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Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Follicular Lymphoma

On December 18, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma (FL), both with or without EZH2 activating mutations, who have received at least two prior lines of systemic therapy (Press release, Epizyme, DEC 18, 2019, View Source [SID1234552521]). Tazemetostat is an oral, first-in-class EZH2 inhibitor being developed for a range of cancers and treatment settings.

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"We are very pleased to have submitted this NDA in hopes of bringing tazemetostat to FL patients and their physicians," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "FL remains a devastating and incurable disease. We believe that if approved, the durable responses and favorable safety observed in patients both with and without an EZH2 activating mutation support tazemetostat’s potential to make a meaningful difference for these patients. This FL NDA submission, on the heels of a positive Oncology Drug Advisory Committee meeting for our epithelioid sarcoma program just yesterday, sets us up for a transformational year in 2020. We are grateful to the patients and medical teams who have meaningfully contributed to advancing tazemetostat to this stage."

Epizyme’s FL NDA submission follows a pre-NDA meeting held with FDA in October 2019, in which the Agency indicated that it considered the proposed clinical package to be sufficient for inclusion as part of the NDA for accelerated approval. The submission is based primarily on updated Phase 2 efficacy and safety data on tazemetostat in this patient population, which were presented at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The data demonstrated that treatment with tazemetostat resulted in clinical benefit as assessed by both investigators and an Independent Review Committee (IRC), and was shown to be generally well tolerated in FL patients with EZH2 activating mutations (n=45) and FL patients with wild-type EZH2 (n=54).

To support a full approval of tazemetostat for FL, Epizyme is conducting a single, global, randomized, adaptive trial to evaluate the combination of tazemetostat with "R2" (Revlimid plus Rituxan), an approved chemo-free treatment regimen, for FL patients in the second-line or later treatment setting. The trial is expected to enroll approximately 500 FL patients, stratified based on their EZH2 mutation status. Site initiation is underway, and the safety run-in portion of the trial has begun.

"Today’s submission marks the second NDA for tazemetostat that Epizyme executed this year, a significant milestone for our company, and a strong conclusion to 2019 across all aspects of our business," said Robert Bazemore, president and chief executive officer of Epizyme. "I am incredibly proud of what this team has achieved this year, which includes two NDA submissions, a favorable ODAC meeting for our epithelioid sarcoma program, important clinical data readouts, expansion of our tazemetostat clinical program into new indications and combinations, and a significant strengthening of our balance sheet with capital to support our planned operations into 2022. We are on the cusp of a potential first approval of tazemetostat, and are ready to make the transition to a commercial-stage organization in early 2020."

The FDA has a 60-day review period to determine whether the FL NDA submission is complete and acceptable for filing.

Arcus Biosciences, in Collaboration with Genentech, Announces Two Randomized Clinical Studies to Advance AB928, a Dual Adenosine Receptor Antagonist, into Novel Combinations for Colorectal and Pancreatic Cancers

On December 18, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company discovering and developing highly-differentiated therapies, reported a clinical collaboration with Genentech, a member of the Roche group, for the evaluation of novel combinations with AB928, Arcus’s dual antagonist of adenosine receptors A2aR and A2bR, for colorectal (CRC) and pancreatic (PDAC) cancers (Press release, Arcus Biosciences, DEC 18, 2019, View Source [SID1234552520]). The collaboration will utilize the MORPHEUS Phase 1b/2 platform for rapid and efficient combination development, with upfront randomization versus control groups, in two studies:

Third-line metastatic CRC: two combination arms, (1) AB928 plus atezolizumab (TECENTRIQ) and regorafenib, and (2) atezolizumab plus regorafenib, will be randomized versus regorafenib monotherapy.
First-line metastatic PDAC: the combination of AB928 plus atezolizumab and gemcitabine/nab-paclitaxel will be randomized versus gemcitabine/nab-paclitaxel.
These new studies further broaden Arcus’s portfolio of ongoing trials with AB928, which include prostate, colorectal, lung and breast cancers – all settings in which adenosine has been shown to play a central role in mediating an immunosuppressive tumor micro-environment, inhibiting the ability of both the body’s immune system and anti-cancer treatments to effectively detect and kill cancer cells.

"We are thrilled to collaborate with Genentech to expeditiously develop the broad potential of AB928 across settings and combinations where blocking the immunosuppressive role of adenosine may be critical," said Bill Grossman, M.D., Ph.D., Chief Medical Officer of Arcus. "This collaboration represents a shared commitment from Arcus and Genentech to maximize the potential of innovative combination treatment approaches, based on a deep knowledge of the underlying cancer biology, to address significant unmet needs."

Under the agreement, each company is supplying its respective anti-cancer agent to support the trial and jointly funding the studies. Additional financial terms were not disclosed.

About AB928

AB928, the first and only dual adenosine A2aR/A2bR receptor antagonist in the clinic, is designed to maximally inhibit the adenosine-driven impairment of tumor-infiltrating lymphocytes (mainly CD8+ T cells and NK cells) and myeloid cells (dendritic cells, macrophages), mediated by A2aR and A2bR, respectively. A2bR is also upregulated by certain cancer cells, such as in prostate cancer and KRAS-mutated cancers. As a result, AB928 may uniquely block adenosine’s immunosuppressive and cancer cell-intrinsic effects. Developed specifically for the oncology setting, AB928 achieves high penetration of tumor tissue, robust potency in the presence of high adenosine concentrations, and minimal shift in potency from non-specific protein binding. AB928 has demonstrated a favorable safety profile with a variety of combination regimens and exhibits pharmacokinetics / pharmacodynamics consistent with once-daily dosing. AB928 is currently being evaluated in several Phase 1b/2 studies across multiple indications.

Exicure Announces Proposed Public Offering of Common Stock

On December 18, 2019 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Exicure, DEC 18, 2019, View Source [SID1234552519]). In addition, Exicure intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of its common stock offered in the public offering. All of the shares are being offered by Exicure. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Exicure intends to use the net proceeds from the offering to advance AST-008 through a Phase 1b/2 clinical trial; to initiate a second arm in its Phase 1b/2 clinical trial in cutaneous squamous cell carcinoma; to develop an SNA-based therapeutic candidate for the treatment of Friedreich’s ataxia, initiate IND-enabling studies and advance it into Phase 1 clinical trials; to develop a second SNA therapeutic candidate for a neurology condition and initiate IND-enabling studies; and for general corporate purposes.

Guggenheim Securities is acting as sole book-running manager for the offering.

The securities described above are being offered by Exicure pursuant to a shelf registration statement on Form S-3 (No. 333-230175) that was declared effective by the Securities and Exchange Commission (SEC) on July 24, 2019. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting: Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

Epizyme Announces FDA Advisory Committee Votes Unanimously in Favor of Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma

On December 18, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) voted 11 – 0 in favor of the benefit-risk profile of tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma (ES) not eligible for curative surgery (Press release, Epizyme, DEC 18, 2019, View Source [SID1234552518]).

"We are incredibly pleased by ODAC’s unanimous support of the benefit-risk of tazemetostat in ES, and we appreciate the tremendous support received from sarcoma physicians and their medical teams, advocates, caregivers and most notably, patients with ES," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "We believe the strength of the totality of data, including the observed durable responses and stabilization of disease, safety and tolerability, are distinguishing characteristics of tazemetostat for patients living with this disease. We are thrilled by the panel’s support and look forward to working closely with the Agency as they continue their review of our NDA. I am confident that we have submitted a comprehensive clinical data package for ES to support tazemetostat’s approval."

ES is a rare and aggressive soft tissue sarcoma characterized by a loss of the INI1 protein. Patients are most commonly diagnosed as young adults, between 20 and 40 years of age, typically with no patients living past five years from diagnosis. ES becomes more aggressive after recurrence or once it has metastasized, with a typical survival of less than one year for patients with metastatic disease.

"Today’s ODAC outcome is a significant step toward addressing the critical needs of ES patients," said Robert Bazemore, president and chief executive officer of Epizyme. "This is a remarkable achievement marking the culmination of years of hard work by the entire Epizyme team. If approved, we will have the opportunity to change how patients with this devastating cancer are treated. Our commercial-readiness is complete, and we look forward to finalizing our dialog with the FDA."

The ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes recommendations to the FDA. The New Drug Application (NDA) for tazemetostat, an investigational, oral, first-in-class EZH2 inhibitor, is currently under Priority Review by the FDA with a PDUFA target action date of January 23, 2020. Epizyme’s NDA submission is based primarily on data from the 62 patient epithelioid sarcoma cohort of its ongoing Phase 2 study of tazemetostat, which were reported at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.

BIOGEN TO REPORT FOURTH QUARTER AND YEAR-END 2019 FINANCIAL RESULTS JANUARY 30, 2020

On December 18, 2019 Biogen Inc. (Nasdaq: BIIB) reported it will report fourth quarter and year-end 2019 financial results Thursday, January 30, 2020, before the financial markets open (Press release, Biogen, DEC 18, 2019, View Source [SID1234552512]).

Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website.