Xynomic Pharma Plans 4 Clinical Trials of Abexinostat for Lymphoma

Xynomic Pharma Plans 4 Clinical Trials of Abexinostat for Lymphoma
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Xynomic Pharma announced it has completed a new Series B financing round and now will initiate eight clinical trials, four of which are for different types of lymphoma, in the next 12 months.

Seven of the eight trials will evaluate Xynomic’s lead therapy candidate, abexinostat, as a treatment for different cancer types. Four of these trials will evaluate the drug candidate for lymphoma patients who have failed prior treatments.

Abexinostat is a new type of histone deacetylase (HDAC) inhibitor — a drug class that prevents genes from being silenced and has been used successfully in cancers originating in T-cells.

In a first trial, abexinostat will be investigated as a monotherapy against relapsed or refractory  follicular lymphoma as part of an accelerated approval protocol already cleared by the U.S. Food and Drug Administration (FDA).

In a second, pivotal trial, abexinostat will be evaluated in China as a monotherapy against relapsed or refractory follicular lymphoma.

In another pivotal trial, abexinostat will be investigated, also in China, as a single agent against diffuse large B-cell lymphoma (DLBCL) patients who failed prior treatments.

A fourth, Phase 1/2 trial will evaluate abexinostat in combination with Janssen’s Imbruvica (ibrutinib) against relapsed or refractory DLBCL and mantle cell lymphoma, in partnership with Janssen and the Memorial Sloan Kettering Cancer Center.

Three other trials will investigate abexinostat in indications other than lymphoma, as part of Xynomic’s Series B financing plan.

In one trial, Xynomic will evaluate abexinostat combined with NovartisVotrient (pazopanib) to treat patients with locally advanced or metastatic renal cell carcinoma as part of a fast-track designation protocol already cleared by the FDA.

In a second Phase 1 trial, abexinostat will be combined with Merck’s Keytruda (pembrolizumab) against multiple solid tumors, in partnership with the University of California, San Francisco (UCSF).

In a third, Phase 1/2 trial, abexinostat will be combined with a leading breast cancer drug against estrogen receptor (ER+) breast cancer.

Finally, Xynomic will conduct a Phase 1 trial to evaluate a second-generation XP-102 candidate against colorectal cancer and melanoma.

With the funds raised in this Series B financing round, the company also launched its own research and development (R&D) Innovation Center in Shanghai, in May 2018. The aim of this new center is to discover and develop small molecule oncology drugs focused on kinase inhibition, immuno-oncology, and epigenetic modification.

Abexinostat recently demonstrated it is suitable for patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukemia in a new European study.

The Phase 2 trial (EudraCT-2009-013691-47) was an attempt to explore the possibility of also treating B-cell related tumors with this type of drug.

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