On April 21, 2017 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology therapies to patients with cancer, reported that two abstracts will be presented at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, NewLink Genetics, APR 21, 2017, View Source [SID1234518649]). Schedule your 30 min Free 1stOncology Demo! Abstract 105 – A Phase 1b dose-escalation study of combined inhibition of IDO1 (GDC-0919) and PD-L1 (atezolizumab) in patients (pts) with locally advanced or metastatic solid tumors, to be presented by our partner on Sunday, June 4, 2017, 10:45 a.m. – 12:15 p.m. ET.
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Abstract 3066 – A Phase 2 randomized, double-blind study of sipuleucel-T followed by IDO pathway inhibitor, indoximod, or placebo in the treatment of patients with metastatic castration resistant prostate cancer (mCRPC), to be presented on Monday, June 5, 2017, 9:00 a.m. – 12:30 p.m. ET.
The complete text of the abstracts will be posted online at 5:00 p.m. ET on Wednesday, May 17.
Month: April 2017
Xenetic Biosciences’ PolyXen™ Platform Technology Accepted for Poster Presentation at the 13th Annual Protein Engineering Summit (PEGS) Boston
On April 20, 2017 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that an abstract highlighting the Company’s proprietary drug development platform technology, PolyXen, which is designed to improve the half-life and other pharmacological properties of biologic drugs, has been accepted for a scientific poster presentation at the 13th Annual PEGS Boston conference to be held May 1-5th, 2017 in Boston, MA (Press release, Xenetic Biosciences, APR 20, 2017, View Source [SID1234537801]).
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The poster presentation details are as follows:
Title: "Polysialylation – A Platform Technology for Enhancing Therapeutic Proteins and Its Clinical Application"
Authors: He Meng, Curtis Lockshin, Sanjay Jain, Dmitry Genkin, Umesh Shaligram, Joseph Martinez, David B Hill, Camille Ehre, Henry Hoppe IV
Date: May 1-2, 2017
Location: Poster Session A
The poster will be accessible following the conference on the Publications page of the Company’s website, www.xeneticbio.com.
Polaris Provides Early Evidence of Response to Arginine Depletion by ADI‑PEG 20 in Argininosuccinate Synthetase Deficient Thoracic Tumors
On April 20, 2017 Polaris Group reported that its lead therapeutic ADI‑PEG 20 (pegylated arginine deiminase) in combination with pemetrexed and cisplatin (ADIPemCis) demonstrated a good safety profile and a strong efficacy signal in argininosuccinate synthetase (ASS1) deficient malignant pleural mesothelioma (MPM) and non-small cell lung carcinoma (NSCLC), as reported in the Journal of Clinical Oncology (Press release, Polaris Pharmaceuticals, APR 20, 2017, View Source [SID1234526286]). In the first nine patients (5 MPM, 4 NSCLC) enrolled in the dose escalation cohorts of this biomarker-directed phase 1 study, partial response was seen in 7 patients (4 MPM, 3 NSCLC). The study was led by Dr. Peter Szlosarek of Barts Cancer Center, Queen Mary University of London, and involved multiple sites in the United Kingdom.
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The main goal of this phase 1 study is to determine the recommended phase 2 dose, safety and tolerability of ADIPemCis in patients with ASS1-deficient MPM and NSCLC. The nine enrolled patients were treated with fixed-dose pemetrexed and cisplatin (PemCis), the standard first-line chemotherapy for MPM and NSCLC, in combination with increasing doses of ADI‑PEG 20. The treatment appeared to be safe and well tolerated. Notably, three out of four MPM patients with a partial response had non-epithelioid tumor histology, which carries an unfavorable prognosis and historically responded poorly to chemotherapy.
"Based on the encouraging efficacy signal from these preliminary results, we have initiated a randomized, double blind, phase 2/3 trial comparing ADIPemCis with PemCis in patients with non-epithelioid MPM," said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc. "With ADIPemCis, we hope to bring an effective treatment to this subset of MPM patients, who have a dire need for medical intervention."
About ADI‑PEG 20
ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.
Syndax Announces Entinostat Data to be Presented at the 2017 American Society of Clinical Oncology Annual Meeting
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
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.