On October 7, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that four poster presentations will be featured at the 2016 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting, October 7-11, 2016 in Copenhagen, Denmark (Press release, Myriad Genetics, OCT 7, 2016, View Source [SID:SID1234515650]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Myriad is a pioneer in personalized medicine and is committed to improving the prevention, detection and treatment of cancer," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad Genetics. "We are excited to present these new studies at ESMO (Free ESMO Whitepaper) that highlight and advance the science of our next-generation companion diagnostics to help inform and improve the treatment of cancer patients."

Please visit the Myriad booth #408 at ESMO (Free ESMO Whitepaper) for more information. Abstracts are available online at: View Source Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates from the Company.

Poster Presentations
Title: Outcomes of clinical testing for tumor BRCA1 and BRCA2 gene analysis for 354 patients: First experience with tumor companion diagnostic for PARP inhibitors.
Presenter: Karen Copeland, M.S.
Date: Saturday, Oct. 8, 2016. 1:00-2:00 p.m.
Location: Poster 874P (Abstract 4031). Hall E.

This study assessed 354 patients with ovarian cancer undergoing BRCA1 and BRCA2 full sequencing and large rearrangement DNA analysis using the Tumor BRACAnalysis CDx test. The results show that, of the 354 samples analyzed, 93 (26.3 percent) tested positive for a pathogenic mutation; 57 were found in BRCA1 and 37 in BRCA2. Of the pathogenic mutations detected, 93.6 percent were sequencing variants and 6.4 percent were large rearrangements. These findings highlight the utility of the Tumor BRACAnalysis CDx test to accurately detect BRCA mutations in patients with ovarian cancer.

Title: The molecular landscape of genome instability in prostate cancer.
Presenter: Kirsten Timms, Ph.D.
Date: Monday, Oct. 10, 2016. 1:00-2:00 p.m.
Location: Poster 115P (Abstract 3247). Hall E.

In this study, DNA from 95 prostate cancer (PC) tumors was analyzed to generate homologous recombination deficiency (HRD) and Microsatellite instability (MSI) and cell cycle progression (CCP) scores. Additionally, 45 DNA damage repair (DDR) genes were sequenced and were considered non-functional if both alleles were mutated and/or deleted. If the second allele was intact, these genes were considered defective but functional. The results showed that non-functional DDR genes (CDK12, PALB2, RPA1, ATM, and BRCA2) were observed in seven tumors and DDR gene defects in eight genes were observed in 11 tumors. Importantly, the HRD score was significantly associated with DDR mutation status, Gleason score and CCP score. A significant proportion of aggressive prostate tumors carry molecular signatures associated with response to therapies targeting DDR deficiencies or to immune-therapeutics. This study demonstrates the importance of assessing both alleles when identifying prostate tumors with DDR gene mutations. In the study, an HRD score of ≥20 identified three times as many potential responders to HRD-dependent therapies compared to non-functional DDR gene mutations.

Title: Characteristics of homologous recombination deficiency (HRD) in paired primary and recurrent high-grade serous ovarian cancer.
Presenter: Jai Patel.
Date: Monday, Oct. 10, 2016. 1:00-2:00 p.m.
Location: Poster 113P (Abstract 3290). Hall E.

In this study, the myChoice HRD test was used to evaluate paired primary and recurrent tumors from 54 patients with high-grade serous ovarian cancer (HGSOC), the vast majority of whom were treated with adjuvant carboplatin and paclitaxel. The objective was to determine if changes in the genomic profile of primary and recurrent tumors might impact the myChoice HRD score. The results showed that there were no significant differences in the genomic markers evaluated between primary and recurrent tumors. Importantly, the myChoice HRD test was not impacted by changes in the genomic profile. This finding suggests that testing recurrent HGSOC tumors would not alter treatment strategies relative to analysis of the primary tumor.

Title: Homologous recombination deficiency (HRD) score shows superior association with outcome compared to its individual score components (LOH, TAI, and LST scores) in platinum treated serous ovarian cancer.
Presenter: Jerry Lanchbury, Ph.D.
Date: Monday, Oct. 10, 2016. 1:00-2:00 p.m.
Location: Poster 112P (Abstract 2504). Hall E.

The myChoice HRD score is the sum of three independent measures of HRD, including loss of heterozygosity (LOH), telomeric-allelic imbalance (TAI) and large-scale state transitions (LST). This study compared the myChoice HRD score to its individual score components (LOH, TAI, and LST). The results showed that the myChoice HRD score is a superior prognostic marker of HR deficiency than the individual scores. There were a significant number of discrepancies between the myChoice HRD score and the individual component, which demonstrated a risk of both false positives and negatives. These findings support the use of myChoice HRD, rather than the individual biomarkers, to inform treatment decisions for patients.

About Tumor BRACAnalysis CDx
Tumor BRACAnalysis CDx is a companion diagnostic test for identifying both germline and somatic cancer-causing mutations in the BRCA1 and BRCA2 genes. Currently, Tumor BRACAnalysis CDx is a CE-marked genomic test designed to detect the presence of a BRCA1 or BRCA2 gene mutation in ovarian tumor tissue. Additionally, Myriad is actively collaborating with leading pharmaceutical companies and academic centers to further develop Tumor BRACAnalysis CDx as a companion diagnostic for use with certain PARP inhibitors, platinum-based drugs and other chemotherapeutic agents.

On October 7, 2016 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has secured an agreement with Dermin Sp. Zo. O. ("Dermin") to utilize Dermin’s supply of Annamycin for its upcoming clinical trial, substantially reducing the expenditures required of Moleculin for drug product and shortening the time required to produce clinical supplies (Press release, Moleculin, OCT 7, 2016, View Source [SID:SID1234515658]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This was an important agreement and key milestone to be reached as it clearly shortens the pathway as well as lowers the expense involved in our clinical timeline and go to market strategy," commented Walter Klemp, Chairman and Acting CEO of Moleculin. "With this agreement in place, our drug product expense for our upcoming clinical trial will be substantially below what we had previously budgeted. Additionally, Dermin’s existing supply alleviates any potential drug production constraints and advances our ability to begin our next trial expeditiously."

Moleculin previously licensed Annamycin to Dermin within a limited region in Europe, enabling Dermin to deploy Polish grant funds toward producing Annamycin. The agreement reached between the two companies allows Moleculin to utilize this Annamycin in its upcoming clinical trials rather than having to produce new Annamycin for its own use. Dermin benefits from a data sharing arrangement giving it access to Moleculin’s clinical data on a faster timeline than it would be able develop on its own.

Mr. Klemp concluded, "We are pleased with this key agreement in place and remain focused on our upcoming milestones. We look forward to beginning our expanded clinical trials on Annamycin by the first half of 2017."

On October 7, 2016 Cambrex Corporation (NYSE:CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported that it has completed the acquisition of PharmaCore, Inc., a privately-owned company located in High Point, North Carolina, specializing in developing, manufacturing and scaling up small molecule APIs for clinical phase projects. This completes the transaction initially announced on September 26, 2016 (Press release, Cambrex, OCT 7, 2016, View Source [SID:SID1234515685]). With the acquisition of PharmaCore, which has been renamed Cambrex High Point, Inc., Cambrex enhances its capabilities and expertise to efficiently develop early clinical phase products and new technologies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On October 6, 2016 Coherus BioSciences, Inc. (NASDAQ:CHRS), a leading pure-play, global biosimilar company with late-stage clinical products, reported that the U.S. FDA has accepted the filing of 351(k) Biologics License Application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate (Press release, Coherus Biosciences, OCT 6, 2016, View Source;p=irol-newsArticle&ID=2210016 [SID:SID1234515636]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta. The biosimilar user fee act (BSUFA) action date is June 9, 2017.

On October 6, 2016 CANCER RESEARCH TECHNOLOGY (CRT) – the development and commercialisation arm of Cancer Research UK – reported that it has received a success payment from GlaxoSmithKline resulting from its collaboration developing molecules targeting cancer epigenetics (Press release, Cancer Research Technology, JUN 6, 2016, View Source [SID1234523177]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the agreement, scientists at the Drug Discovery Unit at the Cancer Research UK Manchester Institute at the University of Manchester received promising early molecules for the project from GlaxoSmithKline and created potential new drug development candidates that target a key protein involved in epigenetic regulation.

CRT will receive development milestones and royalties on sales of products from the collaboration, and has the right to develop the molecules further if GlaxoSmithKline declines to do so.

The Drug Discovery Unit at Cancer Research UK’s Manchester Institute will support GSK scientists developing these drugs and will continue to develop other compounds as part of the collaboration.

Epigenetics – the way cells control how and when genes are turned on or off – can be disrupted in many cancers meaning these drugs could be used to treat many cancers.

Dr Donald Ogilvie, head of the Drug Discovery Unit at Cancer Research UK’s Manchester Institute, said: "We’re extremely pleased with the success of this project, which has allowed us to research a challenging area and ensure that it’s an effective way of targeting cancer.

"The Drug Discovery Unit aims to develop new treatments ready for the clinic as efficiently as possible. By working alongside GlaxoSmithKline scientists we’ve been able to reduce the risk in the development of these drugs and make them more likely to progress through to clinic to achieve our goal of getting new treatments to cancer patients sooner."

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re delighted that our Manchester Drug Development Unit’s work has been so successful, triggering an early success payment from GlaxoSmithKline. This showcases our world class drug development capabilities.

"Drugs targeting epigenetics are a growing area of research and we’re pleased to be making an impact in this area. Being at the forefront of this research alongside one of the world’s biggest pharmaceutical companies means we have a real opportunity to develop new drugs for cancer patients."