SparX Therapeutics, Inc.

CHICAGO, April 11, 2024 /PRNewswire/ -- Signifying a monumental step forward in the domain of powered antibody therapies, SparX is thrilled to announce that the first patient has been successfully dosed with SPX-303, a First-in-Class anti-LILRB2/PD-L1 bispecific antibody drug candidate, reaching a significant milestone in the fight against cancer. This innovative treatment, developed by SparX Group, is currently undergoing clinical trials at the HonorHealth Research Institute, with Dr. Justin Moser leading the study. Dr. Gui-Dong Zhu, Chief Executive Officer of SparX Group, expressed his enthusiasm: "The dosing of the first patient with SPX-303 at HonorHealth Research Institute is a crucial step forward in its clinical development process. We are honored to collaborate with Dr. Moser's team at the Research Institute to bring this innovative therapy into clinical trials. By fusing a best-in-class (BIC) nano-anti-PD-L1 with mAb-anti-LILRB2 epitopes, SPX-303 aims to unlock the full potentials in the immune system's ability to fight cancer. The trailblazing preclinical data of SPX-303 instilled confidence in us to harness its therapeutic prowess in clinical settings, particularly for patients who previously had limited treatment options." Dr. Justin Moser, associate clinical investigator at the Institute and clinical assistant professor at the University of Arizona College of Medicine-Phoenix, shared his optimism about the potential impact of SPX-303. "SPX-303 is designed to combat the myeloid cell-induced immunosuppression that often hinders the effectiveness of current cancer therapies. SPX-303's unique dual mechanism, targeting both myeloid cell and T-cell immune checkpoints, may offer a new avenue for enhancing the immune system's weaponry against cancer," said Dr. Moser. With the successful dosing of SPX-303, SparX Group is initiating three additional study sites for the ongoing Phase 1 clinical study. This study aims to evaluate SPX-303's safety, tolerability, and preliminary efficacy in patients with resistant or refractory solid tumors, potentially ushering in a new era of superior therapeutic solutions. SPX-303 stands as a first-in-its-class bispecific antibody therapy, ingeniously designed to simultaneously target two crucial immune checkpoint proteins, LILRB2 and PD-L1. These proteins play essential roles in maintaining immune balance and preventing autoimmune diseases. However, cancer cells often exploit these checkpoints as a defense against immune attacks. SPX-303 seeks to overcome this by enabling the immune system to recognize and destroy cancer cells effectively, representing a significant leap forward 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 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. For more information about the study, please visit and search for NCT06259552. About the HonorHealth Research Institute HonorHealth Research Institute is an international destination that is at the forefront of providing patients with a better quality of life through its clinical trials and innovative treatment options. Headquartered in Scottsdale, Arizona, the institute's team of physicians and researchers collaborate with experts from across the nation to offer life-changing therapies, drugs and devices. At HonorHealth Research Institute, patients have access to tomorrow's health innovations, today. Learn more at: HonorHealth.com/research. SOURCE SparX Group

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

CHICAGO, Oct. 10, 2023 /PRNewswire/ -- Signifying a monumental step forward in the domain of powered antibody therapies, the SparX Group is thrilled to unveil its strategic alliance with Arovella Therapeutics Ltd (ASX: ALA). This collaboration emphasizes the utilization of SPX-101, an innovative monoclonal antibody (mAb) that targets the Claudin 18.2 (CLDN18.2) tumor specific antigen, as an exciting component in Arovella's CLDN18.2-CAR-iNKT cells as a leading off-the-shelf CAR-iNKT cell therapy. Dr. Gui-Dong Zhu, CEO of the SparX Group, elucidated on the significance of this collaboration: "Our partnership with Arovella represents a transformative phase in advancing mAb-based therapies. Invariant Natural Killer T (iNKT) cells, distinguished by their recognition of lipid antigens via the CD1d molecule, have emerged as potent therapeutic vectors. Arovella's cutting-edge CAR-iNKT platform, encapsulating advanced techniques for in-vitro expansion and post-infusion persistence of iNKT cells, underscores their leadership in this domain. We profoundly acknowledge CLDN 18.2-iNKT cell therapy as a groundbreaking paradigm in oncological therapeutics." Echoing the enthusiasm, Dr. Michael Baker, CEO of Arovella, remarked, "Licensing the CLDN18.2 mAb sequence from SparX represents a seminal phase in our therapeutic trajectory. SparX's sophisticated work, spotlighting the unparalleled attributes of their CLDN18.2 monoclonal antibody, coupled with its safety and specificity, accentuates the global attention this molecular target is garnering. We're uniquely positioned as the only global entity developing a CAR-iNKT cell therapy aimed at CLDN18.2. The synergistic combination of iNKT cells with the CLDN18.2 CAR paves an exciting avenue to develop novel cancer therapeutics." CLDN18.2 manifests predominantly in gastric cancers (GC), gastroesophageal junction cancers (GEJC), pancreatic cancers (PC), and a spectrum of other solid tumors. Both GC and GEJC represent formidable clinical challenges, registering over a million new cases annually worldwide and culminating in 770,000 fatalities. This places them as the fourth leading cause of cancer-related deaths globally. Spearheaded by SparX, SPX-101 embodies a pinnacle of molecular engineering, stemming from SparX's sophisticated SAILINGTM discovery platform. This mAb is designed for optimized therapeutic efficacy, offering the potential to be recognized as a best-in-class molecular entity targeting claudin 18.2. Expounding on the cellular dynamics, Invariant Natural Killer T (iNKT) cells are a specialized T cell subset known for recognizing lipid antigens via the CD1d molecule. These cells possess inherent attributes like tissue infiltration capabilities, counteracting tumor-promoting cells such as myeloid-derived suppressor cells (MDSCs) and tumor-associated macrophages (TAMs), and orchestrating a robust immune response by recruiting auxiliary immune cells against tumor sites. The pathological architecture of tumor development often exposes the CLDN18.2, rendering it accessible to novel treatments such as CAR-iNKT cell therapies. Preliminary clinical findings indicate that iNKT cell therapies might proffer a superior safety profile relative to alternative T cell therapies, notably displaying a reduced propensity for cytokine release syndrome, a prevalent and potential adverse reaction observed in certain cell therapies. 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