ESSA Pharma Presents Data on EPI-7386 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 28, 2019 ESSA Pharma Inc. (Nasdaq: EPIX; TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported in Boston will present new preclinical data on ESSA’s lead Investigational New Drug ("IND") candidate at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Press release, ESSA, OCT 28, 2019, View Source [SID1234549939]).

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In an oral poster presentation titled, "Treatment of castrated resistant prostate cancer, with EPI-7386, a second generation N-terminal domain androgen receptor inhibitor", further preclinical characterization of EPI-7386 will be presented.

Abstract No.:

B117

Abstract Title:

Treatment of castrated resistant prostate cancer with EPI-7386, a second generation N-terminal domain androgen receptor inhibitor

Presenter:

Ronan Le Moigne, PhD

Date:

Monday October 28, 2019

Time:

3:00pm EST/EDT

Location:

Hall D, Hynes Convention Center, Boston, MA

National Comprehensive Cancer Network Oncology Research Program Supports Clinical Trial for Lung Cancer

On October 28, 2019 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported plans to support a phase II randomized trial for lung cancer patients (Press release, NCCN, OCT 28, 2019, View Source [SID1234549938]). The study is titled TH-138: Phase II randomized trial of carboplatin + pemetrexed + bevacizumab, with or without atezolizumab in stage IV non-squamous NSCLC patients who harbor a sensitizing EGFR mutation or have never smoked. Joseph Treat, MD, Professor, Department of Hematology/Oncology, Fox Chase Cancer Center, will serve as principal investigator, with Hossein Borghaei, DO, and J. Nicholas Bodor, MD, PhD, also from Fox Chase Cancer Center, as co-investigators, along with Jyoti Patel, MD, incoming Assistant Director for Clinical Research at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. The study is made possible through collaboration with Genentech, who provided funding and study drugs.

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"Lung cancer is the leading cause of cancer-related death in the United States and worldwide," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "As advances are made in the development of targeted therapies and immunotherapies, there is opportunity for greatly needed improvement in outcomes."

Cigarette smoking remains the primary cause of most lung cancer cases, but nearly 20 percent occur in people who have never smoked1. Those non-smoking related cancers generally have a different molecular profile than those in smokers, including mutations in the epidermal growth factor receptor (EGFR), and may have variable response to checkpoint inhibitors.2

This study will focus on patients whose tumors include an EGFR mutation or who are never smokers (defined as fewer than 100 cigarettes in their lifetime). It will examine whether the anti-PD-L1 inhibitor atezolizumab plus carboplatin, pemetrexed, and bevacizumab will improve progression-free survival and overall survival in this population, as compared to carboplatin, pemetrexed, and bevacizumab.

The study is projected to take 31 months, and include more than 100 patients from across 15-20 cancer centers. It is open to people 18 and older who have not been previously treated with any systemic therapy other than tyrosine kinase inhibitors (TKIs).

The NCCN ORP fosters innovation and knowledge discovery that improve the lives of patients with cancer. Visit NCCN.org/ORP to learn more about past and current clinical investigations.

ORIC Pharmaceuticals Presents Preclinical Data on Glucocorticoid Receptor Antagonist and CD73 Inhibitor Programs at AACR-NCI-EORTC Annual Conference

On October 28, 2019 ORIC Pharmaceuticals, a privately held, clinical-stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported new preclinical data on its lead program ORIC-101 – a selective and potent glucocorticoid receptor (GR) antagonist in Phase 1b – and its CD73 inhibitor program – an orally bioavailable small molecule inhibitor of a key node in the adenosine pathway – at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference on Molecular Targets & Cancer Therapeutics in Boston, Massachusetts (Press release, ORIC Pharmaceuticals, OCT 28, 2019, https://www.prnewswire.com/news-releases/oric-pharmaceuticals-presents-preclinical-data-on-glucocorticoid-receptor-antagonist-and-cd73-inhibitor-programs-at-aacr-nci-eortc-annual-conference-300945867.html [SID1234549937]).

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Glucocorticoid Receptor Antagonist Program

The ORIC-101 preclinical data were presented in abstract LB-A10, "ORIC-101 Overcomes Glucocorticoid-Driven Resistance to Enzalutamide in Castration-Resistant Prostate Cancer."

The glucocorticoid receptor has been identified as a potential antiandrogen bypass mechanism in patients with castration-resistant prostate cancer; thus GR-targeted therapies may overcome this therapeutic resistance to restore or prolong antiandrogen sensitivity. The poster presentation showed that GR is widely expressed in prostate cancer cell lines, organoids, and tumor tissue, and that GR levels are upregulated upon enzalutamide treatment. The data demonstrated that glucocorticoids promote tumor cell growth, stimulate expression of androgen regulated genes, and drive resistance to enzalutamide. Importantly, these effects were completely reversed by ORIC-101, suggesting ORIC-101 overcomes GR-driven resistance to enzalutamide.

ORIC-101 is currently in a Phase 1b study in combination with nab-paclitaxel in patients with advanced solid tumors. ORIC also plans to initiate a second Phase 1b study of ORIC-101 in combination with enzalutamide in patients with metastatic prostate cancer in the fourth quarter of 2019.

CD73 Inhibitor Program

Preclinical data from ORIC’s second program were presented in abstract LB-A19, "Intratumoral Immunosuppression is Reversed by Blocking Adenosine Production with an Oral Inhibitor of CD73."

The poster presentation showed that CD73 can drive adenosine generation from adenosine monophosphate (AMP) in vitro, resulting in suppression of anti-CD3/CD28-induced T cell activation and proliferation. The findings indicated that a novel, orally bioavailable CD73 inhibitor was able to effectively inhibit AMP to adenosine conversion both in vitro and in vivo, while an anti-CD73 antibody had incomplete effects. Small molecule-based inhibition of CD73 also fully restored proliferation and cytokine production of AMP/adenosine-suppressed T cells. Based on these results, an orally bioavailable small molecule inhibitor of CD73 represents a potential therapeutic approach to reverse immunosuppression within the tumor microenvironment.

AcelRx to announce third quarter 2019 results and provide an update on the company’s business on Wednesday, November 6th, 2019

On October 28, 2019 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company, reported that it will release third quarter financial results after market close on Wednesday, November 6, 2019 (Press release, AcelRx Pharmaceuticals, OCT 28, 2019, View Source [SID1234549936]). AcelRx management will host a live webcast and conference call at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) on November 6, 2019 to discuss the financial results and provide an update on the company’s business.

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The webcast is accessible by visiting the Investors page of the company’s website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be accompanied by a slide presentation. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company’s website at www.acelrx.com.

Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers.

Synthetic Biologics to Report 2019 Third Quarter Operational Highlights and Financial Results on November 4, 2019

On October 28, 2019 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, reported that the Company intends to release its operational highlights and financial results for the quarter ended September 30, 2019 on Monday, November 4, 2019, and to host a conference call the same day at 4:30 p.m. ET (Press release, Synthetic Biologics, OCT 28, 2019, View Source [SID1234549935]). The dial-in information for the call is as follows:

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U.S. (toll free): 1-888-347-5280
International: +1 412-902-4280

Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archived replay of the call will be available for approximately ninety (90) days at the same URL, View Source beginning approximately one hour after the call’s conclusion.