US-based oncology drug development company Xynomic Pharma is set to begin a Phase I/II trial that will see the combination of Abexinostat with Ibrutinib to treat relapsed/refractory diffuse large b-cell lymphoma (r/r DLBCL) and mantle cell lymphoma (r/r MCL).
Janssen R&D and Memorial Sloan Kettering Cancer Center (MSK) will also partner with Xynomic Pharmato to conduct the trial, which will enrol 40 patients.
To be led by MSK’s Dr Anita Kumar and Dr Anas Younes, the trial will evaluate the safety and efficacy of the combination of Abexinostat and Ibrutinib in patients with r/r DLBCL or r/r MCL.
The proposed study will also explore the biologic predictors of response and resistance to dual BCRi and HDACi inhibition.
Xynomic Pharma chairman and CEO Mark Xu said: “One of the most important paradigm shifts in today’s cancer treatment landscape is the increasing reliance on combination therapies, as it becomes apparent that no single agent, being a targeted therapy or an I-O therapy, can win the battle against a particular type of tumour alone in the long run.
“Combination therapy is the best approach to block multiple oncogenic pathways to ensure effective and sustainable treatment outcome.
“Dr Younes’ team has shown convincing evidence of potential synergy between Abexinostat and Ibrutinib.”
Abexinostat is a new HDAC inhibitor and is currently undergoing Phase III trials against non-Hodgkin’s lymphoma and renal cell carcinoma.
Ibrutinib is a BTK inhibitor which is jointly developed and commercialised as Imbruvica by Janssen Biotech and Pharmacyclics.
The drug has already been approved for the treatment of multiple haematological malignancies and chronic graft-versus-host-disease (cGVHD).