Venetoclax

- Study to Enroll 80 Patients Unlikely to Benefit from Venetoclax/Azacitide (Aza/Ven) Therapy in the US and Europe -- SELLAS’ Predictive Biomarker and AI Assisted Precision Medicine Models to be Utilized -- Topline Data Expected in Q4 2026 – NEW YORK, March 12, 2026 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced the first patient has been enrolled in its randomized Phase 2 trial evaluating SLS009 (tambiciclib), a highly selective CDK9 inhibitor in newly diagnosed, first-line acute myeloid leukemia (AML) patients. The newly initiated NCT04588922 is designed to enroll approximately 80 patients and includes two AML cohorts with high unmet need and greatest potential benefit: Predictive biomarker cohort: Newly diagnosed patients unlikely to benefit from standard aza/ven therapy based on molecular profilingEarly resistance cohort: Patients who initiate treatment with aza/ven but demonstrate a confirmed lack of any response after two treatment cycles “Enrolling the first patient in this first-line AML Phase 2 study represents an important milestone in the advancement of our SLS009 program and reflects our precision medicine strategy to address challenging subgroups of AML patients through our extensive transcriptomics, genomics, and proteomics models we have established,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. “The strength of our Phase 2 data in r/r AML, particularly in high-risk molecular subtypes, together with the FDA's guidance, provided a strong foundation for moving into earlier lines of therapy. By targeting molecularly defined subgroups and those demonstrating early non-response, we aim to address a critical need in frontline AML and position SLS009 for potential registrational development.” This milestone follows the Company’s previously reported positive Phase 2 results in relapsed/refractory (r/r) AML and the FDA’s guidance recommending advancement into a study that includes newly diagnosed AML patients eligible for venectoclax and azacitidine (aza/ven) therapy. In the completed Phase 2 trial in r/r AML, SLS009 in combination with aza/ven met all endpoints, exceeding the pre-specified ORR threshold of 20%, demonstrating strong efficacy and favorable safety and tolerability with robust anti-tumor activity: 33% overall response rate (ORR) in all evaluable patients across all cohorts and dose levels, and 40% ORR for the recommended 30mg BIW dose level.ORR of 44% in AML patients with myelodysplasia-related changes (AML-MR) at the 30mg BIW doseORR of 50% in ASXL1-mutated AML-MR at 30 mg BIW dose levels and 50% ORR in M4/M5 subtypesMedian overall survival (mOS) of 8.8 months in patients treated with 30mg BIW, with a median of 1 prior line of therapy, and mOS of 8.9 months in AML MR patients vs 2.4 months with best available therapy. About SELLAS Life Sciences Group, Inc. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit www.sellaslifesciences.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 20, 2025 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made. Investor Contact John FrauncesManaging DirectorLifeSci Advisors, LLCjfraunces@lifesciadvisors.com

（来源：新康界）转自：新康界1.康龙化成与礼来达成Orforglipron生产合作3月11日，康龙化成与礼来公司宣布达成口服小分子GLP-1受体激动剂Orforglipron的生产合作协议。礼来拟投资2亿美元支持康龙化成技术建设，未来将扩大合作规模。Orforglipron已提交治疗2型糖尿病与肥胖症的上市申请，康龙化成将凭借全流程研发生产服务能力，助力该创新药尽快惠及中国患者。康龙化成业务覆盖中、美、英三国，服务全球多地合作伙伴。2.宜联生物YL201获第四项突破治疗认定3月10日，宜联生物注射用YL201联合斯鲁利单抗一线治疗广泛期小细胞肺癌，拟纳入国家药监局突破治疗药物程序，这是其第四项突破疗法资格。此前该药物已获针对复发性小细胞肺癌、鼻咽癌、食管鳞癌的突破疗法认定，且获美国FDA突破性疗法认证及三项孤儿药资格。YL201一期临床数据显示小细胞肺癌ORR达63.9%，目前正开展两项III期注册临床，2026年1月宜联生物与罗氏达成全球独家许可协议。3.复宏汉霖启动PD-L1ADC全球2/3期临床3月10日，复宏汉霖在Clinicaltrials.gov注册PD-L1ADC新药HLX43的全球2/3期临床试验，拟入组671例复发性或转移性鳞状非小细胞肺癌患者，预计2030年初完成。试验设HLX43单药、HLX43+HLX07联合治疗两组，以多西他赛为对照。前期临床数据显示，HLX43在鳞癌患者中ORR达33.3%，非鳞癌患者ORR达48.6%，且疗效不受PD-L1表达限制，在多西他赛治疗失败人群中也显潜力。4.三家生物科技企业获融资或临床进展近日，易慕峰生物完成近2亿元Pre-IPO轮融资，累计融资超6亿元，核心产品IMC002已启动晚期胃癌3期临床；莱芒生物完成近2亿元A轮新增融资，其META10技术平台针对T细胞耗竭问题，多条管线进入IIT临床；康方生物全球首创三特异性抗体AK150获临床试验默示许可，用于治疗晚期恶性实体瘤，公司构建了多技术核心的研发创新体系。5.礼来拟斥30亿美元加码在华供应链3月11日，礼来宣布未来十年拟在华投资30亿美元，扩展供应链产能，打造口服固体制剂本土生产体系，重点布局Orforglipron的规模化生产。作为合作核心，礼来已与康龙化成达成战略合作，初始投资2亿美元，并将升级苏州工厂形成协同。礼来2025年营收达652亿美元，市值破万亿美元，核心产品替尔泊肽销售额365亿美元，此次投资将助力其抢占中国糖尿病与肥胖症治疗市场。6.中国生物制药“得福组合”头对头研究登顶顶刊近日，《柳叶刀・肿瘤学》发表中国生物制药“得福组合”（贝莫苏拜单抗+盐酸安罗替尼）III期临床研究结果，其一线治疗PD-L1阳性晚期非小细胞肺癌的PFS和ORR均优于帕博利珠单抗。该研究纳入531例患者，“得福组合”中位PFS达11.0个月，ORR为57%，在鳞癌、PD-L1高表达及肝转移等亚组中均显优势，且安全性良好。这是全球首个“抗血管生成+PD-L1”一线治疗该适应症的III期研究，为肺癌治疗提供新思路。7.和誉医药ABSK061获FDA罕见儿科疾病认定3月11日，和誉医药自主研发的高选择性FGFR2/3抑制剂ABSK061，获FDA授予罕见儿科疾病资格认定，用于治疗软骨发育不全。该资格可助力其获得优先审评券，加速上市进程。ABSK061是全球首个进入临床的FGFR2/3选择性抑制剂，口服给药且安全性良好，目前正开展3-12岁儿童患者II期临床，相较于首代泛FGFR抑制剂，其安全窗与疗效更具优势。8.福泰制药PovetaciceptIII期数据亮眼，拟加速申报近日，福泰制药宣布其治疗IgA肾病的药物PovetaciceptIII期临床36周中期分析达标，治疗组蛋白尿较基线下降52.0%，血尿缓解率85.1%，安全性良好。公司计划2026年3月底前提交BLA申请并使用优先审评券，将审评周期缩短至6个月。该药物还在推进膜性肾病二/三期试验及全身型重症肌无力二期试验，肾脏疾病将成为公司第四大业务板块。9.BCL-2领域先驱综述其发现与临床应用近日，BCL-2研究先驱者在《CellDeathandDifferentiation》发表综述，回顾40年研究历程。BCL-2通过阻止线粒体外膜通透化抑制凋亡，miR-15/16缺失导致其过表达驱动肿瘤发生。抑制剂维奈克拉彻底改变慢性淋巴细胞白血病和急性髓系白血病治疗，但存在耐药挑战。未来方向包括靶向MCL-1/BCL-XL的新型抑制剂、BH3分析技术及联合治疗，BCL-2非凋亡作用也值得探索。10.晶泰控股实现AI制药行业首个盈利2026年3月，晶泰控股发布2025年盈利预喜，营收不少于7.8亿元，同比增193%，净利润超1亿元，成为港股首个盈利的AI应用股。公司采用“AI+自动化研发平台”赋能模式，通过首付款、里程碑付款等实现收入，规避自研管线风险。其核心优势在于“量子物理+AI+机器人”技术闭环，已与全球17家Top20药企合作，管线覆盖多疾病领域，同时拓展消费健康等增量市场。11.NVIDIA发布2026医疗健康AI应用报告2026年1月，NVIDIA发布调研显示，医疗健康与生命科学行业AI应用率升至70%，69%企业使用生成式AI。开源模型为垂直领域解决方案核心，82%受访者认可其重要性；47%企业应用或评估AI智能体，主要用于知识管理、文献分析等场景。AI为行业带来显著商业价值，85%管理层称其提升营收，80%表示降低成本，2026年85%企业计划增加AI预算，聚焦工作流优化与基础设施建设。参考资料：网络公开信息，包括新闻资讯、企业官网、政府文件等。