On May 20, 2019 Imago BioSciences, Inc., a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, reported that an abstract describing clinical data regarding their lysine-specific demethylase (LSD1) inhibitor has been selected for an oral presentation at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) to be held in Amsterdam, The Netherlands from June 13-16, 2019 (Press release, Imago BioSciences, MAY 20, 2019, View Source [SID1234536489]). The abstract was published on the EHA (Free EHA Whitepaper) website.

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!

Title: A Phase 2A Study of the LSD1 Inhibitor IMG-7289 For the Treatment of Myelofibrosis
Abstract Number: S832
Date: Saturday, June 15
Time: 12:30-12:45 CEST
Location: Elicium 2

The abstract represents the first report of clinical data on IMG-7289. The protocol of IMG-7289-CTP-102 is an ongoing Phase 1/2a clinical trial of LSD1 inhibitor IMG-7289 in patients with high or intermediate-2 risk myelofibrosis resistant to or intolerant of approved therapy (see clinicaltrials.gov NCT03136185).

In accordance with EHA (Free EHA Whitepaper) policies, abstracts submitted to the Annual Congress of EHA (Free EHA Whitepaper) are embargoed from the time of submission. The terms and conditions for presentation at the Annual Congress of EHA (Free EHA Whitepaper) prohibit any additional disclosure of data or information to be presented at the Annual Congress to be made public before the presentation.

Following the Annual Congress of EHA (Free EHA Whitepaper), a summary of the presentation will be available in the "News" section of Imago’s website.

About IMG-7289

IMG-7289 is a small molecule discovered by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme regulating cytokine expression and sustaining self-renewal in malignant hematopoietic stem/progenitor cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo efficacy as a single agent and in combination with other therapeutic agents across a range of myeloid malignancies models including the myeloproliferative neoplasms which encompass myelofibrosis, essential thrombocythemia and polycythemia vera. IMG-7289 also shows activity against solid tumors in combination with other checkpoint agents in non-clinical models. IMG-7289 is under evaluation for the treatment of acute myeloid leukemia (see clinicaltrials.gov NCT02842827).

On May 20, 2019 Emergent BioSolutions Inc. (NYSE: EBS) reported that a member of the company’s senior management team will participate in the following investor conferences during the second quarter of 2019 (Press release, Emergent BioSolutions, MAY 20, 2019, View Source;p=RssLanding&cat=news&id=2399088 [SID1234536474]):

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!

RBC Capital Markets – 2019 Global Healthcare Conference
New York, NY
May 21-22, 2019

Goldman Sachs – 40th Annual Global Healthcare Conference (1×1 Meetings Only)
Rancho Palos Verdes, CA
June 11-13, 2019

Three Part Advisors – East Coast IDEAS Conference
Boston, MA
June 12-13, 2019

BMO – Prescriptions for Success Healthcare Conference 2019
New York, NY
June 25, 2019

Presentation dates and times will be updated on the Emergent website www.emergentbiosolutions.com under "Investors" as the information becomes available.

For these conferences, the company will be webcasting its presentation, which may include a discussion of the company’s recent business developments as well as its most recently reported financial results and guidance. The webcasts will be available both live and by replay, accessible from the Emergent website.

On May 20, 2019 Strata Oncology, Inc., a precision oncology company, reported that data from its Strata Trial, a nationwide observational NGS screening protocol providing no-cost tumor sequencing and clinical trial matching for 100,000 advanced cancer patients, will be presented in a poster at the upcoming 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, IL, from May 31-June 4, 2019 (Press release, Strata Oncology, MAY 20, 2019, View Source [SID1234536491]).

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 Strata Trial enables routine genomic testing for advanced cancer patients at the Ochsner Health System, which has opened an array of options for targeted treatment, as well as enrollment in precision medicine clinical trials available at our cancer center," said Marc Matrana, MD, MSc, FACP, Director of the Ochsner Precision Cancer Therapeutics Program.

"Data from the Strata Trial support the feasibility of using a system-wide genomic testing protocol to identify patients who may be eligible for biomarker-driven trials," said Dan Rhodes, co-founder, chief executive officer, Strata Oncology. "Strata is committed to improving outcomes for patients and accelerating drug approvals through a model that integrates universal genomic sequencing for advanced cancer patients and cutting-edge clinical research."

Strata recently announced a clinical development collaboration with Arcus Biosciences, Inc. utilizing Strata’s precision drug development platform and proprietary biomarkers for the evaluation of Arcus’ clinical-stage anti-PD-1 antibody AB122.

Abstract Title: No-Cost Next Generation Sequencing of Advanced Cancer Patients within the Strata Precision Oncology Network Supports Clinical Trial Enrollment
Abstract Number: 3073
Board Number: 65
Session Information: Developmental Therapeutics and Tumor Biology (Nonimmuno)
Date/Time: Saturday June 1, 8:00 AM to 11:00 AM

On May 20, 2019 Early research using blood-based methylated DNA markers, identified through the longstanding collaboration between Exact Sciences and Mayo Clinic, reported a potential to achieve 92% sensitivity and 92% specificity for detecting the most common type of pancreatic cancer (Press release, Exact Sciences, MAY 20, 2019, View Source [SID1234536475]). Researchers presented the findings at Digestive Disease Week (DDW) 2019, the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

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!

"These pancreatic cancer data showcase the strength of our marker discovery collaboration with Mayo Clinic, a partnership that is fueling our product pipeline," said Kevin Conroy, chairman and CEO of Exact Sciences. "We aim to identify a minimally-invasive marker for a disease that often goes undetected until it progresses to an advanced stage, when fewer treatment options exist."

Pancreatic cancer is the third-leading cause of cancer-related deaths in the United States. According to the American Cancer Society, half of all pancreatic cancer patients are diagnosed in later stages when the five-year median survival rate is only 3%. No major guidelines recommend routine screening for average risk patients because the current detection options have not shown to lower a patient’s risk of death.

Lead author and Mayo Clinic gastroenterologist Shounak Majumder, M.D. presented results from the 340-sample, case-control study. A panel of methylated DNA markers in plasma in combination with CA 19-9, achieved a cross-validated sensitivity of 79% in Stage 1, 82% in Stage 2, 94% in Stage 3 and 99% in Stage 4 pancreatic ductal adenocarcinoma (PDAC) with 92% specificity (81-100%). This combination was significantly better than CA 19-9 alone. As Majumder writes in the abstract, "CA 19-9 is unreliable for early detection and may be normal in advanced disease."

Statistical modeling was used to identify the best algorithm to predict disease status in this sample set. Subsequently, the panel was cross validated by randomly splitting the entire data set into training and testing sets. The fitted model from the training set was used to predict disease status in the test set over multiple iterations. This study used a small number of archival patient blood samples, which could lead to over-fitting to this particular sample set and cause subsequent sensitivity and specificity to decline in a larger, prospective population. A prospective validation study is currently underway at Mayo Clinic.

"Powered by more than a decade of work with Exact Sciences, Mayo Clinic researchers continue producing promising data, in this case on blood-based biomarkers for pancreatic cancer detection," said Paul Limburg, MD, MPH, AGAF, Exact Sciences chief medical officer and Mayo Clinic gastroenterologist.i "While further research must be completed, this serves as an early indicator of encouraging news in the fight against this deadly disease."

The Exact Sciences and Mayo Clinic collaboration focuses on identifying biomarkers for 15 of the deadliest cancers. A poster showing Mayo Clinic researchers work on esophageal cancer will also be presented at DDW.

On May 20, 2019 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported that it has dosed the first patient in the combination arm of its Phase 1 study, combining escalating doses of COM701 with a fixed dose of Opdivo (nivolumab) in patients with advanced solid tumors (Press release, Compugen, MAY 20, 2019, View Source [SID1234536492]). The combination dose escalation arm was initiated following the determination of well-tolerated doses with no dose-limiting toxicities reported of COM701 from the monotherapy dose escalation arm of the trial. Bristol-Myers Squibb will supply Opdivo, a PD-1 inhibitor, for the combination arms of the Phase 1 study under the clinical trial collaboration announced in October 2018.

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!

"Our successful progression through the COM701 monotherapy dose escalation arm, enabled us to initiate the combination study with COM701 and Opdivo," stated Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "Enrollment in the monotherapy dose escalation arm is expected to be completed by the end of the third quarter, while the combination dose escalation arm is expected to finish enrolling patients later this year. As a first-in-class drug candidate against a novel drug target backed by a solid biological rationale and biomarker strategy, COM701 has generated interest in our Phase 1 study. We look forward to exploring the clinical potential of the therapy to improve response rates in patients with refractory or relapsed disease across multiple indications with the study’s investigators and our strategic partner, Bristol-Myers Squibb."

The Phase 1 study now has ten participating sites, having recently added Columbia University, MD Anderson Cancer Center, UCLA, the Cleveland Clinic and START Midwest. The primary endpoints for the study are safety and tolerability; secondary endpoints include preliminary anti-tumor activity, pharmacokinetics and pharmacodynamics.

About the COM701 Phase 1 Study

The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as combination administration with Bristol-Myers Squibb’s Opdivo in patients with advanced solid tumors. Additionally, the trial will evaluate evidence of preliminary antitumor activity of COM701 as monotherapy as well as in combination with Opdivo in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer. The Phase 1 study, which is expected to enroll approximately 140 patients, is currently recruiting patients in the United States. Additional information is available at www.clinicaltrials.gov (NTC03667716).

About the Compugen-Bristol-Myers Squibb Clinical Collaboration

In October 2018, Compugen entered into a clinical trial collaboration with Bristol-Myers Squibb to evaluate the safety and tolerability of Compugen’s COM701 in combination with Bristol-Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab), in patients with advanced solid tumors. Under the terms of the collaboration agreement, Compugen will sponsor the ongoing two-part Phase 1 trial, which includes the evaluation of the combination of COM701 and Opdivo in four tumor types, including non-small cell lung, ovarian, breast and endometrial cancer. The collaboration is also designed to address potential future combinations, including trials sponsored by Bristol-Myers Squibb to investigate combined inhibition of checkpoint mechanisms, such as PVRIG and TIGIT. The clinical combination of multiple immune checkpoint inhibition is designed to test the biological rationale of the PVRIG pathway and its synergistic activity with other checkpoint inhibitors demonstrated in preclinical models. In conjunction with this collaboration, Bristol-Myers Squibb made a strategic $12 million investment in Compugen.