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.

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

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.

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."

On October 13, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data from a randomized controlled trial (RCT) showing that use of TissueCypher Barrett’s Esophagus Test results can significantly improve a physician’s accuracy in assessing the risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) in patients diagnosed with Barrett’s esophagus (BE), as well as adherence to guideline-recommended patient management strategies (Press release, Castle Biosciences, OCT 13, 2022, View Source [SID1234622003]).

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EAC is an aggressive form of esophageal cancer associated with poor outcomes, and the only known precursor condition to its development is BE. TissueCypher is Castle’s precision medicine test designed to predict progression to HGD and/or EAC within five years for patients diagnosed with BE.

"The study data showed that participants who ordered or received TissueCypher test results were up to 65.6% more likely to predict progression to HGD or EAC, (p<0.001), when compared to physicians who did not receive TissueCypher test results in our randomized trial," noted John W. Peabody, M.D., Ph.D., first study author and President of QURE Healthcare. "Importantly, subsequent to receiving test results and making their assessment, the intervention group was also more likely to adhere to guideline-recommended management strategies."

These and other results of the RCT were presented through a moderated poster presentation, titled "Results from a randomized controlled trial: introducing a precision medicine diagnostic tool increases adherence to guidelines in patients with Barrett’s esophagus," shared during the 30th United European Gastroenterology (UEG) Week. The poster may be viewed here.

In the RCT, 259 physicians were randomized to three groups and asked to evaluate clinical performance and value (CPV) vignettes with high- and low-risk patient scenarios based on clinical risk factors. A quality-of-care percentage (0-100%) score was generated from the CPVs based on the American College of Gastroenterology (ACG) and the American Society of Gastrointestinal Endoscopy (ASGE) guidelines. Quality-of-care scores improved significantly across all patient cases after physicians were given the TissueCypher test results.

"Barrett’s esophagus remains a persistent and real-world clinical challenge for endoscopists and patients. Individuals with non-dysplastic Barrett’s esophagus constitute the vast majority of cases, and for years, we have seen few updates in the management strategy of this patient population in particular," said Craig Munroe, M.D., gastroenterology medical director at Castle Biosciences. "We were very excited to present the results of the QURE study, which help further demonstrate TissueCypher’s potential to meaningfully advance the care of this important patient population. We believe the clinical utility and objective information provided by our test can equip physicians with the information they need to make more informed treatment plan decisions and move beyond the limitations in the current standard of care for risk stratification of patients with BE."

About TissueCypher Barrett’s Esophagus Test

The TissueCypher Barrett’s Esophagus test is Castle’s precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). TissueCypher is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (ND), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by nine peer-reviewed publications of BE progressor patients with leading clinical centers around the world. The TissueCypher Barrett’s Esophagus Assay is a proprietary Laboratory Developed Test with its own unique CPT PLA code (0108U) and has been on the Medicare Clinical Laboratory Fee Schedule since January 2021. Additionally, the test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022.