Xynomic Pharma Initiates Ph 1/2 Trial Combining Abexinostat with Ibrutinib in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) and Mantle Cell Lymphoma (r/r MCL)

CHEYENNE, WY, USA I December 1, 2017 I Xynomic Pharma, a clinical stage US oncology drug development company, today announced that it will initiate a Ph 1/2 trial, in collaboration with Janssen R&D, LLC (Janssen Pharmaceutical Companies of Johnson & Johnson, hereafter Janssen) and Memorial Sloan Kettering Cancer Center (MSK), to combine Abexinostat with Ibrutinib against r/r DLBCL and r/r MCL. Janssen is providing Ibrutinib only as part of the agreement, with Xynomic providing Abexinostat and support for the trial being conducted at MSK.

To win the dynamic battle against ever-mutating cancers, biopharmaceutical companies increasingly rely on rational combinations of biologically targeted agents to develop more effective and durable treatments. World renowned lymphoma expert Dr. Anas Younes and other researchers at MSK have shown preclinical data demonstrating that dual targeting of Bruton's tyrosine kinase (BTK) in the BCR pathway with Ibrutinib and inhibition of MyD88-driven NF-kB activation with a HDAC inhibitor lead to synergistic anti-lymphoma activity in MyD88 mutated, ABC-subtype DLBCL both in vitro and in vivo.

This trial, to be led by MSK's Drs. Anita Kumar and Anas Younes, will enroll 40 patients to assess the safety and efficacy of the combination of Abexinostat and Ibrutinib in patients with r/r DLBCL or r/r MCL. The trial will also explore the biologic predictors of response and resistance to dual BCRi and HDACi inhibition.

"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 tumor 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. We are honored and excited to partner with his team and Janssen, a global leader in oncology, to explore the full clinical potential of Abexinostat-Ibrutinib combo in these two subtypes of aggressive lymphoma," said Mark Xu, Chairman and CEO of Xynomic.

Abexinostat is a promising novel HDAC inhibitor entering global pivotal Ph 3 trials against non-Hodgkin's lymphoma and renal cell carcinoma. Xynomic's pipeline also includes XP-102 (BI 882370), a novel 2nd-generation pan-RAF inhibitor.

Ibrutinib is a first-in-class BTK inhibitor jointly developed and commercialized as IMBRUVICA® by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company and has been approved for multiple hematological malignances and chronic graft-versus-host-disease (cGVHD).

SOURCE: Xynomic Pharmaceuticals, Inc.

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