FDA Approves Phase II/III Study of KPG-121 with Abiraterone for First-Line mCRPC Treatment

HEFEI, China, June 5, 2024 — Kangpu Biopharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted approval for a Phase II/III clinical trial of KPG-121 in combination with Abiraterone as a first-line treatment for metastatic castration-resistant prostate cancer (mCRPC).

KPG-121, discovered by Kangpu Biopharmaceuticals, is a modulator of the Cereblon (CRBN) E3 ubiquitin ligase complex known as CRL4CRBN. This complex targets the rapid ubiquitination and degradation of casein kinase 1α (CK1α) and transcription factors Aiolos (IKZF3) and Ikaros (IKZF1). KPG-121 has shown capabilities in promoting anti-proliferation and anti-angiogenesis activities, which enhances its immunomodulatory properties. The compound has been noted to significantly boost anti-tumor efficacy when combined with androgen-receptor antagonists such as enzalutamide, abiraterone acetate, apalutamide, or darolutamide in xenograft models, compared to using the androgen-receptor antagonist therapy alone.

A Phase I study was conducted in the United States (NCT03569280) to evaluate the safety, pharmacokinetics, and efficacy of KPG-121 in combination with enzalutamide, abiraterone, or apalutamide for the treatment of patients with metastatic or non-metastatic castration-resistant prostate cancer. Results from this study indicated that KPG-121 was generally well-tolerated, exhibited a favorable pharmacokinetic profile, and demonstrated promising efficacy.

Kangpu Biopharmaceuticals is a clinical-stage company dedicated to the discovery and development of innovative small molecules for the treatment of solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders. The company employs novel solutions such as targeted protein ubiquitination and degradation. Kangpu's pipeline includes potential first-in-class and best-in-class drug candidates developed through proprietary technology platforms, which include NeoMIDES®, gDACs®, and X-SYNERGY®.

Kangpu Biopharmaceuticals continues to make strides in the field of cancer treatment and other critical areas, driven by its innovative approaches and robust pipeline of drug candidates.