, EpCAM has been shown to be
overexpressed in NMIBC cells with minimal to no EpCAM expression
observed on normal bladder cells. Sesen Bio is currently conducting
the Phase 3 VISTA trial, designed to support the registration of
Vicinium for the treatment of high-risk NMIBC in patients who have
previously received two courses of bacillus Calmette-Guérin (BCG)
and whose disease is now BCG-unresponsive. Updated twelve-month
data from the trial are anticipated in mid-2019. Additionally,
Sesen Bio believes that Vicinium’s cancer cell-killing properties
promote an anti-tumor immune response that may potentially combine
well with immuno-oncology drugs, such as checkpoint inhibitors. The
activity of Vicinium in BCG-unresponsive NMIBC is also being
explored at the US National Cancer Institute in combination with
AstraZeneca’s immune checkpoint inhibitor durvalumab.
About Sesen BioSesen Bio, Inc. is a late-stage clinical
company advancing targeted fusion protein therapeutics for the
treatment of patients with cancer. The company’s lead program,
Vicinium®, also known as VB4-845, is currently in a Phase 3
registration trial, the VISTA trial, for the treatment of
high-risk, BCG un-responsive non-muscle invasive bladder cancer.
Updated twelve-month data from the trial are anticipated in
mid-2019. Vicinium incorporates a tumor-targeting antibody fragment
and a protein cytotoxic payload into a single protein molecule
designed to selectively and effectively kill cancer cells, while
minimizing toxicity to non-cancerous bladder cells. For more
information, please visit the company’s website at
www.sesenbio.com.
Cautionary Note on Forward-Looking StatementsAny
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, the possibility that the preliminary data of the Phase 3
VISTA trial are not indicative of final clinical results and final
clinical trial results may not be positive with regard to the
safety or efficacy of Vicinium, 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 the manufacturing
process and technology transfer with FUJIFILM Diosynth
Biotechnologies U.S.A., Inc., expectations regarding regulatory
approvals, expectations regarding the adequacy of our existing
capital resources to fund our operating plan into 2020 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.
SESEN BIO, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands)
December 31, 2018
2017 Assets Current assets: Cash and
cash equivalents $ 50,422 $ 14,680 Prepaid expenses and other
current assets 1,334 301
Total current assets 51,756 14,981 Property and equipment, net 321
522 Restricted cash 20 10 Intangible assets 46,400 46,400 Goodwill
13,064 13,064 Other assets - 120
Total assets $ 111,561 $ 75,097
Liabilities and stockholders' equity Current
liabilities: Accounts payable $ 1,367 $ 907 Accrued expenses
4,746 3,813 Total current
liabilities 6,113 4,720
Other liabilities
313 215 Deferred tax liability 12,528 12,528 Contingent
consideration 48,400 39,600 Stockholders' equity: Common
stock 77 35 Additional paid-in capital 230,154 170,330 Accumulated
deficit (186,024 ) (152,331 ) Total
stockholders' equity 44,207
18,034 Total liabilities and stockholders' equity $
111,561 $ 75,097
SESEN
BIO, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (in thousands, except per share data)
(unaudited)
Three Months Ended December 31,
Twelve Months Ended December
31,
2018
2017
2018
2017
Total revenue $ - $ - $ - $ 425 Operating expenses: Research
and development 4,671 3,108 14,077 12,510 General and
administrative 3,495 1,985 11,623 8,070 Loss (gain) from change in
fair value of contingent consideration (1,100 ) 1,500
8,800 9,100 Total operating
expenses 7,066 6,593 34,500
29,680 Loss from operations (7,066 ) (6,593 )
(34,500 ) (29,255 ) Other income, net 309 46
807 226 Net loss before income
taxes (6,757 ) (6,547 ) (33,693 ) (29,029 ) Provision for income
taxes - - - -
Net loss and comprehensive loss $ (6,757 ) $ (6,547 ) $
(33,693 ) $ (29,029 ) Net loss per share —basic $ (0.09 ) $ (0.22 )
$ (0.55 ) $ (1.11 )
Weighted-average number of common shares
used in net loss per share —basic
77,345 30,385 61,774
26,105 Net loss per share —diluted $ (0.09 ) $ (0.22
) $ (0.55 ) $ (1.11 )
Weighted-average number of common shares
used in net loss per share —diluted
77,345 30,385 61,774
26,105
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190304005273/en/
Erin Clark, Executive Director, Strategic Planning &
Investor Relationserin.clark@sesenbio.com
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