GenSci143 / GeneScience - LARVOL DELTA

Molecular Design and Preclinical Evaluation of GenSci143, a Novel B7-H3- and PSMA-Directed Bispecific Antibody-Drug Conjugate, for the Treatment of Prostate Cancer. (PubMed, Mol Cancer Ther) - "The compelling preclinical efficacy across cancer models with varying levels of target antigen expression and its exceptional plasma stability support the translational relevance of GenSci143. These results indicate that GenSci143 is a promising therapeutic candidate for castration resistant PCa and potentially other malignancies, warranting its further clinical development."

Journal • Preclinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

GenSci143, a novel B7-H3×PSMA bispecific and potential best-in-class ADC, for the treatment of metastatic castration-resistant prostate cancer (AACR 2025) - "In vivo anti-tumor activity of GenSci143 was assessed in CDX models of PCa and compared to that of the DS-7300 and ARX517 analogs. B7-H3 and PSMA were highly co-expressed in PCa tissues (N=102), lending strong support to our dual-targeting therapeutic approach for mCRPC. These results suggest that GenSci143 has the potential to become an effective therapeutic option for mCRPC patients and support its further evaluation in IND-enabling studies."

ADC • Bispecific • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

GenSci143 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Oncology • Solid Tumor

GenSci143 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=180 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

First-in-human • New P1 trial • Oncology • Solid Tumor

Changchun GeneScience Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted clinical‑trial approval for its flagship bispecific antibody‑drug conjugate, GenSci143 (flcube.com) - "The drug is designed for advanced solid tumors that express the tumor‑associated antigens B7‑H3 and prostate‑specific membrane antigen (PSMA)....Phase I/II (dose‑escalation & pharmacodynamics) slated to begin Q1 2026 in the U.S. Phase IIb (tumor‑type stratified) planned for Q2 2027 upon favorable safety data."

IND • New P1/2 trial • Prostate Cancer • Solid Tumor

GenSci143, a Novel B7-H3 × PSMA Bispecific Antibody-Drug Conjugate (BsADC), Demonstrates Broad-Spectrum Preclinical Antitumor Efficacy with a Favorable Safety Profile (AACR-NCI-EORTC 2025) - "Clinical limitations of single-target agents include restricted efficacy in mCRPC monotherapy (e.g., DS-7300a [anti-B7-H3 ADC] and ARX517 [anti-PSMA ADC]), often attributed to tumor heterogeneity and variable target expression...Combination potential with enzalutamide (endocrine therapy) was evaluated in a PCa PDX model...The association with the SLFN11 biomarker may further optimize patient stratification. These results position GenSci143 as a promising therapeutic modality with enhanced efficacy and expanded patient coverage potential for mCRPC and beyond."

Preclinical • Castration-Resistant Prostate Cancer • Gastric Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • CD276 • FOLH1 • SLFN11 • TOP1