On June 28, 2022 Indianapolis-based Community Health Network and GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported a partnership to offer Galleri, GRAIL’s multi-cancer early detection (MCED) blood test, to individuals at Community Health Network’s sites of care (Press release, Grail, JUN 28, 2022, View Source [SID1234616340]). Community Health Network, central Indiana’s leading integrated healthcare system with more than 200 sites of care, will be the first healthcare system to offer the Galleri test to patients in its area.

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Through the partnership, Community Health Network will provide the Galleri test to individuals at elevated risk for cancer, including those over the age of 50. The test will be offered to eligible individuals through their primary care providers at select Community Health Network sites as a complement to existing single cancer screenings.

"As a health network committed to exceptional care for patients, and through the generous support of the Community Health Network’s Foundation, we are excited to be the first healthcare system in central Indiana to provide the Galleri test to patients as part of our network’s full continuum of services," said Patrick McGill, M.D., executive vice president and chief transformation officer at Community Health Network. "MCED tests like Galleri represent cutting-edge innovation that, along with appropriate screenings and care, can give patients diagnosed with cancer in our communities the best chance for successful outcomes."

The Galleri test is a first-of-its-kind MCED blood test. In a clinical study, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancers, over 45 of which lack recommended screening tests today. Using advanced genomics and machine learning, the test also determines the origin of the cancer signal, which can then guide diagnostic workup. Early detection of cancer can improve cancer outcomes, yet today, many cancers are detected in late stages because only five cancer types have recommended screenings – breast, cervical, colon, lung and prostate cancers.

"Healthcare systems are increasingly looking for ways to better meet patient needs, and the Galleri test – which can be administered with a simple blood draw as a complement to other cancer screenings – has the potential to screen for more cancers at earlier stages when there is a better chance for successful treatment," said Bob Ragusa, chief executive officer at GRAIL. "The status quo in cancer screening is simply unacceptable and using Galleri to complement existing screening approaches offers the potential to improve cancer detection in the population and improve public health."

On June 28, 2022 Siemens Healthineers and The Ohio State University Wexner Medical Center reported a new alliance, aimed at advancing personalized medicine and improving access to high quality, cost-effective healthcare (Press release, Siemens Healthineers, JUN 28, 2022, View Source [SID1234616339]). Through the five-year strategic partnership, Siemens Healthineers and Varian, a Siemens Healthineers company, will provide comprehensive technology and services that will build on previous successful collaborative projects. The university and medical center will contribute research initiatives from scientists, physicians and patients. This work forms a living lab, a place where early scientific validation will speed breakthroughs in individualized medicine and health care delivery.

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The initiative includes an outpatient expansion of The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James). Outpatient Care West Campus, scheduled to open in 2023, will feature cutting-edge imaging and treatment technology made by Siemens Healthineers, including Varian, which has worked with the OSUCCC – James for nearly a decade. The advanced precision cancer care in this new outpatient center includes proton therapy (ProBeam 360°) and radiosurgery (Edge radiosurgery system) as well as oncology focused interventional radiology (Artis Q Ceiling). West Campus will build on this technology, including the current treatment planning capabilities (Eclipse), to offer the most advanced diagnostic and treatment planning tools, including Digital PET (Biograph Vision 600) and Dual Source Dual Energy CT (Somatom Drive and Somatom Force). Siemens Healthineers will also bring new technology to Ohio State’s new inpatient hospital, scheduled to open in 2026, and three other outpatient facilities in New Albany, Dublin, and Powell.

This technology investment is another bold step forward in realizing Ohio State‘s vision of a cancer-free world. Working with Siemens Healthineers, including Varian, Ohio State leads the only university-based International Training Center of Radiation Oncology and Cancer Consortium with a training-dedicated linear accelerator and planning environment. The consortium uses big data approaches to advance education, research and patient care at 37 institutions around the world.

"With Varian, Siemens Healthineers is ideally positioned to pioneer the next-generation of cancer technology that addresses the growing need for personalized cancer care, and we view this partnership with OSUWMC as an important opportunity to advance this goal. The James Cancer Hospital is the third largest cancer hospital in the country and we’re proud to build on our longstanding relationship and assist them with innovative technology that will provide data and images to help customize treatment based on patient needs," said David Pacitti, President of Siemens Medical Solutions USA, Inc. and Head of the Americas, Siemens Healthineers.

Researchers at OSUCCC – James and Siemens Healthineers intend to explore opportunities in intelligent radiation dosimetric contouring algorithms that are uniquely tailored to the individual patient. One potential objective is to create a platform that combines clinical, imaging, pathology and genomic data with artificial intelligence to drive pathways of care in nearly real time, allowing providers and patients to make even more well-informed, evidence-based decisions together.

"This work not only supports a key step in our mission to improve the lives of our patients, but together we will research ways technology can accelerate breakthrough health discoveries and the care delivery process for all patients in the future," said Peter Mohler, vice president for research at The Ohio State University and chief scientific officer at its Wexner Medical Center.

One of the initial collaborative projects targeting patient access is the co-development of advanced cardiac imaging methods for the Siemens Healthineers Magnetom Free.Max. The new 80cm bore system offers access to larger and/or claustrophobic patients that previously may not have been able to be scanned. Developing new advanced MRI sequences will expand the system’s capabilities to help even more patients.

The two organizations will also work to advance vascular robotics beginning this summer using the Corindus CorPath GRX system, with goals of enhancing precision, efficiency, and patient access to highly specialized endovascular procedures.

"We are energized by this partnership and its potential to bring our organizations together across multiple enterprise-wide projects that will drive meaningful, life-changing advancements in health care discovery, delivery, and access for all," said Jennifer Dauer, chief strategy and transformation officer at Wexner Medical Center.

On June 28, 2022 Endevica Bio, a company developing first-in-class peptide drug candidates with better safety and efficacy properties, reported the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for its lead investigational product, TCMCB07, allowing the company to proceed with initiating clinical studies (Press release, Endevica Bio, JUN 28, 2022, View Source [SID1234616338]). TCMCB07 is an investigational melanocortin‐4 antagonist peptide designed to treat cachexia in people that have cancer and other chronic diseases. Endevica Bio plans to initiate Phase 2 clinical studies in pancreatic cancer in 2Q 2023.

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"The acceptance of the IND means that Endevica begins its next chapter on our quest to improve the lives of people who are suffering from the effects of cachexia. We have been so encouraged by the pre-clinical data on TCMCB07 that have been generated to date and are looking forward to the next phase of its development," said Russ Potterfield, CEO and Executive Chairman of Endevica.

"People with cachexia are suffering as their bodies can’t adequately process the nutrients they need to survive. The current standard of care, appetite stimulants and corticosteroids, are not adequate in effectively mitigating this condition," said Daniel Marks M.D., Ph.D., Chief Medical Officer of Endevica. "TCMCB07 has a lot of promise in its ability to modulate the body’s behavioral and metabolic response to chronic illness, and we are hopeful that it will be proven to be a safe and effective treatment option."

"We designed TCMCB07 to be a first-in-class peptide drug. We are confident that its ability to cross the blood-brain barrier and act on previously inaccessible target receptors will be profoundly beneficial for patient outcomes. This is just the first product in our pipeline of next-generation peptide therapeutics," said Kenneth Gruber Ph.D., Chief Scientific Officer and Founder of Endevica.

With the IND in place, Endevica will be finalizing its Phase 2a protocol for a multi-national trial, which is expected to generate robust data about this potentially life-saving compound.

On June 28, 2022 VeriSIM Life (VeriSIM) www.verisimlife.com, a leading artificial intelligence (AI)-enabled company providing services to de-risk R&D decision making for breakthrough drug development, reported that it has entered into a collaboration with Mayo Clinic to improve the preclinical translation of promising drug candidates (Press release, Mayo Clinic, JUN 28, 2022, View Source [SID1234616337]).

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Under the terms of the collaboration agreement, VeriSIM will leverage its proprietary BIOiSIM platform and Translational Index approach to reduce the number of outsourced preclinical experiments and help de-risk R&D decisions early-on to ensure expedited development of novel, safe and highly efficacious drugs.

VeriSIM will engage Mayo Clinic physician researchers in key disease areas including oncology, hematology, bone/joint-disorders, and neurological diseases.

"This collaboration will explore the full potential of our combined approach to developing best-in-class drug candidates to serve patients’ unmet needs," said Dr. Jo Varshney, founder and CEO of VeriSIM Life. "We are excited to expand our common mission and work with the world’s top research hospital and its drug discovery programs."

Dr. Jo Varshney, DVM and PhD, founded VeriSIM Life in 2017 alongside a cross-functional team of pharmaceutical scientists, software engineers and AI/ML and simulation experts. VeriSIM offers unprecedented value for the drug development industry by reducing the number of drug compounds likely to treat or cure specific illnesses and diseases.

Mayo Clinic participated in VeriSIM’s Series A financing and has financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

On June 28, 2022 Domain Therapeutics, a biopharmaceutical company focusing on the research and development of innovative drugs targeting G Protein-Coupled Receptors (GPCRs) in immuno-oncology (IO), reported that it obtained a single digit multimillion milestone payment from Merck as part of the €240m ($261m) milestone payments and undisclosed royalties collaboration and license partnership signed in 2017 (Press release, Domain Therapeutics, JUN 28, 2022, View Source [SID1234616336]).

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M1069 is an orally available small molecule antagonist of adenosine receptors discovered jointly by both companies. This productive and successful partnership, based on Domain’s expertise in GPCR medicinal chemistry, pharmacology and drug discovery, led to the identification of the drug candidate M1069 to be included in the oncology pipeline of Merck.

Over the last years, several GPCRs were identified as targets to address tumor immunosuppressive strategies to evade immune responses, even in case of immune-checkpoint inhibitor treatment. M1069 aims at thwarting one of these immunosuppressive strategies whereby adenosine is released in the tumor microenvironment.

In the meantime, the Company has built a unique and well-differentiated pipeline with diverse programs targeting specific immunosuppression mechanisms, aiming to provide therapeutic solutions to patients unresponsive to immune-checkpoint inhibitors. This outstanding ability to deliver candidates against validated GPCR targets, as well as to innovate with first-in-class programs focusing on brand new GPCR targets in immuno-oncology, has put Domain at the forefront of innovation in the field.

"This milestone is a great recognition of the ability of our research teams and of the Company to deliver cutting edge candidates able to reach the clinical development stage," says Dr. Stephan Schann, Vice-President of Research and Partnerships at Domain Therapeutics. "Merck is a valuable and respectful partner and our fruitful collaboration has confirmed Domain’s position as a key player in immuno-oncology R&D."

"We were extremely pleased to see M1069 entering the clinical stage earlier in 2022. Reaching first-in-human & single ascending dose phase 1 constitutes a significant step towards the delivery of a novel drug for the treatment of cancer patients", said Dr. Asmaa Boudribila, Medical Director at Domain Therapeutics. "I look forward to following the next stages of clinical development and to the future successes of this promising product."

"Following the launching in the clinic of M1069 by Merck, Domain is very proud to prepare the entrance into the clinic, at the end of 2022, of its first fully proprietary product, the EP4R antagonist candidate DT-9081. The upcoming entry into the clinical of a candidate targeting a distinct immunosuppressive mode of action will further confirm our position as a leader in GPCR targeting-therapeutics in immuno-oncology," added Pascal Neuville, CEO of Domain Therapeutics. "In the coming years, Domain aims to deliver a series of well-positioned candidates for a personalized medicine approach for patients.

This Phase 1 study is conducted in three cancer centers: New York (US), Nashville (US) and Toronto (CAN).

About Adenosine receptors
Adenosine is a powerful immunosuppressive substance produced inside tumors as a result of stress such as hypoxia. Adenosine can act directly on tumor cells to promote their growth, survival and dissemination. In some cases, it is responsible for resistance to certain anti-tumor interventions, such as chemotherapy and radiation. The adenosine receptors, expressed on the surface of immune cells, mediate the immunosuppressive effects of adenosine. The adenosine-driven impairment of tumor-infiltrating lymphocytes (mainly CD8+ T cells and NK cells) and myeloid cells (dendritic cells, macrophages), mediated by adenosine receptors, requires the development of specific inhibitors. For the last few years, the pharma industry has been investigating the benefit of combining adenosine receptor antagonists with immune checkpoint inhibitors (ICI) in order to decrease adenosine-mediated resistance and restore ICI antitumor activity.