On May 16, 2018 MiNA Therapeutics, the pioneer in RNA activation therapeutics, reported that it will present preliminary results from its Phase I study of small activating RNA (saRNA) candidate MTL-CEBPA in liver cancer at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago from June 1 – 5 (Press release, MiNA Therapeutics, MAY 16, 2018, View Source [SID1234526722]). The data will be featured in a Poster Discussion Session in the Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics session. MiNA will announce the results through a press release following the presentation.

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Poster Discussion Session details:

Title: Preliminary results of a first-in-human, first-in-class phase I study of MTL-CEBPA, a small activating RNA (saRNA) targeting the transcription factor C/EBP-α in patients with advanced liver cancer
Abstract No: 2509
Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Date / Time: June 4, 2018 at 3:00pm – 4:15pmLocation: S406

About MTL-CEBPA
MTL-CEBPA consists of a double stranded RNA formulated into a SMARTICLES liposomal nanoparticle and is designed to activate the CEBPA gene. By restoring CEBPA expression to normal levels, MTL-CEBPA has been demonstrated to attenuate or reverse liver disease in a range of pre-clinical studies including models of liver cancer, liver cirrhosis, non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). MTL-CEBPA is currently under evaluation in OUTREACH, a first-in-human Phase I clinical study in patients with severe liver cancer. The multi-centre Phase I study is assessing the safety and tolerability of MTL-CEBPA in patients with advanced liver cancer who are ineligible or resistant to standard therapies. To learn more about the OUTREACH clinical study, please visit our listing at clinicaltrials.gov

On May 16, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported follow-up data from the phase III ALEX study, showing that, as an initial treatment, Alecensa (alectinib) significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 57% (hazard ratio [HR]= 0.43, 95% CI: 0.32-0.58) compared to crizotinib after two years of follow-up in people with anaplastic lymphoma kinase (ALK)-positive metastatic (advanced) non-small cell lung cancer (NSCLC), as assessed by the investigator (Press release, Hoffmann-La Roche, MAY 16, 2018, View Source [SID1234526740]).1 The median PFS for people who received Alecensa was more than tripled compared to those who received crizotinib (34.8 months [95% CI: 17.7 months-NE) versus 10.9 months [95% CI: 9.1-12.9 months)], respectively, as assessed by the investigator. The safety profile for Alecensa was consistent with that observed in previous studies.

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"Follow-up results from the ALEX study demonstrate the significant sustained benefit of Alecensa, showing that people with metastatic ALK-positive non-small cell lung cancer lived for almost three years without their disease progressing," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "These results further support the use of Alecensa as a standard of care for people who are newly diagnosed with this form of lung cancer."

The longer-term analysis also included follow-up data for secondary endpoints of the ALEX study. Alecensa demonstrated superior efficacy compared to crizotinib regardless of the presence of central nervous system (CNS) metastases at baseline. Investigator-assessed median PFS for people without CNS metastases at baseline was 34.8 months with Alecensa (95% CI: 22.4-NE) versus 14.7 months (95% CI: 10.8-20.3) with crizotinib (HR=0.47, 95% CI: 0.32-0.71). Investigator-assessed median PFS for people with CNS metastases at baseline was 27.7 months in the Alecensa arm (95% CI: 9.2-NE) versus 7.4 months (95% CI: 6.6-9.6) in the crizotinib arm (HR=0.35, 95% CI: 0.22-0.56). 1 The duration of response (DOR) for people who received Alecensa was 33.3 months (95% CI: 31.3-NE) compared to 11.1 months (95% CI: 7.5-13.0 months) for people who received crizotinib.1

The data will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Sunday, 3 June, 2018 at 08:00 – 11:30 am CDT (Abstract #9043).

Alecensa is now approved in more than 45 countries as an initial (first-line) treatment for ALK-positive, advanced NSCLC, including in the United States, Europe and Japan.

About the ALEX study2
ALEX (NCT02075840/B028984) is a randomised, multicentre, open-label, phase III study evaluating the efficacy and safety of Alecensa versus crizotinib in treatment-naïve people with ALK-positive NSCLC whose tumours were characterised as ALK-positive by the VENTANA ALK (D5F3) CDx Assay, a companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. People were randomised (1:1) to receive either Alecensa or crizotinib. The primary endpoint of the ALEX study was PFS as assessed by the investigator, and secondary endpoints include: Independent Review Committee (IRC)-assessed PFS, time to CNS progression, objective response rate (ORR), DOR and overall survival (OS). The multicentre study was conducted in 303 people across 161 sites in 31 countries. OS data are currently considered immature with only about a third of events being reported.

Primary data from the ALEX study were previously presented at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.3 Follow-up results from the ALEX study analysis to be presented at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting showed1:

After a further 10 months of follow-up, Alecensa reduced the risk of disease worsening or death (PFS) by 57% compared to crizotinib (HR=0.43, 95% CI: 0.32-0.58). Median follow-up was 27.8 months versus 22.8 months for Alecensa-treated patients and crizotinib-treated patients, respectively.
Investigator-reported median PFS (the primary endpoint) was 34.8 months in the Alecensa arm (95% CI: 17.7-NE) versus 10.9 months (95% CI: 9.1-12.9 months) in the crizotinib arm.
ORR for people treated with Alecensa was 82.9% (95% CI: 75.95-88.51) compared to 75.5% (95% CI: 67.84-82.12) for people treated with crizotinib, as assessed by the investigator.
Alecensa demonstrated superior efficacy compared to crizotinib regardless of the presence or absence of CNS metastases at baseline. Investigator-assessed median PFS for people without CNS metastases at baseline was 34.8 months with Alecensa (95% CI: 22.4-NE) versus 14.7 months (95% CI: 10.8-20.3) with crizotinib (HR=0.47, 95% CI: 0.32-0.71). Investigator-reported median PFS for people with CNS metastases at baseline was 27.7 months in the Alecensa arm (95% CI: 9.2-NE) versus 7.4 months (95% CI: 6.6-9.6) in the crizotinib arm (HR=0.35, 95% CI: 0.22-0.56).
Improvements were observed in the time between first response to treatment and disease worsening (DOR): 33.3 months with Alecensa versus 11.1 months with crizotinib.
Grade 3-5 adverse events (AEs) were less frequent in the Alecensa arm (44.7%) compared to the crizotinib arm (51.0%). The most common Grade 3-4 AEs were increased liver enzymes (aspartate transaminase; 5.5%, and alanine transaminase; 4.6%) and increased muscle enzymes (creatine phosphokinase; 3.3%). Serious adverse reactions reported in ≥ 2% of people treated with Alecensa were acute kidney injury (2.6%) and decreased red blood cells (anaemia; 2.0%).
AEs leading to dose reduction (16.4% versus 20.5%) and dose interruption (22.4% versus 25.2%) were lower in the Alecensa arm compared with the crizotinib arm. AEs leading to discontinuation were equal in both arms (13.2%).
The FDA approval of Alecensa for the treatment of people with ALK-positive metastatic NSCLC was based on results from the phase III ALEX study from the primary data cutoff in February 2017. Results showed that:

Alecensa significantly reduced the risk of disease worsening or death (PFS) by 47% (HR=0.53, 95% CI: 0.38-0.73, p<0.001) compared to crizotinib as assessed by an IRC.
The median PFS was 25.7 months (95% CI: 19.9-NE) for people who received Alecensa compared with 10.4 months (95% CI: 7.7-14.6) for people who received crizotinib as assessed by an IRC.
Alecensa significantly reduced the risk of the cancer spreading to, or growing in, the brain or CNS compared to crizotinib by 84% (HR=0.16, 95% CI: 0.10-0.28, p<0.0001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).
The safety profile of Alecensa was consistent with that observed in previous studies.
Grade ≥ 3 adverse reactions were reported for 41% of people treated with Alecensa. The most common Grade 3-4 adverse reactions (≥ 3%) were evidence of kidney dysfunction (increased creatinine; 4.1%), evidence of liver dysfunction (hyperbilirubinemia; 5%), low levels of sodium (hyponatremia; 6%), increased liver enzymes (aspartate transaminase; 6%, and alanine transaminase; 6%), and decreased red blood cells (anaemia; 7%). Serious adverse reactions reported in ≥ 2% of people treated with Alecensa were pneumonia (4.6%) and renal impairment (3.9%).
About Alecensa
Alecensa (RG7853/AF-802/RO5424802/CH5424802) is a highly selective, CNS active, oral medicine created at Chugai Kamakura Research Laboratories and is being developed for people with NSCLC whose tumours are identified as ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.4 It is almost always found in people with a specific type of NSCLC called adenocarcinoma.4 Alecensa is now approved in over 45 countries as an initial (first-line) treatment for ALK-positive, metastatic NSCLC, including in the United States, Europe, Japan, Turkey, Cuba, Peru, Thailand, Australia, the Dominican Republic, India, Israel, Paraguay, Switzerland, Bolivia, Serbia, South Korea and Singapore. In addition, Alecensa is approved in the United States, Europe, Japan, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Bolivia, Australia, Singapore, Taiwan, Thailand, Liechtenstein, Argentina, United Arab Emirates, Saudi Arabia, Peru, New Zealand, Cuba, the Dominican Republic, Qatar, Oman, Serbia, Paraguay and Turkey for the treatment of people with advanced (metastatic) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib.

About Roche in lung cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have four approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

On May 16, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that study investigators will present interim data from the ongoing Phase 1 clinical trial for LOXO-292, the company’s highly selective RET inhibitor, in oral and poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held June 1 – 5, 2018 in Chicago, Illinois (Press release, Loxo Oncology, MAY 16, 2018, View Source [SID1234526707]).

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The oral presentation is entitled "A Phase 1 Study of LOXO-292, A Potent and Highly Selective RET Inhibitor, in Patients with RET-Altered Cancers." The submitted abstract utilized a January 2018 data cut-off date. The presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting will utilize an April 2018 data cut-off date. The efficacy data have improved between the January and April data cut-off dates. The abstract has been selected for the "Best of ASCO (Free ASCO Whitepaper)" program.

Additionally, an analysis of patients’ plasma cell free DNA during treatment with LOXO-292 will be presented in a separate poster presentation, entitled "Detection and Clearance of RET Variants in Plasma Cell Free DNA (cfDNA) from Patients (pts) Treated with LOXO-292."

The schedule for the oral and poster presentations are as follows:

Title: A Phase 1 Study of LOXO-292, A Potent and Highly Selective RET Inhibitor, in Patients with RET-Altered Cancers
Presentation Date & Time: Saturday, June 2, 2018, 8:00 – 9:30 a.m. CT
Abstract Number: 102
Session Title: Tumor Genomics: Finding the Target, Hitting the Target
Location: Hall D1
Presenter: Alexander E. Drilon, M.D.

Title: Detection and Clearance of RET Variants in Plasma Cell Free DNA (cfDNA) from Patients (pts) Treated with LOXO-292
Presentation Date & Time: Sunday, June 3, 2018, 8:00 – 11:30 a.m. CT
Abstract Number: 9048
Poster Board Number: 371
Session Title: Lung Cancer—Non-Small Cell Metastatic
Location: Hall A

Conference Call and Webcast Information
Loxo Oncology will be hosting a conference call and live webcast with slides and Q&A on Saturday, June 2, 2018 at 4:00 p.m. CT to discuss the LOXO-292 data after they are presented at ASCO (Free ASCO Whitepaper). To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 3597058. A live webcast of the presentation will be available at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the company’s website for 30 days following the call.

About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary thyroid cancer, and a subset of colon and other cancers. RET point mutations account for approximately 60% of medullary thyroid cancer. Both RET fusion and select RET mutated cancers are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in a Phase 1 trial. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

On May 16, 2018 GRAIL, Inc., a healthcare company focused on the early detection of cancer, reported that new data from the Circulating Cell-free Genome Atlas (CCGA) Study will be presented during the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5 in Chicago (Press release, Grail Bio, MAY 16, 2018, View Source [SID1234526723]). Data will be highlighted in four abstracts, including two oral presentations.

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Previously presented data from the first pre-planned sub-study of CCGA supported the possibility of developing a highly specific blood test for early detection of cancer with a very low rate of false positive results.1

New data from the same sub-study suggest a blood test can be developed to detect multiple types of cancer at early stages (Abstract 12021). Sensitivity analyses were conducted by sequencing blood samples from 878 participants with newly diagnosed cancer with three prototype genome sequencing assays. In general, results were comparable for the three prototype assays. Data for all three assays will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting. Results for the whole-genome bisulfite sequencing assay are reported in this press release. Detection rates (sensitivity at 98 percent specificity) ranged from 56 percent to 80 percent at early stages (stages I-III) in participants with cancer types that generally cause high mortality, including colorectal, esophageal, head and neck, liver, ovarian, pancreatic, and triple-negative breast cancers, as well as lymphoma and multiple myeloma.

Strong biological signal was also detected for lung cancer, the leading cause of cancer death globally, and these data will be highlighted in a late-breaking abstract that will be featured in ASCO (Free ASCO Whitepaper)’s press program on Saturday, June 2, 2018 (Abstract LBA8501).

Cancer types that exhibited low signal at early stages (less than 10 percent sensitivity), included prostate, thyroid, uterine, and renal cancers, and melanoma.

"Our initial CCGA results support the continued development of a highly specific blood test that can detect multiple cancer types early, when tumors can still be removed by surgery and treatment may be more successful," said Anne-Renee Hartman, MD, Vice President of Clinical Development. "These data are especially encouraging, as we were able to detect strong, blood-based biological signal at early stages for cancers that are responsible for the majority of cancer deaths globally, most of which are not typically screened for."

In this initial discovery phase of CCGA, three prototype genome sequencing assays were used to evaluate cancer-defining features in cell-free nucleic acids. The company is now verifying initial results from this CCGA sub-study in an independent data set from the same CCGA sub-study. The assays and GRAIL’s machine learning algorithms will then be optimized to determine the most informative genomic features for continued development and validation of a blood test for early detection of multiple cancer types in larger data sets in the CCGA and STRIVE studies.

Additional Results

Detection rates (sensitivity at 98 percent specificity) with the whole-genome bisulfite sequencing assay at stages I-III for cancer types with strong blood-based biological signal, are detailed in the table below. Detection rates for breast cancer subtypes at stages I-III are also detailed (Abstract 536).

The overall detection rate (sensitivity at 98 percent specificity) for breast cancer at stages I-III was 21 percent. Triple-negative breast cancer had strong biological signal at stages I-III (56 percent). Participants whose cancer was diagnosed through clinical presentation (diagnosis as a result of symptoms or through a different clinical setting than screening) had stronger signal than those diagnosed through screening mammography (sensitivity for stages I-IV breast cancer diagnosed through clinical presentation: 38 percent [95 percent confidence interval: 31 to 46 percent] vs. screen-detected breast cancer: 9 percent [95 percent confidence interval: 5 to 14 percent]).

Abstract LBA8501
Genome-wide sequencing for early stage lung cancer detection from plasma cell-free DNA (cfDNA): The Circulating Cell-free Genome Atlas (CCGA) study
ASCO Press Program: Saturday, June 2, 2018: 8:00-9:00am CDT
Oral Presentation: Monday, June 4, 2018: 8:12-8:24am CDT, Hall B1

Abstract 536
Breast cancer cell-free DNA (cfDNA) profiles reflect underlying tumor biology: The Circulating Cell-free Genome Atlas (CCGA) study
Poster Session: Saturday, June 2, 2018: 8:00-11:30am CDT, Hall A, Poster Board #28

Abstract 12021
Development of a comprehensive cell-free DNA (cfDNA) assay for early detection of multiple tumor types: The Circulating Cell-free Genome Atlas (CCGA) study
Poster Session: Monday, June 4, 2018: 1:15-4:45pm CDT, Hall A, Poster Board #134
Poster Discussion: Monday, June 4, 2018: 4:45-6:00pm CDT, Room S406

Abstract 12003
Prevalence of clonal hematopoiesis of indeterminate potential (CHIP) measured by an ultra-sensitive sequencing assay: Exploratory analysis of the Circulating Cell-free Genome Atlas (CCGA) study
Oral Presentation: Tuesday, June 5, 2018: 9:00-9:12am CDT, Room S406

About the First CCGA Sub-Study

In this pre-planned sub-study of CCGA, three prototype genome sequencing assays were evaluated as potential methods for a blood-based test for early cancer detection. In the first training phase of the sub-study, blood samples from 878 participants with newly diagnosed cancer who had not yet received treatment and 580 participants without diagnosed cancer were sequenced with all three prototype assays. Twenty different cancer types across all stages were included in the sub-study.

The prototype sequencing assays included:

Targeted sequencing of paired cell-free DNA (cfDNA) and white blood cells to detect somatic mutations such as single nucleotide variants and small insertions and/or deletions;
Whole-genome sequencing of paired cfDNA and white blood cells to detect somatic copy number changes; and
Whole-genome bisulfite sequencing of cfDNA to detect abnormal cfDNA methylation patterns.
About CCGA

CCGA is a prospective, observational, longitudinal study designed to characterize the landscape of cell-free nucleic acid (cfNA) profiles in people with and without cancer. The planned enrollment for the study is more than 15,000 participants across 141 sites in the United States and Canada. Approximately 70 percent of participants will have cancer at the time of enrollment (newly diagnosed, have not yet received treatment) and 30 percent will not have a known cancer diagnosis. The groups are demographically similar and representative of a real-world population. The group of participants without cancer includes individuals with conditions that are known to increase cfNA signal, such as inflammatory or autoimmune diseases. Planned follow-up for all participants is at least five years to collect clinical outcomes.

About STRIVE

STRIVE is a prospective, observational, longitudinal cohort study enrolling 120,000 women at the time of their screening mammogram. It is designed to evaluate blood tests for the early detection of multiple cancer types.

On May 16, 2018 Eleven Biotherapeutics, Inc. (Nasdaq: EBIO), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported that the company is changing its name to Sesen Bio, Inc. Sesen Bio will trade under the new Nasdaq ticker symbol "SESN," effective on May 17, 2018 (Press release, Eleven Biotherapeutics, MAY 16, 2018, View Source [SID1234526820]). The former ticker symbol "EBIO" will remain effective through the market close on May 16, 2018. The new website for Sesen Bio is www.sesenbio.com.

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Additionally, the company announced the appointments of Hagop Youssoufian, M.Sc., M.D. as senior medical advisor and Madhu Anant M.Sc., Ph.D., RAC as vice president of regulatory affairs.

"Over the last several years, we have undergone an incredible transformation as a company, and our new name, Sesen Bio, reinforces this evolution and our focused commitment to oncology drug development. Sesen, an ancient symbol of the lotus flower, represents life and our mission to bring forward medicines that will improve and preserve the lives of those with devastating cancers," said Stephen Hurly, president and chief executive officer of Sesen Bio. "The additions of Dr. Youssoufian and Dr. Anant further strengthen our leadership team and drug development capabilities as we work to bring our lead asset, Vicinium, through Phase 3 development for high-grade non-muscle invasive bladder cancer and advance regulatory interactions. 2018 is set to be a significant year for Sesen Bio, as we are well on our way to achieving our vision and bettering the lives of people in need."

Dr. Youssoufian joins Sesen Bio as senior medical advisor with more than 25 years of physician and drug development experience. He has spent over a decade serving as a consultant to more than 100 biotech companies and investment funds, acting in various roles including chief medical officer, clinical monitor and regulatory officer. In his career, Dr. Youssoufian has led a successful U.S. Food and Drug Administration advisory committee meeting and worked on numerous approved treatments, including Sprycel, Taxotere, Erbitux, Cyramza and Lartruvo. Prior to Sesen Bio, Dr. Youssoufian served as chief medical officer for Bind Therapeutics, where he was responsible for all clinical and regulatory programs, including interactions with key opinion leaders, investors and analysts; executive vice president of research and development for Progenics Pharmaceuticals; president of research and development and chief medical officer for Ziopharm Oncology; and chief medical officer at ImClone-Lilly. Dr. Youssoufian earned his M.D. and M.Sc. from the University of Massachusetts Medical School. He is a medical oncologist and geneticist and an elected member of the American Society for Clinical Investigation.

Dr. Anant brings more than 35 years of experience to her role as vice president of regulatory affairs at Sesen Bio. Prior to joining Sesen Bio, she served as the vice president, global regulatory affairs, hospital products for Mallinckrodt Pharmaceuticals where she was responsible for all regulatory activities including, strategy, health authority liaisons and regulatory pathways for development of products. Prior to Mallinckrodt, Dr. Anant served as an independent consultant in numerous roles including, head of regulatory affairs and lead strategist in regulatory affairs, clinical development and medical affairs. Earlier, she served as director, global regulatory sciences, geographic optimization for Bristol-Myers Squibb. There, she led the global regulatory strategies for geographic optimization of mature brands in the cardiovascular, metabolic, anti-infective and oncology therapeutic areas. Dr. Anant earned her Ph.D. from the International University for Professional Studies and her M.Sc. from the Institute of Science in Nagpur, India.

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 studies 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. Three-month data from the ongoing trial are planned for presentation at the 2018 American Urological Association Annual Meeting on May 21, 2018, with 12-month data 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.