Latest news with #HER2-expressing
Toronto Star
14 hours ago
- Business
- Toronto Star
Junshi Biosciences Announces the Acceptance of the sNDA for Toripalimab as the 1st-line Treatment of HER2-expressing Urothelial Carcinoma
SHANGHAI, Aug. 08, 2025 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application ('sNDA') for toripalimab (trade name: TUOYI®) in combination with disitamab vedotin, an antibody-drug conjugate ('ADC') developed by RemeGen Co., Ltd. as the treatment of HER2-expressing (HER2 expression is defined as a HER2 immunohistochemistry test result of 1+, 2+, or 3+) locally advanced or metastatic urothelial carcinoma ('UC'), has been accepted by the National Medical Products Administration ('NMPA'). This is toripalimab's 13th application for marketing submitted in the Chinese mainland. UC is one of the ten most prevalent malignant tumors in the world, and in China, its incidence and mortality rates continue rising annually. According to the latest data from the National Cancer Center, in 2022, the number of new cases of UC in China reached 92,900, and the number of deaths reached over 40,000. UC is a serious threat to the life and health of patients, and there are huge unmet clinical needs.
Yahoo
04-06-2025
- Business
- Yahoo
Radiopharm Theranostics Doses First Patient in Phase 1 ‘HEAT' Trial of 177Lu-RAD202 for Treatment of Advanced HER2-Positive Solid Tumors
Phase 11 First-In-Human study designed to assess safety, tolerability, right dose for Phase 2 and early signs of efficacy of 177Lu-RAD202 in individuals with advanced HER2-positive solid tumors Previous clinical proof-of concept data2 for targeting HER-2 demonstrated the safety and biodistribution of 99mTc-RAD202 in humans SYDNEY, June 04, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, 'Radiopharm' or the 'Company'), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the dosing of the first patient in its Phase 1 'HEAT' clinical trial of RAD202, a proprietary nanobody that targets Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in a wide array of advanced solid tumors. The open-label Phase 1 'HEAT' clinical trial is a dose escalation trial of 177Lu-RAD202 that is designed to determine the recommended Phase 2 dose and to evaluate the safety and preliminary clinical activity of this novel radiotherapeutic in individuals with HER2-expressing advanced cancers. The study is currently being conducted at clinical centers across Australia. 'Dosing patients in the HEAT clinical trial marks an important milestone in our transition to a clinical-stage company,' said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. 'Despite progressive improvements in the management of metastatic HER2-positive disease, the majority of patients experience disease progression on current standard of care and require further therapeutic options. The dosing of the first patient in the 'HEAT' trial represents a significant step toward achieving RAD202's potential to address an unmet need for HER2-positive metastatic patients who are progressing or unable to tolerate current treatment options. With RAD202, we hope to provide an option that can meaningfully improve clinical outcomes for HER2-positive patients, while preserving their quality of life.' HER2 is overexpressed in breast cancer as well as several other solid tumors and represents a validated target in oncology. RAD202 is a proprietary single domain antibody that targets HER2. Ten HER2-positive breast cancer patients previously dosed in a Phase 1 diagnostic study of RAD202 demonstrated clinical proof-of concept as well as the safety and biodistribution of RAD202, validating its potential for the treatment of advanced HER2-expressing cancers2. Preclinical findings3 examining the therapeutic effect in HER2-positive xenografts were also recently reported with 177Lu-RAD202. Collectively, these data further justify first in humans dose finding studies. 'It is a privilege to be the first centre to administer 177Lu-RAD202, targeting HER2-positive tumors in this Phase 1 clinical trial (HEAT).' said Dr Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at St John of God Murdoch Hospital. 'This opens the possibility of novel therapeutic avenues for patients with aggressive tumor types, including breast, ovarian, gastric, pancreatic, bladder, and several other cancers. With the trust put in us by Radiopharm, we look forward to a successful trial with beneficial outcomes for our patients.' About Radiopharm Theranostics Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper. For more information: Riccardo Canevari CEO & Managing Director P: +1 862 309 0293 E: rc@ Anne Marie FieldsPrecision AQ (Formerly Stern IR)E: Paul Hopper Executive Chairman P: +61 406 671 515 E: paulhopper@ MediaMatt Wright NWR Communications P: +61 451 896 420 E: matt@ ________________________________ 1 Zhao et al, Molecular Pharmaceutics 2021 18 (9), 3616-36223 Altunay B. et al, EP-0136, Eur J Nucl Med Mol Imaging (2024) 51 (Suppl 1): S1–S1026. DOI: 10.1007/s00259-024-06838-zSign in to access your portfolio
Yahoo
03-06-2025
- Business
- Yahoo
2025 ASCO ｜Oral Presentation: Disitamab Vedotin Achieves Stellar Efficacy as First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Gastric Cancer
YANTAI, China, June 2, 2025 /PRNewswire/ -- On June 2 (Chicago time), in an oral presentation at the 2025 ASCO Annual Meeting, Dr. Lin Shen from Beijing Cancer Hospital presented the results of a Phase 2 clinical study conducted in China evaluating the efficacy and safety of disitamab vedotin (DV), developed by Remegen Co., Ltd., and toripalimab (PD-1) combined with CAPOX or trastuzumab as the first-line therapy for HER2-expressing patients with locally advanced or metastatic (la/m) gastric cancer. Comparing to the control group who received standard-of-care therapy, the DV combination therapy demonstrated clinically meaningful efficacy improvement, potentially to benefit patients who are non-responders to traditional targeted therapies. The data presented are from the Phase 2 part of a randomized, multi-cohort, seamlessly connecting Phase 2/3 study, which enrolled systematic chemotherapy-native patients with different HER2 expression levels. As of April 7, 2025, the results showed: Among HER2-overexpressing gastric cancer patients, compared to the PD-1-trastuzumab-CAPOX combination therapy, DV and PD-1 + chemotherapy as well as DV and PD-1 + trastuzumab both demonstrated statistically significant efficacy and favorable safety profiles. Objective response rate (ORR): 66.7% vs 82.4% vs 68.8%; Median progression-free survival (mPFS): NR vs NR vs 14.1 months, with risk of disease progression decreasing by 54%（HR=0.46）and 41% (HR: 0.59); 12-month PFS rate: 66.3%, 67% and 53.6%； Common TRAEs of grade 3-5: diarrhea, neutrophil count decreased, platelet count decreased, etc. In patients with HER2-low-expressing gastric cancer, promising efficacy was observed with DV + PD-1 + CAPOX comparing to PD-1 + CAPOX, with a manageable safety profile. ORR: 72.0% vs 47.8%; mPFS: 9.9 vs 7.2 months, with risk of disease progression decreasing by 31% (HR: 0.69); Common TRAEs of grade 3-5: diarrhea, neutrophil count decreased, platelet count decreased, etc. Dose optimization conducted in patients with HER2-median/low-expressing gastric cancer. Compared to PD-1 + CAPOX, DV at 2.5 mg/kg or 2.0 mg/kg combined with PD-1 + reduced-dose CAPOX showed significant efficacy, and better safety over the full-dose chemotherapy. ORR: 71.4% vs 66.7% vs 56.3%; 6-month PFS rate: 71.4%，72.7% and 53.3%. Globally, this is the first study to explore the triple combination therapy of "HER2 ADC + PD-1 + targeted medication" as first-line treatment of patients with la/m gastric cancer, pioneering a new mode of synergistic therapy. The multi-cohort design of this study provides precision treatment regimen for gastric cancer patients with different level of HER2 expression. For the HER2-overexpressing gastric cancer patients, DV + PD-1 + trastuzumab has the potential to become the new standard first-line treatment; for the HER2-low-expressing gastric cancer patients, DV + PD-1 + chemotherapy has the potential to fill the treatment gap of these patients. Based on the data obtained from the phase 2 study, the phase 3 clinical study of the triple combination therapy in patients with HER2-median/low-expressing gastric cancer has been initiated in April, 2025, in which 616 participants were planned to be enrolled, to further validate the efficacy of the DV combination therapy. Gastric cancer is the fifth most common malignant tumor in the world, and China accounts for about 42.6% of new cases and 45.0% of deaths worldwide. HER2 is an important target in the treatment of gastric cancer, while the traditional targeted drug trastuzumab is only effective in the population with high expression (IHC 3+ or IHC 2+/FISH+), and can easily become resistant. There is a lack of effective targeted therapy options for patients with low/median HER2 expression (IHC 1+ or IHC 2+/FISH-), and the efficacy of chemotherapy combined with immunotherapy is not satisfactory. As the first domestic HER2-targeted ADC drug in China, DV not only precisely kills tumor cells with HER2 over expression but also attacks adjacent cells with HER2 low expression through the bystander effect. Preclinical studies have also shown that the combination of DV with PD-1 inhibitor and trastuzumab can enhance anti-tumor activity. View original content to download multimedia: SOURCE RemeGen Co., Ltd Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
17-04-2025
- Business
- Yahoo
Greater Precision of HER2-Expressing Breast Cancer Treatment with 3D Pathology: New JelloX Research Collaboration
In the preliminary findings of a study conducted with the National Taiwan University Hospital, over 50% of sample cases were reclassified as HER2-expressing when 3D pathology was applied. HSINCHU, April 17, 2025 /PRNewswire/ -- JelloX Biotech Inc., a Taiwan-based startup at the forefront of cancer pathology, announced the preliminary results of a research collaboration with the National Taiwan University Hospital (NTUH) on breast cancer patients. The study found that JelloX's 3D pathology technology identified a significantly increased proportion of tumors with HER2-low and HER2-ultralow expression compared to conventional methods, demonstrating this technology's increased sensitivity and potential as a superior diagnostic tool for HER2 detection in breast cancers. Contact JelloX at sales@ to explore partnerships and learn more about the company's cutting-edge 3D pathology technology. According to the US National Cancer Institute, breast cancer is the most prevalent form of cancer. However, the difficulty of precisely determining treatment has made the identification of HER2 expression essential. In HER2-low and HER2-ultralow metastatic breast cancer, the novel antibody-drug conjugate (ADC) Trastuzumab deruxtecan (T-DXd) has demonstrated robust efficacy over conventional chemotherapy. Yet considering HER2 spatial heterogeneity, traditional diagnostic methods have shown to be less precise than 3D pathology in detecting the presence of the HER2 protein. "For the specific challenges posed by metastatic breast cancer and the need to identify predictive biomarkers accurately, the high sampling capacity of 3D pathology holds particular potential," commented Dr. Yen-Yin Lin, CEO of JelloX. "JelloX Biotech's Comprehensive HER2 Diagnostic Solution is poised to revolutionize HER2 diagnostics. With a more comprehensive data set on tumor samples, healthcare providers can be empowered to make more precise diagnoses, ensuring that the right patients receive the right treatment at the right time." New findings with NTUH on HER2 breast cancer In JelloX's research collaboration with NTUH, preliminary findings indicate that more than half of the analyzed cases exhibited diagnostic discrepancies when re-evaluated using the company's advanced 3D pathology methods. Notably, among patients initially classified as HER2-null by traditional methods, more than 66.7% were reclassified as HER2-expressing (HER2-low or HER2-ultralow) using 3D technology, thereby becoming potentially eligible for T-DXd treatment. These findings echo the company's recent results using samples from colorectal and esophageal cancers, demonstrating that 3D pathology may have broader potential across various cancer types. The full findings will be shared at the Global Breast Cancer Conference in South Korea on April 17. Implications for breast cancer treatment and drug guidelines T-DXd has demonstrated significant efficacy in tumors with HER2 expression. However, tumors classified as HER2-null under conventional pathological testing are ineligible for T-DXd treatment. By detecting HER2 more precisely using 3D pathology methods, we can identify more patients eligible for T-DXd therapy. In addition to cancer patients, JelloX's 3D pathology technology has the potential to expand possibilities across healthcare stakeholders: For physicians: This advanced diagnostic tool offers a more comprehensive patient data set and, when integrated with AI, helps reduce physician workloads. For pharmaceutical companies and research institutions: The technology enhances companion diagnostics (CDx) for drug usage and is a valuable tool for new drug development. For healthcare systems: 3D pathology optimizes medical resource allocation and minimizes unnecessary financial and healthcare burdens. About JelloX Biotech Inc. Based in Hsinchu, Taiwan, JelloX Biotech Inc. is a startup that focuses on advancing cancer pathology through 3D digital imaging and AI technology. For more information, please visit: View original content to download multimedia: SOURCE JelloX Biotech Inc. Sign in to access your portfolio
