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Five Investigational New Drug (IND) applications cleared across a range of therapeutic areas and FDA divisions for lead asset, IMVT-1402Proof of concept data from batoclimab trial in Graves’ disease (GD) demonstrate potential of deeper IgG reduction with potent FcRn inhibition to transform treatment for GD patients who are not well controlled on antithyroid drugs (ATDs); initiation of potentially registrational trial to evaluate IMVT-1402 in GD expected by year endIND cleared for IMVT-1402 in rheumatoid arthritis (RA), with potential best-in-class profile in difficult-to-treat (D2T) RA; initiation of potentially registrational trial to evaluate IMVT-1402 in D2T RA expected by March 31, 2025On track to initiate potentially registrational trials with IMVT-1402 in four to five indications, inclusive of GD and D2T RA, by March 31, 2025Batoclimab trials in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) fully enrolled to support data disclosures by March 31, 2025; data from batoclimab trials in thyroid eye disease (TED) now expected in the second half of calendar year 2025; all batoclimab data will inform future trials with IMVT-1402Immunovant to host development update call today, November 7, at 8 a.m. ET NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported development updates and financial results for its fiscal second quarter ended September 30, 2024. Immunovant continues to focus on moving rapidly to unlock the full potential of its lead asset, IMVT-1402, for the benefit of people with underserved autoantibody-driven diseases. With five IND applications now cleared, the company remains on course to initiate four to five potentially registrational clinical development programs by March 31, 2025. These INDs are expected to support evaluation of IMVT-1402 in a variety of indications and therapeutic areas. As previously announced, Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of ten indications by March 31, 2026. “Since announcing the Phase 1 data for IMVT-1402 a year ago, we have made tremendous progress in advancing IMVT-1402 towards multiple potentially registrational study initiations. We’re ahead of our goal to activate three INDs by calendar year end and we are very excited about all five cleared INDs – both those that have been announced and those that have not yet been announced. In terms of announced indications, we believe our first-in-class program with IMVT-1402 in GD has the potential to transform the treatment of GD patients who respond poorly to ATDs,” said Pete Salzmann, M.D., chief executive officer of Immunovant. “We are also excited to announce expansion of our IMVT-1402 development program into Rheumatology. Our first program in Rheumatology will be a potentially registrational study in patients with D2T RA where we believe that deeper IgG reduction has the potential to deliver better clinical outcomes in an important subset of patients with elevated RA-specific autoantibodies (ACPA). People living with D2T RA have already exhausted multiple therapeutic options yet continue to suffer from active disease, persistent disability and pain,” Salzmann continued. “We believe IMVT-1402 can deliver meaningful clinical benefit in ACPA-positive (ACPA+) D2T RA patients, with a potentially best-in-class profile driven by deeper IgG reduction.” FcRn inhibition represents an attractive mechanism as a potential treatment for the approximately 70,000 US patients with D2T, ACPA+ RA. Recently disclosed in-class data demonstrated that both higher baseline ACPA levels and deeper ACPA reduction correlated with better clinical improvement in ACPA+ RA patients treated with an FcRn inhibitor. Having received FDA clearance of the IND for IMVT-1402 in RA, Immunovant plans to initiate a potentially registrational trial in ACPA+ D2T RA by March 31, 2025. The trial builds on in-class learning in terms of its target population (enriched for above-normal ACPA levels) and trial design (open-label lead-in followed by randomized withdrawal). The trial will leverage IMVT-1402’s higher dose (600 mg) during the open-label induction phase of the clinical trial to maximize reduction in ACPA levels. Recent Highlights and Upcoming Milestones Endocrinology Program In September 2024, Immunovant provided a GD program update consisting of new epidemiologic data characterizing unmet need in GD patients who are relapsed, uncontrolled or intolerant of ATDs, additional results from the batoclimab GD study, and an overview of the IMVT-1402 development program in GD. In November 2024, additional data on the efficacy and safety of batoclimab in Graves’ thyroidal and extrathyroidal disease were presented in an oral presentation at the American Thyroid Association (ATA) 2024 Annual Meeting. These data showed that a 60% response rate (defined as T3 and T4 falling below the upper limit of normal (ULN) without increasing the ATD dose) was achieved by Week 2, demonstrating the rapidity of response to batoclimab 680mg dosed weekly. Meaningful improvements in proptosis and lid aperture were also observed at both Week 12 and Week 24. Pronounced improvements in multiple Thyroid-Related Patient-Reported Outcomes (ThyPRO-39) measurement scales were also observed, with ATD-Free Responders (defined as T3 and T4 falling below the ULN and ceasing all ATD medications) reporting greater improvements than other participants. The batoclimab data in Graves’ disease support the potential for deep IgG reduction to modify the underlying pathophysiology of the disease, which could enable a transformation of the treatment of Graves’ disease for patients not well controlled on ATDs. Immunovant remains on track to initiate the first potentially registrational trial of IMVT-1402 in GD by calendar year end. Competition for clinical trial participants with acute, active TED has increased over the course of the company’s Phase 3 program to evaluate batoclimab for the treatment of thyroid eye disease (TED). As a result, top-line results are now expected to be available in the second half of calendar year 2025, along with a decision on whether to advance batoclimab to registration in TED. Data from this trial will be leveraged to inform the overall program in GD for the Company’s lead asset, IMVT-1402. Neurology Program As previously reported, Immunovant completed enrollment of the batoclimab pivotal trial in MG, with top-line results expected to be reported by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG and the design of the MG program for IMVT-1402, which Immunovant expects to initiate by March 31, 2025. Enrollment of study participants has completed in the Phase 2b trial evaluating batoclimab in chronic inflammatory demyelinating polyneuropathy (CIDP) for those patients to be included in the period 1 data readout expected by March 31, 2025. A decision to enroll additional patients in the batoclimab CIDP study will be made following the readout of period 1 data. Those results, as well as observations drawn from public disclosures of other studies in CIDP, will be used to inform the trial design for a potentially registrational program for IMVT-1402 in CIDP. Corporate Update Immunovant also announced today that it appointed Melanie Gloria as Chief Operating Officer, effective November 18, 2024. Ms. Gloria brings over 20 years of experience in the biotechnology industry, including leadership roles at Acelyrin, Horizon Therapeutics and AbbVie. At AbbVie and Horizon she led teams to achieve global approvals of HUMIRA®, Viekera Pak®, Mavyret®, Skyrizi®, Rinvoq®, TEPEZZA®, and ORILISSA®. “I am thrilled to welcome Melanie to Immunovant where her success in driving late-stage drug development will be incredibly valuable,” said Salzmann. “Melanie’s proven drug development capabilities are a great fit for Immunovant’s portfolio.” Webcast Details Immunovant will host a webcast at 8:00 a.m. ET today to discuss these updates. Please click register here to register for the event. The live webcast will also be available under the News & Events section of Immunovant’s website. A replay of the event and presentation will be available immediately following the event. Financial Highlights for Fiscal Second Quarter Ended September 30, 2024: Cash Position: As of September 30, 2024, Immunovant’s cash and cash equivalents totaled approximately $472.9 million. R&D Expenses: Research and development expenses were $97.3 million for the three months ended September 30, 2024, compared to $48.0 million for the three months ended September 30, 2023. The increase was primarily due to activities in preparation for potential future clinical trials of IMVT-1402, including contract manufacturing costs for drug substance, higher overall clinical trial costs related to our batoclimab pivotal clinical trials, and elevated personnel-related expenses. The increase was partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies. G&A Expenses: General and administrative expenses were $18.5 million for the three months ended September 30, 2024, compared to $13.8 million for the three months ended September 30, 2023. The increase was primarily due to higher personnel-related expenses, legal and other professional fees, and information technology costs. Net Loss: Net loss was $109.1 million ($0.74 per common share) for the three months ended September 30, 2024, compared to $58.7 million ($0.45 per common share) for the three months ended September 30, 2023. Net loss for the three months ended September 30, 2024 and September 30, 2023 included $12.7 million and $10.5 million, respectively, related to non-cash stock-based compensation expense. Common Stock: As of September 30, 2024, there were 146,565,049 shares of common stock issued and outstanding. Financial Highlights for Fiscal Six Months Ended September 30, 2024: R&D Expenses: Research and development expenses were $172.7 million for the six months ended September 30, 2024, compared to $98.5 million for the six months ended September 30, 2023. The increase was primarily due to activities in preparation for potential future clinical trials of IMVT-1402, including contract manufacturing costs for drug substance, higher overall clinical trial costs related to our batoclimab pivotal clinical trials, and elevated personnel-related expenses. The increase was partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies. IPR&D Expenses: There were no acquired in-process research and development expenses for the six months ended September 30, 2024. During the six months ended September 30, 2023, acquired in-process research and development expenses were $12.5 million related to the achievement of development and regulatory milestones for batoclimab under the terms of the HanAll in-license agreement. G&A Expenses: General and administrative expenses were $37.3 million for the six months ended September 30, 2024, compared to $29.2 million for the six months ended September 30, 2023. The increase was primarily due to higher personnel-related expenses, legal and other professional fees, and information technology costs. Net Loss: Net loss was $196.3 million ($1.34 per common share) for the six months ended September 30, 2024, compared to $132.6 million ($1.01 per common share) for the six months ended September 30, 2023. Net loss for the six months ended September 30, 2024 and September 30, 2023 included $26.1 million and $21.2 million, respectively, related to non-cash stock-based compensation expense. About Immunovant, Inc. Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com. Forward-Looking Statements This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” “anticipate,” “intend,” and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include statements regarding Immunovant’s expectations regarding the timing, design, and results of clinical trials of IMVT-1402 and batoclimab, including the number and timing of (a) FDA clearance with respect to IND applications, (b) potential registrational programs and clinical trials of IMVT-1402, (c) expected data readouts from batoclimab trials in MG and CIDP, and (d) estimates of the target populations for IMVT-1402, including in RA; Immunovant’s plan to develop IMVT-1402 and batoclimab across a broad range of indications; and potential benefits of IMVT-1402’s unique product attributes and potential best-in-class profile. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive of final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of macroeconomic and geopolitical factors on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402 and/or batoclimab; Immunovant is at various stages of clinical development for IMVT-1402 and batoclimab; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 and batoclimab through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Form 10-Q to be filed with the SEC on November 7, 2024, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. IMMUNOVANT, INC.Consolidated Statements of Operations(Unaudited, in thousands, except share and per share data) Three Months EndedSeptember 30, Six Months EndedSeptember 30, 2024 2023 2024 2023 Operating expenses: Research and development$97,272 $47,959 $172,745 $98,534 Acquired in-process research and development — — — 12,500 General and administrative 18,471 13,841 37,279 29,243 Total operating expenses 115,743 61,800 210,024 140,277 Interest income (6,073) (3,572) (13,254) (7,637)Other income, net (629) (20) (657) (484)Loss before provision for income taxes (109,041) (58,208) (196,113) (132,156)Provision for income taxes 78 454 156 443 Net loss$(109,119) $(58,662) $(196,269) $(132,599)Net loss per common share – basic and diluted$(0.74) $(0.45) $(1.34) $(1.01)Weighted-average common shares outstanding – basic and diluted 146,468,991 131,155,642 146,313,696 130,872,717 IMMUNOVANT, INC.Consolidated Balance Sheets(Unaudited, in thousands, except share and per share data) September 30, 2024 March 31, 2024Assets Current assets: Cash and cash equivalents$472,941 $635,365 Accounts receivable 1,876 5,337 Prepaid expenses and other current assets 32,555 25,068 Total current assets 507,372 665,770 Operating lease right-of-use assets 45 133 Other assets 7,619 — Property and equipment, net 671 462 Total assets$515,707 $666,365 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$20,727 $7,155 Accrued expenses 45,879 41,315 Current portion of operating lease liabilities 47 138 Total current liabilities 66,653 48,608 Total liabilities 66,653 48,608 Commitments and contingencies Stockholders’ equity: Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at September 30, 2024 and March 31, 2024 — — Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2024 and March 31, 2024 — — Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 146,565,049 shares issued and outstanding at September 30, 2024 and 500,000,000 shares authorized, 145,582,999 shares issued and outstanding at March 31, 2024 14 14 Additional paid-in capital 1,469,082 1,441,518 Accumulated other comprehensive income 1,910 1,908 Accumulated deficit (1,021,952) (825,683)Total stockholders’ equity 449,054 617,757 Total liabilities and stockholders’ equity$515,707 $666,365 Contact:Renee Barnett, MBAChief Financial OfficerImmunovant, Inc.info@immunovant.com

关注并星标CPHI制药在线 10月15日，CDE官网显示，和其瑞医药（南京）有限公司1类新药「HMI-115」拟被纳入突破性治疗品种，用于治疗子宫内膜异位症相关的中重度疼痛。 子宫内膜异位症是一种以内膜细胞种植在子宫内膜以外位置为特征的一种雌激素依赖的常见妇科疾病，通常表现为慢性炎症反应，常见症状包括下腹及盆腔痛、痛经、性交痛及不孕。子宫内膜异位症常见于育龄妇女，全球发病率在育龄妇女中约为10%。目前，子宫内膜异位症的病因尚不清楚，也无法治愈，常见治疗方式是止痛和治疗不孕症。 HMI-115是一款靶向泌乳素受体（PRLR）的单克隆抗体，被开发用于治疗子宫内膜异位症和雄激素性秃发，已在动物模型包括非人灵长类(NHP)模型和人体安全性方面展现出优异的特质。该药最初由拜耳作为治疗子宫内膜异位药物开发。2019年4月，和其瑞医药与拜耳签署一项全球独家许可协议，获得HMI-115在全球开展多个适应症的开发和产业化授权。 2014年1月，和其瑞医药宣布HMI-115治疗雄激素性脱发的临床1b期研究取得积极结果。该研究共入组16名雄激素性脱发（12名男性+4名女性）患者，HMI-115治疗24周时，12名男性患者的平均目标区域非毳毛数量与基线相比，每平方厘米增加了14根。同时，HMI-115展现出良好的安全性和耐受性。 此次HMI-115被CDE纳入治疗子宫内膜异位症相关的中重度疼痛的突破性治疗品种，将加速HMI-115该适应症在国内的开发进程。 国内在研子宫内膜异位症新药进展 除了HMI-115，国内还有多款新药被开发用于治疗子宫内膜异位症相关的中重度疼痛，详见下表。在研药物靶点相对集中，主要为GnRH。研发进度上，大多处于1期临床。 Linzagolix进展较快，在国内处于3期临床。该药是Kissei Pharmaceutical开发的一款新型、口服、非肽类促性腺激素释放激素（GnRH）受体拮抗剂，2022年6月在欧盟及英国被批准用于治疗育龄妇女子宫肌瘤中度至重度症状。Linzagolix是第一个获批在非激素给药选择下的口服GnRH拮抗剂，2021年9月，葆正医药与Kissei Pharmaceutical达成授权协议，获得Linzagolix在中国的开发和商业化权利。2022年10月，Linzagolix在国内获批临床，用于治疗子宫内膜异位症相关的疼痛。 HS-10518等多款药物处于1期临床。其中HS-10518是一款靶向于GnRH的1类新药，拟用于治疗子宫内膜异位症相关中重度疼痛、子宫肌瘤相关月经过多等疾病。目前，HS-10518正处于Ⅰ期临床阶段，将在中国健康绝经前成年女性受试者中开展研究。 CMS-D002是康哲药业自主研发的一款小分子GnRH受体拮抗剂，通过与内源性GnRH竞争性结合垂体上的GnRH受体，在中枢神经水平阻断垂体性腺轴，减少内源性FSH和LH的释放，从而抑制下游雌激素、黄体酮和睾酮的分泌，缓解性激素相关疾病的进展。临床前研究表明：CMS-D002具有优异的有效性和安全性，有望开发用于治疗子宫内膜异位症、子宫肌瘤、前列腺癌等疾病。2024年2月，CMS-D002在国内获批临床。 G201-Na是以岭药业的一款小分子GnRH受体拮抗剂，临床前研究显示其药效确切、安全性良好。 BAY 1817080是一款在研P2X3拮抗剂，被开发用于治疗子宫内膜异位症、慢性咳嗽、膀胱过动症等多种疾病。P2X3受体是嘌呤类受体家族中的一员，是非选择性的配体门控离子通道，研究发现其表达在上皮细胞和感觉神经元上，而且P2X3受体的高表达和激活可以导致慢性疼痛模型动物的痛觉敏化。2021年1月，BAY 1817080在国内获批临床，用于治疗子宫内膜异位症。 SHR7280是恒瑞医药研发的一种新型口服小分子GnRH受体拮抗剂。药效学分析显示，SHR7280能够有效抑制雌 二 醇和黄体生成素浓度，并以剂量依赖的方式防止孕激素升高。已公布的SHR7280在子宫内膜异位症的绝经前期女性患者中开展的1/2期临床研究结果显示：该药在绝经前期女性患者中表现出良好的耐受性和药代动力学特性。 此外，GnRH受体拮抗剂瑞卢戈利和艾拉戈克钠也在国内被开发用于治疗子宫内膜异位症相关的疼痛。其中瑞卢戈利是武田开发的一种可口服、非肽类小分子促性腺激素释放激素（GnRH）受体拮抗剂，2019年1月在日本获批，用于改善子宫肌瘤引起的下列症状：月经过多、下腹痛、腰痛、贫血和改善子宫内膜异位症引起的疼痛。目前，国内民生药业、齐鲁制药在开展瑞卢戈利改善子宫肌瘤引起的一些症状，如月经过多、下腹痛、腰痛、贫血等，以及改善子宫内膜异位症引起的疼痛的人体生物等效性试验。 艾拉戈克钠是艾伯维与合作伙伴Neurocrine Bioscienc Chemicabookes共同研发的一种口服GnRH拮抗剂，2018年7月被FDA批准用于治疗与子宫内膜异位症相关的中度至重度疼痛，是十年来首 个获FDA批准用于该适应症的口服疗法。据公开资料，艾拉戈克钠化合物专利2024年07月到期。目前，国内正大天晴、福安药业、齐鲁制药等企业在进行艾拉戈克钠人体生物等效性试验。 总结 作为一种常见妇科病，子宫内膜异位症摧残着不计其数的女性。目前，子宫内膜异位症治疗手段有限，治疗主要目的是缓解痛经。相对国外，我国子宫内膜异位症新药进展较慢，还未有任何一款GnRH拮抗剂被批准用于治疗子宫内膜异位症相关的疼痛，多款药物处于临床试验阶段，其中葆正医药引进的Linzagolix进展较快，已进入3期临床。值得一提是，在研子宫内膜异位症新药除了GnRH拮抗剂，还包括P2X3拮抗剂、PRLR靶向单抗。期待在药企的不懈努力下，我国子宫内膜异位症患者早日迎来新型治疗药物。 END 来源：CPHI制药在线 声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。 投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~