We issued an updated report on Epizyme Inc. EPZM on Aug 14.
The company’s lead pipeline candidate is tazemetostat, a first-in-class EZH2 inhibitor, which is currently being evaluated for the treatment of solid tumors and hematological malignancies as a monotherapy and to treat relapsed and front-line disease as a combination therapy.
Epizyme’s NDA for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally-advanced epithelioid sarcoma (ES), who are not eligible for curative surgery, was accepted by the FDA for priority review in July 2019. The FDA is expected to give its decision on Jan 23, 2020. If approved, tazemetostat will be the first commercially available EZH2 inhibitor and the first treatment specifically indicated for epithelioid sarcoma patients. A potential approval will significantly boost the growth prospects
The company also plans to submit an NDA for accelerated approval of tazemetostat in patients with follicular lymphoma (FL), regardless of their EZH2 mutational status, who have been previously treated with two or more systemic therapies. The company expects to submit the NDA for accelerated approval in the fourth quarter of 2019.
Epizyme is planning to initiate multiple clinical studies to evaluate tazemetostat in earlier treatment lines of follicular lymphoma, and explore new combinations and potential indications in both FL and solid tumors.
The company also intends to discover the potential of tazemetostat in earlier lines of FL as combination therapy. It is planning to conduct a confirmatory program with an adaptive study evaluating the combination of tazemetostat and the chemo-free treatment regimen “R2” [Celgene’s CELG Revlimid plus Roche’s RHHBY Rituxan] in the second line or later treatment setting for FL patients, both with and without EZH2 activating mutations. The final design is subject to alignment with the FDA and the company expects to initiate the safety run-in portion in the second half of 2019.
Epizyme also aims at completing IND-enabling studies on EZM8266, its G9a inhibitor designed to treat patients with sickle cell disease (SCD). It is on track to begin clinical development of the candidate in the second half of 2019 with a dose-finding and safety study.
Epizyme’s proprietary product platform is used to create small molecule inhibitors of a class of enzymes known as histone methyltransferases (HMTs). However, the company faces competition from companies like Glaxo, Novartis NVS, Pfizer and Constellation, which are developing new epigenetic treatments for cancer targeting HMTs.
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