On August 23, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that the first patient dosing in Australia for its proprietary PD-1/IL-2 bispecific antibody fusion protein (R&D code: IBI363) in Phase I clinical trial for the treatment of patients with advanced solid tumors or lymphomas (Press release, Innovent Biologics, AUG 23, 2022, View Source [SID1234618582]). It is first candidate drug to conduct clinical trial in Australia in Innovent’s pipeline.
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The study (NCT05290597) is an open-label, multi-center Phase I study evaluating the safety, tolerability, and preliminary efficacy of IBI363 in subjects with advanced solid tumors or lymphoma, and to determine the recommended Phase 2 dose (RP2D).
Interleukin 2 (IL-2), a cytokine secreted mainly by antigen-activated CD4 + T cells , is vital for maintaining CD4 + regulatory T cell (Treg) level, CD4 + T cell differentiation, and maintaining CD8 + T cell and natural killer cell activity. IL-2 was the first cytokine to be discovered and identified as playing a pivotal role in T-cell growth and expansion. Aldesleukin (IL-2) was approved by U.S. Food and Drug Administration for metastatic renal cell carcinoma and metastatic melanoma in the early 1990s, but it has not been widely used in clinic due to poor selectivity, narrow therapeutic window, and side effects.
IBI363, potential First-in-Class candidate drug, was independently developed by Innovent. Its active ingredient is PD-1/IL-2 bispecific antibody fusion protein. The IL-2 arm of IBI363 has been engineered to maximize efficacy and reduce toxicity, whereas the PD-1 binding arm achieves PD-1 blockade and selective IL-2 delivery. Therefore, IBI363 has both functions of simultaneously blocking PD-1/PD-L1 pathway and activating IL-2 pathway, allowing more precise and efficient targeting and activation of tumor specific T cells. IBI363 not only showed promising anti-tumor activity in a variety of tumor-bearing pharmacological models, but also exhibited prominent antitumor efficacy in PD-1 resistant and metastatic models; meanwhile, IBI363 demonstrated a good safety profile in preclinical in vivo models.
Dr. Morteza Aghmesheh, Southern Medical Day Care Centre Located in New South Wales, Australia, stated： "Wild type IL-2 is clinically validated as monotherapy, but limited by toxicity and low response rate due to poor selectivity. IBI363, a novel PD-1/IL-2 bispecific molecule, designed to selectively activates PD-1 positive T cells by cis-activating IL-2, but not PD-1 negative bystanders or naïve T cells, with the potential to significantly decrease toxicity related to IL-2 and potentially overcome immunotherapy resistance. We look forward to the positive results in the safety/tolerability and efficacy of IBI363 in the clinic."
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "Most patients will develop primary or secondary resistance after treatments of immune checkpoint inhibitors. At present, treatment options are limited upon progression after immunotherapy, and there is a huge unmet clinical needs. IBI363, developed by scientists at Innovent Academy, can enhance anti-tumor immune response by reversing T cell exhaustion, improving the efficacy of immune checkpoint inhibitors especially for patients with resistance to immunotherapy or "cold tumors", while minimizing IL -2 related side effects. We are pleased that the first patient dose of IBI363 has been completed in Australia. In parallel, the IND for IBI363 has been approved by NMPA in China. We are looking forward to the positive results of IBI363 in patients with advanced solid tumors or lymphoma. IBI363 is our first molecule to initiate clinical study in Australia, which marks a solid step of Innovent’s global innovation strategy. The company will also accelerate the development of more innovative molecules with high global potential, taking advantage of cross-regional R & D and clinical resources, adhering to the long-term development strategy of "driven by innovation, developed through globalization" with an aim to benefit cancer patients worldwide."
About IBI363
IBI363, potential First-in-Class candidate drug, was self-developed by Innovent. Its active ingredient is PD-1/IL-2 bispecific antibody fusion protein, which simultaneously blocks PD-1/PD-L1 pathway and activates IL-2 pathway to stimulate T cell activation and proliferation, thus killing tumor cells and inhibiting tumor growth. Currently, Phase 1 studies of IBI363 are conducted in China and Australia (NCT05460767, NCT05290597) to assess the safety, tolerability, and preliminary efficacy of IBI363 in subjects with advanced solid tumors or lymphoma, and to determine the recommended Phase 2 dose (RP2D).