On May 24, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company’s common stock for the third quarter of 2022 (Press release, Merck & Co, MAY 24, 2022, View Source [SID1234614982]). Payment will be made on July 8, 2022 to shareholders of record at the close of business on June 15, 2022.

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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

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On May 24, 2022 Ikonisys SA (Code ISIN: FR00140048X2 / Mnémonique: ALIKO), a company specializing in the early and accurate detection of cancer with a unique fully-automated solution for medical diagnostic labs and the Department of Electronics, Information and Bioengineering (DEIB) of Politecnico di Milano (POLIMI), a world-class scientific institution engaged in cutting-edge research, training and technology transfer, reported the signing of a research contract and the initiation of a project to bear on the challenging problem of identifying specific cells in complex tissues through designing, training and deployment of a deep learning model able to detect them.

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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

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Prof. Giacomo Boracchi of the DEIB will lead the research bringing his expertise in image processing and machine learning. In particular, the approach will aim to recognize clinically relevant cells of specific types in darkfield images of lung tissue acquired from the Ikoniscope20. Segmentation of single cell nuclei is a frequent challenge of microscopy image processing, often being the first step of many quantitative data analysis pipelines.

The ongoing collaboration will allow Ikonisys to further enhance its advanced image analysis capabilities and to accelerate the development of the Ikoniscope AI project with the implementation of deep learning models and novel state-of-art techniques into the instrument’s workflow, leading to the development of new applications or enhancement of the existing ones, especially in the most challenging fields such as Circulating Tumor Cells.

On May 24, 2022 / ENB Therapeutics, Inc., a clinical stage biotechnology company pioneering a new and differentiated class of therapeutics targeting the endothelin B receptor (ETBR) inhibitor, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, ENB-003, for the treatment of pancreatic cancer (Press release, ENB Therapeutics, MAY 24, 2022, View Source [SID1234634068]). This is the second Orphan Drug Designation award for ENB-003, which has also been granted Orphan Drug Designation for melanoma.

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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

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"Immune checkpoint therapies have significantly improved the survival of patients with certain cancers; however, there remain a significant percentage of patients that exhibit no response to these therapies," said Sumayah Jamal, MD-PhD, President, Co-founder and CSO of ENB Therapeutics. "This is especially true for pancreatic cancer patients, where only about 3% of tumors are responsive to the leading anti-PD-1 therapy KEYTRUDA (pembrolizumab). We believe that combining our ETRB inhibitor, ENB-003, with pembrolizumab, has the potential to overcome this resistance, and provide much needed additional treatment options for patients in a broader range of pancreatic tumors."

"Our Phase 1/2 trial will exclude patients with pancreatic tumors that have the molecular alterations known as high microsatellite instability (MSI-H) or defective DNA mismatch repair (dMMR). Thus, we are targeting truly pembrolizumab resistant patients to evaluate the potential for a ENB-003 + pembrolizumab combination as a potential treatment for this population with clear and significant unmet need," said Dr. Jamal.

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. This designation acts as a stimulus for the development of drugs for rare diseases through several incentives, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and the potential for seven years of post-approval marketing exclusivity after FDA approval.

About ENB-003

ENB-003 is a selective endothelin B receptor (ETBR) inhibitor that, in preclinical studies, enhanced the efficacy of immunotherapies such as anti-PD-1, anti-CTLA-4 and CAR T across multiple cancer types in preclinical studies. In an ongoing multi-center Phase 1/2 clinical trial, early efficacy signals suggest that ENB-003 overcomes resistance to the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in heavily pre-treated drug resistant cancer patients. The Phase 2 portion of the ENB-003 + pembrolizumab combination study is expected to start in the first quarter of 2023. The trial will enroll melanoma patients with innate resistance to anti-PD-1 based immunotherapies, platinum refractory and platinum resistant ovarian cancer patients, as well pancreatic cancer patients that have failed standard of care.

On May 24, 2022 Sysmex Inostics, a global leader in the liquid biopsy revolution, reported that it has expanded its offering of CLIA-validated tests to include AML-SEQ, a focused panel to detect mutations of the three most prevalent genes found in Acute Myeloid Leukemia (AML) – IDH1/2 & NPM1 (Press release, Sysmex Inostics, MAY 24, 2022, View Source [SID1234614984]).

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AML-SEQ rounds out the company’s AML Laboratory Developed Test (LDT) offerings with a less expensive test compared to the broader AML-MRD-SEQ panel launched in October 2021. AML-MRD-SEQ is a more extensive panel for the detection of measurable residual disease (MRD) in 68 regions across 20 genes including the clinically established IDH1/2 and NPM1.

"We envision investigators and eventually physicians using AML-SEQ and AML-MRD-SEQ as a one-two-punch in the fight against AML and AML MRD. We are committed to developing tools to support the fight against this devastating disease. We must support management of patients suffering from AML by providing the accurate and sensitive detection of AML biomarkers," said Shinichi Sato, CEO of Sysmex Inostics, Inc.

AML-SEQ adds to the portfolio of ultra-sensitive Plasma-Safe-SeqS technology NGS tests available through Sysmex Inostics’ CLIA lab services in Baltimore, Maryland.

Joins Foundation for the National Institutes of Health Biomarkers Consortium

The FNIH consortium combines significant public and private organizations to develop AML MRD guidelines, establish methods for MRD detection, and achieve better measures for clinical trial design and drug development. Project partners include the National Cancer Institute (NCI), the National Heart Lung and Blood Institute (NHLBI), the U.S. Food and Drug Administration (FDA), several award-winning cancer institutions and leading pharmaceutical and diagnostic companies. For more information about the FNIH AML-MRD Consortium click here.

According to the National Cancer Institute (NCI), an estimated 20,050 new AML cases will be diagnosed in the United States in 2022.1 Rising incidence of cancer and increasing preference of noninvasive treatments is driving the quick expansion of the liquid biopsy market. Globally, the liquid biopsy market is to achieve an annual growth rate of more than 18% over the next few years, reaching $5.8 billion by 2026.2

On May 24, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem Therapies dedicated to improving survival outcomes for patients with cancer reported that it will host its first R&D Day for analysts and investors to be held virtually on Tuesday, June 7th, 2022 from 4:00 pm CEST (10:00 am EST) to 6:00 pm CEST (12:00 pm EST) (Press release, MaaT Pharma, MAY 24, 2022, View Source [SID1234615002]).

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MaaT Pharma’s speakers will discuss the microbiome’s potential in cancer therapy and the latest clinical results of MaaT013 and MaaT033. They will also present the Company’s innovative proprietary drug discovery platform, the next generation of products MaaT03X and the construction of Europe’s largest cGMP manufacturing facility for Microbiome Ecosystem Therapies.

In addition to the presentations by MaaT Pharma’s senior team, the R&D Day will feature talks from world renowned scientists and physicians including:

Dr. Joël Doré – Research Director, INRAE; Scientific Director, MetaGenoPolis and Scientific Advisor to MaaT Pharma, France
Prof. Ernst Holler, M.D. – Senior Professor on Clinical and Experimental Allo-HSCT, Department of Internal Medicine, University Hospital Center Regensburg, Germany
Prof. Florent Malard, M.D. – Professor of Hematology, Saint Antoine Hospital (AP-HP) and Sorbonne University
Prof. Mohamad Mohty, M.D. – Professor, Sorbonne University and Head of the Clinical Hematology and Cellular Therapy Department, Saint-Antoine Hospital (AP-HP), France
Prof. Hassane Zarour, M.D. – Professor of Medicine, Immunology and Dermatology, University of Pittsburg, James and Frances McGlothlin Chair in Melanoma Immunotherapy Research
"MaaT Pharma’s inaugural R&D Day is an opportunity to bring together world-renowned scientists and our talented internal team to share MaaT Pharma’s innovative research and highlight our unique positioning in the microbiome space," said Hervé Affagard, Chief Executive Officer and Co-Founder of MaaT Pharma. "Since our successful IPO in November 2021, we have delivered on the key milestones we had defined and we continue to progress, with the ambition to leverage the microbiome for the benefit of millions of patients fighting cancer."

A question-and-answer session will follow the presentations. Please note that all the presentations are in English with French subtitles. The webcast will be made available on the Company’s website after the event.