Atacicept

▎Armstrong 2025年8月11日，诺华宣布BAFF-R抗体Ianalumab治疗干燥综合征的量项三期临床NEPTUNUS-1、NEPTUNUS-2均达到主要终点，疾病活动度显著改善。Ianalumab有望成为首款干燥综合征新药。 2025年8月12日，诺华公布Ianalumab用于经激素治疗失败原发免疫性血小板减少症（ITP）的三期临床VAYHIT2顶线数据，关键次要终点治疗6个月时血小板计数显著改善。诺华预计将在2027年与一线治疗VAHIT1的结果一起递交上市申请。 Ianalumab最初由Morphosys（2024年被诺华29亿美元收购）研发，Morphosys为抗体工程的先驱，有多款合作开发的抗体药物管线，包括诺华合作的BAFF-R抗体Ianalumab、Anthos合作的FXI抗体Abelacimab、Ultragenyx合作的硬骨素抗体Setrusumab、礼来合作的ACVR2B抗体Bimagrumab、HiBio及天境生物合作的CD38抗体Delzartamab等。 BAFF-R在成熟B细胞的存活中发挥着关键作用，为BAFF的主要受体之一，TACI则同时为BAFF、APRIL的受体。TACI靶点泰它西普已经成药，Atacicept、Povetacicept则在仅仅追赶。诺华Ianalumab则引领了BAFF-R的临床探索，直到如今在干燥综合征、ITP完成POC。 总结 除了干燥综合征、ITP，诺华围绕Ianalumab还在探索狼疮性肾炎、系统性红斑狼疮、化脓性汗腺炎、全身性硬皮病等多项自免适应症。诺华在自免领域积累深厚，引领了IL-17A抗体、BTK抑制剂、BAFF-R抗体、CAR-T等多个赛道的进展。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理； 补体靶向药物技术全梳理； 补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理； 靶点冷暖，行业自知； 中国大分子新药研发格局； 被炮轰的“me too”； 佐剂百年史； 胰岛素百年传奇； CUSBEA：风雨四十载； 中国新药研发的焦虑； 中国生物医药企业的研发竞争； 中国双抗竞争格局； 中国ADC竞争格局； 中国双抗技术全梳理； 中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理； 亘喜生物技术全梳理； 康哲药业技术全梳理； 科济药业技术全梳理； 恺佧生物技术全梳理； 同宜医药技术全梳理； 百奥赛图技术全梳理； 腾盛博药技术全梳理； 创胜集团技术全梳理； 永泰生物技术全梳理； 中国抗体技术全梳理； 德琪医药技术全梳理； 德琪医药技术全梳理2.0； 和铂医药技术全梳理； 荣昌生物技术全梳理； 再鼎医药技术全梳理； 药明生物技术全梳理； 恒瑞医药技术全梳理； 豪森药业技术全梳理； 正大天晴技术全梳理； 吉凯基因技术全梳理； 基石药业技术全梳理； 百济神州技术全梳理； 百济神州技术全梳理第2版； 信达生物技术全梳理； 信达生物技术全梳理第2版； 中山康方技术全梳理； 复宏汉霖技术全梳理； 先声药业技术全梳理； 君实生物技术全梳理； 嘉和生物技术全梳理； 志道生物技术全梳理； 道尔生物技术全梳理； 尚健生物技术全梳理； 康宁杰瑞技术全梳理； 科望医药技术全梳理； 岸迈生物技术全梳理； 礼进生物技术全梳理； 康桥资本技术全梳理； 余国良的抗体药布局； 荃信生物技术全梳理； 安源医药技术全梳理； 三生国健技术全梳理； 仁会生物技术全梳理； 乐普生物技术全梳理； 同润生物技术全梳理； 宜明昂科技术全梳理； 派格生物技术全梳理； 迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理； 普米斯生物技术全梳理； 普米斯生物技术全梳理2.0； 三叶草生物技术全梳理； 贝达药业抗体药全梳理； 泽璟制药抗体药全梳理； 恒瑞医药抗体药全梳理； 齐鲁制药抗体药全梳理； 石药集团抗体药全梳理； 豪森药业抗体药全梳理； 华海药业抗体药全梳理； 科伦药业抗体药全梳理； 百奥泰技术全梳理； 凡恩世技术全梳理。

On track to submit a Biologics License Application (BLA) for accelerated approval of atacicept to U.S. FDA in Q4 2025; potential commercial launch in 2026Announced positive primary endpoint results from the ongoing ORIGIN Phase 3 trialInitiated the PIONEER trial to investigate atacicept in a broader IgAN patient cohort and multiple autoimmune glomerular diseasesExpected to present full primary endpoint results from the ORIGIN 3 trial at a medical congress in Q4 2025 BRISBANE, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the second quarter ended June 30, 2025. “Our team delivered exciting new clinical results from our pivotal ORIGIN 3 trial in the second quarter of 2025, which were consistent with or better than our previous trials for atacicept in patients with IgAN. Based on the strength of the overall data accumulated for atacicept over the past few years, we are excited to move ahead with our BLA submission to the U.S. FDA for accelerated approval. We anticipate submitting the BLA in the fourth quarter of 2025, with an expected commercial launch in 2026,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor. We are thrilled for the potential of atacicept as a possible disease-modifying therapy to address the unmet medical needs of IgAN patients.” Second Quarter 2025 and Recent Business Highlights Announced positive 36-week data from the ongoing pivotal ORIGIN 3 trial of atacicept in patients with IgA Nephropathy (IgAN), including: 46% reduction from baseline in proteinuria for participants treated with atacicept, as measured by 24-hour urine protein-to-creatinine ratio (UPCR); primary endpoint achieved with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001)Atacicept-treated participants demonstrated results across other prespecified endpoints that were consistent with or better than those previously observed in the ORIGIN Phase 2b trialSafety profile of atacicept across ORIGIN program appears favorable, and comparable to placebo Completed full enrollment in the ongoing ORIGIN 3 trialEnrolling participants in the ORIGIN Extend study, which provides ORIGIN study participants with extended access to atacicept until commercial availability in their region, and captures longer-term safety and efficacy dataInitiated the PIONEER trial to evaluate atacicept in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy (pMN), and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patientsStrengthened the Company’s financial positioning with a new credit facility of up to $500 million of term loans with existing partner Oxford Finance LLC, extending the Company’s cash runway well beyond potential commercial launch of atacicept Anticipated Upcoming Milestones Submission of a BLA for atacicept in IgAN to the U.S. FDA in Q4 2025 for accelerated approval; potential commercial launch in 2026Presentation of the full 36-week results from the pivotal ORIGIN 3 trial expected at a medical congress in Q4 2025Initial results from the PIONEER Phase 2 basket trial expected in Q4 2025Pivotal ORIGIN 3 study expected to be completed in 2027 Financial Results for the Quarter Ended June 30, 2025For the quarter ended June 30, 2025, Vera reported a net loss of $76.5 million, or a net loss per diluted share of $1.20, compared to a net loss of $33.7 million, or a net loss per diluted share of $0.62, for the quarter ended June 30, 2024. During the six months ended June 30, 2025, net cash used in operating activities was $109.2 million, compared to $58.6 million for the same period last year. Vera reported $556.8 million in cash, cash equivalents, and marketable securities as of June 30, 2025, which combined with its undrawn debt facility, Vera believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept and beyond. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN, other autoimmune kidney diseases and lupus nephritis. The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different disease areas. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit www.veratx.com Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera’s plans to submit a Biologics License Application to the U.S. FDA for accelerated approval and to potentially receive FDA approval for atacicept in IgAN and launch it commercially, present full primary endpoint results from the ORIGIN 3 trial at a medical congress, obtain initial results from the PIONEER Phase 2 basket trial, and complete the ORIGIN 3 study, as well as statements regarding the timing of each such event; the ability of atacicept to advance the standard of care in IgAN and to address the unmet medical needs of IgAN patients; Vera’s ability to fund its operations through potential approval and U.S. commercial launch of atacicept; and Vera’s plans, commitments, aspirations and goals under the caption “About Vera”. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believe,” “plan,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Debra CharlesworthVera Therapeutics415-854-8051corporatecommunications@veratx.com VERA THERAPEUTICS, INC.Condensed Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)(Unaudited) Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024 Operating expenses: Research and development$58,195 $29,311 $99,473 $52,511 General and administrative 21,946 8,032 37,862 15,944 Total operating expenses 80,141 37,343 137,335 68,455 Loss from operations (80,141) (37,343) (137,335) (68,455)Other income, net 3,610 3,635 9,110 6,364 Net loss$(76,531) $(33,708) $(128,225) $(62,091)Change in unrealized gain/loss on marketable securities$(127) $(277) $134 $(700)Comprehensive loss$(76,658) $(33,985) $(128,091) $(62,791)Net loss per share attributable to common stockholders, basic and diluted$(1.20) $(0.62) $(2.01) $(1.17)Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 63,789,303 54,728,552 63,730,756 52,850,242 VERA THERAPEUTICS, INC.Condensed Balance Sheets(in thousands) June 30, December 31, 2025 2024 (unaudited) Assets Current assets: Cash, cash equivalents and marketable securities$556,827 $640,852 Prepaid expenses and other current assets 14,527 10,366 Total current assets 571,354 651,218 Operating lease right-of-use assets 2,471 3,372 Other noncurrent assets 4,703 1,091 Total assets$578,528 $655,681 Liabilities and stockholders' equity Current liabilities: Accounts payable$13,157 $7,665 Operating lease liabilities 855 1,483 Accrued expenses and other liabilities, current 19,542 16,223 Total current liabilities 33,554 25,371 Long-term debt 74,464 50,687 Operating lease liabilities, noncurrent 2,233 2,468 Total liabilities 110,251 78,526 Stockholders' equity Common stock 64 64 Additional paid-in-capital 1,057,161 1,037,948 Accumulated other comprehensive income 527 393 Accumulated deficit (589,475) (461,250)Total stockholders' equity 468,277 577,155 Total liabilities and stockholders' equity$578,528 $655,681