MULTI-YEAR VISION TO REWRITE THERAPY FOR CANCER AND OTHER SERIOUS DISEASES
Epizyme has a long-term vision to rewrite therapy for cancer and other serious diseases through targeted medicines. Through 2020, our focus is on four transformative activities:
- Transitioning to a commercial-stage organization through the global launch of tazemetostat in patients with certain genetically defined solid tumors (INI1-negative tumors and synovial sarcoma) and patients with non-Hodgkin lymphoma (NHL);
- Expanding the clinical program for tazemetostat to support its utilization in earlier lines of therapy, in combination regimens, and in at least five new tumor types;
- Growing the pipeline, with at least three new product candidates in clinical development and a robust set of preclinical assets behind those; and,
- Further establishing the company’s leadership in the field of epigenetics and chromatin remodeling in oncology and beyond to enable long-term, sustainable business growth.
ACCELERATING TOWARD GLOBAL LAUNCH IN NHL AND SOLID TUMORS
Tazemetostat has demonstrated the potential to treat both hematologic malignancies and solid tumors, which laid the foundation for its aggressive development plan. Epizyme is focused on a number of critical activities aimed at bring tazemetostat to the patients who may benefit as quickly as possible.
We are evaluating tazemetostat in a phase 2 five-arm study in patients with NHL, a phase 2 five-arm study in adult patients with certain genetically defined solid tumors and a phase 1 dose-escalation and expansion study in pediatric patients with genetically defined solid tumors.
Efforts are underway to further accelerate enrollment in the ongoing tazemetostat clinical trials in the U.S. and other countries, advance clinical pharmacology studies to support registration and investing in manufacturing to prepare for approval.
MAXIMIZING TAZEMETOSTAT “PIPELINE WITHIN A PRODUCT” POTENTIAL
Epizyme is actively expanding the utility of tazemetostat into a broad range cancers and treatment settings.
R-CHOP Combination: We are collaborating with the Lymphoma Study Association on a clinical trial evaluating tazemetostat in combination with R-CHOP as a first-line treatment option for elderly, high-risk patients with diffuse large B-cell lymphoma, the most common type of NHL.
Immuno-oncology Combination: We have started a collaboration with Genentech, a member of the Roche Group, to evaluate the potential of tazemetostat to enhance the clinical activity of checkpoint inhibition by combining with Roche’s PD-L1 cancer immunotherapy, Tecentriq™ (atezolizumab.) Tecentriq is the first and only approved anti-PD-L1 cancer immunotherapy treatment by the U.S. FDA.
Mesothelioma: We have a fourth registration-supporting clinical trial underway investigating the treatment potential of tazemetostat in patients with relapsed or refractory mesothelioma, particularly patients with mesothelioma characterized by BAP1 loss-of-function.
Additional Indications: Mesothelioma is the first of five additional cancer indications in which we intend to investigate tazemetostat through 2020. We have many academic collaborations underway to evaluate the role of tazemetostat in new preclinical models and are acting rapidly to initiate additional proof-of-concept studies where there is strong preclinical evidence of tumor sensitivity to EZH2 inhibition in a clearly defined patient population.
PIPELINE GROWTH AND SCIENTIFIC LEADERSHIP
Our scientific expertise has led us to undertake drug discovery and development efforts that encompass histone methyltransferases (HMTs), histone acetyltransferases (HATs) and helicases, which are implicated in multiple types of hematological malignancies, solid tumors and other serious illnesses.
Our long-term growth will be supported by:
- Identifying the most attractive targets for program development by utilizing CRISPR-based screening methodology to pinpoint targets where there is a clear signal for activity in specific tumor types
- Developing novel small molecule inhibitors against select targets and conducting preclinical drug discovery to evaluate their viability as future clinical programs
- Initiating clinical development of at least three new small molecule programs by 2020, including novel G9a inhibitor drug candidate, EZM8266
- Retaining rights to our wholly owned programs in the U.S., as well in certain international areas as part of potential future partnerships
- Evaluating potential new platform and program partnering opportunities both within and outside of oncology that might benefit from having a strategic partner
Epizyme’s goal is to create medicines targeted at specific diseases, that are orally administered, tolerable and easy for patients to take, and are based on a deep understanding of which patients will benefit from them. We believe that we have the opportunity to change the lives of patients living with cancer and other serious diseases and are well positioned to deliver on our vision through 2020.