Iterative Scopes Partners with One GI® to Advance Gastrointestinal Care Through Artificial Intelligence

On October 13, 2022 Iterative Scopes, a pioneer in precision-medicine technologies for gastroenterology, reported that it has partnered with One GI, a gastroenterology management services organization (MSO), to bring its AI Recruitment (AIR) technology to One GI’s clinical research (Press release, Iterative Scopes, OCT 13, 2022, View Source [SID1234622008]). Initially, One GI will use AIR at Gastro One, one of One GI’s clinical research sites in Memphis, Tennessee, with plans to expand to additional research sites within the One GI network. The implementation of AIR will aid in the recruitment of patients for clinical trials focused on inflammatory bowel disease (IBD).

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Both One GI and Iterative Scopes are fast-growing innovators in the gastroenterology space. One GI is a unique, rapidly expanding MSO that brings together community-based practices, including Gastro One, a network of six practices across Tennessee. The MSO currently has 40 sites within its network across Tennessee, Mississippi, Kentucky, Ohio, and Indiana. Iterative Scopes is a pioneer in the application of powerful, proprietary artificial intelligence tools to the practice of gastroenterology and drug development.

The partnership between the two organizations will allow One GI physicians to leverage the AI-based technology from Iterative Scopes to standardize the endoscopic scoring process for patients and identify likely eligible patients to enroll in IBD clinical trials. By initiating the collaboration at Gastro One, the organizations are taking initial steps to develop a hub and spoke recruitment model for One GI, which will democratize access to the novel IBD therapeutics for all patients, regardless of where they receive care.

"Our partnership with Iterative Scopes enables the delivery of innovative technology to community-based gastroenterology practices, demonstrating One GI’s commitment to physician-centered, patient-focused healthcare," said Robbie Allen, CEO of One GI. "Our ultimate mission is to power practices – regardless of their location – to deliver world class GI care, and implementing AIR will allow a broader array of patients to access potentially life-changing clinical trials."

"In addition to helping us offer the most advanced patient care, this partnership fuels the continuous growth of our research department so that we remain at the forefront of GI care, improving outcomes and patients’ lives," said Richard Aycock, MD, Gastro One senior physician. "Dr. Ziad Younes, a global leader in gastroenterology, is pioneering the program within our practices, and we’re enthusiastic about the potential to help advance the GI field even further."

AIR works to simplify the process of matching patients to clinical trials by helping gastroenterologists better understand disease severity more quickly and consistently. The technology uses computational algorithms integrated with existing colonoscopy imagery and videos to determine clinical trial eligibility, speeding up the clinical trial timelines and allowing more patients to access potentially life-changing treatments. The company’s technology automates scoring of a patient’s minimum threshold score of disease severity, as measured by the Mayo Endoscopic Score (MES), as an aid in determining their qualification for pre-screening for IBD clinical trials. Iterative Scopes has already partnered with multiple clinical research sites for IBD and is continuing to expand its reach with notable partners like One GI.

"Iterative Scopes’ mission is to democratize access to high quality care for patients struggling with IBD and other GI conditions, ultimately reducing healthcare disparities in clinical practice," said Sahir Raoof, VP of Business Development at Iterative Scopes. "We are thrilled to be partnering with Dr. Younes and One GI to drive clinical adoption of artificial intelligence to help us advance clinical trial recruitment in an effort to help bring novel therapeutics to IBD patients faster."

GRAIL and Carrum Health Partner to Include Galleri® as Part of Comprehensive Cancer Care Offering to Employers

On October 13, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, and Carrum Health, the first digital health company connecting employers and employees to Centers of Excellence (COEs) through a technology-powered, value-based care platform, reported a first-of-its-kind partnership to include the Galleri multi-cancer early detection (MCED) test as part of Carrum Health’s oncology offering to self-insured employers (Press release, Grail, OCT 13, 2022, View Source [SID1234622007]). This product integration will enable employers who offer Carrum Health benefits to provide eligible employees the Galleri test as part of the comprehensive cancer care Carrum delivers.

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"In developing Carrum’s comprehensive oncology offering we’ve carefully selected partners who share in our mission to tackle both the rising costs of cancer care and solutions that vastly improve the patient experience," said Sach Jain, CEO and founder of Carrum Health. "GRAIL’s early cancer detection test is a critical component in a comprehensive oncology offering and we’re thrilled to extend this benefit to Carrum members."

In a clinical study, the Galleri test demonstrated the ability to detect a shared signal across more than 50 types of cancers, over 45 of which lack recommended screening tests today. Using advanced genomics and machine learning, the test also predicts the origin of the cancer signal, which enables targeted diagnostic evaluation. Recently announced results from the PATHFINDER clinical trial showed adding the Galleri MCED test to standard of care screening more than doubled the number of cancers detected, and the test predicted where a cancer signal originated with 97% accuracy.

"An MCED test like Galleri complements existing screenings and represents a new approach with the potential to find cancer at earlier stages and to improve healthcare outcomes and efficiencies," said Bob Ragusa, chief executive officer at GRAIL. "We are proud to partner with Carrum Health, who shares our commitment to transforming cancer care and reducing rising healthcare costs."

Members who receive a signal detected from the Galleri test can work with a Carrum Health COE for diagnostic evaluation and guideline-concordant treatment planning. As part of Carrum Health’s comprehensive offering, members are paired with a personal patient care specialist who handles all administrative aspects of the program and guides the member throughout the entire journey. Once treatment starts with a selected provider, patients and their care team can leverage the COEs’ expertise for input and guidance as needed and will have access to an oncology-certified nurse and remote support services.

Nutcracker Therapeutics to Present Data for Lead Candidate at 2022 SITC Annual Meeting

On October 13, 2022 Nutcracker Therapeutics, Inc., a biotechnology company dedicated to developing transformative RNA therapies through its proprietary technology platform, reported the upcoming poster presentation of new preclinical data for its lead therapeutic candidate, NTX-0250, which targets human papillomavirus (HPV)-driven cancers (Press release, Nutcracker Therapeutics, OCT 13, 2022, View Source [SID1234622006]). The company will present this data at the 37th annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held in Boston, MA, from November 8-12, 2022.

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The poster presentation will showcase data that demonstrates that NTX-0250, a multimodal, mRNA-based therapeutic, is capable of inducing the complete regression of large murine tumors. The details about the presentation and session information are as follows:

Title: NTX-0250, a multimodal mRNA-based immunotherapy, eradicates large established tumors in a stringent mouse model of HPV16-driven cancer.
Abstract Number: 1084
Presentation Session: Immune-stimulants and immune modulators
Presentation Date and Time: Friday, Nov. 11, 2022, 11:55–1:25 p.m. and Poster Reception (7–8:30 p.m.)
Lead Author: Ole A.W. Haabeth

Poster presentations will be accessible in person and virtually. All accepted abstracts will be available in a Journal for ImmunoTherapy of Cancer (JITC) supplement, which will be published on Nov. 7 at 8 a.m. EST. For more information about the 37th SITC (Free SITC Whitepaper) annual meeting, please visit View Source

Gilead Sciences to Release Third Quarter 2022 Financial Results on Thursday, October 27, 2022

On October 13, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its third quarter 2022 financial results will be released on Thursday, October 27 after the market closes (Press release, Gilead Sciences, OCT 13, 2022, View Source [SID1234622005]). At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s third quarter 2022 financial results and will provide a business update.

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A live webcast will be available on the Investor Relations section of www.gilead.com and will be archived there for one year.

Prestige Biopharma Submitted Pre-BLA Type 4 Meeting Request to FDA for Herceptin Biosimilar

On October 13, 2022 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, reported that it has submitted a request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting to discuss the company’s planned Biologics License Application (BLA) for its Herceptin Biosimilar, HD201(Tuznue) (Press release, Prestige BioPharma, OCT 13, 2022, View Source [SID1234622004]).

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The Biosimilar Biological Product Development (BPD) Type 4 Meeting is to discuss the format and content of a BLA in advance of the final submission. The company will discuss the overall development program of HD201 with the FDA to identify potential filing and review issues. The meeting is expected to take place around November, and the BLA submission by the end of the year.

Prestige Biopharma’s HD201 is a proposed biosimilar to Roche’s Herceptin (trastuzumab) to be prescribed for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer. Trastuzumab targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.

Currently, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a Marketing Authorisation Application (MAA) by the Korea Ministry of Food and Drug Safety. In addition to filing a new MAA to the European Medicines Agency (EMA), the company also plans to apply for authorisation in other advanced biosimilars markets such as UK, Australia, and Singapore.

Lisa Park, CEO of Prestige Biopharma, commented: "This Type 4 Meeting will be the final gate of BLA submission for HD201. In addition to the Bridging Study on biosimilarity of HD201 to US-Herceptin and the Biosimilar Initial Advisory Meeting with FDA in 2019, we have been through a series of meetings with the FDA on each step of the development to prepare the launch of HD201 in US to help more patients in need. We will take this final step to thoroughly review and finalise the application for FDA’s approval."