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Business Upturn
4 days ago
- Business
- Business Upturn
ImmunAbs Announces FDA Phase 2 IND Approval of IM-101, a Novel Complement C5 Inhibitor, for Treatment of Myasthenia Gravis
By Business Wire Published on June 2, 2025, 17:07 IST Seoul, South Korea: ImmunAbs Inc., a clinical-stage biotech specializing in developing antibody therapeutics, today announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial evaluating the safety and efficacy of IM-101, a novel complement C5 inhibitor, for the treatment of Myasthenia Gravis. The forthcoming multicenter, randomized, double-blind, placebo-controlled study will enroll up to 90 patients to evaluate the effectiveness and safety of monthly IM-101 dosing in relieving complement-induced symptoms in MG. 'This IND approval is pivotal for us as it brings us one step closer to delivering a transformative therapy for patients with autoimmune disorders', said Dr. Dongjo Kim, the CEO of ImmunAbs, 'we believe IM-101 has the potential to deliver deeper therapeutic responses and more durable remissions in patients who have failed to achieve sustained remission with current approved treatment.' About Myasthenia Gravis Myasthenia Gravis (MG) is a rare neurological disorder that severely impairs muscle movement and can lead to life-threatening complications. While existing C5 inhibitors have contributed to improved remission rates, many patients still experience residual disease activity due to incomplete complement inhibition. In addition to autoantibody-mediated activation of the classical complement pathway, MG pathogenesis is also significantly influenced by activation of the alternative pathway. ImmunAbs believes that comprehensive inhibition of both the classical and alternative pathways is essential for minimizing residual complement activity and enabling revolutionary treatments for MG. About IM-101 IM-101 is a humanized monoclonal antibody targeting complement C5 with high affinity. In the recently concluded Phase 1 clinical trial, IM-101 demonstrated an excellent safety profile and was well tolerated at all tested doses, with no dose-limiting toxicity or severe adverse events observed. The clinical results showcasing IM-101's outstanding ability to reduce serum free C5 concentrations in healthy volunteers provide strong evidence of its superior efficacy in complement inhibition. About ImmunAbs ImmunAbs is a clinical-stage biotechnology company established in 2017. Committed to delivering transformative treatments globally, the company aims to develop novel antibody therapeutics, particularly concentrating its efforts on the lead program targeting severe autoimmune diseases. Supported by equity funding and national grants from KDDF, which covered development from non-clinical through Phase 1 clinical studies, ImmunAbs is now seeking global partnerships to accelerate the advancement of IM-101 towards market availability. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Business Wire is an American company that disseminates full-text press releases from thousands of companies and organizations worldwide to news media, financial markets, disclosure systems, investors, information web sites, databases, bloggers, social networks and other audiences.
National Post
4 days ago
- Business
- National Post
ImmunAbs Announces FDA Phase 2 IND Approval of IM-101, a Novel Complement C5 Inhibitor, for Treatment of Myasthenia Gravis
Article content SEOUL, South Korea — ImmunAbs Inc., a clinical-stage biotech specializing in developing antibody therapeutics, today announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial evaluating the safety and efficacy of IM-101, a novel complement C5 inhibitor, for the treatment of Myasthenia Gravis. Article content Article content The forthcoming multicenter, randomized, double-blind, placebo-controlled study will enroll up to 90 patients to evaluate the effectiveness and safety of monthly IM-101 dosing in relieving complement-induced symptoms in MG. Article content 'This IND approval is pivotal for us as it brings us one step closer to delivering a transformative therapy for patients with autoimmune disorders', said Dr. Dongjo Kim, the CEO of ImmunAbs, 'we believe IM-101 has the potential to deliver deeper therapeutic responses and more durable remissions in patients who have failed to achieve sustained remission with current approved treatment.' Article content About Myasthenia Gravis Article content Myasthenia Gravis (MG) is a rare neurological disorder that severely impairs muscle movement and can lead to life-threatening complications. While existing C5 inhibitors have contributed to improved remission rates, many patients still experience residual disease activity due to incomplete complement inhibition. In addition to autoantibody-mediated activation of the classical complement pathway, MG pathogenesis is also significantly influenced by activation of the alternative pathway. ImmunAbs believes that comprehensive inhibition of both the classical and alternative pathways is essential for minimizing residual complement activity and enabling revolutionary treatments for MG. Article content About IM-101 Article content IM-101 is a humanized monoclonal antibody targeting complement C5 with high affinity. In the recently concluded Phase 1 clinical trial, IM-101 demonstrated an excellent safety profile and was well tolerated at all tested doses, with no dose-limiting toxicity or severe adverse events observed. The clinical results showcasing IM-101's outstanding ability to reduce serum free C5 concentrations in healthy volunteers provide strong evidence of its superior efficacy in complement inhibition. Article content ImmunAbs is a clinical-stage biotechnology company established in 2017. Committed to delivering transformative treatments globally, the company aims to develop novel antibody therapeutics, particularly concentrating its efforts on the lead program targeting severe autoimmune diseases. Supported by equity funding and national grants from KDDF, which covered development from non-clinical through Phase 1 clinical studies, ImmunAbs is now seeking global partnerships to accelerate the advancement of IM-101 towards market availability. Article content Article content Article content Article content Article content Article content
Business Wire
4 days ago
- Business
- Business Wire
ImmunAbs Announces FDA Phase 2 IND Approval of IM-101, a Novel Complement C5 Inhibitor, for Treatment of Myasthenia Gravis
SEOUL, South Korea--(BUSINESS WIRE)--ImmunAbs Inc., a clinical-stage biotech specializing in developing antibody therapeutics, today announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial evaluating the safety and efficacy of IM-101, a novel complement C5 inhibitor, for the treatment of Myasthenia Gravis. The forthcoming multicenter, randomized, double-blind, placebo-controlled study will enroll up to 90 patients to evaluate the effectiveness and safety of monthly IM-101 dosing in relieving complement-induced symptoms in MG. 'This IND approval is pivotal for us as it brings us one step closer to delivering a transformative therapy for patients with autoimmune disorders', said Dr. Dongjo Kim, the CEO of ImmunAbs, 'we believe IM-101 has the potential to deliver deeper therapeutic responses and more durable remissions in patients who have failed to achieve sustained remission with current approved treatment.' About Myasthenia Gravis Myasthenia Gravis (MG) is a rare neurological disorder that severely impairs muscle movement and can lead to life-threatening complications. While existing C5 inhibitors have contributed to improved remission rates, many patients still experience residual disease activity due to incomplete complement inhibition. In addition to autoantibody-mediated activation of the classical complement pathway, MG pathogenesis is also significantly influenced by activation of the alternative pathway. ImmunAbs believes that comprehensive inhibition of both the classical and alternative pathways is essential for minimizing residual complement activity and enabling revolutionary treatments for MG. About IM-101 IM-101 is a humanized monoclonal antibody targeting complement C5 with high affinity. In the recently concluded Phase 1 clinical trial, IM-101 demonstrated an excellent safety profile and was well tolerated at all tested doses, with no dose-limiting toxicity or severe adverse events observed. The clinical results showcasing IM-101's outstanding ability to reduce serum free C5 concentrations in healthy volunteers provide strong evidence of its superior efficacy in complement inhibition. About ImmunAbs ImmunAbs is a clinical-stage biotechnology company established in 2017. Committed to delivering transformative treatments globally, the company aims to develop novel antibody therapeutics, particularly concentrating its efforts on the lead program targeting severe autoimmune diseases. Supported by equity funding and national grants from KDDF, which covered development from non-clinical through Phase 1 clinical studies, ImmunAbs is now seeking global partnerships to accelerate the advancement of IM-101 towards market availability.
