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Astellas Enters Exclusive License Agreement with Evopoint Biosciences for XNW27011, a Novel Clinical-stage Antibody-Drug Conjugate Targeting CLDN18.2

On May 29, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Evopoint Biosciences (Evopoint Biosciences Co., Ltd.) reported they have entered into an exclusive license agreement for XNW27011, a novel investigational clinical-stage antibody-drug conjugate (ADC) targeting CLDN18.2 (Press release, Astellas, MAY 29, 2025, View Source,-a-Novel-Clinical-stage-Antibody-Drug-Conjugate-Targeting-CLDN18-2 [SID1234653478]). The agreement grants Astellas a worldwide (excluding China’s mainland, Hong Kong, Macao and Taiwan region) exclusive license to develop and commercialize XNW27011.

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XNW27011 is currently being evaluated in a Phase 1/2 study in China in patients with CLDN18.2-expressing solid tumors, including gastric cancer, gastroesophageal cancer and pancreatic cancer. It uses a proprietary topoisomerase I inhibitor payload and linker technology, an approach that has demonstrated clinical success in other approved cancer therapies.

Astellas has significant expertise in developing therapies that target CLDN18.2, including VYLOYTM, the first CLDN18.2-targeted therapy approved in the world. XNW27011 has the potential to address currently unmet patient need and will expand Astellas’ oncology pipeline which currently contains CLDN-targeting therapies utilizing different approaches, as well as ADC’s directed to other targets.

Under the terms of the agreement, Evopoint will receive a $130 million upfront payment and is eligible to receive up to $70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialization milestones totaling up to $1.34 billion, as well as royalties on net sales of XNW27011, if approved.

Aligos Therapeutics to Present at the Jefferies Global Healthcare Conference

On May 29, 2025 Aligos Therapeutics, Inc. (Nasdaq: ALGS) a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported that members of management will present at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025 at 2:00pm ET (Press release, Aligos Therapeutics, MAY 29, 2025, View Source [SID1234653477]).

A live webcast of the presentation will be accessible by visiting the Presentation & Events section on the "Investors" page of Aligos’ website at www.aligos.com. A replay of the webcast will be available following the presentation for at least 30 days.

Experimental Drug Development Centre Granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to Treat Pancreatic Ductal Adenocarcinoma

On May 28, 2025 The Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development, reported 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) (Press release, Experimental Drug Development Centre, MAY 28, 2025, View Source [SID1234654012]). 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) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago from 30 May to 3 June 2025.

Presentation Details at ASCO (Free ASCO Whitepaper) 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.

Theralase® to Present Groundbreaking Research at ASTRO 2025

On May 28, 2025 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical company pioneering light, radiation, sound and drug-activated therapeutics for the treatment of cancer, bacteria and viruses reported promising new preclinical results (Press release, Theralase, MAY 28, 2025, View Source [SID1234653882]). The Company’s latest research demonstrates that radiation-activated Rutherrin is up to 100 times more effective at destroying cancer cells than radiation therapy alone in comparable models.

This data will be showcased at the 2025 American Society for Radiation Oncology ("ASTRO") 67th Annual Meeting, the world’s largest gathering of radiation oncology professionals, taking place in late September in San Francisco, California. ASTRO has selected the Theralase abstract titled, "Rutherrin Activated by Radiation Therapy Induces Synergistic Tumor Regression through Direct Destruction and Immune Activation in Multiple Preclinical Cancer Models", for presentation in a scientific poster session.

The study highlights the potent anti-cancer effects of Rutherrin—a ruthenium-based small molecule drug formulated with recombinant human transferrin for intravenous administration. Once activated by ionizing radiation through a process known as Radio Dynamic Therapy ("RDT"), Rutherrin initiates a two-phase cancer-killing response: the generation of Reactive Oxygen Species ("ROS") for immediate cytotoxicity, followed by Immunogenic Cell Death ("ICD") to stimulate a durable immune response.

Key Findings from the Preclinical Research:

Selective Tumor Targeting: Rutherrin preferentially accumulates in tumor tissues, sparing healthy cells.
Blood-Brain Barrier Penetration: Demonstrated 10x higher concentrations in Glio Blastoma Multiforme ("GBM") tumors than in healthy brain tissue.
Synergistic Mechanism: Combines direct tumor cell destruction with robust immune activation.
Improved Survival Rates: Statistically significant survival benefits compared to radiation therapy alone.
Resistance Overcoming: Effectively inhibits mechanisms associated with multidrug and radiation resistance.
Adaptive Immune Activation: Induces long-term immunity, as evidenced by resistance to tumor rechallenge.
Mark Roufaiel, Ph.D., research scientist at Theralase commented, "These results are highly encouraging. Rutherrin not only enhances the effectiveness of radiation therapy, but also activates a sustained immune response, offering a powerful, dual-action strategy against aggressive and treatment-resistant cancers."

Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer of Theralase, added, "Our focus is to bring this innovative platform to clinical application. Rutherrin represents a major advancement in oncologic treatment, potentially enabling radiation oncologists to dramatically improve patient outcomes. This research provides a strong foundation for integrating Rutherrin with existing cancer therapies to deliver more effective, long-lasting solutions."

Roger DuMoulin-White, B.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer of Theralase, stated, "Based on this compelling data, we are fully committed to completing GLP toxicology studies in 2025. This critical milestone will support the launch of clinical studies in early 2026 targeting GBM, lung, pancreatic, lymphoma and colorectal cancers. We’re excited to continue advancing Rutherrin toward commercialization and transforming cancer care."

About ASTRO

Founded in 1958, ASTRO’s mission is to advance the practice of radiation oncology by promoting excellence in patient care, providing opportunities for educational and professional development, promoting research, disseminating research results and representing radiation oncology in a rapidly evolving health care environment.

The ASTRO Annual Meeting is the premier event in radiation oncology, bringing together leading scientists, clinicians and industry partners to share groundbreaking research and technological innovations. The 2025 meeting in San Francisco will showcase cutting-edge advances in radiation biology, translational medicine and cancer therapeutics.

About Rutherrin

Rutherrin is a patented formulation of Theralase’s lead ruthenium-based small molecule (Ruvidar) combined with recombinant human transferrin making it suitable for intravenous delivery. It has the ability to selectively accumulate in cancer cells versus healthy cells and when radiation-activated provide a one-two punch to cancer, by first destroying the cancer cell through oxidative stress and then activating the immune system for destruction of residual cancer cells. Rutherrin is slated to enter clinical studies in early 2026 for the destruction of deadly cancers; including: brain, lung, pancreatic, colorectal and lymphoma.

Invectys, Inc. Announces Presentation of First-in-Human Clinical Trial Design on HLA-G–Targeted CAR T Therapy at ASCO 2025

On May 28, 2025 Invectys, Inc., a clinical-stage biotechnology company pioneering novel cancer immunotherapies, reported that MD Anderson Investigators Drs. Samer Srour and Aung Naing will present a Trial-in-Progress poster at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30–June 3 in Chicago, Illinois (Press release, Invectys, MAY 28, 2025, View Source [SID1234653612]).

The presentation will detail the ongoing Phase 1/2a clinical trial evaluating IVS-3001, Invectys’ first-in-human chimeric antigen receptor (CAR) T-cell therapy targeting HLA-G, a non-classical MHC class I molecule overexpressed in various solid tumors. HLA-G functions as a powerful immune checkpoint, enabling tumor cells to evade immune surveillance. By engineering CAR T cells to recognize and eliminate HLA-G–expressing cancer cells, IVS-3001 aims to restore the immune system’s ability to combat tumors.

Presentation Details:

Abstract Title: Safety and efficacy of HLA-G–targeted CAR T cells (IVS-3001) in patients with advanced HLA-G–positive solid tumors: Clinical trial in progress
Abstract Number: TPS2679
Session: Developmental Therapeutics—Immunotherapy
Session Type: Poster Session
Poster Board Number: 320b
Date and Time: Monday, June 2, 2025, 1:30 PM – 4:30 PM CDT
Location: McCormick Place Convention Center, Chicago, IL
The Phase 1/2a trial is designed to assess the safety, tolerability, and preliminary efficacy of IVS-3001 in patients with advanced solid tumors expressing HLA-G. The study also aims to evaluate the therapy’s pharmacokinetics and immunogenicity.

"We are excited to share our progress on IVS-3001 at ASCO (Free ASCO Whitepaper) 2025. Patients with solid tumors have profound unmet clinical need. HLA-G is an especially exciting target for cell therapy, as it is both a widely expressed tumor marker and a potent immune checkpoint. Thus, HLA-G directed therapies have the potential to treat a vast variety of solid tumors." said Dr. Jake Kushner, CEO of Invectys. "This study represents a key step forward in our mission to develop innovative immunotherapies that address unmet needs in oncology."