On May 20, 2019 Personalis, Inc., a leader in advanced genomics for cancer, reported that it has entered into a research agreement with FLX Bio, Inc., a biopharmaceutical company developing orally-available, small molecule drugs targeting the immune drivers of cancer and inflammatory diseases (Press release, FLX Bio, MAY 20, 2019, View Source [SID1234536476]). Under the terms of the agreement, FLX Bio will utilize Personalis’ universal cancer immunogenomics platform, ImmunoID NeXT, to evaluate therapy-related changes in tumors of advanced cancer patients participating in a Phase 1/2 clinical trial evaluating FLX475, a CCR4 antagonist, as monotherapy or in combination with pembrolizumab.

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"Using the ImmunoID NeXT Platform for our FLX475 studies will help confirm its mechanism of action and demonstrate that inhibiting the CCR4 receptor with FLX475 blocks the migration of regulatory T-cells (Treg) into tumors," said Brian Wong, M.D., Ph.D., President and CEO of FLX Bio, Inc. "With this cutting edge platform, we may be able to show that FLX475, by blocking Treg migration, decreases immune suppression and stimulates an immune response against cancer cells in the tumor microenvironment."

Via the deep interrogation and analysis of ~20,000 genes in both DNA and RNA, ImmunoID NeXT consolidates multiple biomarker assays into one; providing a multidimensional view of the tumor and the tumor microenvironment (TME) from a single sample. The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery applications, simultaneously enabling the analysis of: tumor escape mechanisms (including HLA typing and somatic mutation detection), immune repertoire profiles, neoantigen load, tumor mutational burden (TMB), microsatellite instability (MSI), oncoviruses, and immune checkpoint gene expression.

With the ImmunoID NeXT Platform, FLX Bio will be able to compare pre- and post-treatment tumor biopsy samples, providing a comprehensive picture of treatment-related changes in tumors. In addition, FLX Bio will use the platform to assess levels of a variety of inflammation-related and immune cell type-related markers in its ongoing Phase 2 clinical studies of FLX475.

FLX Bio is now enrolling patients with multiple types of cancer in the Phase 1 portion of its open-label, dose-escalation and cohort expansion Phase 1/2 study. The study is being conducted at leading cancer centers across the United States, Australia and Asia. The study will evaluate the tolerability profile of FLX475 as a monotherapy and in combination with pembrolizumab. Additionally, using Personalis’ ImmunoID NeXT Platform as well as other biomarkers, the study will also assess changes in the tumor microenvironment of both monotherapy and combination therapy. For more information please visit clinicaltrials.gov identifier NCT03674567.

"We’re delighted to work with FLX Bio, innovators who share our vision that a more comprehensive approach to tumor immunogenomic profiling is necessary to enable the development of more efficacious, next-generation cancer therapies," Personalis CEO, John West, said. "ImmunoID NeXT is ideal for applications such as this: maximizing the data generated from a single tumor sample with the goal of characterizing the complex interplay between the tumor cells and immune cells of the tumor microenvironment. Our companies share a common belief that the complexity and dynamic nature of the tumor-immune interactions demands that combinatorial biomarkers will likely be required to most effectively predict responders and non-responders to these therapies."

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.

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"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 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]):

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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 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST) reported that Dr. Patricia Keller, Senior Scientist at Constellation Pharmaceuticals, presented a poster titled Targeting epigenetic dysregulation in bladder cancer through inhibition of EZH2 at the Bladder Cancer: Transforming the Field meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Denver on May 19 (Press release, Constellation Pharmaceuticals, MAY 20, 2019, View Source [SID1234536473]).

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The poster discusses results of Constellation’s work with its second-generation EZH2 inhibitor CPI-0209 in bladder cancer models, exploring whether ARID1A mutation status affected responsiveness to CPI-0209 treatment. ARID1A, a protein that is a key component of the SWI/SNF chromatin remodeling complex, is mutated in about 25% of muscle-invasive bladder cancers.

Constellation used CPI-0209 in long-term phenotypic growth assays in a panel of 21 bladder cancer cell lines, demonstrating preferential treatment sensitivity that correlated with increased cell death in cell lines harboring ARID1A mutations. Transcriptional profiling after CPI-0209 treatment showed widespread activation of EZH2 target gene expression. In vivo, once-daily treatment with CPI-0209 in bladder cell-line derived xenografts harboring ARID1A mutations produced dose-dependent tumor growth inhibition and regression. Treatment with CPI-0209 and the chemotherapeutic agent cisplatin demonstrated combinatorial effects on cell viability in vitro and on tumor growth in vivo. The poster can be viewed in the Investors & Media/Presentations section of our website.

On May 20, 2019 Compugen Ltd. (NASDAQ: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported financial results for the first quarter ended March 31, 2019 (Press release, Compugen, MAY 20, 2019, View Source [SID1234536472]).

"2019 continues to be marked by strong execution and we anticipate reaching additional important milestones in the second half of the year," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "Patient recruitment and site engagement in our Phase 1 study for COM701 are progressing as planned, and we now have 10 leading sites participating in our study. Enrollment in the monotherapy dose escalation arm is expected to be completed by the end of the third quarter, clearing the way for us to begin enrolling patients in the monotherapy expansion cohorts later this year. In addition, based on the progress made in the COM701 monotherapy dose escalation arm, we are confident in moving forward with the combination dose escalation arm of the study for which we expect to complete enrollment this year."

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"In parallel, we are also advancing our earlier stage pipeline focused on first-in-class molecules modulating immuno-suppressive cells in the tumor microenvironment, mainly cells from the myeloid lineage, as well as pursuing discovery efforts targeted at identifying proteins and pathways which are involved in immune resistance mechanisms to PD-1 therapies. Our goal is to generate a sustainable pipeline to ensure we have high potential first-in-class assets in addition to COM701, both for internal development as well as for additional partnering opportunities."

Recent Corporate Highlights

Dosed first patient in the combination arm of Phase 1 study, combining escalating doses of COM701 with a fixed dose of Opdivo (nivolumab) in patients with advanced solid tumors. Combination arms of the study are conducted under the clinical collaboration agreement signed with Bristol-Myers Squibb in October 2018.

Presented trial-in-progress posters at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium in January and the 2019 AACR (Free AACR Whitepaper) annual meeting in April. At AACR (Free AACR Whitepaper), the Company reported that the fifth dose level patient cohort of COM701 monotherapy has been completed and that no dose-limiting toxicities were found. Clinical and laboratory assessment for safety and tolerability are ongoing for this and earlier dose level patient cohorts.

Awarded by the U.S. Patent and Trademark Office U.S. Patent No. 10,213,505, which covers the composition comprising the COM701 and the backup antibodies and U.S. Patent No. 10,227,408, which covers composition comprising an anti-PVRIG antibody having CDRs of COM701 and backup antibodies.

Published two peer-reviewed papers in Cancer Immunology Research demonstrating the role of PVRIG as a novel immune checkpoint target for cancer immunotherapy.

Financial Results
Revenues for the first quarter of 2019 were $0, compared with $10 million in the comparable period of 2018. The revenues for the first quarter of 2018 reflect the upfront payment of $10 million from the license agreement with MedImmune/AstraZeneca.

R&D expenses for the first quarter ended March 31, 2019 were $6.3 million, compared with $7.1 million for the comparable period in 2018. The decrease in R&D expenses is attributed to the cost reduction measures announced by the Company during the first quarter of 2019. Further reduction in expenses will be reflected over the course of 2019.

Net loss for the first quarter of 2019 was $8.4 million, or $0.14 per basic and diluted share, compared with a net income of $0.1 million, or $0.0 per basic and diluted share, in the comparable period of 2018.

As of March 31, 2019, cash, cash related accounts, short-term and long-term bank deposits totaled $38.2 million, compared with $45.7 million at December 31, 2018. During the three months ended March 31, 2019, the Company sold approximately 961,000 ordinary shares under its "at-the-market" (ATM) facility pursuant to a sales agreement entered into with Cantor Fitzgerald & Co. in May 2018 for aggregate proceeds of $3.4 million, net of commissions to Cantor and expenses related to the offering. The Company has no debt.

Conference Call and Webcast Information
Compugen will hold a conference call to discuss its first quarter 2019 results today, May 20, 2019, at 8:30 a.m. ET. To access the live conference call by telephone, please dial 1-888-668-9141 from the U.S., or +972-3-918-0687 internationally. The conference call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.