On August 2, 2018 Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage company developing novel epigenetic therapies, reported financial results for the second quarter of 2018 and provided key business updates (Press release, Epizyme, AUG 2, 2018, View Source [SID1234528418]).

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"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, president and chief executive officer of Epizyme. "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."

Partial Clinical Hold Update

A partial clinical hold pausing the enrollment of new patients into tazemetostat clinical trials was implemented in the second quarter of 2018 in the United States, France and Germany following a safety report of a single pediatric patient who developed a secondary T-cell lymphoblastic lymphoma (T-LBL). Epizyme has reconsented all patients in its clinical trials and updated its informed consent form based on this safety report. The company also reviewed the single T-LBL case in detail, recently completed a comprehensive assessment of tazemetostat safety data and clinical activity observed to date across clinical trials, and convened a panel of external experts to review and validate the assessment. This information will be included in a formal response to regulatory authorities.

Epizyme plans to continue its engagement with the U.S. Food and Drug Administration (FDA) in the weeks ahead and then finalize its response to regulatory authorities, including changes that may be proposed to study protocols. Once the company has gained alignment with regulators in the U.S., France and Germany, it is anticipated that the partial clinical hold would be lifted and that enrollment activities would be allowed to proceed in those countries.

ES Program Update

At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2018, Epizyme plans to present updated Phase 2 data from patients with epithelioid sarcoma (ES) who are receiving tazemetostat as a monotherapy. Enrollment in this trial was completed in July 2017. A recent assessment of interim data from the full 62-patient ES cohort in this study has shown that the objective response rate has remained consistent with what was observed in the initial 31 enrolled patients. In addition, durability data from the cohort continue to mature.

Epizyme is continuing to prepare its first New Drug Application (NDA) submission for tazemetostat for the treatment of patients with ES. In order to include more mature durability data

in its submission and based on the potential impact of the partial clinical hold on the timing of the company’s pre-NDA meeting with the FDA, Epizyme now plans to submit its NDA in the first half of 2019.

DLBCL Program Update

Epizyme has been conducting a Phase 2 trial that is assessing tazemetostat activity in cohorts of patients with relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL). These cohorts include DLBCL patients with EZH2 activating mutations and with wild-type EZH2 who are receiving tazemetostat as monotherapy. The trial also includes a cohort of DLBCL patients who are receiving tazemetostat in combination with prednisolone. Epizyme has conducted an interim assessment of data from this trial and concluded that the clinical activity seen in these cohorts is not sufficient to warrant further development of tazemetostat in DLBCL as a monotherapy or in combination with prednisolone. Epizyme plans to present clinical data from each of these study cohorts at a medical meeting in the second half of 2018. The company has two additional combination studies in DLBCL ongoing and plans to evaluate other potential combinations in this aggressive and difficult-to-treat cancer longer term.

Recent Progress

New Chief Medical Officer: Epizyme recently appointed Dr. Shefali Agarwal as chief medical officer. In this role, Dr. Agarwal will oversee all of the company’s activities related to the global strategic development of tazemetostat and additional pipeline candidates. A trained medical oncologist, Dr. Agarwal brings to Epizyme nearly two decades of clinical research and regulatory expertise as well as leadership experience in clinical development, clinical operations and medical affairs.

Positive Data in Follicular Lymhoma (FL): At the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, positive interim data were reported from the follicular lymphoma cohorts in Epizyme’s ongoing Phase 2 study of tazemetostat in non-Hodgkin lymphoma. The data as of May 1, 2018 showed that tazemetostat continued to demonstrate meaningful clinical activity as a monotherapy and was generally well tolerated in adult patients with relapsed and/or refractory FL. An objective response rate (ORR) of 71 percent was observed in the cohort of FL patients with EZH2 activating mutations (n=28), with an interim median duration of response (DOR) of approximately 32 weeks. An ORR of 33 percent was observed in the fully-enrolled cohort of FL patients with wild-type EZH2 (n=54), with an interim median DOR of approximately 76 weeks. The median DOR figures in these cohorts continue to mature, with more than half of the responders still on therapy. After resolving the partial clinical hold, Epizyme plans to re-engage with the FDA to refine the company’s registration plans for tazemetostat in relapsed and/or refractory FL.

Clinical Activity in Mesothelioma: At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, clinical data were reported from Epizyme’s Phase 2 study of tazemetostat as a monotherapy in relapsed and/or refractory malignant mesothelioma patients with BRCA1-associated protein 1 (BAP1) loss-of-function. The primary endpoint in this trial was met with 51 percent of patients (31/61) having achieved disease control at 12 weeks, exceeding the pre-specified disease control rate threshold of ³35 percent. Tazemetostat was generally well tolerated in this study.

Second Quarter 2018 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $215.6 million as of June 30, 2018, which compares to $247.9 million as of March 31, 2018.

Revenue: Revenue for the second quarter of 2018 was $12.0 million, which compares with $10.0 million in revenue for the second quarter of 2017. The increase is due to greater milestone-related revenue from the company’s collaboration and license agreement with GlaxoSmithKline.

R&D Expenses: Research and development (R&D) expenses were $31.3 million for the second quarter of 2018, which compares to $27.3 million for the second quarter of 2017. The increase is primarily due to greater tazemetostat manufacturing expense, increased clinical and regulatory activities associated with tazemetostat’s development and preclinical studies related to the company’s G9a inhibitor candidate.

G&A Expenses: General and administrative (G&A) expenses were $10.9 million for the second quarter of 2018, which compares to $11.2 million for the second quarter of 2017. The decline is primarily due to reduced consulting costs.

Net Loss: The company’s net loss was $29.1 million, or $0.42 per share, for the second quarter of 2018, which compares to a net loss of $28.0 million, or $0.48 per share, for the second quarter of 2017.

Financial Guidance

Epizyme has extended its cash runway guidance based on changes that are being made to its planned operating expenditures. The company now expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into the fourth quarter of 2019.

Conference Call Reminder

As previously announced, management plans to host a conference call and webcast at 8:30 a.m. ET today to discuss the company’s second quarter 2018 results and other business updates. To participate, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 5734199. A live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast also will be archived on the website for 60 days.

About the Tazemetostat Clinical Trial Program

Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; follicular lymphoma (FL); and combination studies in diffuse large B-cell lymphoma (DLBCL) and non–small cell lung cancer (NSCLC).

On August 2, 2018 Medivir AB (Nasdaq Stockholm: MVIR) reported that the first patient has been enrolled and is being dosed with remetinostat gel 1% in an investigator-initiated phase II clinical study in patients with basal cell carcinoma (BCC) (Press release, Medivir, AUG 2, 2018, View Source [SID1234528308]). This clinical study will be conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Dr Kavita Sarin. Medivir will be providing remetinostat drug supply for this study, and will have full access to, and the rights to use, all clinical data after the study is complete.

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The primary objective of the study is to assess the effects of topical remetinostat on the overall response rate in a cohort of BCC patients and could establish that remetinostat has the potential for use in other skin-associated cancers in addition to CTCL. Further details of the study can be found at www.clinicaltrials.gov with the reference NCT03180528.

"This study highlights the potential of remetinostat to be used in conditions beyond early-stage cutaneous T-cell lymphoma," said Christine Lind, CEO of Medivir. She continues, "We look forward to the completion of the study and communication of the clinical outcomes."

For further information, please contact:
Christine Lind, CEO, Medivir AB, phone: +46 (0)8 5468 3100
Erik Björk, CFO, Medivir AB, mobile: +46 (0)72 228 2831

About remetinostat
Remetinostat is a histone deacetylase (HDAC) inhibitor. The unique design of remetinostat enables topical application, making it active only in the skin. As soon as it reaches the blood stream, it is degraded, avoiding the side effects associated with other HDAC inhibitors.

On August 2, 2018 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported that it will release second quarter 2018 financial results on Wednesday, August 8, 2018 after the U.S. financial markets close. Celldex executives will host a conference call at 4:30 p.m. EDT on the same day to review the second quarter 2018 financial results and to provide an update on key research and development and business objectives for the remainder of 2018.

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The conference call and presentation will be webcast live over the Internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 4768019.

A replay of the call will be available approximately two hours after the live call concludes through August 15, 2018. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 4768019. The webcast will also be archived on the Company’s website.

On August 2, 2018 Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that William G. Rice, Chairman, Ph.D., President and Chief Executive Officer, and Gregory K. Chow, Senior Vice President and Chief Financial Officer, will participate at the Canaccord Genuity 38th Annual Growth Conference being held from Wednesday, August 8th to Thursday, August 9th, 2018, at the Intercontinental Hotel, Boston, MA (Press release, Aptose Biosciences, AUG 2, 2018, View Source;p=RssLanding&cat=news&id=2361651 [SID1234528373]).

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Dr. Rice will provide a corporate overview of the Company’s recent activities and strategic direction.

Time: 12:30 p.m. ET
Date: Thursday, August 9, 2018
Location: Intercontinental Hotel, Boston, MA
A live webcast of the Aptose presentation will be accessible by visiting:

View Source

The webcast will be archived shortly after the live event and will be available for 90 days through the Aptose website at www.aptose.com

On August 2, 2018 Evelo Biosciences, Inc. (Nasdaq:EVLO) (Evelo), a clinical stage biotechnology company developing monoclonal microbials designed to act on the gut-body network for the treatment of a wide range of diseases, reported financial results and provided a business update for the second quarter ended June 30, 2018 (Press release, Evelo Biosciences, AUG 2, 2018, View Source [SID1234528391]).

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"Our recent accomplishments represent important progress across our business, as we entered the clinic with our first monoclonal microbial, EDP1066, and continued to advance our broad portfolio of preclinical product candidates in a range of inflammatory and oncology indications," said Simba Gill, Ph.D., President and Chief Executive Officer of Evelo. "Looking to the second half of 2018, we are focused on advancing EDP1815 and EDP1503 into their first clinical trials in inflammatory disease and oncology, respectively, as we seek to advance our diversified portfolio of monoclonal microbials toward ten potential clinical readouts between 2019 and 2020 across different diseases and underlying biologies. We are also committed to further understanding of the gut-body network more broadly, as highlighted by our recently-signed research collaboration with world-leaders at Harvard University, which will enable us to further explore the gut’s role in modulating immune activity throughout the body."

Second Quarter and Recent Business Highlights:

Pipeline:

In May 2018, the U.S. Food and Drug Administration accepted an Investigational New Drug application to begin a 70-patient open-label Phase 2 clinical trial of EDP1503, a monoclonal microbial for the treatment of cancer. The University of Chicago will conduct this investigator-sponsored open-label clinical trial, which is designed to evaluate the safety, tolerability, and efficacy of EDP1503 in combination with a checkpoint inhibitor in patients with metastatic melanoma.
In April 2018, Evelo dosed the first subject in its 96-subject Phase 1 clinical trial of EDP1066, a monoclonal microbial for the treatment of inflammatory diseases. This clinical trial is designed to evaluate the safety and tolerability of a range of daily doses of EDP1066 in healthy volunteers and in patients with psoriasis and atopic dermatitis. Additional exploratory endpoints include the effect of EDP1066 on validated clinical measures of disease and on an integrated set of biomarkers.
Harvard University Research Collaboration:

In June 2018, Evelo entered into a research collaboration with scientists at Harvard University to study the gut-body network. Evelo will work with three of the world’s leading experts in immunology and microbiology at Harvard Medical School: Diane Mathis, Ph.D., the Morton Grove-Rasmussen Professor of Microbiology and Immunobiology, Christophe Benoist, M.D., Ph.D., the Morton Grove-Rasmussen Professor of Immunohematology, and Dennis Kasper, M.D., the William Ellery Channing Professor of Medicine and Professor of Microbiology and Immunobiology. The collaboration aims to further elucidate the mechanisms by which microbes acting on cells in the gut have the potential to treat disease elsewhere in the body. Under the multi-year agreement, Evelo has an exclusive option to license from Harvard intellectual property rights that may arise from this research collaboration.
Corporate:

In June 2018, Evelo was added to the Russell 3000, Russell 2000 and Russell Microcap Indexes as part of the Russell Investments’ annual reconstitution.
In May 2018, Evelo completed its initial public offering of common stock at $16.00 per share, raising $75.8 million in net proceeds after deducting underwriting discounts and commissions and other offering expenses.
Upcoming Anticipated Milestones:

Initiation of the University of Chicago’s investigator-sponsored, open-label Phase 2 clinical trial of EDP1503 in combination with a PD-1 inhibitor in patients with metastatic melanoma expected in the second half of 2018.
Initiation of a Phase 1 clinical trial of EDP1815, an anti-inflammatory monoclonal microbial product candidate, in patients with psoriasis and atopic dermatitis in the fourth quarter of 2018.
Initiation of a Phase 2 clinical trial of EDP1503 in combination with a checkpoint inhibitor in patients with multiple cancer types in the first half of 2019.
Initial clinical data from ongoing Phase 1 clinical trial of EDP1066 in patients with psoriasis and atopic dermatitis in the first half of 2019.
Second Quarter 2018 Financial Results:

Cash Position: As of June 30, 2018, cash and cash equivalents were $178.9 million, as compared to cash and cash equivalents of $38.2 million as of December 31, 2017. This increase was due to net proceeds of $81.3 million from the issuance of Series C Preferred Stock, net proceeds of $75.8 million from Evelo’s initial public offering and $5.0 million of additional drawings from Evelo’s existing debt facility, partially offset by cash used to fund operating activities for the first half of 2018. Evelo expects that its cash and cash equivalents will enable it to fund its planned operating expenses and capital expenditure requirements into the second half of 2020.
Research and Development Expenses: R&D expenses were $10.2 million for the three months ended June 30, 2018, compared to $4.7 million for the three months ended June 30, 2017. The increase of $5.5 million was due primarily to increases in costs related to Evelo’s inflammation and gut-body network platform expenses as well as increased personnel costs.
General and Administrative Expenses: G&A expenses were $5.1 million for the three months ended June 30, 2018, compared to $1.5 million for the three months ended June 30, 2017. The increase of $3.6 million was due primarily to increased general and administrative personnel costs, professional and consulting fees, and facility expenses supporting Evelo’s growing organization and public company infrastructure.
Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $16.7 million for the three months ended June 30, 2018, or $0.85 per basic and diluted share, as compared to a net loss attributable to common stockholders of $7.8 million for the three months ended June 30, 2017, or $2.09 per basic and diluted share.