FDA Asked to Place Abexinostat, Possible Follicular Lymphoma Treatment, on Fast Track

Xynomic Pharmaceuticals has filed a request with U.S. Food and Drug Administration (FDA) asking that abexinostat, its lead therapeutic candidate for relapsed or refractory follicular lymphoma, be given fast track designation.

The designation is given to therapies that show potential to treat serious health conditions or those with unmet need, and is intended to speed their development and review by providing more frequent meetings and discussions with the agency.

An FDA decision on the filing is expected within 60 days, the company said in a press release.

Abexinostat is an oral inhibitor, or blocker, of histone deacetylase (HDAC) enzymes, which cause a remodeling in chromosomes and a change in genes being produced in cells. By blocking these enzymes, abexinostat aims to increase the amount of tumor suppressor genes being produced to possibly prevent the growth and division of cancer cells.

The treatment is being investigated for a variety of lymphoma types, but follicular lymphoma patients have shown the best responses to treatment so far.

A Phase 2 clinical trial (EudraCT-2009-013691-47) of abexinostat in Europe enrolled 100 patients with non-Hodgkin’s lymphoma or chronic lymphocytic leukemia who had not responded to multiple lines treatment.

The treatment was given for a median of 2.8 months, but those with follicular lymphoma continued for a median of 5.6 months. The response rate in the overall population was 28%, but among patients with follicular lymphoma that response rate was 56%, followed by people with T-cell lymphoma (40%), and those with diffuse large B-cell lymphoma (31%).

Xynomic is also exploring abexinostat as a fourth-line therapy for follicular lymphoma in the ongoing FORERUNNER Phase 2 trial (NCT03600441). This open-label study has enrolled up to 139 people at clinical sites in the United States, France, and Spain.

FORERUNNER’s main goal is the number of complete or partial responses to abexinostat treatment, but it will also evaluate duration of responses, time to disease progression, quality of life, and overall survival as secondary measures.

The company is also preparing a Phase 1/2 study (NCT03934567), to be conducted in collaboration with the Chinese Academy of Medical Sciences, to evaluate abexinostat in Chinese patients with non-Hodgkin’s lymphoma.

Similar to previous and ongoing clinical trials, its researchers will evaluate the safety, tolerability, and preliminary efficacy of oral abexinostat in patients who failed to respond to standard of care.

Xynomic recently announced that people with relapsed or refractory DLBCL and mantle cell lymphoma are also being treated with abexinostat in combination with Janssen’s Imbruvica (ibrutinib) in an ongoing Phase 1/2 trial (NCT03939182).

This dose-expansion trial is being conducted at Memorial Sloan Kettering Cancer Center sites in New York and New Jersey, and now enrolling up to 40 patients. More information can be found here.