Cocarboxylase

Ongoing clinical trial has reached target enrollment of 109 patients across clinical sites in the United States and France Open-label dose optimization and proof of concept study of PT-112 monotherapy includes interim data results, with top-line read-out and conference presentations expected in late 2024 NEW YORK, March 8, 2024 /PRNewswire/ -- Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing immunogenic small molecule approaches in oncology, has completed enrollment of its Phase 2 clinical trial of lead therapeutic candidate, PT-112, reaching its target enrollment of 109 patients with late-line metastatic castration-resistant prostate cancer (mCRPC) (ClinicalTrials.gov Identifier: NCT02266745). The study is evaluating PT-112 in patients who have been treated with at least three prior life-prolonging therapies for mCRPC, and who exhibited radiographic evidence of disease progression at study entry. Patients with bone-only metastatic disease are also included in the study. These requirements create a representative treatment population following standard of care of androgen receptor signaling inhibitors, taxane chemotherapies, and any other drug approved by FDA on the basis of overall survival. The clinical trial enrolled patients across leading sites in the United States (23) and France (9). "This clinical trial is the largest study to date of PT-112 and will establish the optimal dose in line with the FDA's Project Optimus, as well as proof of concept in our late-line mCRPC patient population," said Promontory Therapeutics Chief Medical Officer Johan Baeck, MD. "Data from our earlier Phase 1/2 studies have shown that PT-112 is clinically safe and active, and promotes immunogenic cancer cell death induced by the inhibition of ribosomal biogenesis, which is a promising mechanism of action for late-stage patients with prostate cancer — an 'immune-cold' disease with no broadly approved and effective immunotherapy." Promontory Therapeutics plans for a Type C meeting with the FDA in the second half of 2024, followed by an End-of-Phase 2 meeting with FDA and further engagement with European regulatory authorities. In addition to safety and efficacy findings among late-stage metastatic patients, the study aims to generate meaningful supportive data via correlative research, including on immune activation by PT-112 monotherapy as evaluated by the propagation of new T cell populations, as well as reductions in circulating tumor cells and ctDNA. "Promontory is grateful to our clinical partners across the U.S. and France, including Gustave Roussy Paris, for completing enrollment of this critical Phase 2 study. We are confident in PT-112's potential as an effective treatment for patients with mCRPC who have progressed on androgen receptor directed therapy, chemotherapy or radioligand therapy and who lack any effective immunotherapy," said Promontory Therapeutics Chief Executive Officer Robert Fallon. "We look forward to presenting topline safety, efficacy, and correlative data at relevant research and medical conferences later this year." About PT-112 PT-112 is the first small-molecule conjugate of pyrophosphate in clinical development in oncology. PT-112 has numerous advantages — including its tolerability and inhibition of ribosomal biogenesis which leads to immunogenic cell death, through the release of damage associated molecular patterns that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a highly potent inducer of this immunological form of cancer cell death. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and data were published in eClinicalMedicine, part of The Lancet. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in a mini-oral presentation at the ESMO 2020 Virtual Congress, and the Phase 2a dose confirmation cohort in non-small cell lung cancer patients was reported at ESMO I-O 2022. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH 2020 is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, and includes the Phase 2 proof of concept study in thymic epithelial tumors under the company's formal CRADA with the NCI. Interim data from the NCI study were published at ASCO 2023. About Promontory Therapeutics Promontory Therapeutics Inc. is a privately held, clinical stage pharmaceutical company focused on small molecule immunotherapy, based in New York City. Clinical data generated across three Phase 1 studies have demonstrated single-agent and combination anti-cancer activity and an attractive tolerability profile, and two Phase 2 studies of PT-112 are underway. The company's research and development work has been conducted in the United States, Europe and Asia. The company sponsored the completed clinical study of PT-112 in combination with the PD-L1 inhibitor avelumab, and has an active Phase 2 trial under formal CRADA collaboration with the National Cancer Institute (NCI), utilizing PT-112 in thymic epithelial tumors, rare cancers with no FDA approved drug, where PT-112 has received Orphan Drug designation. Promontory Therapeutics is also a company member of the Paris-Saclay Cancer Cluster, Europe's emerging bio-cluster for oncology, and was a 2023 Nominee for Best Startup by the Prix Galien USA. To learn more about Promontory Therapeutics, visit the company's website here. CONTACTS: Promontory Therapeutics Brooke Raphael, MS VP, Strategy & Operations Tel: +1 (646) 974-6453 Email: [email protected] Investors: Stan Musial Tel: +1 (646) 222-6932 Email: [email protected] ICR Westwicke Media: Alexis Feinberg Tel: +1 (203) 939-2225 Email: [email protected] SOURCE Promontory Therapeutics Inc.

每周药品注册受理数据，分门别类呈现，一目了然。(2.19-2.25）新药上市申请药品名称企业名称分类受理号HY22017胶囊长春海悦药业股份有限公司2.3CXHS2400012特立帕肽注射液深圳翰宇药业股份有限公司2.2CXHS2400015盐酸氨溴索口服冻干片华润三九医药股份有限公司2.2CXHS2400013盐酸氨溴索口服冻干片华润三九医药股份有限公司2.2CXHS2400014新药临床申请药品名称企业名称分类受理号177Lu-LNC1008注射液烟台蓝纳成生物技术有限公司1CXHL2400195ENN0403胶囊轶诺(浙江)药业有限公司1CXHL2400215ENN0403胶囊轶诺(浙江)药业有限公司1CXHL2400216HJ787软膏成都华健未来科技有限公司1CXHL2400196HJ787软膏成都华健未来科技有限公司1CXHL2400197HJ787软膏成都华健未来科技有限公司1CXHL2400198HJ787软膏成都华健未来科技有限公司1CXHL2400199HS-10382片江苏豪森药业集团有限公司1CXHL2400206HS-10382片江苏豪森药业集团有限公司1CXHL2400207INR101注射液云核医药(天津)有限公司1CXHL2400200JP001片北京慧宝源生物技术股份有限公司2.4;2.3CXHL2400202RAG-17注射液中美瑞康核酸技术(南通)研究院有限公司1CXHL2400208SG1001片深圳市祥根生物有限公司1CXHL2400203SIPI6398片上海中泽医药科技有限公司1CXHL2400205SR1375胶囊上海赛默罗生物科技有限公司1CXHL2400209SR1375胶囊上海赛默罗生物科技有限公司1CXHL2400210SR1375胶囊上海赛默罗生物科技有限公司1CXHL2400211SSS39注射剂沈阳三生制药有限责任公司1CXHL2400204VB15010片深圳扬厉医药技术有限公司1CXHL2400212VB15010片深圳扬厉医药技术有限公司1CXHL2400213吸入用XQ-001成都倍特新启生物医药有限责任公司1CXHL2400201注射用YN17浙江永宁药业股份有限公司1CXHL2400214注射用瑞卢戈利诺桥制药(成都)有限责任公司2.2CXHL2400194ADRX-0706上海德烽药业有限公司1CXSL2400124AK112注射液康方赛诺医药有限公司1CXSL2400151AK112注射液康方赛诺医药有限公司1CXSL2400150AK130注射液中山康方生物医药有限公司1CXSL2400152BR101注射液浙江博锐生物制药有限公司1CXSL2400120CM383注射液康诺亚生物医药科技(成都)有限公司1CXSL2400154EMB-06注射液上海岸迈生物科技有限公司1CXSL2400125GQ1010注射液启德医药科技(苏州)有限公司1CXSL2400149JS001sc注射液上海君实生物医药科技股份有限公司2.1CXSL2400134LAE102注射液来凯医药科技(上海)有限公司1CXSL2400155SHR-2173注射液广东恒瑞医药有限公司1CXSL2400129TVAX-008注射液远大赛威信生命科学(南京)有限公司1CXSL2400132VVN1901滴眼液维眸生物科技(浙江)有限公司1CXSL2400121VVN1901滴眼液维眸生物科技(浙江)有限公司1CXSL2400122VVN1901滴眼液维眸生物科技(浙江)有限公司1CXSL2400123司普奇拜单抗注射液康诺亚生物医药科技(成都)有限公司1CXSL2400137注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2400141注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2400143注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2400144注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2400145注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2400146注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2400147注射用BL-B01D1成都百利多特生物药业有限责任公司1CXSL2400148注射用HB0052上海华奥泰生物药业股份有限公司1CXSL2400142注射用KKD001上饶市康可得生物科技有限公司1CXSL2400130注射用MK-2870默沙东研发(中国)有限公司1CXSL2400139注射用MK-2870默沙东研发(中国)有限公司1CXSL2400140注射用SHR-9839上海恒瑞医药有限公司1CXSL2400126注射用SHR-A1921苏州盛迪亚生物医药有限公司1CXSL2400128注射用SHR-A2009苏州盛迪亚生物医药有限公司1CXSL2400127注射用ZB001上海泽纳仕生物科技有限公司1CXSL2400133混合活化杀伤(MAK)免疫细胞注射液北京拓华伟业生物科技有限公司1CXSL2400119达雷妥尤单抗注射液正大天晴药业集团南京顺欣制药有限公司3.3CXSL2400135达雷妥尤单抗注射液正大天晴药业集团南京顺欣制药有限公司3.3CXSL2400136四价流感病毒裂解疫苗(MDCK细胞)成都新诺明生物科技有限公司2.2CXSL2400138带状疱疹减毒活疫苗成都柏奥特克生物科技股份有限公司2.5CXSL2400131重组带状疱疹疫苗(CHO细胞)江苏中慧元通生物科技股份有限公司1.2CXSL2400153仿制药申请药品名称企业名称分类受理号布立西坦注射液江西银涛药业股份有限公司3CYHL2400040托吡司特片河北凯威恒诚制药有限公司3CYHL2400041托吡司特片河北凯威恒诚制药有限公司3CYHL2400042托吡司特片河北凯威恒诚制药有限公司3CYHL2400043环孢素滴眼液(II)深圳欣祺医药科技有限公司3CYHL2400044琥珀酰明胶注射液山东齐都药业有限公司4CYHL2400046琥珀酰明胶电解质醋酸钠注射液山东齐都药业有限公司4CYHL2400045瑞卢戈利片齐鲁制药有限公司3CYHL2400039丙戊酸钠口服溶液浙江赛默制药有限公司4CYHS2400631丙戊酸钠缓释片(I)重庆药友制药有限责任公司4CYHS2400666丙泊酚乳状注射液南京健友生化制药股份有限公司4CYHS2400694丙泊酚乳状注射液南京健友生化制药股份有限公司4CYHS2400695乙酰半胱氨酸注射液成都瑞尔医药科技有限公司3CYHS2400664乙酰半胱氨酸颗粒湘北威尔曼制药股份有限公司4CYHS2400659乙酰半胱氨酸颗粒湘北威尔曼制药股份有限公司4CYHS2400660二羟丙茶碱注射液河北龙海药业有限公司3CYHS2400690二羟丙茶碱注射液广东鼎信医药科技有限公司3CYHS2400692利奈唑胺氯化钠注射液大翔医药集团有限公司3CYHS2400655去氧胆酸注射液南京迈诺威医药科技有限公司3CYHS2400661吡仑帕奈口服混悬液锦州奥鸿药业有限责任公司4CYHS2400628吡格列酮二甲双胍片安徽金太阳生化药业有限公司3CYHS2400667吸入用布地奈德混悬液鲁南贝特制药有限公司4CYHS2400650呋塞米片石家庄四药有限公司3CYHS2400646哌柏西利片石药集团欧意药业有限公司4CYHS2400665复合磷酸氢钾注射液广州合和医药有限公司3CYHS2400685复合磷酸氢钾注射液重庆赛维药业有限公司3CYHS2400681复合磷酸氢钾注射液仁合益康汇泽药业河北有限公司3CYHS2400682复方氨基酸注射液(17AA-III)四川太平洋药业有限责任公司4CYHS2400640多巴丝肼片杭州泓友医药科技有限公司4CYHS2400673头孢地尼颗粒成都赛捷医药科技有限公司4CYHS2400693左乙拉西坦口服溶液吉林四环澳康药业有限公司4CYHS2400683左卡尼汀口服溶液哈尔滨誉衡制药有限公司4CYHS2400656左西孟旦注射液重庆德诚永道医药有限公司4CYHS2400658布洛芬混悬液湖北亨迪药业股份有限公司4CYHS2400679布洛芬混悬液湖北亨迪药业股份有限公司4CYHS2400680异烟肼注射液河北龙海药业有限公司3CYHS2400641恩格列净二甲双胍缓释片乐普药业股份有限公司3CYHS2400622恩格列净二甲双胍缓释片乐普药业股份有限公司3CYHS2400623恩格列净二甲双胍缓释片乐普药业股份有限公司3CYHS2400624来特莫韦注射液重庆希韦医药科技有限公司4CYHS2400691枸橼酸托瑞米芬片重庆士立德医药科技有限公司4CYHS2400643枸橼酸托瑞米芬片重庆士立德医药科技有限公司4CYHS2400644比拉斯汀口崩片山东新时代药业有限公司3CYHS2400668比索洛尔氨氯地平片天大药业(珠海)有限公司4CYHS2400634氨溴特罗口服溶液湖北欣泽霏药业有限公司3CYHS2400652氯化钙注射液山东齐都药业有限公司3CYHS2400618氯化钾缓释片天津力生制药股份有限公司3CYHS2400677氯化钾缓释片天津力生制药股份有限公司3CYHS2400678法莫替丁注射液海南全星制药有限公司3CYHS2400674注射用哌拉西林钠四川制药制剂有限公司3CYHS2400610注射用哌拉西林钠四川制药制剂有限公司3CYHS2400611注射用拉氧头孢钠齐鲁安替制药有限公司3CYHS2400635注射用拉氧头孢钠齐鲁安替制药有限公司3CYHS2400636注射用拉氧头孢钠齐鲁安替制药有限公司3CYHS2400637注射用硫酸艾沙康唑福安药业集团湖北人民制药有限公司4CYHS2400639洛索洛芬钠凝胶贴膏江苏万高药业股份有限公司4CYHS2400648特利加压素注射液海南中和药业股份有限公司3CYHS2400670甘油果糖氯化钠注射液江苏亚尧生物科技有限公司3CYHS2400653盐酸伐地那非片山东华铂凯盛生物科技有限公司4CYHS2400621盐酸克林霉素棕榈酸酯颗粒广州一品红制药有限公司3CYHS2400625盐酸奥洛他定颗粒成都倍特药业股份有限公司3CYHS2400662盐酸屈他维林注射液石家庄四药有限公司4CYHS2400630盐酸左西替利嗪口服溶液山西辅仁恒峰药业有限公司3CYHS2400642盐酸罗哌卡因注射液广东鼎信医药科技有限公司4CYHS2400687盐酸罗哌卡因注射液广东鼎信医药科技有限公司4CYHS2400688盐酸美金刚口服溶液河北合渡药业有限公司3CYHS2400620盐酸艾司洛尔注射液上海炫鑫医药科技有限公司3CYHS2400627盐酸西替利嗪滴剂福建大谱生物医药有限公司4CYHS2400645盐酸贝尼地平片山西鑫煜制药股份有限公司4CYHS2400671盐酸贝尼地平片山西鑫煜制药股份有限公司4CYHS2400672硫酸镁注射液石家庄杏泽医药科技有限公司3CYHS2400619碘佛醇注射液重庆煜洋药业有限公司4CYHS2400638磷酸奥司他韦胶囊浙江普洛康裕制药有限公司4CYHS2400689立他司特滴眼液齐鲁制药有限公司3CYHS2400663米诺地尔搽剂药大制药有限公司3CYHS2400654美索巴莫注射液西洲医药科技(浙江)有限公司3CYHS2400686美阿沙坦钾片重庆圣华曦药业股份有限公司4CYHS2400612美阿沙坦钾片重庆圣华曦药业股份有限公司4CYHS2400613聚乙二醇3350散福州基石医药科技有限公司3CYHS2400651艾司奥美拉唑镁肠溶干混悬剂广州一品红制药有限公司3CYHS2400632艾司奥美拉唑镁肠溶干混悬剂广州一品红制药有限公司3CYHS2400633艾拉莫德片重庆圣华曦药业股份有限公司4CYHS2400614西咪替丁注射液山西惠达林曦医药科技有限公司3CYHS2400649酒石酸美托洛尔片江苏贝佳制药有限公司4CYHS2400675酒石酸美托洛尔片江苏贝佳制药有限公司4CYHS2400676重酒石酸间羟胺注射液江西泰吉立生物医药科技有限公司3CYHS2400669重酒石酸间羟胺注射液海南爱科制药有限公司3CYHS2400647阿戈美拉汀片安徽艾立德制药有限公司4CYHS2400657雌二醇片浙江仙琚制药股份有限公司4CYHS2400626非那雄胺片江苏润邦药业有限公司4CYHS2400615马来酸氟伏沙明片苏州第三制药厂有限责任公司4CYHS2400616马来酸氟伏沙明片苏州第三制药厂有限责任公司4CYHS2400617马来酸氯苯那敏注射液辽宁海神联盛制药有限公司3CYHS2400684进口申请药品名称企业名称分类受理号AZD5305AstraZeneca AB1JXHL2400038AZD5305AstraZeneca AB1JXHL2400039AZD5305AstraZeneca AB1JXHL2400040AZD5305AstraZeneca AB1JXHL2400041AZD9833片ASTRAZENECA AB1JXHL2400037DE-117B滴眼液Santen Pharmaceutical Co., Ltd.5.1JXHL2400033IDRX-42IDRX, Inc.1JXHL2400034IDRX-42IDRX, Inc.1JXHL2400035布地奈德硫酸沙丁胺醇吸入气雾剂AstraZeneca Pharmaceuticals LP2.4JXHL2400036拉索昔芬片Sermonix Pharmaceuticals, Inc.2.4JXHL2400042雌二醇透皮喷雾剂Gedeon Richter Plc.5.1JXHS2400017AMG 451Amgen Inc.1JXSL2400047Itepekimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400044MEDI5752AstraZeneca AB1JXSL2400048Riliprubart注射液Sanofi-aventis Recherche & Developpement1JXSL2400045Riliprubart注射液Sanofi-aventis Recherche & Developpement1JXSL2400046纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400014纳武利尤单抗注射液Bristol-Myers Squibb Pharma EEIG2.2JXSS2400015中药相关申请药品名称企业名称分类受理号宝心艾维西木口服液新疆维吾尔药业有限责任公司4CYZL2400001小儿黄金止咳颗粒北京东方运嘉药业有限公司1.1CXZS2400008不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。