1stOncology™: Cancer Intelligence Service – Page 498 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Debiopharm Licenses SunRock Biopharma’s Anti-HER3/HER2 Antibody to Explore the Full Potential of Bispecific ADC Debio 2512

On September 30, 2025 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based, biopharmaceutical company reported having signed a license agreement for SunRock Biopharma’s SRB21, an HER3/HER2 antibody (Press release, Debiopharm, SEP 30, 2025, View Source [SID1234656361]). SunRock Biopharma is a Galician company supported by the regional government, Xunta de Galicia, through Xesgalicia, devoted to the development of antibodies against highly invasive tumors with an urgent clinical need in oncology. Debiopharm has exercised its option to license SunRock Biopharma’s bispecific antibody, which targets both HER2 and HER3 human epidermal growth factor receptors. This agreement, initially announced in 2023, will combine this antibody with Debiopharm’s proprietary MultiLINK Linker Technology to develop a new antibody-drug conjugate (ADC) under the name Debio 2512.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

Debiopharm will leverage their "Trifecta" approach with this bispecific antibody to create a fit-for-purpose ADC using proprietary linkers and smart payload selection. Bispecific ADCs target multiple antigens simultaneously potentially offering higher efficacy and specificity while reducing off-target effects and overcoming resistance mechanisms. This dual-targeting strategy may allow for more potent delivery of cytotoxic payloads directly to cancer cells while sparing healthy tissues, offering breakthrough options for patients with resistant cancer types.

"Bi-specific ADCs hold significant promise as the next generation of cancer therapies," mentioned Bertrand Ducrey, CEO of Debiopharm. "We’re excited to confirm this licensing option as it allows us to apply our MultilinkTM Linker Technology to a dual-targeted design that could pave the way for breakthrough therapies in HER-driven cancers."

HER2-driven cancers are widely recognized as more aggressive forms of disease, marked by faster growth, earlier relapse, and a higher likelihood of treatment resistance.1 While recent therapies have provided meaningful advances, many patients ultimately develop resistance and metastasis, limiting the durability of response and long-term survival benefits. A bi-specific antibody targeting HER3 and HER2 represents a highly promising advancement for ADC development. By targeting simultaneously HER2 and HER3, this approach has the potential to overcome resistance mechanisms that limit current HER2-directed therapies.

"The licensing of SRB21 represents a significant milestone for SunRock Biopharma and a strong validation of our bi-specific antibodies platform," said Laureano Simón, CEO of SunRock Biopharma. "Through our collaboration with Debiopharm, we aim to accelerate the development of next-generation bi-specific ADCs, tailored to offer new hope to patients with HER2-resistant tumors."

"Patients fighting HER2-driven cancers require treatment approaches that can safely and effectively target and outsmart resistant or recurrent disease," explained Frederic Levy, CSO at Debiopharm. "The development of bi-specific ADCs targeting HER3 and HER2 in conjunction with our "Trifecta" approach represents a highly promising advancement in hard-to-treat cancers."

Natera Announces Publication of Signatera™ Validation Study in Testicular Cancer

On September 30, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the publication of a peer-reviewed manuscript in the Journal of Clinical Oncology – Precision Oncology (JCO PO) (Press release, Natera, SEP 30, 2025, View Source [SID1234656360]). The paper features results from a multi-institutional study evaluating circulating tumor DNA (ctDNA) as a prognostic biomarker for patients with germ cell tumors (GCT), including testicular cancer.

Testicular cancer represents approximately 95% of all GCTs1 and is the most common malignancy in men aged 15-35.2 Serum tumor markers (STM) play a central role in the management of testicular cancer, but their utility is limited since they can be normal or falsely elevated in a substantial proportion of patients. While early stages can be cured with surgery alone or with the addition of chemotherapy and/or radiotherapy, a subset of patients may receive chemotherapy that may not be necessary. Having reliable biomarkers to stratify recurrence risk and guide these decisions is a critical challenge in advancing care for this patient population.

This multicenter, retrospective study analyzed 324 plasma samples from 74 patients with testicular cancer, across stages I-III. Signatera was used to assess ctDNA levels before, during and after treatment. Results demonstrated that Signatera-positivity was significantly associated with shorter event-free survival (EFS) in both post-surgical and surveillance settings. By comparison, conventional STMs did not consistently correlate with outcomes. When assessed together during surveillance, ctDNA outperformed STMs in predicting EFS. Key findings include:

The Signatera-based ctDNA-positivity rate pre-surgery was 91.6% for stage I, and 100% for both stage II and III.
Post-surgery (<12 weeks), Signatera-positive patients had a significantly shorter EFS compared to Signatera-negative patients (EFS HR: 5.11, p=0.019). In contrast, patients with elevated STMs showed no significant difference in EFS compared to those with normal STM levels (EFS HR: 2.97, p=0.149).
In the surveillance setting, Signatera-positive patients experienced a significantly shorter EFS compared to Signatera-negative patients (HR: 12.45, p<0.0001). This was not reflected in patients stratified by STM levels (HR: 1.74, p=0.194).
"These findings demonstrate that ctDNA can identify which patients with testicular cancer are at high risk of recurrence or progression," said Nabil Adra, M.D., associate professor of medicine at Indiana University and principal investigator of the study. "This study gives us new key evidence on the potential of ctDNA to meaningfully improve how we monitor and manage this disease."

"Testicular cancer is the most common cancer in young men," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "Serum tumor biomarkers are widely used but often leave gaps in decision-making. These results, which represent the largest published study of ctDNA in testicular cancer to date, highlight the unique value of Signatera to reliably detect molecular residual disease and predict clinical outcomes."

RefleXion Medical Announces First Clinical Outcomes for SCINTIX Therapy in Lung and Bone Tumors

On September 30, 2025 RefleXion Medical, an external‑beam theranostic oncology company, reported first results from the PREMIER Registry (NCT05406167) evaluating its SCINTIX biology-guided radiotherapy, or BgRT, platform in patients with lung and bone tumors (Press release, RefleXion, SEP 30, 2025, View Source [SID1234656359]). The findings, presented at the 2025 ASTRO Annual Meeting, showed local control of 100 percent at nine months post-treatment with no reported Grade 2 or higher adverse events. The data represent the first prospective, multi-institutional evidence of SCINTIX therapy’s clinical impact.

"The PREMIER Registry findings mark a milestone for our field," said Sean Shirvani, M.D., MPH, chief medical officer at RefleXion. "We are beginning to see the clinical translation of a technology that can autonomously guide radiation based on real-time biology. Achieving 100% local control in both lung and bone tumors with imaging up to nine months after treatment, without significant toxicity, represents an important step forward in expanding the reach of radiotherapy for patients with advanced cancer."

By Feb. 25, 2025, five cancer centers had enrolled 45 patients in the registry, with 28 providing follow-up imaging for analysis. Fifteen patients were treated for lung tumors, including early-stage and metastatic disease, and 13 for bone metastases. The median patient age was 69.5 years, with 39% female.

Across 39 follow-up scans, investigators reported a local control rate – defined as complete response (CR), partial response (PR), or stable disease (SD) – of 100% across available follow-up imaging. Tumor response rates (CR+PR) were 41% overall, including 47% for bone metastases and 35% for lung tumors. No Grade 2 or higher treatment-related adverse events were observed.

RefleXion plans to expand registry enrollment and continue long-term follow-up to strengthen the dataset and evaluate correlations between treatment parameters, imaging metrics and patient outcomes.

These early results underscore RefleXion’s goal of establishing SCINTIX therapy as a first-in-class treatment option for both localized and metastatic disease. As the registry grows, the company expects the evidence to further support BgRT’s integration into routine cancer care.

RefleXion (booth #1433) is also presenting early results characterizing performance of its future, next-generation platform1 that offers a 20-fold increase in PET sensitivity, which may increase patient eligibility for SCINTIX therapy. Presentations will be held every 30 minutes in the RefleXion booth during exhibit hours.

Accuray and the University of Wisconsin-Madison Announce Memorandum of Understanding to Advance Online Adaptive Radiotherapy in Support of Improving Cancer Patient Care

On September 30, 2025 Accuray Incorporated (NASDAQ: ARAY) and the University of Wisconsin School of Medicine and Public Health (UW SMPH) reported the signing of a memorandum of understanding (MOU) to advance online adaptive radiotherapy (OART) on the Accuray helical radiation treatment delivery platform (Press release, University of Wisconsin, SEP 30, 2025, View Source [SID1234656357]). As part of the MOU, the two parties outlined their intent to collaborate on clinical research, education and training, and adaptive technology development, to help empower medical care teams to raise the bar in the personalization and precision of cancer care.

"I couldn’t be prouder to announce this proposed collaboration with the University of Wisconsin and the renowned team at their Department of Human Oncology. We share a mutual goal to expand the curative power of radiotherapy with technologies that not only help extend survivorship but also quality of life―and we believe OART can help to do just that. The proposed collaboration aims to leverage our respective strengths to reshape the overall OART experience for providers so that ultimately, clinical departments of all sizes can find it feasible to incorporate this advanced treatment option into their practice," said Mu Young Lee, SVP, Research & Product Development at Accuray.

University of Wisconsin–Madison researchers invented the first helical radiation delivery platform, the TomoTherapy System. It ushered in a new era in radiation medicine that enabled clinicians, for the first time, to leverage a system specifically designed for integrated 3D daily image-guidance with intensity-modulated radiation therapy (IG-IMRT) to increase the precision and accuracy of treatments and help better control patients’ cancer. Since the TomoTherapy System’s introduction, Accuray has continued to evolve the helical platform with the purpose of further enhancing its precision and accuracy, as well as introducing advances in the areas of image quality, speed, versatility, and workflow efficiencies.

"The origins of the TomoTherapy System began right here at UW–Madison, and our clinical researchers have deep experience in bringing future innovations from bench to bedside," said Nita Ahuja, MD, MBA, Dean of the school and Vice Chancellor for Medical Affairs at the University of Wisconsin–Madison. "This MOU focused on online adaptive radiotherapy for personalized, precision cancer care signifies our commitment to keeping patients at the center of our research efforts, while also allowing important translational medicine training opportunities for the next generation of clinical researchers and physician-scientists."

AbbVie Submits Biologics License Application (BLA) to U.S. FDA for Pivekimab sunirine (PVEK) – an Investigational Antibody-Drug Conjugate (ADC) to Treat Rare Cancer with Limited Treatment Options

On September 30, 2025 AbbVie (NYSE: ABBV) reported submission of a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of investigational Pivekimab sunirine (PVEK) for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (Press release, AbbVie, SEP 30, 2025, View Source;an-investigational-antibody-drug-conjugate-adc-to-treat-rare-cancer-with-limited-treatment-options-302570103.html [SID1234656356]). The submission is based on data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of PVEK in BPDCN. BPDCN is a rare and aggressive blood cancer that has features of both leukemia and lymphoma. Patients typically present with skin lesions and the disease often spreads to the bone marrow, central nervous system and the lymph nodes. First-line treatments are typically intensive chemotherapy and often followed by stem cell transplant. The need for additional and innovative treatment is high for both newly diagnosed patients and for those whose prior treatments have resulted in relapsed or refractory disease.

PVEK is a CD123-targeting Antibody-Drug Conjugate (ADC) in clinical development for hematological malignancies (blood cancers), including BPDCN and acute myeloid leukemia (AML). ADCs are designed to deliver potent cancer cell death-inducing agents called ‘payloads’ directly to the cancer cells expressing a specific protein. CD123 (IL-3Rα) is a protein overexpressed in BPDCN, making it an ideal target for therapy.

"Meaningful innovations in cancer research and treatment are happening every day. It is important that these innovations reach patients who desperately need them, including those with rare cancers who have limited options," said Roopal Thakkar, executive vice president, research and development and chief scientific officer, AbbVie. "We look forward to next steps in the regulatory process for our latest Antibody-Drug Conjugate (ADC), our first ADC in blood cancer, and how it may advance treatment for those living with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)."

About the CADENZA Trial
CADENZA is a Phase 1/2 multicenter, open-label study designed to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing schedule for PVEK monotherapy and to assess the safety, tolerability, PK, immunogenicity, and antileukemia activity of PVEK when administered to subjects with CD123+ hematologic malignancies (including subjects with BPDCN, AML, and others).

About Pivekimab Sunirine (PVEK)
PVEK is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML). PVEK is currently being evaluated as monotherapy for patients with BPDCN and in combination with Vidaza (azacitidine) and Venclexta (venetoclax) for patients with untreated and relapsed/refractory AML. In October 2020, the FDA granted PVEK Breakthrough Therapy designation in relapsed/refractory BPDCN.