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BostonGene Announces Three Abstract Acceptances at ESMO Congress 2023

On October 17, 2023 BostonGene, a leading provider of AI-based molecular and immune profiling solutions, reported that it will present three abstracts at ESMO (Free ESMO Whitepaper) Congress 2023 (Press release, BostonGene, OCT 17, 2023, View Source [SID1234636094]). This highly influential oncology event brings together clinicians, researchers, patient advocates, journalists and healthcare industry representatives from around the world to exchange and debate translational cancer science, present potentially practice-changing data and stimulate multidisciplinary discussions to improve treatment options for our patients. The event will be held on October 20 – 24, 2023, in Madrid, Spain, at the IFEMA MADRID. BostonGene will also exhibit in Hall 5, booth 550.

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BostonGene session details are below:

Abstract: 1215P
Title: Comparative analysis of cfDNA liquid biopsy and tumor-based next-generation sequencing (NGS) approaches
Date: Sunday, October 22
Presenter: Chris Davitt, PhD, BostonGene

This study compared the utility of cell-free DNA (cfDNA) liquid biopsy with tumor-based next-generation sequencing approaches, revealing a 66.2% and 31.4% increase in the detection of single nucleotide variants and insertions and deletions, respectively, in clinically actionable gene panels using cfDNA.

Abstract: 1963P
Title: Comprehensive profiling of chordoma reveals tumor microenvironment subtypes and unique molecular findings
Date: Monday, October 23
Presenter: Alexander Bagaev, PhD, BostonGene

Whole exome and whole transcriptome sequencing of chordoma patients identified distinct tumor microenvironment (TME) subtypes. In total, 89% of patients had immune-enriched (IE and IE/F) TMEs, highlighting potential avenues for targeted therapies, particularly immune checkpoint inhibitors, in the management of advanced chordomas.

Abstract: 1982P
Title: Transcriptomic analysis and tumor microenvironment (TME) classification reveals unique immune biology in HIV patients with Kaposi Sarcoma (KS)
Date: Monday, October 23
Presenter: Krystle Nomie, PhD, BostonGene

Transcriptomic analysis of HIV-positive and HIV-negative Kaposi Sarcoma (KS) patients revealed unique tumor microenvironment (TME) characteristics related to treatment response, suggesting potential avenues for novel therapeutic strategies in KS and emphasizing the importance of understanding the interplay between immune status and the TME.

To learn more or to schedule a meeting with BostonGene during the event, please contact Maria Proia at [email protected].

For more information, please visit the ESMO (Free ESMO Whitepaper) Congress 2023 website.

Radionetics Oncology Announces Initiation of Phase 1 Radiopharmaceutical Program Against a Novel Target for Adrenocortical Carcinoma

On October 17, 2023 Radionetics Oncology, Inc., a clinical stage radiopharmaceutical company focused on the discovery and development of novel agents for the treatment of a wide range of oncology indications, reported that the first subject has been dosed in its Phase 1 study of 68Ga-R8760 (Press release, Radionetics Oncology, OCT 17, 2023, View Source [SID1234636093]).

Study R8760-101 (NCT05999292) is evaluating the safety and dosimetry of 68Ga-R8760, a first-in-class small molecule radioligand imaging agent being developed for patients diagnosed with adrenocortical carcinoma. 68Ga-R8760 was discovered by Radionetics Oncology for identifying melanocortin 2 receptor (MC2R)-expressing adrenocortical cancer lesions to select patients who may benefit from MC2R-directed radioconjugate therapy. The multi-center study is being conducted in the United States in collaboration with global leaders in the treatment of adrenocortical carcinoma.

"Adrenocortical carcinoma is a disease with a desperate need for new agents, as the last drug approved by the FDA was in 1970. MC2R is highly expressed on adrenocortical carcinoma tumors with limited expression in healthy tissue outside of the adrenal gland itself. Theranostic targeting of MC2R may provide a new approach for identifying and treating adrenocortical carcinoma," said Dr. Gary Hammer, M.D., Ph.D., the Millie Schembechler Professor of Adrenal Cancer at the University of Michigan Rogel Cancer Center and scientific advisor to Radionetics Oncology.

"Starting this exciting clinical study is an important milestone and was achieved within two years of the founding of Radionetics Oncology," said Brett Ewald, Chief Operating Officer. "Our team has a deep understanding of G-protein coupled receptors (GPCRs), leading to the identification of novel and compelling first-in-class imaging and therapeutic targets for oncology, such as MC2R. This coupled with our company’s chemistry, biology, and clinical expertise allows us to rapidly develop potent and selective radiopharmaceutical agents for clinical evaluation." Radionetics Oncology is developing a pipeline of new radiopharmaceuticals against novel targets and plans to have three clinical programs by 2024.

About 68Ga-R8760

68Ga-R8760 is a gallium-68-labeled small molecule radioligand conjugate that selectively binds with high affinity to MC2R, a highly expressed target on adrenocortical carcinoma. It is the first imaging agent developed to localize and identify MC2R-expressing tumors and is being developed to identify patients with adrenocortical carcinoma who may benefit from a MC2R-directed therapeutic agent that is also being developed by Radionetics Oncology. Adrenocortical carcinoma is a rare cancer of the adrenal cortex with limited treatment options, especially in the recurrent or metastatic setting. Despite significant research efforts, the median survival of patients with metastatic disease is less than 15 months.

Biocytogen/Eucure Biopharma to Present Complete Clinical Data from YH003 (anti-CD40 mAb) Phase I Trial at ESMO 2023

On October 17, 2023 Eucure Biopharma, a wholly owned subsidiary of Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315), reported that it will attend and present a poster at the ESMO (Free ESMO Whitepaper) Congress 2023, taking place in Madrid, Spain from October 20-24, 2023 (Press release, Biocytogen, OCT 17, 2023, View Source [SID1234636092]). The poster will summarize data from a completed phase I study of YH003, an independently developed anti-CD40 monoclonal antibody (mAb).

Poster title: Phase I open-label, dose escalation and expansion study of YH003, an anti-CD40 agonist monoclonal antibody in combination with toripalimab in patients (pts) with advanced solid tumours.
Presenting author: Dr. Ben Markman
Clinical Trial #: NCT04481009
Final publication number (FPN): 1041P
Category: Investigational immunotherapy
Presentation date: Monday 23 October

Clinical data indicates that YH003 has favorable pharmacokinetics, and is well tolerated when used in combination with the anti-PD-1 mAb Toripalimab. The combination therapy has also shown encouraging anti-tumor activity in patients with advanced solid tumors.

About YH003

YH003 is a humanized IgG2 agonistic anti-CD40 monoclonal antibody. Whether used as a single agent or in combination with anti-PD-1 monoclonal antibody drugs, YH003 demonstrated strong anti-tumor effects in multiple tumor models in Biocytogen’s humanized CD40 mice, without exhibiting hepatotoxicity or other toxicities. Pharmacodynamic studies in mice indicates that YH003 significantly increased the infiltration of anti-tumor T cells into tumors. Currently, YH003 is undergoing phase II multi-regional clinical trials (MRCTs) for the treatment of patients with unresectable/metastatic pancreatic ductal adenocarcinoma (PDAC) and melanoma.

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]).

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).