Full Press Release Details
Inmagene Doses First Patient in the ADAPTIVE Phase 2b Trial of IMG-007, a
Nondepleting Anti-OX40 mAb with an Extended Half-life, in Patients with Moderate-to-Severe Atopic Dermatitis
San Diego, CA, July 1, 2025 - Inmagene Biopharmaceuticals ( Inmagene ), a clinical-stage biotechnology company dedicated to developing
innovative and differentiated therapies for immunological and inflammatory diseases, today announced the successful dosing of the first patient in its global multicenter Phase 2b dose-finding study (ADAPTIVE Trial, NCT07037901) of IMG-007 in patients with moderate-to-severe atopic dermatitis (AD).
We are thrilled to have the first patient dosed in this trial, building on the encouraging clinical data observed earlier, said Jonathan Wang,
PhD, Founder, Chairman, and Chief Executive Officer of Inmagene. IMG-007 targets the OX40 receptor, blocking OX40 OX40L signaling in both the bloodstream and tissues, while its silenced
antibody-dependent cell-mediated cytotoxicity function abolishes T-cell depleting effect, thereby potentially minimizing safety risks. In addition, its extended half-life supports the potential for convenient
dosing. Together, these attributes make IMG-007 a potentially differentiated therapeutic candidate for AD patients.
ADAPTIVE is a randomized, double-blind, placebo-controlled Phase 2b trial designed to evaluate the efficacy and safety of several subcutaneous dose regimens
of IMG-007 in adult participants with active moderate-to-severe AD who have had inadequate response to and/or intolerance of
topical AD therapies. The trial aims to enroll approximately 220 patients across four treatment arms (high, medium, low dose of IMG-007 and placebo) in a 1:1:1:1 ratio.
The trial consists of two distinct treatment periods:
The primary endpoint of
the study is mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 20. Key secondary endpoints include mean percentage change from baseline in EASI score at Week 16, as well as proportion of patients achieving EASI-75 ( 75% improvement in EASI score) and Investigator s Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at Week 16 and 20, respectively.
Topline results from the Phase 2b ADAPTIVE trial are expected in the fourth quarter of 2026. This dose-finding study is designed to generate data that will
guide the design and selection of optimal dosing regimens for future Phase 3 clinical trials.
IMG-007 is a humanized, subcutaneously administered, non-depleting
IgG1 monoclonal antibody targeting OX40. It features a silenced antibody-dependent cell-mediated cytotoxicity function and an extended half-life. The OX40 OX40L signaling plays a key role in T cell activation, expansion, and survival, making it
an attractive target for the treatment of
immunological and inflammatory diseases. In nonclinical studies,
IMG-007 demonstrated potent inhibition of OX40 OX40L signaling. Its subcutaneous formulation has shown a half-life of 34.7 days at the anticipated therapeutic dose level, supporting the potential for
infrequent and convenient dosing. In a Phase 2a trial in patients with moderate-to-severe atopic dermatitis, IMG-007 exhibited
sustained clinical activity and was well tolerated, with no reported cases of pyrexia or chills. IMG-007 was originally discovered by HUTCHMED.
About Inmagene Biopharmaceuticals
Inmagene is a global
clinical-stage biotechnology company dedicated to developing innovative therapeutics for immunological and inflammatory diseases. The company s lead asset, IMG-007, is currently in Phase 2 development for
the treatment of moderate-to-severe atopic dermatitis and alopecia areata. Inmagene s pipeline also includes IMG-004, a non-covalent, reversible oral BTK inhibitor characterized by an extended half-life and sustained pharmacodynamic effect, supporting the potential for once-daily dosing.
IMG-004 is ready to advance into Phase 2 clinical development. For more information, please visit www.inmagenebio.com.
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materials with the Securities and Exchange Commission ( SEC ), including the Registration Statement on Form S-4 (File No. 333-285881) (the
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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
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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
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For further information, please contact:
Anna Vardanyan, MD, PhD
Senior Vice President of Corporate and Business Development
LifeSci Advisors, LLC