Oxford Nanopore Announces PromethION Plus Flow Cell and Human Genetics Updates at ASHG 2025




Oxford Nanopore Announces PromethION Plus Flow Cell and Human Genetics Updates at ASHG 2025

OXFORD, England–(BUSINESS WIRE)–#Nanopore–At the American Society of Human Genetics (ASHG) 2025 industry session on 16th October, Oxford Nanopore Technologies will share its latest developments in enabling translational and clinical human genetics communities to deliver improved insights into mechanisms for disease in one integrated analysis.

The team will highlight the unique capabilities of the PromethION in delivering comprehensive whole genomes and methylomes, alongside transformational, information-rich targeted assays using Adaptive Sampling.

By delivering fully comprehensive genomic insights, Oxford Nanopore customers are deploying the technology in translational clinical settings to solve diagnostic odysseys in rare disease, enhance cancer characterisation, and drive novel discoveries in common complex disease.

Oxford Nanopore will introduce the PromethION Plus Flow Cell – a new ultra-high-output flow cell designed to deliver increasingly cost effective, comprehensive genomes and methylomes.

Driving value for human geneticists with adaptive sampling and new rapid workflows

At ASHG, Oxford Nanopore will share a series of updates that support the human genetics and translational research communities. These advances expand access to rapid, information-rich genomic and epigenomic analysis through new workflows and targeted sequencing solutions, including:

• The use of adaptive sampling for targeted sequencing –a fast and flexible method to enrich regions of interest that is unique to Oxford Nanopore, eliminating the need for laborious and time intensive optimisations in common capture methods. Multiple applications include:
  • A hereditary cancer panel that interrogates 258 genes associated with inherited cancer risk and enables laboratories to speed up sample-to-answer.
  • Rapid tumour methylation profiling
  • Comprehensive pharmacogenomics panels

Launch of a 24-hour workflow for comprehensive human genome analysis, that delivers sample-to-answer insights in a single day, supporting critical research in Neonatal Intensive Care Units (NICUs) and enabling rapid and comprehensive genomic insights in rare disease.

PromethION Plus Flow Cells for fully comprehensive, cost-effective human genomes and methylomes

PromethION Plus will deploy an improved flow cell chemistry designed to deliver high data output, enhanced consistency, and value for high throughput human research applications – without the need for flow cell washing. Delivering comprehensive genomic and epigenetic data, PromethION Plus Flow Cells will uniquely be delivered at scale on the PromethION 24 device.

This marks an important step toward multiplexing multiple genomes per PromethION Flow Cell, providing a clear pathway to significantly reducing the cost of premium, fully comprehensive, scaled human genomes and epigenomes below $345 (at 30x coverage), and beyond with future chemistry upgrades on the development roadmap.

PromethION Plus Flow Cells will be introduced in limited release in Q4 2025, with broader availability in 2026.

The new flow cells benefit all human genetics applications where comprehensive genomic and epigenetic data is required at scale. This includes discovery within population-scale studies, as well as high-throughput characterisation of clinical samples, such as those analysed in rare disease or cancer.

Technical overview

Optimised for use with 15–30 kb fragment libraries, PromethION Plus Flow Cells will deliver high output, rich sequencing data for robust and reliable calling of a broad range of genetic variants, including methylation.

Users can expect:

• Significantly increased flow cell output with large fragment libraries (>15kb)
• Reduced hands-on-time with no wash protocols (15kb libraries)
• Lower input requirements
• Best value per 30x genome for high throughput sequencing customers

Prepares the platform for faster kit chemistry to deliver further output improvements planned for 2026

ASHG event

Oxford Nanopore will host an industry education session at ASHG:

Sequencing from large scale to single cell – the new era of biological discovery
Location: Room 153 ABC

Date: Thursday, October 16th

Time: 12:00 pm — 1:00 pm EDT

About Oxford Nanopore Technologies

Oxford Nanopore Technologies’ goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis. The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used in more than 125 countries to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments.

Oxford Nanopore Technologies products are intended for molecular biology applications and are not intended for diagnostic purposes. For more, visit: https://nanoporetech.com/

Contacts

Media@nanoporetech.com 

New Surescripts First-Fill Abandonment Solution Empowers Providers with Insights to Help Improve Patient Care, Increase Medication Adherence and Advance Value-Based Care Performance




New Surescripts First-Fill Abandonment Solution Empowers Providers with Insights to Help Improve Patient Care, Increase Medication Adherence and Advance Value-Based Care Performance

Partnership with Arcadia Will Help Accelerate Decisions and Keep Patient Care on Track

ARLINGTON, Va.–(BUSINESS WIRE)–#HealthIT–Surescripts®, the nation’s leading health intelligence network, introduces First-Fill Abandonment solution to give provider organizations early insights about patient access to prescriptions when a medication goes unfilled, enabling care managers with faster and more accurate data to meaningfully address gaps in patients’ care and better support value-based care performance.

Equipped with earlier insights through First-Fill Abandonment, provider organizations will gain more power and precision to improve patient outcomes by tailoring their strategies based on patient-specific abandonment trends, including:

• Locations with the highest abandonment rates inside a health system
• Prescribers within a health system with the highest abandonment rates
• Most frequently abandoned drugs from prescriptions written by the health system

“As a physician, prescribing a treatment is just one step in the patient care journey but once they leave the office, we typically do not have the ability to know if the patient has gotten the prescription we’ve written,” said Dr. Lynne Nowak, Chief Data and Analytics Officer for Surescripts. “It’s why we developed this solution and are excited to bring enhanced visibility to the next steps in the prescribing process, empowering care providers with meaningful insights, like when a patient does not pick up their medication, so they can perform faster, more targeted interventions to help keep patient care on track.”

More than 1 in 4 new prescriptions written are not filled due to a number of factors, including abandonment by patients, according to a report. First-Fill Abandonment delivers patient insights that help address the most common barriers to care: cost and access.

First-Fill Abandonment proactively compares new prescriptions sent across the Surescripts network and flags when a medication isn’t picked up by the patient. When a prescriber is notified that a patient hasn’t received a new medication, they can work with care coordinators and the patient to help address potential barriers that may lead to improved medication adherence and better care.

In addition to offering First-Fill Abandonment to health systems and electronic health records vendors, Surescripts is partnering with Arcadia, a leading healthcare data platform, to offer this product to their provider customers.

“In value-based care, even a single missed prescription can have a cascading effect on health outcomes, quality measures like HEDIS and Star ratings, and costs. We can’t afford to wait months for claims data to understand medication adherence,” said Michael Meucci, President and CEO of Arcadia. “By integrating near real-time First-Fill Abandonment insights from Surescripts into Arcadia’s platform, providers gain earlier visibility into when patients face barriers to starting therapy. This allows care teams to intervene faster, improve adherence, and ultimately deliver better results for patients and their organizations.”

With First-Fill Abandonment, provider organizations can:

• Stay informed with a 12-month look-back period of first fill abandonment trends
• Configure targeted first fill abandonment rates to align with their organization’s strategies for patient care
• Evaluate medication-based care improvement initiatives
• Uplift STARS & HEDIS measures focused on clinical outcomes

Learn more at HLTH:

Surescripts at HLTH 2025 – October 19-22, Las Vegas, NV

Stop by booth #2318, to learn more about how Surescripts is collaborating across healthcare, bringing innovative technology to care providers, delivering real-time insights, and automating administrative tasks to help keep patient care on track.

About Surescripts

Our purpose is to serve the nation through simpler, trusted health intelligence sharing, in order to increase patient safety, lower costs and ensure quality care. At Surescripts, we bring healthcare together to inform and accelerate decisions, helping keep patient care on track. With the Surescripts Network Alliance®, we’re empowering the healthcare ecosystem with intelligence and interoperability for smarter, faster prescribing, prior authorization, treatment, care management and more. Visit us at surescripts.com and follow us on LinkedIn.

About Arcadia

Arcadia helps providers, payers, and government organizations transform healthcare data into predictive insights that drive better outcomes, increase revenue, and reduce costs. Its industry-leading platform amasses data from across the healthcare ecosystem and converts it into actionable analytics, AI-driven intelligence, and performance benchmarks, enabling smarter decisions and accelerating impact across the enterprise. National and regional health systems and payers, along with governmental organizations – including Aetna, Highmark Blue Cross Blue Shield, Intermountain Health, Ochsner Health, and the State of California – trust Arcadia to operationalize their data and lead the way in data-driven healthcare. Visit arcadia.io for more information.

Arcadia® is a trademark of Arcadia Solutions, LLC. All rights reserved.

Contacts

Media Contact:
Kate Giaquinto

(571) 290-6859

Kate.Giaquinto@surescripts.com

Media Contact:
Drew Schaar, Arcadia

Drew.Schaar@arcadia.io

Liberate Bio Demonstrates First In Vivo CAR-M–Mediated B-Cell Depletion in Non-Human Primates




Liberate Bio Demonstrates First In Vivo CAR-M–Mediated B-Cell Depletion in Non-Human Primates

Findings establish CAR-M as a potential new immune-reset modality with improved safety over in vivo CAR-T approaches

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Liberate Bio, Inc., a biotechnology company developing genetic medicines that deliver RNA therapies directly to immune cells, today announced new preclinical data presented at the American Society of Gene and Cell Therapies’ Advancing Cell and Gene Therapies for Cancer conference in Philadelphia.

In a non-human primate study, Liberate’s in vivo CAR-M therapy achieved greater than 99% depletion of circulating B cells after two well-tolerated doses. To the company’s knowledge, this represents the first demonstration that CAR-modified monocytes and macrophages (CAR-M) can mediate B-cell depletion in primates, establishing a new potential therapeutic pathway for immune system reset in autoimmune and B-cell–driven diseases.

Transient increases in cytokines, including IL-6 and TNF-α, were observed after each dose, resolving within 48 hours and showing no signs of T-cell proliferation. Combined with less than 1% delivery to T cells, the results indicate that CAR-M may offer a safer in vivo reprogramming profile than CAR-T, with a reduced risk of cytokine release syndrome (CRS) and ICANS.

“This is a foundational milestone for the field of in vivo cell therapy,” said Walter R. Strapps, Ph.D., Chief Scientific Officer of Liberate Bio. “By reprogramming monocytes and macrophages instead of T cells, we’ve shown that it’s possible to deplete B cells through an entirely new immune compartment—one that naturally traffics to both circulation and tissues while avoiding the excessive immune activation that limits current CAR-T approaches.”

Liberate’s proprietary RAPTOR™ platform directly screens lipid nanoparticles (LNPs) in non-human primates to identify delivery vehicles that target extrahepatic immune cells. The lead LNP from this platform selectively delivered CAR-encoding mRNA to monocytes and macrophages, producing the observed 99% B-cell depletion, demonstrating both potency and reversibility—an encouraging feature for therapeutic use in patients with moderate autoimmune disease who may not tolerate the intensity of CAR-T therapy.

“In vivo CAR-M opens the door to treating millions of patients who have been beyond the reach of traditional cell therapy,” said Shawn P. Davis, Ph.D., Chief Executive Officer of Liberate Bio. “We envision a future where immune programming can be performed safely, repeatably, and at scale—extending the benefits of engineered cell therapies to autoimmune and oncology patients alike.”

Liberate Bio plans to advance its first in vivo CAR-M candidate toward IND-enabling studies, with the goal of supporting the first clinical evaluation in the second half of 2026 through an investigator-initiated trial. This milestone will mark the transition of Liberate’s platform from preclinical validation to human proof-of-concept, advancing a new therapeutic class designed to reprogram immune cells in vivo safely. The company’s initial clinical focus will include autoimmune indications, such as systemic lupus erythematosus and multiple sclerosis, as well as oncology programs, including relapsed/refractory multiple myeloma (rrMM), where malignant B cells persist in circulation and bone marrow.

About Liberate Bio

Liberate Bio is building the next generation of genetic medicines by solving the most fundamental challenge in the field: delivery beyond the liver. The company’s proprietary RAPTOR™ platform combines high-throughput in vivo screening in non-human primates with AI-driven design and optimization, creating the first biological dataset powerful enough to train artificial intelligence on real delivery outcomes.

Using this feedback loop, Liberate Bio has engineered lipid nanoparticles that target specific immune and bone marrow–resident cell types, including monocytes, macrophages, and hematopoietic stem cells (HSCs). This approach enables the programmable delivery of mRNA, gene editing, and other payloads directly to the cells that drive disease — unlocking the potential to treat oncology, autoimmune, and rare genetic disorders from within the body.

Liberate Bio’s first programs focus on in vivo CAR-M therapies to reprogram immune cells safely and at scale. Longer term, the company’s platform provides a foundation for a new class of AI-informed, systemically delivered genetic medicines that extend to multiple organs and therapeutic areas.

For more information about the company’s technologies, team, and mission, visit www.liberatebio.com

Contacts

wstrapps@liberatebio.com

Hospital for Special Surgery and General Atlantic Launch National Platform to Expand Access to Orthopedic and Spine Outpatient Care




Hospital for Special Surgery and General Atlantic Launch National Platform to Expand Access to Orthopedic and Spine Outpatient Care

NEW YORK–(BUSINESS WIRE)–Hospital for Special Surgery (“HSS”), the nation’s top-ranked orthopedic hospital, is joining General Atlantic, a leading global investor, in its launch of a new, independently operated national platform of ambulatory surgery centers (“ASCs”) dedicated to delivering advanced, patient-centered orthopedic and spine outpatient care. To support the platform’s buildout, HSS and General Atlantic have also agreed to acquire Legent Health (“Legent”), a portfolio company of BTG Pactual Strategic Capital (“Strat Cap”). Legent is a leading operator of orthopedic and spine facilities, providing an immediate foundation for scale and growth.

The platform represents a significant step forward in expanding patient access to high-quality, accessible orthopedic and spine care nationwide, while addressing rising demand for advanced outpatient solutions. Legent CEO Jordan Fowler will lead the new platform, which combines Legent’s proven operating infrastructure and experienced management team, HSS’s depth of clinical knowledge and community of more than 1,750 alumni surgeons, and General Atlantic’s expertise in building and scaling physician-aligned healthcare platforms.

Many procedures that once required hospital stays can now be performed safely and efficiently in ASCs. The new independent platform aims to expand patient access to advanced orthopedic and spine care closer to home, delivering lower-cost care with improved outcomes in a more comfortable environment. The platform is purpose-built to create lasting partnerships with surgeons and health systems, providing physicians with opportunities for ownership and alignment through meaningful equity participation, clinical autonomy, and special access to HSS’s clinical protocols and advisory services. This will enable physicians and health systems to participate in the site-of-care shift and benefit from ASC-level efficiencies and economics. Over time, HSS and General Atlantic intend to expand the platform nationally through acquisitions, new partnerships, and de novo facilities.

“As the world’s leading academic medical center specializing in musculoskeletal health since 1863, HSS has a special responsibility to deliver the highest-quality care, improve mobility, and enhance quality of life,” said Bryan Kelly, MD, MBA, President, CEO, and Surgeon-in-Chief Emeritus at HSS. “Through this collaboration, we will extend HSS’s clinical expertise and patient-first standards to markets where demand for orthopedic and spine care outpaces supply, and where quality care is limited outside the hospital setting.”

“This platform brings together HSS’s clinical knowledge and General Atlantic’s company-building expertise to create community-based platforms that will expand patient access to premier orthopedic and spine care,” said Robbert Vorhoff, Managing Director and Global Head of Healthcare at General Atlantic. “We are excited to work alongside HSS and Legent to support physicians, deliver quality care, and improve patient outcomes and satisfaction across the country.”

Jordan Fowler, CEO and Chairman of Legent, commented, “Legent was founded on the belief that ambulatory surgery centers can deliver a superior patient and physician experience while lowering costs for everyone involved. We look forward to continuing to provide the highest quality of care and bringing our mission to more patients as part of this pioneering new platform.”

James Frank, Head of Strat Cap at BTG Pactual Global Alternatives, said, “We are proud of the value created through our partnership with the Legent management team. We wish General Atlantic, HSS, and the management team continued success as they embark on this next phase.”

Goodwin Procter LLP and Paul, Weiss, Rifkind, Wharton & Garrison LLP served as legal advisors to HSS and General Atlantic. Ducera Partners LLC served as financial advisor, and Gibson, Dunn & Crutcher LLP and McDermott Will & Schulte LLP served as legal advisors to Legent and Strat Cap.

About Hospital for Special Surgery

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 16th consecutive year), No. 3 in rheumatology by U.S. News & World Report (2025-2026), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report “Best Children’s Hospitals” list (2024-2025). Founded in 1863, the Hospital has the lowest readmission rates in the nation for orthopedics, and among the lowest infection and complication rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. In addition, more than 200 HSS clinical investigators are working to improve patient outcomes through better ways to prevent, diagnose, and treat orthopedic, rheumatic and musculoskeletal diseases. The HSS Innovation Institute works to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 165 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.

About General Atlantic

General Atlantic is a leading global investor with more than four and a half decades of experience providing capital and strategic support for over 830 companies throughout its history. Established in 1980, General Atlantic continues to be a dedicated partner to visionary founders and investors seeking to build dynamic businesses and create long-term value. Guided by the conviction that entrepreneurs can be incredible agents of transformational change, the firm combines a collaborative global approach, sector-specific expertise, a long-term investment horizon, and a deep understanding of growth drivers to partner with and scale innovative businesses around the world. The firm leverages its patient capital, operational expertise, and global platform to support a diversified investment platform spanning Growth Equity, Credit, Climate, and Sustainable Infrastructure strategies. General Atlantic manages approximately $114 billion in assets under management, inclusive of all strategies, as of June 30, 2025, with more than 900 professionals in 20 countries across five regions. For more information on General Atlantic, please visit: www.generalatlantic.com.

About PSN Group, LLC

PSN is a privately held provider of surgical services through its network of surgical hospitals and ambulatory surgery centers operating under the brand Legent Health. Headquartered in Plano, Texas, PSN aligns closely with physicians and payors to provide high quality, high value surgical care in a manner that prioritizes patient service and experience. For more information: https://www.legenthealth.com.

About BTG Pactual Strategic Capital

​BTG Pactual (BPAC11) is the largest investment bank in Latin America with a market capitalization of ~US$ 30B. Strat Cap is an opportunistic investment strategy focused on hybrid solutions in defensive sectors in the U.S. and is part of BTG Pactual’s ~US$ 9.4B Global Alternatives division. Strat Cap partners with management teams and business owners to create value and is led by a seasoned investment team with relevant experience in private equity, credit, and structured solutions. All figures are as of 2Q2025. For more information, please visit http://www.btgstratcap.com.

Contacts

Media Contacts
Hospital for Special Surgery
Tracy Hickenbottom

Assistant Vice President, Public Relations & Social Media

mediarelations@hss.edu
(212) 606-1197

General Atlantic
media@generalatlantic.com

BTG Pactual Strategic Capital
Elaine.Irvin@Btgpactual.com

ProteinQure Reports Broad Brain Distribution of Peptide-siRNA Conjugates in Non-Human Primates




ProteinQure Reports Broad Brain Distribution of Peptide-siRNA Conjugates in Non-Human Primates

TORONTO–(BUSINESS WIRE)–ProteinQure announced new preclinical results today, demonstrating efficient delivery of small interfering RNA (siRNA) to the central nervous system (CNS) in non-human primates. Using intrathecal administration of proprietary peptide-oligonucleotide conjugates that leverage receptor-mediated transport, the study provides evidence of widespread distribution of siRNA throughout the brain.

The data establishes ProteinQure’s platform as competitive with best-in-class approaches. In the 28-day study, the ProteinQure conjugates were directly compared to lipid-based approaches that are considered leading CNS delivery platforms in clinical development. “These results highlight the potential of our siRNA conjugate technology to overcome long-standing barriers in nucleic acid delivery to the brain,” said Lucas Siow, CEO of ProteinQure. “By coupling optimized peptides to oligonucleotides, we have achieved broad CNS biodistribution in primates, with superiority in certain cell types — a critical step toward advancing oligonucleotide therapeutics for neurological disorders.”

These findings and additional early data on ProteinQure’s blood-brain barrier shuttle program will be presented at the 21st Annual Meeting of the Oligonucleotide Therapeutics Society in Budapest, October 2025.

Contacts

Lucas Siow

lucas@proteinqure.com

PeptiDream, PDRadiopharma and Curium Group Enroll First Patient to Registrational Clinical Trial of 64Cu-PSMA-I&T for Prostate Cancer in Japan




PeptiDream, PDRadiopharma and Curium Group Enroll First Patient to Registrational Clinical Trial of 64Cu-PSMA-I&T for Prostate Cancer in Japan

KAWASAKI, Japan–(BUSINESS WIRE)–PeptiDream Inc., a public Kanagawa, Japan-based biopharmaceutical company (President: Patrick C. Reid, hereinafter “PeptiDream”)(Tokyo: 4587), PDRadiopharma Inc. (President: Masato Murakami, Headquarters: Chuo-ku, Tokyo, Japan, “PDRadiopharma”), a wholly owned subsidiary of PeptiDream, and Curium Group, a world leader in nuclear medicine (CEO: Renaud Dehareng, Headquarters: Boston, Massachusetts, the United States), today announced that a registrational Phase 2 clinical trial (jRCT: 2031250225) has been initiated in Japan for ⁶⁴Cu-PSMA-I&T, a PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells.

⁶⁴Cu-PSMA-I&T is being assessed as a diagnostic PET imaging agent labeled with the radioisotope Copper-64, being developed with its therapeutic pair, ¹⁷⁷Lu-PSMA-I&T. The development is conducted under the strategic collaboration between PDRadiopharma and Curium aiming at advancing innovative radiopharmaceuticals for prostate cancer in Japan.

The open-label, single-arm Phase 2 study will evaluate the sensitivity, specificity, and safety of ⁶⁴Cu-PSMA-I&T. The trial will enroll approximately 70 patients who have been newly diagnosed with unfavorable intermediate, high or very high-risk prostate cancer and are scheduled for prostatectomy with pelvic lymph node dissection. This study is being conducted as a registrational trial in Japan and will utilize bridging data from Curium’s ongoing global clinical trials.

In parallel, a clinical trial for ¹⁷⁷Lu-PSMA-I&T as a therapeutic agent is being planned to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC).

Patrick C. Reid, President & CEO of PeptiDream commented: “Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their prostate cancer targeting radiopharmaceuticals to patients in Japan.”

Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: “We are excited to initiate the development of ⁶⁴Cu-PSMA-I&T in Japan. Both ⁶⁴Cu-PSMA-I&T and ¹⁷⁷Lu-PSMA-I&T are considered potential products for diagnosing and treating PSMA-expressing prostate cancer. There is demand in Japan for PSMA PET diagnosis, as many urologists wish to use this imaging modality in clinical practice. In collaboration with Curium, we aim to address this need and utilize radiopharmaceuticals to provide new medical treatments for patients.”

Renaud Dehareng, CEO of Curium Group commented: “Conducting these registrational trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to prostate cancer patients in Japan.”

Global Clinical Trial Progress

For ¹⁷⁷Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.

For ⁶⁴Cu-PSMA-I&T, trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, ClinicalTrials.gov identifier NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, ClinicalTrials.gov identifier; NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer.

Contacts

Inquiries:

PeptiDream Inc.
Contact: Yuko Okimoto, IR & Public Affairs

Email: info@peptidream.com
Website: https://www.peptidream.com/en/
X: https://x.com/PeptidreamInc

PDRadiopharma Inc.
Contact: Noriko Tanaka, General Affairs

Email: s-info-hq@pdradiopharma.com

Curium
Camilla Campell

VP, Head of Global Communications

communications@curiumpharma.com

Genentech Data at ESMO 2025 Showcase Advances in Science and Cancer Care Across Multiple Tumor Types




Genentech Data at ESMO 2025 Showcase Advances in Science and Cancer Care Across Multiple Tumor Types

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it will present more than 30 abstracts across more than 10 cancer types at the European Society for Medical Oncology (ESMO) Congress 2025, held October 17-21, 2025 in Berlin, Germany. The data underscore Genentech’s commitment to deliver transformative medicines for some of the most challenging cancer types, including breast cancers, lung cancers, gastrointestinal and genitourinary cancers.

Key presentations include:

• Giredestrant: Primary results from the Phase III evERA Breast Cancer study, the first positive head-to-head Phase III trial investigating an all-oral selective estrogen receptor (ER) degrader-containing regimen versus a standard of care combination in the post-cyclin-dependent kinase inhibitor setting for people with ER-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival in both the intention-to-treat and ESR1-mutated populations. Data will be presented as a late-breaking oral abstract.

• Tecentriq: Results from the IMvigor011 trial, the first global Phase III study pioneering a circulating tumor DNA (ctDNA)-guided approach to post-surgery treatment in muscle-invasive bladder cancer (MIBC). Topline results show that people who had detectable ctDNA and were treated with Tecentriq^® (atezolizumab) had statistically significant and clinically meaningful improvements in disease-free survival (DFS) and overall survival (OS). Data will be presented as part of the Presidential Symposium.

• Alecensa: Final OS data from the pivotal ALEX study of Alecensa^® (alectinib). Alecensa is an established first-line treatment and a standard of care for people with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Data will be presented as a late-breaking oral abstract and published simultaneously in the Annals of Oncology.

• Alecensa: Updated results from the Phase III ALINA study, reinforcing the role of adjuvant Alecensa as the standard of care for patients with resected ALK-positive NSCLC. After a median follow-up of approximately four years, Alecensa DFS data compared with chemotherapy will be presented.

Overview of key presentations featuring Genentech medicines:

* Investigator Initiated Study (IIS). The study is sponsored by MEDSIR and supported by Genentech, a member of the Roche Group.

** Investigator Initiated Study (IIS). The study is sponsored by the National Cancer Institute (NCI), conducted by the Alliance for Clinical Trials in Oncology and supported by Genentech, a member of the Roche Group.

What is Itovebi?

Itovebi^® (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy.

Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you.

It is not known if Itovebi is safe and effective in children.

Important Safety Information

What are the possible side effects of Itovebi?

Itovebi may cause serious side effects, including:

• High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe or fatal. Untreated severe hyperglycemia can lead to a condition called diabetic ketoacidosis that can happen in people treated with Itovebi. Diabetic ketoacidosis is a serious condition that requires treatment in a hospital and that can lead to death. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including:
  • difficulty breathing
  • nausea and vomiting (lasting more than 2 hours)
  • stomach pain
  • excessive thirst
  • dry mouth
  • more frequent urination than usual or a higher amount of urine than normal
  • blurred vision
  • unusually increased appetite
  • weight loss
  • fruity-smelling breath
  • flushed face and dry skin
  • feeling unusually sleepy or tired
  • confusion
• Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth:
  • pain
  • redness
  • swelling
  • ulcers
• Diarrhea. Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea

Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects.

The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include:

• decreased white blood cell counts, red blood cell counts, and platelet counts
• decreased blood levels of calcium, potassium, sodium, and magnesium
• increased creatinine blood levels
• tiredness
• increased blood levels of the liver enzyme alanine transaminase (ALT)
• nausea
• rash
• loss of appetite
• COVID-19 infection
• headache

Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (877) 436-3683.

Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of diabetes or high blood sugar
• have kidney problems
• are pregnant or plan to become pregnant. Itovebi can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi.
• You should use effective non-hormonal birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about what birth control method is right for you during this time.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi.

Males with female partners who are able to become pregnant:

• You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose.

• are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information, including Patient Information, for additional Important Safety Information.

Who is Alecensa for?

Alecensa is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene:

• To help prevent lung cancer from coming back in patients after their tumor has been removed by surgery (adjuvant), or
• As treatment if your lung cancer has spread to other parts of the body (metastatic).

Your doctor will perform a test to make sure that Alecensa is right for you. It is not known if Alecensa is safe and effective in children.

Important Safety Information

Everyone reacts differently to treatment with Alecensa. It’s important to know the most serious and most common side effects with Alecensa.

Your doctor may lower the dose or stop treatment with Alecensa if any side effects occur. Contact your doctor right away if you have any of the following side effects.

Alecensa may cause serious side effects, including:

Liver problems (hepatotoxicity). Liver problems are common with Alecensa and can be severe. A doctor will do blood tests at least every 2 weeks for the first 3 months, and then 1 time each month and as needed during treatment with Alecensa. Tell your doctor right away if you get any of the following signs and symptoms:

• Feeling tired
• Feeling less hungry than usual
• Yellowing of the skin or whites of the eyes
• Dark urine
• Itchy skin
• Nausea or vomiting
• Pain on the right side of stomach area
• Bleeding or bruising more easily than normal

Lung problems. Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever.

Kidney problems. Alecensa may cause very slow heartbeats that can be severe. Your doctor will check your heart rate and blood pressure during treatment with ALECENSA. Tell your doctor right away if you feel dizzy, lightheaded, or if you faint during treatment with ALECENSA. Tell your doctor if you take any heart or blood pressure medicines.

Slow heartbeat (bradycardia). Alecensa may cause very slow heartbeats that can be severe. A doctor will check a patient’s heart rate and blood pressure during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they feel dizzy, lightheaded, or if they faint during treatment with Alecensa. Patients taking Alecensa should tell their doctor if they take any heart or blood pressure medicines.

Severe muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with Alecensa and can be severe. Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Tell your doctor right away if you have any new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Hemolytic anemia can happen in some people who take Alecensa. If this happens, you may not have enough healthy red blood cells. Your doctor may temporarily stop Alecensa and do blood tests, if needed, to check for this problem. If you develop hemolytic anemia, your doctor may either restart you on Alecensa at a lower dose when the hemolytic anemia goes away, or may stop your treatment with Alecensa. Tell your doctor right away if you experience yellow skin (jaundice), weakness or dizziness, or shortness of breath.

What should I tell my doctor before taking ALECENSA?

Before you take Alecensa, tell your doctor about all of your medical conditions, including if you:

• have liver problems
• have lung or breathing problems
• have a slow heartbeat
• are pregnant or plan to become pregnant. Alecensa can harm an unborn baby.

Females who are able to become pregnant:

• Your doctor will do a test to see if you are pregnant before starting treatment with Alecensa
• You should use effective birth control (contraception) during treatment with Alecensa and for 5 weeks after the last dose of Alecensa
• Tell your doctor right away if you become pregnant during treatment with Alecensa or think you may be pregnant

Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with Alecensa and for 3 months after the last dose of Alecensa

• Are breastfeeding or plan to breastfeed. It is not known if Alecensa passes into your breast milk. Do not breastfeed during treatment with Alecensa and for 1 week after the last dose of Alecensa. Talk to your doctor about the best way to feed your baby during this time

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking Alecensa?

Avoid spending time in the sunlight during treatment with Alecensa and for 7 days after the final dose of Alecensa. Your skin may be sensitive to the sun (photosensitivity) and you may burn more easily and get severe sunburns. Use sun protecting measures, such as sunscreen and lip balm with SPF 50 or greater to help protect against sunburn.

The most common side effects of Alecensa include:

• constipation
• tiredness
• swelling in hands, feet, ankles, face, and eyelids
• rash
• cough

These are not all of the possible side effects of Alecensa. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients and caregivers may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in full Prescribing Information, including Patient Information.

What is Tecentriq?

Tecentriq is a prescription medicine used to treat:

Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown

• Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment
• Tecentriq may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer:
  • has not progressed after first treatment with TECENTRIQ or atezolizumab and hyaluronidase-tqjs and the chemotherapy medicines carboplatin and etoposide.

It is not known if Tecentriq is safe and effective when used:

• In children for the treatment of SCLC.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Lung problems

• cough
• shortness of breath
• chest pain

Intestinal problems

• diarrhea (loose stools) or more frequent bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness

Liver problems

• yellowing of your skin or the whites of your eyes
• severe nausea or vomiting
• pain on the right side of your stomach area (abdomen)
• dark urine (tea colored)
• bleeding or bruising more easily than normal

Hormone gland problems

• headaches that will not go away or unusual headaches
• eye sensitivity to light
• eye problems
• rapid heartbeat
• increased sweating
• extreme tiredness
• weight gain or weight loss
• feeling more hungry or thirsty than usual
• urinating more often than usual
• hair loss
• feeling cold
• constipation
• your voice gets deeper
• dizziness or fainting
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems

• decrease in your amount of urine
• blood in your urine
• swelling of your ankles
• loss of appetite

Skin problems

• rash
• itching
• skin blistering or peeling
• painful sores or ulcers in mouth or nose, throat, or genital area
• fever or flu-like symptoms
• swollen lymph nodes

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Call or see your healthcare provider right away for any new or worse signs or symptoms, including:

• Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
• Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• Persistent or severe muscle pain or weakness, muscle cramps
• Low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

• chills or shaking
• itching or rash
• flushing
• shortness of breath or wheezing
• dizziness
• feeling like passing out
• fever
• back or neck pain

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq if you have severe side effects.

Before you receive Tecentriq, tell your healthcare provider about all of your medical conditions, including if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. Tecentriq can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:
  • Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq.
  • You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

• feeling tired or weak
• Nausea
• hair loss
• constipation
• diarrhea
• decreased appetite

Tecentriq may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Tecentriq. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555

Please see full Prescribing Information and Medication Guide for additional Important Safety Information.

About Genentech

Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions.

Contacts

Media Contact: Jared Preston, (650) 467-6800

Advocacy Contact: Julie Burns, (860) 881-6594

Investor Contacts: Loren Kalm (650) 225-3217

Bruno Eschli, +41 616875284

Read full story here

AdvanCell to Present Promising Clinical Trial Results of ADVC001, a Novel Lead-212-based PSMA-targeted Alpha Therapy for Prostate Cancer, at ESMO 2025




AdvanCell to Present Promising Clinical Trial Results of ADVC001, a Novel Lead-212-based PSMA-targeted Alpha Therapy for Prostate Cancer, at ESMO 2025

• Results from the Phase 1b dose escalation of the TheraPb Phase 1/2 trial are the first clinical data for a Lead-212 (212Pb)-based-PSMA radioligand therapy
• The abstract presents a favorable safety profile for 212Pb-ADVC001 and promising anti-tumor activity, underscoring its potential to enhance therapeutic options for patients with metastatic prostate cancer
• The upcoming presentation at ESMO will feature updated safety and efficacy results from all seven Phase 1b treatment cohorts

SYDNEY, Australia–(BUSINESS WIRE)–AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, announces a presentation at the European Society for Medical Oncology (ESMO) Congress, taking place in Berlin, Germany, from October 17-21, 2025.

The presentation will feature promising results from the Phase 1b dose escalation of the Phase 1/2 TheraPb study, evaluating ADVC001, a Lead-212-based PSMA-targeted alpha therapy, in metastatic castration-resistant prostate cancer (mCRPC).

This will be the first presentation of clinical data from a 212Pb-PSMA therapy at a major oncology conference – an important milestone in advancing targeted alpha therapies for prostate cancer and a clear demonstration of AdvanCell’s leadership in radioligand therapy. The abstract presents a favorable safety profile for 212Pb-ADVC001 and promising anti-tumor activity, underscoring the potential of 212Pb-ADVC001 to enhance therapeutic options for patients with metastatic prostate cancer.

The abstract is available online on the ESMO website (link), and features data as of a May 9, 2025 cut-off. The poster to be presented at ESMO will include updated safety and efficacy data and additional treatment cohorts.

Details of the abstract and presentation:

Results from the Phase 1b Dose Escalation of 212Pb-ADVC001 in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC): The TheraPb Trial

• Presenter: Aaron Hansen, MD, BSc, MBBS, FRACP, Princess Alexandra Hospital, Brisbane, Australia
• Presentation Number: 2388P
• Session: Prostate Cancer Poster Session
• Session Time/ Place: Saturday, October 18 / 12:00-12:45 PM CET / Hall 25
• Poster Display Time: 9:00 AM – 5:00 PM CET

About the TheraPb trial

The TheraPb trial (NCT05720130) is a prospective, open-label Phase 1/2 dose-escalation and expansion study designed to determine the safety and tolerability of escalating doses of 212Pb-ADVC001 administered every 6, 4, 2 or 1 week(s) during the dose-finding Phase 1b. The Phase 2 expansion will assess the efficacy and safety of 212Pb-ADVC001 at the recommended Phase 2 doses across three indications. The trial incorporates randomization and dose optimization elements to rigorously evaluate optimal dosing strategies of 212Pb-ADVC001 in PSMA-positive mCRPC and in hormone-sensitive prostate cancer (mHSPC).

About 212Pb-ADVC001

212Pb-ADVC001 is a novel, proprietary and patented small molecule PSMA-targeting radioligand with optimized physicochemical properties labelled with 212Pb, an alpha-emitting payload (radionuclide) with a high dose rate, short half-life (10.6 hours) and simple decay scheme. 212Pb-ADVC001 is designed to deliver radiation at a cellular level to more effectively kill prostate cancer cells while minimizing toxicity.

About AdvanCell

AdvanCell is a vertically integrated, clinical-stage radiopharmaceutical company dedicated to developing innovative cancer therapies that harness the power of targeted alpha-emitting radionuclides. By leveraging its proprietary Lead-212 platform, advanced and scalable manufacturing capabilities, cutting-edge science and world-class clinical development capabilities, AdvanCell aims to deliver novel treatments that improve outcomes for patients with cancer globally.

For more information, visit www.advancell.com.au and follow us on LinkedIn.

Contacts

Andrew Adamovich, CEO

contact@advancell.com.au

For media inquiries, please contact:
MEDiSTRAVA

Mark Swallow, Frazer Hall, Sylvie Berrebi

advancell@medistrava.com
+44 (0)20 3928 6700

Natera to Present 14 Studies at ESMO, Including IMvigor011 Oral Presentation in Presidential Symposium




Natera to Present 14 Studies at ESMO, Including IMvigor011 Oral Presentation in Presidential Symposium

Six oral presentations highlight Signatera’s expanding role across solid tumors, including definitive predictive data in adjuvant bladder cancer

AUSTIN, Texas–(BUSINESS WIRE)–Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that 14 studies featuring its technology will be presented at the European Society for Medical Oncology (ESMO) Congress, taking place October 17–21 in Berlin, Germany. The slate includes six oral presentations, reinforcing Natera’s position as a leader in molecular residual disease (MRD) testing across multiple cancer types.

Bladder Cancer Highlights

The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, has been selected for a Presidential Symposium on October 20. With positive topline results announced in August, this oral presentation will include additional data on Signatera’s ability to predict disease-free survival (DFS) and overall survival (OS) benefit from adjuvant Tecentriq® (atezolizumab) in muscle-invasive bladder cancer (MIBC). IMvigor011 is the first prospective, phase III study in MIBC to be read out that uses a bespoke MRD-guided approach.

MRD analysis from the Phase 3 CheckMate 274 trial will also be shared in an oral presentation on October 17. CheckMate 274 randomized high-risk MIBC patients 1:1 to Opdivo® (nivolumab) or placebo for ≤ 1 year of adjuvant treatment. The results showed that DFS for Signatera-positive patients treated with nivolumab more than doubled compared to placebo (7.4 months vs 2.8 months; HR: 0.35). In contrast, no significant improvement in DFS was observed with the use of nivolumab among Signatera-negative patients.

Additional ESMO Data

Additional oral presentations include results from the SunRISe-4 trial in MIBC, the INTERCEPT trial in colorectal cancer, and Natera’s early cancer detection program.

“Across multiple different Phase 3 trials, we’ve now shown how Signatera MRD can help identify patients with bladder cancer who are most likely to benefit from adjuvant immunotherapy,” said Matthew Galsky, M.D., Lillian and Howard Stratton Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Associate Director for Translational Research at the Tisch Cancer Center. “These key studies are building a powerful foundation for bespoke MRD to guide different forms of treatment, improve outcomes for patients with bladder cancer and change medical practice.”

“We are proud to showcase the breadth of research using Signatera at this year’s ESMO Congress, including oral presentations across bladder, colorectal, breast, and other cancers,” said Minetta Liu, M.D., chief medical officer of oncology at Natera. “The diversity of these datasets underscores the growing impact of bespoke MRD assessment in reshaping how we detect and monitor cancer, providing tools to personalize treatment recommendations in oncology–with the ultimate goal of improving outcomes for patients.”

Full list of presentations featuring Natera’s technology at ESMO includes:

October 17, 2:50 PM CEST | 3068O (Oral Presentation)

Presenter: Matthew D. Galsky, M.D.

Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274

October 17, 4:40 PM CEST | LBA 112 (Mini Oral Presentation)

Presenter: Andrea Necchi, M.D.

Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results

October 18, 9:00 AM CEST | 185eP

Presenter: Michael Galo

Treatment response using a tumor-informed circulating DNA test (TIctDNA) comparing with radiologic outcomes in non-small cell lung cancer (NSCLC)

October 18, 12:00 PM CEST | 1132P

Presenter: Floortje Backes, M.D.

Utility of circulating tumor DNA (ctDNA) dynamics for evaluating early treatment response in patients with recurrent/metastatic endometrial (rEC) and recurrent/platinum-resistant ovarian cancer (rPROC)

October 18, 12:00 PM CEST | 2609P

Presenter: Arnab Basu, MBBS, MPH, FACP, M.D.

Clinical Performance of a Tumor-Informed Whole Genome-Based (WGS) ctDNA Assay for Recurrence Detection and Treatment Response Monitoring in Localized and Advanced/Metastatic Renal Cell Carcinoma (RCC)

October 19, 12:00 PM CEST | 764P

Presenter: Masaaki Miyo, M.D., Ph.D.

Association of ultrasensitive whole genome sequencing (WGS)-based tumor-informed molecular residual disease (MRD) detection with lymph node metastasis (LNM) after local excision of pathological T1 colorectal cancer: Results from DENEB, a CIRCULATE-Japan GALAXY substudy

October 19, 2:45 PM CEST | 734MO (Mini Oral Presentation)

Presenter: Yoshiaki Nakamura, M.D., Ph.D.

Performance of a blood-based, early cancer detection (ECD) screening test for colorectal cancer (CRC) in cell-free (cf)DNA

October 19, 2:50 PM CEST | 732MO (Mini Oral Presentation)

Presenter: Emerick Osterlund, M.D., Ph.D.

Circulating tumor DNA (ctDNA) clearance and correlation with outcome in the INTERCEPT colorectal cancer (CRC) study

October 19, 12:00 PM CEST | 823P

Presenter: Kozo Kataoka, M.D.

A Phase II Study of mFOLFOXIRI Following Metastasectomy in Oligometastatic Colorectal Cancer: (FANTASTIC)

October 19, 3:40 PM CEST | LBA 31 (Oral Presentation)

Presenter: Yara L. Verschoor

Neoadjuvant immunotherapy induces immune activation and responses in MMR-proficient colon cancers

October 20, 12:00 PM CEST | 620TiP

Presenter: Benjamin Verret, M.D.

HEROES: De-escalation of anti-HER2 therapies in HER2-positive metastatic breast cancer with long-term persistent response and undetectable minimal residual disease in circulating tumor DNA

October 20, 12:00 PM CEST | 354P

Presenter: Adrian Lee, Ph.D.

Hormonal and immune mediators of resistance to primary endocrine therapy

October 20, 12:00 PM CEST | 336P

Presenter: Arielle J. Medford, M.D.

Circulating tumor DNA detection in stage 1 HER2 positive and triple negative breast cancer (SAFE-DE)

October 20, 4:30 PM CEST | LBA 8 (Oral Presentation)

Presenter: Thomas B. Powles, MBBS, MRCP, M.D.

IMvigor011: a Phase 3 trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer

Notes

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 300 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Anti-TIGIT Domvanalimab Plus Anti-PD-1 Zimberelimab and Chemotherapy Showed 26.7 Months of Median Overall Survival as First-Line Treatment of Unresectable or Advanced Gastroesophageal Adenocarcinomas in the Phase 2 EDGE-Gastric Study




Anti-TIGIT Domvanalimab Plus Anti-PD-1 Zimberelimab and Chemotherapy Showed 26.7 Months of Median Overall Survival as First-Line Treatment of Unresectable or Advanced Gastroesophageal Adenocarcinomas in the Phase 2 EDGE-Gastric Study

• First overall survival (OS) results from Arm A1 of the Phase 2 EDGE-Gastric study will be presented on October 18 at the European Society for Medical Oncology (ESMO) 2025 Congress
• These data support the ongoing development of domvanalimab plus zimberelimab and chemotherapy in the Phase 3 STAR-221 study in the same patient population

HAYWARD, Calif.–(BUSINESS WIRE)–Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, today announced the first OS results from Arm A1 of the Phase 2 EDGE-Gastric study in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma. The ongoing, multi-arm, global Phase 2 EDGE-Gastric study is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy in this patient population. This study was conducted in partnership with Gilead Sciences. These results will be presented in a mini oral session at the ESMO 2025 Congress (Presentation Number 2112MO).

“It is impressive to see that 50 percent of the patients enrolled in Arm A1 of the EDGE-Gastric study went on to live for more than two years,” said Dr. Sun Young Rha, professor of Medical Oncology in the Department of Internal Medicine and the director of Songdang Institute for Cancer Research, Yonsei University College of Medicine, Yonsei University Health System in Seoul, Korea. “A 26.7-month median overall survival is well beyond what would be required to demonstrate clinically meaningful benefit over standard of care.”

“These survival results add to the totality of data for domvanalimab and the role of anti-TIGIT-based combinations for the treatment of different cancers and reinforce our conviction that an Fc-silent anti-TIGIT antibody may provide differentiated efficacy and safety,” said Richard Markus, M.D., Ph.D., chief medical officer of Arcus. “These promising results reinforce our confidence in the ongoing Phase 3 STAR-221 study.”

In addition to describing OS data, this presentation also includes updated progression-free survival (PFS) and objective response rate (ORR) data, which are consistent with prior reports on this study. At data cutoff (DCO, March 3, 2025), safety and efficacy were evaluated in all patients enrolled and treated (n=41), and median study follow-up was 26.4 months. Efficacy was observed across all PD-L1 subgroups. With a median time on treatment of 49 weeks (range: <1-117 weeks), the domvanalimab plus zimberelimab and chemotherapy regimen demonstrated sustained efficacy with longer follow-up.

Summary of EDGE-Gastric Arm A1 Efficacy Results:

No unexpected safety signals were observed at the time of data cutoff. The regimen of domvanalimab plus zimberelimab and chemotherapy was generally well tolerated and had a safety profile that is consistent with that of anti-PD-1 plus chemotherapy. Immune-mediated treatment-emergent adverse events related to domvanalimab and/or zimberelimab occurred in 9 patients (22%), and infusion-related reactions occurred in 3 patients (7%).

Domvanalimab and zimberelimab are investigational molecules, and neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established.

About the EDGE-Gastric Study

The ongoing, multi-arm, multi-cohort global Phase 2 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 in Arm A1, with previously untreated G/GEJ/E adenocarcinoma, received 1600mg of domvanalimab intravenously (IV) every four weeks (Q4W) plus 480mg of zimberelimab IV Q4W + FOLFOX (oxaliplatin 85 mg/m2 IV, leucovorin 400mg/m2 IV, fluorouracil 400mg/m2 IV bolus + 2400mg/m2 continuous 46-48-hour IV infusion) every two weeks.

About the STAR-221 Study

The ongoing, global STAR-221 trial (NCT05568095) enrolled approximately 1,050 participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The primary endpoints of the study are overall survival in PD-L1-high tumors, PD-L1-positive tumors and in the intent-to-treat population (all PD-L1 levels); secondary endpoints include progression-free survival, objective response rate and duration of response. Participants were randomized 1:1 between two arms:

• 1600mg of domvanalimab intravenously (IV) every four weeks plus 480mg of zimberelimab IV every four weeks plus FOLFOX (oxaliplatin, leucovorin, fluorouracil) every two weeks or 1200mg of domvanalimab plus 360mg of zimberelimab every three weeks plus CAPOX (capecitabine and oxaliplatin) every three weeks
• 240mg of nivolumab IV every two weeks plus FOLFOX every two weeks or 360mg of nivolumab plus CAPOX every three weeks

About Domvanalimab

Domvanalimab is the first and most clinically advanced Fc-silent investigational monoclonal antibody that is specifically designed with Fc-silent properties to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint receptor on immune cells that acts as a brake on the anticancer immune response. By binding to TIGIT with Fc-silent properties, domvanalimab is believed to work by freeing up immune-activating pathways and activate immune cells to attack and kill cancer cells without depleting the peripheral regulatory T cells important in avoiding immune-related toxicity.

Combined inhibition of both TIGIT and programmed cell death protein-1 (PD-1) is believed to significantly enhance immune cell activation, as these checkpoint receptors play distinct, complementary roles in anti-tumor activity. Domvanalimab is being evaluated in combination with anti-PD-1 monoclonal antibodies, including zimberelimab in multiple ongoing and planned early and late-stage clinical studies in various tumor types.

About Zimberelimab

Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types.

Zimberelimab is being evaluated in the U.S. and globally as a foundational anti-PD-1 treatment option in multiple ongoing clinical studies in combination with other immunotherapies. Guangzhou Gloria Biosciences Co. Ltd., which holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab for the treatment of recurrent or metastatic cervical cancer and for relapsed or refractory classical Hodgkin’s lymphoma. Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead.

About Arcus Biosciences

Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination therapies for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- and/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including domvanalimab, an Fc-silent anti-TIGIT antibody being studied in combination with zimberelimab, an anti-PD-1 antibody, for upper gastrointestinal and non-small cell lung cancer, casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com.

Arcus Forward-Looking Statements

This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements on the potential for differentiation with domvanalimab. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to risks associated with: interim data not being replicated in other studies evaluating the same investigational molecules or regimen; the unexpected emergence of adverse events or other undesirable side effects from studies evaluating domvanalimab and/or zimberelimab; Arcus’s ability to complete ongoing studies; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release except to the extent required by law.

The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.

Contacts

Investor Inquiries:
Pia Eaves

VP of Investor Relations & Strategy

(617) 459-2006

peaves@arcusbio.com

Media Inquiries:
Holli Kolkey

VP of Corporate Affairs

(650) 922-1269

hkolkey@arcusbio.com

Maryam Bassiri

AD, Corporate Communications

(510) 406-8520

mbassiri@arcusbio.com