1stOncology™: Cancer Intelligence Service – Page 3857 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

MAIA Biotechnology to Present Latest Findings for Second Generation THIO Program at Turkish Biochemical Society’s International Biochemistry Congress 2023

On October 17, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, reported its participation in the International Biochemistry Congress 2023, organized by the Turkish Biochemical Society, which will be held in Turkey from October 29 to November 1, 2023 (Press release, MAIA Biotechnology, OCT 17, 2023, View Source [SID1234636090]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

On October 30th, MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D. will deliver a presentation detailing the latest findings from an investigational new drug-enabling study of MAIA’s second generation telomere-targeting agents derived from lipid-modified THIO molecules. The title of Dr. Gryaznov’s presentation will be "Telomerase-driven Telomeric DNA Modification as Potential Broad-spectrum Cancer Treatment Platform."

"The objective for our second-generation telomere-targeting molecule program is to discover new compounds with improved specificity towards cancer cells relative to normal cells and potentially increased anticancer activity, as well as better chemistry manufacturing control characteristics," said Vlad Vitoc, M.D., MAIA’s Chief Executive Officer. "Previous preclinical studies of several of our second-generation THIO-like agents have shown significantly higher efficacy than THIO. We look forward to presenting the latest findings at the end of this month."

THIO is currently in Phase 2 human clinical trials for non-small cell lung cancer treatment.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

First Results of Median Technologies’ iBiopsy® HCC Detection AI Model Developed on the PHELICAR Clinical Data Registry, to Be Presented at the ESMO Congress (Oct 20-24, 2023, Madrid, Spain)

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]).

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).

Arcus Biosciences to Present Data from Ongoing EDGE-Gastric Study at ASCO Plenary and to Report Third-Quarter Financial Results on November 7

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.

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.

IDEAYA Biosciences Announces Proffered Paper Oral Presentation at ESMO 2023 for Phase 2 Clinical Data Update for Darovasertib and Crizotinib Combination in Metastatic Uveal Melanoma

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]).

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).

ConcertAI’s TeraRecon partners with Optellum to integrate AI-powered early lung cancer diagnosis and precision treatment planning

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.

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.