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
Vicinium Program Updates
Second Quarter 2018 Financial Results
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™ 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 Bio
Sesen 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 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 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. |
|||||||||||
| 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 Ended |
Six Months Ended |
||||||||||||||||||
|
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 | |||||||||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20180814005161/en/
THRUST Strategic Communications
Monique Allaire, 617-895-9511
monique@thrustir.com
or
Alicia
Davis, 910-620-3302
alicia@thrustir.com