Verastem to Present Results from Pivotal Phase 3 DUO Study in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma at a Research and Development Event at ASH 2017

On December 5, 2017 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, will present clinical data from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) at a Research and Development reception at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 Annual Meeting (Press release, Verastem, DEC 5, 2017, View Source;p=RssLanding&cat=news&id=2321050 [SID1234522395]). The event will take place on Sunday, December 10, 2017 in Atlanta.

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The event, which follows the oral presentation of the DUO data results at ASH (Free ASH Whitepaper), will feature a slide presentation and moderated panel discussion with recognized experts in the treatment of hematologic malignancies, including CLL/SLL, and a live Q&A session. Speakers will include Ian Flinn, MD, PhD, Sarah Cannon Research Institute, who will present results from the Phase 3 DUO study, and Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center, who will provide an update on duvelisib for the treatment of Peripheral T-Cell Lymphoma (PTCL). In addition, Lori Kunkel, MD, Verastem Clinical and Scientific Advisory Board, and Steven Bloom, Verastem Chief Strategy Officer, will participate in the discussion panel and Q&A session, which will be moderated by Robert Forrester, Verastem President and Chief Executive Officer.

The event will take place during the ASH (Free ASH Whitepaper) 2017 Annual Meeting and is open to analysts and institutional investors. Interested parties can access a live webcast of the event beginning Sunday, December 10, 2017 at 8:15 p.m. ET on the "Presentations" page of the company’s website View Source;p=irol-calendar. A replay of the webcast will be archived on the company’s website for 90 days following the event. For more information or to RSVP, please contact Maeve Conneighton at [email protected].
Duvelisib is Verastem’s first in class oral dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma which is currently being developed for the treatment of CLL/SLL, peripheral T cell lymphoma (PTCL), and other hematologic malignancies.

Moleculin’s WP1066 Drug gets FDA Brain Tumor IND Clearance

On December 5, 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 ("MD Anderson"), reported the physician-sponsored Investigational New Drug ("IND") application for a Phase I trial of Moleculin’s drug WP1066 in patients with recurrent malignant glioma and brain metastasis from melanoma has been allowed by the US Food and Drug Administration ("FDA") (Press release, Moleculin, DEC 5, 2017, View Source [SID1234522382]).

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"We are so pleased to now have a second drug enter the clinical stage," commented Walter Klemp, Chairman and CEO of Moleculin. "We believe WP1066 represents a new class of anticancer drugs able to fight tumors on two fronts by directly inhibiting cell signaling supporting tumor activity, and independently stimulating a natural immune response. This constitutes a new approach to treating brain tumors and tumor metastasis to the brain.

Mr. Klemp concluded, "Since the discovery of WP1066 at MD Anderson by Prof. Waldemar Priebe, it has now been studied by many independent groups and is widely recognized as a potent inhibitor of the activated form of a protein called STAT3, which has been implicated in many difficult to treat tumors, including brain tumors. Animal studies have shown that inhibition of STAT3 directly blocks tumor proliferation and its survival, while most importantly boosting the immune system’s ability to fight cancer. We finally have our first opportunity for a clinical proof of concept and confirmation of promising preclinical activity."
This IND was sponsored by Dr. Amy Heimberger, who will serve as the principal investigator for the Phase I trial at MD Anderson Cancer Center to evaluate safety and efficacy. Details about the trial can be viewed on www.clinicaltrials.gov.

Abbott to Present at J.P. Morgan Healthcare Conference

On December 4, 2017 Abbott (NYSE: ABT) reported that it will present at the 36th Annual J.P. Morgan Healthcare Conference on Monday, Jan. 8, 2018 (Press release, Abbott, DEC 4, 2017, View Source [SID1234522346]). Brian Yoor, executive vice president of finance and Chief Financial Officer, will present at the conference at 6 p.m. Central time.

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A live audio webcast of the presentation will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the presentation will be available the next day.

NantKwest to Present Data at the 59th Annual Meeting of the American Society of Hematology

On December 4, 2017 NantKwest Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, reported an oral presentations will be given at the upcoming 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta, Georgia on Saturday, December 9, 2017 (Press release, NantKwest, DEC 4, 2017, http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=RssLanding&cat=news&id=2320823 [SID1234522350]).

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Presentation Title

CD19-Chimeric Antigen Receptor (CAR) Engineered Natural Killer (NK) Cell Therapy: Novel "Off the Shelf" Immunotherapy in CD20 Resistant B-Cell Non-Hodgkin Lymphoma (NHL) Cell Lines, Primary NHL Cells, and a Human Lymphoma Xenograft Model Target Activated Natural Killer (CD19.taNK) Cellular Therapy: A Novel Immunotherapeutic Approach to the Treatment of Non-Hodgkin Lymphoma (NHL)

Abstract #110: View Source

Presenter: Sneha Purvey, MD, Department of Hematology and Oncology, Tufts Medical Center, Boston, MA

Date: Saturday, December 9, 2017, 9:45AM, Building C, Level 1, C101 Auditorium (Georgia World Congress Center)

Presentation Summary

This oral presentation will present preclinical data on the company’s CD19.taNK program. CD19.taNK cell therapy is based on the use of engineered NK cells expressing a human anti-CD19 CAR that target CD19 expressing cells. The study was designed to more deeply understand the mechanism of action associated with NK-based therapy in B cell NHL and determine the potential for CD19.taNK cells as an "off the shelf" therapy.

The study author’s identified high levels of NK activating ligands indicative of a conserved mechanistic response to CD19-CAR NK cell therapy. In addition, the authors determined that CD19.taNK cell therapy induced significant single-agent cytolytic activity against a wide range NHL cells, including primary DLBCL cells, and cells resistant to standard anti-CD20 antibody.

"CD20 targeted antibody therapy represent one of the most effective and widely used therapeutic interventions in blood cancers. However, resistance is common, occurring in a large percentage of patients," said Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest. "For next generation therapies, such as our CD19.taNK cell therapy, circumventing resistance requires both a deeper understanding of the mechanisms of resistance and the mechanisms of action. We believe these study results provide encouraging data elucidating the significant, single-agent cytolytic activity of CD19.taNK cell therapy and takes us one step closer in our focus to transition this novel NK cell therapy to clinical cancer care."

Oncolytics Biotech® to Present at the Oncolytic Virotherapy Summit

On December 4, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, also known as pelareorep, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn ‘cold’ tumors ‘hot’, reported that it will present at the Oncolytic Virotherapy Summit (Press release, Oncolytics Biotech, DEC 4, 2017, View Source [SID1234522351]). Dr. Matt Coffey, Oncolytics’ President and Chief Executive Officer, will present on Wednesday, December 6 at 11:00 a.m. ET as part of a panel presentation and then present specifically on pelareorep in a Clinical Case Study presentation at 2:30 p.m. ET on the same day. The conference takes place on December 5th, 6th and 7th in Miami, Florida.

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"The Oncolytic Virotherapy Summit offers us another opportunity to highlight our extensive experience with pelareorep in the clinic and to illustrate its ability to induce an inflamed tumor phenotype amongst our peers and for potential partners," said Dr. Coffey. "Our clinical experience with pelareorep has led us to favorable feedback from the FDA following our end-of-phase 2 meeting which helps us define a clear regulatory path in metastatic breast cancer and a single 400-patient phase 3 registration study. Our phase 3 protocol will be made available following evaluation and completion of discussions with clinical advisors, potential partners and the EMA."

The panel presentation: "How Can We Improve The Efficacy of Oncolytic Virotherapies?", also including management from PsiOxus Therapeutics, Vyriad and Replimune Group, will cover:

Viral modulation of the tumor microenvironment
Increasing the viral impact with activated immune responses
Combination drug therapies to stimulate the immune response and prevent immunosuppression
Viral delivery for largest impact
Dr. Coffey’s individual presentation: "Clinical Progress and Robust Safety Findings of Using Reovirus as an Immuno-Oncology Viral Agent to Treat Cancer", will highlight:

The role of REOLYSIN in the activation of the immune system and the induction of an inflamed tumor phenotype in the tumor microenvironment
Overall survival data from the Company’s randomized phase 2 metastatic breast cancer study
The largest pooled safety database of any oncolytic virus
About REOLYSIN/Pelareorep
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.