On January 5, 2018 Exicure, Inc., the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional, spherical nucleic acid (SNA) constructs, reported that the company is scheduled to present at the 10th Annual Biotech Showcase conference held January 8-10, 2018 in San Francisco (Press release, Exicure, JAN 5, 2018, View Source;p=RssLanding&cat=news&id=2325180 [SID1234523073]).

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Dr. David Giljohann, Chief Executive Officer of Exicure, will present a company overview on Tuesday, January 9th at 10:15 a.m. Pacific Time at the Hilton Union Square in San Francisco.

A live webcast of the presentation will be available on the Events & Presentations section of Exicure’s website and will also be archived following the presentation.

On January 5, 2018 AgeX Therapeutics, Inc., a subsidiary of BioTime, Inc. (NYSE American: BTX), reported that it will present at Biotech Showcase, January 8-10, 2018 at the Hilton San Francisco Union Square (Press release, BioTime, JAN 5, 2018, View Source;p=RssLanding&cat=news&id=2325217 [SID1234522928]).

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Michael D. West, Ph.D., Chief Executive Officer, will present at the conference as follows:

Date: Tuesday, January 9
Time: 2:30 PM PST
Track: Yosemite-B (Ballroom Level)
Venue: Hilton San Francisco Union Square, 333 O’Farrell Street

According to the event organizers, Biotech Showcase features more than 3,500 decision makers from 2,100 life sciences companies in a variety of plenary sessions, fireside chats, and panels. This year’s event is expected to draw over 900 investors from 50-plus countries, in anticipation of 400-plus public and private company presentations.

A copy of Dr. West’s presentation will be available on the AgeX website.

On January 4, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that it has initiated a Phase 3 clinical study to evaluate the safety and efficacy of DCC-2618, a pan-KIT and PDGFRα inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST) (Press release, Deciphera Pharmaceuticals, JAN 4, 2018, View Source [SID1234522871]).

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"We are extremely pleased to initiate the INVICTUS study with DCC-2618 in heavily pretreated GIST patients, specifically fourth-line and fourth-line plus patients," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "We expect to report top-line results in 2019 and, if successful, this pivotal Phase 3 study could serve as the basis for a New Drug Application (NDA), providing a much-needed therapeutic option for these patients for whom there are no approved treatments. We also plan to initiate a second Phase 3 study later this year evaluating DCC-2618 in second-line GIST patients who have progressed or are intolerant to front-line therapy with imitanib."

"While effective treatments are available for patients with early-stage GIST, in 9 out 10 patients the disease will eventually progress due to the development of secondary drug resistance mutations," said Professor Jean-Yves Blay, Medical Oncologist, General Director Centre Léon Bérard, Comprehensive cancer Centre of Lyon, France. "A therapy with the potential to provide broad coverage across the full spectrum of KIT and PDGFRα mutations would represent a much-needed improvement over currently approved treatment options for patients with later-stage GIST."

Initiation of the INVICTUS study follows results from the ongoing Phase 1 clinical trial presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2017, in which durable disease control by DCC-2618 was observed in heavily pretreated patients with GIST.

INVICTUSPhase 3 Study
The INVICTUS Phase 3 clinical study is a randomized, double-blind, placebo-controlled, international, multicenter trial to evaluate the safety, tolerability, and efficacy of DCC-2618 compared to placebo in patients with advanced GIST patients whose previous therapies have included imatinib, sunitinib, and regorafenib. The trial is expected to enroll approximately 120 patients randomized 2:1 to either 150 mg once daily of DCC-2618 or placebo. The primary efficacy endpoint is median progression free survival (PFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR); Time to Tumor Progression (TTP); and Overall Survival (OS). See www.clinicaltrials.gov for further information (NCT03353753).

About DCC-2618
DCC-2618 is a pan-KIT and PDGFRα kinase switch control inhibitor in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors, glioblastoma multiforme and systemic mastocytosis. DCC-2618 was specifically designed to improve the treatment of GIST patients by inhibiting the full spectrum of mutations in KIT and PDGFRα. DCC-2618 is a pan-KIT and pan-PDGFRα inhibitor that blocks initiating KIT mutations in exons 9, 11, 13, 14, 17, and 18, known to be present in GIST patients and the D816V exon 17 mutation known to be present in ASM patients. DCC-2618 inhibits PDGFRα mutations in exon 18, including the D842V mutation that drives a subset of GIST.

On January 4, 2018 Genelux Corporation, a privately-held biopharmaceutical company focused on the development of its proprietary oncolytic immunotherapy platform, is reported that Gynecologic Oncology Associates/Women’s Cancer Research Foundation (GOA/WCRF) in Newport Beach, California has been added as a clinical site for its Phase 2 VIRO-15 Study: Oncolytic Vaccinia Immunotherapy in Recurrent Ovarian Cancer (Press release, Genelux, JAN 4, 2018, View Source [SID1234532452]).

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GOA/WCRF, a renowned gynecologic oncology care & research center, is now actively enrolling patients. The Principal Investigator at the site is Alberto A. Mendivil, MD, FACOG, FACS, with the following sub-investigators:

Lisa N. Abaid, MD, MPH
Tiffany L. Beck, MD, MPH
John V. Brown, MD
Kristina M. Mori, MD

Adding GOA/WCRF will accelerate the clinical development timeline of GL-ONC1 and completion of this important Phase 2 study.

Thomas Zindrick, Genelux CEO, said, "We are pleased to welcome one of the largest and most well-respected gynecological practices in the country to the VIRO-15 Study. We look forward to working with GOA/WCRF, especially given the investigators’ expertise in the conduct of ovarian cancer clinical research."

GOA/WCRF joins Florida Hospital Cancer Institute as participating sites in the study. These geographically diverse sites will drive enrollment and bring a convenient trial location to western United States.

John P. Micha, MD, President/Founder/Board Member of WCRF and founder of GOA, commented, "GL-ONC1 immunotherapy is one of the most exciting and promising gynecologic oncology treatment modalities to come along in recent years for late stage ovarian cancer. Our patients and staff have renewed hope that we will be able to improve clinical outcomes in the not too distant future."

About the Study

The open label, Phase 2 study (NCT02759588) is currently recruiting participants with recurrent ovarian, fallopian tube, or primary peritoneal cancer. It is expected to enroll up to a total of 40 patients in two cohorts. Patients will receive GL-ONC1 as a monotherapy treatment regimen, consisting of intraperitoneal bolus infusions on 2 consecutive days. The study’s primary endpoint is progression-free survival, and secondary endpoints include incidence of adverse events, anti-tumor response, objective response, disease control rate, and overall survival.

About GL-ONC1

GL-ONC1, Genelux’ lead product candidate, is an attenuated therapeutic vaccinia virus, a non-pathogenic virus, modified by Genelux to increase its safety, tumor selectivity and anti-tumor activity. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Clinical results in over 100 subjects treated in Genelux studies have shown GL-ONC1 is well tolerated with documented antitumor activities and clinical benefits.

About Gynecologic Oncology Associates (GOA) & Women’s Cancer Research Foundation (WCRF)

Founded in 1985, GOA is the largest gynecologic oncology practice on the West Coast. WCRF is a nonprofit organization. The physicians from the WCRF have been pioneers in clinical research to improve cure rates for women with ovarian, uterine, endometrial, cervical and other gynecological cancers. WCRF designs, conducts and publishes research on leading-edge medical advances. WCRF has developed collaborative research relationships with many prominent pharmaceutical and biotech companies. GOA/WCRF physicians have received many honors in recognition of their excellence in cancer care, including Best Physicians in Orange County, America’s Best Oncologists, ACOG/Ortho National Research Award and many other honors for teaching and clinical care

On January 4, 2018 Arvinas LLC, a private biotechnology company focused on creating a new class of drugs based on protein degradation, reported a research collaboration and license agreement with Pfizer Inc. (NYSE: PFE) for the discovery and development of drug candidates using Arvinas’ proprietary PROTAC (PROteolysis TArgeting Chimeras) Platform, a novel technology used to create small molecule therapeutics aimed at degrading disease-causing cellular proteins (Press release, Arvinas, JAN 4, 2018, View Source [SID1234585092]).

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The multi-year agreement covers the discovery and development of potential PROTAC clinical candidates designed to degrade several key disease-causing proteins in multiple therapeutic areas. Arvinas will drive discovery efforts, and Pfizer will be accountable for clinical development and commercialization of any products that may result from this collaboration. Under the terms of the agreement, Arvinas may receive up to $830 million in upfront and potential development and commercialization milestone payments upon achievement of specified preclinical, clinical and commercial milestones. In addition, Arvinas may be entitled to receive tiered royalties based on global product sales on any products that may result from this collaboration.

"As a global industry leader, Pfizer is uniquely positioned to partner with us as we exploit the potential of PROTACs in multiple disease areas," stated John Houston, Ph.D., President and Chief Executive Officer of Arvinas. "This marks another key milestone as we continue to expand the use of our targeted protein degradation platform and advance Arvinas’s first candidates into the clinic."

"Protein degradation is an area of considerable interest for us, and we look forward to working with Arvinas to determine the potential applicability of this approach across multiple therapeutic areas," said John Ludwig, Ph.D., Head of Medicinal Sciences, Pfizer.

The PROTAC Platform offers potential improvements over traditional small molecule inhibitors by using the cell’s natural and selective ubiquitin- proteasome system to degrade disease-causing proteins. By removing target proteins directly rather than simply inhibiting them, PROTACs can provide multiple advantages over small molecule inhibitors which can require high systemic exposure to achieve sufficient inhibition, often resulting in toxic side effects and eventual drug resistance. With multiple protein targets, Arvinas’ PROTAC platform has demonstrated that a transient binding event at a range of binding sites and affinities can translate into very potent degradation of the target protein.