A clinical stage oncology drug development company Xynomic Pharmaceuticals Holdings, Inc. has reportedly announced that it has dosed the first patient in a Phase 1/2 trial. Apparently, the trial combines abexinostat with ibrutinib in patients suffering from relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) or relapsed/refractory mantle cell lymphoma (r/r MCL) at Memorial Sloan Kettering Cancer Center (MSK).

The trial will enroll almost 40 patients to assess the safety and efficacy of the combination in patients with r/r MCL or r/r DLBCL. It will also study the biologic predictors of resistance and response to histone deacetylase (HDAC) inhibition and dual B-cell receptor (BCR). Janssen Biotech, Inc. is offering ibrutinib as part of the trial, with Xynomic offering abexinostat and financial support for the study being conducted at MSK.

According to the reliable sources, mantle cell lymphoma (MCL) has an annual incidence of around 6,500 in G7 countries. The United States Food and Drug Administration (FDA) has approved Ibrutinib for relapsed MCL and has response rates of 60-70 percent and median duration of response of 18 months.

Apparently, Abexinostat as a mono treatment has been demonstrated to have 15.4 percent response rate (7.7 percent partial response and 7.7 percent complete response) in r/r MCL patients. Experts at MSK have been analyzing whether abexinostat/ibrutinib combo can potentially improve response rates and duration of responses in r/r MCL patients, subject to the evaluation upon the completion of the trial.

According to the Leukemia & Lymphoma Society (LLS), diffuse large B-cell lymphoma (DLBCL) is the most common hostile non-Hodgkin's lymphoma (NHL) subtype. It has demonstrated preclinical data representing that dual targeting of tyrosine kinase (BTK) of Bruton in the inhibition of NF-kB activation driven by MyD88 with a HDAC inhibitor and in the BCR pathway with ibrutinib cause a synergistic anti-lymphoma activity in MyD88 altered, ABC-subtype DLBCL both in vivo and in vitro.

Source credits: https://www.nasdaq.com/press-release/xynomic-dosed-first-patient-in-phase-12-lymphoma-trial-20190606-00733