IMG-007

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

Treatment with three doses of 300 mg (Cohort 1) and 600 mg (Cohort 2) IMG-007 over four weeks resulted in a dose-related clinical activity of hair regrowth.Patients in Cohort 2 showed a sustained improvement in Severity of Alopecia Tool (SALT) score, which did not plateau by Week 36, approximately eight months after the last dose: The mean reduction in SALT score at Week 36 was 21.7% in patients with baseline SALT score of 50 to 100, and 30.1% in the subset of patients with baseline SALT score of 50 to <95A durable inhibition of inflammatory markers of T helper (Th)1, Th2 and CD8+ T cells were observed at Week 16, approximately three months after the last dose IMG-007 was overall well-tolerated with no reports of pyrexia or chills SAN DIEGO, April 24, 2025 (GLOBE NEWSWIRE) -- Inmagene Biopharmaceuticals (“Inmagene” or the “Company”), a clinical-stage biotechnology company focused on developing innovative and differentiated therapies for immunological and inflammatory (“I&I”) diseases, today reports topline results from the Phase 2a trial of IMG-007 in patients with severe alopecia areata (“AA”). “AA is an I&I disease with tremendous unmet needs, especially for drugs with more favorable safety profiles,” said Jonathan Wang, Ph.D., founder, Chairman and CEO of Inmagene. “The marked and durable clinical and pharmacodynamic activities observed in Cohort 2 after a 4-week treatment, combined with a well-tolerated profile, suggest that blocking the OX40-OX40L signaling may be a novel approach to the treatment of AA.” The Phase 2a trial (NCT06060977) was a multiple ascending dose study evaluating the safety, pharmacokinetics, and efficacy of IMG-007 in adult AA patients with 50% or greater scalp hair loss, measured by the SALT score. A total of 29 patients were enrolled from 11 centers in the U.S. and Canada, including 6 patients in Cohort 1 who received up to three intravenous (IV) doses of 300 mg over four weeks (Baseline, Week 2 and 4) and 23 patients in Cohort 2 who received up to three IV doses of 600 mg over four weeks. Patients were followed up to Week 24. Sixteen patients in Cohort 2 also participated in an optional extended follow-up period up to Week 36. Key disease characteristics at baseline included a mean duration of current AA episode of 3.0 years and a mean SALT score of 80.4. Nine of 29 (31%) enrolled patients had baseline SALT scores of 95 or greater. Scalp biopsy samples were collected at Baseline and Week 16 for the evaluation of inflammatory biomarkers. Key study endpoints included safety and percentage change from baseline in SALT score over time. The four-week treatment resulted in a dose-related clinical activity of hair regrowth. Patients in Cohort 1 did not show a meaningful reduction from baseline (a mean of 1.1%) in SALT score at Week 24. Patients in Cohort 2 showed a mean reduction from baseline in SALT score of 14.3% at Week 24 and 21.7% at Week 36, which did not plateau by Week 36, approximately eight months after the last dose. At Week 36, 25% of patients in Cohort 2 achieved 30% or greater reduction from baseline in SALT score. In Cohort 2, patients who had a baseline SALT score of 50 to less than 95 showed a greater degree of improvement compared to those in the overall group (Table 1). Table 1. Improvement in SALT score in patients in Cohort 2 who had baseline SALT score of 50 to less than 95 Week 24 (n=17)Week 36 (n=11)Mean % reduction from baseline in SALT score20.1%30.1%Proportion of patients achieving ≥ 30% reduction from baseline in SALT score11.8%36.4% At baseline, patients showed activations of inflammatory markers of Th1, Th2, and CD8+ T cells in the AA lesional scalp, compared to the non-lesional scalp. A four-week treatment with three doses of 600 mg IMG-007 resulted in a marked inhibition of inflammatory markers of Th1, Th2 and CD8+ T cells at Week 16, approximately three months after the last dose. IMG-007 was generally well-tolerated, with no serious adverse events (SAEs). All treatment-emergent adverse events (TEAEs) were mild or moderate in intensity. TEAEs which occurred in at least 2 patients in any treatment group were headache (4 [13.8%]), nasopharyngitis (3 [10.3%]), hypertension (2 [6.9%]), and streptococcal infection (2 [6.9%]). There were no reports of pyrexia or chills. “Alopecia areata is a common chronic I&I disease affecting up to 2% of the population, including children. Currently, oral JAK inhibitors are the only systemic treatment options, but they require daily dosing and carry serious safety warnings, thus requiring routine clinical and laboratory monitoring. Safe and effective biologic therapies are desirable for the long-term management of this devastating disease,” said Yufang Lu, M.D., Ph.D., Chief Medical Officer of Inmagene. “The promising results from Cohort 2 in this study suggest that IMG-007 could be a potential biologic therapy for the long-term treatment of patients with AA.” Data from this study will be presented at an upcoming scientific conference. About Inmagene Inmagene is a global clinical-stage biotechnology company focused on developing novel therapeutics for immunological and inflammatory (“I&I”) diseases. The company has multiple drug candidates with best-in-class potential. The lead asset IMG-007, a nondepleting anti-OX40 monoclonal antibody with extended half-life, is in Phase 2 development for moderate-to-severe atopic dermatitis (AD) and alopecia areata (AA). IMG-004, a non-covalent reversible oral BTK inhibitor with an extended half-life and pharmacodynamic effect, enabling once-daily dosing potential, is ready for Phase 2 development. For more information, please visit www.inmagenebio.com. About IMG-007 IMG-007 is a humanized, non-depleting, subcutaneous-enabled, anti-OX40 IgG1 mAb with a silenced antibody-dependent cell-mediated cytotoxicity (ADCC) function and an extended half-life. The OX40-OX40L axis is important in T cell activation, expansion, and survival, thereby playing 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. IMG-007’s SC formulation has demonstrated a half-life of 34.7 days which would support the potential for competitive dose regimens. In a Phase 2a study in patients with moderate-to-severe atopic dermatitis, IMG-007 demonstrated sustained clinical activity and a well-tolerated profile with no reports of pyrexia or chills. IMG-007 was originally discovered by HUTCHMED. Participants in the Solicitation This 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 Solicitation This 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 Statements This 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. Additional Information and Where to Find It Investors and security holders will be able to obtain free copies of the Registration Statement, the Proxy Statement and other documents filed by Ikena with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed by Ikena with the SEC will also be available free of charge on Ikena’s website at www.ikenaoncology.com, or by contacting Ikena’s Investor Relations at rcohen@ikenaoncology.com. For further information, please contact:Inmagene:Anna Vardanyan, MD, PhDSVP of Corporate and Business Developmentpublic.relations@inmagenebio.com Investor Relations:Bruce MackleLifeSci Advisors, LLCbmackle@lifesciadvisors.com