Innovent Biologics, Inc.a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its PD-1/IL-2α-bias Bispecific Antibody Fusion Protein (R&D code: IBI363), for the treatment of unresectable locally advanced or metastatic melanoma (except choroidal melanoma) who progressed on or after at least one line of systemic therapy, which must include a PD-1/L1 inhibitor. Currently, Phase 1/2 clinical studies are conducting in China, the United States and Australia to explore the efficacy and safety of IBI363 in various advanced malignant tumors.

At the ESMO Plenary meeting on June 14, 2024, Innovent reported promising efficacy signals observed in melanoma patients who had previously received immunotherapy: 37 patients with melanoma who had previously received immunotherapy received 1mg/kg of IBI363 and underwent at least one tumor evaluation after baseline, and 11 patients achieved objective responses, including 1 CR and 10 PR, with ORR and DCR of 29.7% and 73.0%, respectively.

Dr. Hui Zhou, Senior Vice President of Innovent, said, “Melanoma is the most common fatal skin cancer in Europe and the United States. In China, although melanoma is a rare malignant tumor, the case fatality rate is high, and the incidence is increasing year by year. Despite the success of immune checkpoint inhibitors in the treatment of melanoma, there is currently no drug approved for immunotherapy failed melanoma around the world, and the ORR of traditional chemotherapy ± anti-vascular therapy for immunotherapy failed melanoma is only 3.8% to 6.8%, with a median PFS of less than 3 months, and the benefit is very limited[1]-[2]. Therefore, there is an urgent clinical need for patients who have previously failed immunotherapy. As a First in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363 monotherapy has shown encouraging efficacy and a favorable safety profile in melanoma subjects who have previously received immunotherapy. We will continue to explore the efficacy and safety of IBI363 in melanoma to provide more effective clinical treatment for patients with immune-resistant melanoma.”

Fast Track Designation (FTD) is a rapid review process designed to facilitate the clinical development of a drug that may treat serious conditions and fulfill an unmet medical need. According to regulations, drug candidates that obtain FTD qualifications will have more opportunities to communicate with the FDA during subsequent drug development and review processes, which will help speed up the clinical development and approval of the drug.

IBI363 is a First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein independently developed by Innovent Biologics, which has two functions: blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 was modified to retain its affinity for IL-2Rα, but weakened its binding ability to IL-2Rβ and IL-2Rγ, thereby reducing toxicity. The PD-1 binding arm can simultaneously block PD-1 and selectively deliver IL-2. Since the newly activated tumor specific T cells express both PD-1 and IL-2α, this differential strategy allows for more precise and effective targeting and activation of this T cell subpopulation. IBI363 not only showed good antitumor activity in a variety of tumor-bearing pharmacological models, but also showed outstanding efficacy in PD-1 resistance and metastasis models. Starting from the urgent clinical needs, Innovent Biologics is conducting clinical studies in China, the United States and Australia to explore the efficacy and safety of IBI363 in advanced tumors.

 

Source: innoventbio.com

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