On June 28, 2022 SonALAsense, a pioneer in the development of SONALA-001 and sonodynamic therapy (SDT), a new drug-device combination developed to manage deadly cancers so patients can become survivors, reported clinical, organizational and growth updates (Press release, SonALAsense, JUN 28, 2022, View Source [SID1234616341]). It is the only company with SDT in clinical trials .

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"At SonALAsense, we have been on a journey to develop a non-invasive treatment option for patients with rare brain cancers who often have little hope," said Mark de Souza, PhD, Founder and Chief Executive Officer. "Today we are excited to announce the culmination of our hard work as we confidently advance SDT into clinical trials as the only non-invasive drug-device combination therapy for the treatment of recurrent glioblastoma multiforme (rGBM) and diffuse intrinsic pontine glioma (DIPG)."

Clinical Update
SonALAsense is working on two trials to evaluate the therapeutic potential of SONALA-001 SDT for DIPG and rGBM. The DIPG trial is actively recruiting and the rGBM clinical trial will begin recruiting shortly.

The primary objective of the Phase 1/2 DIPG study is to evaluate the safety and tolerability of ALA SDT and determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of MR-Guided Focused Ultrasound (MRgFUS) energy in combination with SONALA-001 in patients with DIPG. This rare, and deadly, childhood brain tumor is aggressive and affects the pons or brainstem, which controls many of the body’s functions.

The Phase 2 trial in rGBM builds on positive proof of concept results from the first-in-human Phase 0/1 clinical trial of SONALA-001 SDT in recurrent high grade gliomas (rHGG) being conducted by Dr. Nader Sanai at the Ivy Brain Tumor Center. The initial results indicated that SDT rapidly led to targeted oxidative stress and cell death in human HGG tissue without off-target effects and was well tolerated in patients. The Phase 0/1 trial is continuing to enroll rHGG patients.

Growth Update
SonALAsense was founded and is led by scientific, medical and administrative professionals with decades of experience in developing and commercializing drug-device systems in photodynamic therapy and new drug therapies for rare diseases. They have assembled a diverse and exceptional team of thought leaders who are committed to improving treatment options for patients.

"We continue to expand the depth and breadth of our leadership and scientific expertise," said Stuart Marcus, MD, PhD, Founder, Chief Medical Officer, and Chief Scientific Officer at SonALAsense. "Many of my colleagues have worked alongside me for two decades, applying our accumulated knowledge as a close-knit team to efficiently bring this breakthrough technology from bench to bedside and positively impact the lives of those battling these deadly brain tumors."

Three new established individuals have joined the SonALAsense team of industry veterans. April Freeman has joined as Director of Patient Engagement and Advocacy, along with respected doctors Margaret Dugan and Graeme Woodworth who have recently joined the Scientific Advisory Board.

Ms. Freeman has more than 15 years of experience in the biotech industry, working as a patient advocate at bluebird bio and at BridgeBio where she worked closely with Dr. de Souza.

Dr. Dugan has led several drug development programs in oncology through FDA approval, including temozolomide, the standard of care in GBM. She is the former Senior VP & Global Program Head at Novartis Oncology and held clinical development positions at Schering-Plough and American Cyanamid.

Dr. Woodworth is Professor of Neurosurgery at the University of Maryland School of Medicine and Director of its Brain Tumor Treatment & Research Center. He is a leading neurosurgeon and researcher in the therapeutic potential of focused ultrasound to treat brain tumors.

Funding Update
The Company’s growth strategy continues to advance after raising $25 million funding from successful Series A and B financing rounds and a ~$2 million NCI SBIR grant to help fund the DIPG clinical trial. Proceeds from the financing have allowed the Company to build a team of R&D experts focused on advancing SDT through clinical trials for patients with rGBM and DIPG.

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.