FDA Grants Fast Track Designation for Vicinium
in NMIBC
Company Focused on Defining Registration
Pathway for Vicinium and Preparing for BLA Submission in 2019
Sesen Bio, Inc. (NASDAQ: SESN), a late-stage clinical company
developing next-generation antibody-drug conjugate (ADC) therapies
for the treatment of cancer, today reported pipeline updates and
operating results for the second quarter ended June 30, 2018.
“The first half of 2018 was full of successful milestones for
Sesen Bio, and I am excited to have joined the company at such an
important time in its evolution,” said Dr. Thomas Cannell,
president and chief executive officer of Sesen Bio, who was
recently appointed on August 7, 2018. “The three-month data from
the Phase 3 VISTA Trial demonstrate a strong complete response rate
and favorable safety with Vicinium for high-grade non-muscle
invasive bladder cancer, and we look forward to assessing
twelve-month efficacy data in less than a year’s time. Now, with
Fast Track designation for Vicinium, we are focused on advancing
our engagement with the FDA, kicking off critical manufacturing
readiness activities, initiating pre-commercial efforts and
preparing for our very first BLA submission for Vicinium for this
highly deserving patient population. I am very confident in what
the future holds for Sesen Bio and look forward to delivering on
the important milestones we have ahead.”
Business Update
- In June 2018, Sesen Bio completed an
underwritten public offering of its common stock raising gross
proceeds of approximately $46 million. The company believes this
financing extends the company’s cash runway into 2020 based on its
current operating plan.
Vicinium Program Updates
- In August 2018, the U.S. Food and Drug
Administration (FDA) granted Fast Track designation to Vicinium™
for the treatment of BCG-unresponsive, high-grade non-muscle
invasive bladder cancer (NMIBC). Fast Track designation is intended
to expedite the development and review process of therapeutics that
address unmet medical needs, including opportunities for more
frequent interactions with the FDA.
- In June 2018, the National Cancer
Institute (NCI) initiated patient dosing in the Phase 1 trial of
Vicinium in combination with AstraZeneca’s PD-L1 checkpoint
inhibitor, Imfinzi™ (durvalumab). The NCI is evaluating the
combination under a Cooperative Research and Development Agreement,
which was executed in June 2017.
- In May 2018, Sesen Bio presented
positive, three-month data from its ongoing Phase 3 VISTA Trial of
Vicinium for the treatment of patients with high-grade NMIBC who
have been previously treated with bacillus Calmette-Guérin (BCG),
during a plenary session at the American Urological Association
Annual Meeting.
- In the cohort of patients with
carcinoma in situ (CIS) with or without papillary disease whose
cancer recurred within six months of their last course of BCG
treatment, treatment with Vicinium demonstrated a complete response
rate of 39 percent. In evaluable patients in the cohort of patients
with CIS with or without papillary disease whose cancer recurred
after six months, but before 11 months, after their last course of
BCG treatment, treatment with Vicinium demonstrated a complete
response rate of 80 percent. This translates into a 42 percent
complete response rate for the combined cohorts of CIS patients who
were BCG-unresponsive within 12 months of their last BCG
treatment.
- In patients with papillary disease
without CIS whose cancer recurred within six months of their last
course of BCG treatment, treatment with Vicinium demonstrated a 68
percent recurrence-free rate at three months.
- To date, Vicinium has been
well-tolerated by patients in the VISTA Trial. Sesen Bio
anticipates reporting twelve-month data from its Phase 3 VISTA
Trial in mid-2019.
Second Quarter 2018 Financial
Results
- Cash Position: Cash and cash
equivalents were $62.9 million as of June 30, 2018, compared to
$15.8 for the same period in 2017.
- R&D Expenses: Research and
development expenses were $2.8 million for the quarter ended June
30, 2018, compared to $2.9 million for the same period in 2017.
This decrease was due primarily to a reduction in Vicinium-related
development expenses.
- G&A Expenses: General and
administrative expenses were $2.4 million for the quarter ended
June 30, 2018, compared to $2.2 million for the same period in
2017. This increase was due primarily to an increase in
professional fees.
- Net Loss: Net loss was $9.0
million, or $0.16 per share, for the quarter ended June 30, 2018,
compared to net loss of $7.3 million, or $0.30 per share, for the
same period in 2017.
- Financial Guidance: Following
the company’s public offering in June 2018, Sesen Bio believes it
will have capital sufficient to fund its current operating plans
into 2020.
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™ in patients
with high-grade non-muscle invasive bladder cancer (NMIBC) that is
carcinoma in situ (CIS), which is cancer found on the inner lining
of the bladder that has not spread into muscle or other tissue)
and/or papillary, which is cancer that has grown from the bladder
lining out into the bladder but has not spread into muscle or other
tissue, who have been previously treated with bacillus
Calmette-Guérin (BCG). The primary endpoint of the trial is the
complete response rate in patients with CIS 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. Twelve-month data 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™, also known as VB4-845, is Sesen
Bio’s lead product candidate and is a next-generation antibody-drug
conjugate (ADC), developed using the company’s proprietary Targeted
Protein Therapeutics platform, for the treatment of high-grade
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 linker 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-grade NMIBC in patients who have previously
received two courses of bacillus Calmette-Guérin (BCG) and whose
disease is now BCG-unresponsive. 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 next-generation antibody-drug conjugate therapies
for the treatment of cancer based on the company’s Targeted Protein
Therapeutics platform. 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-grade non-muscle invasive
bladder cancer. 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
sparing healthy 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 three-month 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 regulatory
approvals, expectations regarding the adequacy of our existing
capital resources to fund our operations 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 BALANCE SHEETS(unaudited)(in
thousands)
June 30, December
31, 2018
2017
Assets Current assets:
Cash and cash equivalents
$ 62,961 $ 14,680
Prepaid expenses and other current
assets
806 301
Total current assets
63,767 14,981 Property and equipment, net 421 522 Restricted cash
20 10 Intangible assets 46,400 46,400 Goodwill 13,064 13,064 Other
assets 41 120 Total assets $ 123,713
$ 75,097
Liabilities and stockholders'
equity Current liabilities:
Accounts payable
$ 1,310 $ 907
Accrued expenses
3,223 3,813
Total current liabilities
4,533 4,720 Other liabilities 288 215 Deferred tax liability 12,528
12,528 Contingent consideration 42,300 39,600 Stockholders'
equity:
Common stock
77 35
Additional paid-in capital
229,239 170,330
Accumulated deficit
(165,252 ) (152,331 ) Total stockholders' equity
64,064 18,034 Total liabilities and
stockholders' equity $ 123,713 $ 75,097
SESEN BIO, INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS(unaudited)(in
thousands, except per share data)
Three Months EndedJune
30,
Six Months EndedJune 30,
2018
2017
2018
2017
Total revenue $ - $ - $ - $ 425 Operating expenses: Research
and development 2,779 2,909 6,034 5,783 General and administrative
2,351 2,241 4,303 4,454 Loss from change in fair value of
contingent consideration 3,900 2,200
2,700 3,700 Total operating expenses
9,030 7,350 13,037
13,937 Loss from operations (9,030 ) (7,350 ) (13,037 )
(13,512 ) Other income, net 72 34
116 135 Net loss and comprehensive loss
$ (8,958 ) $ (7,316 ) $ (12,921 ) $ (13,377 ) Net loss per share
—basic and diluted $ (0.16 ) $ (0.30 ) $ (0.28 ) $ (0.54 )
Weighted-average number of common shares used in net loss per share
—basic and diluted 56,421 24,685
46,105 24,648
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version on businesswire.com: https://www.businesswire.com/news/home/20180814005161/en/
THRUST Strategic CommunicationsMonique Allaire,
617-895-9511monique@thrustir.comorAlicia Davis,
910-620-3302alicia@thrustir.com
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