On May 25, 2018 IntegraGen reported it will be in attendance at 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held in Chicago from June 1st to June 5th (Press release, Integragen, MAY 25, 2018, View Source [SID1234526899]). The Annual ASCO (Free ASCO Whitepaper) Meeting brings together more than 32,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field.

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!

Since its foundation in 1996 AOP Orphan Pharmaceuticals AG has successfully grown from a single person organization to a fully integrated worldwide acting orphan pharmaceutical company with more than 200 employees (Press release, AOP Orphan Pharmaceuticals, MAY 25, 2018, View Source [SID1234527058]). To prepare for the next stage of growth and expansion it has now been decided to enhance the management capacity through the implementation of a new leadership structure: Executive Board of Directors supported by the Executive Management Team.

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!

After more than twenty years as CEO of AOP Orphan Pharmaceutical AG, Dr Rudolf Widmann has handed over the CEO function to Mr Andreas Steiner, who has been in his former role as CFO already a board member and instrumental for the development for AOP for the last five years. Dr. Widmann remains a member in the Executive Board with full focus on Research & Development. The Executive Board is completed by Dr Guenther Krumpl, a highly experienced medical and pharmaceutical expert, who will focus on Strategic Corporate Development.

The Executive Management Team is formed by high level professionals, most of them graduated in natural science and have acquired extensive research experience from both university institutions and industry research facilities. This Team takes responsibility for implementation and execution of AOP Orphan ambitious expansion plans.

On May 25, 2018 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported it will participate in the Jefferies 2018 Global Healthcare Conference on Wednesday, June 6, 2018, in New York City (Press release, Medtronic, MAY 25, 2018, View Source;p=RssLanding&cat=news&id=2350842 [SID1234527092]).

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!

Karen Parkhill, executive vice president and chief financial officer of Medtronic, will answer questions about the company beginning at 9:00 a.m. EDT (8:00 a.m. CDT).

A live audio webcast of the session will be available on June 6, 2018, by clicking on the Investors Events link at View Source An archived audio file will be available for replay on the same webpage later in the day.

On May 24, 2018 Foundation Medicine, Inc. (NASDAQ:FMI) reported a collaboration with Merck, known as MSD outside the United States and Canada, to develop companion diagnostic tests for use with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy and the first approved immunotherapy for microsatellite instability (MSI) high or mismatch repair deficient solid tumors (Press release, Foundation Medicine, MAY 24, 2018, View Source [SID1234526886]). The companion diagnostic tests will leverage FoundationOne CDx, Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors incorporating multiple companion diagnostics. The companies will collaborate on the development of a pan-cancer companion diagnostic to measure MSI. In addition, they plan to develop companion diagnostics for tumor mutational burden (TMB), as well as additional potential novel biomarkers of response.

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!

"By collaborating, Merck and Foundation Medicine can continue to push the frontier on innovation in immuno-oncology and personalized cancer care, making a positive difference in the lives of individuals with cancer," said Melanie Nallicheri, chief business officer and head, biopharma for Foundation Medicine. "The addition of MSI and TMB companion diagnostics to FoundationOne CDx re-affirms the validity and clinical utility of these critical immuno-oncology biomarkers, can simplify diagnostic testing through the use of one test that provides physicians with necessary information to both rule-in and rule-out potential treatment options based on each patient’s genomic and biomarker status, and can help accelerate patient access to personalized healthcare."

"Rapidly evolving knowledge of cancer biology and immuno-oncology continues to improve understanding of how to deploy our medicines to identify those patients most likely to respond effectively," said Dr. Eric Rubin senior vice president oncology clinical development, Merck Research Laboratories. "We look forward to working with Foundation Medicine on this companion diagnostics strategy."

FoundationOne CDx, an FDA-approved CGP assay for all solid tumors, assesses genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment options. FoundationOne CDx is also FDA-approved as a broad companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, 12 of which are approved as first line therapy for their respective indications. FoundationOne CDx also reports genomic biomarkers, such as MSI and TMB, that can help inform the use of other targeted oncology therapies, including immunotherapies and relevant clinical trial information. In all of these ways, FoundationOne CDx is available to biopharma companies as an FDA-approved platform for clinical research and as a CGP platform for biopharma companies seeking to develop companion diagnostics for their precision therapeutics.

FoundationOne CDx is available to order online at www.foundationmedicine.com/genomic-testing/order, or visit View Source to sign up for an account.

On May 24, 2018 Cotinga Pharmaceuticals Inc. (TSX-V:COT) (OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported the clearance of a protocol amendment for its ongoing clinical trial of COTI-2 (Press release, Cotinga, MAY 24, 2018, https://globenewswire.com/news-release/2018/05/24/1511485/0/en/Cotinga-Pharmaceuticals-Announces-FDA-Clearance-of-Significant-Protocol-Changes-for-COTI-2-Clinical-Program.html [SID1234533153]). The multi-part protocol amendment expands the trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers. The Company will initially evaluate COTI-2 combined with standard of care cisplatin in up to 30 patients with any of ovarian, fallopian tube, primary peritoneal, endometrial, cervical, lung, pancreatic or colorectal cancer, or head and neck squamous cell carcinoma.

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!

"Following extensive work with our academic collaborators and the FDA, we are pleased to expand the ongoing clinical trial of our lead asset, COTI-2, to evaluate its potential as a combination therapy in various cancers with severe unmet medical need," said Alison Silva, President and Chief Executive Officer. "We have already begun to roll-out the initial part of the protocol amendment for our sites at MD Anderson Cancer Center and Northwestern University, and we will continue to work closely with investigators to ensure the process runs smoothly. We look forward to announcing the first patient dosed with combination therapy and providing updates as we continue to advance the clinical development of COTI-2."

Phase 1b/2a Trial of COTI-2
The ongoing trial of COTI-2 will now focus on evaluating COTI-2 as a combination therapy for the potential treatment of a wide spectrum of cancers. In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating monotherapy with COTI-2 was generally safe and well-tolerated. Monotherapy with COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy.

The current protocol amendment being implemented by the Company in May 2018 expands the ongoing trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers.

This protocol amendment evaluates COTI-2 combined with standard of care cisplatin in up to 30 patients with any of the following malignancies: ovarian, fallopian tube, primary peritoneal, endometrial, cervical, lung, pancreatic or colorectal cancer, or head and neck squamous cell carcinoma. Patients in this dose finding study will be given a 60 mg/m2 IV dose of cisplatin every three weeks in combination with an oral dose of COTI-2 five days per week. Up to five COTI-2 dose levels will be evaluated ranging from 0.5 mg/kg to 3.5 mg/kg and patient assessments will occur every eight weeks. Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacokinetics and various signals of efficacy. Additional details on the protocol amendment are available on clinicaltrials.gov.