On November 8, 2017 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, reported that the Company will present at the following upcoming investor conferences (Press release, Verastem, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315302 [SID1234521768]):

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The Stifel Nicolaus 2017 Healthcare Conference on Tuesday, November 14, at 10:15 a.m. ET in New York City, NY, USA

The Jefferies 2017 London Healthcare Conference on Thursday, November 16, at 5:20 p.m. GMT in London, UK
A live webcast of each presentation will be available on the investors section of the Company’s website at www.verastem.com. An archived presentation will be available for 90 days.

On November 8, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that an overview of the Company’s business strategy and commercial and development-stage programs will be given at the Jefferies 2017 London Healthcare Conference being held at the Waldorf Hilton in London. The Company presentation is on Wednesday, November 15th at 4:00 PM GMT (Press release, Spectrum Pharmaceuticals, NOV 8, 2017, View Source [SID1234521765]).

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A live webcast of Spectrum’s presentation will be available at View Source

On November 8, 2017 Seattle Genetics, Inc. (NASDAQ: SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas"), reported dosing of the first patient in EV-103, a phase 1b clinical trial evaluating the safety and tolerability of enfortumab vedotin in combination with pembrolizumab or atezolizumab, two types of immune checkpoint inhibitor (CPI) therapies, for first- or second-line treatment of patients with locally advanced or metastatic urothelial cancer (Press release, Seattle Genetics, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315341 [SID1234521763]). Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) designed to deliver the cell-killing agent monomethyl auristatin E (MMAE) to the target Nectin-4.

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"The initiation of EV-103 is an important step in investigating the utility of enfortumab vedotin in earlier lines of therapy, including the first-line setting, for locally advanced and metastatic urothelial cancer, where patients ineligible for cisplatin-based chemotherapy continue to have limited treatment options," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "This study represents Seattle Genetics’ third ADC under clinical evaluation in combination with CPIs, highlighting our vision that ADCs could be the preferred partners for immuno-oncology agents for patients with solid tumors and hematological cancers."

The EV-103 study is a single arm, open label multicenter trial that will enroll up to 85 patients with locally advanced or metastatic urothelial cancer who are ineligible for first line cisplatin-based chemotherapy or have progressed following treatment with a regimen containing platinum-based chemotherapy. Enfortumab vedotin will be administered during weeks one and two of every three-week cycle, and pembrolizumab or atezolizumab will also be administered during week one of this period. The primary objective of the trial is to assess the safety and tolerability of enfortumab vedotin in combination with CPI therapy. Secondary endpoints include the recommended dose in combination with CPIs, overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS), among other measures.

"We are pleased to be moving forward with evaluating enfortumab vedotin in combination with CPI therapy, as we look to further investigate the potential of this agent in some of the hardest-to-treat cancers," said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. "Many patients do not respond to or relapse after treatment with CPIs, and we are committed to exploring additional ways to potentially address the unmet needs of the urothelial cancer community."

Enfortumab vedotin is also being studied as monotherapy in a pivotal clinical trial for patients with advanced urothelial cancer who have received prior CPI therapy, called EV-201 (NCT03219333), to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations.

For more information about the EV-103 clinical trial, please visit www.clinicaltrials.gov.

About Urothelial Cancer

Urothelial cancer is most commonly found in the bladder (90 percent). According to the American Cancer Society, approximately 79,000 people in the U.S. will be diagnosed with bladder cancer during 2017 and almost 17,000 will die from the disease. Outcomes are poor for patients diagnosed with metastatic disease, with a five-year survival rate of five percent.

About Enfortumab Vedotin

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary, industry-leading linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Astellas, which is expressed on many solid tumors.

About Astellas

Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at View Source

On November 8, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center, reported the appointment of Dr. Sandra Silberman as Chief Medical Officer ("CMO") in charge of New Products (Press release, Moleculin, NOV 8, 2017, View Source;-new-products [SID1234521745]).

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"Dr. Silberman is a highly experienced, well-esteemed oncologist and CMO," commented Walter Klemp, Chairman and CEO of Moleculin. "Among her many accomplishments, she was the project leader for Gleevec, a blockbuster cancer drug. We’ve benefitted from her guidance during her time on our Science Advisory Board, but as we have gained momentum with our WP1066 and WP1122 Portfolios, we now need the focus of a highly qualified CMO. We are honored to have such an accomplished physician leading these planned clinical projects."

Mr. Klemp concluded, "This appointment allows Dr. Robert Shepard, our CMO in charge of Hematology, to devote his full attention to the clinical trials of Annamycin."

Dr. Silberman’s career in clinical development began at Pfizer, Inc., where she oversaw the initiation of Tarceva clinical trials. She then led the global development of Gleevec at Novartis. Sandra was the first Vice President and Global Therapeutic Area Head in Oncology at Eisai, a role in which she advanced five original compounds into Phases I through III, gaining the first approval for Eisai’s proprietary drug, Halavan. Subsequently, she served as a senior advisor to a number of biopharmaceutical companies, including Bristol-Myers Squibb, AstraZeneca, Imclone, Roche, and numerous biotech companies as an independent industry consultant. She joined Quintiles in 2009 as the Vice President of Oncology and Global Head of Translational Medicine in the newly formed Innovation division, overseeing drug development and novel technologies for new partnerships with the pharmaceutical and biotechnology industries. Sandra earned her B.A., Sc.M. and Ph.D. from the Johns Hopkins University School of Arts and Sciences, School of Public Health and School of Medicine, respectively. Her major focus of investigation and doctoral thesis was in the burgeoning area of tumor immunology. She received her M.D. from Cornell University Medical College, completing a postdoctoral training and her fellowship in hematology/oncology at the Brigham & Women’s and the Dana Farber Cancer Institute in Boston. She continued to do research in tumor immunology with a clinical investigator award from the NIH and became an Instructor in Medicine at Harvard Medical School. She then served as an attending physician at Yale University Hospital. Sandra has continued in clinical practice throughout her career in industry, and is currently an attending physician in the Hematology/Oncology clinic at the Duke VA in Durham, NC.

On Nobember 8, 2017 Verseon, a technology-based pharmaceutical company employing a computer-driven platform to develop a diverse drug pipeline, reported its anticancer drug candidates at the BIO-Europe conference in Berlin yesterday (Press release, Verseon, NOV 8, 2017, View Source [SID1234521718]). Dr. Anirban Datta, Director of Discovery Biology, presented preclinical studies across a range of cancer cell lines, which show that the Company’s compounds may be especially well-suited for the treatment of multidrug resistant solid tumors.

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One of the most common ways in which cancer cells render chemotherapies ineffective is by triggering an overproduction of transport proteins that expel many organic substances, including drugs. The preclinical data presented at BIO-Europe demonstrate that Verseon’s drug candidates are significantly less susceptible to this mode of tumor resistance. In vitro studies furthermore show that the Company’s compounds maintain efficacy across multiple cell lines that are resistant to common chemotherapy agents.

Verseon’s drug candidates inhibit microtubule formation by targeting tubulin. They act against cancer cells by suppressing blood vessel growth and by interrupting the cell division cycle preventing mitosis, both proven treatment strategies for cancer. Lead candidates also show pharmacokinetics suitable for administration as infusion, an important prerequisite for inclusion in infusion-based chemotherapy regimens.

"There is an ongoing need for anticancer agents less susceptible to tumor resistance that can be used in conjunction with existing and new drugs," said Dr. Datta. "The fact that our tubulin inhibitors are mostly unaffected by major transporters could change the standard of care for cancer chemotherapy. In particular, using transporter overexpression as a biomarker to drive treatment decisions could lead to more effective precision second-line therapy."

About Verseon’s oncology program
Verseon plans to use its promising class of tubulin inhibitors to target multidrug resistant cancers. Several drug candidates show potency in functional and cellular assays. Furthermore, Verseon’s inhibitors maintain their efficacy across multiple chemotherapy-resistant cancer cell lines and are mostly unaffected by the overexpression of common transporters, a primary source of multidrug resistance.