On January 24, 2023 Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, reported it submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its noninvasive, stool-based, at-home screening test to detect colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals (Press release, Geneoscopy, JAN 24, 2023, View Source [SID1234626515]). The FDA designated the test as a Breakthrough Device in January 2021.

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"Over 50 million Americans between the ages of 45 and 85 are eligible to be screened for CRC.1,2 Unfortunately, despite CRC being the second leading cause of cancer death in the U.S., millions of eligible Americans do not get screened – many due to a lack of knowledge of the importance of screening, lack of access to screening and concerns about the invasive nature of options like colonoscopy," said Dr. Erica Barnell, Chief Science Officer and Geneoscopy’s co-founder. "We are committed to closing this gap for patients who require screening and look forward to working with the FDA to bring a convenient and reliable screening option to patients that may allow for earlier detection and treatment – and potentially save lives."

The PMA submission is based on the favorable results from the pivotal CRC-PREVENT trial, in which Geneoscopy’s test demonstrated 94% sensitivity for CRC and 45% sensitivity for advanced adenomas, representing the highest sensitivity profile reported to date for any noninvasive CRC screening test in a prospective clinical study.

Additionally, in the 45-49 age population, Geneoscopy’s test demonstrated 100% sensitivity for cancer and 44% sensitivity for advanced adenomas, at an 89% specificity. CRC-PREVENT is the first prospective study of a stool-based test to report CRC sensitivity in patients ages 45-49, an age group most recently added to the recommended screening population by the United States Preventive Services Task Force and the American Cancer Society. The robust sensitivity profile for CRC and advanced adenomas will offer significant value to this patient population.

"The completion of our PMA submission is a major milestone – Geneoscopy’s first regulatory approval application," said Andrew Barnell, Chief Executive Officer and Geneoscopy’s co-founder. "This product and the years of effort from our team that have brought us here exemplify the dedication to our mission to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The impact this test can have on patient health is beyond exciting, as is the validation of our stool RNA platform. We believe this platform will yield additional tests, including increasingly more precise CRC screening and high-value diagnostic testing for other gastrointestinal indications."

About CRC-PREVENT

CRC-PREVENT was a Phase 3 prospective, single-arm study designed to evaluate the efficacy of Geneoscopy’s noninvasive, stool-based, at-home screening test to detect colorectal cancer and advanced adenomas in average-risk individuals. Using a collection kit, participants submitted self-collected stool samples via express delivery and underwent an optical colonoscopy examination. All significant lesions discovered during the colonoscopy were biopsied or removed and sent for histopathology. A comparative analysis was conducted to determine sensitivities and specificities for colorectal cancer, advanced adenomas, non-advanced adenomas, hyperplastic polyps, and colonoscopies with no findings.

About Colorectal Cancer & Screening

Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer death in the United States. CRC usually begins as a growth (or polyp) that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, many newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold standard for CRC screening in the U.S. Yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and potential time away from work. Currently available noninvasive screening methods demonstrate lower sensitivity to detect early-stage CRC and high-risk precancerous lesions, including advanced adenomas, which are estimated to be a precursor in 95 percent of CRC cases.3

On January 24, 2023 Geneseeq Technology Inc. reported that Geneseeq’s multi-cancer minimal residual disease detection (MRD) and multi-cancer early detection (MCED) kits were both CE Marked for liquid biopsy use in solid tumor patients (Press release, Geneseeq, JAN 24, 2023, View Source [SID1234626514]).

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The markings will enable Geneseeq to expand its global business operations and establish new partnerships in the European market.

The MRD detection kit (Shielding) employs ultra-deep sequencing technology ATG-SEQ to detect low amounts of circulating tumor DNA (ctDNA) in the peripheral blood post-surgical intervention.

For early cancer detection, the in vitro diagnostic kit uses highly sensitive next-generation sequencing-based technology MERCURY to assess multi-omics features of circulating free DNA (cfDNA) and detect tumorigenesis in health population.

In 2022, the council of the European Union has decided to improve cancer screening and strengthening cancer prevention through early detection1.

"Obtaining the CE marks for both our MRD and MCED kits is an important milestone for Geneseeq to bring personalized liquid biopsy tests to patients worldwide," said Dr. Xue Wu, Geneseeq Technology CEO.

On January 24, 2023 Biomica Ltd., a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported its CEO and VP R&D will both be participating in 7th Annual Microbiome Movement Drug Development Europe, taking place in London, UK, between January 31 and February 2, 2023 (Press release, Biomica, JAN 24, 2023, View Source [SID1234626513]).

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The 7th Microbiome Movement – Drug Development Summit Europe aims to unite Europe’s leading drug developers and microbiome experts to share their latest discoveries on microbiome functionality, translation, clinical development, biomarker discovery and manufacturing scale-up. In attendance from Biomica will be CEO Dr. Elran Haber and VP R&D Dr. Shiri Meshner.

Dr. Haber will take part in two industry panel discussions. These are entitled, "How to Turn Outstanding Microbiome Science into Effective & Efficient Products", taking place on February 1, 2023, at 9:30am GMT and "Working with Microbiome Investors", scheduled to take place later that day at 4:30pm GMT.

Dr. Meshner will be presenting on February 1, 2023, at 2:55pm, and the presentation is entitled, "Rationally Designed LBPs – From Computational & Pre-clinical Data to Clinical Studies."

Dr. Haber and Dr. Meshner will both be available for one-on-one meetings at the conference, and those interested should be in touch with the investor or public relations team.

On January 24, 2023 ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer, reported clearance of its first Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for IMPT-314, a bispecific "OR-Gate" autologous CAR T-cell therapy targeting the B-cell antigens CD19 and CD20 (Press release, ImmPACT-Bio, JAN 24, 2023, View Source [SID1234626512]). IMPT-314 will be studied in a Phase 1/2 clinical trial in patients with aggressive B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL).

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"This IND clearance is a significant milestone for our company," said Sumant Ramachandra, M.D., Ph.D., president and chief executive officer of ImmPACT Bio. "Results from an investigator-led study evaluating this CAR T-cell therapy demonstrated that 70 percent of patients achieved a complete response with significant durability of remission. These initial efficacy results combined with the favorable safety profile show that IMPT-314 could potentially be a best-in-class treatment for patients with B-cell lymphomas. We look forward to initiating this Phase 1/2 trial to help cancer patients who need new therapies."

ImmPACT Bio plans to initiate the Phase 1/2 clinical trial of IMPT-314 in the first quarter of 2023. In January 2022, the Company raised $111 million in a Series B financing round to build a talented team of cell therapy, oncology, and immunology specialists, as well as its clinical manufacturing and quality control laboratory facility in Los Angeles.

Based on the pioneering work of Yvonne Chen, Ph.D., associate professor at the University of California, Los Angeles (UCLA), this CD19/CD20-directed bispecific CAR has demonstrated clinically meaningful and differentiated results in an ongoing investigator-led study at UCLA. Principal investigator Sarah Larson, M.D., studied patients with non-Hodgkin lymphoma (NHL), including various subtypes of aggressive B-cell lymphoma, DLBCL, non-indolent or refractory follicular lymphoma (FL), and mantle cell lymphoma (MCL). Data from the study demonstrated 90 percent of patients (9/10) had an objective response with 70 percent (7/10) of patients achieving a durable complete response (CR). Of note, no patients had neurotoxicity, also known as immune effector cell-associated neurotoxicity syndrome (ICANS). Patients had Grade 1 or no cytokine release syndrome (CRS). Median follow-up was more than 20 months and median progression-free survival (PFS) is 18.2 months. These results from the first 10 evaluable patients were recently published in Cancer Discovery. The UCLA study continues to enroll additional patients.

"Dr. Chen designed this bispecific CAR to address antigen escape, which is a key challenge for current approved CD19 therapies for hematological malignancies," said Dr. Larson. "We tested this anti-CD19/CD20 CAR-T cell therapy in patients with relapsed or refractory NHL and are encouraged about the potential of this therapy for patients."

In addition to IMPT-314, ImmPACT Bio is investigating two other platform logic-gated CAR technologies targeting solid tumors with preclinical candidates.

About Non-Hodgkin Lymphoma

Non-Hodgkin lymphoma (also known as non-Hodgkin’s lymphoma or NHL) is a type of cancer that forms in the lymphatic system, which is part of the immune system that helps protect the body from infection and disease. In NHL, white blood cells called lymphocytes grow abnormally and can form growths (tumors) throughout the body. There are many subtypes of NHL. Diffuse large B-cell lymphoma and follicular lymphoma are among the most common subtypes. Symptoms include swollen lymph nodes, fever, belly pain, or chest pain. Treatments may include chemotherapy, radiation therapy, stem-cell transplant, or medications.

On January 24, 2023 Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, reported an agreement with AstraZeneca and Daiichi Sankyo, for the development, clinical validation and early adoption of an AI-powered product to aid pathologists with an accurate and reproducible assessment of HER2 immunohistochemistry (IHC) scoring in breast cancer patients (Press release, Ibex Medical Analytics, JAN 24, 2023, https://www.prnewswire.com/news-releases/ibex-medical-analytics-enters-collaboration-with-astrazeneca-and-daiichi-sankyo-to-develop-ai-based-her2-scoring-product-301729092.html [SID1234626511]).

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Scoring of HER2 (human epidermal growth factor receptor 2) protein expression in breast cancer is used to identify patients who are likely to benefit from HER2-directed therapies. Currently, pathologists routinely score HER2 in tumor samples visually using a microscope, which can be challenging in cases of low HER2 expression as scoring is subjective and may lead to varied interpretations. Computational tools developed using Artificial Intelligence have the potential to support pathologists in accurate and objective scoring of HER2, which can help oncologists in selecting therapies that are approved for treating patients with HER2-positive or HER2-low breast cancer.

"Recognizing the vital role pathologists play in the diagnosis and treatment of cancer patients, we are thrilled to partner with AstraZeneca and Daiichi Sankyo to clinically validate our automated HER2 scoring product and offer it to laboratories around the world," said Joseph Mossel, Co-founder and CEO of Ibex Medical Analytics. "As the most commonly diagnosed cancer in women, this collaboration will allow pathologists to utilize our technology to optimize breast cancer diagnosis and ultimately improve the identification of patients eligible for HER2-directed therapy."

Ibex’s Galen Breast HER2 is an IHC scoring product that detects tumor areas and quantifies HER2 expression into four standard categories, 0, 1+, 2+ and 3+, based on the 2018 ASCO (Free ASCO Whitepaper)/CAP scoring guidelines1. As part of this collaboration, Ibex will work with AstraZeneca and Daiichi Sankyo to develop and clinically validate its HER2 IHC scoring product and generate evidence that further supports adoption of the technology.

A multi-site validation study on Galen Breast HER2 involved a cohort of 453 breast tumors of diverse subtypes. The study demonstrated that Galen’s AI algorithm provides an accurate and automated HER2 score for pathologists and was recently presented at the San Antonio Breast Cancer Symposium2.

Beyond this collaboration, Ibex supports pathologists with AI-based diagnostic solutions that help detect and grade different types of invasive and non-invasive breast cancer and other tumor types, and are used in everyday practice in laboratories, hospitals and health systems worldwide. Ibex’s Galen Breast solution demonstrated robust outcomes in detecting and grading multiple types of breast cancer and other clinically relevant features across clinical studies performed on numerous diagnostic workflows, one of which was recently published in Nature’s peer-reviewed npj Breast Cancer journal3,4.

In addition to HER2, Ibex is further expanding Galen Breast to include automated quantification of additional IHC-stained slides, such as ER, PR and Ki-67, intended to provide pathologists with a comprehensive set of tools for breast cancer diagnosis. With these expanded capabilities, Galen Breast may further enhance diagnostic efficiency and enable more accurate and objective scoring of breast biomarkers, improving treatment decisions and patient care.