On May 24, 2022 Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, reported that the company’s automated polyp detection algorithm for colorectal cancer (CRC) screening, SKOUT, demonstrated statistical superiority of overall adenoma detection in a randomized, controlled prospective clinical trial, compared to routine colonoscopy (Press release, Iterative Scopes, MAY 24, 2022, View Source [SID1234615003]). The 27% relative improvement in adenomas per colonoscopy (APC) detection in a relatively average-risk patient population reflects one additional adenoma detected among every 4.5 patients screened and occurred without decreasing safety or workflow efficiency, important considerations for gastroenterologists performing the procedures. The results from the registration trial were also accepted for publication in Gastroenterology.

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SKOUT is a computer-aided device (CADe) that uses artificial intelligence and advanced computer vision technology to recognize suspicious tissue and provide real-time feedback to gastroenterologists. The goal is to detect suspicious lesions early, which has been shown to decrease incidence of CRC.1 CRC is the second leading cause of cancer deaths in the United States and Europe.2,3

Aasma Shaukat, MD, MPH, the Robert M. and Mary H. Glickman Professor of Medicine and Gastroenterology at NYU Grossman School of Medicine, presented the findings in an oral presentation entitled "Increased Adenoma Detection with the use of a novel computer aided detection device, SKOUT: Results of a multicenter randomized clinical trial in the US" during a "Late-Breaking Clinical Science Abstract Plenary" session (No. 5095) on Tuesday, May 24 at 8:15 AM PDT. Her comments were the first public disclosure of data from the clinical trial, which Iterative Scopes submitted to the FDA in a 510(k) filing for review in November 2021. The 510(k) clearance for SKOUT is pending, it is not currently for sale in the United States.

"The results from this study indicate that CADe polyp-detection devices can enhance the quality of colonoscopy and are an important addition in the endoscopy suite," said Dr. Shaukat. "Improving detection of adenomas per colonoscopy without increasing the rate of removal of healthy tissue has the potential of making our colonoscopy practice even more effective in the prevention of colorectal neoplasia."

Colonoscopies are routinely performed to screen for CRC with the goal of detecting precancerous lesions, known as adenomas.1 Studies show that colonoscopies are highly operator dependent, and endoscopists miss up to 26% of adenomas.4

In the SKOUT registration study, 1359 randomized subjects were included in the primary analysis in two separate cohorts. One cohort underwent a colonoscopy procedure with the implementation of the SKOUT AI software, and the other group underwent a colonoscopy procedure without implementation of the SKOUT AI software. Twenty-two board-certified, experienced gastroenterologists from five academic medical and community centers in the United States participated in the trial.

Both primary study endpoints were met. Adenomas per colonoscopy increased significantly with the use of SKOUT compared to the control, and true histology rate (THR) did not significantly change between cohorts. APC is a quality metric of colonoscopy procedure efficacy and is defined as the number of detected adenomas in a procedure divided by the total number of screening colonoscopies.4 A recently published analysis of state cancer registries found that incidence of post-colonoscopy CRC within three years of baseline examination decreased among endoscopists with higher APC rates.5

THR is a measure of resection of non-neoplastic lesions. A decrease in THR may indicate a rise in the resection of histologically unimportant (healthy) tissue. In this study THR did not change significantly with the use of SKOUT compared to the control. These results were consistent in both the screening and surveillance populations.

The study resulted in additional findings demonstrating improved detection of clinically important lesions. The study met secondary endpoints showing that the use of SKOUT did not affect procedure withdrawal time nor total procedure time. This indicates that this technology may be able to be integrated smoothly into routine clinical practice. Full study results have been accepted by Gastroenterology and will be released in the near term.

Kahi CJ, Imperiale TF, Juliar BE, et al. Effect of screening colonoscopy on colorectal cancer incidence and mortality. Clin Gastroenterol Hepatol 2009;7:770-775.
Dyba T, Randi G, Bray F, et al. The European cancer burden in 2020: Incidence and mortality estimates for 40 countries and 25 major cancers. European Journal of Cancer 2021; 157: 308-347.
Rebeca S, Kimberly M, Ann Godin S, Colorectal Cancer Statistic, 2020. CA Cancer J Clin 2020; 70:145-164.
Zhao S, Wang S, Pan P, et al. Magnitude, risk factors, and factors associated with adenoma miss rate of tandem colonoscopy: a systematic review and meta-analysis. Gastroenterology 2019;156:1661-1674.e11.
Anderson J, Hisey W, Robinson C, et al. Mean adenomas per colonoscopy is inversely associated with post colonoscopy colorectal cancers: data from the New Hampshire Colonoscopy Registry validating this quality measure. Paper presented at: American College of Gastroenterology 2021 Annual Scientific Meeting; October 22-27, 2021; Las Vegas, Nevada.

On May 24, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem Therapies dedicated to improving survival outcomes for patients with cancer reported that it will host its first R&D Day for analysts and investors to be held virtually on Tuesday, June 7th, 2022 from 4:00 pm CEST (10:00 am EST) to 6:00 pm CEST (12:00 pm EST) (Press release, MaaT Pharma, MAY 24, 2022, View Source [SID1234615002]).

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MaaT Pharma’s speakers will discuss the microbiome’s potential in cancer therapy and the latest clinical results of MaaT013 and MaaT033. They will also present the Company’s innovative proprietary drug discovery platform, the next generation of products MaaT03X and the construction of Europe’s largest cGMP manufacturing facility for Microbiome Ecosystem Therapies.

In addition to the presentations by MaaT Pharma’s senior team, the R&D Day will feature talks from world renowned scientists and physicians including:

Dr. Joël Doré – Research Director, INRAE; Scientific Director, MetaGenoPolis and Scientific Advisor to MaaT Pharma, France
Prof. Ernst Holler, M.D. – Senior Professor on Clinical and Experimental Allo-HSCT, Department of Internal Medicine, University Hospital Center Regensburg, Germany
Prof. Florent Malard, M.D. – Professor of Hematology, Saint Antoine Hospital (AP-HP) and Sorbonne University
Prof. Mohamad Mohty, M.D. – Professor, Sorbonne University and Head of the Clinical Hematology and Cellular Therapy Department, Saint-Antoine Hospital (AP-HP), France
Prof. Hassane Zarour, M.D. – Professor of Medicine, Immunology and Dermatology, University of Pittsburg, James and Frances McGlothlin Chair in Melanoma Immunotherapy Research
"MaaT Pharma’s inaugural R&D Day is an opportunity to bring together world-renowned scientists and our talented internal team to share MaaT Pharma’s innovative research and highlight our unique positioning in the microbiome space," said Hervé Affagard, Chief Executive Officer and Co-Founder of MaaT Pharma. "Since our successful IPO in November 2021, we have delivered on the key milestones we had defined and we continue to progress, with the ambition to leverage the microbiome for the benefit of millions of patients fighting cancer."

A question-and-answer session will follow the presentations. Please note that all the presentations are in English with French subtitles. The webcast will be made available on the Company’s website after the event.

On May 24, 2022 Ikonisys SA (Code ISIN: FR00140048X2 / Mnémonique: ALIKO), a company specializing in the early and accurate detection of cancer with a unique fully-automated solution for medical diagnostic labs and the Department of Electronics, Information and Bioengineering (DEIB) of Politecnico di Milano (POLIMI), a world-class scientific institution engaged in cutting-edge research, training and technology transfer, reported the signing of a research contract and the initiation of a project to bear on the challenging problem of identifying specific cells in complex tissues through designing, training and deployment of a deep learning model able to detect them.

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Prof. Giacomo Boracchi of the DEIB will lead the research bringing his expertise in image processing and machine learning. In particular, the approach will aim to recognize clinically relevant cells of specific types in darkfield images of lung tissue acquired from the Ikoniscope20. Segmentation of single cell nuclei is a frequent challenge of microscopy image processing, often being the first step of many quantitative data analysis pipelines.

The ongoing collaboration will allow Ikonisys to further enhance its advanced image analysis capabilities and to accelerate the development of the Ikoniscope AI project with the implementation of deep learning models and novel state-of-art techniques into the instrument’s workflow, leading to the development of new applications or enhancement of the existing ones, especially in the most challenging fields such as Circulating Tumor Cells.

On May 24, 2022 Shasqi, a clinical-stage biotechnology company developing click chemistry-activated oncology therapeutics, reported the additions of Steve Abella, M.D., as Chief Medical Officer and Scott Wieland, Ph.D., MBA, as Senior Vice President of Clinical Development (Press release, Shasqi, MAY 24, 2022, View Source [SID1234615000]).

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"To maximize the potential of our novel, click chemistry-based platform and continue expanding our portfolio of programs, clinical experience and leadership are critical," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "As we reach the end of dose escalation of SQ3370, we will initiate Phase 2 studies in advanced sarcomas and other solid tumors. In addition, we are rapidly advancing our second program toward the clinic, which activates high doses of monomethyl auristatin E, a commonly used antibody-drug conjugate payload, at the tumor. Now is the perfect time to add the deep expertise in clinical strategy and execution that both Steve and Scott bring to the team. We look forward to their contributions and working with them."

"Shasqi has made tremendous progress advancing SQ3370 into and through the clinic and building a robust pipeline of click chemistry-activated therapeutics to harness potent payloads and target them precisely to the tumor," said Dr. Abella. "I’m excited to join the company’s mission and help expand the reach of their platform."

"A click chemistry-based approach has enormous potential to dramatically improve the efficacy of powerful therapies that can be localized at the tumor site using a variety of delivery methods such as direct injection or biomarker targeting," said Dr. Wieland. "I look forward to seeing where we can take this technology and what the next iterations of Shasqi’s approach can achieve in improving the cancer therapeutic landscape and the lives of patients."

Dr. Steve Abella

Dr. Abella has been working in oncology clinical research for nearly 35 years, including more than 12 years in the pharmaceutical industry. Before joining Shasqi, he served as Chief Medical Officer at Vida Development Sciences. Prior to Vida, Steve served as Chief Medical Officer at BioClin Therapeutics. Prior to that, he served as Senior Director at Gilead Sciences where he led the non-Hodgkin’s lymphoma and leukemia drug development efforts and served as a core member of the oncology senior leadership team. Prior to Gilead, he served as Executive Director at Amgen, predominately responsible for the white cell franchise (Neulasta/Nepogen) and led global development efforts across clinical research and medical affairs. Before he joined the biopharmaceutical industry, he spent 15 years in academic oncology, serving as a Professor of Pediatric, Oncology, and Medicine at the Barbara Ann Karmanos Cancer Institute where he focused on stem cell transplantation and oncology clinical trials. Steve completed his fellowship and residency training at Wayne State University School of Medicine after graduating with a degree in medicine from the Universidad Central del Este. He attended the University of Pennsylvania for undergraduate studies.

Dr. Scott Wieland

Dr. Wieland is a biopharmaceutical veteran with over 30 years of experience in the biopharmaceutical industry. Over the course of his career, Scott has served in a variety of roles and responsibilities, most recently as Executive Vice President of Development at Nanobiotix, a nanomedicine company based in Paris, France. Scott started his career leading the Behavioral Pharmacology lab at CoCensys, then moved into a variety of positions across several small biopharmaceutical companies. Scott has been responsible for drug discovery, safety pharmacology, toxicology, bioanalytical development, manufacturing, formulation, clinical supply and distribution, regulatory affairs, and all aspects of clinical trials and development during his career. Scott received a bachelor’s degree in Physiological Psychology from UC Santa Barbara, CA. He received his master’s and Ph.D. in Psychology/Biopsychology with a minor in Neuropharmacology from the University of Arizona, Tucson, AZ, and an MBA in Management from Webster University, St. Louis, MO.

About CAPACTM and SQ3370

SQ3370 is the first click chemistry-based treatment to be tested in humans. It utilizes Shasqi’s proprietary CAPAC platform, an approach that activates cancer drugs at a tumor with decreased systemic toxicity. Shasqi is validating its platform with SQ3370, which is designed to activate a powerful chemotherapeutic, doxorubicin, at the tumor site. The investigational product is based on the chemical reaction between a drug protected through a trans-cyclooctene modification (a protodrug) and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Shasqi believes its click-chemistry approach can improve the efficacy and safety of many existing therapeutics across various modalities with a limited therapeutic window.

On May 24, 2022 Genexine (KOSDAQ: 095700), a publicly traded, clinical stage biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, reported that Neil Warma, CEO of Genexine will be presenting virtually at the H.C. Wainwright Global Investment Conference being held on May 23-26, 2022 (Press release, Genexine, MAY 24, 2022, View Source [SID1234614999]).

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The presentation will provide an overview of Genexine’s pipeline, business operations and corporate achievements, as well as discuss upcoming milestones with the Company’s lead assets, including GX-I7 (a first-in-class long-acting recombinant interleukin 7, in development for TNBC and GBM) and GX-188 (a first-in-class DNA vaccine, in development for cervical and head and neck cancers).

Details of the presentation are as follows:

Event: H.C. Wainwright Global Investment Conference
Date & Time: On-demand, beginning 7.00 a.m. ET, Tuesday May 24, 2022
Webcast Link: Genexine_Wainwright_investor_conf.

A replay of the presentation will be available for 90 days at the link above or by visiting www.genexine.com. Registered investors will be able to schedule a one-on-one meeting via the conference portal.