logo
Ono Pharma Announces an Oral Presentation on Phase 2 Data for Tirabrutinib and a Poster Session on ONO-4578 (EP4 Antagonist) at the American Society of Clinical Oncology (ASCO) Annual Meeting

Ono Pharma Announces an Oral Presentation on Phase 2 Data for Tirabrutinib and a Poster Session on ONO-4578 (EP4 Antagonist) at the American Society of Clinical Oncology (ASCO) Annual Meeting

Business Wire24-04-2025

OSAKA, Japan--(BUSINESS WIRE)--Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; 'ONO') announced that it will present positive results from the Phase 2 PROSPECT study of tirabrutinib (ONO-4059) for the treatment of relapsed or refractory primary central nervous system lymphoma during an oral presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) being held May 30 to June 3, 2025, in Chicago, Illinois. The company will also present data on ONO-4578, an investigational EP4 antagonist, for the treatment of locally advanced resectable rectal cancer, during a poster presentation.
"We are fully committed to developing innovative drugs for cancer patients. This announcement is an important step forward in demonstrating that we can potentially provide new value to patients,' said Tatsuya Okamoto, Corporate Officer / Executive Director, Clinical Development at ONO. 'We aim to offer new treatment options in cancer care globally and contribute to improving patients' quality of life."
Details for both studies and data to be presented are as follows:
Tirabrutinib (ONO-4059)
Abstract Title: Tirabrutinib for the treatment of relapsed or refractory primary central nervous system lymphoma: Efficacy and safety from the phase II PROSPECT study.
Abstract Submission ID: 487376
Session Type and Title: Rapid Oral Abstract – Central Nervous System Tumors
Session Date and Time: May 31, 2025, 3:00-4:30 PM CDT
Presenter: Lakshmi Nayak, MD, Dana-Farber Cancer Institute
ONO-4578
Abstract Title: Neoadjuvant ONO-4578, an EP4 antagonist, in combination with nivolumab after chemoradiation therapy in locally advanced resectable rectal cancer.
Session Type and Title: Poster Session Gastrointestinal Cancer – Colorectal and Anal
Abstract Number for Publication: 3588
Poster Board: 257
Session Date and Time: May 31, 2025, 9:00 AM-12:00 PM CDT
Presenter: Yusuke Takahashi, Lower Gastrointestinal Surgery, National Hospital Organization Osaka National Hospital
About Ono Pharmaceutical Co., Ltd
Ono Pharmaceutical Co., Ltd. delivers innovative therapies for patients worldwide. Upholding its philosophy of 'Dedicated to the Fight against Disease and Pain,' Ono targets areas with unmet medical needs including oncology, immunology, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery. Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care. For more information, please visit the company's website at https://www.ono-pharma.com/en.

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Industrial 3-axis accelerometer has high offset stability
Industrial 3-axis accelerometer has high offset stability

Business Wire

time6 hours ago

  • Business Wire

Industrial 3-axis accelerometer has high offset stability

BUSINESS WIRE)--Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has introduced a 3-axis accelerometer for the industrial market that combines high offset stability over temperature and time, good linearity, low noise density, and excellent robustness. The SCA3400-D01 XYZ accelerometer is meant for use in industrial applications such as structural health monitoring (SHM), machine control, inertial measurement units, and construction tools and systems. This product will be exhibited at Sensors Converge 2025 to be held at the Santa Clara Convention Center (Booth #716), California from 24 to 26 June 2025. The offset stability of an accelerometer refers to the consistency of its output when at rest, but subject to varying temperatures or the effects of aging. Ideally, this output should be zero, but it is often not, and so equipment makers need to calibrate their designs to account for this. The more stable the offset is, the greater the accuracy of the sensor's measurements. Also, high offset stability enables equipment makers to calibrate their designs for the product's lifetime, rather than expecting users to regularly recalibrate to maintain accuracy. In the case of the SCA3400-D01, the offset drift over lifetime 0.5 mg for the X and Y axes and 2 mg for the Z axis. The offset error introduced by varying its operating temperature is 2 mg on the X and Y axes and 3 mg on the Z axis. The Murata SCA3400-D01 offers exceptional performance in terms of accuracy. It exhibits a linearity error figure of 1 mg over a 1.2 g range and a noise density of 20 µg/√Hz, both of which contribute to more precise measurements. Another feature of the 3-axis accelerometer that should appeal to industrial equipment makers is the user-selectable dynamic range and low-pass filtering, which enables designers to configure the part for the best combination of resolution, linearity, and noise performance for the application. The part also has self-diagnostic features that enable it to detect when a measured signal is reliable. The SCA3400-D01 (8.6 × 7.6 × 3.3 mm; 0.34" × 0.30" × 0.13") is built on the latest version of Murata's proven 3D MEMS process and uses the company's latest ASIC design and processes. It will be available as single parts on an evaluation PCB, sample bags of four parts, and reels containing either 100 or 1,000 pieces. For more details, please visit the product page, or for inquiries regarding this product, please contact us. About Murata Murata Manufacturing Co., Ltd. is a worldwide leader in the design, manufacture and sale of ceramic-based passive electronic components & solutions, communication modules and power supply modules. Murata is committed to the development of advanced electronic materials and leading edge, multi-functional, high-density modules. The company has employees and manufacturing facilities throughout the world.

BrightGene Presents Positive Phase 2 Data for Dual GLP-1R/GIPR Agonist for Weight Management and Type 2 Diabetes and Preclinical Data for Novel Amylin Analog at American Diabetes Association's 85th Scientific Sessions
BrightGene Presents Positive Phase 2 Data for Dual GLP-1R/GIPR Agonist for Weight Management and Type 2 Diabetes and Preclinical Data for Novel Amylin Analog at American Diabetes Association's 85th Scientific Sessions

Yahoo

time7 hours ago

  • Yahoo

BrightGene Presents Positive Phase 2 Data for Dual GLP-1R/GIPR Agonist for Weight Management and Type 2 Diabetes and Preclinical Data for Novel Amylin Analog at American Diabetes Association's 85th Scientific Sessions

Phase 2 data highlights best-in-class potential of dual GLP-1R/GIPR agonist BGM0504 for weight management and metabolic risk reduction in individuals with type 2 diabetes and overweight, non-obese individuals Preclinical data for BGM1812 supports further development as next-generation amylin analog for obesity treatment SUZHOU, China, June 23, 2025 /CNW/ -- BrightGene Pharmaceutical Co., Ltd., an international, innovation-driven pharmaceutical company, presented data from two Phase 2 studies for BGM0504, its investigational dual agonist targeting glucagon-like peptide-1 receptor (GLP-1R) and glucose-dependent insulinotropic polypeptide receptor (GIPR), along with preclinical data for its novel amylin analog, BGM1812, at the 85th Scientific Conference of the American Diabetes Association (ADA). Results from two separate Phase 2 studies in BGM0504 demonstrated significant potential for weight management and metabolic risk reduction in individuals with type 2 diabetes (including superiority to semaglutide), and in overweight and obese non-diabetic individuals, respectively. Preclinical data for BGM1812 demonstrated superior receptor activation, robust weight loss and synergistic potential with GLP-1/GIP dual agonism, supporting its development as a next-generation amylin analog for obesity treatment. "These Phase 2 data highlight the significant, best-in-class potential of BGM0504 as a treatment for type 2 diabetes and obesity, including potential superiority to semaglutide and a strong safety profile, while our preclinical data for BGM1812 support its continued development as a next-generation amylin analog for obesity treatment, underscoring the additional promise in our pipeline," said Dr. Jiandong Yuan, CEO, BrightGene. "Building on our extensive peptide expertise and strong heritage in high-quality, efficient drug development, BrightGene is committed to accelerating innovative therapeutics to help address unmet patient needs in metabolic disease and other important therapeutic areas." BGM0504 Phase 2 Study in Type 2 Diabetes This multicenter, randomized, double-blind (placebo-controlled) and open-label (semaglutide positive-controlled) evaluated the pharmacokinetics, safety and efficacy of once-weekly subcutaneous injection of BGM0504 across the primary endpoint, change from baseline in HbA1c at Week 12 of target dose administration, and multiple secondary endpoints including PPG-2h, FPG, body weight, HbA1c and combined HbA1c/body weight targets proportions, HOMA2-B, blood lipids, systolic blood pressure (SBP) and diastolic blood pressure (DBP). The study enrolled 67 participants with type 2 diabetes between the ages of 18 and 65, 64 received dose after randomization, randomized into five groups: 5mg (n=13), 10mg (n=12), 15mg (n=13), positive-control group (semaglutide; n=16) or placebo (n=13). Enrolled participants included adults with a baseline HbA1c between 7.0% and 10.0%, and a body mass index (BMI) between 19.5 and 35 kg/m2. At Week 12 of target dose administration, treatment with BGM0504 resulted in reductions in HbA1c across the three dose groups that were statistically significant compared with the placebo group and greater than treatment with semaglutide, including -1.72% in the 5mg dose group, -1.94% in the 10mg dose group, and -2.48% in 15mg dose group, compared to -1.43% in semaglutide and -0.28% in placebo. Similar results were observed in multiple secondary endpoints, including PPG-2h, FPG, body weight, and HbA1c and combined HbA1c/body weight target proportions, while varying improvement trends were observed in HOMA2-B, blood lipids, SBP and DBP. Most treatment emergent adverse events (TEAEs) were Grade 1 or 2 during the rapid titration stage and gradually tolerated after reaching the target dose. The most common treatment-related gastrointestinal AEs were diarrhea, nausea and abdominal distension; no hypoglycemic or other unexpected adverse reactions occurred. BGM0504 Phase 2 Study in Obesity This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of BGM0504 in 120 Chinese adults with obesity during multiple-dose administration (subcutaneous injection). Enrolled participants included adults with a BMI ≥ 24kg/m2 (mean BMI at enrollment ≥ 27kg/m2) with prediabetes and/or at least one obesity-related comorbidity, or adults with obesity (BMI≥ 28kg/m2, mean BMI at enrollment ≥ 30kg/m2). Participants were randomized into four groups: 5 mg (n=30), 10 mg (n=30), 15 mg(n=30), or placebo (n=30). The study consisted of a titration phase (2-6 weeks), 24-week treatment with once-weekly dosing, and a 2-week follow-up. Study results demonstrated reductions in waist circumference ranging from −8.0 cm to −12.98 cm (p < 0.001), and significant weight reductions ranging from -10.77% to 19.78% (LS means, placebo adjusted). Results also showed improvements in systolic blood pressure ranging from −11.60 to −13.03 mmHg and diastolic blood pressure ranging from −5.98 to −7.50 mmHg (p < 0.05). Secondary outcomes further supported the efficacy of BGM0504, and all doses were well tolerated with common adverse events. BGM1812 Preclinical Study In a preclinical study, BGM1812 demonstrated strong receptor activation with 1.8× and 2.2× increased agonist activity (EC50) at the amylin and calcitonin receptors, respectively, versus petrelintide. The agonist also demonstrated dose-dependent weight loss in 0.012 - 0.12 mg/kg dose range in the diet-induced obese (DIO) rat model. At 0.04 mg/kg, BGM1812 achieved greater weight reduction than petrelintide. In addition, BGM1812 significantly preserved relative lean mass while reducing relative fat mass. Additionally, the combination of BGM1812 and BGM0504 resulted in greater and more sustained weight loss than either semaglutide+cagrilintide or amycretin in the DIO rat model. About BGM0504 The peptide hypoglycemic drug BGM0504 injection is a dual agonist of GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide) receptors independently developed by BrightGene. BGM0504 can stimulate the downstream pathways of GIP and GLP-1, produce biological effects such as controlling blood sugar, reducing weight and treating non-alcoholic steatohepatitis (NASH), and show potential for the treatment of various metabolic diseases. BGM0504 is currently in Phase 3 trials in China for weight management and type 2 diabetes and has completed a Phase 1 bridging study for weight management in the U.S. To date, BGM0504 has been investigated in more than 1,000 patients and demonstrated superior efficacy and a strong safety profile. About BGM1812 BGM1812 is a novel amylin analog designed using AI/ML-driven optimization to enhance agonist activities and formulation properties. A potent and ultra long-acting amylin, BGM1812 has the potential to be a once weekly oral tablet. About BrightGene BrightGene is an international, innovation-driven pharmaceutical company, listed on the Shanghai Stock Exchange, dedicated to developing and manufacturing high-quality therapeutics to address unmet patient needs. Founded in 2001, BrightGene has evolved from an established global leader in high-hurdle generics and biosimilars to developing innovative metabolic and respiratory therapeutics. An established leader in challenging chemistry and conjugation, BrightGene has proprietary, cutting-edge platforms in peptides, siRNA, nanobodies, as well as advanced formulations, and 272 patents. The company remains a global supplier of 15 APIs and 2 drug products to the US and EU. BrightGene is headquartered in China. Additional information is available at View original content: SOURCE Bright Gene View original content: 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

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store