Cambridge, Massachusetts-based Epizyme emphasized its efforts to move tazemetostat back into clinical trials in its second-quarter financial report.
Cambridge, Massachusetts-based Epizyme emphasized its efforts to move tazemetostat back into clinical trials in its second-quarter financial report. That’s not necessarily the best news, although it’s more promising than the news that it is shuttering part of its relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL) program.
In April, the company announced that after a safety report of a pediatric patient developing a secondary lymphoma, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on its Phase II program to study tazemetostat. This affected new enrollment of patients with genetically defined solid tumors and hematologic malignancies, and required Epizyme to update its informed consent, investigator’s brochure and study protocols. Patients who did not experience disease progression were allowed to continue tazemetostat treatment.
The patient developed a secondary T-cell lymphoblastic lymphoma (T-LBL). The company reconsented all patients in the trial and complied with other parts of the clinical hold. It also reviewed the T-LBL case and recently completed a comprehensive assessment of the drug’s safety data. It plans to submit the data to the FDA and European regulators, because the study is also being conducted in France and Germany. Epizyme believes that partial clinical hold will be lifted and enrollment can continue.
“In the second quarter, we presented encouraging new clinical data regarding tazemetostat’s anti-tumor activity and tolerability in follicular lymphoma and mesothelioma,” said Robert Bazemore, Epizyme’s president and chief executive officer, in a statement. “As we enter the second half of 2018, we have focused the organization on several strategic priorities. First and foremost, we are working diligently to resolve the partial clinical hold and resume enrollment in tazemetostat clinical studies. In addition, we are progressing tazemetostat toward a first NDA for the treatment of epithelioid sarcoma, continuing to advance its development in follicular lymphoma based on the strength of our clinical data, and advancing our novel inhibitor of G9a, EZM8266, toward the clinic. We believe the actions we have taken will allow us to capitalize on our near-term tazemetostat opportunities while also extending our cash runway.”
In terms of the DLBCL program, the company has been running a Phase II trial evaluating tazemetostat in patients with DLBCL, including DLBCL patients with EZH2 activating mutations and with wild-type EZH2 who are receiving the drug as monotherapy, and a cohort receiving tazemetostat with prednisolone. After an interim data analysis, the company decided it didn’t warrant more investment in tazemetostat in DLBCL as a monotherapy or in combination with prednisolone. It will continue with two more additional combination studies in DLBCL, but those two treatment arms have been abandoned.
From a financial position, the company as of June 30 had $215.6 million in cash, down from $247.9 as of March 31, 2018. Its revenue for the second quarter was $12 million, up from $10 million in the same period in 2017. The improvement is due to more milestone-related revenue from its collaboration and licensing deal with GlaxoSmithKline.
The company is also preparing its first New Drug Application (NDA) submission for tazemetostat in epithelioid sarcoma, but because of the clinical hold, has delayed it until the first half of next year.
None of that sounds dramatically promising for investors, but Gaurao Bhade, writing for Seeking Alpha, thinks differently. He writes, “With first-in-class EZH2 inhibitor, tazemetostat, inching closer towards regulatory approval in indications such as hematologic malignancies and certain solid tumors, Epizyme has started appearing as an attractive investment opportunity in 2018.”
He does note, however, that the company is heavily reliant on tazemetostat.
