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]).

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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.

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).

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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.

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]).

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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.

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.