OCALA, Fla., Nov. 04, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that data from the completed Phase 2 cisplatin-resistant advanced recurrent ovarian cancer clinical study utilizing Ampligen® (rintatolimod) was accepted in a late-breaking abstract at the 40th Annual SITC Meeting being held November 5-9, 2025 at National Harbor, MD. Details of the poster presentation are as follows: Title: A Phase II Trial of Combination Locoregional Chemoimmunot ...

SITC poster to be presented on Friday, November 7, 2025, emphasizes robust anti-cancer activity of next generation Bria-OTS+ platform Lead candidates Bria-BRES+™ (breast cancer) and Bria-PROS+™ (prostate cancer) completing GMP manufacturing for planned clinical trials $2 million National Cancer Institute (NCI) Small Business Innovative Research (SBIR) award supports manufacturing and planned clinical evaluation of Bria-PROS+ Bria-OTS+ represents a novel, cost-effective, off-the-shelf potent next generation ...

LUND, SE / ACCESS Newswire / November 3, 2025 / BioInvent International AB ("BioInvent")(STO:BINV) (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in- class immune-modulatory antibodies for cancer immunotherapy, today announced that it will present new data from the safety run-in portion of its ongoing trial evaluating BI-1206 in combination with rituximab and Calquence ® (acalabrutinib) for the treatment of non-Hodgkin's lymphoma (NHL) in a poster at t ...

OS Therapies Announces Overall and Event Free Survival Key Subgroup Data for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metastatic OsteosarcomaOctober 22, 2025 9:15 AM EDT | Source: OS TherapiesNew York, New York--(Newsfile Corp. - October 22, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced additional overall and event free survival data generated fr ...

HTL0039732 (also known as NXE0039732) is Nxera’s novel oral EP4 antagonist with the potential to treat a wide range of cancers in combination with other immunotherapiesHTL0039732, was found to be well-tolerated, confirmed target engagement and demonstrated encouraging early efficacy in two distinct tumor types when administered in combination use with atezolizumabPhase 1 trial met the key objectives and identified a dose for a Phase 2 expansion trial, which is now underwayCancer Research UK’s Centre for Dr ...

临床试验数据与结果 - 公司合作伙伴Cancer Research UK在2025年10月17-21日于柏林举行的欧洲肿瘤内科学会大会上公布了其免疫疗法药物HTL0039732正在进行的1/2a期临床试验中已成功完成的1期部分数据[1] - 该首次人体试验旨在评估HTL0039732作为单药治疗（n=13）以及与检查点抑制剂atezolizumab联合使用（n=22）在标准疗法耐药或难治的晚期实体瘤患者中的安全性、耐受性、药代动力学、药效学和抗肿瘤活性[2] - 1期研究达到了主要目标，确定了用于2a期扩展试验的推荐剂量，即与atezolizumab联合使用时为160mg每日一次[5] - HTL0039732耐受性良好，单药或联合治疗均未出现4/5级治疗相关不良事件或剂量限制性毒性，联合治疗组中3级治疗相关不良事件发生率为14%（22名患者中的3名）[5] - 根据RECIST标准，两名患者对HTL0039732和atezolizumab的联合治疗确认达到部分缓解（肿瘤缩小超过30%），一名为既往检查点抑制剂治疗出现疾病进展的转移性肾细胞癌患者，另一名为通常无法从检查点抑制剂单药治疗中获益的微卫星稳定结直肠癌患者[5] - 在此1期研究中，2名ccRCC患者中有1名观察到部分缓解（50%），11名MSS-CRC患者中有1名观察到部分缓解（约9%）[5] - 2a期试验扩展了四个患者队列，包括MSS CRC、胃或胃食管结合部腺癌、透明细胞肾细胞癌和转移性去势抵抗性前列腺癌，首位患者已于2025年9月给药[2] 药物机制与潜力 - HTL0039732是公司新型口服EP4拮抗剂，通过阻断前列腺素E2通过EP4受体的信号传导来增强免疫系统检测和控制癌细胞的能力，有望与其它免疫疗法联用治疗多种癌症[4][8] - 在联合用药中，HTL0039732显示出良好的耐受性，确认了靶点结合，并在两种不同肿瘤类型中表现出令人鼓舞的早期疗效[4] - 在免疫疗法耐药的肿瘤中出现的放射学反应显示出改进当前治疗的潜力，其数据表现优于其他相同作用机制的药物，有潜力成为同类最佳[6] 试验管理与公司背景 - Cancer Research UK的药物开发中心正在赞助和管理这项正在进行的1/2a期临床试验，试验由首席研究员和共同首席研究员领导，主要研究中心位于剑桥，并在实验癌症医学中心网络的其他多个中心开放招募[3] - 公司拥有试验产生结果的许可权[3] - 公司是一家技术驱动的生物制药公司，利用其NxWave™发现平台推进超过30个活跃项目组成的广泛管线，涵盖从早期发现到后期临床阶段[10] - 公司专注于在肥胖和代谢疾病、神经学/神经精神疾病以及免疫学和炎症等一些增长最快的医学领域解决未满足的需求[10]

OS Therapies Granted Final Type C Meeting by U.S. FDA and pre-MAA Meeting by U.K. MHRA for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic OsteosarcomaOctober 17, 2025 9:15 AM EDT | Source: OS TherapiesFinal FDA Type C Meeting December 11, 2025 - biomarker data to be availableOctober 10, 2025 FDA/Osteosarcoma Institute Workshop narrows focus for OST-HER2 overall survival, biomarker correlation & canine osteosarcoma dataNew York, New York--(Newsfile Corp. ...

Pooled analysis supports the rationale for the ongoing MAIA-ovarian trial evaluating COM701 as maintenance therapy in the earlier setting of platinum sensitive ovarian cancer , /PRNewswire/ -- Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, today announced that pooled analysis of previously presented data, supporting the anti-tumor activity and safety profile of COM701 in heavily pre-treat ...

OS Therapies Announces Statistically Significant Positive Final 2-Year Overall Survival Data from Phase 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully-Resected, Pulmonary Metastatic OsteosarcomaOctober 10, 2025 6:00 AM EDT | Source: OS Therapies75% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p < 0.0001)100% of patients who achieved 12 month event free survival achieved 2 year overall survivalNew York, New ...

核心观点 - 公司宣布其与欧洲药品管理局（EMA）的报告员（荷兰药品评估委员会）于2025年10月6日举行的会议取得了积极的监管进展 [2] - 会议结果确认了支持其OST-HER2项目申请有条件上市许可（CMA）的关键数据，并为后续的确认性临床试验规划了路径 [3][4] 监管会议成果 - 公司与报告员在安全性、非临床数据以及化学、制造和控制（CMC）数据方面达成一致，这些数据支持其正在进行的OST-HER2 2b期临床试验 [3] - 报告员建议，显示统计学显著性的最终两年总生存期（OS）结果，可作为考虑有条件上市许可（CMA）的合适主要终点 [3] - 安全性数据被确认为积极，并且来自其他李斯特菌候选药物的数据（涵盖超过500名患者）可能足以支持CMA申请 [8] - 非临床数据和CMC数据包均被视为足以支持CMA提交 [8] - 截至2025年7月的疗效数据令人鼓舞，报告员指出12个月无事件生存期（EFS）可能不是最合适的终点，总生存期（OS）可能更能衡量临床获益 [8] - 此次会议是迈向预计在2025年12月获得的EMA正式科学建议的重要里程碑 [4] 市场授权申请进展 - 在英国药品和健康产品管理局（MHRA）启动上市许可申请（MAA）提交程序后，该机构已授予公司一个加速的市场准入科学建议会议 [6] - 此次会议旨在确保申请方与监管机构在MAA审查过程中的问题保持一致，以加速患者获得药物 [6] 产品与管线概述 - 公司是一家临床阶段的生物技术公司，专注于癌症免疫疗法和抗体药物偶联物 [2] - 主要资产OST-HER2是一种免疫疗法，利用李斯特菌的免疫刺激作用引发针对HER2蛋白的强烈免疫反应 [11] - OST-HER2已获得美国FDA的罕见儿科疾病认定、快速通道和孤儿药认定，以及EMA的孤儿药认定 [11] - OST-HER2已在美国农业部获得用于治疗犬骨肉瘤的有条件批准 [11] - 公司预计在2025年向美国FDA提交OST-HER2用于骨肉瘤的生物制品许可申请（BLA） [11] - 公司还在推进其下一代可调谐抗体药物偶联物（tADC）平台 [12]