On January 3, 2018 Bristol-Myers Squibb Company (NYSE:BMY) and Celgene Corporation (NASDAQ:CELG) reported that they have entered into a definitive merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately $74 billion (Press release, Bristol-Myers Squibb, JAN 3, 2019, View Source [SID1234532379]). Under the terms of the agreement, Celgene shareholders will receive 1.0 Bristol-Myers Squibb share and $50.00 in cash for each share of Celgene. Celgene shareholders will also receive one tradeable Contingent Value Right (CVR) for each share of Celgene, which will entitle the holder to receive a payment for the achievement of future regulatory milestones. The Boards of Directors of both companies have approved the combination.

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The transaction will create a leading focused specialty biopharma company well positioned to address the needs of patients with cancer, inflammatory and immunologic disease and cardiovascular disease through high-value innovative medicines and leading scientific capabilities. With complementary areas of focus, the combined company will operate with global reach and scale, maintaining the speed and agility that is core to each company’s strategic approach.

Based on the closing price of Bristol-Myers Squibb stock of $52.43 on January 2, 2019, the cash and stock consideration to be received by Celgene shareholders at closing is valued at $102.43 per Celgene share and one CVR (as described below). When completed, Bristol-Myers Squibb shareholders are expected to own approximately 69 percent of the company, and Celgene shareholders are expected to own approximately 31 percent.

"Together with Celgene, we are creating an innovative biopharma leader, with leading franchises and a deep and broad pipeline that will drive sustainable growth and deliver new options for patients across a range of serious diseases," said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb. "As a combined entity, we will enhance our leadership positions across our portfolio, including in cancer and immunology and inflammation. We will also benefit from an expanded early- and late-stage pipeline that includes six expected near-term product launches. Together, our pipeline holds significant promise for patients, allowing us to accelerate new options through a broader range of cutting-edge technologies and discovery platforms."

Dr. Caforio continued, "We are impressed by what Celgene has accomplished for patients, and we look forward to welcoming Celgene employees to Bristol-Myers Squibb. Our new company will continue the strong patient focus that is core to both companies’ missions, creating a shared organization with a goal of discovering, developing and delivering innovative medicines for patients with serious diseases. We are confident we will drive value for shareholders and create opportunities for employees."

"For more than 30 years, Celgene’s commitment to leading innovation has allowed us to deliver life-changing treatments to patients in areas of high unmet need. Combining with Bristol-Myers Squibb, we are delivering immediate and substantial value to Celgene shareholders and providing them meaningful participation in the long-term growth opportunities created by the combined company," said Mark Alles, Chairman and Chief Executive Officer of Celgene. "Our employees should be incredibly proud of what we have accomplished together and excited for the opportunities ahead of us as we join with Bristol-Myers Squibb, where we can further advance our mission for patients. We look forward to working with the Bristol-Myers Squibb team as we bring our two companies together."

Compelling Strategic Benefits

Leading franchises with complementary product portfolios provide enhanced scale and balance. The combination creates:
Leading oncology franchises in both solid tumors and hematologic malignancies led by Opdivo and Yervoy as well as Revlimid and Pomalyst;
A top five immunology and inflammation franchise led by Orencia and Otezla; and
The #1 cardiovascular franchise led by Eliquis.

The combined company will have nine products with more than $1 billion in annual sales and significant potential for growth in the core disease areas of oncology, immunology and inflammation and cardiovascular disease.

Near-term launch opportunities representing greater than $15 billion in revenue potential. The combined company will have six expected near-term product launches:
Two in immunology and inflammation, TYK2 and ozanimod; and
Four in hematology, luspatercept, liso-cel (JCAR017), bb2121 and fedratinib.

These launches leverage the combined commercial capabilities of the two companies and will broaden and enhance Bristol-Myers Squibb’s market position with innovative and differentiated products. This is in addition to a significant number of lifecycle management registrational readouts expected in Immuno-Oncology (IO).

Early-stage pipeline builds sustainable platform for growth. The combined company will have a deep and diverse early-stage pipeline across solid tumors and hematologic malignancies, immunology and inflammation, cardiovascular disease and fibrotic disease leveraging combined strengths in innovation. The early-stage pipeline includes 50 high potential assets, many with important data readouts in the near-term. With a significantly enhanced early-stage pipeline, Bristol-Myers Squibb will be well positioned for long-term growth and significant value creation.

Powerful combined discovery capabilities with world-class expertise in a broad range of modalities. Together, the Company will have expanded innovation capabilities in small molecule design, biologics/synthetic biologics, protein homeostasis, antibody engineering and cell therapy. Furthermore, strong external partnerships provide access to additional modalities.

Compelling Financial Benefits

Strong returns and significant immediate EPS accretion. The transaction’s internal rate of return is expected to be well in excess of Celgene’s and Bristol-Myers Squibb’s cost of capital. The combination is expected to be more than 40 percent accretive to Bristol-Myers Squibb’s EPS on a standalone basis in the first full year following close of the transaction.
Strong balance sheet and cash flow generation to enable significant investment in innovation. With more than $45 billion of expected free cash flow generation over the first three full years post-closing, the Company is committed to maintaining strong investment grade credit ratings while continuing its dividend policy for the benefit of Bristol-Myers Squibb and Celgene shareholders. Bristol-Myers Squibb will also have significant financial flexibility to realize the full potential of the enhanced late- and early-stage pipeline.
Meaningful cost synergies. Bristol-Myers Squibb expects to realize run-rate cost synergies of approximately $2.5 billion by 2022. Bristol-Myers Squibb is confident it will achieve efficiencies across the organization while maintaining a strong, core commitment to innovation and delivering the value of the portfolio.

Terms and Financing

Based on the closing price of Bristol-Myers Squibb stock on January 2, 2019, the cash and stock consideration to be received by Celgene shareholders is valued at $102.43 per share. The cash and stock consideration represents an approximately 51 percent premium to Celgene shareholders based on the 30-day volume weighted average closing stock price of Celgene prior to signing and an approximately 54 percent premium to Celgene shareholders based on the closing stock price of Celgene on January 2, 2019. Each share also will receive one tradeable CVR, which will entitle its holder to receive a one-time potential payment of $9.00 in cash upon FDA approval of all three of ozanimod (by December 31, 2020), liso-cel (JCAR017) (by December 31, 2020) and bb2121 (by March 31, 2021), in each case for a specified indication.

The transaction is not subject to a financing condition. The cash portion will be funded through a combination of cash on hand and debt financing. Bristol-Myers Squibb has obtained fully committed debt financing from Morgan Stanley Senior Funding, Inc. and MUFG Bank, Ltd. Following the close of the transaction, Bristol-Myers Squibb expects that substantially all of the debt of the combined company will be pari passu.

Accelerated Share Repurchase Program

Bristol-Myers Squibb expects to execute an accelerated share repurchase program of up to approximately $5 billion, subject to the closing of the transaction, market conditions and Board approval.

Corporate Governance

Following the close of the transaction, Dr. Caforio will continue to serve as Chairman of the Board and Chief Executive Officer of the company. Two members from Celgene’s Board will be added to the Board of Directors of Bristol-Myers Squibb. The combined company will continue to have a strong presence throughout New Jersey.

Approvals and Timing to Close

The transaction is subject to approval by Bristol-Myers Squibb and Celgene shareholders and the satisfaction of customary closing conditions and regulatory approvals. Bristol-Myers Squibb and Celgene expect to complete the transaction in the third quarter of 2019.

Advisors

Morgan Stanley & Co. LLC is serving as lead financial advisor to Bristol-Myers Squibb, and Evercore and Dyal Co. LLC are serving as financial advisors to Bristol-Myers Squibb. Kirkland & Ellis LLP is serving as Bristol-Myers Squibb’s legal counsel. J.P. Morgan Securities LLC is serving as lead financial advisor and Citi is acting as financial advisor to Celgene. Wachtell, Lipton, Rosen & Katz is serving as legal counsel to Celgene.

Bristol-Myers Squibb 2019 EPS Guidance

In a separate press release issued today, Bristol-Myers Squibb announced its 2019 EPS guidance for full-year 2019, which is available on the "Investor Relations" section of the Bristol-Myers Squibb website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call

Bristol-Myers Squibb and Celgene will host a conference call today, at 8:00 a.m. ET to discuss the transaction. The conference call can be accessed by dialing (800) 347-6311 (U.S. / Canada) or (786) 460-7199 (International) and giving the passcode 4935567. A replay of the call will be available from January 3, 2019 until January 17, 2019 by dialing (888) 203-1112 (U.S. / Canada) or (719) 457-0820 (International) and giving the passcode 4935567.

A live webcast of the conference call will be available on the investor relations section of each company’s website at Bristol-Myers Squibb View Source and Celgene View Source." target="_blank" title="View Source." rel="nofollow">View Source

Presentation and Infographic

Associated presentation materials and an infographic regarding the transaction will be available on the investor relations section of each company’s website at Bristol-Myers Squibb View Source and Celgene View Source as well as a joint transaction website at www.bestofbiopharma.com.

On January 3, 2019 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage drug discovery and development company applying synthetic biology to beneficial microbes to develop novel living medicines, reported an overview of recent progress and outlined key objectives and anticipated milestones for 2019 (Press release, Synlogic, JAN 3, 2019, View Source [SID1234532396]).

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"2018 was a significant year for Synlogic as we advanced our two lead clinical programs and platform. We have demonstrated proof of mechanism in both programs in healthy volunteers and are currently evaluating safety and activity in patients with disease. In addition, we broadened our pipeline with the addition of our first immuno-oncology development candidate, SYNB1891," said Aoife Brennan, M.B. Ch.B., Synlogic’s president and chief executive officer. "In 2019 we look forward to presenting data from our two ongoing clinical programs that will inform the development of our Synthetic Biotic platform. With the recent expansion of our internal GMP-manufacturing capabilities, we are well positioned to maintain the momentum of the past year and continue to advance programs through clinical development as expeditiously as possible."

2019 Goals and Catalysts

Pipeline

SYNB1020: An orally delivered, first-in-class, Synthetic Biotic medicine designed for treatment of elevated blood ammonia levels (hyperammonemia) in chronic liver disease or genetic urea cycle disorders (UCDs).
In mid-2019, Synlogic expects to present top-line data from its randomized, double-blind, placebo -controlled Phase 1b/2a clinical trial evaluating SYNB1020 in patients with cirrhosis and elevated ammonia. The main endpoints of the study are safety and tolerability, as well as evidence of ammonia lowering in patients.
SYNB1618: An orally delivered, Synthetic Biotic medicine designed for the treatment of phenylketonuria (PKU).
In mid-2019, Synlogic expects to present top-line data from its randomized, double-blind, placebo-controlled Phase 1/2a clinical trial evaluating SYNB1618 in patients with PKU. The study is designed to evaluate safety and tolerability in this population as well as pharmacokinetics and pharmacodynamics as determined by the production of biomarkers specifically associated with SYNB1618 activity.
SYNB1891: Synlogic’s first immuno-oncology (IO) development candidate, a STING agonist-producing Synthetic Biotic medicine, designed to act as a dual innate immune activator, for the treatment of non-immunologically responsive solid tumors.
In the second half of 2019 the Company expects to file an IND application to enable advancement of SYNB1891 into a Phase 1 clinical study.
Pre-clinical data and early pipeline programs:
The company expects to publish and present data at major scientific and medical meetings throughout the year demonstrating the breadth and potential of its Synthetic Biotic platform.
Synlogic and AbbVie will continue to advance their ongoing collaboration to develop a Synthetic Biotic medicine for the treatment of inflammatory bowel disease (IBD).
Corporate

Synlogic ended the third quarter of 2018 with $133 million in cash and cash equivalents and expects that this will fund Company operations through 2020 under its current plan.
The Company will continue to explore additional strategic opportunities to expand the reach of its Synthetic Biotic platform.
2018 Accomplishments and Highlights:

Pipeline

SYNB1020:
Dosed first patient in Phase 1b/2a trial of SYNB1020 for the treatment of hyperammonemia in patients with cirrhosis and elevated ammonia. The clinical trial is a single and multiple dose-escalation, randomized, double-blind, placebo-controlled study of orally administered SYNB1020 in patients with cirrhosis and elevated blood ammonia, designed to evaluate safety, tolerability, kinetics, and pharmacodynamics as well as the ability of SYNB1020 to lower blood ammonia. Synlogic enrolled and treated an initial open-label sentinel cohort of six subjects with mild disease to ensure that SYNB1020 was safe in patients with liver disease who often have compromised barrier function and might be susceptible to infection. This part of the study is complete and Synlogic is enrolling patients with more advanced disease with elevated blood ammonia at baseline.
Presented data supporting continued development of SYNB1020 for the treatment of liver disease at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). Synlogic presented data from a cross-sectional study designed to establish ammonia measurement parameters and ammonia levels in healthy volunteers at clinical sites that are participating in Synlogic’s ongoing Phase 1b/2a clinical trial of SYNB1020 in patients with cirrhosis and elevated ammonia. Preclinical data from a rat model were also presented by Synlogic’s collaborators that demonstrated dose-dependent lowering of blood ammonia by Synthetic Biotic strains designed to consume ammonia, confirming earlier preclinical observations in mouse models of liver disease.
SYNB1618:
Announced positive interim data from the healthy volunteer arm of its ongoing Phase 1/2a clinical trial evaluating SYNB1618 for the treatment of PKU. The data demonstrated a statistically significant, dose-dependent effect on treatment-associated biomarkers, indicating proof-of-mechanism, and also established a go-forward dose for the treatment arm in patients with PKU.
Published preclinical data in Nature Biotechnology identifying key biomarkers of SYNB1618 activity in healthy animal and disease models. The data demonstrated that oral administration of SYNB1618 significantly reduced blood phenylalanine (Phe) levels, the key metabolite associated with PKU, in mouse models of PKU and resulted in dose-dependent pharmacodynamics in healthy non-human primates (NHPs).
Fast Track designation granted to SYNB1618 for PKU by the U.S. Food and Drug Administration (FDA).
SYNB1891:
Presented preclinical data highlighting the potential of Synthetic Biotic medicines in IO and announced first IO clinical candidate at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). A webcast of the presentation is available on the Synlogic website. Data presented at the meeting demonstrate the platform’s potential for the treatment of cancer and inflammation and specifically highlight the unique advantages of Synlogic’s approach to stimulate the innate immune system.
Corporate

Successfully completed two public offerings of common stock in January and April, resulting in approximately $83 million in total net proceeds.
The Company announced executive leadership changes including the appointment of Aoife Brennan, M.B., B.Ch., as president and chief executive officer, and the appointment of Antoine Awad as Head of Technical Operations.
Synlogic expanded its manufacturing capabilities to enable production of clinical trial material for its oral and immuno-oncology programs via entry into an agreement to lease GMP clean-room space from the Azzur Group, LLC. The agreement provides the Company with infrastructure that enables advancement of clinical programs through early and mid-phase studies and supports the production of both solid and oral formulations.
Advanced collaboration with AbbVie to develop Synthetic Biotic-based treatments for IBD resulting in payment to Synlogic of a $2.0 million milestone.
Synlogic was added to both the Russell 3000Index and the NASDAQ Biotechnology Index (Nasdaq: NBI).

On January 3, 2019 Adaptive Biotechnologies reported that Chad Robins, chief executive officer and co-founder, will present at the 37th Annual J.P. Morgan Healthcare Conference on January 8, 2019 at 11:30 am PT (2:30 pm ET) in San Francisco (Press release, Adaptive Biotechnologies, JAN 3, 2019, View Source [SID1234532413]). Robins will also participate in a panel presentation, Reinventing the Disease Continuum Through Precision Health, on January 7, 2019 at 5:00 pm PT (8:00 pm ET) to discuss the impact of immune profiling on the future of immune-driven medicine.

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A live webcast of the presentation and Q&A session can be accessed from the Newsroom under Events on the Adaptive website at adaptivebiotech.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 90 days.

On January 3, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO) reported that Bill Newell, Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference on Thursday, Jan. 10, 2019 at 11:30 a.m. PT / 2:30 p.m. ET at the Westin St. Francis Hotel in San Francisco (Press release, Sutro Biopharma, JAN 3, 2019, View Source [SID1234532429]).

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A live webcast of the presentation will be accessible through the Events and Presentations page of the Investor Relations section of the company’s website at www.sutrobio.com. A replay of the webcast will be available for approximately 30 days following the event.

On January 3, 2019 Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of cancer, reported positive preliminary efficacy data for the primary endpoint of its ongoing Phase 3 registration trial, the VISTA Trial, of Vicinium for the treatment of patients with high-grade non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG) and deemed BCG-unresponsive (Press release, Eleven Biotherapeutics, JAN 3, 2019, View Source [SID1234532380]). The data reported show clinically meaningful complete response rates in evaluable Carcinoma in situ patients at three, six, nine and 12 months of follow-up in the trial consistent with the data in the completed Phase 1 and Phase 2 clinical trials. Importantly, Vicinium continues to be generally well-tolerated in treated patients.

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"Non-muscle invasive bladder cancer is a very prevalent cancer that can progress to become incurable. The usual treatment for patients who relapse or become refractory to BCG, today’s standard-of-care, is complete bladder removal or radical cystectomy," said Michael A.S. Jewett, M.D., Professor of Surgery, Division of Urology, University of Toronto. "Removing the bladder is a potentially morbid and complex surgery with potential for side effects that can drastically reduce a patient’s quality of life. In fact, many patients choose not to undergo bladder removal. I am very encouraged by the data generated to-date with intravesical Vicinium as an alternative after BCG failure. Based on the strength of the clinical activity observed, and the consistently favorable safety and tolerability, I believe that Vicinium has the potential to change the treatment outcome for patients."

VISTATrial Design
The Phase 3 VISTA Trial is a single-arm, multi-center clinical trial designed to support the approval of Vicinium for the treatment of patients with high-grade, BCG-unresponsive NMIBC. The trial enrolled a total of 133 patients across three cohorts based on histology and time to disease recurrence after adequate BCG:

Cohort 1 (n=86): Carcinoma in situ patients with or without papillary disease whose cancer was determined to be refractory or recurred within six months of their last course of adequate BCG
Cohort 2 (n=7): Carcinoma in situ patients with or without papillary disease whose cancer was determined to be refractory or recurred after six months, but less than 12 months, after their last course of adequate BCG
Cohort 3 (n=40): patients with papillary disease without Carcinoma in situ whose cancer was determined to be refractory or recurred within six months of their last course of adequate BCG
The data reported build upon preliminary three-month data presented from a subset of patients in May 2018 and are for the primary endpoint of the VISTA Trial, which is the complete response rate and duration of response in patients in Cohort 1. The company also reported data from Cohort 2, separately and pooled with Cohort 1, based on final U.S. Food and Drug Administration guidance on treatment of BCG-unresponsive Carcinoma in situ patients (defined as patients with recurrent Carcinoma in situ within 12 months of adequate BCG therapy)1.

The patient population in Cohort 3 represents an opportunity for future label expansion, and the company plans to report efficacy data from this cohort, as well as the secondary endpoints in the VISTA Trial, in mid-2019.

Preliminary Efficacy Results in Carcinoma in situ Patients

Cohort 1 (n=86)

Time point Evaluable Patients 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%)

Cohort 2 (n=7)

Time point Evaluable Patients 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%)

Pooled Cohorts 1 and 2 (n=93)

Time point Evaluable Patients 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%)

Notably, the interim Phase 3 complete response rates in pooled patients from Cohorts 1 and 2 are in-line with the complete response rates in pooled patients in the completed Phase 2 clinical trial.

Preliminary Phase 3 CRR vs Phase 2 CRR

Time point Phase 3 Pooled CRR
(95% Confidence Intervals)

Phase 2 Pooled CRR
(95% Confidence Interval)

3-months 39% (29%, 49%) 40% (26%, 56%)
6-months 27% (18%, 37%) 27% (15%, 42%)
9-months 20% (12%, 29%) 18% (8%, 32%)
12-months 14% (7%, 23%) 16% (7%, 30%)

The company also reported an update on the durability of responses in the VISTA Trial. While the median has not yet been reached, the preliminary data show that Vicinium treatment resulted in a prolonged duration of response in many patients. This is particularly notable given that, in order for patients to remain on study, they have to have achieved a complete response at each assessment time period. These findings suggest that Vicinium has the potential to benefit patients by delaying the time to a radical cystectomy, a secondary endpoint that will be measured and reported in mid-2019.

Preliminary Safety Results
Vicinium continues to be well-tolerated by patients treated in the VISTA Trial. As of the December 3, 2018 data cut off, in patients across all three cohorts (n=133), 78 percent 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 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 percent 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).

"We are very pleased with these preliminary data, which are consistent with the data in our completed Phase 2 clinical trial of Vicinium for the treatment of high-grade NMIBC, and further support our belief that Vicinium has the potential to change how patients are treated after BCG," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "The design of the VISTA Trial aligns with FDA’s guidance for NMIBC drug development, and the findings are highly encouraging, demonstrating that treatment with Vicinium results in clinically meaningful efficacy and favorable safety and tolerability. Overall, the data reinforce our belief that Vicinium is positioned to provide a valuable benefit to patients by treating their disease with long-term responses and extending their time to face such a decision as removing their bladder. 2019 is set to be a transformational year for Sesen Bio, and we look forward to advancing the VISTA Trial and assessing the full 12-month data from all patients later this year."

The VISTA Trial completed enrollment in the second quarter of 2018, and complete 12-month efficacy data from all patients in the clinical trial are expected to be reported at a medical meeting in mid-2019.

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 4263106. 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 in patients with high-grade non-muscle invasive bladder cancer (NMIBC) that is Carcinoma in situ, 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 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. Twelve-month data from all patients in 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-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 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-grade NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Complete 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 Non-Muscle Invasive Bladder Cancer
Bladder cancer is the sixth most commonly diagnosed cancer in the United States, and approximately 80 percent of patients have non-muscle invasive bladder cancer (NMIBC). In NMIBC, cancer cells are in the lining of the bladder or have grown into the lumen of the bladder but have not spread into muscle or other tissue. NMIBC primarily affects men and is associated with carcinogen exposure. Initial treatment includes surgical resection; however, there is a high rate of recurrence and more than 60 percent of all patients diagnosed with NMIBC will receive bacillus Calmette-Guérin (BCG) immunotherapy. While BCG is effective in many patients, challenges with tolerability have been observed and many patients will experience recurrence of disease. If BCG is not effective or a patient can longer receive BCG, the recommended option for treatment is radical cystectomy, the complete removal of the bladder.