Latest news with #DamianO'Connell
Yahoo
28-05-2025
- Business
- Yahoo
Experimental Drug Development Centre Granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to Treat Pancreatic Ductal Adenocarcinoma
EBC-129 is the first made-in-Singapore antibody-drug conjugate (ADC) to enter clinical development. It selectively targets a tumour-specific N-glycosylated epitope on both CEACAM5 and CEACAM6. The Fast Track Designation highlights the potential of EBC-129 to address critical unmet needs in pancreatic ductal adenocarcinoma (PDAC). Updated clinical data from the ongoing Phase 1 study of EBC-129 will be presented at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO). SINGAPORE, May 28, 2025 /CNW/ -- The Experimental Drug Development Centre (EDDC), Singapore's national platform for drug discovery and development, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for EBC-129 for the treatment of pancreatic ductal adenocarcinoma (PDAC). EBC-129 is a first-in-class antibody drug conjugate (ADC) targeting a novel, tumour-specific N256-glycosylated epitope on CEACAM5 and CEACAM6. It is currently undergoing Phase 1 clinical trials for the treatment of patients with solid tumours with high unmet medical need. The Fast Track Designation facilitates the expedited development of EBC-129, enabling more frequent engagement with the FDA to discuss the clinical development plan. It also provides potential eligibility for Priority Review and Accelerated Approval, as well as rolling review of any future Biologic License Application (BLA). "The FDA's Fast Track Designation for EBC-129 underscores the promise of this novel ADC in addressing the critical need for expanded treatment options for PDAC patients and represents an important step in our efforts to accelerate its development. We view this as both a validation of our efforts and a responsibility to move decisively to advance EBC-129 as a new option to patients in need," said Professor Damian O'Connell, Chief Executive Officer of EDDC. Updated clinical data from the ongoing Phase 1 study of EBC-129 will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from 30 May to 3 June 2025. Presentation Details at ASCO 2025: Title: Clinical activity of EBC-129, a first-in class, anti-N256-glycosylated CEACAM5 and CEACAM6 antibody-drug conjugate (ADC), in patients with pancreatic ductal adenocarcinoma (PDAC) in a Phase 1 study Rapid Oral Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Date and Time: Monday, June 2, 2025, 11:30 AM – 1:00 PM GMT-5 Abstract Number: 4018 Presenter: Assistant Professor Robert W. Lentz, MD, Division of Medical Oncology, Department of Medicine, University of Colorado Anschutz School of Medicine About EBC-129 EBC-129 is an ADC that targets a tumour-specific N256-glycosylation site conserved on CEACAM5 and CEACAM6. CEACAM5 and CEACAM6 are known to have functional importance in tumour formation, migration and metastasis. In the ongoing trial, the tumour-specific marker is found to be widely expressed in multiple solid tumour types, including gastric, oesophageal, pancreatic, lung, colorectal, and appendiceal cancers, based on an analytically validated immunohistochemistry (IHC) assay. The payload used in EBC-129 is monomethyl auristatin E (MMAE) which has been extensively tested and approved for clinical use in other marketed ADCs and has demonstrated synergy with PD-1 inhibitors. The ongoing Phase 1 trial of EBC-129 is assessing the safety and tolerability of EBC-129 as a single agent and in combination with pembrolizumab in patients with advanced solid tumours. Enrolment for the PDAC cohort in the Phase 1 dose expansion study is now complete, while recruitment continues for the gastroesophageal adenocarcinoma (GEA) and IHC-positive cohorts. For information about the trial, please visit trial identifier NCT05701527. About the Experimental Drug Development Centre The Experimental Drug Development Centre (EDDC) is Singapore's national platform for drug discovery and development, formed from the integration of the Experimental Therapeutics Centre (ETC), Drug Discovery and Development (D3), and Experimental Biotherapeutics Centre (EBC) in 2019. EDDC aims to develop therapeutics and diagnostics that save and improve the lives of patients in Singapore, Asia and around the world. Hosted by the Agency for Science, Technology and Research (A*STAR), EDDC works collaboratively with public sector and industry partners to translate the great science arising from Singapore's biomedical and clinical sciences R&D into innovative healthcare solutions. For more information about EDDC, please visit View original content to download multimedia: SOURCE EXPERIMENTAL DRUG DEVELOPMENT CENTRE View original content to download multimedia:
Cision Canada
28-05-2025
- Business
- Cision Canada
Experimental Drug Development Centre Granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to Treat Pancreatic Ductal Adenocarcinoma
EBC-129 is the first made-in-Singapore antibody-drug conjugate (ADC) to enter clinical development. It selectively targets a tumour-specific N-glycosylated epitope on both CEACAM5 and CEACAM6. The Fast Track Designation highlights the potential of EBC-129 to address critical unmet needs in pancreatic ductal adenocarcinoma (PDAC). Updated clinical data from the ongoing Phase 1 study of EBC-129 will be presented at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO). SINGAPORE, May 28, 2025 /CNW/ -- The Experimental Drug Development Centre (EDDC), Singapore's national platform for drug discovery and development, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for EBC-129 for the treatment of pancreatic ductal adenocarcinoma (PDAC). EBC-129 is a first-in-class antibody drug conjugate (ADC) targeting a novel, tumour-specific N256-glycosylated epitope on CEACAM5 and CEACAM6. It is currently undergoing Phase 1 clinical trials for the treatment of patients with solid tumours with high unmet medical need. The Fast Track Designation facilitates the expedited development of EBC-129, enabling more frequent engagement with the FDA to discuss the clinical development plan. It also provides potential eligibility for Priority Review and Accelerated Approval, as well as rolling review of any future Biologic License Application (BLA). "The FDA's Fast Track Designation for EBC-129 underscores the promise of this novel ADC in addressing the critical need for expanded treatment options for PDAC patients and represents an important step in our efforts to accelerate its development. We view this as both a validation of our efforts and a responsibility to move decisively to advance EBC-129 as a new option to patients in need," said Professor Damian O'Connell, Chief Executive Officer of EDDC. Updated clinical data from the ongoing Phase 1 study of EBC-129 will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from 30 May to 3 June 2025. Presentation Details at ASCO 2025: Title: Clinical activity of EBC-129, a first-in class, anti-N256-glycosylated CEACAM5 and CEACAM6 antibody-drug conjugate (ADC), in patients with pancreatic ductal adenocarcinoma (PDAC) in a Phase 1 study Rapid Oral Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Date and Time: Monday, June 2, 2025, 11:30 AM – 1:00 PM GMT-5 Abstract Number: 4018 Presenter: Assistant Professor Robert W. Lentz, MD, Division of Medical Oncology, Department of Medicine, University of Colorado Anschutz School of Medicine About EBC-129 EBC-129 is an ADC that targets a tumour-specific N256-glycosylation site conserved on CEACAM5 and CEACAM6. CEACAM5 and CEACAM6 are known to have functional importance in tumour formation, migration and metastasis. In the ongoing trial, the tumour-specific marker is found to be widely expressed in multiple solid tumour types, including gastric, oesophageal, pancreatic, lung, colorectal, and appendiceal cancers, based on an analytically validated immunohistochemistry (IHC) assay. The payload used in EBC-129 is monomethyl auristatin E (MMAE) which has been extensively tested and approved for clinical use in other marketed ADCs and has demonstrated synergy with PD-1 inhibitors. The ongoing Phase 1 trial of EBC-129 is assessing the safety and tolerability of EBC-129 as a single agent and in combination with pembrolizumab in patients with advanced solid tumours. Enrolment for the PDAC cohort in the Phase 1 dose expansion study is now complete, while recruitment continues for the gastroesophageal adenocarcinoma (GEA) and IHC-positive cohorts. For information about the trial, please visit trial identifier NCT05701527. About the Experimental Drug Development Centre The Experimental Drug Development Centre (EDDC) is Singapore's national platform for drug discovery and development, formed from the integration of the Experimental Therapeutics Centre (ETC), Drug Discovery and Development (D3), and Experimental Biotherapeutics Centre (EBC) in 2019. EDDC aims to develop therapeutics and diagnostics that save and improve the lives of patients in Singapore, Asia and around the world. Hosted by the Agency for Science, Technology and Research (A*STAR), EDDC works collaboratively with public sector and industry partners to translate the great science arising from Singapore's biomedical and clinical sciences R&D into innovative healthcare solutions. For more information about EDDC, please visit
Korea Herald
08-04-2025
- Business
- Korea Herald
Engine Biosciences and Experimental Drug Development Centre Partner to Advance Novel Therapies to Combat Cancer
SINGAPORE, April 8, 2025 /PRNewswire/ -- Engine Biosciences (Engine), a Singapore- and Silicon Valley-based biotechnology company pioneering precision medicine for cancer, announced a new partnership with the Experimental Drug Development Centre (EDDC), Singapore's national platform for drug discovery and development hosted by the Agency for Science, Technology and Research (A*STAR). This first-of-its-kind collaboration unites Engine's NetMAPPR platform and proprietary oncology intellectual property with EDDC's drug discovery and development expertise to create first-in-class precision cancer treatments. The first project under this partnership focuses on ENB-871, a novel pairing of a drug target and patient selection biomarkers discovered through Engine's NetMAPPR platform. This platform combines AI, computation, biology, and chemistry to identify, validate, and prioritise drug targets with strong clinical and commercial potential, driving the development of new therapies that exploit specific vulnerabilities in tumours. This program shows significant promise for treating tumours with particular genetic mutations that predict sensitivity to the ENB-871 targeted therapy, including breast, liver, kidney and prostate cancers – diseases afflicting large and growing patient populations in Singapore and worldwide. In total, the potential addressable population exceeds 500,000 patients per year. The teams will collaborate to develop small molecule degraders targeting ENB-871, including demonstration of in vivo efficacy. By bringing together Engine's proprietary technology and deep translational insights with EDDC's strengths in designing and developing therapies, this partnership aims to create targeted cancer treatments tailored to patients' specific profiles, improving treatment effectiveness and outcomes. Engine and EDDC may also identify additional drug targets and research programs for collaboration during the partnership. "We're excited by the synergies created by bringing together our two platforms, leveraging first-in-class Singapore research and innovation to advance transformative cancer therapies. This marks another key step in Engine's mission to develop more effective, targeted and safer drugs for cancer patients." said Jeffrey Lu, CEO and Co-Founder of Engine Biosciences. "The future of drug development lies in precision-driven innovation. Our partnership with Engine enables us to develop therapies tailored to specific patient populations through Engine's biomarker-driven patient selection approaches. We are particularly excited to launch our first collaborative project around monovalent small molecule degraders, building on EDDC's expanding capabilities in this field. Beyond this, we look forward to strengthening our partnership by advancing more precision therapies that have the potential to transform the lives of cancer patients in need," shared Damian O'Connell, CEO of EDDC. About Engine Biosciences Engine Biosciences (Engine) is a venture-backed Singapore and Silicon Valley based company discovering and developing impactful precision medicines by deciphering complex biology with integrated computation and experimentation, with particular depth in oncology gained over several years of substantial investment and focus. Having pinpointed many promising drug targets and predictive biomarkers for patients most likely to benefit, Engine is advancing its pipeline of oncology therapeutics towards the clinic internally and with collaborators, and in other disease areas through partnerships. Engine's team is motivated by opportunities to address significant unmet needs with more selective and effective precision medicines. For more information, please visit and follow Engine on LinkedIn. About EDDC The Experimental Drug Development Centre (EDDC) is Singapore's national platform for drug discovery and development, formed from the integration of the Experimental Therapeutics Centre (ETC), Drug, Discovery and Development (D3), and Experimental Biotherapeutics Centre (EBC) in 2019. EDDC aims to develop therapeutics and diagnostics that save and improve the lives of patients in Singapore, Asia and around the world. Hosted by the Agency for Science, Technology and Research (A*STAR), EDDC works collaboratively with public sector and industry partners to translate the great science arising from Singapore's biomedical and clinical sciences R&D into innovative healthcare solutions. For more information about EDDC, please visit
