ALG-000184

SOUTH SAN FRANCISCO, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today reported recent business progress and financial results for the fourth quarter and full year 2023. “Last year we built the foundation for a critical 2024 by closing a $92 million PIPE from healthcare-dedicated institutional investors and successfully completing our Phase 2a enabling activities for ALG-055009,” stated Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics. “In addition, we presented unprecedented antiviral activity from our ALG-000184 program for chronic hepatitis B (CHB). With these important accomplishments in hand, we are well positioned to deliver important planned milestones in 2024, which include releasing topline data in subjects with metabolic dysfunction-associated steatohepatitis (MASH) in the ALG-055009 Phase 2a study (HERALD) and completing Phase 2 enabling activities for ALG-000184 by the end of the year. We look forward to sharing our achievements with our stakeholders throughout this year.” Recent Business Progress Aligos Portfolio of Drug Candidates ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH Phase 2a enabling activities, including completion of supporting nonclinical/Phase 1 studies and manufacturing of drug supply, were completed The Phase 2a HERALD protocol was filed with the FDA in Q4 2023 First subject dosed expected in Q2 2024 and topline HERALD data anticipated in Q4 2024 ALG-000184: Potential best-in-class small molecule CAM-E for CHB Dosing continues in the ongoing Phase 1a/1b ALG-000184-201 study, with multiple subjects now having been dosed for >1 year (total planned dosing duration is 96 weeks). Interim data readouts are planned to be presented this year at the following conferences: Asian Pacific Association for the Study of the Liver (APASL), European Association for the Study of the Liver (EASL), and American Association for the Study of Liver Diseases (AASLD) Phase 2 enabling activities, including regulatory interactions and drug supply manufacturing, are underway ALG-097558: Potential best-in-class small molecule pan-coronavirus protease inhibitor The ongoing Phase 1 first in human study is nearing completion of dosing (Q2), with topline data to be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) Annual Meeting, occurring in April 2024 Phase 2 enabling activities are underway with financial support from the National Institute of Allergy and Infectious Diseases (NIAID) Financial Results for the Fourth Quarter and Full Year 2023 Cash, cash equivalents and investments totaled $135.7 million as of December 31, 2023, compared with $125.8 million as of December 31, 2022. Additionally, in October 2023, we raised $92.1 million in gross proceeds in a private placement financing, before deducting placement agent’s fees and other expenses. Including the proceeds from the private placement financing, we continue to believe our cash balance provides sufficient cash to fund planned operations through the end of 2025. Net losses for the three months ended December 31, 2023 were $27.9 million or basic and diluted net loss per common share of $(0.22), compared to net losses of $21.9 million or basic and diluted net loss per common share of $(0.51) for the three months ended December 31, 2022. Net losses for the year ended December 31, 2023 were $87.7 million or basic and diluted net loss per common share of $(1.36), compared to net losses of $96.0 million or basic and diluted net loss per common share of $(2.25) for the year ended December 31, 2022. Research and development (R&D) expenses for the three months ended December 31, 2023 were $22.3 million, compared with $19.1 million for the same period of 2022. The increase was primarily due third party expenses due to the milestone payments made as a result of dosing the first patient in a clinical trial. Total R&D stock-based compensation expense incurred for the three months ended December 31, 2023 was $1.5 million, compared with $1.9 million for the same period of 2022. R&D expenses for the year ended December 31, 2023, were $73.0 million, compared with $85.1 million for the same period of 2022. The decrease was primarily due to a decrease in third-party expenses mainly related to our discontinued STOPs and ASO programs in 2022, partially offset by increases in our ongoing activities and related expenditures associated with our CAM clinical trial activities and MASH program, as well as the milestone payment to Katholieke Universiteit Leuven (KU Leuven) under its collaboration agreement related to the coronaviruses and the dosing of the first patient in a Phase 1 clinical trial. Total R&D stock-based compensation expense incurred for the year ended December 31, 2023 was $6.8 million, compared with $8.0 million for the same period of 2022. General and administrative (G&A) expenses for the three months ended December 31, 2023 were $6.4 million, compared with $7.1 million for the same period of 2022. The decrease in G&A expenses for this comparative period is primarily due to a decrease in facility costs. Total G&A stock-based compensation expense incurred for the three months ended December 31, 2023 was $1.1 million, compared with $1.6 million for the same period of 2022. G&A expenses for the year ended December 31, 2023, were $30.6 million, compared with $26.4 million for the same period of 2022. This was due to an increase in third-party expenses primarily due to higher legal and patent attorney costs, partially offset by a decrease in facility expenses. Total G&A stock-based compensation expense incurred for the year ended December 31, 2023 was $5.8 million, compared with $6.7 million for the same period of 2022. About Aligos Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction associated steatohepatitis (MASH) and viruses with high unmet medical need such as chronic hepatitis B (CHB) and coronaviruses. 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 that the company is well positioned to deliver planned milestones in 2024 and looking forward to sharing achievements with stakeholders throughout 2024; with respect to ALG-055009, that the first subject is expected to be dosed in Q2 2024 and that topline HERALD data are anticipated in Q4 2024; with respect to ALG-000184, that interim data readouts from the Phase 1a/1b study are planned to be presented in 2024 at the APASL, EASL and AASLD conferences; with respect to ALG-097558, that the Phase 1 first in human study is nearing completion of dosing for Q2 2024 with topline data to be presented at the ECCMID Annual Meeting in April 204; and that the company continues to believe 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 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’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 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) Three Months Ended Twelve Months Ended December 31, December 31, 2023 2022 2023 2022 (Unaudited) (Unaudited) (Unaudited) (audited) (1) Revenue from Collaborations $ 2,009 3.537 9,338 13,907 Revenue from Customers 672 - 6,191 - Operating Expenses: Research and development 22,257 19,100 73,040 85,077 General and administrative 6,421 7,119 30,616 26,410 Total operating expenses 28,678 26,219 103,656 111,487 Loss from operations (25,997 ) (22,682 ) (88,127 ) (97,580 ) Interest and other income, net (1,925 ) 845 1,243 1,640 Loss before income tax expense (27,922 ) (21,837 ) (86,884 ) (95,940 ) Income tax benefit (expense) 30 (49 ) (795 ) (106 ) Net loss (27,892 ) (21,886 ) (87,679 ) (96,046 ) Basic and diluted net loss per common share $ (0.22 ) $ (0.51 ) $ (1.36 ) $ (2.25 ) Weighted-average number of shares used in computing basic and diluted net loss per common share 126,726,942 42,836,163 64,260,588 42,695,227 Aligos Therapeutics, Inc. Condensed Consolidated Balance Sheets (In thousands) December 31, 2023 December 31, 2022 (Unaudited) (audited) (1) Assets Current assets: Cash and cash equivalents $ 135,704 $ 81,347 Short-term investments - 44,480 Prepaid expenses and other current assets 5,380 7,718 Total current assets 141,084 133,545 Other assets 10,443 13,148 Total assets $ 151,527 $ 146,693 Liabilities and Stockholders’ Equity Current liabilities $ 23,906 $ 33,129 Other liabilities, noncurrent 35,541 9,664 Total liabilities 59,447 42,793 Total stockholders’ equity 92,080 103,900 Total liabilities and stockholders’ equity $ 151,527 $ 146,693 _____________________________________________ (1) The condensed, consolidated statement of operations for the year ended December 31, 2022, and balance sheet as of December 31, 2022 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, 2022. Investor Contact Jordyn Tarazi Vice President, Investor Relations & Corporate Communications +1 (650) 910-0427 jtarazi@aligos.com Media Contact Veronica Eames LifeSci Communications veames@lifescicomms.com

▎药明康德内容团队编辑本期看点1. SystImmune公司两款抗体偶联药物（ADC）的早期临床数据亮眼，针对不同类型的乳腺癌患者，疾病控制率（DCR）均在90%左右。2. Replimune Group公司公布了其溶瘤病毒疗法RP1的两项临床研究结果，有望为PD-1抑制剂耐药或不适合接受PD-1抑制剂治疗的皮肤癌患者提供新的治疗选择。3. 下一代ADC疗法DAN-222的早期临床结果积极，与PARP抑制剂的作用互补，两者联用可增强疗效，且不受患者BRCA或同源修复缺陷状态的限制。4. Anixa Bioscience公司开发的α-乳清蛋白疫苗有望预防和治疗三阴性乳腺癌。药明康德内容团队整理BL-M07D1、BL-B01D1：公布1期临床试验数据SystImmune公司公布了其两款ADC候选疗法BL-M07D1和BL-B01D1的1期临床试验的积极结果。BL-M07D1以曲妥珠单抗为基础，具有两个特异性结合域，靶向人表皮生长因子受体2（HER2）。每个BL-M07D1分子携带7-8个单位的SystImmune专有的ED-04毒素。该候选疗法可与过度表达会驱动癌细胞增殖和存活的HER2结合，然后被癌细胞内化。在抗体介导的内化过程中，BL-M07D1被运送到癌细胞的溶酶体，释放出其治疗载荷，激活导致癌细胞死亡的通路。此次公布的针对BL-M07D1开展的1期研究的数据显示，在50例HER2+转移性乳腺癌患者中，缓解率为80%，确认的缓解率超过60%，DCR达到100%。之前接受过HER2 ADC治疗并不影响BL-M07D1的疗效，18名此类患者显示出与总人群类似的总缓解率。该研究的初步结果显示，38名接受过大量先前治疗的HER2低表达转移性乳腺癌患者的总缓解率（ORR）为50%，DCR为86%。安全性方面，在接受治疗的130名患者中，只有1名患者出现了2级间质性肺病（ILD）。BL-B01D1是一款靶向表皮生长因子受体（EGFR）和HER3的ADC，每个BL-B01D1分子携带7-8个单位的SystImmune专有的ED-04毒素。此次公布的针对BL-B01D1开展的1期研究的数据显示，先前接受过治疗的HER2-/HR+乳腺癌（n=38）、三阴性乳腺癌（n=35）和HER2+乳腺癌（n=23）患者亚组的ORR分别为44.7%、31.4%和39.1%，DCR分别为91.4%、94.7%和87%。安全性方面，在至少接受过一次BL-B01D1治疗的127例患者中，未观察到ILD。RP1：公布两项1/2期临床试验的数据Replimune Group公司公布了其溶瘤病毒疗法RP1联用PD-1抑制剂nivolumab治疗PD-1抑制剂治疗失败的黑色素瘤和非黑色素瘤皮肤癌（NMSC）患者的临床试验IGNYTE的数据，以及RP1作为单药治疗曾接受过实体器官或造血细胞移植的皮肤癌患者的临床试验ARTACUS的数据。IGNYTE研究的结果显示，该联合疗法在PD-1抑制剂治疗失败的黑色素瘤患者（n=156）中的ORR为31.4%，完全缓解（CR）率为12%，临床获益率（CBR）约为50%。在获得缓解的患者中，100%的患者在6个月时缓解仍在持续，截至2023年11月6日，78%的患者的缓解仍在持续，中位缓解持续时间超过24个月。该联合疗法的耐受性良好，治疗相关不良事件主要为1-2级。IGNYTE试验中报告的NMSC队列的数据来自首批30例患者，所有患者都接受了至少6个月的随访，包括皮肤鳞状细胞癌、Merkel细胞癌、基底细胞癌和血管肉瘤患者。数据显示，对于NMSC患者，该联合疗法的ORR为30%，CBR为60%。该联合疗法在这一患者群体中耐受性良好，其安全性与迄今为止该疗法在皮肤癌中的总体表现一致。ARTACUS研究的结果显示，RP1单药治疗曾接受过实体器官移植或造血细胞移植的皮肤癌患者的ORR为34.8%（8/23），5名患者达到CR，3名患者达到部分缓解（PR）。这些患者一般不适合接受抗PD-1治疗，因为这种治疗可能会诱发移植排斥反应。截至2023年9月18日的数据，大多数患者仍处于持续缓解状态。RP1单药治疗的耐受性良好，没有证据表明存在异体移植排斥反应。其安全性与在非免疫功能低下的晚期皮肤癌患者中观察到的安全性相似。DAN-222：公布1期临床试验数据Dantari公司公布了其下一代ADC疗法DAN-222单药和与PARP抑制剂（niraparib）联用治疗转移性HER2-乳腺癌患者的1期临床试验数据。DAN-222是一种含有拓扑异构酶1抑制剂（TOPO1）有效载荷的新型高容量偶联药物。TOPO1产品的主要风险是骨髓毒性，而DAN-222在临床前模型中的骨髓暴露率低，且与PARP抑制剂的作用机制互补，因此具有广泛的应用潜力，可作为PARP抑制剂和其他药物的联合疗法提供新的效用。重要的是，这种互补性增强的疗效与患者的BRCA状态和广义的同源修复缺陷状态无关。此次公布的结果显示，DAN-222单药和与niraparib联用的安全和耐受性良好，并显示出良好的抗肿瘤活性。38%接受DAN-222单药治疗的患者达到了疾病稳定（SD)，67%接受DAN-222联用niraparib治疗的患者达到了SD。α-乳清蛋白疫苗：公布1期临床试验数据Anixa Bioscience公司公布了其开发的乳腺癌疫苗用于高风险可手术的三阴性乳腺癌患者和具有三阴性乳腺癌高遗传风险的患者的1期临床试验的积极数据。该疫苗通过激活针对在生命周期中的某些时间点具有功能，但随后会“退休”的内源性蛋白的免疫反应来发挥作用。其中一种蛋白是乳腺特异性的泌乳蛋白——α-乳清蛋白，它在哺乳期后的正常和衰老组织中会消失，但存在于大多数三阴性乳腺癌中。该候选疫苗还含有一种佐剂，可激活先天性免疫反应，使免疫系统对新出现的肿瘤做出反应，防止肿瘤生长。因此，该候选疫苗可针对表达α-乳清蛋白的乳腺肿瘤提供先发制人的免疫保护。此次公布的结果显示，该候选疫苗疫苗安全且耐受性良好，在所有剂量水平下均观察到抗原特异性T细胞反应，免疫介导的T细胞活化生物标志物IFNγ和IL-17从基线开始逐渐增加。Vepdegestrant（ARV-471）：公布1b期临床试验数据Arvinas公司和辉瑞（Pfizer）公布了在研PROTAC蛋白降解剂vepdegestrant（ARV-471）联用palbociclib的1b期临床试验的积极数据。该试验入组患者为局部晚期或转移性ER+/HER2-乳腺癌患者，既往接受过中位4线治疗。ARV-471是一款口服、靶向降解ER的PROTAC蛋白降解剂。ARV-471可在肿瘤细胞内降解几乎所有的ER分子，并在许多ER驱动的动物肿瘤模型中，引起肿瘤大量的缩小。此次公布的中期结果表明，接受联合疗法乳腺癌患者的CBR（定义为确认CR、PR或SD≥24周的比率）为63%，ORR为42%，中位无进展生存期（PFS）为11.1个月，证明vepdegestrant联合palbociclib治疗乳腺癌的潜力。Bexmarilimab：公布1/2期临床试验数据Faron Pharmaceuticals公司公布了其靶向Clever-1的单克隆抗体bexmarilimab正在进行的1/2期研究的积极临床进展。Bexmarilimab是Faron公司全资拥有的研究性免疫疗法，旨在通过靶向髓系细胞功能和激活免疫系统，克服对现有疗法的耐药性并优化临床疗效。Bexmarilimab能与巨噬细胞上的免疫抑制受体Clever-1结合，该受体有助于肿瘤生长和转移（即帮助癌症躲避免疫系统）。通过靶向巨噬细胞上的Clever-1受体，bexmarilimab可改变肿瘤微环境，将巨噬细胞从免疫抑制（M2）状态重编程为免疫刺激（M1）状态，上调干扰素的产生，启动免疫系统攻击肿瘤，使癌细胞对标准治疗敏感。此次公布的结果显示，bexmarilimab单药治疗可诱导巨噬细胞活化并增加IFNɣ信号传导，从而使晚期转移性实体瘤患者的疾病得到控制，生存期获得延长。在皮肤黑色素瘤、胃癌、肝细胞癌、ER+乳腺癌和胆道癌患者中观察到的DCR为25%-40%不等。在一项分析中，疾病控制与生存率的提高相关，并与治疗前肿瘤内Clever-1阳性率高和治疗中血清干扰素γ（IFNγ）水平升高相关。安全性方面，bexmarilimab安全且耐受性良好，未报告严重不良反应。LYT-200：公布1期临床试验数据PureTech Health公司公布了其靶向半乳糖凝集素-9（galectin-9）的候选抗体疗法LYT-200作为单一疗法以及与靶向PD-1的抗体tislelizumab联用治疗转移性实体肿瘤的效果。在临床前模型中，LYT-200作为单药的效果优于PD-1抑制剂。在活体癌症模型中，LYT-200还能与PD-1抑制剂协同激活CD4和CD8 T细胞。此次公布的结果显示，LYT-200单药治疗的耐受性良好，没有观察到剂量限制性毒性，仅有低级别的不良反应，在接受过大量先前治疗的胰腺癌患者和1名结直肠癌患者中，LYT-200的使患者获得了长期的SD，已超过了一年。此外，LYT-200与tislelizumab联用的安全性良好，并且具有抗肿瘤活性。迄今为止，接受联合治疗的4名头颈癌患者中有3人的病情得到控制，其中1名患者已保持CR状态9个月，1名患者已保持深度PR状态8个月，1名患者已保持SD状态4个月，这些患者的治疗仍在进行中。两名可评估的尿道癌患者的病情分别稳定了7个月和3个月，目前也仍在接受治疗。BI-1607：公布1b期临床试验数据BioInvent Internationa公司公布了其开发的第二款抗FcγRIIB（一种抑制性Fc受体，是抗肿瘤免疫中的T细胞检查点）抗体BI-1607联合曲妥珠单抗治疗HER2+晚期实体肿瘤患者的首个积极临床数据，这些患者此前曾接受过含有曲妥珠单抗的治疗并出现进展。BI-1607旨在提高现有癌症治疗（如曲妥珠单抗）的疗效并克服肿瘤的耐药性。床前数据表明，使用BI-1607治疗可增强当前抗HER2方案（如曲妥珠单抗）的疗效。此次公布的结果显示，治疗剂量范围为75-900 mg时，BI-1607治疗的耐受性良好，未观察到严重不良事件。截至目前，11名可评估患者中有6名患者达到SD，疾病控制已持续21周。XTX101：公布1期临床试验数据Xilio Therapeutics公司公布了其靶向CTLA-4的抗体XTX101单药治疗难治性实体肿瘤患者的1期临床试验的最新数据。结果显示，XTX101单药治疗通常耐受性良好，治疗相关不良事件主要为1级或2级，没有患者因治疗相关不良事件而停止治疗。接受2期推荐剂量XTX101治疗的12名可评估患者的DCR为33%，其中1名PD-L1阴性的IV期非小细胞肺癌患者实现了PR，并维持了36周，肝转移灶完全消退。1名三阴性乳腺癌患者，1名黑色素瘤患者和1名微卫星稳定型结直肠癌患者实现了SD。Palazestrant（OP-1250）：公布1b/2期临床试验的新数据Olema Oncology公司公布了其候选药物palazestrant（OP-1250）联用CDK4/6抑制剂Ibrance（palbociclib）治疗晚期和/或转移性ER+/HER2-乳腺癌患者的1b/2期临床试验的初步数据。OP-1250是一种具有完全ER拮抗剂（CERAN）和选择性ER降解剂（SERD）这两种双重活性的口服小分子药物。此前，OP-1250已获得了FDA授予的快速通道资格。此次公布的数据显示，palazestrant与palbociclib之间没有观察到药物相互作用，且在联合使用时，它们的代谢或暴露量都没有增加。无论是在ESR1突变型肿瘤还是ESR1野生型肿瘤患者中，都观察到了肿瘤的缓解和持久的SD，包括那些先前接受过CDK4/6抑制剂治疗的患者。7名患者出现PR，其中两名为确认的PR。所有患者的CBR为46%，在基线时ESR1发生突变的患者的CBR为60%，先前未接受过CDK4/6抑制剂治疗的患者的CBR为71%。53%的患者的靶病灶有缩小。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] Sana Biotechnology Publishes Early Clinical Data Showing that SC291, a CD19-directed Allogeneic CAR T Therapy, Evades Immune Detection in Presence of Intact Immune System. Retrieved December 4, 2023, from https://ir.sana.com/node/8481/pdf[2] Atsena Therapeutics Announces Positive 12-month Safety and Efficacy Data from Ongoing Phase I/II Clinical Trial of ATSN-101 in Patients with Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D (LCA1). Retrieved December 4, 2023, from https://www.globenewswire.com/news-release/2023/12/04/2789910/0/en/Atsena-Therapeutics-Announces-Positive-12-month-Safety-and-Efficacy-Data-from-Ongoing-Phase-I-II-Clinical-Trial-of-ATSN-101-in-Patients-with-Leber-Congenital-Amaurosis-Caused-by-Bi.html、[3] GT Biopharma Announces IND Submission for GTB-3650 for Treatment of CD33+ Leukemia. Retrieved December 4, 2023, from https://www.globenewswire.com/news-release/2023/12/04/2790126/0/en/GT-Biopharma-Announces-IND-Submission-for-GTB-3650-for-Treatment-of-CD33-Leukemia.html[4] VAX-24 Phase 1/2 Adult Proof-of-Concept Data Published in The Lancet Infectious Diseases Highlight Best-in-Class Potential of Vaxcyte’s 24-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate. Retrieved December 4, 2023, from https://www.globenewswire.com/news-release/2023/12/04/2790538/0/en/VAX-24-Phase-1-2-Adult-Proof-of-Concept-Data-Published-in-The-Lancet-Infectious-Diseases-Highlight-Best-in-Class-Potential-of-Vaxcyte-s-24-Valent-Pneumococcal-Conjugate-Vaccine-PCV.html[5] Pacylex Pharmaceuticals Reports Safety and Efficacy Results from Its Phase 1 First-In-Human Study of Zelenirstat (PCLX-001). Retrieved December 4, 2023, from https://pacylex.reportablenews.com/pr/pacylex-pharmaceuticals-reports-safety-and-efficacy-results-from-its-phase-1-first-in-human-study-of-zelenirstat-pclx-001[6] Sirnaomics Announces Successful Completion of Cohort 1 from Phase I Clinical Study of GalNAc-Based RNAi Therapeutic STP122G for Anticoagulant Treatment. Retrieved December 5, 2023, from https://www.prnewswire.com/news-releases/sirnaomics-announces-successful-completion-of-cohort-1-from-phase-i-clinical-study-of-galnac-based-rnai-therapeutic-stp122g-for-anticoagulant-treatment-302006412.html[7] Olema Oncology Announces Palazestrant Demonstrates Attractive Combinability with CDK4/6 Inhibitors Ribociclib and Palbociclib in Phase 1b/2 Studies. Retrieved December 5, 2023, from https://ir.olema.com/news-releases/news-release-details/olema-oncology-announces-palazestrant-demonstrates-attractive[8] Dragonfly Therapeutics Initiates Phase 1/1b Study of its IL-2 Immunotherapy in Patients with Advanced Solid Tumors. Retrieved December 5, 2023, from https://www.prnewswire.com/news-releases/dragonfly-therapeutics-initiates-phase-11b-study-of-its-il-2-immunotherapy-in-patients-with-advanced-solid-tumors-302006150.html[9] BioInvent Enrolls First Patient in Phase 1/2a Clinical Trial with TNFR2 Antibody BI-1910. Retrieved December 5, 2023, from https://www.accesswire.com/813359/bioinvent-enrolls-first-patient-in-phase-12a-clinical-trial-with-tnfr2-antibody-bi-1910[10] BioInvent Presents Positive First Clinical Data on Anti-FcyRIIB Antibody BI-1607. Retrieved December 5, 2023, from https://www.accesswire.com/813405/bioinvent-presents-positive-first-clinical-data-on-anti-fcyriib-antibody-bi-1607[11] Novadip Biosciences SA announces significant clinical milestones for both of its clinical-stage programs. Retrieved December 5, 2023, from https://www.prnewswire.com/news-releases/novadip-biosciences-sa-announces-significant-clinical-milestones-for-both-of-its-clinical-stage-programs-302004557.html[12] J INTS BIO Gives Presentation of Phase 1/2 study of 'JIN-A02', a Novel Oral 4th Generation EGFR TKI, at ESMO Asia 2023. Retrieved December 5, 2023, from https://www.prnewswire.com/news-releases/j-ints-bio-gives-presentation-of-phase-12-study-of-jin-a02-a-novel-oral-4th-generation-egfr-tki-at-esmo-asia-2023-302005578.html[13] SystImmune, Inc. Announces the Presentation of Breast Cancer Clinical Trial Results at the 2023 San Antonio Breast Cancer Conference and US Clinical Trial Developments. Retrieved December 5, 2023, from https://www.prnewswire.com/news-releases/systimmune-inc-announces-the-presentation-of-breast-cancer-clinical-trial-results-at-the-2024-san-antonio-breast-cancer-conference-and-us-clinical-trial-developments-302006810.html[14] Replimune Shares Initial Primary Analysis Results from CERPASS Clinical Trial in Advanced Cutaneous Squamous Cell Carcinoma and Presents New Data from IGNYTE Clinical Trial of RP1 in Anti-PD1 Failed Melanoma and Non-Melanoma Skin Cancers. Retrieved December 5, 2023, from https://www.globenewswire.com/news-release/2023/12/05/2790782/0/en/Replimune-Shares-Initial-Primary-Analysis-Results-from-CERPASS-Clinical-Trial-in-Advanced-Cutaneous-Squamous-Cell-Carcinoma-and-Presents-New-Data-from-IGNYTE-Clinical-Trial-of-RP1-.html[15] RIBOMIC Phase I and II Data Published in the Eye: Full TOFU/RAMEN/TEMPURA Trial Results Demonstrate Clinical Proof of Concept of Umedaptanib Pegol in Exudative Age-Related Macular Degeneration (nAMD). Retrieved December 5, 2023, from https://www.businesswire.com/news/home/20231204246876/en[16] Century Therapeutics Receives FDA Clearance of IND Application for CNTY-101 in Systemic Lupus Erythematosus. Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/06/2791671/0/en/Century-Therapeutics-Receives-FDA-Clearance-of-IND-Application-for-CNTY-101-in-Systemic-Lupus-Erythematosus.html[17] Coherus Presents Phase 1/2 Clinical Data on Casdozokitug, a First-in-Class IL-27-Targeted Antibody, at the 2023 ESMO Immuno-Oncology Congress. Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/06/2791515/33333/en/Coherus-Presents-Phase-1-2-Clinical-Data-on-Casdozokitug-a-First-in-Class-IL-27-Targeted-Antibody-at-the-2023-ESMO-Immuno-Oncology-Congress.html[18] Delix Presents Interim Data From Phase I Trial of Novel Neuroplastogen at ACNP Annual Meeting. Retrieved December 7, 2023, from https://www.businesswire.com/news/home/20231206561331/en[19] CDR-Life Announces First Patient Dosed in Phase 1 Study with Boehringer Ingelheim Evaluating Potential Treatment for Geographic Atrophy. Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/06/2791553/0/en/CDR-Life-Announces-First-Patient-Dosed-in-Phase-1-Study-with-Boehringer-Ingelheim-Evaluating-Potential-Treatment-for-Geographic-Atrophy.html[20] Crescendo Biologics announces first U.S. patients dosed in expanded Phase 1b clinical trial of CB307 for patients with mCRPC. Retrieved December 7, 2023, from https://www.globenewswire.com/ca/news-release/2023/12/06/2791637/0/en/Crescendo-Biologics-announces-first-U-S-patients-dosed-in-expanded-Phase-1b-clinical-trial-of-CB307-for-patients-with-mCRPC.html[21] Anixa Biosciences and Cleveland Clinic Present Positive New Data from Phase 1 Study of Breast Cancer Vaccine. Retrieved December 7, 2023, from https://www.prnewswire.com/news-releases/anixa-biosciences-and-cleveland-clinic-present-positive-new-data-from-phase-1-study-of-breast-cancer-vaccine-302007568.html[22] Faron Announces Publication of Full Analysis from Phase 1/2 MATINS Trial of Bexmarilimab in Solid Tumors in Cell Reports Medicine. Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/07/2792226/0/en/Faron-Announces-Publication-of-Full-Analysis-from-Phase-1-2-MATINS-Trial-of-Bexmarilimab-in-Solid-Tumors-in-Cell-Reports-Medicine.html[23] PureTech Presents Data from Phase 1 Trial of LYT-200 Targeting Galectin-9 in Solid Tumors at the ESMO Immuno-Oncology Congress 2023. Retrieved December 7, 2023, from https://www.businesswire.com/news/home/20231207651720/en[24] Xilio Therapeutics Announces Initiation of Enrollment for Phase 1 Combination Trial of XTX101, a Tumor-Activated, Fc-Enhanced Anti-CTLA-4, and Updated Phase 1 Monotherapy Data. Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/07/2792409/0/en/Xilio-Therapeutics-Announces-Initiation-of-Enrollment-for-Phase-1-Combination-Trial-of-XTX101-a-Tumor-Activated-Fc-Enhanced-Anti-CTLA-4-and-Updated-Phase-1-Monotherapy-Data.html[25] NextPoint Therapeutics Announces IND Clearance from the FDA to Advance NPX887, a Novel Therapeutic Targeting HHLA2 to Reactivate Exhausted T and NK Cells in HHLA2+ Solid Tumors. Retrieved December 7, 2023, from https://www.businesswire.com/news/home/20231207185510/en[26] Vittoria Biotherapeutics Announces FDA Clearance of IND Application for VIPER-101 to Treat T-Cell Lymphoma. Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/07/2792443/0/en/Vittoria-Biotherapeutics-Announces-FDA-Clearance-of-IND-Application-for-VIPER-101-to-Treat-T-Cell-Lymphoma.html[27] Aligos Therapeutics Presents Positive Clinical Data at Hep-DART 2023 from Phase 1 Studies in HBV (ALG-000184) and NASH (ALG-055009). Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/07/2792883/0/en/Aligos-Therapeutics-Presents-Positive-Clinical-Data-at-Hep-DART-2023-from-Phase-1-Studies-in-HBV-ALG-000184-and-NASH-ALG-055009.html[28] SpyBiotech Announces First Patient Dosed in Phase I Trial of SPYVLP01. Retrieved December 8, 2023, from https://www.businesswire.com/news/home/20231207232622/en[29] First Patient Dosed in Spago Nanomedical's Clinical Phase I/IIa Study within the Tumorad(R) Program. Retrieved December 8, 2023, from https://www.accesswire.com/814264/first-patient-dosed-in-spago-nanomedicals-clinical-phase-iiia-study-within-the-tumoradr-program[30] Dantari's Novel High-Capacity Drug Conjugate DAN-222 Shows Promising Antitumor Activity in Patients with Metastatic HER2-Negative Breast Cancer. Retrieved December 8, 2023, from https://www.prnewswire.com/news-releases/dantaris-novel-high-capacity-drug-conjugate-dan-222-shows-promising-antitumor-activity-in-patients-with-metastatic-her2-negative-breast-cancer-302005214.html[31] Regor Announces Promising Safety And Single Agent Efficacy Data Evaluating RGT-419B In HR+/HER2- Advanced Breast Cancer Patients Who Have Progressed On CDK4/6 Inhibitors And Endocrine Therapy. Retrieved December 8, 2023, from https://www.prnewswire.com/news-releases/regor-announces-promising-safety-and-single-agent-efficacy-data-evaluating-rgt-419b-in-hrher2--advanced-breast-cancer-patients-who-have-progressed-on-cdk46-inhibitors-and-endocrine-therapy-302009555.html免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新