On May 17, 2018 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that two abstracts on its lead product candidate BPX-501 have been selected for presentation at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden on June 14-17, 2018 (Press release, Bellicum Pharmaceuticals, MAY 17, 2018, View Source [SID1234526757]).

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The presentations will include updated interim survival results from pediatric patients with primary immunodeficiencies (PIDs) and acute myelogenous leukemia (AML) who are undergoing a curative haplo-HSCT with BPX-501.

Oral Presentation Details

Title:Administration of BPX-501 Cells Following Alpha/Beta T-cell and B-cell-Depleted HLA‑Haploidentical HSCT (haplo-HSCT) in Children with Primary Immunodeficiencies Abstract: S871
Session Title: Stem cell transplantation – Clinical II
Date: Saturday, June 16
Time: 4:00 – 4:15 p.m. CEST

Poster Presentation Details

Title:Administration of BPX-501 Cells Following Alpha/Beta T-cell and B-cell-Depleted HLA‑Haploidentical HSCT (haplo-HSCT) in Children with Acute Myelogenous Leukemia Abstract: PS989
Session Title: Acute myeloid leukemia – Clinical
Date: Saturday, June 16
Time: 5:30 – 7:00 p.m. CEST

The BPX-501 clinical presentations at the conference will include updated information beyond that included in the abstracts currently available online on the EHA (Free EHA Whitepaper) conference website.

About BPX-501
BPX-501 is an adjunct T-cell therapy administered after allogeneic HSCT, comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe safety switch. It is designed to provide a safety net to eliminate alloreactive BPX-501 T cells (via administration of activator agent rimiducid) should uncontrollable GvHD or other T-cell mediated transplant complications occur. This may enable physicians to more safely perform stem cell transplants by administering BPX-501 engineered T cells to speed immune reconstitution, provide control over viral infections, and enhance graft-versus-leukemic activity while minimizing GvHD side effects.

On May 17, 2018 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that multiple abstracts from its robust clinical development portfolio will be presented at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois, from June 1-5, 2018 (Press release, Seattle Genetics, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349592 [SID1234526775]).

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"The abstracts being presented at ASCO (Free ASCO Whitepaper) 2018 highlight the depth of our clinical program in multiple solid tumors and hematological malignancies," said Robert Lechleider, M.D., Senior Vice President, Clinical Development at Seattle Genetics. "Of note, an oral presentation will feature updated data from a phase 1 study of enfortumab vedotin for patients with metastatic urothelial cancer. Data from this study formed the basis of the recent FDA Breakthrough Therapy Designation for enfortumab vedotin. In addition, multiple posters featuring sub-analyses from the ECHELON-1 trial of ADCETRIS provide continued strong rationale for ADCETRIS combination use in the treatment of patients with frontline Stage 3 and 4 classical Hodgkin lymphoma."

The abstracts published in advance of the ASCO (Free ASCO Whitepaper) meeting were made available yesterday on the ASCO (Free ASCO Whitepaper) website at www.asco.org.

Urothelial Cancer

(Abstract #4504) "Updated results from the enfortumab vedotin phase 1 (EV-101) study in patients with metastatic urothelial cancer (mUC)"

Presenter: J. Rosenberg, M.D., Memorial Sloan Kettering Cancer Center

Oral Abstract Session: Genitourinary (Nonprostate) Cancer

Date and Time: Sunday, June 3, 9:12 a.m.-9:24 a.m. CDT (session begins at 8:00 a.m.)

Location: Arie Crown Theater

(Abstract #TPS4590) "EV-201 Study: A single-arm, open-label, multicenter study of enfortumab vedotin for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor therapy"

Presenter: J. Rosenberg, M.D., Memorial Sloan Kettering Cancer Center

Poster Session: Genitourinary (Nonprostate) Cancer

Date and Time: Saturday, June 2, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #414a

Hodgkin Lymphoma

(Abstract #7534) "Improving outcomes with brentuximab vedotin (BV) plus chemotherapy in patients with newly diagnosed advanced stage Hodgkin lymphoma"

Presenter: D. Straus, M.D., Memorial Sloan Kettering Cancer Center

Poster Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #171

(Abstract #7541) "Brentuximab vedotin (BV) plus chemotherapy in patients with newly diagnosed advanced stage Hodgkin lymphoma (HL): North American results"

Presenter: R. Ramchandren, M.D., Barbara Ann Karmanos Cancer Institute

Poster Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #178

(Abstract #7542) "Long-term follow-up of brentuximab vedotin +/- dacarbazine as first line therapy in elderly patients with Hodgkin lymphoma"

Presenter: J. Friedburg, M.D., University of Rochester Medical Center

Poster Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #179

(Abstract #7539) "Brentuximab vedotin with chemotherapy for stage III or IV Hodgkin lymphoma (HL): Impact of cycle 2 PET result on modified progression-free survival (mPFS)"

Presenter: R. Chen, M.D., Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center

Poster Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #176

Breast Cancer

(Abstract #1015) "Clinical benefit of tucatinib after isolated brain progression: A retrospective pooled analysis of tucatinib phase 1b studies in HER2+ breast cancer"

Presenter: R. Murthy, M.D., University of Texas MD Anderson Cancer Center

Poster Session: Breast Cancer – Metastatic

Date and Time: Saturday, June 2, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #96

Discussed at Poster Discussion at Hall D1 on Saturday, June 2, 1:15 p.m.-2:30 p.m. CDT

Cervical Cancer

(Abstract #TPS5601) "A single-arm, phase 2, multicenter, international trial of tisotumab vedotin (HuMax-TF-ADC) in previously treated, recurrent or metastatic cervical cancer"

Presenter: R. Coleman, M.D., The University of Texas MD Anderson Cancer Center

Poster Session: Gynecologic Cancer

Date and Time: Monday, June 4, 1:15 p.m.-4:45 p.m. CDT

Location: Hall A, Poster Board #327b

Additional Cancers

(Abstract #3093) "SEA-CD40, a non-fucosylated CD40 agonist: Interim results from a phase 1 study in advanced solid tumors"

Presenter: J. Grilley-Olson, M.D., UNC Lineberger Comprehensive Cancer Center/University of North Carolina Chapel Hill

Poster Session: Developmental Therapeutics – Immunotherapy

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #307

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.