On October 20, 2022 RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a new modality for treating all stages of cancer, reported eight clinical abstracts evaluating the potential use and utility of its novel technology were accepted for presentation during the American Society for Radiation Oncology (ASTRO) 2022 Annual Meeting, Oct. 23-26, in San Antonio (Press release, RefleXion Medical, OCT 20, 2022, View Source [SID1234622239]). Additionally, ASTRO will serve as the setting for introducing SCINTIX as the new product name for RefleXion’s flagship BgRT technology and treatment, provided only through the company’s X1 platform.

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"This body of work highlights the advanced conventional capabilities of the X1 and reveals key future possibilities for SCINTIX technology in which each tumor’s unique biology guides its own treatment."

"We are so pleased to once again have multiple posters and presentations highlighting the potential for our innovative SCINTIX technology in 21st-century radiation oncology practice," said Shervin ‘Sean’ Shirvani, M.D., M.P.H, chief medical officer at RefleXion. "This body of work highlights the advanced conventional capabilities of the X1 and reveals key future possibilities for SCINTIX technology in which each tumor’s unique biology guides its own treatment."

The following presentations taking place during ASTRO 2022 evaluate the RefleXion X1 machine with SCINTIX technology:

Sunday, Oct 23: Poster Q&A 1 – Lung Cancer and DEIH (Exhibit Hall 1)

4:45 PM 2907 "Characterizing Metastatic Non-Small Cell Lung Cancer Presenting to an Academic Medical Center in an Era of Changing Treatment Paradigms."
Monday, Oct 24: Quick Pitch 04 – Radiation and Cancer Physics (Room 304)

8:05 AM 1018 "Combined Biology-Guided Radiotherapy and Lutetium PSMA Treatment in Metastatic Prostate Cancer."
8:10 AM 1020 "BgRT Motion Management Maintains Target Dose Coverage for Respiratory and Non-Respiratory Motion."
Tuesday, Oct 25: Poster Q&A 7 – Hematologic Malignancies and Digital Health Informatics (Exhibit Hall 1)

4:00 PM 2283 "Repeatability and Reproducibility of Radiomic Features Produced over Time by the Fan-Beam kV-CT on a Novel Ring Gantry-Based PET/CT Linear Accelerator."
Wednesday, Oct. 26, 12:30 PM: Poster Q&A 10 – Physics (Exhibit Hall 1)

3234 "Robustness of Biology-Guided Radiotherapy Delivery to PET Biodistribution Changes within Target."
3301 "IMRT and SBRT Treatment Planning Study for the First Clinical Biology-Guided Radiotherapy System.
3326 "Systematic Study of Patient-Specific Organs at Risk Auto-Segmentation on Daily kVCT Images for Adaptive Head and Neck Radiotherapy."
3331 "Feasibility and Dosimetric Benefits of Adaptive Planning in Prostate Cancer Radiotherapy Using a Novel Treatment Planning Machine with Integrated Dual kVCT/PET Imaging Systems."
The company will showcase technology from the RefleXion X1 machine in its booth, #3745, including live demonstrations of its breakthrough tracking technology that uses radiotracers as biological guides, and the SCINTIX treatment planning workflow.

On October 20, 2022 Novocure (NASDAQ: NVCR) reported a review article of anti-cancer mechanisms of action of Tumor Treating Fields (TTFields) has been published in the Journal of Molecular Cell Biology (JMCB) (Press release, NovoCure, OCT 20, 2022, View Source [SID1234622238]).

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"will guide strategies focused on the timing and combination of TTFields with other therapies, to further improve survival outcomes in patients with solid organ cancers."

The review article, written by Shadi Shams of Rowan University School of Osteopathic Medicine and Chirag B. Patel, MD, PhD, Assistant Professor and McNair Scholar, Department of Neuro-Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston, summarizes the known mechanisms of action of TTFields that have been reported by in vitro and in vivo studies of cancer. TTFields are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology and electrical properties) than cancer cells.

The review article cites that many studies to date have focused on TTFields’ effect on cancer cell division. More recently, research has demonstrated the effects of TTFields expand beyond preventing cancer cell division. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Along with disruption of mitosis, the review article states that preclinical research has also shown interference with cancer cell motility and migration, activation of downstream anti-tumor immunity, downregulation of genes important for DNA damage repair, and other potential mechanisms. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models.

"A fast-growing body of research, both in vitro and in vivo, is converging to demonstrate the multiple inhibitory effects of TTFields on cancer growth," the article states.

Shams and Patel state in the review article that further investigation and understanding of how TTFields work "will guide strategies focused on the timing and combination of TTFields with other therapies, to further improve survival outcomes in patients with solid organ cancers."

"This publication of peer-reviewed research on Tumor Treating Fields’ mechanisms of action encapsulates a thorough, scientific history of our therapy in the preclinical setting," said Novocure’s Chief Science Officer Uri Weinberg, MD, PhD. "We are very proud of the research that has been conducted to date and are energized by the interest in Tumor Treating Fields among our peers in the scientific community. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors."

About Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfieldstherapy.com.

On October 20, 2022 Takeda (TSE:4502/NYSE:TAK), Zedira and Dr. Falk Pharma GmbH reported a collaboration and licensing agreement to develop ZED1227/TAK-227, a Phase 2b investigational therapy for the treatment of celiac disease (Press release, Takeda, OCT 20, 2022, View Source [SID1234622237]). TAK-227 is a potential first-in-class therapy designed to prevent the immune response to gluten in celiac disease, a serious autoimmune disease where the ingestion of gluten leads to inflammation and damage to the small intestine. There are currently no approved therapies for the treatment of celiac disease.

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"The continued development of TAK-227 in partnership with Zedira and Dr. Falk Pharma has the potential to offer a meaningful benefit to patients with celiac disease who suffer from symptoms and ongoing intestinal injury despite maintaining a gluten-free diet," said Chinwe Ukomadu, M.D., Ph.D., head, Gastroenterology Therapeutic Area Unit at Takeda. "With three novel programs now in the clinic, Takeda is at the forefront of developing transformative therapies for celiac disease and is advancing multiple therapies for patients living with this challenging lifelong autoimmune condition."

TAK-227 (ZED1227)1 is a selective, oral small molecule designed to inhibit tissue transglutaminase (TG2), an enzyme that generates immunogenic gluten peptide fragments upon the breakdown of gluten in the stomach and intestinal tissue. TAK-227 targets the dysregulated transglutaminase to prevent mucosal damage in the small intestine by preventing the body’s immune response to gluten, a disease process mediated by activation of gluten-specific T cells. A Phase 2a proof-of-concept study published in the New England Journal of Medicine previously demonstrated a protective effect of TAK-227 on the duodenal mucosa and symptoms during a six-week gluten challenge.2 The compound was also found to be safe and well tolerated.

"Patients with celiac disease urgently need appropriate therapeutic options to manage the significant negative impacts of the disease on health and daily quality of life," said Roland Greinwald, Ph.D., Managing Director Medicine & Pharmaceutics at Dr. Falk Pharma.

Martin Hils, Ph.D., CEO at Zedira, added "Takeda’s R&D expertise in gastroenterology, commercial footprint, and its strong commitment to develop therapies to treat celiac disease, make it an ideal partner to help us bring TAK-227 to patients."

Under the terms of the agreement, Takeda and Dr. Falk Pharma will conduct global clinical studies for TAK-227 in celiac disease. Takeda will receive an exclusive license to develop and commercialize TAK-227 in the United States and other territories outside of Europe, Canada, Australia and China. Zedira and Dr. Falk Pharma will receive an upfront payment and are eligible to receive potential development, regulatory and commercial milestones, as well as royalties on net sales. Originally discovered by Zedira, Dr. Falk Pharma licensed the European rights to ZED1227 from Zedira in 2011 and assumed responsibility for preclinical and clinical development of the program.

Takeda is advancing a portfolio of investigational therapies for the potential treatment of celiac disease. In addition to TAK-227, Takeda is developing two other investigational celiac disease therapies that recently entered Phase 2 clinical trials. TAK-062 is a potential best-in-class, highly potent glutenase – a protein that degrades ingested gluten – that was computationally engineered to treat celiac disease. TAK-101 is a potential first-in-class, immune-modifying nanoparticle containing gliadin proteins designed to promote immune tolerance to gluten in celiac disease by preventing gliadin-specific T-cell activation.

About Celiac Disease
Celiac disease is a systemic, immune-mediated disorder characterized by chronic enteropathic inflammation, and precipitated by exposure to dietary gluten in genetically predisposed individuals.3 Global prevalence of celiac disease is ~1%, with highest rates in women, in relatives of individuals with celiac disease, and in those with other immune-mediated disorders; prevalence of celiac disease is increasing worldwide, yet many cases remain undetected or not formally diagnosed.4,5,6 The amount of daily tolerable gluten varies widely among individuals with celiac disease. Although some can tolerate >50 mg/day, others develop mucosal abnormalities with gluten consumption of 10 mg/day, and mucosal damage has been associated with chronic exposures of as little as 1 mg/day.7,8,9 Celiac disease can cause symptoms, including abdominal pain, diarrhea, nausea, and vomiting. Long-term complications of celiac disease may include malnutrition, accelerated osteoporosis, nervous system problems and problems related to reproduction. There is no approved therapy for celiac disease. The only available management option for patients is maintaining a gluten-free diet, which involves strict, lifelong avoidance of exposure to gluten proteins from wheat, barley, and rye, which is not always effective.10

On October 20, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus on lung disease, reported that it will release financial results for the third quarter ended September 30, 2022 before the open of trading on Thursday, November 3 (Press release, Biodesix, OCT 20, 2022, View Source [SID1234622236]). Biodesix’s management will host a conference call and webcast to discuss its financial results and provide a general business update at 8:00 a.m. Eastern Time on the same day.

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Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

On October 20, 2022 Pacira BioSciences, Inc. (NASDAQ:PCRX) reported that it will report its third quarter financial results before the open of the U.S. markets on Thursday, November 3, 2022 (Press release, Pacira Pharmaceuticals, OCT 20, 2022, View Source [SID1234622235]). Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

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For listeners who wish to participate in the question and answer session via telephone, please pre-register here. All registrants will receive dial-in information and a PIN allowing them to access the live call. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com. For those unable to participate in the live call, a replay of the webcast will be available on the Pacira website for approximately two weeks following the call.