Company Announces Confirmed Meetings with the
U.S. Food and Drug Administration in May and June 2019 to Review
Registration Strategy for Vicinium®
Management to Host a Business Update Call Today
at 8:00 a.m. EDT
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
first quarter ended March 31, 2019. The Company also reported
updated, preliminary primary and additional secondary endpoint data
from the Company’s Phase 3 VISTA trial further supporting the
strong benefit-risk profile of Vicinium for the potential treatment
in patients with high-risk, bacillus Calmette-Guérin (BCG)
unresponsive, non-muscle invasive bladder cancer (NMIBC). The
updated preliminary Phase 3 clinical data, along with the Phase 2
clinical trial data, will serve as the basis for upcoming meetings
with the U.S. Food and Drug Administration (FDA).
“We are very encouraged by the most recent analysis of our
12-month Phase 3 VISTA trial data, which will be the basis for our
meetings with the FDA in May and June,” said Dr. Thomas Cannell,
president and chief executive officer of Sesen Bio. “We
believe these preliminary data, along with a closely matched Phase
2 data set, support a compelling benefit-risk profile, and give us
confidence in the regulatory approvability and strong commercial
viability of Vicinium. The huge unmet need for patients with
NMIBC is widely acknowledged and has been exacerbated by the
recurring global shortage of BCG. We will continue to work
closely with the FDA in our effort to expeditiously bring a product
to market that has the potential to save and improve the lives of
patients with NMIBC.”
Phase 3 VISTA Trial Progress and Updates
- Updated, Preliminary VISTA Trial
Data Reported in BCG-unresponsive NMIBC: In March, Sesen Bio
announced updated 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 registration
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 (at least two courses of BCG with at
least five doses in the first course and two doses in the second
course). Primary endpoints include complete response rate and
duration of response for patients in Cohort 1. Secondary endpoints
include time to disease recurrence for patients in Cohort 3, and
time to cystectomy, progression-free survival, event-free survival,
and overall survival for all patients across cohorts. As of the
March 1, 2019 data cutoff, updated preliminary primary and
secondary efficacy data for each of the trial cohorts were as
follows:
Cohort 1 (n=86) Complete Response Rate Time point
EvaluablePatients
Complete Response Rate 3-months n=86 37%
6-months n=86 26% 9-months n=85 19%
12-months n=84 15%
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 (n=7) Complete Response Rate Time point
EvaluablePatients
Complete Response Rate 3-months n=7 57%
6-months n=7 57% 9-months n=7 43%
12-months n=7 14%
Patients with Carcinoma in situ with or without papillary
disease that was determined to be refractory or recurred after six
months, but less than 11 months, after their last course of
adequate BCG
Pooled Cohorts 1 and 2 (n=93) Complete Response Rate
Time point
EvaluablePatients
Complete Response Rate(95% Confidence Interval) 3-months
n=93 39% (29%- 49%) 6-months n=93 28%
(19%-38%) 9-months n=92 21% (13%-30%) 12-months
n=91 15% (9%-24%)
Patients with Carcinoma in situ with or without papillary
disease that was determined to be refractory or recurred less than
11 months, after their last course of adequate BCG
- Duration of Response: The median
duration of response for patients in Cohort 1 (n=86) is 287 days
(95% CI, 127-NA), 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, 54% had a complete response for a
total of 12 months or longer after starting therapy, using the
Kaplan-Meier method.
- Time to Disease Recurrence:
High-risk papillary (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-risk
papillary-only NMIBC. The median time to disease recurrence for
patients in Cohort 3 (n=40) is 402 days (95% CI, 170-NA), using the
Kaplan-Meier method.
- Time to Cystectomy: The 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, >75% of patients are
estimated to remain cystectomy-free at 2.5 years, using the
Kaplan-Meier method. Additional ad hoc analysis of responders and
non-responders for all patients shows that responders are
approximately 15 times more likely to remain cystectomy-free at 2.5
years compared to non-responders.
- Additional Secondary Endpoint Data
from Phase 3 VISTA Trial Support a Growing Body of Evidence
Demonstrating the Durable Anti-tumor Activity of Vicinium:
Since the last data update reported in March, Sesen Bio has
completed preliminary analyses of the remaining secondary endpoints
in the VISTA trial, including progression-free survival, overall
survival, and event-free survival, as measured across all patient
cohorts. Reported data is as of the March 1, 2019 cutoff:
- Progression-Free Survival:
>85% of all 133 patients treated with Vicinium are estimated to
remain progression-free at 2 years, using the Kaplan-Meier method.
Progression-free is defined as the time from the date of first dose
of study treatment to disease progression (e.g. T2 or more advanced
disease) or death as a first event.
- Event-Free Survival: 30% of all
133 patients treated with Vicinium are estimated to remain
event-free at 12 months, using the Kaplan-Meier method. Event-free
survival is defined as the time from the date of first dose of
study treatment to disease recurrence, progression, or death as a
first event.
- Overall Survival: 91% of all 133
patients treated with Vicinium have an overall survival of >2.5
years, using the Kaplan-Meier method. Overall survival is defined
as the time from the date of first dose of study treatment to death
from any cause.
- Vicinium Continues to be
Well-tolerated by Patients Treated in the Phase 3 VISTA Trial:
As of the March 1, 2019 data cut off, in patients across all
cohorts (n=133), 78% of 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 by the clinical investigators to be
manageable and reversible, and only five patients (4%) 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 kidney injury (Grade 3), pyrexia (Grade
2), cholestatic hepatitis (Grade 4) and renal failure (Grade 5).
There were no age-related increases in adverse events observed in
the Phase 3 VISTA trial.
- Positive Data and Safety Monitoring
Board (DSMB) Review of Phase 3 VISTA Trial Data: In March, the
independent DSMB completed its ninth planned safety review for the
Phase 3 VISTA trial and recommended the trial continue without
modification.
- Completion of Full-Scale
GMP Manufacturing Run at FUJIFILM Provides Encouraging
Preliminary Results, Supporting Analytical Comparability Plan to be
Reviewed with the FDA: In October 2018, Sesen Bio entered into
an agreement for the manufacturing process and technology transfer
of Vicinium production with FUJIFILM Diosynth Biotechnologies
U.S.A., Inc. (FUJIFILM). In April 2019, the first full,
commercial-scale GMP run was completed at FUJIFILM. Preliminary
indicators of success, including the bacterial growth and
purification profiles, support FUJIFILM’S ability to produce the
bulk drug substance form of Vicinium for commercial purposes if
Sesen Bio receives regulatory approval to market Vicinium. Full
quality release testing is underway, and results are expected to be
completed in May 2019.
- Updated Phase 3 VISTA Trial Data
Along with Closely Matched Phase 2 Clinical Trial Data to Serve as
Basis for Upcoming FDA Meetings:
- Type C CMC Meeting Scheduled for May
20, 2019. In conjunction with the technology transfer of
Vicinium production with FUJIFILM, the Company will seek alignment
with the FDA on an analytical comparability plan that can be used
to assess comparability between the supply used in clinical trials
and the potential commercial supply produced by FUJIFILM.
- Pre-BLA Meeting Scheduled for June
6, 2019: In concurrence with the FDA’s recommendation that the
Company schedule a meeting in mid-2019, Sesen Bio has confirmed a
meeting date with the FDA in June to discuss its intended
registration strategy for Vicinium for the treatment of high-risk
NMIBC.
First Quarter 2019 Financial Results
- Cash Position: Cash and cash
equivalents were $42.4 million as of March 31, 2019, compared to
$50.4 million as of December 31, 2018, and $19.7 million as of
March 31, 2018, the comparable period one year ago.
- Revenue: No revenue was recorded
for the three months ended March 31, 2019, nor for the same period
in 2018.
- R&D Expenses: Research and
development (R&D) expenses for the first quarter of 2019 were
$4.7 million compared to $3.3 million in R&D expenses for the
same period in 2018. The increase was primarily due to $1.7 million
in costs related to the ongoing manufacturing process and
technology transfer with FUJIFILM, and increased internal and
external staffing costs, partially offset by reduced expenses
related to the Phase 3 VISTA trial.
- G&A Expenses: General and
administrative expenses for the first quarter of 2019 were $3.1
million compared to $2.0 million for the same period in 2018.
The increase was primarily due to higher legal costs, an increase
in professional fees and market research costs.
- Net Loss: Net loss was $6.5
million, or $0.08 per share, for the first quarter of 2019,
compared to $4.0 million, or $0.11 per share, for the first quarter
of 2018.
- 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 Information
To participate in the conference call, please dial (844)
831-3025 (domestic) or (315) 625-6887 (international) and refer to
conference ID 7176228. 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 Trial
The 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 the duration of 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. 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.
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 a minimum of two courses of
bacillus Calmette-Guérin (BCG) and whose disease is now
BCG-unresponsive. 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 Bio
Sesen 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-unresponsive non-muscle
invasive bladder cancer (NMIBC). Vicinium is a locally-administered
targeted fusion protein composed of an anti-EPCAM antibody fragment
tethered to a truncated form of Pseudomonas Exotoxin A for the
treatment of high-risk NMIBC. For more information, please visit
the company’s website at www.sesenbio.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
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,
expectations regarding our upcoming FDA meetings, 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. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited) (in thousands, except per share data)
Three Months Ended March 31,
2019
2018
Total revenue $ - $ - Operating expenses: Research and
development 4,686 3,255 General and administrative 3,055 1,952 Gain
from change in fair value of contingent consideration (1,000
) (1,200 ) Total operating expenses 6,741
4,007 Loss from operations (6,741 ) (4,007 ) Other
income, net 261 44 Net loss and
comprehensive loss $ (6,480 ) $ (3,963 ) Net loss per share —basic
and diluted $ (0.08 ) $ (0.11 ) Weighted-average number of common
shares used in net loss per share —basic and diluted 77,458
35,674
SESEN BIO, INC. CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands) (Unaudited) March 31,
December 31, 2019 2018 Assets
Current assets: Cash and cash equivalents $ 42,437 $ 50,422 Prepaid
expenses and other current assets 3,014 1,334
Total current assets 45,451 51,756 Property and equipment,
net 272 321 Restricted cash 20 20 Intangible assets 46,400 46,400
Goodwill 13,064 13,064 Other assets 232 -
Total assets $ 105,439 $ 111,561
Liabilities and stockholders' equity Current liabilities:
Accounts payable $ 1,683 $ 1,367 Accrued expenses $ 5,234 $ 4,746
Other current liabilities 136 - Total
current liabilities 7,053 6,113 Other liabilities 398 313 Deferred
tax liability 12,528 12,528 Contingent consideration 47,400 48,400
Stockholders' equity: Common stock 77 77 Additional paid-in
capital 230,487 230,154 Accumulated deficit (192,504 )
(186,024 ) Total stockholders' equity 38,060
44,207 Total liabilities and stockholders' equity $
105,439 $ 111,561
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190513005207/en/
Erin Clark, Executive Director, Strategic Planning &
Investor Relationsir@sesenbio.com
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