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GeneCentric Therapeutics to Present First Data on Cancer Subtyping Platform for Bladder Cancer, Potential for Use as Drug Response Biomarker

On May 30, 2018 GeneCentric Therapeutics reported that it will present the first data on the application of its proprietary Cancer Subtyping Platform (CSP) to bladder cancer and its potential utility to provide drug response biomarkers for the disease (Press release, GeneCentric Therapeutics, MAY 30, 2018, View Source [SID1234526958]). The gene expression subtyping data will be presented in a poster session at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, IL on June 2, 2018.

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"Gene expression subtypes of bladder cancer have shown considerable potential as drug response biomarkers," said Dr. Myla Lai-Goldman, CEO/Founder of GeneCentric and senior author on the study. "However, to date subtype signatures have required data on several thousand genes, limiting their use to research settings. This research demonstrates that by applying our CSP platform, subtypes can be generated with a 60-gene signature Cancer Profiler, opening the door to broad use in drug development and ultimately, clinical practice." She noted that with an estimated 81,190 new bladder cancer cases in the US and 17,240 deaths, and the emergence of promising immuno and targeted therapies, there is a significant need for biomarkers predictive of drug response.

The studies, conducted by GeneCentric scientists in collaboration with researchers at the University of North Carolina Chapel Hill’s Lineberger Cancer Center, assigned four gene expression subtypes based on approximately 2700 genes from 408 bladder cancer patients in The Cancer Genome Atlas (TCGA). The researchers then developed a subtype signature based on 60 genes and tested the 60-gene set in two additional data sets.

Analysis of the gene signatures suggested additional study of their potential as therapeutic biomarkers independently as well as in combination with other molecular features. For example, subtypes showed differences in the expression profiles of genes that are promising therapeutic targets in bladder cancer, such as FGFR3 and ERBB2. The differences were consistent across multiple data sets. Bladder cancer subtypes also showed variability in immune profiles that is likely to inform the response to immunotherapy. Subtypes were also found to be significantly prognostic for Stage 2 and 3 bladder cancer.

Details of the presentation are as follows:

Title: "Bladder Cancer Gene Expression Subtypes (60 gene signature) Defines Prognosis, Differential Immune Response and Biomarker Associations."
Abstract Number: 4538

Date: June 2, 2018
Time: 8:30AM-11:30AM
Location: Hall A
Presenter: Greg Mayhew, PhD, Director, Bioinformatics, GeneCentric Therapeutics

Oncologists from The US Oncology Network and US Oncology Research to Present Data from More Than 40 Abstracts During the 54th Annual ASCO Meeting

On May 30, 2018 McKesson Specialty Health reported that oncologists from The US Oncology Network (The Network) and US Oncology Research will showcase detailed findings from 43 studies during the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), held June 1–5, 2018, in Chicago with more than 32,000 oncology professionals in attendance (Press release, McKesson, MAY 30, 2018, View Source [SID1234526957]). The study abstracts accepted for presentation represent substantial contributions made by community oncologists towards the understanding and advancement of cancer care.

"Research conducted by community oncologists and presented at this year’s ASCO (Free ASCO Whitepaper) meeting demonstrates the dedication of these professionals in not only advancing investigational treatment options, but also offering cutting-edge research to their patients," said Michael Seiden, M.D., Ph.D., president and chief medical officer for The US Oncology Network and US Oncology Research. "There have been tremendous advancements in cancer care, and being selected for a clinical study is no longer seen as a last option, but rather as access to some of the latest investigational therapies for treating a wide range of cancers. Our community-based oncology network, made up of 1,400 independent physicians, allows access to resources and emerging treatments across the country. This meeting provides a time to focus on the unmet needs of patients through clinical trials that are leading the way in the fight against cancer."

Key study presentations will include topics such as genome sequencing in lung cancer, metastatic breast cancer, real-world evidence in bladder cancer and melanoma, and Phase 3 data from the PROTECT study in asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer.

"The ability for community oncologists to participate in groundbreaking cancer research must remain a high priority for all research organizations, including those programs supported by the National Cancer Institute," said Nicholas J. Vogelzang, M.D., FASCO, FACP, medical oncologist with Comprehensive Cancer Centers of Nevada, an affiliate of The US Oncology Network, and 2018 recipient of an OncLive Giants of Cancer Care award. "It is critically important for oncologists around the world, regardless of the type of center they are practicing in, to be able to find time to conduct research and make advancements in cancer care. I’m proud to be an active clinical investigator within The US Oncology Network, where several studies have been selected for presentation at this year’s ASCO (Free ASCO Whitepaper) annual meeting. This conference is a time for us to share knowledge and gain insights to better and more effectively treat patients, while contributing to our collective mission to eradicate cancer."

Key oral presentations will include:

Results of PROTECT: A randomized phase 3 trial of PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer
Abstract #: 5006
Date/Time: Monday, June 4, 3-6:00 p.m.
Location: Hall D1
Affiliated Author: Nicholas J. Vogelzang, M.D., FASCO, FACP, Comprehensive Cancer Centers of Nevada, US Oncology Research

Genome-wide sequencing for early stage lung cancer detection from plasma cell-free DNA (cfDNA): The Circulating Cancer Genome Atlas (CCGA) study
Abstract #: LBA8501
Date/Time: Monday, June 4, 8-11:00 a.m.
Location: Hall B1
Affiliated Author: Donald Richards, M.D., Ph.D., Texas Oncology, The US Oncology Network

Efficacy of sacituzumab govitecan (anti-Trop-2-SN-38 antibody-drug conjugate) for treatment-refractory hormone-receptor positive (HR+)/HER2- metastatic breast cancer (mBC)
Abstract #: 1004
Date/Time: Sunday, June 3, 8-11:00 a.m.
Location: Hall D2
Affiliated Author: Joyce O’Shaughnessy, M.D., Texas Oncology, The US Oncology Network, US Oncology Research

First results from the primary analysis population of the phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRalt)
Abstract #: 4503
Date/Time: Sunday, June 3, 8–-11:00 a.m.
Location: Arie Crown Theater
Affiliated Author: Mark T. Fleming, M.D., Virginia Oncology Associates, US Oncology Research

Prevalence of clonal hematopoiesis of indeterminate potential (CHIP) measured by an ultra-sensitive sequencing assay: Exploratory analysis of the Circulating Cancer Genome Atlas (CCGA) study
Abstract #: 12003
Date/Time: Tuesday, June 5, 8–11:00 a.m.
Location: S406
Affiliated Author: Michael Seiden, M.D., Ph.D., The US Oncology Network, US Oncology Research

An additional 29 poster presentations and nine published abstracts affiliated with US Oncology Research will be featured as part of the ASCO (Free ASCO Whitepaper) program. The full schedule of US Oncology Research–affiliated data presentations, including location information, can be found here.

For more information or to be put in touch with a trial investigator, please contact Edie DeVine at 209-814-9564 or [email protected]. Please visit Booth #5123 on the Main Floor at ASCO (Free ASCO Whitepaper).

Triumvira Immunologics to Participate in Two Upcoming Conferences

On May 30, 2018 Triumvira Immunologics, a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack multiple types of cancers, reported that it will present a company overview at the 4th Annual Immuno-Oncology Business Development & Licensing and Investment Forum (IOBDLI), in Chicago on June 1, and attend the 2018 BIO International Convention in Boston on June 4-5 (Press release, Triumvira Immunologics, MAY 30, 2018, View Source [SID1234526956]).

At the IOBDLI Forum, Triumvira Scientific Founder and Acting Chief Scientific Officer, Dr. Jonathan Bramson, will provide an overview of the company’s T Cell-Antigen Coupler (TAC) technology, as well as updates on Triumvira’s lead drug, CD19-TAC01, which is targeted to enter clinical development in H1 2019 for the treatment of patients with CD19 positive B-cell malignancies. Dr. Bramson will be presenting at 3:20 p.m. CT on June 1.

At BIO International, President and Chief Executive Officer, Dr. Paul Lammers will be available for private meetings during the day on June 4-5 to discuss potential collaboration and licensing opportunities for the Company’s novel immuno-oncology platform T Cell-Antigen Coupler (TAC).

About the IOBDLI Forum
The 4th Annual Immuno-Oncology BD&L and Investment Forum, a by-invitation-only event to be held at the Waldorf Astoria Chicago Hotel, is designed to bring together thought leaders from cancer research institutes, patient advocacy groups, pharma and biotech to facilitate partnering, funding and investment.

About the 2018 BIO International Convention
The BIO International Convention, to be held at the Boston Convention and Exhibition Center, is hosted by the Biotechnology Innovation Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.

Oragenics Reports Positive Interim Safety Analysis Results from Its Phase 2 Clinical Trial of AG013 for Oral Mucositis

On May 30, 2018 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis (OM), reported positive results from its interim safety analysis as requested by FDA on patients from its Phase 2 clinical trial of AG013 for the treatment of OM (Press release, Oragenics, MAY 30, 2018, View Source [SID1234526953]). The study provides information that, we believe, likely indicates that the overall incidence of severe OM is less than would be anticipated in the general population.

The Phase 2 trial is a double-blind, placebo-controlled, 2-arm, multi-center trial in which approximately 200 patients will be randomized in a 1:1 ratio to receive either placebo or AG013. Safety was evaluated on the basis of treatment-emergent adverse events, vital signs, weight, physical examinations, clinical laboratory assessments and the presence of AG013 in whole blood. Tolerability measures (taste, consistency and smell) were collected from the patient diaries. In addition, the reasons for study treatment discontinuation were also summarized. To date, 24 patients have been randomized and 19 patients included in the safety evaluation.

Following review of the data by an independent Data Safety Monitoring Board (DSMB), it was concluded that the clinical trial can proceed with no changes to the study. The data analysis indicated that the distribution of adverse events were similar between AG013 and placebo. The serious adverse events reported were consistent with those commonly reported in a head and neck cancer population receiving traditional chemoradiation therapy treatments and included fevers, neutropenia, anemia, nausea and vomiting, infections and oral (mouth and throat) pain. There were no reports of bacteremia or sepsis. Of patients that discontinued participation in the clinical study, 4 patients experienced adverse events, including 3 patients who developed nausea and vomiting, 2 patients that were non-compliant with the study procedures and 3 patients developed severe OM.

The purpose of the Phase 2 study (NCT03234465) is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing the incidence and severity of OM in patients undergoing traditional chemoradiation for the treatment of head and neck cancer. Key measures include as measured by the duration, time to development, and overall incidence of OM (World Health Organization scale used) during the active treatment phase, beginning from the start of chemoradiation therapy until 2 weeks following its completion.

"We are pleased with the conclusions reached by the DSMB. Of particular interest was the low number of study discontinuations due to the development of severe OM which resulted in patients seeking alternative treatments for their condition. We are also pleased to note that we believe the overall incidence of severe OM is less than would be anticipated in the general population. While recognizing the preliminary nature of this phase of the study, such a finding might well suggest mitigation of severe OM by AG013," said Alan Joslyn, Oragenics’ President and Chief Executive Officer. "Given the clearance by the DSMB, we will proceed with patient enrollment for our AGO13 clinical trial, which we hope to accelerate by the addition of clinical sites in the U.S. and Europe. We expect to report top-line results of the completed phase 2 trial in late 2019."

"The DSMB’s findings are completely in line with the safety and tolerability signals observed in patients receiving induction chemotherapy for head and neck cancer and reported in the Phase 1b trial and pave the way for completion of a robust Phase 2," said Dr. Stephen Sonis, an expert in the field and advisor to Oragenics. "The unique delivery platform by which AG013 delivers hTTF1 represents an innovative approach with the potential to favorably impact the incidence and course of this devastating side effect of radiation therapy for patients being treated for head and neck cancer."

AG013 is an ActoBiotics therapeutic candidate formulated as a convenient oral rinsing solution and designed by our strategic collaboration partner ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation (NYSE: XON) to deliver the therapeutic molecule Trefoil Factor 1 to the mucosal tissues in the oral cavity. Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and play an important role in subsequent repair. AG013 received Fast Track designation from the U.S. Food and Drug Administration in November 2016.

Under an Exclusive Channel Collaboration Agreement with ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation, Oragenics has an exclusive, worldwide license, to develop and commercialize AG013 to treat OM in cancer patients

Spectrum Pharmaceuticals to Present Corporate Update at the Jefferies 2018 Global Healthcare Conference on June 6th
PDF Version

On May 30, 2018 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported that an overview of the company’s business strategy and commercial and development-stage programs will be given at the Jefferies 2018 Global Healthcare Conference being held at the Grand Hyatt in New York (Press release, Spectrum Pharmaceuticals, MAY 30, 2018, http://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-present-corporate-update-jefferies-2018 [SID1234526952]). The company presentation is on Wednesday, June 6, 2018, at 10:30 AM EDT.