On October 25, 2023 SparX Biopharmaceutical reported its Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) for SPX-303, a First-in-Class anti-LILRB2/PD-L1 bispecific antibody drug candidate. This monumental step underscores SparX’s steadfast commitment to unveiling groundbreaking solutions for patients grappling with advanced or refractory solid tumors.
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Dr. Gui-Dong Zhu, Chief Executive Officer of SparX Biopharmaceutical, expressed his enthusiasm: "This IND submission marks a crucial juncture in our determined pursuit to revolutionize cancer treatment. The initial data for SPX-303 is not only promising but fortifies our resolve to materialize its therapeutic potential in a clinical milieu, especially for those patients constrained by limited treatment avenues."
Upon the greenlight from the agency, SparX Biopharmaceutical is poised to commence a Phase 1 clinical study, evaluating the safety, tolerability, and preliminary efficacy of SPX-303 in patients beleaguered by advanced or refractory solid tumors. This inaugural human trial stands as a critical endeavor in assessing the unprecedented therapeutic capacities of SPX-303, setting an era of innovative and enhanced healthcare solutions..
Developed by SparX, SPX-303 emerges as a novel bispecific antibody therapy, designed to concurrently engage two fundamental immune checkpoint proteins, LILRB2 and PD-L1. Both proteins are quintessential regulators in upholding the immune system’s homeostasis and robustness, forestalling autoimmune malfunctions. LILRB2 predominantly mitigates excessive innate immune responses, preserving the body’s inherent defensive balance, while PD-L1, frequently amplified in tumor cells, judiciously regulates T cell activation, ensuring a precise and restrained immune response. Cancer, with its deceptive mechanisms, often exploits these checkpoints, thereby gaining a defensive shield against immune attacks and proliferating unrestrained. SPX-303 is meticulously crafted to breach this shield, enabling the immune system to identify and robustly obliterate malignant cells, marking a new epoch in cancer therapy.
(Press release, Sparx Therapeutics, OCT 25, 2023, View Source [SID1234661037])