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New Clinical Findings Published in Scientific Journal Nature Validate LIXTE's Ongoing Ovarian and Colorectal Cancer Trials
Globenewswire· 2025-07-09 12:05
Article Indicates that Inhibition of PP2A Enhances Immunotherapy Responsewith LIXTE’s Proprietary Compound LB100 PASADENA, Calif., July 09, 2025 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, today announced that the medical journal Nature has published findings by a team of physician-scientists that validate LIXTE’s ongoing clinical trials with its proprietary compound LB100 for Ovarian and Colorectal canc ...
Tempest Receives Clearance to Proceed with Pivotal Trial of Amezalpat Combination Therapy for First-Line HCC in China
Globenewswire· 2025-06-30 12:00
Core Insights - Tempest Therapeutics has received approval from the National Medical Products Administration (NMPA) in China to initiate a pivotal trial for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC) [1][2][3] Company Overview - Tempest Therapeutics is a clinical-stage biotechnology company focused on developing targeted and immune-mediated therapeutics for cancer treatment [8] - The company is headquartered in Brisbane, California, and has a diverse portfolio of small molecule product candidates [8] Drug Development - Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist that shows promise in treating cancer by targeting tumor cells and modulating the tumor microenvironment [7] - The planned Phase 3 study will be a global, blinded, 1:1 randomized trial comparing amezalpat plus atezolizumab and bevacizumab against a placebo combination for first-line treatment of HCC [3] - The company has received agreement from both the FDA and EMA on the study design and statistical plan for the Phase 3 trial [3] Hepatocellular Carcinoma (HCC) Insights - HCC is an aggressive cancer with over 900,000 new diagnoses globally each year, and it is projected to become the third leading cause of cancer death by 2030 [4] - The highest incidence and mortality rates of HCC are found in East Asia, with increasing rates in Europe and the US [4] - Chronic liver diseases, including hepatitis B and C, NAFLD, NASH, and cirrhosis, account for 90% of HCC cases [5] Clinical Trial Context - The ongoing global randomized Phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab has shown clinical superiority in overall survival compared to the standard of care [7] - Early-stage HCC patients face a 70-80% recurrence rate post-surgery, which is associated with poorer prognosis [6]
俄公布国家航天项目计划
Huan Qiu Wang Zi Xun· 2025-06-29 23:31
Group 1 - The core viewpoint of the article is that the Russian Academy of Sciences has announced new national projects in the field of space exploration, with funding to begin this year [1][4][6] - The projects aim to maintain Russia's position as one of the top three space powers globally, focusing on areas such as astronomy, planetary research, and biomedical projects [4][7] - Significant projects include the deployment of the world's first 10-meter cooled telescope for terahertz radiation observation and the launch of various space telescopes for studying cosmic phenomena [4][5][6] Group 2 - The Russian space program includes comprehensive missions to Venus, Mars, and the Moon, with specific goals such as searching for signs of life and analyzing lunar soil [5][6] - The funding for lunar exploration will begin this year, with estimates suggesting over 1 trillion rubles will be allocated in the next three years and approximately 4.5 trillion rubles by 2036 [6][7] - The new national projects are currently in the final approval stage by the government, with expectations for rapid implementation following presidential approval [7][8]
从开源看“智能向善”(评论员观察)
Ren Min Ri Bao· 2025-06-17 22:10
人工智能会缩小还是扩大发展差距?这一直是社会关注的话题。 相比于西方发达国家,许多发展中国家属于人工智能领域的"跟跑者""后进者",不仅缺少有竞争力的科 技企业,也缺乏足够的技术、人才储备,甚至在相关基础设施上都存在严重不足。国际货币基金组织制 定的"人工智能准备指数"显示,截至2024年4月,发达国家这一指数为0.68,而新兴国家和低收入国家 分别为0.46和0.32。 不过,会不会"扩大发展差距",关键在于如何运用技术,在于以何种理念开发人工智能。不妨来看两个 案例。 一个是,今年缅甸中部发生地震后,相关方面利用DeepSeek,在7小时内开发了一套中缅英互译系统, 有效解决语言障碍问题,为中国救援队伍参与国际救援提供了助力。 另一个是,日本一家AI应用企业基于通义千问打造的日语模型EZo,成功在日本医疗保健领域和多个公 共服务机构落地。目前,通义千问的衍生模型数已超10万个。 数字红利不能成为数字霸权,智能革命不应导致智能鸿沟。坚持"智能向善",才能让人工智能真正成为 造福人类的公共产品 开源策略,超越了筑"小院高墙"、搞"三六九等"、分"远近亲疏"的做法,降低了研究、应用的门槛,使 更多人能参与到人工 ...
Rezolve Ai Locks In $70 Million ARR Months Ahead of Plan; Now on Track to Exceed $100 Million ARR by Year-End
Globenewswire· 2025-06-12 12:00
Blistering Growth from a Standing Start Confirms Rezolve Ai’s Position at the Forefront of Enterprise AI, with Strategic Partnerships from Microsoft and GoogleNEW YORK, June 12, 2025 (GLOBE NEWSWIRE) -- Rezolve Ai (NASDAQ: RZLV), the company reinventing retail through real-time AI-driven consumer engagement, today announced that it has secured more than $70 million in Annual Recurring Revenue (ARR) months ahead of schedule putting the company on a clear trajectory to surpass its targeted $100 million ARR be ...
Xilio Therapeutics Appoints Akintunde Bello, Ph.D., to its Board of Directors
Globenewswire· 2025-06-10 20:30
Company Overview - Xilio Therapeutics, Inc. is a clinical-stage biotechnology company focused on discovering and developing tumor-activated immuno-oncology therapies aimed at improving outcomes for cancer patients while minimizing systemic side effects [4] Leadership Appointment - Akintunde (Tunde) Bello, Ph.D., has been appointed to the board of directors of Xilio Therapeutics, bringing over 25 years of experience in oncology research and development [1][2] - Dr. Bello has a strong track record in developing novel therapies, including significant contributions to cancer immunotherapies such as anti-CTLA-4 and PD-1 [2][3] Expertise and Background - Dr. Bello previously served as senior vice president at Bristol Myers Squibb, overseeing clinical pharmacology and pharmacometrics across multiple therapeutic areas [3] - His academic credentials include a B.Sc. in biomedical sciences, an M.Sc. in instrumentation and analytical science, and a Ph.D. in pharmaceutical sciences [3] Strategic Goals - The company aims to leverage Dr. Bello's expertise to advance its pipeline, including XTX501, a masked PD-1/IL-2 bi-specific therapy, and other bi-specific and tri-specific T cell engager programs [2][3] - Xilio's innovative approach focuses on optimizing the therapeutic index by localizing anti-tumor activity within the tumor microenvironment [4]
Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination Granted U.S. FDA Priority Review for First-Line Maintenance Treatment of Extensive-Stage Small Cell Lung Cancer
Prnewswire· 2025-06-10 11:05
Core Insights - The FDA has accepted the supplemental New Drug Application (sNDA) for Zepzelca in combination with atezolizumab for first-line maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC), with a PDUFA action date set for October 7, 2025 [1][2] - The sNDA submission is based on the Phase 3 IMforte trial results, which showed statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for the combination therapy compared to atezolizumab alone [2][6] - Jazz Pharmaceuticals will host an investor webcast to discuss the Zepzelca data, featuring commentary from experts in the field [3] Company Overview - Jazz Pharmaceuticals is a global biopharma company focused on developing innovative medicines for serious diseases, including a growing portfolio of cancer treatments [25][26] - The company is headquartered in Dublin, Ireland, and is dedicated to transforming the lives of patients with limited therapeutic options [25][26] Industry Context - Small cell lung cancer (SCLC) accounts for approximately 13% of lung cancers in the U.S., with around 30,000 new cases reported annually [4] - SCLC is known for its aggressive nature and rapid spread, leading to a high unmet need for effective treatment options [4]
Tempest Receives Orphan Drug Designation from the European Medicines Agency for Amezalpat for the Treatment of Patients with HCC
GlobeNewswire News Room· 2025-06-05 12:00
EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, underscoring the urgent need for new treatment optionsThe multiple regulatory designations were granted following strong positive results from a global randomized Phase 1b/2 study in first-line HCC demonstrating superior outcomes for amezalpat combination therapy across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to sta ...
Xilio Therapeutics Announces Updated Phase 2 Data for Vilastobart, a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic Microsatellite Stable Colorectal Cancer
Globenewswire· 2025-05-31 12:00
Core Insights - Xilio Therapeutics announced a preliminary objective response rate (ORR) of 26% in heavily pre-treated patients with metastatic microsatellite stable colorectal cancer (MSS CRC) without liver metastases, demonstrating deep and durable responses lasting up to 37 weeks [1][4][10] - The combination therapy of vilastobart and atezolizumab showed a differentiated safety profile with a low incidence of immune-related adverse events, particularly colitis [2][7][11] - The ongoing Phase 2 trial is evaluating vilastobart in combination with atezolizumab, with plans to expand the study to include a higher dose level [9][13] Patient Data - As of May 12, 2025, 44 patients with metastatic MSS CRC were treated with vilastobart at 100 mg every six weeks and atezolizumab at 1200 mg every three weeks, with a median age of 55 years [3][5] - 80% of patients had previously received three or more lines of anti-cancer therapy, indicating a heavily pre-treated population [3] Anti-Tumor Activity - The preliminary ORR of 26% included seven partial responses, with six confirmed responses, and substantial decreases in tumor biomarkers such as circulating tumor DNA [4][10] - In patients without liver metastases, responses were deep and durable, with reductions in target lesions of up to 71% from baseline [10] Safety Profile - The combination therapy exhibited a low incidence of immune-mediated adverse events, with only 7% of patients experiencing colitis [7][11] - Common treatment-related adverse events included fatigue (30%), infusion-related reactions (23%), and diarrhea (18%) [11] Future Development Plans - Xilio is enrolling a cohort of patients at a higher dose level of 150 mg Q6W for vilastobart in the ongoing Phase 2 trial, with additional data expected in the first half of 2026 [9][12] - The company is seeking partnership opportunities to accelerate the development of the vilastobart program [12]
Exelixis (EXEL) FY Conference Transcript
2025-05-27 19:30
Exelixis (EXEL) FY Conference Summary Company Overview - **Company**: Exelixis (EXEL) - **Event**: Sixth Annual Oncology Innovation Summit - **Date**: May 27, 2025 Key Points Commercial Performance - **Cabo Performance**: Cabo had a strong Q1, with increasing prescriptions and market share in renal cell carcinoma (RCC) [4][8] - **Clinical Trials Orders**: Clinical trials orders fluctuated between 4 million and 22 million per quarter historically, with a recent order of 12 million [4] - **Net Approval**: The approval for neuroendocrine tumors (NET) occurred late in the quarter, impacting tracking metrics [5][8] Market Dynamics - **IQVIA Tracking Issues**: IQVIA's tracking was inaccurate this quarter, attributed to the complexity of real-world data and seasonality [6][12][13] - **Gross to Net Dynamics**: The gross to net ratio was higher in Q1, influenced by the phase-in of the rebate period under the IRA [14][15] Future Projections - **Revenue Growth**: Exelixis anticipates Cabo's revenue to grow from approximately $2 billion to $3 billion by 2030, driven by the NET launch and continued momentum in the base business [15] - **Rebate Impact**: A 1% rebate phase-in under the IRA is expected to have a minimal impact on overall business [16][26] NET Launch Insights - **Patient Dynamics**: The launch of Cabo for NET is expected to be steady rather than a bolus due to the advanced state of patients [30][31] - **Broad Label Impact**: The broad label for Cabo is anticipated to positively affect a wide range of patients, with no specific pockets of accelerated uptake identified [32][33] Competitive Landscape - **Lutathera Comparison**: Lutathera presents unique challenges for patients, and Cabo is positioned to capture market share from oral cytotoxics rather than directly competing with Lutathera [36][37] - **Somatostatin Analogs**: Cabo is expected to be used alongside background somatostatin analogs, enhancing its therapeutic impact [39] Pipeline Developments - **ZENZA Study**: The Stellar 303 study has elevated liver metastases patients to a co-primary endpoint due to differentiated event rates observed [40][41] - **Head and Neck Cancer Trials**: The Stellar 305 study aims to evaluate Zanza in combination with Keytruda, learning from previous trial outcomes [45][46] - **Early Pipeline**: The bispecific program (628) has generated significant interest, focusing on combining PD-L1 and NKG2A mechanisms [61][62] Regulatory and Market Considerations - **Non-Clear Cell RCC Study**: The ongoing study aims to establish a new standard of care in the non-clear cell RCC segment, with results expected later this year [55][56] - **Collaboration with Merck**: Exelixis is collaborating with Merck on various studies, with details to be shared as trials progress [58][60] Additional Insights - **Market Research**: Continuous market research and KOL engagement are crucial for understanding patient dynamics and optimizing marketing strategies [37][38] - **Regulatory Landscape**: The evolving regulatory environment, particularly regarding rebates and pricing, will impact future revenue and market strategies [19][20] This summary encapsulates the key insights and developments discussed during the Exelixis FY Conference, highlighting the company's commercial performance, market dynamics, future projections, and ongoing pipeline developments.