CDH17

MANCHESTER, N.H., Sept. 30, 2024 /PRNewswire/ -- BioAI, an emerging biotech company applying multimodal artificial intelligence (AI) to novel biomarker discovery, development, and diagnostics, has announced a strategic partnership with Arbele, a biopharmaceutical company dedicated to developing novel immunotherapeutic platforms for gastrointestinal cancers. The collaboration aims to leverage BioAI's PredictX platform to develop AI-based models using Arbele's clinical trial data, with a focus on colorectal cancer (CRC) biomarker screening. The goal is to create a companion diagnostic test for Arbele's drug assets, enhancing patient selection through advanced AI technology. "By joining forces with Arbele, we are excited to apply our novel AI platform and expertise to accelerate the development of innovative treatment options for gastrointestinal cancers," said Thomas Colarusso, CEO of BioAI. "This partnership underscores our commitment to revolutionizing personalized medicine through cutting-edge machine learning." Arbele's CEO & Founder, Dr. John Luk, commented, "BioAI's machine learning capabilities offer a transformative approach to biomarker identification and patient stratification. This collaboration is a critical step in improving outcomes for patients with high mortality cancers." The initial phase of the partnership will focus on developing a prototype machine learning classifier model for quantifying CDH17 expression patterns in CRC samples, using a combination of H&E (hematoxylin and eosin) and IHC (immunohistochemistry) stained images. This initiative aims to standardize and improve the pathologic assessment of treatment response biomarkers to facilitate more effective patient selection for Arbele's specific therapeutic programs. Both companies expect that this collaboration will pave the way for future advances in precision medicine, ultimately benefiting patients with gastrointestinal cancers. About BioAI BioAI is a leading provider of multimodal AI for digital health in precision medicine, offering world-leading machine learning technology to develop digital biomarkers and H&E based predictive models. They partner with leading pharmaceutical, biotechnology, clinical laboratories, and academic cancer centers around the world. With the PredictX Platform, BioAI aims to revolutionize personalized medicine by improving drug efficacy and patient outcomes. For more information about BioAI and its innovative machine learning technologies, visit bioaihealth.com. About Arbele Arbele is a biotech and biopharmaceutical company focused on developing proprietary immunotherapeutic platforms targeting cadherin-17 and other specific tumor targets for gastrointestinal cancers. By inventing "first in class" antibody-based biologics, Arbele aims to address critical unmet needs in cancer treatment. For more information about Arbele, please visit arbelebio.com. SOURCE BioAI Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

GUANGZHOU, China, May 02, 2024 (GLOBE NEWSWIRE) -- Guangzhou Bio-gene Technologies, a biotechnology company engaged in the discovery, development, and delivery of novel cell therapies for the treatment of blood malignancies and solid tumors, today announced that the first patient was treated with BG1805, an investigational autologous CAR-T cell therapy targeting CLL-1, a member of the C-type lectin-like receptor family. BG1805 is being evaluated in a Phase 1 clinical study for the treatment of relapsed/refractory acute myeloid leukemia (AML), a severe disease affecting adults and children. “CLL-1 is an important drug target for the treatment of AML patients. We are very excited about the preclinical pro BG1805 and early clinical data from Investigator Initiated Trials (IIT).” said Dr. Min Luo, CTO, Guangzhou Bio-gene Technologies. “BG1805 is the first cell therapies in our pipeline that has advanced into formal clinical development, marking a major milestone for the company.” The ongoing Phase 1 trial of BG1805 is a multicenter, open-label study with relapsed/refractory AML. The primary objectives of the Phase 1 trial are the assessment of safety, tolerability, and identification of the recommended Phase 2 dose and lymphodepletion regimen. Key safety endpoints for the trial include treatment-emergent and treatment-related adverse events, and key efficacy endpoints include proportion of patients with complete or partial responses, proportion eligible for hematopoietic stem cell transplant, and proportion achieving minimal residual disease negative status. Multiple sites for the Phase 1 clinical trial of BG1805 are now open for enrollment. For more information, visit clinicaltrials.gov (NCT06118788). Guangzhou Bio-gene Technologies is developing several additional innovative autologous CAR-T cell therapies directed at important blood malignancy and solid tumor targets, including CD7, GPRC5D, B7H3, Claudin18.2, CDH17 as well as allogenic CAR-γδT therapies targeting CD19 and CLL-1/CD33. About BG1805 BG1805 is an investigational autologous CAR-T cell therapy targeting CLL-1, currently in a Phase 1 clinical study. BG1805 has previously been studied in Investigator Initiated Studies (IIT) and has demonstrated significant efficacy in both adults and children. About Guangzhou Bio-gene Technologies Guangzhou Bio-gene Technologies, a biotechnology company in Guangzhou, China, is dedicated the discovery, development, and delivery of novel cell therapies for the treatment of blood malignancies and solid tumors. A leader in CAR-T cell therapies, the company has advanced one autologous CAR-T candidate into Phase 1 clinical trials, six autologous CAR-T candidates into IIT studies and two allogenic CAR-T candidates into IIT studies. For more information, please visit . Contact Guangzhou Bio-gene Technologies, Ltd.: Bert E. Thomas IV +1.410.627.1734 bthomas@gzbiogene.com

The second DMC review recommends the continuation of dose escalation in the clinical trial as per protocol. The interim safety assessment was based on the review of safety data from 18 metastatic gastrointestinal cancer patients, including patients that have tolerated multiple doses of cabotamig. The DMC review confirms the safety risk profile of cabotamig being consistent with published T-cell engagers. SEATTLE, April 26, 2024 /PRNewswire/ -- Arbele, a clinical-stage biotechnology company focused on the development of novel immunotherapies targeted for advanced gastrointestinal cancers, today announced the positive recommendation from the second meeting of the Data Monitoring Committee (DMC) to continue the A001 Phase I clinical trial evaluating cabotamig (ARB202) in patients with advanced gastrointestinal (GI) cancers without modification to the trial protocol. The DMC, composed of a group of independent experts, arrived at this recommendation after review of the interim safety data of patients enrolled in the A001 trial. This safety assessment was based on the review of safety data from 18 patients, including patients that have been treated with multiple doses of cabotamig. This positive recommendation confirms tolerability profile of cabotamig is consistent with published safety data of T-cells engagers in other indications. "We are greatly indebted to the courageous subjects who have participated in this early study of cabotamig that have allowed us better understand the safety profile while optimizing the dosing of this promising therapy" said Dr Dennis Wong, Chief Medical Officer at Arbele. About A001 Trial The A001 trial is a multi-center, open label, FIH continuous study designed to evaluate the safety, tolerability, PK, PD, and anti-tumor activity of cabotamig administered intravenously in patients with unresponsive advanced GI malignancies expressing CDH17. The first part of the study consists of a dose-escalation stage (single ascending doses (SAD) Phase Ia) enrolling approximately 28 patients, and then a multiple dose ascending/ranging study (MAD). Except for colorectal cancer patients, all other patients are screened for tumors expressing CDH17 using TibTech™ proprietary automated tissue diagnostic platform. If CDH17 is expressed, patients will be eligible to enter screening to be dosed. Colorectal cancer patients may be eligible without CDH17 marker testing. For more information about A001, visit . About Cabotamig ARB202 is a first-in-class bispecific antibody based on Arbele's patented CDH17 biomarker. It targets both CDH17 on GI cancer as well as CD3 on T cells. The unique differential binding affinities of ARB202 toward CDH17 and CD3 allows it to have high specificity and cytotoxicity, while avoiding the "on-target" normal CDH17 expressing cells. Preclinical data showed that ARB202 can facilitate T-cell attachment to cancer cells, activation and release of IL-2, thereby demonstrating target engagement activation and cytotoxicity. About CDH17 Cadherin-17 (CDH17) is an adhesion molecule that binds to self and integrin α2β1. Its expression in humans is limited to gastrointestinal tissue, most studied in the adherens junctions along with E-cadherin on the basal lateral surface of colon epithelial cells. Its expression is tightly regulated and believed to be involved in the tight control of solutes between epithelial cells in the gut which prevents the movement of water and proteins into the lumen. Its aberrant expression at the cell surface in GI neoplastic cells has been well documented. CDH17 has been shown to be involved in cancer progression and is associated with poor prognosis. The soluble form, sCDH17 was previously found to increase with tumor staging and decrease with tumor debulking. Given CDH17 is expressed de novo or overexpressed at abnormally levels in GI cancers including CRC, GEJ, CCA, and PDAC, it provides a way to target T-cells to GI malignant cells within a suppressive tumor micro-environment. About Arbele Arbele is founded in 2016 by former senior executives from multinational pharmaceutical companies, with R&D presence in Seattle, Sydney, Singapore and Hong Kong. It focuses on the development of breakthrough diagnostic platforms and innovative immunotherapy; to provide early intervention and treatment for people with gastrointestinal cancers including but not limited to colorectal cancer, pancreatic cancer, gastric cancer, gastroesophageal junction cancer, liver cancer and cholangiocarcinoma, for which effective treatment options are scanty with high mortality rates. For more information on ARBELE, please visit Media and Investor Contact: Dr Diana Hay, PhD Executive Director, Business Development & IP [email protected] SOURCE Arbele