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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.

Poster Presentation:

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.

"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."

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.

"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."

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]).

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.

"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."