On October 17, 2023 Median Technologies (ALMDT:PA) (Paris:ALMDT) reported that the first results of its iBiopsy HCC detection AI model developed on the PHELICAR clinical data registry will be presented during the annual congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), taking place from Oct 20 to 24, in Madrid, Spain (Press release, MEDIAN Technologies, OCT 17, 2023, View Source [SID1234636089]).

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The study, conducted using data from the PHELICAR clinical data registry (CDR), was led by Pr. Olivier Ludicarme, Head of Specialty, and Emergency Imaging Department at the Pitié-Salpêtrière AP-HP Hospital, Paris, France, and his team as well as teams from the Beaujon and Paul-Brousse AP-HP Hospitals. The primary focus of this study was on the evaluation of Median’s iBiopsy AI model for the detection of Hepatocellular carcinoma (HCC), ultimately targeting the early diagnosis of HCC.

HCC constitutes more than 90% of primary liver cancers, ranking as the third leading cause of death by cancer worldwide1. Notably, the 5-year survival rate of liver cancer patients is only between 3% to 13% if the cancer is diagnosed at advanced stage (C) yet rises significantly to 36% when diagnosed at early stage (A) and even higher when diagnosed at very early stage (0)2.

Results presented at the ESMO (Free ESMO Whitepaper) 2023 Congress under the abstract Computer-Aided HCC Lesion Detection Based on Deep Learning and CT Images (abstract 1209MO) describe the first development step of a model slated for integration into Median’s AI/ML tech-based end-to-end CADe/CADx3 Software as Medical Device (SaMD) for HCC early diagnosis, on multiphase CT images (Arterial and Portal phase). This initial work is centered on the detection features of Median’s future iBiopsy HCC CADe/CADx SaMD and is based on a cohort of 753 patients from AP-HP, suffering from chronic liver disease and HCC. For the study, data from 561 patients were used for the algorithm’s training & tuning, whereas data from 192 patients were used for its testing.

Median’s iBiopsy AI model, designed to detect HCC lesions as small as 10 mm in diameter, showcased promising results, achieving an impressive sensitivity rate of 92% on the test set. This notable achievement significantly surpasses the average sensitivity of 69%4 observed among radiologists without AI/ML tech-based computer aided detection. The next phase of research will focus on the small-size lesions to improve the diagnosis of very early stage (0) and early-stage (A) HCC.

Study results will be presented during the session Basic Science & Translational Research (ID 81), to be held on Sunday 22 October, session time: 8:30 – 10:05 am CEST, oral presentation time: 9:10 am CEST, Santander Auditorium – Hall 9.

As a reminder, PHELICAR is part of a large research collaboration agreement signed in March 2020 between AP-HP and Median Technologies, aiming at carrying out studies to be used for the development and validation of Median’s iBiopsy AI/ML tech-based algorithms. More specifically, PHELICAR is a large-scale clinical data registry (CDR) to accurately identify the specific tumor phenotypes to better diagnose and predict patient outcome in HCC and supports the ongoing rise of predictive and personalized medicine.

The Median iBiopsy team will attend the ESMO (Free ESMO Whitepaper) 2023 Congress and be at booth #522, Hall 5, from October 20 to 23 (exhibition dates) to discuss the study results as well as iBiopsy advancements.

About iBiopsy: iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), benefiting from Median’s expertise in medical image processing. iBiopsy targets the development of AI/ML tech-based Software as Medical Devices (SaMD), to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on Lung Cancer, Liver Cancer (HCC) and Liver Disease (NAFLD/NASH).

On October 17, 2023 Arcus Biosciences, Inc. (NYSE:RCUS) reported that data from cohort A1 of the ongoing Phase 2 EDGE-Gastric study will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Monthly Plenary Series on November 7, 2023 (Press release, Arcus Biosciences, OCT 17, 2023, View Source [SID1234636088]). EDGE-Gastric (also known as ARC-21), a collaboration between Arcus and Gilead Sciences, is a Phase 2 platform study evaluating various combinations of domvanalimab, an Fc-silent anti-TIGIT monoclonal antibody, and zimberelimab, an anti-PD-1 antibody, in patients with locally advanced unresectable or metastatic gastric (G), gastroesophageal junction (GEJ) or esophageal (E) adenocarcinoma. Cohort A1 evaluates the combination of domvanalimab plus zimberelimab and chemotherapy given as an initial treatment in approximately 40 patients.

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The ASCO (Free ASCO Whitepaper) Monthly Plenary Series is a virtual forum for presentation and discussion of the latest cancer research. According to ASCO (Free ASCO Whitepaper), live presentations are accessible to virtual attendees and available on-demand, and abstract presentations are accompanied by a discussant presentation and followed by a live Q&A session. Abstracts accepted for the Monthly Plenary Session are also placed at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2024.

Title: EDGE-Gastric Arm A1: Phase 2 study of domvanalimab, zimberelimab, and FOLFOX in first-line (1L) advanced gastroesophageal cancer.
Presenter: Yelena Y. Janjigian, M.D., Chief, Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center
Date: Tuesday, November 7, 2023
Time: 12:00 p.m. – 1:00 p.m. PT / 3:00 p.m. – 4:00 p.m. ET
Webcast: The livestream presented by ASCO (Free ASCO Whitepaper) is free to register on their website.

In addition, Arcus will release third quarter results and pipeline updates after market close on November 7, 2023. Following the release, Arcus management will host a conference call to discuss the financial results, EDGE-Gastric results and other pipeline updates.

Date: Tuesday, November 7, 2023
Time: 2:00 p.m. PT / 5:00 p.m. ET

Investors interested in listening to the conference call may do so by dialing (646) 904-5544 (local) or (833) 470-1428 (toll-free), using Conference ID: 258096. To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

About EDGE-Gastric

The ongoing, multi-arm, global EDGE-Gastric trial (NCT05329766) is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab and the anti-PD-1 antibody zimberelimab in patients with locally advanced unresectable or metastatic gastric (G), gastroesophageal junction (GEJ) or esophageal (E) adenocarcinoma. Patients with previously untreated G/GEJ/E adenocarcinoma received 1600 mg of domvanalimab intravenously (IV) every four weeks (Q4w) plus 480 mg of zimberelimab IV Q4W + FOLFOX (oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2 IV, fluorouracil 400 mg/m2 IV bolus + 2400 mg/m2 continuous 46-48-hour IV infusion) every two weeks.

On October 17, 2023 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the publication of the abstract for a proffered paper session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 (ESMO 2023) relating to selected clinical data from the company’s ongoing Phase 2 clinical trial evaluating darovasertib in combination with crizotinib in patients having metastatic uveal melanoma (MUM) (Press release, Ideaya Biosciences, OCT 17, 2023, View Source [SID1234636087]).

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Dr. Meredith McKean, M.D., MPH, Director, Melanoma and Skin Cancer Research at Sarah Cannon Research Institute, who is a clinical investigator on the Phase 2 clinical trial, will present the clinical data as summarized in the abstract, as follows:

Session No. 1081O
Title: ctDNA reduction and clinical efficacy of the darovasertib + crizotinib (Daro + Crizo) combination in metastatic uveal melanoma (MUM)
Date: Monday, October 23, 2023 at 8:50-9:00 am CEST
Dr. Meredith McKean, M.D., MPH, Sarah Cannon Research Institute (Nashville, TN, U.S.A)
In summary, the Phase 2 evaluation of the darovasertib and crizotinib combination in first-line and pretreated MUM patients showed a manageable safety profile and demonstrated clinical efficacy that appears superior to current standards of care. Human leukocyte antigen (HLA)-A*02:01 (HLA-A2) status was determined in a subset of patients enrolled in the company’s clinical trials evaluating darovasertib. Clinical efficacy was observed in both HLA-A2 positive (HLA-A2(+)) and HLA-A2 negative (HLA-A2(-)) patients. ctDNA was reduced in almost all patients and ctDNA molecular responses were deep and sustained in the majority of patients.

The reported data support IDEAYA’s ongoing registrational Phase 2/3 study for potential accelerated approval of darovasertib and crizotinib for treatment of first-line HLA-A2(-) MUM patients, where there are no FDA approved therapies.

A press release summarizing the top-line results will be available on Monday, October 23, 2023, at approximately 6:00 am ET, and will be available on the Company’s website, at its Investor Relations portal (View Source).

On October 17, 2023 ConcertAI’s TeraRecon, the advanced visualization and clinical AI SaaS company, reported its strategic collaboration with Optellum Ltd (Oxford, UK), a global leader in AI clinical decision support for early lung cancer diagnosis and precision treatment planning (Press release, ConcertAI, OCT 17, 2023, View Source [SID1234636086]). Through this partnership, the Optellum Virtual Nodule Clinic solution will be seamlessly integrated into TeraRecon’s Eureka Clinical AI platform, with the goal of helping clinicians across their install base drive more early lung cancer diagnoses and curative treatments. Eureka is the first such enterprise AI platform to integrate with Optellum.

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Lung cancer often shows no symptoms until a late stage when treatment options are more limited and outcomes less positive. However, continuous and automated analysis of the approximately 90 million CT scans US patients receive per year, such as emergency room and cardiac studies, could enable an "early detection system." Virtual Nodule Clinic, the first FDA and CE-MDR-cleared decision support for early-stage lung cancer, integrates a Patient Discovery AI, based on Natural Language Processing, with a clinically validated Lung Cancer Prediction (LCP) score based on imaging AI/Radiomics and deep-learning neural networks. The combination assists clinicians in detecting at-risk patients across a health system and prioritization of those at highest risk for follow-up interventions.

The integration of Virtual Nodule Clinic with the Eureka Clinical AI platform supports thoracic oncology care teams, led by pulmonologists, to identify and track more patients, earlier, with accelerated time to a confirmatory cancer diagnosis while reducing invasive procedures on benign lesions. TeraRecon’s solutions are deployed 1000’s of locations, and now combined with with Optellum’s AI solutions, medical professionals around the world will be able to provide timely, personalized lung cancer care.

"ConcertAI is one of the leading cancer research and clinical AI-focused companies in the world. TeraRecon’s collaboration with Optellum marks a significant milestone in advancing lung cancer diagnosis and aiding thoracic oncology teams in treatment," said Jeff Elton, PhD, CEO of ConcertAI. "The addition of the Virtual Nodule Clinic solution to the TeraRecon Eureka Clinical AI platform will provide thorasic care teams and pulmonologists with state-of-the-art tools to identify and diagnose early-stage lung cancer efficiently and accurately."

"We are thrilled to partner with ConcertAI’s TeraRecon to expand the reach of Optellum’s Virtual Nodule Clinic to drive patient identification and stage-shift across their customer base," said Václav Potěšil, PhD, Founder & Chief Business Officer at Optellum. "Our ultimate goal is to radically reshape lung cancer outcomes, leveraging the power of the Optellum AI platform to drive the right patients into early intervention and precision treatment with targeted- and immune-therapies, and save thousands of lives."

The companies will announce their partnership at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress 2023 in Madrid, the world’s premier medical oncology congress. In the ESMO (Free ESMO Whitepaper) scientific program, Optellum’s clinical partners will present the first results towards extending the LCP platform into AI-guided precision treatment in the "NSCLC, Early Stage".

The Eureka Clinical AI platform is renowned for its comprehensive suite of advanced imaging analytics, clinical decision support tools, and workflow optimization solutions. By being the first to integrate Optellum’s Virtual Nodule Clinic into the Eureka Clinical AI Platform, TeraRecon solidifies its position as a leader in transforming lung cancer care through innovative AI applications.

Eureka Clinical AI is the leading AI SaaS imaging interpretation and clinical decision augmentation solution from TeraRecon. As the industry’s most broadly deployed platform, it is unique in that it is open to third-party AI algorithms, allowing consolidated management of all AI interpretation solutions with seamless PACS integrations. Multi-specialty care teams can see results and receive mobile alerts to confirm AI findings, ensuring optimal and timely patient interventions, management and coordinated care delivery.

On October 17, 2023 Bio4t2 reported to have received regulatory approvals to repeatedly administer patients with T cells engineered to express a chimeric antigen receptor (CAR) targeting BT-001, an antigen on solid tumors identified using the PrismCore platform (Press release, Bio4T2, OCT 17, 2023, View Source [SID1234636085]). The CAR-T, termed B4t2-001, are predicted to engraft without preparative chemotherapy (lymphodepletion) based on the Bio-Engine technology enabling multiple infusions for each recipient to further improve the therapeutic effect.

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Clinical trial repeatedly infuses CAR-T without lymphodepletion to treat solid tumors.

Bio4t2, global clinical stage biopharmaceutical company combines PrismCore and Bio-Engine technologies to advance cutting-edge CAR-T therapy in phase 1 clinical trial.
Bio4t2, global clinical stage biopharmaceutical company combines PrismCore and Bio-Engine technologies to advance cutting-edge CAR-T therapy in phase 1 clinical trial.
The PrismCore platform generates CAR-T that recognizes overexpressed self-antigens on solid tumors. Bio-Engine adapts the CAR-T to transiently recognize a subset of circulating blood cells to boost the numbers of infused genetically modified T cells without the need for preparative chemotherapy. Bio4t2 harnesses these technologies to unlock the commercial potential of CAR-T in patients with invasive cancers.

A prior pilot investigator-initiated trial (clinicaltrials.gov NCT05621486) demonstrated that B4t2-001 can engraft to the range of 40 to 50% of circulating lymphocytes, even when lymphodepletion was omitted, and resulted in anti-tumor effects.

"This new phase 1 trial builds off our pilot clinical study which concluded a few weeks ago," said Dr. Laurence Cooper MD-PhD, Executive Chairman of the board. "Treating solid tumors depends on identifying targets that are uniformly expressed across cancer cells and engrafting CAR-T without immunological exhaustion. We combine our PrismCore and Bio-Engine technologies to achieve both goals and advance our cutting-edge CAR-T for the many patients with solid tumors," added Dr. Cooper.

"PrismCore identifies targets on invasive cancers and Bio-Engine harnesses normal blood cells to create a niche for CAR-T engraftment without the use of preparative chemotherapy," said Farzad Haerizadeh, PhD, Chief Scientific Officer, and co-founder. "Based on the success of our pilot clinical study, Bio4t2’s CAR-T is predicted to attack the tumor again and again without the cost, complexity, and toxicities, associated with lymphodepletion," said Haerizadeh.

About the clinical trial

The phase 1 investigator-initiated study (clinicals.gov NCT06072989) evaluates intra-patient repeat administration and inter-patient ascending doses of B4t2-001 targeting BT-001 without lymphodepletion in adult patients with solid tumors at Shanghai East and Shanghai Artemed hospitals in the People’s Republic of China. Furthermore, this trial assesses the safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy of autologous CAR-T.