IMG-007

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