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Y-mAbs Presents Translational Pharmacokinetics of CD38-SADA from Pretargeted RIT Platform at 2025 American Association for Cancer Research (AACR) Annual Meeting
GlobeNewswire· 2025-04-27 19:00
Core Insights - Y-mAbs Therapeutics, Inc. presented preclinical and translational pharmacokinetics (PK) data of CD38-SADA at the 2025 AACR Annual Meeting, focusing on its potential for cancer treatment [1][2] Group 1: Presentation Details - The poster titled "Preclinical and translational pharmacokinetic (PK) modeling of the self-assembling and disassembling (SADA) bispecific fusion protein CD38-SADA for first-in-human (FIH) pretargeted radioimmunotherapy (PRIT)" was presented, detailing plasma concentrations of CD38-SADA in animal models [2][5] - The presentation took place on April 27, 2025, from 2:00 p.m. to 5:00 p.m. CT at Poster Section 25 [5] Group 2: Research Findings - The study characterized the concentration- and time-dependent equilibrium between CD38-SADA tetramers and monomers, with the model showing that low molecular weight CD38-SADA monomers cleared from plasma 20 times faster than the tetramers [3] - The preclinical PK model provided insights into the circulating levels of CD38-SADA protein in vivo, which informed the design and initial dosing regimen of the first-in-human Phase 1 Trial 1201 [4] Group 3: Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [6] - The company's product pipeline includes DANYELZA®, the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma [6] Group 4: CD38-SADA PRIT Technology - CD38-SADA is a bispecific fusion protein that binds to CD38 and Lu-DOTA, facilitating a two-step pre-targeted radioimmunotherapy process [7][8] - The technology has shown robust anti-tumor efficacy in preclinical studies and is currently being investigated in adults with relapsed, progressive, or refractory non-Hodgkin lymphoma [8]
JETOUR Showcases Advanced Off-Road Technology at Auto Shanghai 2025 with Global Media Test Drive Event
GlobeNewswire· 2025-04-27 18:00
Core Insights - JETOUR hosted a test drive event for over 200 global media and influencers, showcasing its technological advancements in off-road capability, hybrid power, and intelligent innovation [1] - The event highlighted the T1, T2 i-DM, and a preview of the G700, demonstrating the brand's commitment to technical expertise and innovation [1] JETOUR T1 - The T1 is a lite off-road SUV featuring a 2.0T engine and an 8-speed automatic transmission, providing smooth performance in urban and highway conditions [2] - The XWD intelligent four-wheel drive system allows for instantaneous power redistribution, enhancing off-road capabilities and driver confidence [3][4] - The T1 offers seven driving modes, including Sport, Snow, and Sand, catering to various driving preferences [4] JETOUR T2 i-DM - The T2 i-DM combines rugged design with eco-friendly efficiency, featuring a fifth-generation 1.5TGDI hybrid engine with a thermal efficiency of 44.5% [5] - The vehicle's electric motor enables quiet starts, while the hybrid system provides robust torque for off-road performance [7] - Advanced features like hill descent control and electronic suspension enhance off-road capabilities and stability [8] G700 Preview - The G700, a premium all-terrain SUV, showcased its autonomous parking capabilities, utilizing 12 ultrasonic sensors and four 360° cameras for effortless navigation [9] - Anticipation for the G700's global debut in September in the UAE is high, with expectations for it to lead in the premium SUV segment [10] Global Expansion and Strategy - JETOUR is expanding its presence in the Middle East and plans to enter markets in Africa, South America, Asia-Pacific, and the CIS region [13] - The company's multi-technology strategy includes traditional fuel, hybrid, and intelligent systems, addressing diverse consumer needs [13][14] - JETOUR aims to redefine adventure travel, making it accessible and enjoyable for families worldwide [15]
Abpro and Celltrion Unveil Preclinical Data for ABP-102/CT-P72 at AACR 2025, Showcasing Potential Best-in-Class HER2 x CD3 T-Cell Engager
GlobeNewswire· 2025-04-27 18:00
Core Insights - Abpro Holdings, Inc. and Celltrion have presented preclinical data for ABP-102/CT-P72, a bispecific T-cell engager targeting HER2-overexpressing tumors, at the AACR Annual Meeting 2025, indicating its potential to outperform existing HER2-targeted therapies in efficacy and safety [1][2][3] Company Overview - Abpro is a biotechnology company focused on next-generation antibody therapies for severe diseases, utilizing its proprietary DiversImmune® platform [9] - Celltrion is a leading biopharmaceutical company based in South Korea, specializing in innovative therapeutics and has a global presence in over 110 countries [11] Product Development - ABP-102/CT-P72 is designed to selectively target HER2-overexpressing tumor cells while minimizing toxicity in normal tissues, representing a significant advancement in bispecific antibody therapies [2][6] - The product is co-developed with Celltrion and aims to address toxicity barriers that have previously limited HER2-targeted T-cell engagers [3][7] Preclinical Findings - Preclinical data suggest that ABP-102/CT-P72 achieves potent cytotoxicity in HER2-overexpressing cancer models while significantly reducing activity against HER2-low cells, addressing limitations of prior therapies [8] - In vivo studies indicate that ABP-102/CT-P72 can achieve up to a two-fold increase in tumor suppression compared to a benchmark HER2 x CD3 bispecific antibody [8] - The engineered design of ABP-102/CT-P72 minimizes cytokine-related toxicities and has shown improved tolerability in dose escalation studies, suggesting a broader therapeutic window [5][8] Clinical Development Plans - Clinical trials for ABP-102/CT-P72 are planned to commence in the first half of 2026, with the aim of bringing this promising therapy to patients with HER2-driven cancers [5][6]
Revolution Medicines Presents Initial Data from Zoldonrasib (RMC-9805) Study in Patients with KRAS G12D Mutant Non-Small Cell Lung Cancer at the 2025 AACR Annual Meeting
GlobeNewswire· 2025-04-27 16:05
Core Insights - Zoldonrasib, a RAS(ON) G12D-selective inhibitor, shows acceptable tolerability and promising initial antitumor activity in patients with KRAS G12D mutant non-small cell lung cancer (NSCLC) [1][2] Group 1: Clinical Data - New clinical data for zoldonrasib was presented at the American Association for Cancer Research (AACR) Annual Meeting, highlighting its potential as a treatment for NSCLC [1][2] - The Phase 1 study (RMC-9805-001) involved 90 solid tumor patients treated with 1200 mg once daily, demonstrating an acceptable safety profile consistent with previous data in pancreatic cancer [3] - The most common treatment-related adverse events (TRAEs) included nausea (39%), diarrhea (24%), vomiting (18%), and rash (12%), primarily Grade 1 or 2 in severity [3] Group 2: Efficacy Results - Preliminary antitumor activity was assessed in 18 efficacy-evaluable NSCLC patients, showing an objective response rate of 61% (11 patients) and a disease control rate of 89% (16 patients) [4] - The data indicates a high unmet need for new treatments in this patient population, as there are currently no approved targeted therapies for RAS G12D mutant cancers [5] Group 3: Company Overview - Revolution Medicines is focused on developing targeted therapies for RAS-addicted cancers, with a pipeline that includes multiple RAS(ON) inhibitors [6] - The company is advancing zoldonrasib as a monotherapy and in combination therapies, aiming to provide innovative treatment options for hard-to-treat cancers [2][6]
SpringWorks Therapeutics Announces Expected CHMP Opinion in Q2 2025 for Nirogacestat for the Treatment of Adults with Desmoid Tumors in the European Union
GlobeNewswire· 2025-04-27 14:35
Core Viewpoint - SpringWorks Therapeutics, Inc. anticipates a favorable opinion from the CHMP of the EMA regarding the marketing authorization application for nirogacestat in Q2 2025, aimed at treating adults with desmoid tumors [1] Company Overview - SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, with FDA-approved products including OGSIVEO (nirogacestat) for desmoid tumors and GOMEKLI™ (mirdametinib) for neurofibromatosis type 1 associated plexiform neurofibromas [2]
2025 (Spring) Pharmaceutical Machinery Exposition Concludes Successfully
GlobeNewswire· 2025-04-27 09:15
Core Insights - The 66th National Pharmaceutical Machinery Exposition successfully concluded on April 25, 2025, at Chongqing International Expo Center, organized by HAINAN JING-BO-XIN EXHIBITION CO., LTD. [1] - The exposition attracted 1,686 exhibitors from 24 countries and regions, showcasing over 10,000 products across an exhibition space of 180,000 square meters, with more than 60,000 visitors from 88 countries and regions [3]. Industry Overview - The exposition included a Malaysia-China procurement matchmaking session, facilitating one-on-one meetings between over 20 Chinese manufacturers and six Malaysian pharmaceutical companies [3]. - The organizing committee hosted three thematic forums and 93 technical exchange sessions, featuring keynote speeches from renowned experts and industry professionals [4]. - The Second CIPM Synthetic Biology and Biomanufacturing Industry Development Conference was a significant highlight, attracting over 1,000 professionals from various sectors including pharmaceuticals, food, cosmetics, and pesticides [4]. Historical Context - The China National Pharmaceutical Machinery Exposition has been held biannually since the 1990s and has been recognized as a key exhibition supported by China's Ministry of Commerce since 2004 [5]. - The event expanded in 2008 to include the China International Pharmaceutical Machinery Exposition (CIPM), covering production, processing, packaging, testing, and auxiliary equipment for various industries [5]. - Over the years, CIPM has evolved into a premier global event that integrates trade, technology exchange, and industry dialogue [5].
CG Oncology Announces Best-in-Disease Durability Data in BOND-003 Cohort C and Promising Early Signal in Cohort P for Cretostimogene Grenadenorepvec at the American Urological Association Annual Meeting
GlobeNewswire· 2025-04-26 20:10
Core Insights - CG Oncology presented promising data on cretostimogene grenadenorepvec monotherapy for high-risk non-muscle invasive bladder cancer (NMIBC) at the 2025 AUA Annual Meeting, indicating its potential as a backbone therapy for bladder cancer treatment [2][6] Efficacy Data - The Phase 3 BOND-003 Cohort C study reported a robust 24-month complete response (CR) rate of 42.3% by Kaplan-Meier (K-M) estimation, with 75.5% achieving CR at any time [1][3] - 58.3% of patients demonstrated durable complete responses at 24 months, and 97.3% remained free from progression to muscle-invasive bladder cancer (MIBC) [1][3] - The median duration of response (DOR) was 28 months, with no Grade 3 or greater treatment-related adverse events reported [1][5] Safety Profile - The treatment was well-tolerated, with 97.3% of patients completing all expected treatments and a median resolution time of one day for any treatment-related adverse events [5][6] - The most common treatment-related adverse events (≥10%) included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria [5] Study Population - The BOND-003 Cohort C study included 110 highly pretreated patients, with a median of 12 prior Bacillus Calmette Guerin (BCG) doses, some patients having received as many as 66 doses [5][6] - Cohort P data indicated a high-grade recurrence-free survival rate of 90.5% at 3 and 9 months in patients with BCG-unresponsive Ta/T1 disease [4][5] Future Outlook - CG Oncology is actively investigating the potential of cretostimogene in addressing unmet needs in bladder cancer treatment, with ongoing studies and an Expanded Access Program initiated for eligible patients [6][8]
IO Biotech Showcases Scientific Leadership Through Cancer Vaccines Educational Session at the American Association for Cancer Research (AACR) Annual Meeting 2025
GlobeNewswire· 2025-04-26 19:05
Core Insights - IO Biotech is advancing novel immune-modulatory therapeutic cancer vaccines, with a focus on reshaping the tumor microenvironment and enhancing T cell activation [1][2][3] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company based in Copenhagen, Denmark, with a US headquarters in New York, specializing in off-the-shelf therapeutic cancer vaccines [3] - The company is developing its lead investigational cancer vaccine candidate, Cylembio® (IO102-IO103), which has received Breakthrough Therapy Designation from the FDA for advanced melanoma treatment [3] Scientific Contributions - Dr. Mads Hald Andersen, a co-founder of IO Biotech, presented at the 2025 AACR Annual Meeting, discussing advancements in cancer vaccine research and the dual mechanism of action of IO102-IO103 [1][2] - The vaccine targets both tumor cells and immune-suppressive cells, potentially reprogramming the tumor microenvironment to be more immune-permissive [2] Research and Development - The educational session at AACR highlighted key developments in RNA-based and immune-modulatory vaccines, showcasing the latest innovations in cancer immunotherapy [1][2] - IO Biotech's T-win® platform is designed to activate T cells against both tumor and immune-suppressive cells, representing a novel approach in cancer vaccine development [3]
Valneva Provides Update on Recommendation for Use of Its Chikungunya Vaccine by French Authorities
GlobeNewswire· 2025-04-26 17:10
Core Points - Valneva SE's chikungunya vaccine IXCHIQ has faced updated recommendations from France's Haute Autorité de Santé (HAS) due to serious adverse events reported in elderly individuals with comorbidities during the vaccination campaign in La Reunion and Mayotte [1][2] - The French health authorities have suspended the use of IXCHIQ for individuals aged 65 and older while maintaining its recommendation for those aged 18 to 64 [2] - Valneva has supplied 40,000 doses of IXCHIQ to La Reunion amid a significant chikungunya outbreak with approximately 40,000 confirmed cases since the start of 2025 [1][4] Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, addressing unmet medical needs [7] - The company has a strong track record in advancing vaccines from early research and development to approvals, currently marketing three proprietary travel vaccines [8] - Valneva's revenues from its commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [9] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant medical and economic burdens expected to grow due to climate change [6] - The World Health Organization (WHO) has recognized chikungunya as a major public health problem, highlighting the need for effective vaccines and interventions [6]
New share capital registered
GlobeNewswire· 2025-04-26 15:34
Core Points - Kaldvik AS has announced the issuance of new shares to acquire key assets in the fish farming value chain on the east coast of Iceland [1] - The share capital increase has been registered, resulting in a new registered share capital of NOK 12,851,120.10, divided into 128,511,201 shares [2] Company Information - Each share carries one vote at the Company's general meeting and has a nominal value of NOK 0.10 [2] - Contact information for the CEO and CFO is provided for further inquiries [2]