更新于：2024-11-21
ALG-000184
更新于：2024-11-21
概要
基本信息
非在研机构- |
最高研发阶段临床1期 |
首次获批日期- |
最高研发阶段(中国)临床1期 |
特殊审评- |
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关联
3
项与 ALG-000184 相关的临床试验A Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of Multiple Doses of ALG-000184.
This Phase 1 study consists of two parts, all conducted in healthy volunteers (HVs).
In Part 1, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Itraconazole; participants will be assigned to receive multiple doses of ALG-000184 and Itraconazole over a two week period.
In Part 2, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Carbamazepine; participants will be assigned to receive multiple doses of ALG-000184 and ascending doses of Carbamazepine over an 18 day period.
The 2 parts may be conducted in parallel.
In Part 1, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Itraconazole; participants will be assigned to receive multiple doses of ALG-000184 and Itraconazole over a two week period.
In Part 2, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Carbamazepine; participants will be assigned to receive multiple doses of ALG-000184 and ascending doses of Carbamazepine over an 18 day period.
The 2 parts may be conducted in parallel.
开始日期2025-01-09 |
申办/合作机构 |
一项随机双盲、安慰剂对照、口服ALG-000184的首次人体Ⅰ期研究以评估健康志愿者单次给药剂量递增（第1部分）和多次给药剂量递增（第2部分）以及慢性乙型肝炎受试者多次给药（第3部分）的安全性、耐受性、药代动力学和药效学。
评估口服ALG-000184在健康志愿者单次给药剂量递增（第1部分）和多次给药剂量递增（第2部分）以及慢性乙型肝炎受试者多次给药（第3部分）的安全性、耐受性、药代动力学和药效学。
开始日期2021-07-26 |
申办/合作机构  缔脉生物医药科技（上海）有限公司初创企业 [+3] |
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Orally Administered ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single-Ascending Doses (Part 1) and Multiple-Ascending Doses in Healthy Volunteers (Part 2), and Multiple Doses in Subjects With Chronic Hepatitis B (Part 3)
A Randomized Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
开始日期2020-10-22 |
申办/合作机构 |
100 项与 ALG-000184 相关的临床结果
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100 项与 ALG-000184 相关的转化医学
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100 项与 ALG-000184 相关的专利（医药）
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47
项与 ALG-000184 相关的新闻（医药）2024-11-06
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today reported recent business progress and financial results for the third quarter 2024.
“This quarter we reached a key milestone when we announced the positive topline HERALD data in MASH subjects,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “With placebo-adjusted median relative reductions in liver fat of up to 46.2%, we continue to believe ALG-055009 has best-in-class potential. We are completing Phase 2b enabling studies and evaluating a variety of options to fund continued development, including potential partnering where discussions are underway. In addition, we are progressing ALG-000184 for CHB towards a Phase 2 study next year. Lastly, we expect to begin externally funded clinical studies for ALG-097558 later this year in COVID subjects. 2024 has been an exciting year for the company, and we believe we are laying the groundwork for important future successes in 2025 and beyond.”
Recent Business Progress
Aligos Portfolio of Drug Candidates
ALG-000184: Potential first-/best-in-class small molecule CAM-E for CHB
Dosing continues in this ongoing Phase 1a/1b study, with subjects expected to dose for up to 96 weeks. Additional interim data readouts are planned to be presented this year at the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting (TLM) 2024Received positive feedback from the FDA and the National Medical Products Administration in China to move forward with sustained HBV DNA suppression as the primary efficacy endpoint for future studies designed to support the potential registration of ALG-000184 for the treatment of hepatitis B infectionAnnounced a clinical collaboration with Xiamen Amoytop Biotech Co., Ltd. Amoytop agreed to sponsor and perform a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in China Phase 2 enabling activities are underway, including drug supply manufacturing
ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH
Topline HERALD data were presented in September 2024, demonstrating that ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at Week 12 as measured by MRI-PDFF Doses of 0.5 mg to 0.9 mg ALG-055009 demonstrated statistically significant reductions in liver fat at Week 12, with placebo-adjusted median relative reductions up to 46.2% as measured by MRI-PDFF. Up to 70% of subjects achieved ≥30% relative reduction in liver fat compared to baselineALG-055009 demonstrated a favorable tolerability profile with no clinical hyper/hypothyroidism. Incidence of gastrointestinal-related treatment emergent adverse events were similar in ALG-055009 dose groups compared to placebo. Specifically, a non-dose-related, lower incidence of diarrhea was observed in ALG-055009 dose groups compared to placeboTreatment with ALG-055009 resulted in significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a) (LpA), and apolipoprotein B (ApoB). In addition, dose dependent increases in sex hormone binding globulin (SHBG), a marker of THR-β target engagement in the liver, were observed Additional data readouts are planned to be presented this year at AASLD’s The Liver Meeting (TLM) 2024
ALG-097558: Potential best-in-class small molecule pan-coronavirus protease inhibitor
Three additional clinical studies are expected to begin in 2024 AGILE University of Liverpool, a UK-government supported platform trial (with MRC and Wellcome Trust funding), has agreed to sponsor and perform a study in high-risk COVID patients evaluating ALG-097558 as monotherapy or in combination with remdesivirThe NIAID has agreed to sponsor clinical studies evaluating pharmacokinetic (PK) differences in special populations (renal/hepatic impairment subjects) Phase 2 enabling activities, including nonclinical and clinical studies, are underway with financial support from the NIH
Financial Results for the Third Quarter 2024
Cash, cash equivalents and investments totaled $74.9 million as of September 30, 2024, compared with $135.7 million as of December 31, 2023. We continue to believe our cash balance provides sufficient cash to fund planned operations through the end of 2025.
Net loss for the three months ended September 30, 2024 were $19.3 million or basic and diluted net loss per common share of $(3.07), compared to net losses of $18.0 million or basic and diluted net loss per common share of $(10.37) for the three months ended September 30, 2023.
Research and development (R&D) expenses for the three months ended September 30, 2024 were $16.8 million, compared with $15.9 million for the same period of 2023. The increase was primarily due to an increase in third party expenses for the clinical trials. Total R&D stock-based compensation expense incurred for the three months ended September 30, 2024 was $1.2 million, compared with $1.6 million for the same period of 2023.
General and administrative (G&A) expenses for the three months ended September 30, 2024 were $4.6 million, compared with $6.4 million for the same period of 2023. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third party expenses including legal expenses. Total G&A stock-based compensation expense incurred for the three months ended September 30, 2024 was $0.9 million, compared with $1.6 million for the same period of 2023.
Interest and other income, net, for the three months ended September 30, 2024 was income of $1.0 million compared with income of $1.1 million for the same period of 2023.
About Aligos
Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biopharmaceutical company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses.
For more information, please visit www.aligos.com or follow us on LinkedIn or X.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements with respect to Aligos being positioned for success; the potential of the company’s three clinical programs, Phase 2 enabling activities, and financial support from the NIH for ALG-097558; the collaboration with Xiamen Amoytop; studies to support potential registration, and Phase 2 enabling activities for ALG-000184; the planned readouts for ALG-055009 at this year’s AASLD; the continuation of dosing in the ongoing Phase 1a/1b study for ALG-000184 with subjects planning to dose for up to 96 weeks; the planned presentation of additional interim data readouts at this year’s AASLD; and the company’s continued belief its cash balance provides sufficient cash to fund planned operations through the end of 2025. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the impact of global events and other macroeconomic conditions on the Aligos’ business. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
Aligos Therapeutics, Inc Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (Unaudited)
Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023
Revenue from Collaborations19 2,154 311 7,329 Revenue from Customers1,250 1,085 3,005 5,519 Operating Expenses:
Research and development16,774 15,867 54,238 50,783 General and administrative4,626 6,443 17,669 24,195 Total operating expenses21,400 22,310 71,907 74,978
Loss from operations(20,131) (19,071) (68,591) (62,130)
Interest and other income, net963 1,059 19,834 3,168 Loss before income tax expense(19,168) (18,012) (48,757) (58,962)
Income tax expense(91) (29) (304) (825)Net loss(19,259) (18,041) (49,061) (59,787)Basic and diluted net loss per common share(3.07) (10.37) (7.84) (34.59)Weighted-average shares common stock, basic and diluted6,272,291 1,739,847 6,258,706 1,728,282
Aligos Therapeutics, Inc.Condensed Consolidated Balance Sheets(In thousands) September 30, 2024 December 31, 2023 (Unaudited) (audited) (1)Assets
Current assets:
Cash and cash equivalents$35,331 $135,704Short-term investments 39,591 -Prepaid expenses and other current assets 4,900 5,380Total current assets 79,822 141,084Other assets 8,604 10,443Total assets$88,426 $151,527
Liabilities and Stockholders’ Equity
Current liabilities$20,956 $23,906Other liabilities, noncurrent 17,374 35,541Total liabilities 38,330 59,447Total stockholders’ equity 50,096 92,080Total liabilities and stockholders’ equity$88,426 $151,527 _____________________________________________ (1) The balance sheet as of December 31, 2023 has been derived from the audited consolidated financial statements at that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Investor ContactJordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com
临床2期临床结果财报临床1期
2024-10-28
·药明康德
▎药明康德内容团队编辑
本期看点
1. 口服选择性FGFR3靶向疗法TYRA-300的早期临床结果亮眼，接受剂量≥90 mg/天的FGFR3突变转移性尿路上皮癌（mUC）患者的疾病控制率（DCR）为100%。
2. 泛RAS抑制剂RMC-6236在经治胰腺导管腺癌（PDAC）患者中展现出令人鼓舞的抗肿瘤活性和安全性，携带任意RAS突变的PDAC患者在6个月的总生存率为91%。
3. 治疗转移性透明细胞肾细胞癌（ccRCC）的小分子HIF-2a抑制剂casdatifan在一项1/1b期临床试验中的DCR达81%。
药明康德内容团队整理
TYRA-300：公布1/2期临床试验数据
Tyra Biosciences公司公布了其潜在“first-in-class”的口服疗法TYRA-300治疗转移性尿路上皮癌（mUC）患者的1/2期研究SURF301的数据。TYRA-300是一种FGFR3选择性抑制剂，旨在避免抑制FGFR1、FGFR2和FGFR4时产生的毒性，且无论是否存在与耐药性相关的FGFR3门卫（gatekeeper）突变都能发挥作用。
截至2024年8月15日的数据，接受剂量≥90 mg/天的FGFR3突变mUC患者的DCR为100%，54.5%（6/11）的患者达到部分缓解（PR），其中3例仍在治疗中，接受90 mg/天剂量的患者中有50%（5/10）达到PR。安全性方面，TYRA-300的耐受性总体良好，FGFR2和FGFR1相关毒性不常见。
RMC-6236：公布1/1b期临床试验数据
Revolution Medicines公司宣布，其在研泛RAS抑制剂RMC-6236在经治胰腺导管腺癌患者中展现出令人鼓舞的抗肿瘤活性和安全性。RMC-6236是一款口服、可靶向突变和野生型RAS在GTP结合（具活性，ON）状态下的选择性抑制剂。此次公布的1/1b期多中心、开放标签、剂量递增和剂量扩展研究RMC-6236-001旨在评估RMC-6236作为单药治疗携带RAS突变或野生型RAS晚期实体瘤患者的效果。
结果显示，RMC-6236单药作为二线疗法可改善携带任意RAS突变PDAC患者的中位无进展生存期（PFS）与总生存期（OS）。在二线治疗中，携带KRAS G12X突变（KRAS G12X指的是KRAS蛋白第12位的甘氨酸因为基因突变，转换成其它氨基酸）的PDAC患者的中位PFS为8.5个月，中位OS为14.5个月。携带任意RAS突变的PDAC患者在二线治疗中的中位PFS为7.6个月，中位OS为14.5个月。携带KRAS G12X突变与携带任意RAS突变的PDAC患者在6个月时的总生存率分别为89%与91%。在二线治疗组中，携带KRAS G12X突变患者的客观缓解率（ORR）为29%，在三线及以上治疗组（3L+）中为22%，这些患者的DCR分别为91%和89%。目前该疗法的3期临床试验RASolute 302正在进行中。
Casdatifan：公布1/1b期临床试验数据
Arcus Biosciences公司公布了其在研小分子HIF-2a抑制剂casdatifan治疗转移性透明细胞肾细胞癌的1/1b期临床试验数据。HIF-2a是一种致癌转录因子，参与多个器官和肿瘤中的氧感应。由于VHL通路的基因异常，ccRCC几乎普遍与HIF-2a失调有关。通过选择性抑制HIF-2a，casdatifan可使一系列涉及肿瘤增殖和存活、耐药性和血管生成的通路失效，从而导致癌细胞死亡。
截至2024年8月30日的数据，中位随访时间为11个月。在100 mg每日剂量扩展队列（n=32）中，DCR达81%，ORR为34%（2个待确认的缓解），许多患者仍在接受治疗。安全性方面，casdatifan具有可接受且可管理的安全性。
▲Casdatifan治疗ccRCC患者的1/1b期试验数据（图片来源：参考资料[7]）
NX-5948：公布1a/1b期临床试验数据
Nurix Therapeutics公司公布其在研蛋白降解剂NX-5948在治疗复发/难治性华氏巨球蛋白血症（WM）患者的1a/1b期临床试验中的最新数据。NX-5948是一种口服、可穿越血脑屏障的小分子布鲁顿氏酪氨酸激酶（BTK）蛋白降解剂。Nurix此前报告称，NX-5948对一系列对现有BTK抑制剂耐药的肿瘤细胞系表现出高效的抑制活性，这对于经过大量前期治疗的B细胞恶性肿瘤患者群体尤为重要。
截至2024年10月10日的数据，在9例可评估应答的患者中，7例患者（77.8%）出现客观缓解，两例患者病情稳定（22.2%）。所有7例缓解均在8周的首次评估中观察到，其中5例患者仍在接受治疗，2例患者的治疗时间超过一年。不论患者基线MYD88和CXCR4的突变状态如何，均观察到应答。
Bel-sar（AU-011）：公布1期临床试验数据
Aura Biosciences公司宣布，其在研病毒样偶联药物（VDC）bel-sar（AU-011）在治疗非肌层浸润性膀胱癌（NMIBC）患者的1期临床试验中获得积极早期数据。Bel-sar由靶向肿瘤表面表达的糖蛋白的类病毒颗粒（VLP）与可由光激活的细胞毒性药物偶联生成。它被设计为具有双重作用机制，既能诱导肿瘤细胞坏死，又能激发强大且持久的抗肿瘤免疫反应。
该试验共纳入了13名患者，主要终点是评估bel-sar单独使用（n=5）和bel-sar结合光激活（n=8）局部给药的安全性和可行性。次要终点是评估生物活性及肿瘤微环境（TME）中的免疫介导变化。13名研究参与者中，10名为低级别疾病患者，另外3名为高级别疾病患者。在接受bel-sar结合光激活治疗的患者（n=8）中，5名低级别疾病患者中有4名在组织病理学评估中显示无肿瘤细胞残留，达到了临床完全缓解（CR）。3名高级别疾病患者中有2名在膀胱镜检查中显示肿瘤明显缩小。
ONCT-534：公布1/2期临床试验数据
Oncternal Therapeutics公司公布了其在研雄激素受体（AR）抑制剂ONCT-534治疗复发性或难治性转移性去势抵抗性前列腺癌（mCRPC）患者的1/2期研究的最新数据。ONCT-534在前列腺癌模型中对未发生突变的AR以及多种形式的AR突变和异常都具有活性。ONCT-534具有治疗对AR通路抑制剂耐药（包括AR扩增、AR配体结合域突变或AR配体结合域缺失型剪接变体）的mCRPC患者的潜力。
截至2024年9月30日的数据，每天两次的给药方案耐受性良好，没有出现与治疗相关的3级或更高级别的毒性反应。1名患者在接受每日两次160 mg剂量ONCT-534治疗后，前列腺特异性抗原（PSA）升高，但在随后4周以每日两次300 mg剂量ONCT-534治疗后，PSA下降了50%，同时计算机断层扫描（CT）显示与基线相比，靶病灶减少了16%。循环肿瘤细胞（CTCs）的计数和生物标志物分析显示，在另外6名患者中，ONCT-534对AR调控基因的表达和AR的核转位有令人鼓舞的效果。
Lunresertib+camonsertib：公布1期联合治疗试验数据
Repare Therapeutics公司公布了1期临床试验MYTHIC的最新数据，该试验评估了其PKMYT1抑制剂lunresertib和口服小分子ATR抑制剂camonsertib（lunre+camo）的组合疗法。在这项分析中，Repare公司对接受2期段推荐剂量（RP2D）的患者进行了约9个月的随访。结果显示，lunre+camo在保持临床疗效的同时，成功地减轻了与抗肿瘤药物机制相关的贫血。此外，在这些患者中未观察到任何级别的血小板减少或严重的中性粒细胞减少。
ATX-559：IND申请获得FDA许可
Accent Therapeutics公司宣布美国FDA已批准其潜在“first-in-class”的DHX9抑制剂ATX-559的IND申请，可在实体瘤患者中开展1期研究，重点关注BRCA1/2缺陷的乳腺癌和微卫星不稳定性高（MSI-H）和/或错配修复缺陷（dMMR）的实体瘤，预计首例患者将在2024年第四季度接受给药。
DHX9是一种DNA/RNA螺旋酶，据报道在复制、转录、翻译、RNA剪接、RNA处理以及维持基因稳定性等方面发挥着重要作用，该酶是一个有吸引力的新肿瘤学靶点。ATX-559通过抑制DHX9可利用关键的肿瘤弱点，导致癌症特异性细胞死亡。
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参考资料（可上下滑动查看）
[1] Revolution Medicines Presents Updated Data from RMC-6236 Monotherapy Study in Patients with Advanced Pancreatic Ductal Adenocarcinoma. Retrieved October 23, 2024 from https://www.globenewswire.com/en/news-release/2024/10/23/2967583/0/en/Revolution-Medicines-Presents-Updated-Data-from-RMC-6236-Monotherapy-Study-in-Patients-with-Advanced-Pancreatic-Ductal-Adenocarcinoma.html
[2] Multiple Clinical Complete Responses Demonstrated Following Single Low Dose Administration of Bel-sar in Patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) in Ongoing Phase 1 Trial. Retrieved October 18, 2024, from https://ir.aurabiosciences.com/news-releases/news-release-details/multiple-clinical-complete-responses-demonstrated-following
[3] Oncternal Therapeutics Announces Updated Safety and Efficacy Data for Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer. Retrieved October 25, 2024, from https://www.globenewswire.com/news-release/2024/10/22/2967000/0/en/Oncternal-Therapeutics-Announces-Updated-Safety-and-Efficacy-Data-for-Phase-1-2-Study-of-ONCT-534-for-the-Treatment-of-R-R-Metastatic-Castration-Resistant-Prostate-Cancer.html
[4] Nurix Therapeutics Presents Positive Results from the Ongoing Clinical Trial of Its BTK Degrader NX-5948 in Patients with Relapsed/Refractory Waldenstrom’s Macroglobulinemia. Retrieved October 21, 2024, from https://www.globenewswire.com/en/news-release/2024/10/19/2965795/0/en/Nurix-Therapeutics-Presents-Positive-Results-from-the-Ongoing-Clinical-Trial-of-Its-BTK-Degrader-NX-5948-in-Patients-with-Relapsed-Refractory-Waldenstrom-s-Macroglobulinemia.html
[5] Repare Therapeutics Announces Updated Positive Safety and Tolerability Results from the Phase 1 MYTHIC Clinical Trial. Retrieved October 25, 2024, from https://ir.reparerx.com/news-releases/news-release-details/repare-therapeutics-announces-updated-positive-safety-and
[6] Tyra Biosciences Reports Interim Clinical Proof-of-Concept Data for TYRA-300, an Investigational Oral FGFR3-Selective Inhibitor, in Phase 1/2 SURF301 Study in Patients with Metastatic Urothelial Cancer (mUC). Retrieved October 25, 2024, from https://www.callunapharma.com/wp-content/uploads/2024/01/Calluna_Pharma_Launch_PR.pdf
[7] First Clinical Data for Arcus Biosciences’ HIF-2a Inhibitor, Casdatifan, Showed Promising Clinical Activity and Tumor Shrinkage in Patients with Metastatic Kidney Cancer. Retrieved October 25, 2024, from https://investors.arcusbio.com/investors-and-media/press-releases/press-release-details/2024/First-Clinical-Data-for-Arcus-Biosciences-HIF-2a-Inhibitor-Casdatifan-Showed-Promising-Clinical-Activity-and-Tumor-Shrinkage-in-Patients-with-Metastatic-Kidney-Cancer/default.aspx
[8] Interius BioTherapeutics Doses First Patient with in vivo Chimeric Antigen Receptor (CAR) Gene Therapy for B-cell Malignancies. Retrieved October 25, 2024, from https://interiusbio.com/2024/10/interius-biotherapeutics-doses-first-patient-with-in-vivo-chimeric-antigen-receptor-car-gene-therapy-for-b-cell-malignancies/
[9] Spur Therapeutics Showcases Positive New Data from Phase 1/2 GALILEO-1 Trial of FLT201, Its Novel Gene Therapy Candidate for Gaucher Disease, in Oral Presentation at ESGCT 31st Annual Congress. Retrieved October 25, 2024, from https://www.globenewswire.com/news-release/2024/10/23/2967469/0/en/Spur-Therapeutics-Showcases-Positive-New-Data-from-Phase-1-2-GALILEO-1-Trial-of-FLT201-Its-Novel-Gene-Therapy-Candidate-for-Gaucher-Disease-in-Oral-Presentation-at-ESGCT-31st-Annua.html
[10] Find Therapeutics Announces First Subject Dosed in Phase 1 Clinical Study of FTX-101. Retrieved October 25, 2024, from https://www.prnewswire.com/news-releases/find-therapeutics-announces-first-subject-dosed-in-phase-1-clinical-study-of-ftx-101-302278520.html
[11] Zymeworks Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating ZW171 in Advanced Mesothelin-Expressing Cancers. Retrieved October 25, 2024, from https://www.globenewswire.com/news-release/2024/10/21/2966023/0/en/Zymeworks-Announces-First-Patient-Dosed-in-Phase-1-Clinical-Trial-Evaluating-ZW171-in-Advanced-Mesothelin-Expressing-Cancers.html
[12] Aligos Therapeutics Announces U.S. FDA Clearance of IND Application for ALG-000184. Retrieved October 25, 2024, from https://www.globenewswire.com/news-release/2024/10/22/2966892/0/en/Aligos-Therapeutics-Announces-U-S-FDA-Clearance-of-IND-Application-for-ALG-000184.html
[13] Pierre Fabre宣布在PFL-002/VERT-002的I/II期首次给药，这是一种MET改变的NSCLC靶向治疗. Retrieved October 25, 2024, from https://www.prnasia.com/story/465694-1.shtml
[14] Inozyme Pharma Announces Positive Interim Data from Phase 1 SEAPORT 1 Trial of INZ-701. Retrieved October 25, 2024, from https://www.globenewswire.com/news-release/2024/10/24/2968997/0/en/Inozyme-Pharma-Announces-Positive-Interim-Data-from-Phase-1-SEAPORT-1-Trial-of-INZ-701.html
[15] Apogee Therapeutics Announces Results Up to 9 Months from Phase 1 Trial of APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases. Retrieved October 25, 2024, from https://www.globenewswire.com/news-release/2024/10/24/2968646/0/en/Apogee-Therapeutics-Announces-Results-Up-to-9-Months-from-Phase-1-Trial-of-APG777-its-Novel-Half-Life-Extended-Anti-IL-13-Antibody-for-the-Treatment-for-Atopic-Dermatitis-and-Other.html
[16] BridgeBio Shares Positive Data from High Dose Cohort of Phase 1/2 CANaspire Study of Gene Therapy BBP-812 for Canavan Disease at ESGCT 2024. Retrieved October 25, 2024, from https://www.globenewswire.com/news-release/2024/10/24/2968601/0/en/BridgeBio-Shares-Positive-Data-from-High-Dose-Cohort-of-Phase-1-2-CANaspire-Study-of-Gene-Therapy-BBP-812-for-Canavan-Disease-at-ESGCT-2024.html
[17] Precision BioSciences Receives First Approval of Clinical Trial Application to Initiate PBGENE-HBV First-In-Human Study for the Treatment of Chronic Hepatitis B. Retrieved October 25, 2024, from https://investor.precisionbiosciences.com/news-releases/news-release-details/precision-biosciences-receives-first-approval-clinical-trial
[18] First Patients Dosed in Phase 1 Clinical Study of ImmunityBio’s CAR-NK Cell Therapy for the Treatment of Relapsed B-Cell Non-Hodgkin Lymphoma. Retrieved October 25, 2024, from https://ir.immunitybio.com/news-releases/news-release-details/first-patients-dosed-phase-1-clinical-study-immunitybios-car-nk?field_nir_news_date_value[min]=
[19] Aprea Therapeutics Presents Preliminary Findings on Oral WEE1 Inhibitor APR-1051 at EORTC-NCI-AACR International Conference on Molecular Targets and Therapeutics. Retrieved October 25, 2024, from https://ir.aprea.com/news-releases/news-release-details/aprea-therapeutics-presents-preliminary-findings-oral-wee1
[20] Autolus Therapeutics Presents Clinical Data Update at the 2024 Lymphoma, Leukemia & Myeloma Congress. Retrieved October 25, 2024, from https://www.globenewswire.com/news-release/2024/10/16/2964125/0/en/Autolus-Therapeutics-Presents-Clinical-Data-Update-at-the-2024-Lymphoma-Leukemia-Myeloma-Congress.html
[21] Accent Therapeutics Announces FDA Clearance of IND Application for ATX-559, a First-In-Class Oral DHX9 Inhibitor. Retrieved October 25, 2024, from https://www.prnewswire.com/news-releases/accent-therapeutics-announces-fda-clearance-of-ind-application-for-atx-559-a-first-in-class-oral-dhx9-inhibitor-302285845.html
[22] Calluna Pharma launches and announces EUR 75 million Series A financing to develop novel therapies for inflammatory and fibrotic diseases. Retrieved October 25, 2024, from https://www.businesswire.com/news/home/20241023939388/en/Calluna-Pharma-Successfully-Completes-Phase-1-Clinical-Study-of-CAL101-a-First-in-Class-Therapeutic-for-Fibrotic-and-Fibro-Inflammatory-Indications/#:~:text=Calluna%20Pharma%20Successfully%20Completes%20Phase%201%20Clinical%20Study,CAL101%20is%20now%20entering%20Phase%202%20clinical%20development
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2024-10-22
Company to conduct a Phase 1 Drug-Drug Interaction StudyPhase 2 filing on track for Q1 2025 SOUTH SAN FRANCISCO, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) for a Phase 1 Drug-Drug Interaction (DDI) study of ALG-000184, a capsid assembly modulator (CAM-E) for the treatment of Chronic Hepatitis B (CHB). “The acceptance of our third U.S. IND is an important milestone for Aligos,” said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “This IND clearance allows us to begin the next stages of our clinical development for ALG-000184, including the advancement of the compound into Phase 2 clinical trials. ALG-000184 is the first novel, oral drug candidate for the treatment of HBV infection that can inhibit multiple components of the viral lifecycle, leading to more complete suppression of the virus compared to other therapeutic modalities.” The DDI study is designed to evaluate the effect of a cytochrome P450 inhibitor and inducer on ALG-000184 pharmacokinetics. In addition, Phase 2 enabling activities are ongoing, with a planned filing in Q1 2025 for the Phase 2 study. This clinical trial will be a randomized, double-blind, active controlled study of ALG-000184 vs. standard of care in HBeAg-positive and HBeAg-negative CHB subjects. “ALG-000184 has demonstrated impressive data to date with broad antiviral activity,” stated Hardean Achneck, MD, Chief Medical Officer at Aligos Therapeutics. “ALG-000184 has the potential to improve outcomes compared to the current standard of care. We look forward to finalizing the Phase 2 study design in conjunction with KOLs and the FDA and anticipate enrolling patients next year.” Data from ≤72 weeks following an oral daily dose of 300 mg ALG-000184 has demonstrated the ability to disrupt the entire HBV lifecycle through best-in-class reductions of the relevant viral markers: HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Dosing through 96 weeks is ongoing, with interim data readouts expected at upcoming scientific conferences. ALG-000184 has a clear regulatory path endorsed by the FDA and CDE (China) for chronic suppressive therapy with a potential superiority label compared to standard of care. About ALG-000184 ALG-000184 was derived from initial IP licensed from the laboratory of Dr. Raymond Schinazi at Emory University, which was further optimized by Aligos. ALG-000184 is a potent potential best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for chronic hepatitis B (CHB). Phase 1a studies have demonstrated after single and multiple daily doses that ALG-000184 was well-tolerated, with no safety signals observed, and demonstrated linear PK and excellent antiviral activity. In longer term Phase 1b studies of ALG-000184 300mg QD x ≤96 weeks ± Entecavir (ETV) and ALG-000184 monotherapy have demonstrated best-in-class sustained reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Dosing is ongoing through 2025 with interim data readouts expected at upcoming scientific conferences. Phase 2 enabling activities are ongoing, with a planned Phase 2 IND filing in Q1 2025. ALG-000184 has a clear regulatory path endorsed by the FDA and CDE (China) for chronic suppressive therapy with a potential superiority label compared to standard of care. About Chronic Hepatitis B There were more than 290 million chronic carriers of Chronic Hepatitis B (CHB) worldwide as of July 2020 and approximately 30 million individuals become newly infected every year despite the availability of a prophylactic vaccine. In 2015, there were more than 90 million cases of CHB in China alone, while the European Union, United States and Japan accounted for nearly 8 million cases. Complications from CHB include cirrhosis, end-stage liver disease, and hepatocellular carcinoma, which collectively resulted in approximately 900,000 deaths in 2015, according to the World Health Organization. CHB is the primary cause of liver cancer worldwide, and the mortality associated with HBV-related liver cancer continues to increase. About Aligos Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biopharmaceutical company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. For more information, please visit www.aligos.com or follow us on LinkedIn or X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
Investor ContactAligos Therapeutics, Inc.Jordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com Media ContactInizio EvokeJake RobisonVice PresidentJake.Robison@inizioevoke.com
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 完全性房室传导阻滞 | 临床1期 | 新西兰 | 2020-10-22 | |
| 完全性房室传导阻滞 | 临床1期 | 英国 | 2020-10-22 | |
| 完全性房室传导阻滞 | 临床1期 | 中国 | 2020-10-22 | |
| 慢性乙型肝炎 | 临床1期 | 中国 | 2020-10-22 | |
| 慢性乙型肝炎 | 临床1期 | 新西兰 | 2020-10-22 | |
| 慢性乙型肝炎 | 临床1期 | 摩尔多瓦 | 2020-10-22 | |
| 慢性乙型肝炎 | 临床1期 | 英国 | 2020-10-22 | |
| 慢性乙型肝炎 | 临床1期 | 毛里求斯 | 2020-10-22 | |
| 慢性乙型肝炎 | 临床1期 | 中国香港 | 2020-10-22 | |
| 慢性乙型肝炎 | 临床1期 | 澳大利亚 | 2020-10-22 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1期 | 22 | 壓蓋廠衊鑰選選窪範鏇(齋鏇鬱鹽鏇鬱鹹觸網廠) = In a multiple regression model, baseline HBsAg (< or ≥4 log10 IU/ ml) and steady state plasma ALG-001075 exposure (AUC or Ctrough) statistically significantly predicted change from baseline in HBsAg at week 24 (p < 0.00018, R2 = 0.65). 襯糧鏇糧鹹獵網選積願 (範觸願糧鑰構廠餘廠憲 ) 更多 | 积极 | 2024-06-01 | |||
临床1期 | 22 | 齋蓋選選鏇壓選簾鏇夢(簾衊鏇衊襯蓋窪鏇蓋鏇) = 壓餘淵艱壓淵淵鬱淵壓 廠顧觸築積鬱壓網選襯 (獵糧壓網鬱窪鹽顧夢觸, 0.4) 更多 | 积极 | 2024-06-01 | |||
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GlobeNewswire 人工标引  | 临床1期 | - | (夢窪夢壓鹽網築構醖廠) = Oral dosing with 300 mg of ALG-000184 ± entecavir (ETV) for up to 48 weeks in untreated HBeAg positive chronic hepatitis B patients demonstrated a favorable safety profile and greater suppression of HBV DNA and RNA versus ETV alone 構鏇壓選憲顧鹽夢襯齋 (憲艱餘願壓網鬱選窪艱 ) 更多 | 积极 | 2023-12-07 | ||
临床1期 | 慢性乙型肝炎 HBeAg+ | - | ALG-000184 + Entecavir (ETV) | 製鏇鬱網範積襯範構範(鹹齋膚鹹鑰餘鬱蓋願艱) = Grade 4 TEAE of ALT elevation, which peaked at 416 U/L (10.1xULN) on Day 171 鏇艱積淵廠網糧簾選積 (廠選蓋餘壓壓糧鏇襯網 ) | - | 2023-11-10 | |
临床1期 | - | (積簾選蓋醖醖衊遞顧鹽) = No Grade ≥2 treatment emergent laboratory abnormalities 鹽構鏇壓蓋選壓網選夢 (齋鹹鏇網窪醖艱顧網範 ) | 积极 | 2022-04-29 | |||
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