A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Systemic Lupus Erythematosus - ZB012-02-001

开始日期2024-11-21

申办/合作机构

Zenas BioPharma LLC.

CTIS2024-512707-40-00

/ Recruiting临床2期

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients with Relapsing Multiple Sclerosis - ZB012-02-002

开始日期2024-11-07

申办/合作机构

Zenas BioPharma LLC.

NCT06559163

/ Recruiting临床2期

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Systemic Lupus Erythematosus

This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).

开始日期2024-09-17

申办/合作机构

Zenas BioPharma LLC.

100 项与奥贝利单抗相关的临床结果

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100 项与奥贝利单抗相关的转化医学

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100 项与奥贝利单抗相关的专利（医药）

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项与奥贝利单抗相关的文献（医药）

2025-02-01·ADVANCES IN THERAPY

Pharmacokinetics, Pharmacodynamics, Bioavailability, and Immunogenicity of Obexelimab Following Subcutaneous Administration in Healthy Japanese and Non-Japanese Volunteers

Article

作者: Quinn, Shauna ; Arora, Sujata ; Matijevic, Mark ; Gao, Minggeng ; Kirk, Rachel ; Poma, Allen ; Fischer, Tanya ; Wang, Xiaodong

INTRODUCTION:

Obexelimab is an investigational, bifunctional, non-depleting, humanized monoclonal antibody that binds CD19 and FcγRIIb to inhibit B cells, plasmablasts, and CD19-expressing plasma cells. In clinical trials, intravenous (IV) administration of obexelimab has been well-tolerated, and demonstrated clinical activity in patients with rheumatoid arthritis, systemic lupus erythematosus, and immunoglobulin G4-related disease. This study was performed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of obexelimab following subcutaneous (SC) administration, and compare PK/PD profiles between healthy Japanese and non-Japanese volunteers.

METHODS:

This was a Phase I, open-label, parallel group, multiple-dose study. Participants were randomized to five cohorts to receive three doses of obexelimab as 125 mg SC every 14 days (q14d), 250 mg SC q14d, 375 mg SC q14d, 250 mg IV q14d, and 125 mg SC every 7 days, then monitored during a 28-day safety follow-up period. PK/PD assessments were performed after the first and third doses.

RESULTS:

A total of 50 healthy volunteers (25 Japanese and 25 non-Japanese) were enrolled and distributed evenly between dose cohorts. All SC dosing regimens were well-tolerated. Dose-proportional PK was observed following SC doses with a bioavailability of approximately 60%. No clinically meaningful differences in PK parameters were found between healthy Japanese and non-Japanese participants. Antidrug antibodies (ADA) were detected in 6/50 (12%) participants after dosing. ADA had no or minimal impact on PK in all six ADA positive participants. Near-complete CD19 receptor occupancy and an absolute B-cell count nadir of approximately 50% baseline levels were maintained for the duration of the study in both populations.

CONCLUSION:

Obexelimab SC administration demonstrated favorable bioavailability, was well-tolerated, and showed no clinically meaningful ethnic differences in PK/PD. These results support further clinical development of SC obexelimab to treat B-cell mediated autoimmune diseases.

TRIAL REGISTRATION:

NCT02867098.

2023-12-02·Expert opinion on biological therapy

Antibody based therapeutics for autoimmune hemolytic anemia

Review

作者: Fattizzo, Bruno ; Cavallaro, Francesca ; Barcellini, Wilma

INTRODUCTION:

Autoimmune hemolytic anemia (AIHA) treatment has been revolutionized by the introduction of target therapies, mainly monoclonal antibodies (MoAbs).

AREAS COVERED:

The anti-CD20 rituximab, which targets Ab production by B-cells, induces 80% of response in warm-type AIHA (wAIHA) and 50-60% in cold agglutinin disease (CAD). Other B-cell targeting MoAbs including ianalumab, povetacicept, and obexelimab are under active study. The anti-CD38 MoAb daratumumab has been used in several reports to target long-lived plasma-cells responsible for AIHA relapse, being effective even in multi-refractory cases. Anti-complement MoAbs will soon change the treatment paradigm in CAD; the anti-C1s sutimlimab rapidly increased Hb in more than 80% of the cases. Finally, MoAbs inhibiting the neonatal Fc receptor (FcRn), such as nipocalimab, can reduce the half-life of the pathogenic autoAbs, representing a promising treatment for wAIHA.

EXPERT OPINION:

MoAbs offer the potential to improve efficacy by reducing toxicity. However, there is a huge need for clinical trials exploring response duration rather than short-term efficacy. Complement inhibitors and anti-FcRns do not abrogate autoAb production and are being developed as long-term therapies. Thus, the combination of B-cell/plasma cell targeting drugs deserves to be explored. On the other hand, their rapid efficacy should be exploited for the acute AIHA phase.

2023-12-01·Arthritis & rheumatology (Hoboken, N.J.)

Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co‐Expression Patterns: A Double‐Blind, Randomized, Placebo‐Controlled, Phase 2 Trial

Article

作者: Khosroshahi, Arezou ; James, Judith A ; Rathi, Gaurav ; Koumpouras, Fotios ; Askanase, Anca ; Arora, Sujata ; Guthridge, Joel ; Matijevic, Mark ; June, Joshua ; Merrill, Joan T ; Burington, Bart ; Zack, Debra J ; Wax, Stephen ; Smith, Miles ; Foster, Paul ; Machua, Wambui ; Wang, Xiaodong ; Gao, Minggeng ; Sheikh, Saira Z

Objective:

Obexelimab is an investigational, bifunctional, noncytolytic monoclonal antibody that binds CD19 and FcyRIIb to inhibit B cells, plasmablasts, and plasma cells. This trial evaluated the efficacy and safety of obexelimab in the treatment of patients with systemic lupus erythematosus (SLE).

Methods:

During screening, patients with active, non–organ‐threatening SLE received corticosteroid injections to ameliorate symptoms while immunosuppressants were withdrawn (≤10 mg/day prednisone equivalent and ≤400 mg/day hydroxychloroquine allowed). Patients with improved disease activity were randomized 1:1 to obexelimab 5 mg/kg intravenously or placebo once every 2 weeks until week 32 or loss of improvement (LOI).

Results:

In this study, 104 patients were randomized. Analysis of the primary endpoint, proportion of patients reaching week 32 without LOI, used an efficacy‐evaluable (EE) population defined as patients who completed the study or withdrew for flare or treatment‐related toxicity. This endpoint did not reach statistical significance: 21 of 50 obexelimab‐treated patients (42.0%) versus 12 of 42 patients (28.6%) treated with a placebo (P = 0.183). Time to LOI was increased in obexelimab‐treated patients versus patients treated with a placebo in the EE (hazard ratio [HR] 0.53, P = 0.025) and intention‐to‐treat (HR 0.59, P = 0.062) populations. In obexelimab‐treated patients, B cells decreased approximately 50%, and trough concentration and inclusion in baseline gene expression clusters with high B cell pathway modules were associated with increased time to LOI. Obexelimab was associated with infusion reactions but was generally safe and well‐tolerated.

Conclusion:

Although the primary endpoint was not reached, secondary analysis showed time to LOI was significantly increased in obexelimab‐treated patients, and analysis of patient subsets defined by gene expression patterns at baseline suggests a responding subpopulation.image

项与奥贝利单抗相关的新闻（医药）

2025-09-02

·FierceBiotech

Royalty bestows Zenas with $300M deal to push autoimmune asset across FDA finish line

Royalty Pharma will rake in 5.5% of worldwide net sales as well as some other undisclosed payments connected to obexelimab’s commercialization.\n Zenas BioPharma has secured up to $300 million from Royalty Pharma in return for royalties on sales of lead autoimmune candidate obexelimab. The cash is intended to help Zenas get its star asset across the phase 3 finish line in IgG4-related disease and into commercialization, the companies announced in a Sept. 2 release.Royalty is bestowing Zenas with a $75 million upfront payment, with more $75 million payouts available if Zenas’ phase 3 trial succeeds and if obexelimab is approved by the FDA for IgG4-RD and systemic lupus erythematosus. IgG4-RD top-line data are expected by the end of the year, Zenas said in the release, and obexelimab is currently in a phase 2 trial for SLE that should read out in the middle of next year.The initial payment should sustain Zenas’ operations through the first quarter of 2027, according to the release.In return, Royalty will rake in 5.5% of worldwide net sales as well as some other undisclosed payments connected to obexelimab’s commercialization.“This transaction underscores our conviction in the potential of obexelimab as a franchise molecule and provides us with financial flexibility to rapidly advance our clinical programs and fund the commercial launch of obexelimab if approved for the treatment of IgG4-RD,” Zenas CEO and founder Lonnie Moulder said in the release. Zenas is also putting obexelimab through its paces in a phase 2 multiple sclerosis trial, with data expected early in the fourth quarter of 2025.While Zenas has two other pipeline programs, ZB002 and ZB004, obexelimab is the Massachusetts-based biotech’s only asset in publicly disclosed clinical trials. Zenas bought exclusive global rights to the candidate in 2021 from Xencor in a deal worth as much as $480 million. In September 2023, Zenas snagged $50 million upfront from Bristol Myers Squibb in exchange for the right to develop and commercialize obexelimab in Asia and Australia.

临床2期临床3期引进/卖出

2025-08-12

·GlobeNewswire-Health Care

Zenas BioPharma Reports Second Quarter 2025 Financial Results and Provides Corporate Updates

- Topline results from pivotal Phase 3 INDIGO trial in Immunoglobulin G4-Related Disease expected around year-end 2025 - - Completed enrollment of Phase 2 MoonStone trial in Relapsing Multiple Sclerosis; results expected early in the fourth quarter 2025 - - Enrollment of Phase 2 SunStone trial in Systemic Lupus Erythematosus expected to be completed by year-end 2025; topline results expected mid-2026 - - Cash, cash equivalents and investments of $274.9 million as of June 30, 2025, expected to provide cash runway into the fourth quarter of 2026 - WALTHAM, Mass., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for autoimmune diseases, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate updates. “We are very pleased with the rapid advancement of our broad obexelimab development program, including the completion of enrollment for the Phase 2 MoonStone trial in patients with Relapsing Multiple Sclerosis this past quarter. We look forward to reporting the results from the primary analysis of the trial, and importantly, the topline results from the Phase 3 INDIGO trial of obexelimab in patients with IgG4-RD,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “Given the differentiated profile of obexelimab, along with our extensive development capabilities and commercialization experience, we are well positioned to execute on the significant opportunity ahead to potentially impact the lives of patients living with autoimmune diseases worldwide.” Recent corporate highlights Obexelimab, a CD-19 x FcγRIIb inhibitor of B cell function Immunoglobulin G4-Related Disease (IgG4-RD): Advanced the Phase 3 INDIGO trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with IgG4-RD. INDIGO is the largest clinical trial conducted in patients living with IgG4-RD to date. Target enrollment of the INDIGO trial concluded in November 2024, and Zenas expects to report topline results around year-end 2025. Relapsing Multiple Sclerosis (RMS): Completed enrollment of the Phase 2 MoonStone trial, a multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with RMS. Zenas expects to report results from this trial, including the 12-week primary endpoint results, early in the fourth quarter of 2025.Systemic Lupus Erythematosus (SLE): Continued enrollment of the Phase 2 SunStone trial, a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of obexelimab in patients with SLE. Zenas expects to complete enrollment of the Phase 2 SunStone trial by year-end 2025 and report topline results in mid-2026. Second quarter 2025 financial results As of June 30, 2025, the Company’s cash, cash equivalents and investments were $274.9 million. The Company expects that its cash, cash equivalents and investments, as of June 30, 2025, will fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026.Research and development (R&D) expenses were $43.0 million for the quarter ended June 30, 2025, compared to $33.8 million for the quarter ended June 30, 2024. The increase of $9.2 million in R&D expenses primarily relates to an increase in costs related to the clinical development of obexelimab and an increase in personnel costs partially offset by a decrease in costs related to our partnered programs.General and administrative (G&A) expenses were $12.1 million for the quarter ended June 30, 2025, compared to $5.9 million for the quarter ended June 30, 2024. The increase of $6.2 million in G&A expenses was due to an increase in personnel costs, including stock-based compensation expense, pre-commercialization activities including hiring and other expenses associated with operating as a public company.Net loss was $52.2 million for the quarter ended June 30, 2025, compared to net loss of $38.0 million for the quarter ended June 30, 2024. About ObexelimabObexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Obexelimab has been evaluated in five completed clinical trials in a total of 198 subjects who received obexelimab either as an intravenous infusion or as a subcutaneous injection. Obexelimab was well tolerated and demonstrated pharmacologic activity across these five clinical trials, providing the Company an initial clinical proof of concept for obexelimab as a potent B cell inhibitor for the treatment of patients living with certain autoimmune diseases. Currently, Zenas is conducting multiple Phase 2 and Phase 3 trials of obexelimab in several autoimmune diseases including Immunoglobulin G4-Related Disease, Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus. About Zenas BioPharma, Inc.Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas’ lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on LinkedIn. Forward looking statementsThis press release contains “forward-looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning the timing and results of ongoing and future clinical trials, including expectations on the timing of reporting INDIGO trial topline results, results of the 12-week primary endpoint analysis for the MoonStone trial and the anticipated timing of completing enrollment and reporting topline results for the SunStone trial; the ability to potentially impact the treatment of autoimmune diseases; its growth strategy; and cash runway guidance. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; significant political, trade, regulatory developments, including changes in relations between the U.S. and China; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, which is located in China; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain, speak only as of the date of this press release and may prove incorrect. These statements are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, these forward-looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. The Zenas BioPharma word mark, logo mark, and the “lightning bolt” design are trademarks of Zenas BioPharma, Inc. or its affiliated companies. Zenas BioPharma, Inc. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands except share and per share amounts) Unaudited Three Months Ended June 30, 2025 2024 Revenue: License and collaboration revenue $— $— Total revenue — — Operating expenses: Research and development 43,027 33,807 General and administrative 12,136 5,895 Total operating expenses 55,163 39,702 Loss from operations (55,163) (39,702) Other income, net: Other income, net 2,960 1,725 Total other income, net 2,960 1,725 Income tax (provision) benefit (20) — Net loss to common stockholders $(52,223) $(37,977) Net loss per share attributable to common stockholders - basic and diluted $(1.25) $(24.23) Weighted-average common stock outstanding - basic and diluted 41,865,400 1,567,269 Zenas BioPharma, Inc.SELECTED CONSOLIDATED BALANCE SHEET DATA(in thousands)Unaudited June 30 2025 Cash, cash equivalents and investments $274,893 Working capital 225,359 Total assets 293,085 Accumulated deficit (473,187)Total stockholders’ equity 239,626 Investor and Media Contact:Argot PartnersZenas@argotpartners.com

临床2期临床3期财报免疫疗法临床结果

2025-05-16

·泽纳仕生物科技

Zenas BioPharma公布2025年第一季度财务业绩并发布公司业务更新

- 针对IgG4相关疾病的 INDIGO 3 期关键试验预计将于2025年年底左右得到顶线结果- 针对复发性多发性硬化症的MoonStone 2 期试验的招募工作已经结束；预计将于 2025年第四季度初得到顶线结果- 针对系统性红斑狼疮的SunStone 2 期试验的入组工作预计将于2025年年底完成；预计将于2026年年中取得顶线结果-任命研发负责人兼首席医疗官Lisa von Moltke 博士和首席科学官 Haley Laken 博士，加强领导团队- 截至2025年3月31日，现金、现金等价物和投资达3.142亿美元，预计将为2026年第四季度提供资金支持美国马萨诸塞州沃尔瑟姆,2025年5月15日(GlOBE NEWSWIRE)- Zenas BioPharma, Inc.(以下简称 “Zenas” 或 “公司”)(纳斯达克股票代码:ZBIO)是一家处于临床阶段的全球生物制药公司，致力于成为炎症与免疫定向疗法开发和商业化的领导者，今天公布了截至2025年3月31日的第一季度财务业绩，并提供了最新的公司业务更新。Zenas公司创始人兼首席执行官Lonnie Moulder说:"我们很高兴看到我们的Obexelimab项目在正在进行的2期和3期临床试验中继续保持良好势头，我们预计今年晚些时候将公布复发性多发性硬化症和IgG4-RD患者试验的初步结果。随着Lisa和Haley的加入，我们的团队实力得到了增强，我们完全有能力开展临床试验，推动Obexelimab成为一种差异化的B细胞抑制剂，为患者提供更安全、更有效、更便捷的治疗方案。"近期公司要闻Obexelimab-一种 CD-19 x FcγRIIb B 细胞功能抑制剂:IgG4相关性疾病（IgG4-RD）:继续推进INDIGO 3期试验，这是一项全球性的3期、基于注册目的、随机、双盲、安慰剂对照研究，旨在评估Obexelimabd对IgG4-RD患者的疗效和安全性。INDIGO是迄今为止在 IgG4-RD患者中开展的规模最大的临床试验。2024年第四季度，Zenas 完成了INDIGO试验的目标入组，预计将在2025年年底左右报告INDIGO试验的顶线结果。复发性多发性硬化症(RMS)：MoonStone 2期试验的患者筛选工作已经结束，最后一名受试者预计将于6月初入组，该试验是一项多中心、随机、双盲、安慰剂对照研究，旨在评估Obexelimab对RMS患者的疗效和安全性。公司预计在2025年第四季度初报告该试验的顶线结果，包括12 周的主要终点结果。系统性红斑狼疮(SLE)：SunStone 2期试验继续推进中，这是一项多中心、随机、双盲、安慰剂对照研究，旨在评估Obexelimab对系统性红斑狼疮患者的疗效和安全性。公司预计到 2025年底完成这项研究的入组工作，并在2026年年中报告其顶线结果。其他公司要闻除了在Obexelimab方面取得进展之外，公司在第一季度及近期：任命医学博士Lisa von Moltke为研发负责人兼首席医学官，任命Haley Laken博士为首席科学官，加强了公司的领导团队。von Moltke博士拥有30多年的美国和国际药物开发经验，涉及多个治疗领域，包括自身免疫性疾病、早期和晚期临床开发，以及大型和新兴成长型公司的商业化。Laken博士在研究、开发运营、研发战略和业务开发方面拥有超过25年的领导经验。将甲状腺眼病项目ZB001(胰岛素样生长因子-1 受体(抗 IGF-1R)单克隆抗体)的地区权利授权给Zai Lab(Zai)。公司收到了一笔预付款，并有资格在未来收到里程碑付款和特许权使用费，作为对 Zai 在大中华区开发和商业化 ZB001 及相关项目的独家转授权的对价。2025年第一季度财报截至2025年3月31日，公司的现金、现金等价物和投资为 3.142亿美元。公司预计，截至2025年3月31日，其现金、现金等价物和投资将为2026年第四季度的运营支出和资本支出需求提供资金。截至2025年3月31日的季度，许可与合作收入为 1,000 万美元，是与Zai签订的次级许可协议所收到的一次性不可退还的预付现金。截至2024年3月31日的季度，公司未确认任何许可与合作收入。截至2025年3月31日的季度，研发(R&D)费用为3490万美元，而截至2024 年3 月31日的季度为2260万美元。研发费用增加1230万美元，主要与奥Obexelimab的临床开发和生产相关的成本增加有关。截至2025年3月31日的季度，运营和行政支出(G&A)为1240万美元，而截至 2024年3月31日的季度为490万美元。G&A增加750万美元的原因是人事费用(包括股票薪酬费用)、商业化前活动(包括招聘)以及其他费用(包括作为上市公司运营的相关费用)的增加。截至 2025年3月31日的季度净亏损为3360万美元，截至2024年3月31日的季度净亏损为2780万美元。关于ObexelimabObexelimab是一种双功能单克隆抗体，可同时结合CD19和FcγRIIb(广泛存在于B细胞系中)，从而抑制与许多自身免疫性疾病有关的细胞的活性，而不会耗竭它们。Obexelimab的作用机制和慢性给药方案可以广泛而有效地解决B细胞系在慢性自身免疫性疾病中的致病作用。Obexelimab已在五项已完成的临床试验中进行了评估，共有198名患者通过静脉输注或皮下注射接受了Obexelimab治疗。在这五项临床试验中，Obexelimab的耐受性和临床活性均表现良好，为公司提供了一个初步的临床概念验证，即Obexelimab是一种有效的B细胞抑制剂，可用于治疗某些自身免疫性疾病。目前，Zenas正在开展多项Obexelimab治疗自身免疫性疾病的2期和3期试验，包括IgG4相关性疾病、复发性多发性硬化症和系统性红斑狼疮。关于Zenas BioPharmaZenas BioPharma是一家全球生物制药公司，致力于成为为世界各地患者开发和商业化免疫学疗法的领导者。我们的核心业务战略是将经验丰富的领导团队与严谨的候选产品组合相结合，在全球范围内发现、收购和开发我们认为能为自身免疫疾病患者带来卓越临床疗效的候选产品。Zenas的主要候选产品Obexelimab是一种双功能单克隆抗体，能同时结合CD19和FcγRIIb(广泛存在于 B 细胞系中)，从而抑制与许多自身免疫性疾病有关的细胞的活性，而不会消耗这些细胞。我们相信，Obexelimab的作用机制和慢性给药方案可以广泛而有效地解决B细胞系在慢性自身免疫性疾病中的致病作用。欲了解有关Zenas BioPharma的更多信息，请访问网站：www.zenasbio.com，LinkedIn及微信公众号上关注我们。前瞻性说明本新闻稿包含 “前瞻性声明”，其中涉及风险、不确定性和突发事件，许多风险、不确定性和突发事件超出了公司的控制范围，可能导致实际结果、业绩或成果与预期结果、业绩或成果存在实质性差异。本新闻稿中除历史事实陈述外的所有陈述均为前瞻性陈述。在某些情况下，您可以通过 “可能”、“将要”、“应该”、“期望”、“计划”、“预期”、“也许”、“打算”、“目标”、“项目”、“考虑”、“相信”、“估计”、“预测”、“潜在”或 “继续”等词语或这些词语的反义词或其他类似表述来识别出前瞻性表述，尽管并非所有前瞻性表述都包含这些词语。前瞻性表述包括但不限于有关正在进行的和未来的临床试验的时间和结果的表述，包括对INDIGO试验顶线结果报告时间的预期、MoonStone试验的最后一名入组患者和12周主要终点数据，以及SunStone试验完成入组和顶线结果报告的预期时间；发展战略；现金流信息；本新闻稿中的前瞻性表述仅涉及截至本新闻稿发布之日的情况，受许多已知和未知风险、不确定性和假设的影响，可能导致公司的实际结果与前瞻性表述中的预期结果存在实质性差异，这些风险、不确定性和假设包括但不限于公司的经营历史较短，自公司成立以来的亏损，以及预计在可预见的未来将发生不断增加的亏损；公司需要大量额外融资以实现公司目标；临床开发的不确定性，临床开发耗时长、成本高、结果不确定，以及在完成或未能完成公司现有候选产品或任何未来候选产品的开发和商业化过程中与额外成本或延迟相关的风险；临床试验中患者入组和用药的延迟或困难；公司候选产品引起的任何重大不良事件或不良副作用的影响；潜在的竞争，包括来自大型和专业制药及生物技术公司的竞争，其中许多公司已经在公司目前的适应症方面拥有获得批准的疗法；公司从目前或未来的合作或授权协议中获益的能力，以及成功完成未来合作的能力；公司在美国或任何其他司法管辖区获得任何候选产品商业化的监管批准的能力，以及任何此类批准的适应症可能比公司寻求的更狭窄的风险；公司对公司高级管理人员及其他临床和科研人员服务的依赖性，以及公司留住这些人员或招聘更多管理人员或临床和科研人员的能力；公司发展组织、管理公司发展和扩大公司业务的能力；与公司候选产品生产相关的风险(生产过程非常复杂)，以及公司的第三方生产商在生产过程中可能遇到困难的风险；公司为候选产品或公司未来可能开发的候选产品获得并保持足够的知识产权保护的能力；公司依赖第三方开展临床前研究和临床试验的情况；公司履行其他方授予公司的候选产品开发和商业化权利许可下的义务的情况；重大政治、贸易和监管动态，包括中美关系的变化；与公司供应商运营相关的风险，其中许多供应商位于美国境外，包括公司目前唯一的药物物质和药物产品合同生产机构，位于中国的药明康德生物制品(香港)有限公司；以及公司截至2025年3月31日的10-Q年报中 “风险因素 ”一节所述的其他风险和不确定性，以及我们向美国证券交易委员会提交的其他信息。本新闻稿中的前瞻性陈述本身具有不确定性，仅截至本新闻稿发布之日，并可能被证明是不正确的。尽管公司认为这些信息构成了前瞻性声明的合理基础，但这些信息可能是有限的或不完整的，而且我们的声明不应被理解为表明公司已对所有可能获得的相关信息进行了详尽的调查或审查。由于前瞻性声明本身存在风险和不确定性，其中有些风险和不确定性无法预测或量化，有些风险和不确定性超出了公司的控制范围，因此不应将这些前瞻性声明视为未来事件的保证。前瞻性声明中反映的事件和情况可能无法实现或不会发生，未来的实际结果、活动水平、业绩以及事件和情况可能与前瞻性声明中预测的有实质性差异。此外，公司在不断变化的环境中运营，新的风险和不确定因素可能不时出现，管理层无法预测所有风险和不确定因素。除非适用法律另有规定，否则公司不承诺公开更新或修订此处包含的任何前瞻性声明，无论是否因任何新信息、未来事件、环境变化或其他原因所致。Zenas BioPharma文字商标和Logo是Zenas BioPharma公司或其关联公司的商标。投资及媒体联系： Argot PartnersZenas@argotpartners.com关注我们获得更多相关信息

临床3期临床2期免疫疗法高管变更临床结果

100 项与奥贝利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11496	-	-	DB15032

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
温热型自身免疫性溶血性贫血	临床3期	意大利	Zenas BioPharma LLC.	2023-09-25
温热型自身免疫性溶血性贫血	临床3期	波兰	Zenas BioPharma LLC.	2023-09-25
温热型自身免疫性溶血性贫血	临床3期	西班牙	Zenas BioPharma LLC.	2023-09-25
温热型自身免疫性溶血性贫血	临床3期	中国台湾	Zenas BioPharma LLC.	2023-09-25
温热型自身免疫性溶血性贫血	临床3期	英国	Zenas BioPharma LLC.	2023-09-25
免疫球蛋白G4相关疾病	临床3期	美国	Zenas BioPharma LLC.	2022-09-30
免疫球蛋白G4相关疾病	临床3期	中国	Zenas BioPharma LLC.	2022-09-30
免疫球蛋白G4相关疾病	临床3期	日本	Zenas BioPharma LLC.	2022-09-30
免疫球蛋白G4相关疾病	临床3期	阿根廷	Zenas BioPharma LLC.	2022-09-30
免疫球蛋白G4相关疾病	临床3期	加拿大	Zenas BioPharma LLC.	2022-09-30

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临床结果

适应症

分期

评价

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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


NCT05786573 (SApHiAre, ASH2024)	临床2期	-	6	Obexelimab	糧襯襯獵鑰鑰窪憲積鏇(壓夢鬱壓鹽鏇餘窪鹹築) = 積積製鬱醖繭築窪簾製廠鹽衊膚簾鹽憲鹹鏇觸 (鏇憲壓齋衊網襯糧製蓋 )	积极	2024-11-05
NCT02725476 (Pubmed \| Lancet Rheumatol)	临床2期	免疫球蛋白G4相关疾病	15	Obexelimab 5 mg/kg	鏇襯餘壓簾範廠網齋選(壓窪醖繭夢鬱範遞憲簾) = 13 (87%) of 15 patients reported adverse events, one of which (an infusion reaction) resulted in treatment discontinuation 鏇構築製築築餘衊艱憲 (鹹廠襯廠憲淵積網艱廠 )	积极	2023-08-01
ACR2020	临床2期	系统性红斑狼疮 CD27+ \| APP	68	Obexelimab	膚顧淵範繭窪壓觸鏇製(憲膚顧艱艱選網遞襯夢) = 淵選選膚獵構鏇築築選積壓壓簾鑰繭築繭簾艱 (築壓醖範鬱顧觸鏇膚顧 ) 更多	积极	2020-11-09
				Placebo	膚顧淵範繭窪壓觸鏇製(憲膚顧艱艱選網遞襯夢) = 範簾鹽憲衊築鏇齋簾遞積壓壓簾鑰繭築繭簾艱 (築壓醖範鬱顧觸鏇膚顧 ) 更多
NCT02725515 (CTgov)	临床2期	系统性红斑狼疮	105	XmAb5871 (XmAb5871)	獵衊鹹選顧積齋範繭積 = 繭積醖糧範淵憲願淵窪範網範網繭蓋鑰網構獵 (蓋膚壓窪繭糧夢醖範憲, 膚積繭積餘鹹範窪範夢 ~ 鬱網築顧遞齋膚夢願廠) 更多	-	2019-08-09
				Placebo to match XmAb5871 (Placebo)	獵衊鹹選顧積齋範繭積 = 鏇鏇鹹簾製構艱齋選觸範網範網繭蓋鑰網構獵 (蓋膚壓窪繭糧夢醖範憲, 淵襯顧壓積鏇願夢顧遞 ~ 衊膚範醖艱網鏇廠淵淵) 更多
EULAR2019	临床2期	系统性红斑狼疮 anti-dsDNA \| ENA antibodies	104	XmAb5871	糧醖觸繭觸顧獵餘齋鏇(顧齋膚夢獵觸糧積顧鏇) = 獵夢餘衊蓋積築艱觸製夢獵鹽網鏇觸壓鹹積遞 (簾醖繭壓簾襯壓顧願蓋 )	积极	2019-06-12
				Placebo	糧醖觸繭觸顧獵餘齋鏇(顧齋膚夢獵觸糧積顧鏇) = 築鹹鏇鬱願遞鏇鑰鏇簾夢獵鹽網鏇觸壓鹹積遞 (簾醖繭壓簾襯壓顧願蓋 )
NCT02725476 (CTgov)	临床2期	免疫球蛋白G4相关疾病	20	XmAb5871 (XmAb5871 5 mg/kg)	夢窪鹹鏇鬱醖遞淵鏇齋 = 齋膚壓壓製選蓋餘築遞網選築淵餘襯淵願壓製 (膚艱醖窪艱簾廠蓋餘範, 鹽鹽觸積衊簾襯構鏇鹽 ~ 遞蓋糧網鑰餘觸築顧衊) 更多	-	2018-12-07
				XmAb5871 (XmAb5871 Fixed Dose)	夢窪鹹鏇鬱醖遞淵鏇齋 = 襯鬱醖範鹽願衊廠網蓋網選築淵餘襯淵願壓製 (膚艱醖窪艱簾廠蓋餘範, 顧獵夢願蓋鏇鑰簾餘遞 ~ 觸築構衊觸窪襯鬱鏇鹹) 更多
NCT02725515 (Corporate Publications) 人工标引	临床2期	系统性红斑狼疮	104	Obexelimab	遞蓋膚網膚鏇餘網衊觸(製獵夢衊鏇淵網製選衊) = 鏇鏇構製鏇淵構鏇獵艱膚築蓋構窪鏇憲壓鬱淵 (衊餘膚鬱襯遞獵築艱齋, 28.2 ~ 56.8) 更多	积极	2018-10-21
				Placebo	遞蓋膚網膚鏇餘網衊觸(製獵夢衊鏇淵網製選衊) = 糧鹹齋齋範壓醖衊構糧膚築蓋構窪鏇憲壓鬱淵 (衊餘膚鬱襯遞獵築艱齋, 15.7 ~ 44.6) 更多
NCT02725476 (Corporate Publications) 人工标引	临床2期	免疫球蛋白G4相关疾病	15	XmAb®5871	積製廠糧餘衊淵醖憲獵(廠壓蓋簾觸鑰積觸憲積) = 選壓範繭鑰鏇襯夢繭夢蓋夢齋廠鏇壓廠襯窪範 (鹹積艱鹹積積鑰觸艱壓 )	积极	2017-11-08