该ADAPTIVE 2b期临床研究的目的是在中重度特应性皮炎患者中评估IMG-007的不同给药方案

预计该研究的顶线结果将于2026年第四季度发布

圣地亚哥，加利福尼亚， 2025年7月2日 – 勤智资本已投企业创响生物（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在治疗中重度特应性皮炎（AD）患者中的2b期国际多中心、剂量探索研究（ADAPTIVE研究，临床试验登记号：NCT07037901）中成功实现首例患者给药。

 王健博士

 创响创始人、董事长兼CEO

“本次临床试验是基于前期研究中所获得的积极数据，我们对顺利完成首例患者给药感到鼓舞。IMG-007靶向OX40受体，在血液和组织中有效阻断OX40-OX40L信号通路，它消除了抗体依赖性的细胞介导的细胞毒效应（ADCC）以避免T细胞耗竭，从而降低潜在的安全性风险。它具有长半衰期，可支持更灵活的患者给药方案。这些独特的优势，使得IMG-007有望成为一种高度差异化且前景广阔的特应性皮炎治疗药物。”

ADAPTIVE研究是一项随机、双盲、安慰剂对照的2b期临床试验，旨在评估IMG-007的多种皮下注射给药方案在外用药物疗效不佳或无法耐受的、正在病程中的中重度AD患者中的有效性和安全性。本研究计划入组220例患者，按照1：1：1：1的比例随机分配至4个治疗组（IMG-007高剂量、中剂量、低剂量和安慰剂组）。

·   第一阶段：为期20周的随机双盲、安慰剂对照治疗期

·   第二阶段：为期32周的双盲、活性药治疗期。在该治疗期内，所有患者，包括此前随机分配至安慰剂组的患者，均接受活性药治疗

本研究的主要终点指标为第20周，湿疹面积和严重程度指数评分（EASI）较基线变化的平均百分比。关键的次要终点包括：第16周，EASI较基线变化的平均百分比和达到EASI-75缓解标准（即EASI评分改善≥75%）的患者比例；以及在16周和20周，研究者整体评分（IGA）为0或1分（完全清除或几乎清除）的患者比例。

预计该2b期ADAPTIVE临床试验的顶线结果将于2026年第四季度公布。该项剂量探索研究致力于获得临床数据，为后续3期临床研究中最佳给药方案设计和选择提供科学依据。

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目前处于2期临床研发阶段，用于治疗中重度特应性皮炎和斑秃。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持久的药效学作用，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-007

IMG-007是一种人源化抗OX40单克隆抗体，采用皮下注射给药方式，它消除了抗体依赖性的细胞介导的细胞毒效应，同时具有较长的半衰期。OX40-OX40L信号通路在T细胞活化、增殖和存活中发挥关键作用，使其成为治疗自身免疫性和炎症性疾病的潜力靶点。非临床研究证实，IMG-007能够高效阻断OX40-OX40L信号通路。其皮下注射制剂的半衰期为34.7天，能够支持开发更具竞争力的给药方案。在一项针对中重度特应性皮炎的2a期临床试验中，IMG-007展现出持久的临床疗效和良好的安全性特征，且未报告发热或寒颤等不良反应。该药物最初由HUTCHMED公司发现。

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, and declared effective on June 11, 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 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 the Registration Statement, 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; Inmagene’s ongoing clinical trial, including expected enrollment and timing for data readouts and the potential to generate critical data for the design and optimal dosing regimens for a Phase 3 trial; and the potential benefits of IMG-007, including to minimize safety risks and offer convenient dosing and as a differentiated and promising therapeutic candidate for AD patients. 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, 2024, 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.

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