SparX Biopharmaceutical Announces FDA Greenlight for IND Application of SPX-303, A First-In-Human anti-LILRB2/PD-L1 Antibody Drug

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Oct 30, 2023, 11:00 ET

CHICAGO, Oct. 30, 2023 /PRNewswire/ -- Signifying a monumental step forward in the domain of powered antibody therapies, SparX Biopharmaceutical Corp. proudly announces that its Investigational New Drug (IND) application for SPX-303, a First-in-Class anti-LILRB2/PD-L1 bispecific antibody drug candidate, has been greenlighted by the U.S. Food and Drug Administration (FDA). This approval propels SparX's enduring commitment to deliver groundbreaking solutions to patients grappling with advanced or refractory solid tumors.

Dr. Gui-Dong Zhu, Chief Executive Officer of SparX Biopharmaceutical, shared his exhilaration: "Receiving the FDA's green light on our IND application is a seminal moment in our ongoing journey to redefine the paradigms of cancer treatment. The preclinical data for SPX-303 not only showcases promise but facilitate out confidence to harness its therapeutic prowess in a clinical setting, particularly for patients who previously had limited treatment options."

With this FDA endorsement, SparX Biopharmaceutical is primed to launch a Phase 1 clinical study, aiming to assess the safety, tolerability, and preliminary efficacy of SPX-303 in patients beleaguered by advanced or refractory solid tumors. This human trial is geared to evaluate the therapeutic potential of SPX-303, potentially heralding a new dawn of innovative and superior healthcare outcomes.

Developed by SparX, SPX-303 is a First-in-Its Class bispecific antibody therapy, ingeniously engineered to engage two cardinal immune checkpoint proteins, LILRB2 and PD-L1, simultaneously. Acting as pivotal fulcrums in sustaining the immune system's equilibrium and vigor, these checkpoints help deter autoimmune anomalies. While LILRB2 majorly tempers overactive innate immune reactions, preserving the body's natural defense harmony, PD-L1—often overexpressed in tumor cells—judiciously modulates T cell activation, curating a precise immune response. Yet, cancers often manipulate these immune-checkpoints, equipping themselves with a defense mechanism against immune retaliation. SPX-303 is meticulously designed to dismantle this barrier, empowering the immune system to discern and fervently annihilate malignant cells, thereby charting a transformative trajectory in cancer therapy.

About SparX Biopharmaceutical:

A research-driven, development-stage biopharmaceutical trailblazer, SparX Biopharmaceutical Corp. has a mission of "amplifying human immunity with groundbreaking antibody therapies." Through the utilization of big data analytics, including machine learning, SparX decrypts potential interactions within the vast complexity of biological information. With meticulous pharmacological analyses, backed by in vitro and in vivo evaluations using advanced mouse models, SparX is on a relentless quest to develop unparalleled or superior therapeutics. SparX's robust target discovery platform, combined with the multifaceted SAILING™ antibody optimization system and groundbreaking bi-ADC technology, is poised to redefine the success metrics of empowered antibody drug development. Equipped with in-house cGMP facilities, SparX is on track to become a self-sustaining, fully integrated biopharmaceutical entity.

SOURCE SparX Group