Inmagene Receives IND Clearance from FDA for OX40 Antagonist
Posted on Sunday 01 May 2022 17:29
SAN DIEGO, CA, USA and SHANGHAI, China and SYDNEY, Australia I April 30, 2022 I Inmagene Biopharmaceuticals (“Inmagene”) announces that the U.S. Food and Drug Administration (FDA) has cleared drug candidate IMG-007, a monoclonal antibody directed against OX40, to enter Phase I clinical development. Inmagene is developing IMG-007 in partnership with HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13).
IMG-007 is very potent in blocking the binding of OX40 to OX40L, thereby reducing OX40L-dependent downstream signaling and cytokine release from T cells. It has the potential to treat T cell-mediated immune diseases OX40+, including atopic dermatitis (AD).
The planned Phase 1 study is a double-blind, randomized, placebo-controlled, dose-escalation study in healthy adult subjects and patients with Alzheimer’s disease. The study will be used to explore the safety and tolerability of IMG-007 in healthy subjects, as well as its efficacy and safety in patients with AD.
In Australia, this phase 1 study has also received Human Research Ethics Committee (HREC) approval and recognition from the Therapeutic Goods Administration (TGA) clinical trial benchmark.
“The research data has given us confidence that IMG-007 is one of the most potent OX40 drug candidates in the world,” said Dr. Jonathan Wang, Chief Executive Officer of Inmagene. “Inmagene is advancing many innovative drug candidates like IMG-007 from the discovery or candidate stage to global clinical studies.
Dr. Jean-Louis Saillot, Chief Development Officer of Inmagene, said: “Antagonism of the OX40/OX40L interaction by monoclonal antibodies has been shown to be effective in phase 2 clinical trials, which highlights the importance of targeting this axis as a promising approach. for the treatment of immune disorders, including Alzheimer’s disease. IMG-007 has demonstrated first-rate potential in preclinical studies. We look forward to the launch of the IMG-007 clinical program in hopes of developing an innovative, safe and effective solution. treatment option for patients with AD and other immunological diseases.”
IMG-007 is a novel antagonistic monoclonal antibody targeting the OX40 receptor. It was originally discovered by HUTCHMED, with Inmagene taking responsibility for candidate-stage development. Inmagene has an exclusive option to license the worldwide rights to IMG-007.
OX40 is a costimulatory receptor member of the NGFR/TNFR superfamily expressed primarily on activated T cells. Ligation of OX40 by its ligand OX40L leads to improved survival, proliferation and effector functions of T cells. Preclinical research results show that IMG-007 can bind to the human OX40 receptor with a high affinity, thus effectively blocking the binding of OX40 to OX40L. This blockade can effectively reduce OX40L-dependent downstream signaling and cytokine release from T cells. By selectively shutting down OX40+ T cell function, IMG-007 may potentially provide a treatment option for immune-mediated diseases by pathological OX40+ T lymphocytes, such as atopic dermatitis.
Inmagene is a global clinical-stage biotechnology company focused on developing novel therapies for immunology-related diseases. The company is building a strong development pipeline of 19 drug candidates.
The most advanced compound in Inmagene’s pipeline is IMG-020, or izokibep. It has several ongoing global phase II studies for the treatment of autoimmune diseases, including psoriatic arthritis, ankylosing spondylitis, uveitis, and more. IMG-020 also received IND approval from the CDE for Phase III in plaque psoriasis. Additionally, IMG-004 and IMG-007 will initiate Phase I studies globally in the coming months.
Believing in “innovation without borders”, the Inmagene team strives to integrate effective resources around the world to make these therapies accessible to patients around the world. Based on its proprietary QuadraTek™ drug discovery platform, Inmagene operates 12 “Smart Innovation” programs to create and develop new drug candidates with worldwide rights. Inmagene also licenses drug candidates and, together with its partners, conducts development activities on a global scale, including multicenter clinical trials on a global scale. Inmagene has forged strategic partnerships with multiple partners, such as HUTCHMED and Affibody AB, to develop highly innovative drug candidates. For more information, visit: www.inmagenebio.com
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage biopharmaceutical company. It is engaged in the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,600 people across its companies, at the center of which is a team of around 1,500 people in oncology/immunology. Since its inception, the company has advanced 12 cancer drug candidates from in-house discovery to clinical studies worldwide, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch-med.com.
THE SOURCE: Inmagene Biopharmaceuticals