Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT™

On September 22, 2022 Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, reported that SKOUT has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for adults undergoing colorectal cancer screening or surveillance (Press release, Iterative Scopes, SEP 22, 2022, View Source [SID1234621368]). SKOUT, a real-time computer-aided polyp detection device developed by Iterative Scopes, uses advanced computer vision technology designed to recognize suspicious tissue and provide real-time feedback to gastroenterologists. The device was evaluated in the largest U.S.-based multicenter clinical study for a computer aided polyp detection (CADe) device completed to date, which determined that SKOUT significantly improved overall adenoma detection in screening and surveillance colonoscopy compared to standard colonoscopy.1

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In March 2021, Provation and Iterative Scopes entered a partnership focused on delivering artificial intelligence-based solutions to healthcare providers and researchers. Provation is a market leader in gastrointestinal (GI) documentation, with more than 3,500 customer facilities including 80% of the top academic and large health systems, and the company will act as an exclusive distributor of SKOUT to help broaden the technology’s reach among the country’s top GI-focused organizations.

Colorectal cancer is the second leading cause of cancer-related deaths in the United States and Europe,2 3 due in part to the high volumes of adenomas – approximately 26%4 – that endoscopists miss when conducting a colonoscopy. In its registration trial, SKOUT was found to improve adenoma detection, as measured by adenomas per colonoscopy (APC). Furthermore, increased detection was not limited to diminutive polyps. Higher APC rates have been shown to lead to improved patient outcomes; a recent study showed that the incidence of colorectal cancer within three years of examination decreases with higher APC rates.5

"Even among the best endoscopists, there is room for improvement in adenoma detection, which can impact patient outcomes," said Sloane Allebes Phillips, VP of Clinical Operations at Iterative Scopes. "We are enthusiastic about the fact that even gastroenterologists with an already high baseline rate of adenoma detection demonstrated an improvement with SKOUT. Now that SKOUT is FDA-cleared, clinicians will be able to better detect adenomas with more efficiency, and ultimately change the standard of gastrointestinal care."

SKOUT is indicated as a computer-aided detection tool to assist qualified and trained endoscopists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. SKOUT demonstrated a 27% relative increase in the detection of adenomas per colonoscopy, with an average of one additional adenoma resected for every 4.5 patients examined. Importantly, in the proximal colon, SKOUT demonstrated a 44% relative increase in 5-9 mm polyp detection, and a 29% relative increase in 5-9 mm polyp detection overall.1 These results validate the need for technological advancements that can help improve colonoscopies, and SKOUT’s artificial intelligence capabilities position it to do so.

"Knowing that patients can walk away from their appointment with the confidence that they received a high quality and detailed colonoscopy is what excites us most about SKOUT’s FDA clearance," said Aasma Shaukat, MD, MPH, Robert M. and Mary H. Glickman Professor of Medicine and Gastroenterology at NYU Grossman School of Medicine, and a primary investigator on the SKOUT registration study. "Confidence and peace-of-mind on behalf of providers and patients alike will allow clinicians to provide stronger recommendations and solutions for their patients."

"We are thrilled that our partner Iterative Scopes has received FDA clearance for their AI-Assisted Polyp Detection device, SKOUT. We have been very impressed with its study results and are eager to share our vision for integrating this technology into our solutions," said Daniel Hamburger, CEO at Provation. "SKOUT is a true game-changer for the field of gastroenterology, and we can’t wait to start seeing its impact on patient care."

SKOUT’s intuitive user interface seamlessly integrates with existing clinical workflows and does not increase total procedure or withdrawal time.1 When a potential polyp is detected, the system calls attention to the polyp on the procedure monitor by drawing a blue bounding box around it and tracking the polyp as it moves on the screen. If a medical tool enters the frame, the bounding box automatically disappears to avoid obstructing the physician’s view during polyp removal.

Nanobiotix to Announce Half Year 2022 Financial Results on September 28, 2022

On September 22, 2022 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that it will report its financial results for half-year ending June 30, 2022, on Wednesday, September 28, 2022, after the close of the US market (Press release, Nanobiotix, SEP 22, 2022, View Source [SID1234621367]).

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The announcement will be followed by a conference call and live audio webcast on Thursday, September 29, 2022, at 8:00 AM ET / 2:00 PM CET. During the call, Laurent Levy, chief executive officer, and Bart Van Rhijn, chief financial officer, will briefly review the Company’s half-year results and provide an update on business activities before taking questions from participants.

A live webcast of the call may be accessed by visiting the investors section of the company’s website at www.nanobiotix.com. Participants may register for the call here. They will be able to join the call via dial-in or one-click dial-out. It is recommended to join 10 minutes prior the event start.
Participants are invited to email their questions in advance to [email protected].

A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.

TAE Life Sciences Sponsored Study Details Results of Proton Boron Fusion Therapy Biological Effectiveness

On September 22, 2022 TAE Life Sciences (TLS), a biological-targeted radiation therapy company developing next-generation boron neutron capture therapy (BNCT), reported the publication of a study in the September 22 issue of the Journal of Medical Physics that assessed whether alpha particles generated through the combination of boron target drugs and proton radiation would generate a reaction that would be sufficient to enhance the biological effectiveness of proton therapy in the treatment of prostate cancer (Press release, TAE Life Sciences, SEP 22, 2022, View Source [SID1234621366]).

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Proton Boron Capture Therapy (PBCT) is a novel approach of particle therapy aimed at enhancing proton biological effectiveness by exploiting the fusion reaction between low-energy protons and a boron drug to destroy cancer cells via radiation delivery. The combination aims to produce damaging alpha particles exclusively across the tumor without harming healthy tissue in the beam entrance. TAE Life Sciences and the Department of Radiation Physics at The University of Texas MD Anderson Cancer Center conducted a study, "Effect of boron compounds on the biological effectiveness of proton therapy", to identify whether PBCT will produce an increased biological effect in destroying the tumor.

Results indicate that boron-11 concentrations of 80.4 ppm from sodium borocaptate (BSH) or 86.9 ppm from 4-borono-L-phenylalanine (BPA) treatments did not affect the biological effectiveness of proton beams due to proton–boron reactions in the DU145 prostate cancer cell line. These results align with theoretical results indicating that the contribution to the total absorbed dose and biological effectiveness due to alpha particles from proton–boron reaction is negligible. The findings also indicate that BSH radiosensitized DU145 cells to X-rays, low-linear energy transfer (LET) protons, and higher LET protons, but this radiosensitization was not related to DNA damage.

"TAE Life Sciences is proud of this proton boron fusion study," said Bruce Bauer, PhD, CEO of TAE Life Sciences. "We are encouraged by the continued development of BNCT and its unique ability to one day provide patients with new treatment options for recurrent and difficult to treat cancers."

"The study tested whether different boron compounds enhance the effectiveness of proton beams in killing cancer cells via proton-boron nuclear reactions. The results suggest that the tested boron compounds do not enhance cancer cell kill when combined with proton therapy, which leaves BNCT as probably the only advanced radiation therapy modality capable of combining the targeting properties of boron compound drugs to enhance radiation-induced cancer cell killing while minimizing side effects in health tissue." said Gabriel Sawakuchi, Ph.D., Associate Professor, Department of Radiation Physics, MD Anderson.

About BNCT

BNCT is a combination treatment based on the reaction that occurs when a non-toxic compound containing boron-10 is irradiated with a low-energy neutron beam. BNCT differs radically from other radiation therapy and shows promise in becoming the next-generation cancer treatment. Research has shown BNCT has the capability of killing cancer cells that are resistant to traditional radiation therapy with limited harm to healthy tissue. Current advances in both neutron radiation technology and medicinal boron drug targeting are enabling BNCT’s potential to improve patient care while also improving treatment economics. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.

Checkpoint Therapeutics to Participate in Two Upcoming Investor Conferences

On September 22, 2022 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that James Oliviero, President and Chief Executive Officer, will participate in two upcoming investor conferences (Press release, Checkpoint Therapeutics, SEP 22, 2022, View Source [SID1234621365]). Details are as follows:

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Cantor Fitzgerald’s Oncology, Hematology & HemeOnc Conference:

Ladenburg Thalmann Healthcare Conference:

Mr. Oliviero will be presenting at the Ladenburg Thalmann Healthcare Conference. A webcast of the presentation will be available on the News & Events page, located within the Investors section of Checkpoint’s website, View Source, for approximately 30 days after the meeting. Checkpoint will also participate in one-on-one meetings during the conference.

Onconova Therapeutics To Present At The Ladenburg Thalmann 2022 Healthcare Conference

On September 22, 2022 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the Company will be participating in-person in the Ladenburg Thalmann 2022 Healthcare Conference, which is taking place at the Sofitel Hotel in New York, NY (Press release, Onconova, SEP 22, 2022, View Source [SID1234621364]).

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Steven Fruchtman, M.D., President & CEO of Onconova, will present a corporate overview to include an update on the company’s portfolio, followed by a 10-minute analyst-led fireside chat, on September 29th, 2022, at 12:00 p.m. ET. The presentation can be viewed here or on the "Corporate Events and Presentations" section of the Onconova website and will be archived for 90 days. Dr. Fruchtman and other members of the Onconova management team will also be available for in-person one-on-one meetings during the conference on September 29th, 2022. Those interested in requesting a meeting should contact their Ladenburg Thalmann representative.