Filed by Ikena Oncology, Inc.
pursuant to Rule 425 under the Securities Act of 1933
and deemed filed pursuant to Rule 14a-12
under the Securities Exchange Act of 1934
Subject Company: Ikena Oncology, Inc.
Commission File No.: 001-40287
Date: January 10, 2025
Inmagene Reports Positive Topline Results of IMG-007, a Nondepleting
Anti-OX40 Monoclonal Antibody with an Extended Half-life, for the Treatment of Atopic Dermatitis
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A 4-week treatment with
IMG-007 resulted in a mean reduction in eczema area and severity index (EASI) of 77% and EASI-75 response of 54%, at week 16 |
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Durable inhibition of inflammatory markers was observed for up to 24 weeks |
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IMG-007s subcutaneous (SC) formulation demonstrated an extended
half-life of approximately 35 days |
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IMG-007 was overall well-tolerated with no reports of pyrexia or
chills |
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IMG-007s ability to block OX40/OX40L signaling without depleting
T cells, coupled with an extended half-life, underscores its potential for a differentiated clinical profile and convenient dosing regimens |
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Initiation of a Phase 2b dose-finding study with IMG-007s SC
formulation in patients with moderate-to-severe atopic dermatitis (AD) is planned for Q1 2025 |
San Diego, CA, January 9, 2025 Inmagene Biopharmaceuticals (Inmagene or the Company), a clinical-stage biotechnology
company developing innovative and differentiated therapies for immunological and inflammatory (I&I) diseases, today reports additional positive topline results from the Phase 2a trial of IMG-007 in
patients with moderate-to-severe AD, along with the results of a Phase 1 trial of IMG-007s SC formulation.
IMG-007 is the only clinical-stage monoclonal antibody which specifically blocks OX40/OX40L signaling in both
blood and tissues without depleting T cells, said Jonathan Wang, founder, Chairman and CEO of Inmagene, IMG-007s extended half-life combined with the sustained efficacy demonstrated will
enable us to explore long dosing intervals, such as every 24 weeks, for maintenance therapy in AD and other potential indications.
IMG-007 is a nondepleting anti-OX40 monoclonal antibody (mAb) engineered to have a silenced antibody-dependent cellular cytotoxicity (ADCC) function to minimize potential safety risks, and a prolonged half-life to
enable potentially less frequent dosing regimens. The Phase 2a open-label trial (NCT05984784) of 13 patients across centers in the U.S. and Canada evaluated the safety, pharmacokinetics (PK) and efficacy of intravenous
(IV) IMG-007 in adult patients with moderate-to-severe AD. Similar to the interim results reported in May 2024,
administration of three doses of IMG-007 at Week 0, 2, and 4 resulted in marked and durable clinical activity as assessed by EASI and other outcome measures.
After 4 weeks of treatment with IMG-007, the mean percent change of EASI and the
EASI-75 response at Week 16 were 77% and 54%, respectively, which are within the range shown by other investigational OX40/OX40L-targeting mAbs with longer duration (at least 16 weeks) of treatments. In
addition, durable inhibition of serum inflammatory markers of diverse T helper (Th) cells, including Th1, Th2 and Th17 cells, was observed for up to 24 weeks. IMG-007 was generally well-tolerated, with no
serious adverse events (SAEs), no adverse events (AEs) leading to treatment discontinuation, and no treatment-related AEs. There were no reports of pyrexia or chills.