SPX-303 / SparX - LARVOL DELTA

A first-in-human phase 1 study on the safety, PK, receptor occupancy, and pharmacodynamic markers of SPX-303, a first-in-class LILRB2×PD-L1 bispecific antibody (AACR 2025) - "Secondary endpoints include antitumor activity as well as characterization of the PK and PD of SPX-303. This study is currently open and enrolling in escalation cohorts."

Clinical • IO biomarker • P1 data • PK/PD data • Oncology • Solid Tumor

SparX to Present Phase 1 Clinical Updates of SPX-303, a Dual Checkpoint Bispecific Antibody, at Two Events During AACR 2025 (PRNewswire) - "SparX Biopharmaceutical Corp. announced today that it will present clinical updates on its lead asset, SPX-303, a first-in-class anti-LILRB2/PD-L1 bispecific antibody, during the Trial-in-Progress poster session at the 2025 American Association for Cancer Research (AACR) Annual Meeting on April 28, from 2:00 PM to 5:00 PM. The presentation marks the one-year anniversary of the first patient dosing of this novel bispecific antibody in its ongoing Phase 1 clinical trial....The SPX-303 poster will be presented at Poster #CT116-11 in the Phase I Clinical Trials in Progress session at McCormick Place, Chicago..."

Trial status • Solid Tumor

SparX Group Announces First Patient Dosed with SPX-303 Injection, the First in Its Class of anti-LILRB2/PD-L1 Bispecific Antibody Drugs (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....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."

Trial status • Colorectal Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Discovery and characterization of LILRB2XPD-L1 bispecific antibody SPX-303 (AACR 2024) - "In in vitro functional assays, SPX-303 exhibits effects comparable to the parental monomeric anti-LILRB2 (SPX-104) in redirecting macrophage polarization from M2 to M1 stage, as observed in both cultured PBMC and human monocyte-derived macrophage (HMDM) models. Collectively, these results support SPX-303 as a novel therapeutic antibody that effectively enhances anti-cancer immunity in the treatment of advanced solid tumors. The pre-clinical data as well as the clinical plan of SPX-303 will be presented."

Oncology • Solid Tumor

A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=232 | Recruiting | Sponsor: SparX Biotech(Jiangsu) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=232 | Not yet recruiting | Sponsor: SparX Biotech(Jiangsu) Co., Ltd.

New P1 trial • Head and Neck Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

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

IND • New P1 trial • Solid Tumor