Epizyme Announces 2015 Financial Results and Financial Guidance

On March 9, 2016 Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for patients with cancer, reported certain 2015 and recent accomplishments and reported financial results for the fourth quarter of and full year 2015 (Press release, Epizyme, MAR 9, 2016, View Source [SID:1234509434]). In addition, earlier today, Epizyme announced a multi-year vision for the company’s growth through 2020.

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Key 2015 Accomplishments

Regained control of key pipeline assets: In 2015, Epizyme reacquired from Eisai the rights to tazemetostat worldwide outside of Japan and assumed leadership of the tazemetostat development strategy. The company also extended and focused its collaboration agreement with Celgene on three specific targets, regaining worldwide rights to the rest of its preclinical pipeline programs excluding the three programs partnered with GlaxoSmithKline (GSK).

Executed on robust clinical development strategy for tazemetostat: At multiple major medical meetings in 2015, Epizyme presented proof-of-concept data from an ongoing phase 1 trial with tazemetostat that demonstrated clinically meaningful activity and an acceptable safety profile in patients with non-Hodgkin lymphoma (NHL) and in patients with certain genetically defined solid tumors. Based on the findings, Epizyme initiated a global development plan for tazemetostat, which includes a five-arm, phase 2 study in patients with NHL, a three-arm phase 2 study in adult patients with certain genetically defined solid tumors, and a dose-escalation and dose-expansion phase 1 study in pediatric patients with certain genetically defined solid tumors. Epizyme also obtained FDA acceptance of INDs in the U.S. for tazemetostat for the treatment of diffuse-large B-cell lymphoma (DLBCL), the largest subset of NHL, and for certain genetically defined solid tumors.

Expanded pipeline of preclinical assets: Epizyme made substantial progress in its discovery pipeline, identifying and initiating preclinical work against five new targets, against which the company is developing small molecules wholly owned by Epizyme.
Strengthened its scientific leadership: Throughout 2015, Epizyme continued to enhance its platform capabilities. The company’s extensive epigenetics expertise with histone methyltransferases (HMTs) led to the expansion of its efforts to encompass other chromatin modifying proteins (CMPs). Epizyme has identified a prioritized set of HMT and CMP targets from which it plans to build a sustainable pipeline of potential new therapies.

Based on these significant advancements throughout 2015, Epizyme has outlined a vision and strategic plan through 2020, focused on quickly bringing tazemetostat to market, maximizing the potential of tazemetostat in a broad range of cancers and treatment settings, continuing the growth of its pipeline and further establishing the company’s scientific leadership in the field of chromatin modifying proteins. More details on the vision and strategy can be found here.

"In 2015, we made substantial progress across all aspects of the organization, which has provided a solid foundation on which to build our future," said Robert Bazemore, President and Chief Executive officer of Epizyme. "We have a unique lead product candidate, tazemetostat, that is in three registration-supporting clinical trials today, with multiple new clinical trials planned to begin in the near future. In addition, we are driving forward five new wholly owned programs, and we are continuing to expand our pipeline. We believe that Epizyme has the opportunity for tremendous growth and value creation in the short and long-term, and we look forward to executing on the strategic vision that we have laid out for the company."

Full Year 2015 Results and Financial Guidance

Collaboration revenue was $2.6 million for the year ended December 31, 2015, compared to $41.4 million for the prior year. The decrease in collaboration revenue primarily reflects the completion of a significant portion of the Company’s performance obligations under its collaborations during 2014 and achievement of a $3.0 million milestone under its agreement with GSK during 2014. The company expects to recognize an additional $1.9 million of deferred revenue related to the Celgene agreement through December 31, 2016 as the company completes its pinometostat phase 1 clinical trials.

Research and development (R&D) expenses were $111.2 million for the year ended December 31, 2015 compared to $75.6 million for the year ended December 31, 2014. The increase in costs were primarily driven by the expansion of tazemetostat clinical trials and related EZH2 activities and the $40.0 million upfront payment to Eisai in the first quarter of 2015 to reacquire rights to tazemetostat worldwide outside of Japan, partially offset by reductions in external spending on pinometostat and discovery and preclinical programs during 2015 compared to the prior year. After adjusting for the 2015 in-process research and development payment made to Eisai of $40.0 million, Epizyme expects that R&D expenses will increase in 2016, when compared to 2015. The planned increase is primarily driven by the costs of its ongoing and planned clinical trials with tazemetostat, including its registration-supporting trials in patients with non-Hodgkin lymphoma and adult and pediatric patients with certain genetically defined solid tumors, as well as planned combination studies in patients with DLBCL and the planned study in patients with BAP1 loss-of-function mesothelioma. In addition, discovery and preclinical research costs are expected to increase as the company advances its wholly owned small molecule programs against five novel targets, continues the research efforts for its Celgene partnered programs, and expands its target identification and discovery activities. Epizyme plans to offset a portion of the increased cost of its research and development programs through strategic collaborations that it will be evaluating later this year.

General and administrative (G&A) expenses increased to $23.9 million for the year ended December 31, 2015, compared to $20.9 million for the year ended December 31, 2014. The increase in G&A expense was largely due to increased intellectual property-related legal costs and personnel-related expenses associated with scaling up Epizyme’s business operations.

Net loss was $132.4 million for the year ended December 31, 2015, compared to a net loss of $55.0 million for the year ended December 31, 2014. The year-over-year decline was driven by a decrease in collaboration revenue, as well as by the costs associated with reacquiring tazemetostat rights from Eisai.

Cash and cash equivalents as of December 31, 2015 were $208.3 million, compared with $190.1 million as of December 31, 2014. Epizyme’s follow-on public offering in January 2016 raised $130.1 million in net proceeds, after underwriting discounts and commissions, upon the sale of 15.3 million common shares. As this event occurred in fiscal 2016, it is not reflected in the December 31, 2015 cash and cash equivalent balances.

Financial Guidance from Epizyme states that the Company believes its cash and cash equivalents of $208.3 million as of December 31, 2015, together with the net proceeds of $130.1 million from the January 2016 follow-on offering, will be sufficient to fund the Company’s operations through at least the end of 2017, and importantly through many key milestones.

About Tazemetostat

Epizyme is developing tazemetostat for the treatment of patients with non-Hodgkin lymphoma and for patients with certain genetically defined solid tumors. Tazemetostat is a first-in-class small molecule inhibitor of EZH2 created by Epizyme using its proprietary product platform. In some human cancers, aberrant EZH2 enzyme activity results in dysregulation of genes that control cell proliferation resulting in the rapid and unconstrained growth of tumor cells. Tazemetostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-6438.

Additional information about tazemetostat, including clinical trial information, can be found here.

GenVec Reports Fourth Quarter and 2015 Year-End Financial Results

On March 9, 2016 GenVec, Inc. (NASDAQ: GNVC) reported financial results for the fourth quarter and year ended December 31, 2015 (Press release, GenVec, MAR 9, 2016, View Source [SID:1234509430]). For the year ended December 31, 2015, the company reported a net loss of $6.5 million, or $0.39 per share, compared with a net loss of $2.5 million, or $0.16 per share, for the year ended December 31, 2014. The company ended the year with $8.7 million in cash, cash equivalents, and investments.

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"During 2015, CGF166 moved into the dose escalation portion of the Phase 1/2 trial in patients with severe hearing loss. In early January after a total of nine patients had been treated, we were notified by our partner Novartis that enrollment had been paused based on a review of data by the trial’s Data Safety Monitoring Board in accordance with prespecified criteria in the protocol," said Douglas J. Swirsky, president and CEO of GenVec. "It is important to note that we are not aware of any significant adverse events in the trial, and while there is no certainty, we believe that enrollment in the dose escalation portion will resume in the coming months. As a result, we believe that the trial will be completed sometime in 2017 as previously expected."

"During 2015 and early 2016, we accomplished a great deal to ramp up GenVec’s business development capabilities and focused our efforts on partnering with the goal of maximizing the value of our AdenoVerse gene delivery and manufacturing platform," Mr. Swirsky continued. "We advanced our work on a second-generation neural stem cell-based cancer treatment with our partner TheraBiologics, and strengthened our intellectual property portfolio, adding patents key to protecting and enabling work with our new gorilla and monkey adenovectors. These vectors are highly suited to the development of molecular vaccines and some of the newer gene-based medicine strategies, such as CAR-T and CRISPR/Cas-9. Last but not least, we’ve kept our operations lean and highly efficient, with a clear understanding that the task at hand is to maintain a low cash burn rate and build value through collaborations."

2016 Guidance

For 2016, GenVec anticipates a cash burn between $6 million and $7 million for 2016 and believes its existing resources are sufficient to fund operations into the second quarter of 2017.

2015 Financial Results

For 2015, revenue decreased 85% to $0.9 million from $6.0 million in 2014, a decrease in revenue for the year of $5.1 million versus the prior year. The decline was primarily the result of milestone payments totaling $5 million from Novartis in 2014; continuation of the CGF166 clinical trial enrollment during 2015 did not trigger additional milestone payments. Additionally, there was a $0.2 million reduction in revenues year-over-year from our work under the contract with the DHS related to our animal health program that was completed in February 2015.

Operating expenses for 2015 decreased 13% to $7.5 million from $8.6 million in 2014. General and administrative expenses decreased 22% to $4.9 million in 2015 from $6.3 million in 2014. In 2015, lower expenses were primarily attributable to the relocation of our corporate offices in 2014 and lower professional costs. These reduced costs were partially offset by increased personnel costs in 2015 as compared to 2014, incurred primarily to enhance GenVec’s business development capabilities.

Research and development expenses increased 13% to $2.6 million in 2015 from $2.3 million in 2014, primarily attributable to increased personnel costs.

Fourth Quarter 2015 Results

For the fourth quarter ended December 31, 2015, GenVec reported a net loss of $1.6 million, or $0.10 per share, compared with net income of $1.7 million, or $0.11 per share, for the comparable prior year period.

The company reported revenues of $0.2 million in the fourth quarter of 2015 compared to $3.5 million for the same period in 2014. The first patient was treated in Novartis’ Phase 1/2 clinical trial of CGF166 in October 2014, triggering a payment of $3 million to GenVec. No milestone payment was realized in the fourth quarter of 2015. Additionally, we experienced a $0.1 million reduction in fourth quarter 2015 revenue for services performed for Novartis in connection with this program as compared to the comparable prior year period. Our work under the contract with the DHS related to our animal health program was completed in February 2015; as a result we experienced reduced revenues of $0.2 million in the fourth quarter of 2015 as compared to the comparable prior year period.

Operating expenses in the fourth quarter of 2015 were $1.8 million, which is comparable to the prior year period. General and administrative expenses in the fourth quarter of 2015 were $1.3 million, which is an increase of 2% and is comparable to the prior year period. Research and development expenses decreased 7% in 2015 from $0.6 million in the fourth quarter of 2014 to $0.5 million in the fourth quarter of 2015 primarily resulting from lower professional costs.

Cash Position

As of March 3, 2016, the company had $7.2 million in cash, cash equivalents, and investments (unaudited).

Epizyme Unveils Corporate Strategy to Guide Efforts over Next Five Years

On March 9/2016 Epizyme, Inc., (NASDAQ:EPZM) a clinical stage biopharmaceutical company creating novel epigenetic therapies for patients with cancer, reported its corporate vision and strategy through 2020 (Press release, Epizyme, MAR 9, 2016, View Source [SID:1234509477]).

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During the next five years, Epizyme will focus on four transformative activities:

Transitioning to a commercial-stage organization through the global launch of tazemetostat in patients with non-Hodgkin lymphoma (NHL) and in patients with certain genetically defined solid tumors;
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 oncology 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.
"Our entire company is driven by our vision of rewriting cancer therapy through targeted medicines for patients with unsolved diseases," said Robert Bazemore, President & Chief Executive Officer. "Epizyme is committed to scientific excellence and pipeline innovation, which has allowed us to become the leading company in the discovery and development of epigenetic therapies in oncology. We have a clear set of priorities for 2016 designed to position us to deliver for patients and our stakeholders over the short, intermediate, and long term."

Accelerating Tazemetostat Registration

Epizyme is focused on a number of critical activities intended to accelerate the development of tazemetostat, aiming to bring it patients who may benefit as quickly as possible. Tazemetostat has demonstrated the potential to treat both hematologic malignancies and solid tumors, which laid the foundation for its aggressive development plan. Epizyme is currently evaluating tazemetostat in multiple global registration-supporting clinical trials, including a phase 2 five-arm study in patients with NHL, a phase 2 three-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. Planned activities include:

Accelerating enrollment in the ongoing tazemetostat clinical trials through expansion into the U.S. and other countries, doubling the number of trial sites for the NHL study, and opening up to 45 trial sites for the genetically defined solid tumor studies.
Assessing expedited paths to market, including opportunities to proceed without randomized clinical trials prior to market entry.
Advancing clinical pharmacology studies to support registration and making manufacturing investments to prepare for approval.
Strengthening company functions needed to support an expedited development and launch plan.
"We have a number of important clinical and data milestones on the horizon in 2016, including reporting interim findings from our five-arm phase 2 study of tazemetostat in patients with NHL in the middle of this year," said Peter Ho, M.D., Ph.D., Chief Medical Officer. "The study is enrolling patients ahead of our expectations, and we look forward to assessing the data mid-year and with sufficient evidence of activity, we intend to move quickly into discussions with regulatory authorities to establish the path forward in each subtype of NHL."

Maximizing Tazemetostat Potential

In parallel to the accelerated development efforts for tazemetostat, Epizyme is working to expand the future utility of tazemetostat for a broad range of patients and physicians. Company activities to enable this include:

Exploring the potential of tazemetostat in front-line NHL by initiating a phase 1b/2 clinical trial of tazemetostat in combination with the current standard of care, R-CHOP. This study is expected to initiate in the second quarter of 2016.
Evaluating the additional potential of tazemetostat to enhance the clinical activity of immuno-oncology therapies by combining with an anti-PD1 or PDL-1 agent. Preclinical studies in the field show that EZH2 inhibitors, including tazemetostat, may potentially prime tumor cells and the microenvironment for synergy with immune checkpoint inhibitors. We plan to enter into a collaboration with a partner for this phase 1b combination study in the second quarter of 2016, and initiate the study mid-year.
Identifying new indications where tazemetostat may provide benefit and initiating clinical development in five new indications over the next five years. The first of these is BAP1 loss-of-function mesothelioma, which will enter clinical development in the third quarter of 2016.
Acting rapidly to initiate proof-of-concept studies where there is strong preclinical evidence of tumor sensitivity to EZH2 inhibition in a clearly defined patient population.
Continuing to invest in academic collaborations to evaluate the role of tazemetostat in new preclinical models.
Pipeline Growth and Scientific Leadership

Epizyme’s scientific expertise has led the company to expand its efforts to encompass histone methyltransferases (HMTs), as well as other chromatin modifying proteins (CMPs), which are implicated in multiple forms of hematological malignancies, solid tumors and other serious illnesses.

"Epizyme’s leadership in the areas of epigenetics and chromatin modification is the foundation of our long-term growth," said Robert Copeland, Ph.D., President of Research and Chief Scientific Officer. "We have demonstrated that our discovery platform can rapidly identify important therapeutic targets and effectively create small molecule drug candidates against those targets. We believe we have many opportunities to replicate the success we’ve seen with tazemetostat as we go forward."

To enable Epizyme’s long-term growth, the company plans to:

Build on the significant anti-tumor potential of histone methyltransferase inhibition and chromatin modifying protein inhibition by investing in the continued expansion and utilization of its proprietary platform to develop a pipeline of HMT and other CMP inhibitors.
Identify 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.
Develop small molecule inhibitors against five novel targets identified by Epizyme that the company has designated as priority programs. These efforts are underway along with preclinical drug discovery to evaluate their viability as future clinical programs.
Initiate clinical development of at least three new small molecule oncology programs by 2020.
Retain rights to its wholly owned programs in the U.S., as well in certain foreign areas as part of potential future partnerships.
Evaluate potential new platform and program partnering opportunities both within and outside of oncology that might benefit from having a strategic partner, and provide additional downstream value-creation.
Summary

Bazemore concluded: "We are confident that we will continue to achieve great things to bring value for patients and our stakeholders. We have significant assets in tazemetostat, our early-stage pipeline, and our scientific platform, and following our financing in January, we have the resources to maximize their value through key milestones. In short, we have a clear strategy and are in a strong position to accomplish our goal."

About Tazemetostat

Epizyme is developing tazemetostat for the treatment of patients with non-Hodgkin lymphoma and for patients with certain genetically defined solid tumors. Tazemetostat is a first-in-class small molecule inhibitor of EZH2 created by Epizyme using its proprietary product platform. In some human cancers, aberrant EZH2 enzyme activity results in dysregulation of genes that control cell proliferation resulting in the rapid and unconstrained growth of tumor cells. Tazemetostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-6438.

Additional information about tazemetostat, including clinical trial information, can be found here.

Advaxis Truly Personalized Cancer Immunotherapy Moves Forward With Signing of an Exclusive Supply Agreement With Synthetic Genomics for Synthetic DNA

On March 09, 2016 (Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, and SGI-DNA, a wholly owned subsidiary of Synthetic Genomics, Inc. (SGI), reported that the companies have entered into a five-year exclusive supply agreement (Press release, Advaxis, MAR 9, 2016, View Source [SID:1234509453]). Under the terms of the agreement, SGI-DNA will manufacture for Advaxis synthetic DNA which will be used in Advaxis’ personalized Listeria monocytogenes (Lm)-based immunotherapy, known as MINE (My Immunotherapy Neo-Epitopes).

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The goal of MINE is to use Advaxis’ Lm Technology to develop neo-epitope immunotherapies based on the specific and unique neo-epitopes found in an individual patient’s tumor. These neo-epitopes are built into DNA plasmids made exclusively by SGI-DNA for Advaxis and then inserted by Advaxis into patient specific immunotherapy constructs (ADXS-NEO), targeting the unique neo-epitope sequences identified in the patient’s tumor cells.

SGI-DNA’s synthetic DNA business is built on scientific advancements and breakthroughs from leading scientists including J. Craig Venter, Hamilton Smith, Clyde Hutchison, Dan Gibson and their teams, and utilizes DNA technologies to produce complex synthetic DNA. SGI-DNA also offers the BioXpTM 3200 System, the world’s first DNA printer, as well as a comprehensive suite of genomic services, including whole genome sequencing, library design, bioinformatics services, and reagent kits to enable synthetic biology.

"SGI-DNA is unparalleled in its commitment to innovative science, genomic services, bioinformatics and their ability to support DNA synthesis of components of Advaxis Lm immunotherapies," said Daniel O’Connor, President and Chief Executive Officer of Advaxis. "Our work with SGI-DNA will assist us in the development of our Lm Technologies and our innovative work with neo-epitopes to move us toward our planned filing of an Investigational New Drug Application later this year."

"We are excited to work with the Advaxis team and support their research and development program," said Nathan Wood, President of SGI-DNA. "We believe that SGI’s technical expertise in gene synthesis will help Advaxis meet its goal of making practical and effective personalized neo-epitope based treatments available for patients with cancer."

SGI-DNA’s proficiency with genomic sequencing, synthesis, and bioinformatics will factor in Advaxis’ current MINE research with Memorial Sloan Kettering Cancer Center (MSK).

Genmab Announces European Regulatory Submission for Ofatumumab in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL

On March 9, 2016 Genmab A/S (Nasdaq Copenhagen: GEN) reported that a variation to the Marketing Authorization has been submitted to the European Medicines Agency (EMA) for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) (Press release, Genmab, MAR 9, 2016, View Source [SID:1234509441]).

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The application was submitted by Novartis under the ofatumumab collaboration between Novartis and Genmab.

The application is based on the results from a Phase III study, COMPLEMENT 2, which evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL. Top-line results from this trial were reported in April 2015. The study met the primary endpoint with a median progression free survival in patients receiving ofatumumab in combination with FC of 28.9 months compared to 18.8 months in patients receiving FC alone (HR =0.67, p=0.0032).

"Today’s regulatory submission in Europe brings us another step closer to making ofatumumab available to a wider group of patients with relapsed CLL and we look forward to the EMA’s response," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About CLL
CLL is the most common form of leukemia in the western world, accounting for 30% of adult leukemias.1 Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment.2

About COMPLEMENT 2
COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomized, Phase III study, which included 365 patients in 18 countries with relapsed CLL. Patients in the study were randomized 1:1 to treatment with up to six cycles of ofatumumab in combination with fludarabine and cyclophosphamide or up to six cycles with fludarabine and cyclophosphamide alone.

The primary endpoint of the study was PFS, which was assessed by an Independent Review Committee (IRC) according to the International Workshop for Chronic Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines.3 Secondary endpoints included overall response rate, overall survival, patient reported outcomes, time to response, duration of response, time to progression, time to next therapy, safety assessments and quality of life.

About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. Arzerra is also approved as extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL in the U.S. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.

Arzerra is not approved anywhere in the world in combination with fludarabine and cyclophosphamide as treatment for relapsed CLL.

Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).

Arzerra is marketed under a collaboration agreement between Genmab and Novartis. Novartis has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.