Foundation Medicine and Flatiron Health Announce First-of-its-Kind Integration of Genomic Profiling Into OncoEMR®

On June 29, 2021 Foundation Medicine, Inc. reported it’s comprehensive genomic profiling (CGP) tests for their patients without leaving Flatiron Health’s OncoEMR platform (Press release, Foundation Medicine, JUN 29, 2021, View Source [SID1234584491]).

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This integration, the first of a series planned by Flatiron, will support more efficient clinical decision making by allowing electronic ordering, order tracking and receipt of Foundation Medicine’s CGP test results all within the OncoEMR platform. Almost all oncology practices use an electronic medical record (EMR) system to input, view and manage the full patient medical record in a single location, replacing a traditional paper chart with a digital one.1 EMR platforms also support clinical teams by enabling them to more efficiently order and track tests, view results, communicate treatment plans to patients and enable the completion of charting, documentation, and billing.

"With the number of targeted treatments growing exponentially, the opportunity for cancer care transformation has never been greater. Clinicians increasingly rely on genomic insights to guide clinical decision-making, and Foundation Medicine is committed to implementing new solutions that enable widespread access to CGP," said Kathleen Kaa, Interim Chief Commercial Officer at Foundation Medicine. "The integration of Foundation Medicine tests into OncoEMR, and other leading EMR systems to follow, is just one way we’re improving our offerings to fuel precision medicine for cancer patients. The integrations will create efficiencies for oncology healthcare teams to deliver precision treatment plans based on individual genomic insights to their patients."

"We are excited to welcome Foundation Medicine in the first of our planned CGP integrations with OncoEMR," said James Hamrick, MD, MPH, Vice President, Clinical Oncology at Flatiron Health. "This kind of integration marks an important milestone in advancing precision medicine, helping oncologists have access to the information they need to select therapies."

The two companies are planning similar integrations with other CGP platforms and EMRs, respectively, in the oncology space, with the goal of helping every patient to realize the benefit of precision cancer care. These workflow-streamlining integrations are being designed by clinical and product experts in partnership with oncology practices.

I-Mab Announces Upcoming Participation at July Conference

On June 29, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported its participation in the following conference in July. Details of the conference are as follow:

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CMBI Healthcare Corporate Day (Virtual)

Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Mr. Tianyi Zhang, Executive Director Investor Relations

One-on-one and small group meetings: July 7-9, 2021

For more information, please contact your CMBI representative.

FDA Grants Fast Track Designation to CNS Pharmaceuticals for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme

On June 29, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational drug, Berubicin, for the treatment of patients with recurrent glioblastoma multiforme (GBM) (Press release, CNS Pharmaceuticals, JUN 29, 2021, View Source [SID1234584489]). As previously reported, the Company has also received Orphan Drug Designation from the FDA for Berubicin for the treatment of patients with recurrent GBM.

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"Receiving Fast Track Designation from the U.S. FDA is a huge achievement in our advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain. If there were ever a disease where the unmet clinical need demands action, it is GBM. Patients have almost no meaningful options and thousands lose their fight against this terrible cancer every year. With this designation, we now have an accelerated pathway to approval for Berubicin and a clear opportunity to more expediently bring this potentially impactful investigational therapy to individuals battling this challenging disease," commented John Climaco, CEO of CNS Pharmaceuticals.

Fast Track Designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.

CNS recently announced the start of patient enrollment in its potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme. For more information about this study, please visit ClinicalTrials.gov and reference Identifier NCT04762069.

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

Applied BioMath, LLC Announces Collaboration with Ichnos Sciences for Systems Pharmacology Modeling for a Bispecific Antibody in Oncology

On June 29, 2021 Applied BioMath (www.appliedbiomath.com), an industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with Ichnos Sciences for the development of a systems pharmacology model for a bispecific antibody in oncology (Press release, Applied BioMath, JUN 29, 2021, View Source [SID1234584488]). Applied BioMath will develop this model to help predict human pharmacokinetics (PK), efficacious dose ranges, first-in-human dose selection, and risk mitigation strategies for cytokine release with immune cell engagers in Oncology.

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"We look forward to collaborating with Applied BioMath and using our preclinical data to develop models which will support us in predicting model-derived PK parameters and optimum dosing regimens in the clinic," said Girish Gudi, Vice President, Global Head of Drug Metabolism and Clinical Pharmacology at Ichnos Sciences.

Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about the mode of action of therapeutics with an understanding of human disease mechanisms. This approach employs proprietary algorithms and software designed specifically for systems pharmacology model development, simulation, and analysis. "One of the advantages of our modeling approach is the accuracy with which it translates from in vitro data and models to in vivo," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "By incorporating the mechanism of action into our model and leveraging the data available from all phases of R&D, we are able to translate and predict the human dose regimen and PK with far better accuracy than existing methods."

Lilly Declares Third-Quarter 2021 Dividend

On June 29, 2021 The board of directors of Eli Lilly and Company (NYSE: LLY) (the "Board") reported that it has declared a dividend for the third quarter of 2021 of $0.85 per share on outstanding common stock (Press release, Eli Lilly, JUN 29, 2021, View Source [SID1234584486]).

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The dividend is payable on September 10, 2021 to shareholders of record at the close of business on August 13, 2021.