Inmagene Biopharmaceuticals Ltd.

IMG-007在300mg（组1）和600mg（组2）剂量下，经过在4周内3次给药后，显示出与剂量相关的毛发再生临床疗效观察剂量组2患者的脱发严重程度评分（SALT评分）呈现持续改善，疗效维持至第36周 （即末次给药后8个月），且未达到平台期第36周时，基线SALT评分为50到100分的患者中，SALT评分平均下降21.7%；在基线SALT评分为50到95分（不含95分）的患者中，SALT评分平均下降30.1%在第16周（末次给药后约3个月后），观察到与Th1、Th2和CD8+T细胞相关的炎性标志物被持久抑制IMG-007 总体耐受性良好，未出现发热或寒颤等不良反应圣地亚哥，加利福尼亚， 2025年4月25日 – 创响生物（Inmagene Biopharmaceuticals, 下简称“创响”），一家处于临床阶段，专注于自身免疫和炎症疾病（I&I）领域创新和差异化治疗的新药研发公司，今天宣布，IMG-007在重度斑秃（AA）患者中的临床2a期研究取得了顶线结果。 王健博士 创响创始人、董事长兼CEO“斑秃是一种存在着巨大未满足临床需求的自身免疫性疾病，病人特别需要更安全的药物。在4周治疗后，剂量组2的患者中观察到显著且持久的临床疗效和药效学活性，同时，IMG-007表现出良好的耐受性，说明阻断OX40-OX40L信号通路有望成为治疗斑秃的新方法。”这项2a期临床研究（NCT06060977）是一项多次给药剂量递增研究，旨在评估IMG-007在脱发50%或以上的斑秃患者中的安全性、药代动力学和有效性。研究使用SALT评分作为评估指标，共纳入来自美国和加拿大11家研究中心的29位患者。其中，剂量组1的6名患者和剂量组2的23名患者在4周内（基线，第2周和第4周）分别接受了3次300mg和600mg的静脉输注。所有患者均随访至第24周，剂量组2中16名患者自愿参加了更长时间的研究，并随访至第36周。疾病的主要基线特征包括：患者平均病程为3年，平均SALT评分为80.4分。在全部29位患者中，9位（31%）基线SALT评分为95分及以上。在剂量组2中，在基线和第16周收集了头皮组织样本，用于炎症生物标志物分析，主要研究终点包括安全性和SALT评分较基线的百分比随时间的变化。经过4周治疗后，观察到剂量依赖性的毛发再生临床疗效。在24周评估时，剂量组1患者的SALT评分相比基线未出现有意义的降低（平均改变为1.1%）；而剂量组2的患者在24周时SALT评分相比基线平均降低14.3%，至36周（末次给药后约8个月）时，平均降低21.7%，并且未达到平台期。在第36周，剂量组2中25%的患者达到SALT评分相比基线降低≥30%的疗效标准。在剂量组2基线SALT评分为50至95分（不含95分）的患者中观察到较整组更为显著的临床改善（表1）。表1：剂量组2患者中基线SALT评50至95分（不含95分）的SALT评分改善_24周 (n=17)36周 (n=11)SALT评分较基线变化百分比20.1%30.1%SALT评分较基线降低≥30%患者比例11.8%36.4%在剂量组2中，在基线时观察到斑秃区域的皮肤样本中与Th1, Th2和 CD8+T细胞相关的炎性标志物水平比未出现斑秃病征区域的皮肤样本较高。 经过IMG-007治疗4周后（600mg, 3次给药），在第16周（即末次给药后约3个月）观察到与Th1, Th2和 CD8+T细胞相关的炎性标志物水平被显著抑制。IMG-007的总体耐受性良好，未报告严重不良事件 （SAE）。所有治疗中出现的不良事件（TEAE）的严重程度均为轻度或中度。在任一治疗组中，发生在至少2例患者的TEAEs包括头痛（4[13.8%]），鼻咽炎（3[10.3%]），高血压（2[6.9%]）和链球菌感染（2[6.9%]）。研究中也未有关于发热或寒颤的报告。本研究的数据将在后续的学术会议上发表。 陆雨芳博士 创响首席医学官“斑秃是一种累及约2%人群（包括儿童）的常见慢性自身免疫性疾病。目前，口服JAK抑制剂是唯一的系统治疗方案，但需要每天用药，因有严重的安全性风险，需要定期进行临床和实验室监测。对这类需要长期治疗的疾病，安全且有效的生物药会非常有价值。本研究中剂量组2所展现的积极的结果说明，IMG-007有望成为患者用于对斑秃进行长期管理的生物药。”关于创响生物创响生物是一家全球领先的临床阶段生物技术公司，专注于自身免疫及炎症疾病（I&I）领域的新药研发。其先导化合物IMG-007是一种长半衰期、非耗竭性抗OX40单克隆抗体，目前在进行针对中重度特应性皮炎和斑秃的临床2期研究。另一重要候选药物IMG-004是一种非共价、可逆的BTK抑制剂，具备超长的半衰期及药效学作用，有每日一次给药的潜力，已达到进入2期临床研究的条件。更多信息，请访问www.inmagenebio.com .关于IMG-007IMG-007为人源化抗OX40单克隆抗体，可皮下注射给药，消除了抗体依赖性的细胞介导的细胞毒（ADCC）效应，具有较长的半衰期。非临床研究表明，IMG-007能够有效阻断OX40-OX40L信号通路，而该信号通路在多种自身免疫和炎症性疾病的发病机制中起着关键作用。其皮下注射制剂的半衰期为34.7天，具有支持更具竞争力的给药方案的潜力。在针对中重度特应性皮炎的2a期临床研究中，IMG-007显示出持久的临床疗效和良好的安全性特征，且未观察到发热或寒战等不良反应。该药物最初由HUTCHMED公司发现。前瞻性声明本新闻稿包含前瞻性陈述。虽然创响认为这些预测是基于合理的假设，但这些前瞻性陈述可能会受到多种风险和不确定因素的影响，实际结果可能与此类前瞻性陈述中的预期存在重大差异。Participants in the SolicitationThis press release may be deemed to be solicitation material in respect of the previously announced proposed merger involving Ikena Oncology, Inc. (“Ikena”) and Inmagene. In connection with the proposed transactions, Ikena has filed and will file relevant materials with the Securities and Exchange Commission (“SEC”), including the Registration Statement on Form S-4 (File No. 333-285881) (the “Registration Statement”), initially filed by Ikena with the SEC on March 18, 2025, which contains a proxy statement (the “Proxy Statement”) and prospectus. This communication is not a substitute for the Registration Statement, the Proxy Statement or for any other document that Ikena may file with the SEC and or send to Ikena’s stockholders in connection with the proposed transactions. Ikena, Inmagene, and their respective directors and certain of their executive officers may be considered participants in the solicitation of proxies from Ikena’s stockholders with respect to the proposed transactions under the rules of the SEC. Information about the directors and executive officers of Ikena is set forth in its proxy statement, which was filed with the SEC on April 26, 2024, and in subsequent documents filed with the SEC. Additional information regarding the persons who may be deemed participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, is included in the Registration Statement, the Proxy Statement and other relevant materials to be filed with the SEC when they become available. You may obtain free copies of these documents as described below. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS OF IKENA ARE URGED TO READ THE REGISTRATION STATEMENT, THE PROXY STATEMENT AND OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT IKENA, INMAGENE, THE PROPOSED TRANSACTIONS AND RELATED MATTERS.No Offer or SolicitationThis communication does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitation of any vote or approval with respect to the proposed transactions herein or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U. S. Securities Act of 1933, as amended, and otherwise in accordance with applicable law.Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Inmagene’s and Ikena’s actual results may differ from their expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” “propose” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained in this press release include, but are not limited to, statements about: the proposed merger and related transactions; The potential of IMG-007 including as a biologic therapy for the long-term treatment of patients with AA; blocking the OX40-OX40L signaling may be a novel approach to the treatment of AA; the estimated patient population of AA; and the Company’s pipeline having best in class potential. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside Inmagene’s and Ikena’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to the risk that the conditions to closing of the proposed merger or concurrent financing are not satisfied, including the failure to timely obtain shareholder approval for the merger agreement and the transactions contemplated thereby, if at all; uncertainties as to the timing of the consummation of the proposed merger; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed transactions; risks associated with the possible failure to realize certain anticipated benefits of the proposed transactions, including with respect to future financial and operating results; the potential for the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger agreement and any agreements entered into in connection therewith; risks associated with the clinical development and regulatory approval of product candidates; risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these product candidates; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; ; clinical results may not be indicative of results that may be observed in the future; Inmagene’s ability to successfully commercialize IMG-007 and any future product candidates, if approved, the rate and degree of market acceptance of IMG-007 and any future product candidates and the favorability of pricing regulations, reimbursement practices from third-party payors or healthcare reform initiatives in the United States and abroad; developments and projections relating to Inmagene’s competitors, its industry or the market opportunities for IMG-007 or any future product candidates; regulatory, political, environmental and public health developments in the United States and foreign countries; and the ability of Inmagene to maintain and protect its intellectual property rights. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section titled “Risk Factors” in the Registration Statement and in Ikena’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 6, 2025, and in other filings that Ikena makes and will make with the SEC in connection with the proposed merger, including the Proxy Statement described below under “Additional Information and Where to Find It.” You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Inmagene and Ikena expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Ikena or Inmagene.获取更多详细信息的途径投资者及证券持有人可通过美国证券交易委员会（SEC）官方网站http://www.sec.gov免费获取Ikena公司提交的《注册说明书》《股东委托投票书》及其他SEC备案文件副本。Ikena向SEC提交的文件副本亦可免费通过以下方式获取：访问公司官网www.ikenaoncology.com，或联系投资者关系部邮箱rcohen@ikenaoncology.com。更多信息，请联系：创响生物Anna Vardanyan, MD, PhDSenior Vice President, Business and Corporate Developmentpublic.relations@inmagenebio.com 投资者关系:Bruce MackleLifeSci Advisors, LLCbmackle@lifesciadvisors.com

使用IMG-007治疗4周后，患者湿疹面积和严重程度评分（EASI）较基线下降77%，并且54%的患者达到EASI-75的改善标准 观察到在24周内，炎性标志物得到了持久的抑制 IMG-007皮下注射给药（SC）剂型半衰期长达约35天 IMG-007总体耐受性良好，未出现发热或寒颤等不良反应 IMG-007能够阻断OX40-OX40L信号转导，但不引起T细胞耗竭，并且具有较长的半衰期，突显了其差异化的临床特征及其潜在的便捷给药优势 预计将在2025年第一季度启动IMG-007 SC在中重度特应性皮炎（AD）患者中的Phase 2b剂量发现研究 圣地亚哥，加利福尼亚， 2025年1月10日 – 创响生物（Inmagene Biopharmaceuticals, 下简称“创响”），一家处于临床阶段，专注于自身免疫和炎症疾病（I&I）领域创新和差异化治疗的创新药研发公司，今天宣布IMG-007在中重度AD患者中的临床2a期研究取得了更多积极顶线结果，同时IMG-007 SC的1期临床研究也取得了研究结果。  王健博士  创响创始人、董事长兼CEO “IMG-007是全球唯一处于临床阶段、能在血液和组织中特异性地阻断OX40-OX40L信号传导，同时不清除T细胞的单克隆抗体。IMG-007 的长半衰期与抗OX40/OX40L的研究性单克隆抗体类分子共同表现出的持久疗效相结合，将会让在AD 和其他潜在适应症的维持治疗阶段探索更长的给药间隔（例如每24周一次）成为可能。” IMG-007 为非耗竭性抗OX40单克隆抗体，通过生物工程改造，消除了抗体依赖的细胞介导的细胞毒性（ADCC）效应，从而降低了潜在的安全性风险。同时，该改造延长了抗体的半衰期，可能有助于减少给药频率。该项2a期开放临床研究（NCT05984784）共纳入来自美国和加拿大的13例患者，评估IMG-007静脉注射（IV）给药在成人中重度AD患者中的安全性、药代动力学（PK）和有效性。与2024年5月发布的中期分析结果相似，在研究的第0、2、4周共三次给药，观察到EASI及其他终点指标均表现出显著且持久的临床疗效。 在给药后第16周，EASI评分较基线平均下降了77%，并且54%的患者达到了EASI-75的改善标准。该疗效表现与其他靶向OX40/OX40L的研究性单克隆抗体在较长治疗周期（至少16周）中的疗效相当。此外，研究中还观察到IMG-007对多种辅助性 T 细胞 （包括 Th1、Th2 和 Th17 细胞） 的血清炎症标志物有持续时间长达 24 周的抑制作用。IMG-007 的总体耐受性良好，未报告严重不良事件 （SAE），无导致停药的不良事件 （AE），且未观察到研究药物相关的 AE。研究中也未有关于发热或寒颤的报告。 此外，创响还开展了一项评估IMG-007皮下注射制剂在16名健康受试者中的安全性和PK特征的1期临床研究（NCT06304740）。研究结果表明，IMG-007 SC的药代动力学特征总体上与静脉注射剂型相似。在预期有效剂量下，18周的随访周期内，血清中药物浓度始终保持在足以阻断OX40/OX40L信号传导所需的水平以上。IMG-007单次皮下注射的平均消除半衰期为34.7天，显著长于其他处于临床开发阶段的OX40/OX40L单克隆抗体。研究还表明，IMG-007 SC具有良好的耐受性和安全性。最常见的不良事件为注射部位反应（ISRs），如注射部位发红、疼痛和瘙痒，且其发生率在安慰剂组（75%）中高于IMG-007组（25%）。所有报告的注射部位反应均为轻度。 创响预计在2025年第一季度，启动在IMG-007皮下注射剂在中重度AD患者中的Phase 2b剂量发现研究。  陆雨芳博士  创响首席医学官 “IMG-007 在 AD 患者中的 2a 期临床研究得到了令人振奋的积极顶线结果。在仅仅 4 周给药后，观察到显著的临床疗效与生物标志物数据以及良好的安全数据，表明消除ADCC活性的 IMG-007不仅保留了预期的阻断 OX40的生物活性，同时提高了耐受性。AD 是一种需要长期治疗的慢性复发性疾病，目前批准的生物制剂通常需要每 2 或 4 周频繁注射。IMG-007 的皮下注射制剂具有较长的半衰期，同时耐受性良好，这可能为 AD 的长期治疗提供一种差异化的给药方案。” 关于创响生物 创响生物是一家全球领先的临床阶段生物技术公司，专注于自身免疫及炎症疾病（I&I）领域的新药研发。公司拥有一条高度差异化的临床管线，其中多个候选药物展现出同类最佳的潜力。其先导化合物IMG-007是一种非耗竭性抗OX40单克隆抗体，目前正处于2期临床研究阶段。另一重要候选药物IMG-004是一种非共价、可逆的BTK抑制剂，具备超长的半衰期及显著的药效学作用，展示出每日一次给药的潜力，已准备进入2期临床研究。更多信息，请访问www.inmagenebio.com. 关于IMG-007 IMG-007为人源化抗OX40单克隆抗体，消除了ADCC效应，同时具有较长的半衰期。OX40与OX40L信号通路在多种自身免疫和炎症性疾病的发病机制中起着关键作用。非临床研究表明，IMG-007能够有效阻断OX40-OX40L信号通路。其皮下注射制剂的半衰期为34.7天，表明它具有支持开发更具竞争力的给药方案的潜力。目前，IMG-007正在进行二期临床研究。该药物最初由HUTCHMED公司发现。 前瞻性声明 本新闻稿包含前瞻性陈述。虽然创响认为这些预测是基于合理的假设，但这些前瞻性陈述可能会受到多种风险和不确定因素的影响，实际结果可能与此类前瞻性陈述中的预期存在重大差异。 Forward-Looking Statements This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential benefits of IMG-007, including its potential to provide a differentiated clinical profile and convenient dosing regimens, its ADCC function potentially improving IMG-007’s tolerability profile and retaining desired biological activity of OX40 blockage and its prolonged half-life enabling potentially less frequent dosing regimen; the planned Phase 2b dose-finding study with IMG-007’s SC formulation in patients with moderate to severe AD and the timing thereof; the Company’s plans to explore the potential for long dosing intervals for IMG-007 for maintenance therapy in AD and other potential indications; the Company’s highly differentiated clinical-stage pipeline having multiple candidates with best-in-class potential; and IMG-004 being ready for Phase 2 development. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: preliminary results may not be indicative of results that may be observed in the future; the timing and success of clinical trials and potential safety and other complications thereof; there have been no head-to-head trials conducted comparing IMG-007 to other investigational OX40/OX40L-targeting mAbs with longer duration of treatments; the uncertainties associated with the Company’s platform technologies, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed; risks related to the inability of the Company to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs, including additional capital from the proposed merger with Ikena Oncology, Inc. (Ikena) and the concurrent private placement; the risk that the conditions to closing of the proposed merger and concurrent private placement are not satisfied and other risks related to the timing, approvals, consummation and anticipated benefits of the proposed merger.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Inmagene expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. 更多信息，请联系： 创响生物 Anna Vardanyan, MD, PhD Senior Vice President, Business and Corporate Development public.relations@inmagenebio.com 投资者关系: Bruce Mackle LifeSci Advisors, LLC bmackle@lifesciadvisors.com

IMG-007, the only clinical-stage nondepleting anti-OX40 monoclonal antibody (mAb), is being evaluated in adult patients with alopecia areata (AA) and atopic dermatitis (AD). The enrollment of the Phase 2a study in AA patients has been completed. Topline results are anticipated in Q4 2024. May 07, 2024 -- Inmagene Biopharmaceuticals (“Inmagene” or the “Company”), a clinical-stage biotechnology company developing innovative and differentiated therapies for immunological and inflammatory diseases, today announced that the Company completed target enrollment in its Phase 2a trial evaluating IMG-007 in adult patients with AA. IMG-007 is a nondepleting anti-OX40 mAb engineered to have a silenced ADCC function to minimize safety risk and a prolonged half-life to enable once every 12 weeks (Q12W) dosing. The Phase 2a open label trial (NCT06060977) enrolled 29 AA patients with 50% or greater scalp hair loss from 11 sites in the U.S. and Canada. Eligible patients were to receive three intravenous infusions of 300 mg or 600 mg IMG-007 over 4 weeks (Week 0, 2 and 4) and to be followed up for 24 weeks. Key study endpoints include safety and efficacy as measured by the severity of alopecia tool (SALT) score. “Emerging evidence supports an important role of OX40-OX40L signaling pathway in AA pathogenesis. IMG-007 is the first OX40/OX40L antagonist being evaluated in a clinical trial in AA patients,” said Yufang Lu, MD, PhD, Chief Medical Officer of Inmagene. “This trial will not only evaluate IMG-007’s efficacy in AA, but also include robust biomarker analysis to help us better understand how OX40 inhibition may alter disease patholophysiology and its relationship to clinical outcomes in AA patients.” Inmagene is a global clinical-stage biotechnology company developing novel therapeutics for immunological and inflammatory (I&I) diseases. The company’s highly differentiated clinical-stage pipeline has multiple candidates with best-in-class potential. The lead asset IMG-007, a nondepleting anti-OX40 mAb, is in two global Phase 2a clinical trials in atopic dermatitis (AD) and alopecia areata (AA). IMG-004, a non-covalent reversible BTK inhibitor with an extended half-life and pharmacodynamic effect, enabling its potential for once-daily dosing, is completing a Phase 1 multiple-dose study. IMG-008, a long-acting anti-IL-36R mAb is entering global Phase 1 clinical development. IMG-007 is a humanized anti-OX40 IgG1 mAb, with a silenced ADCC function and an extended half-life. The OX40-OX40L axis is important in T cell activation, expansion, and survival, thereby having an important role in the pathogenesis of a spectrum of I&I diseases. In nonclinical studies, IMG-007 potently blocked the signaling between OX40 and OX40L. Phase 1 single dose study demonstrated a 31-day half-life at anticipated therapeutic dose levels, enabling the potential for once every 12 weeks (Q12W) dosing, and a favorable safety profile, without any reports of pyrexia or chills. IMG-007 is being evaluated for the treatment of moderate-to-severe atopic dermatitis and alopecia areata in two Phase 2a studies. The content above comes from the network. if any infringement, please contact us to modify.