Fam-trastuzumab deruxtecan-NXKI

iStock, Syahrir Maulana As next-generation antibody-drug conjugates reshape cancer care, digital pathology and artificial intelligence are transforming how HER2 is measured. The advances aim to help clinicians identify low and ultra-low expressors, match patients to the right therapies and make more precise treatment decisions. The latest generation of antibody drug conjugates (ADCs) has become a focal point in oncology because they can target cancer cells more precisely. But getting the benefit hinges on accurately measuring how much HER2 protein is present in a patient’s tumor to guide treatment. Traditional lab tests can miss important details, especially for patients with low HER2 expression, but digital pathology and artificial intelligence (AI) are making it much easier to accurately measure HER2 levels. This means more patients can get the most effective ADC treatments for their specific cancer, and doctors can make better decisions about care. The ADC and HER2 Evolution The technology surrounding ADCs has existed for more than 20 years, with gradual advancements in three distinct components: the payload, linker and antibody, explained Dr. Rob Monroe, vice president and chief scientific officer of oncology at Danaher Corporation and chief medical officer at Leica Biosystems. Scientific advances, such as better designed antibodies and more stable linker systems, have allowed for more effective payload release, Monroe said. This in turn has led to therapeutics like Daiichi Sankyo/AstraZeneca’s Enhertu. Enhertu is a targeted antibody- ADC indicated for HER2-positive or HER2-low breast cancer, HER2-positive gastric/gastroesophageal junction cancer, and HER2-mutant non-small cell lung cancer. HER2 is now having a “rebirth” under the premise of digital and computational pathology and the ability to identify low and ultra-low responders, said Jennifer Faikish, vice president and franchise head of oncology at Danaher Corporation. The advancements offer the ability to dive deeper into cell biology and see small levels of protein expression that can make patients eligible for targeted therapies. A traditional visual pathologist might have a hard time distinguishing these protein signals with the eye, due to different staining patterns that are difficult to see with lower expressors, Faikish said. AI however, can be trained on a vast amount of HER2 images and outcomes for subtle pattern detection, outperforming basic image analysis, Monroe said. Adoption Hurdles Despite the incredible potential of both digitization and AI, there is still some time before widespread adoption, Monroe and Faikish agreed. Currently, both technologies are an addition to a pathologist’s workflow, Monroe said. Also, relative to radiology images, pathology images are significantly larger: on order of 10 to 20 times. They’re gigabyte therefore, they are much more difficult to manipulate as a pathologist orresearcher. Novel technology implementation and cybersecurity concerns are also among the reasons behind the slow U.S. adoption, Faikish added. Digital or computational pathology adoption is globally quoted at around 25% of labs, led by EU markets and then some U.S academic labs, she said. Ultimately, digitization will have workflow advantages, such as centralization of imaging in a cloud-based environment, to allow pathologists to share knowledge, she said. Like many new technologies, the reimbursement certainly lags in the U.S. and other countries, Faikish said. Associations like the Digital Pathology Association and the College of American Pathologists are very focused on driving reimbursement, including both the services that pathologists provide and for oversight to run these advanced technologies. In terms of the lack of digital standardization and interoperability, that’s a “critical issue that’s facing the field,” Monroe said, noting the many different systems and There’s a movement to have Digital Imaging and Communications in Medicine, an international standard for storing, transmitting and managing medical imaging data, apply to pathology, he added. Bright Outlook In terms of future collaboration among pathologists, data scientists and oncologists evolving over the next five years, Faikish noted the incredible potential for digital and computational pathology in terms of advancing companion diagnostics, therapy predictions and potential diagnosis. There is also potential for assays to have multi-ADC targets, AI for best match selection and oncologist-led trials for sequencing and combinations, Monroe added. You can hear more on this week’s Denatured podcast episode.

Milestone validates the clinical potential of BSI-082 as a synergistic combination partner for antibody-drug conjugates (ADCs). NEWARK, DE, UNITED STATES, February 3, 2026 / EINPresswire.com / -- Biosion , Inc. (“Biosion”), a global, clinical-stage biotechnology company developing innovative antibody-based therapeutics, today announced that the first patient has been dosed in a Phase 1a/1b Investigator-Initiated Trial (IIT) evaluating BSI-082 , a highly differentiated, fully human anti-SIRPα monoclonal antibody. The study is sponsored by and being conducted at the Mays Cancer Center, a National Cancer Institute (NCI)-designated Cancer Center and part of The University of Texas at San Antonio’s Health Science Center. This clinical milestone highlights the medical community's strong interest in Biosion's oncology assets and follows the company's recent transformative partnership with Aclaris Therapeutics for its immunology portfolio. Collaborating to Unlock Innate Immunity BSI-082 is engineered to block the CD47-SIRPα "don't eat me" signal, a critical checkpoint tumor cells use to evade macrophage phagocytosis. Unlike other candidates in the class, BSI-082 was designed using Biosion’s proprietary H³ Antibody Discovery Platform to overcome historical development challenges. Key differentiators of BSI-082 include: ●Broad Population Coverage: High-affinity binding to SIRPα variants V1, V2, and V8, covering >90% of the human population. ●Superior Safety Profile: Engineered Fc domain minimizes binding to red blood cells (RBCs) and platelets, significantly reducing the risk of anemia and thrombocytopenia often seen with anti-CD47 therapies. ●Preserved T-Cell Function: No binding to SIRPγ, ensuring that adaptive immune responses remain active and uninhibited. “The initiation of this trial by a premier institution like the Mays Cancer Center serves as powerful validation of BSI-082’s scientific rationale and therapeutic potential,” said Mingjiu Chen, Ph.D., Founder and CEO of Biosion. “BSI-082’s unique profile—specifically its ability to potently block the ‘don’t eat me’ signal without compromising patient safety—positions it as an ideal combination partner for standard-of-care therapies, particularly antibody-drug conjugates (ADCs). We are honored to support Dr. Sarantopoulos and his team in this study, which represents a key step in our strategy to maximize the value of our oncology assets through high-quality clinical partnerships.” Study Design and Strategic Combinations The Phase 1a/1b study is an open-label, dose-escalation and dose-expansion trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BSI-082 in patients with locally advanced or metastatic solid tumors. ●Phase 1a: Will establish the Recommended Dose for Expansion (RDE) of BSI-082 as a monotherapy. ●Phase 1b: Will evaluate BSI-082 in combination with trastuzumab deruxtecan (T-DXd) in patients with HER2-positive solid tumors. Preclinical data has demonstrated that SIRPα blockade can synergistically enhance the antitumor activity of ADCs by promoting antibody-dependent cellular phagocytosis (ADCP). “Targeting the innate immune system via the SIRPα-CD47 axis offers a compelling therapeutic strategy for refractory tumors,” said John Sarantopoulos, M.D., associate professor of medicine in the Division of Hematology and Oncology, medical oncologist, and principal investigator at the Mays Cancer Center. “We are excited to lead the clinical evaluation of BSI-082, whose design addresses key limitations of earlier generation agents. We look forward to exploring its potential to improve outcomes for patients, particularly in combination with ADCs.” About Biosion Biosion is a global, clinical-stage biotechnology company dedicated to developing innovative antibody therapies to improve outcomes for patients with immunological and oncological diseases. By leveraging its proprietary core technology platforms—including the H³ Antibody Discovery platform, the SynTracer ® HT Endocytosis platform, and the Flexibody ® Bispecific platform—the company develops highly differentiated innovative medicines to address significant unmet medical needs worldwide. Through its flexible "Discover-Develop-Partner" model, Biosion has established over 10 global partnerships, with 9 programs currently in clinical development. These include monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs). Biosion maintains integrated operations across the United States, China, and Australia. For more information, please visit www.biosion.com . Contact Investor & Media Relations: Anthony Yeh, Ph.D., Chief Strategy Officer, Biosion, Inc. Email: BD@biosion.com Anthony Yeh Biosion.Inc +1 302-257-5085 BD@biosion.com Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.