On April 20, 2017 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, reported a poster presentation highlighting entinostat at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 2-6, 2017 in Chicago, Illinois. The poster will feature data from the ongoing phase 2 ENCORE 601 trial of entinostat in combination with KEYTRUDA (pembrolizumab) for the treatment of advanced melanoma patients who had progressed on prior immune checkpoint inhibitor therapy. Schedule your 30 min Free 1stOncology Demo! Poster Presentation:
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Title: ENCORE 601: A phase II study of entinostat (ENT) in combination with pembrolizumab (PEMBRO) in patients with melanoma
First Author: Melissa Lynne Johnson, MD, Sarah Cannon Research Institute
Abstract Number: 9529
Poster Session: Melanoma/Skin Cancers
Poster Board: 137
Date and Time: Saturday, June 3, 2017, 1:15-4:45 PM CT
Author: [email protected]
VBL Therapeutics Announces Positive DSMC Review in Phase 3 GLOBE Trial Investigating VB-111 in rGBM
On April 20, 2017 VBL Therapeutics (NASDAQ:VBLT), reported that the Independent Data Safety Monitoring Committee (DSMC) met to conduct its second safety review of the Phase 3 GLOBE Study investigating ofranergene obadenovec (VB-111) in recurrent glioblastoma (rGBM) (Press release, VBL Therapeutics, APR 20, 2017, View Source [SID1234518656]). The DSMC is an independent multidisciplinary group that conducts detailed reviews of un-blinded study data, discusses potential safety concerns and provides recommendations regarding trial continuation. The committee reviewed the GLOBE safety data collected through a cutoff date in March 2017 and unanimously recommended that the study continue as planned. Schedule your 30 min Free 1stOncology Demo! "We are pleased with the outcome of the DSMC," said Dror Harats, Chief Executive Officer of VBL Therapeutics. "Based on enrollment trends and events that triggered the DSMC review, we currently expect the GLOBE Trial interim analysis to occur in mid-2017, and top-line results from the full dataset to be available in early 2018."
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The Phase 3 GLOBE study in rGBM is comparing VB-111 in combination with Avastin (bevacizumab) to Avastin alone and has recruited 256 patients in the US, Canada and Israel. The study is proceeding under a Special Protocol Assessment (SPA) granted by the FDA, with full endorsement by the Canadian Brain Tumor Consortium (CBTC). VB-111 has received orphan drug designation in the United States and Europe and was granted Fast Track designation by the FDA for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation.
About Ofranergene Obadenovec (VB-111)
Ofranergene obadenovec is a unique biologic agent that uses a dual mechanism to target solid tumors. Based on a non-integrating, non-replicating, Adeno 5 vector, ofranergene obadenovec utilizes VBL’s proprietary Vascular Targeting System (VTS) to target the tumor vasculature for cancer therapy. Unlike anti-VEGF or TKIs, ofranergene obadenovec does not aim to block a specific pro-angiogenic pathway; instead, it uses an angiogenesis-specific sensor (VBL’s PPE-1-3x proprietary promoter) to specifically induce cell death in angiogenic endothelial cells in the tumor milieu. This mechanism retains activity regardless of baseline tumor mutations or the identity of the pro-angiogenic factors secreted by the tumor and shows activity even after failure of prior treatment with other anti-angiogenics. In addition, ofranergene obadenovec induces specific anti-tumor immune response, which is accompanied by recruitment of CD8 T-cells and apoptosis of tumor cells.
Ofranergene obadenovec completed a Phase 2 study in rGBM, which showed a statistically significant improvement in overall survival in patients treated with ofranergene obadenovec through progression, compared to either patients treated with ofranergene obadenovec followed by bevacizumab alone, or to historical bevacizumab data. In a Phase 2 trial for recurrent platinum-resistant ovarian cancer, ofranergene obadenovec demonstrated a statistically significant increase in overall survival and 60% durable response rate (as measured by reduction in CA-125), approximately twice the historical response with bevacizumab plus chemotherapy in ovarian cancer. In a Phase 2 study in recurrent, iodine-resistant differentiated thyroid cancer, ofranergene obadenovec met the primary endpoint and provided evidence of disease stabilization with a positive safety profile, along with a dose-response and evidence of an overall survival benefit. Ofranergene obadenovec has received Fast Track Designation for recurrent glioblastoma in the U.S. and orphan drug status for glioblastoma in both the U.S. and EU.
Atossa Genetics Receives Positive Interim Review From Independent Safety Committee in Phase 1 Endoxifen Dose Escalation Study
On April 20, 2017 Atossa Genetics, Inc. (NASDAQ: ATOS), a clinical-stage pharmaceutical company, reported that it has received a positive interim review on its Phase 1 study of endoxifen, which is an active metabolite of the FDA approved drug tamoxifen, which is indicated for breast cancer and breast cancer prevention in high risk patients (Press release, Atossa Genetics, APR 20, 2017, View Source [SID1234518655]). The Independent Safety Committee reviewed the blinded data generated from the first cohort of the study (8 subjects) and concluded that the study may advance to the next dosing level. Schedule your 30 min Free 1stOncology Demo! "This positive safety determination is on the critical path for our Phase 1 study," stated Steven Quay, CEO and President. "It is the first assessment of our clinical safety and tolerability data and it indicates that proceeding to the next dosing level with our proprietary topical Endoxifen is warranted. We can now advance to the next level of the study which is to escalate the dosage in a new cohort of subjects as we continue to monitor safety and tolerability in the first cohort of the study."
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The objectives of this double-blinded, placebo-controlled, repeat dose study of 48 healthy female subjects is to assess the pharmacokinetics of proprietary formulations of both oral and topical endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted in two parts based on route of administration.
The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.
H3 Biomedicine Extends Collaboration with Foundation Medicine to Develop Precision Therapies for Cancer
On April 20, 2017 H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of Eisai’s global Oncology Business Group, reported that is has extended its multi-year collaboration with Foundation Medicine, Inc. for the discovery and development of precision medicines in oncology, which was signed in February 2015 (http:/bit.ly/2plSOPS) (Press release, H3 Biomedicine, APR 20, 2017, View Source [SID1234518654]). Schedule your 30 min Free 1stOncology Demo! H3 and Foundation Medicine will continue to build upon the progress the two companies have made during the collaboration. The companies will collaborate to interrogate the FoundationCORETM dataset, with the goal of expanding the translation of ongoing H3 programs and identifying new, actionable cancer drivers.
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"Having access, through Foundation Medicine, to a high quality, large scale data set for identification of novel driver events and clinical translation helps create a competitive edge for H3 within the current oncology drug development market," said Markus Warmuth, M.D., President and Chief Executive Officer of H3 Biomedicine. "The collaboration with Foundation Medicine has broadened the scope of our clinical programs and has pointed us in new, unique directions and we look forward to continuing this successful collaboration."
"The genomics data in FoundationCORE is a better reflection of patients seeking treatment in current clinical practice compared with publically available data sets, and it will continue to evolve as new therapies are adopted," said Lihua Yu, Vice President of Data Science and IT at H3 Biomedicine. "Thorough computational analysis beyond variant calls allows us to connect genomic aberrations with disease context which can directly impact the trajectory of our pipeline."
ZIOPHARM Oncology to Present Updated Clinical Results of Gene Therapy Candidate Ad-RTS-hIL-12 + Veledimex in Recurrent Glioblastoma at the 2017 ASCO Annual Meeting
On April 20, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, reported that it will present updated results from its Phase 1, multicenter, dose-escalation study of Ad-RTS-hIL-12 + orally administered veledimex in patients with recurrent or progressive glioblastoma at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held June 2-6 in Chicago (Press release, Ziopharm, APR 20, 2017, View Source [SID1234518653]). Ad-RTS-hIL-12 + veledimex is a novel, viral gene therapy candidate for the controlled expression of interleukin-12 (IL-12), a pro-inflammatory cytokine critical for stimulating anti-cancer immune responses. Schedule your 30 min Free 1stOncology Demo! Details for the poster presentation at ASCO (Free ASCO Whitepaper) 2017:
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Title: Expanded phase I study of intratumoral Ad-RTS-hIL-12 plus oral veledimex: Tolerability and survival in recurrent glioblastoma
Abstract Number: 2044
Session: Central Nervous System Tumors
Date and Time: Monday, June 5, 2017, 1:15 — 4:45 p.m. CT