Oxcia AB has announced a strategic shift in the clinical development of its lead drug candidate, OXC-101, prioritizing hematological cancers, with a specific focus on acute myeloid leukemia (AML). This decision follows a comprehensive review of strategy and available data, according to the company.
Focus on Acute Myeloid Leukemia
Preclinical studies of OXC-101 have demonstrated promising results in both AML and other hematological malignancies. Data from the ongoing Phase I/II MAATEO study have corroborated these findings, leading Oxcia to initiate an expansion phase targeting patients with refractory/relapsed AML (R/R AML). In this expansion, OXC-101 is being administered in combination with idarubicin, an anthracycline.
"The first AML patient to be treated with OXC-101 in an innovative combination treatment has recently been recruited, which is very exciting," said Ulrika Warpman Berglund, CEO of Oxcia. The company aims to accelerate patient recruitment by expanding the study to include more centers, such as Rigshospitalet in Copenhagen. Oxcia is also pursuing Orphan Drug Designation (ODD) for OXC-101 in AML.
Previous Studies in Solid Tumors
OXC-101 was previously evaluated in the MASTIFF study, a Phase I/II trial involving severely ill patients, including an expansion cohort focused on advanced ovarian and prostate cancers. While OXC-101 demonstrated a clinically relevant effect by halting cancer growth in a significant proportion of patients, some experienced dose-limiting side effects, specifically neutropenia.
Addressing Neutropenia
Neutropenia, a decrease in neutrophil granulocytes critical for immune function, is being further investigated through preclinical studies to understand the underlying mechanisms. "We are now conducting preclinical studies to better understand these mechanisms. Next, we will investigate which doses, indications and patient groups we could proceed with in solid tumors. However, the focus of Oxcia's development is on AML," emphasizes CEO Ulrika Warpman Berglund.
Oxcia AB is focused on developing novel treatments for diseases caused by cancer or inflammation, targeting oxidative DNA damage and DNA Damage Response (DDR) pathways. The company's pipeline includes OXC-201, a preclinical candidate targeting inflammatory and fibrosis-related diseases like pulmonary fibrosis and allergic asthma.
