Immunity Pharma Ltd.

「  本文共：15条资讯，阅读时长约：3分钟 」今日头条苏州丹码MIC A/B抗体国内报IND。丹码生物1类生物制品DM919注射液的临床试验申请获NMPA受理。DM919是一款MIC A/B单抗，此前已获得FDA临床许可，即将在美国开展新药研究，评估单药治疗及anti-PD1单抗联合治疗用于晚期实体瘤患者的安全性和初步疗效。MIC A/B在癌变、感染、DNA损伤等应激反应中显著上调，进而激活表达NKG2D的NK细胞、CD8+T细胞来清除表达MICA/B的肿瘤细胞等。国内药讯1.奥赛康Claudin18.2抗体启动胃癌Ⅲ期临床。奥赛康Claudin18.2抗体ASKB589在Clinicaltrials.gov网站上注册一项Ⅲ期临床，拟评估该新药与PD-1抑制剂替雷利珠单抗和化疗联合方案对比PD-1抑制联合化疗，一线治疗晚期胃癌的有效性与安全性。去年年底，这一联合治疗方案已在国内登记启动一线治疗CLDN18.2阳性、晚期胃癌的Ⅲ期临床，该项试验由北京肿瘤医院医学博士沈琳牵头开展。2.维亚臻siRNA降脂新药拟纳入突破性品种。维亚臻生物1类化药VSA003注射液获CDE拟纳入突破性治疗品种，拟定适应症为”成人纯合子型家族性高胆固醇血症（HoFH）”。VSA003是一款肝脏靶向小干扰RNA（siRNA）药物，通过靶向降解ANGPTL3信使RNA，增加对LDL-C和甘油三酯（TG）等的清除，有望为高胆固醇血症、高甘油三酯血症和HoFH患者提供新的治疗潜力。3.天演CTLA-4安全抗体结直肠癌早期临床积极。天演药业CTLA-4安全抗体ADG126（muzastotug）联合PD-1抑制剂帕博利珠单抗（Pembro）治疗转移性微卫星稳定型结直肠癌患者的Ⅰb/Ⅱ期研究结果积极。9例同时无腹膜和肝转移的患者接受10mg/kg每3周一次的治疗，确认的缓解率达到22%，总体疾病控制率高达100%。该项研究中，3级治疗相关不良事件（TRAE）的发生率为10.8%，无4级或5级治疗相关不良事件，停药率为6.5%。4.恩凯赛药NK细胞疗法获批临床。上海恩凯赛药自主研发的非基因修饰自然杀伤细胞注射液NK010获FDA批准开展I期临床试验。在临床前研究中，NK010细胞注射液在卵巢癌、肝癌等实体肿瘤以及急性髓系白血病等动物模型中均表现出积极的抗肿瘤活性。恩凯赛药计划在I期临床中评估NK010用于卵巢癌适应症的安全性与初步疗效。5.南京清普长效镇痛新药报IND。南京清普生物宣布其非阿片类镇痛新药管线的第三款长效产品QP6211的临床试验申请已获得CDE受理，拟开发用于术后镇痛或各种顽固性疼痛（如癌痛）的治疗。QP6211是清普生物基于自主知识产权的系列缓释注射剂平台开发，已在临床前研究中显示出局部注射后可实现活性成分1周以上持续释放，有望成为全球首款同分子5-7天长效制剂。国际药讯1.罗氏PD-L1单抗皮下剂获批欧盟上市。罗氏PD-L1单抗Tecentriq（阿替利珠单抗）皮下注射制剂获欧盟委员会批准上市，涵盖其静脉制剂在欧盟获批的包括肺癌、膀胱癌、乳腺癌和肝癌所有适应症。在Ib/Ⅲ期试验IMscin001中，与需要30-60分钟的静脉（IV）输注相比，只需7分钟的皮下注射Tecentriq在血液中的水平（药代动力学）显示出非劣效性。2.武田免疫调节新药获批新适应症。武田宣布其人免疫球蛋白皮下注射制剂Hyqvia获FDA批准新适应症，用于维持治疗慢性炎症性脱髓鞘性多发性神经病（CIDP）患者。在III期研究（ADVANCE-CIDP 1）中，与安慰剂相比，Hyqvia治疗患者的复发率降低了18.3%（p=0.0314）。Hyqvia是基于Halozyme公司的重组人玻璃酸酶（rHuPH20）技术开发而来，也是目前唯一一款获批的免疫球蛋白皮下注射制剂。3.罗氏TIGIT单抗食管癌Ⅲ期临床积极。罗氏旗下基因泰克TIGIT抗体tiragolumab与 PD-L1抑制剂atezolizumab和化疗构成的治疗方案，在一线治疗食管鳞状细胞癌（ESCC）的Ⅲ期临床SKYSCRAPER-08达到双主要终点。与对照组相比，tiragolumab联合疗法组由IRF评估的中位PFS显著更高（6.2个月vs5.4个月，HR：0.56，95% CI：0.45-0.70，P<0.0001），两组中位OS分别为15.7个月和11.1个月（HR：0.70，95% CI：0.55-0.88，P=0.0024）。联合治疗安全性与已知研究一致。4.VEGF靶向基因疗法眼科Ⅱ期临床积极。REGENXBIO公司与艾伯维联合开发的通过AAV8载体携带表达抗VEGF抗体片段的转基因疗法ABBV-RGX-314，在治疗湿性年龄相关性黄斑变性（AMD）的Ⅱ期临床获积极结果。6个月治疗数据显示，接受第3剂量水平ABBV-RGX-314治疗的患者年化注射率减少达到80％，有50％的患者无需接受进一步注射治疗；临床中无与药物相关的严重不良事件（SAEs）报告。5.创新生物活性肽疗法渐冻症临床积极。Immunity Pharma公司生物活性肽IPL344治疗肌萎缩侧索硬化（ALS）的Ⅱa期试验结果积极。数据显示，IPL344治疗患者的ALSFRS-R（测量ALS功能评分量表修订版）平均下降斜率为-0.53，疾病进展减慢了48%（p=0.028）；患者的中位生存期达到29个月；患者血浆生物标志物神经丝轻链（NfL）浓度平均降低20%。此外，药物展现良好耐受性。6.Comanche公司融资开发先兆子痫RNAi药物。Comanche Biopharma公司宣布完成由New Enterprise Associates（NEA）领投的7500万美元的B轮融资，以用于支持其主要RNAi候选药物CBP-4888的临床开发。CBP-4888靶向胎盘产生的sFLT1 mRNA亚型，旨在通过减少胎盘产生的sFLT1蛋白以降低母体血液中的sFLT1蛋白水平。该新药拟开发用于治疗常见且严重的妊娠并发症--先兆子痫（preeclampsia）。医药热点1.汕大医学院附属肿瘤医院院士会诊中心揭牌。近日，汕头大学医学院附属肿瘤医院在大学路院区举办院士会诊中心揭牌仪式。据悉，汕头大学医学院附属肿瘤医院院士会诊中心揭牌运行后，双方将在人才团队建设培养、病例会诊、远程医疗、手术指导、临床研究等多方面展开切实合作，共同推进肿瘤医院肿瘤放射治疗学科的建设，让肿瘤患者享受先进诊疗技术，提高肿瘤患者的生存率及生存质量。2.重庆医科大学增加一所附属医院。1月9日上午，重庆医科大学和北碚区人民政府合作共建“重庆医科大学附属北碚医院”正式揭牌。未来，重庆市第九人民医院将在教学、科研、医疗工作等方面接受重庆医科大学的指导，以重庆医科大学强大的学科群综合实力为支撑，加强对技术、人才培养、管理示范等方面的合作，实现校地共赢发展，满足人民日益增长的医疗健康需求。3.福建省4家知名大医院被医保局处罚。日前，福建省医保局官网上挂出4则通知，4家知名三甲大医院被处理，其共同的原因是，这些医院存在“双通道”流转处方数据传送不规范和处方审核不严等情况，导致部分医师出现超量开药的情形。经研究，决定对其作出限期整改处理，要求在收到本通知之日起5个工作日内将整改报告提交福建省医保基金中心。这4家医院是福建省立医院、福建中医药大学附属人民医院、福建医科大学附属第一医院以及福建医科大学孟超肝胆医院。评审动态  1. CDE新药受理情况（01月18日) 2. FDA新药获批情况（北美01月16日）股市资讯上个交易日 A 股医药板块 -0.08%涨幅前三     跌幅前三艾 力 斯 +6.64%  绿康生化-9.99%智翔金泰+4.49%  赛伦生物-4.77%莎普爱思+3.84%  赛科希德-3.78%[天士力]公司收到国家药品监督管理局核准签发关于人脐带间充质干细胞注射液项目的《药物临床试验批准通知书》，同意开展伴冠状动脉旁路移植术指征的慢性缺血性心肌病导致的慢性心力衰竭的临床试验。[西藏药业]2023年度业绩预增公告预计归母净利润为8亿元左右，同期增长116%左右;扣非净利润为7.8亿元左右，同期增长111%左右。[哈三联]2023年度业绩预告预计归母净利润为6,840.00万元至8,040.00万元，同期增长126.42%到166.14%;扣非净利润为2.500.00万元到3.700.00万元，同期增长130.18%到240.67%。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

Treatment with IPL344 was well tolerated Changes in the slope of decline in ALSFRS-R demonstrated 48% slower disease progression (p=0.028); and 64% slower progression when adjusted for disease stage and rate (p=0.034) Study suggests benefits in weight gain, respiration, and survival Plasma neurofilament (NfL) reduction observed following IPL344 treatment JERUSALEM, Jan. 17, 2024 /PRNewswire/ -- Immunity Pharma, a clinical-stage neurology-focused biopharmaceutical company, today announced positive top line results from the Phase 2a trial with IPL344 in amyotrophic lateral sclerosis (ALS) patients. The study demonstrated statistically significant efficacy as measured by change in the slope decline of ALSFRS-R. The drug was well tolerated, and the study suggests benefits in weight gain, respiration, and survival. Neurofilament (NfL) reduction was observed following IPL344 treatment. In this study, once-daily treatment with IPL344 for up to 36 months was well tolerated, with no major drug related serious adverse events (SAE). No participants discontinued treatment due to drug-related AEs. IPL344 treated patients showed a mean slope of decline in ALSFRS-R of -0.53, equating 48% slower disease progression (p=0.028). Adjustment for disease stage and rate-indicating covariates, indicated a 64% slower ALSFRS-R progression (p=0.034). In addition, a statistically significant increase rather than decrease was observed in body weight of IPL344 treated patients (p=0.02; compared to the PRO-ACT database of patients treated with placebo). Median survival of patients in this study was 29 months vs. 19 months of placebo treated patients in the ceftriaxone study (post-treatment follow-up is still ongoing), indicating a trend toward reduced risk of death in favor of IPL344 (p=0.13). There was a non-significant trend for preserved respiration capacity (44% slower reduction in average %SVC loss per month vs. historical placebo; p=0.15). Biomarker data for plasma neurofilament light (NfL) levels were obtained for eight subjects. NfL concentrations were reduced during IPL344 treatment in all but one participant. In the six subjects that had blood sampling past the initial dose-escalating phase, plasma NfL concentrations were reduced by a mean of 20%, suggesting decrease of neuronal injury following IPL344 treatment. "We are excited that treatment with IPL344 was well tolerated in people with ALS and demonstrated encouraging signs of efficacy across multiple parameters. This data will soon be submitted for publication in a scientific journal," said Dr. Ilana Cohen, Immunity Pharma's VP of R&D. "If confirmed in a subsequent larger phase 3 study, the magnitude of reduction in ALSFRS-R progression observed in this study is greater than that achieved with currently approved drugs." "These early-stage data support further development of IPL344 as a treatment for ALS, and merit further investigation in a large number of participants. We intend to progress PL344 to a pivotal clinical trial in ALS," said Immunity's CEO, Eran Ovadia. About the Phase 2a ALS Clinical Trial The Phase 1/2a trial was an open-label study with once-daily IPL344 treatment administered IV (home administration). Subjects were allowed to stay in the study for up to 3 years. The study includes a 28-day Phase 1dose-escalating portion, after which subjects may continue to the Phase 2a portion of the study. The study was conducted at the Hadassah Medical Center in Jerusalem (NCT03652805, NCT03755167). The Phase 1/2a study included nine participants with probable or definite ALS and a progression rate >0.55 points/month on the ALS functional rating scale-revised (ALSFRS-R) that received open-label treatment with once-daily IPL344 for up to 36 months. Efficacy outcomes included the rate of progression on ALSFRS-R, slow vital capacity (SVC), weight, and survival compared with historical placebo from the PRO-ACT database and ceftriaxone study. The statistical analysis included a method previously proposed by Dr. Schoenfeld designed to quantify inter-center and inter-study variability, to pinpoint whenever ALSFRS-R slowdown exceeds the normal variability. This analysis shows that, despite the small number of participants the magnitude of ALSFRS-R slope reduction is larger than the threshold needed for significance and is beyond that expected by inter-study variation. About IPL344 IPL344 is a biologically active peptide that stimulates therapeutic cell-signaling processes including activation of the Akt pathway, which is down-regulated in neurodegenerative diseases. IPL344 was discovered in the Weizmann institute of Science, Israel, at Prof. Irun Cohen's Laboratory. IPL344 is being developed as an intravenous injection for the treatment of ALS initially through a Phase 1/2a clinical trial in ALS patients. IPL344 received orphan drug designation from FDA and EMA, which grants exclusivity for at least seven years. About Immunity Pharma Immunity Pharma Ltd. (IPL) is a privately-held clinical-stage neurology-focused biopharmaceutical company that develops therapies for neurodegenerative diseases, with an initial focus on Amyotrophic lateral sclerosis (ALS). IPL's drugs are biologically active peptides that stimulate therapeutic cell-signalling processes and mitigate progression of neurodegenerative diseases by inducing intra-cellular survival-supporting processes. IPL's drugs are being developed as treatment for ALS, Parkinson's disease and other neurodegenerative diseases. For more information, please visit SOURCE Immunity Pharma