On September 9, 2021 ITM AG, a leading radiopharmaceutical company, reported that it will host a virtual industry satellite symposium titled, "A Global Perspective on the Management of Neuroendocrine Tumors – the Evolving Role of Targeted Radionuclide Diagnostics and Therapy" at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, ITM Isotopen Technologien Munchen, SEP 9, 2021, View Source [SID1234587556]). The symposium will feature renowned key opinion leaders in the field and will be held on Friday, September 17th, 2021, from 10:30 am – 12:00 pm CEST on channel 3, open to ESMO (Free ESMO Whitepaper) registered participants.

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The speakers are key precision oncology experts and will lead critical discussions addressing the changes within the treatment and diagnosis of neuroendocrine tumors. They will cover a range of topics examining the impact of NET diagnostic paradigms, treatment guidelines, and recent advancements within the clinical studies of Targeted Radionuclide Therapy. In addition to the ongoing COMPETE trial, the new phase III trial COMPOSE, a prospective study in high Grade 2 and Grade 3 gastroenteropancreatic NETs, will be presented. Participants will be able to interact with the speakers in a Q&A session at the end of the event.

Scientific Program and Participating Experts:

Welcome & Introduction
Raj Srirajaskanthan, MD, FRCP King’s College Hospital, London, UK (5 mins)
Changes in the Incidence and Prevalence of NETs – Impact of New Diagnostic Paradigms
Simon Singh, MD, MPH Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada (20 mins)
The Evolution of Guidelines for the Treatment of NETs
Namrata Vijayvergia, MD, FACP Fox Chase Cancer Center, Philadelphia, U.S. (20 mins)
The Role of Targeted Radionuclide Therapy in Clinical Trials
Grace Kong, MBBS (Hons), FRACP, FAANMS Peter MacCallum Cancer Center, Melbourne, Australia (20 mins)
Q&A and Closing Remarks (25 mins)
For further information please visit ITM’s ESMO (Free ESMO Whitepaper) 2021 Symposium website or the official ESMO (Free ESMO Whitepaper) webpage.

On September 9, 2021 US Medical Innovations, LLC (USMI), a U.S. FDA-registered life-science and biomedical device company and the Jerome Canady Research Institute for Advanced and Biological Technological Sciences (JCRI-ABTS) reported that Jerome Canady MD, CEO will be presenting at the Baird Global Healthcare Conference on Tuesday, September 14th from 10:15 to 10:45 AM ET (Press release, US Medical Innovations, SEP 9, 2021, View Source [SID1234587555]).

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Dr. Canady will present results from their FDA-approved Phase I Clinical Trial evaluating Cold Atmospheric Plasma for the treatment of Stage IV, Recurrent, Metastatic Solid tumors (FDA IDE #190165) and their recent discovery identifying the mechanism in which Canady Helios Cold Plasma induces apoptosis in breast cancer. JCRI-ABTS Discovers the Mechanism using Canady Helios Cold Plasma to Induce Cell Death in Breast Cancer.

The trial was completed April 15, 2021 at Rush University Medical Center (Chicago, IL) and Sheba Medical Center-Tel HaShomer (Ramat Gan, Israel). The Principal Investigators were Professor Steven Gitelis, M.D., and Professor Aviram Nissan, M.D. respectively.

On September 9, 2021 CG Oncology, Inc. reported a clinical trial collaboration to evaluate the safety and efficacy of CG0070, an oncolytic immunotherapy, in combination with OPDIVO (nivolumab), Bristol Myers Squibb’s anti-PD-1 therapy, for the treatment of metastatic urothelial cancer in a Phase 1/2 clinical study (Press release, CG Oncology, SEP 9, 2021, View Source [SID1234587554]).

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CG0070, CG Oncology’s lead immuno-oncology candidate, is in an ongoing Phase 3 monotherapy study and has been administered in over 100 patients to date for the treatment of high-risk, non-muscle invasive bladder cancer (NMIBC). CG0070 is based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroying various cancer cells, including bladder tumor cells, through their defective retinoblastoma (Rb) pathway.

"We are excited to initiate this important clinical trial with our lead oncolytic immunotherapy, CG0070, in combination with OPDIVO in metastatic urothelial cancer," said Arthur Kuan, CEO of CG Oncology. "The clinical results to date for CG0070 make it a potential promising agent in bladder cancer and other tumor types, as monotherapy or in combination with immune checkpoint inhibitors."

CG Oncology will sponsor the study and Bristol Myers Squibb will provide nivolumab. Additional details of the collaboration were not disclosed.

OPDIVO is a trademark of Bristol-Myers Squibb Company.

On September 9, 2021 Navigation Sciences reported that the company has been awarded a $400,000 Phase 1 Small Business Technology Transfer Program (SBIR/STTR) grant from the National Cancer Institute (NCI) to advance the development of a bronchoscope-based tissue marker (NaviSci EndoMarker) for use in its NaviSci Intelligent Surgical System for tissue conserving removal of early-stage lung tumors (Press release, Navigation Sciences, SEP 9, 2021, View Source [SID1234587553]). The NaviSci System, currently undergoing a clinical feasibility study, is designed to accurately determine surgical margins in real-time and enable tumor removal through a targeted, minimally invasive surgery.

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"The EndoMarker we are developing provides a second-generation tumor localization approach to simplify clinical workflow and expand adoption of the system," said Jayender Jagadeesan, Ph.D. Principal Investigator on the grant, Associate Professor at Harvard Medical School, and a Navigation Sciences co-founder. "The initial system in clinical development relies on visual localization or C-arm CT imaging to guide placement of the marker. Bronchoscopy-based placement of the EndoMarker prior to surgery will facilitate use of the NaviSci technology in hospitals that do not have interoperative imaging capabilities."

"Surgery, the standard of care for lung tumors, is evolving as more cancers are being detected early, allowing surgeons to remove less tissue with wedge resections and segmentectomies to conserve lung function," said Raphael Bueno, M.D., a co-investigator on the grant, Chief, Division of Thoracic and Cardiac Surgery, Brigham and Women’s Hospital and a Navigation Sciences co-founder. "The NaviSci System aims to address the critical need in this environment to assess margins in real-time and remove tumors completely, reducing the risk of recurrence."

The NaviSci System localizes a tumor by marking the nodule with a sensor-enabled fiducial marker called a J-Bar that tracks its position. The marker couples with a second sensor on a surgical stapler used to cut the lung during surgery. Use of proprietary software, along with the sensors, provides the surgeon with ‘GPS’ guidance so the distance from the marker (i.e., tumor) to the resection margin can be measured in real time. With support from the grant, the EndoMarker will be developed for bronchoscopy-based placement of the J-Bar.

"The NCI grant programs are highly competitive, and this award provides validation of our innovative approach and the clinical need for tissue-conserving lung surgery and potentially other soft tissue cancers," said Alan D. Lucas, Navigation Science’s CEO. "The number of patients is expected to grow substantially in the coming years with increased adoption of CT screening, driven in part by recommendations that a larger population be tested, along with more favorable reimbursement." Currently, there are more than 225,000 new cases of lung cancer diagnosed in the U.S. annually, of which more than 76,000 are early-stage tumors.

The grant is titled, "Bronchoscopic lung navigation system for accurately excising lung nodules." Hisashi Tsukada, M.D., Ph.D., Assistant Professor of Surgery at Brigham and Women’s Hospital is a co-investigator on the grant, along with Dr. Bueno and Dr. Jagadeesan, the Principal Investigator.

On September 9, 2021 Novocure (NASDAQ: NVCR) reported the United States Food and Drug Administration (FDA) has granted breakthrough designation to the NovoTTF-200T System, a Tumor Treating Fields (TTFields) delivery system intended for use together with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer (Press release, NovoCure, SEP 9, 2021, View Source [SID1234587552]). The designation offers Novocure an opportunity to interact with FDA experts through several different program options to address regulatory topics efficiently as they arise during the premarket review phase and allows for prioritized review of regulatory submissions.

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The FDA granted breakthrough device designation in part based on clinical data from Novocure’s phase 2 pilot HEPANOVA trial testing the safety and efficacy of TTFields together with sorafenib for the treatment of advanced liver cancer. In granting the designation, the FDA determined that the TTFields delivery system for advanced liver cancer is a breakthrough technology that has the potential to be a more effective treatment for this life-threatening condition, and therefore meets the FDA’s stringent requirements for breakthrough device designation.

"We are very pleased that the FDA has granted breakthrough designation for Tumor Treating Fields together with atezolizumab and bevacizumab to treat advanced liver cancer," said Asaf Danziger, Novocure’s CEO. "Our data suggest that TTFields have the potential to extend survival in this particularly aggressive disease. We are working closely with trial investigators and intend to initiate a randomized controlled trial studying TTFields in combination with atezolizumab and bevacizumab as soon as possible."

TTFields are electric fields that disrupt cancer cell division. TTFields are intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields have exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields.

Use of Tumor Treating Fields for the treatment of liver cancer is investigational only.

About Liver Cancer

Liver cancer is a leading cause of cancer deaths worldwide and is the sixth leading cause of cancer deaths annually in the U.S. The incidence of liver cancer is approximately 42,000 new cases annually in the U.S. The five-year survival rate with existing standards of care is less than 20%.

Hepatocellular carcinoma is the most widespread type of cancer that originates from the liver. Advanced liver cancer has spread either to the lymph nodes or to other organs and because these cancers are widespread, they cannot be treated with surgery. The current common standard treatment for patients with advanced disease and those who progressed on loco-regional therapy is systemic therapy with sorafenib, lenvatinib, or atezolizumab plus bevacizumab.