On May 29, 2025 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, reported its upcoming contributions to the 2025 Annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting in Chicago, Illinois (Press release, Debiopharm, MAY 29, 2025, View Source [SID1234653504]).

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The contributions feature three clinical poster presentations and one translational research abstract publication, highlighting Debio 0123’s potential across solid tumors. Among them is new data from the Debio 0123-SCLC-104 trial in small-cell lung cancer, offering insights into the candidate’s therapeutic potential in this difficult-to-treat disease. A Trial in Progress (TiP) poster from the investigator-initiated MedSir study—co-authored by Debiopharm—will present the design and methodology of the study investigating the combination of Debio 0123 with Trodelvy in breast cancer patients. In parallel, a separate TiP poster for the Debio 0123-102 monotherapy study will outline the framework and objectives of the ongoing dose expansion phase.

"Presenting our latest data on Debio 0123 at ASCO (Free ASCO Whitepaper) 2025 is a proud milestone for our team," said Angela Zubel, Chief Development Officer at Debiopharm. "This research highlights the promise of WEE1 inhibition as a precision strategy to target the vulnerabilities of aggressive cancers. Our goal is to push the boundaries of innovation to bring transformative therapies to patients who urgently need new options."

Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

ASCO 2025 Contribution

Title

Presenter/Author

Abstract #e15127

*Publication only

In silico evaluation of the interaction of P-gp and 3A4 substrates with the WEE1 inhibitor Debio 0123 and clinical application in the Debio 0123-104 combination trial with carboplatin and etoposide.

Anne Bellon, PhD, PharmD

Debiopharm

Abstract #TPS3172

Poster Bd #: 479b

Phase IB/II study to evaluate safety and preliminary efficacy of the WEE1 inhibitor Debio 0123 in combination with sacituzumab govitecan (SG) in triple-negative or hormone receptor–positive (HR+)/HER2-negative (HER2–) advanced breast cancer (ABC): The WIN-B study.

Maria Gion, MD, PhD

Medical Oncologist at Ramón y Cajal University Hospital

*Medsir and Debiopharm

Session Title: Gynecologic Cancer

ASCO 2025 Contribution

Title

Presenter/Author

Abstract #TPS5634

Poster Bd #: 524a

Debio 0123, a highly selective WEE1 inhibitor in adult patients with advanced solid tumors: A phase 1 dose escalation and expansion monotherapy study.

Maria M. Rubinstein, MD

Memorial Sloan Kettering Cancer Center, New York, NY

Session Title: Lung Cancer—Non–Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

ASCO 2025 Contribution

Title

Presenter/Author

Abstract #8098

Poster Bd #: 219

Debio 0123, a highly selective WEE1 inhibitor, in combination with carboplatin (C) and etoposide (E), in patients (pts) with recurrent small cell lung cancer (SCLC): Determination of recommended dose (RD) from a phase 1 escalation.

Valentina Gambardella, MD, PhD

Department of Medical Oncology, Hospital Clínico Universitario, INCLIVA Biomedical Research Institute, University of Valencia, Valencia, Spain

About DNA-Damage Repair (DDR)

When cells have damaged DNA, they need to undergo a repair process called DDR to be able to survive. Cancer cells rely heavily on DDR as they divide and grow uncontrollably. Inhibition of DDR, particularly in combination with other anticancer agents, prevents cancer cells from repairing their DNA, which ultimately activates a self-destruction program in cancer cells. DDR inhibitors such as Debiopharm’s WEE1 inhibitor Debio 0123 are being tested in clinical and preclinical studies.

Debiopharm’s commitment to patients

Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally.

On May 29, 2025 Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the Biologics License Application (BLA) seeking accelerated approval in the U.S. for patritumab deruxtecan (HER3-DXd), based on the HERTHENA-Lung01 Phase 2 trial for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies, has been voluntarily withdrawn (Press release, Merck & Co, MAY 29, 2025, View Source [SID1234653490]).

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The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance, as well as discussions with the U.S. Food and Drug Administration. The decision is unrelated to the Complete Response Letter that was received in June 2024 and outlined findings pertaining to an inspection of a third-party manufacturing facility.

Patritumab deruxtecan is a specifically engineered HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck

Results from the HERTHENA-Lung02 Phase 3 trial, including previously reported statistically significant progression-free survival (PFS) along with topline OS results, will be presented during an oral presentation (#8506) at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO25) Annual Meeting on Sunday, June 1, 2025.

HERTHENA-Lung02 is evaluating patritumab deruxtecan monotherapy versus doublet chemotherapy, consisting of platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy, in patients with EGFR-mutated (exon 19 deletion or L858R mutated) advanced NSCLC after disease progression with a third generation EGFR tyrosine kinase inhibitor (TKI) treatment. Patients achieving tumor response will continue to receive patritumab deruxtecan or chemotherapy until disease progression, per investigator assessment.

"EGFR-mutated non-small cell lung cancer has proven to be difficult-to-treat in the second-line metastatic setting and beyond," said Ken Takeshita, MD, global head, R&D, Daiichi Sankyo. "While we are disappointed with the overall survival results of HERTHENA-Lung02, we are conducting further biomarker analyses to better identify patients that may benefit from patritumab deruxtecan to guide our continued development in lung cancer. We remain confident in the broad development program of this HER3 directed antibody drug conjugate, which currently includes multiple clinical trials across 15 types of cancer."

"Lung cancer is one of the leading causes of cancer-related deaths worldwide and these results are a reminder of how challenging it can be to treat these patients with EGFR-mutated non-small cell lung cancer in the second and later line settings," said Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "We would like to thank the patients, their families, and investigators for their participation in this study."

The safety profile seen in HERTHENA-Lung02 was consistent with that observed for patritumab deruxtecan in previous lung cancer clinical trials, with no new safety signals identified.

About HERTHENA-Lung01

HERTHENA-Lung01 is a global, multicenter, open-label, two-arm Phase 2 trial evaluating the safety and efficacy of patritumab deruxtecan in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy. Patients were randomized 1:1 to receive 5.6 mg/kg (n=225) or an uptitration regimen (n=50). The uptitration arm was discontinued as the dose of 5.6 mg/kg of patritumab deruxtecan was selected following a risk-benefit analysis conducted from a separate Phase 1 trial assessing the doses in a similar patient population.

The primary endpoint of HERTHENA-Lung01 was objective response rate (ORR) as assessed by blinded independent central review (BICR). Secondary endpoints included duration of response, PFS, disease control rate, and time to response – all assessed by both BICR and investigator assessment – as well as investigator-assessed ORR, OS, safety and tolerability. The ORR data and additional results for key secondary endpoints of HERTHENA-Lung01 were published in the Journal of Clinical Oncology in September 2023.

HERTHENA-Lung01 enrolled 277 patients in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

About HERTHENA-Lung02

HERTHENA-Lung02 is a global, multicenter, open-label, Phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (5.6 mg/kg every three weeks) monotherapy versus four cycles of doublet chemotherapy) pemetrexed and platinum chemotherapy) in patients with metastatic or locally advanced NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R) after failure of third-generation (e.g., osimertinib, lazertinib, aumolertinib, alflutinib) EGFR TKI therapy. Patients in the chemotherapy arm without disease progression after four cycles of pemetrexed and platinum chemotherapy are able to continue treatment with maintenance pemetrexed with no restriction on the number of cycles.

The primary endpoint of HERTHENA-Lung02 is PFS as assessed by BICR. Secondary endpoints included OS, ORR, duration of response, clinical benefit rate, time to response, disease control rate, and safety. Patients enrolled in the study underwent brain imaging to allow for assessment of intracranial endpoints, including intracranial PFS as assessed by BICR.

HERTHENA-Lung02 enrolled 586 patients in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

About EGFR-Mutated Non-Small Cell Lung Cancer

Nearly 2.5 million lung cancer cases were diagnosed globally in 2022. Lung cancer is the most common cancer and the leading cause of cancer-related deaths worldwide.9 NSCLC accounts for about 87% of all lung cancers1. Approximately 10% to 15% of patients with NSCLC in the U.S. and Europe, and 30% to 40% of patients in Asia have an EGFR mutation.3,4

NSCLC is diagnosed at an advanced stage in up to 70% of patients.2 For patients with tumors that have an EGFR mutation, the established first-line treatment in the metastatic setting includes EGFR-directed therapy with or without platinum-based chemotherapy.While these therapies have improved outcomes, most patients eventually experience disease progression and receive subsequent therapies.5,6,7,8

About HER3

HER3 is a member of the HER family of receptor tyrosine kinases.11 It is estimated that about 83% of primary NSCLC tumors and 90% of advanced EGFR-mutated tumors express HER3 after prior EGFR TKI treatment.12 HER3 is associated with poor treatment outcomes, including shorter relapse-free survival and significantly reduced survival.13,14 There is currently no HER3 directed therapy approved for the treatment of any cancer.

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd) is an investigational HER3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, patritumab deruxtecan is composed of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

About the Patritumab Deruxtecan Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of patritumab deruxtecan across cancers. Trials in combination with other anticancer treatments are also underway.

On May 29, 2025 Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported that the first patient has been dosed in the second cohort of its dose escalation study of Phase I/II STARLIGHT-1 trial for EB103, a CD19-redirected ARTEMIS T-cell therapy to treat patients with Advanced B-Cell Non-Hodgkin’s Lymphomas (NHL) (Press release, Estrella Biopharma, MAY 29, 2025, View Source [SID1234653505]).

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The second cohort will evaluate EB103 at a higher dose level following a review of safety data from the first dose cohort. As previously announced, no dose-limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs) were observed in the first cohort. The initiation of dosing in the second cohort reflects steady progress in Estrella’s mission to complete Phase I of STARLIGHT-1.

"We are excited to announce another important milestone in our STARLIGHT-1 trial and are encouraged by the favorable safety profile and the complete response observed in the first cohort," said Cheng Liu, Chief Executive Officer of Estrella. "EB103 has a significant potential to address key limitations of traditional CAR-T therapies by mitigating safety risks and expanding accessibility to high-risk patient groups, including those with HIV-associated lymphoma and central nervous system (CNS) lymphoma – conditions that are excluded from existing CAR-T options. We look forward to evaluating EB103 at higher doses and delivering the treatments to patients soon."

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T-cells seek out CD19-positive cancer cells, bind to these cells, and destroy them.

On May 29, 2025 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported that it is scheduled to participate in the following upcoming investor events (Press release, Arrowhead Pharmaceuticals, MAY 29, 2025, View Source [SID1234653491]):

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Jefferies Global Healthcare Conference – June 4-5, 2025

Type: Fireside Chat Presentation
Date/Time: June 4, 2025, 9:20 a.m. EDT

46th Annual Goldman Sachs Global Healthcare Conference – June 9-11, 2025

Type: Fireside Chat Presentation
Date/Time: June 9, 2025, 2:00 p.m. EDT

Presentation webcasts may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

On May 29, 2025 Accuray Incorporated (NASDAQ: ARAY) reported its participation in the Jefferies Global Healthcare Conference 2025 (Press release, Accuray, MAY 29, 2025, View Source [SID1234653492]). The management team is scheduled to participate in a fireside chat on Wednesday, June 4th, 2025, at 5:30pm EDT/2:30pm PDT.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the call will also be available from the Investor Relations section of the company’s website at investors.accuray.com. A webcast replay can be accessed on the website and will remain available for 90 days.