On May 8, 2017 Immunocore Limited, the world’s leading TCR company developing biological drugs to treat cancer, infectious diseases and autoimmune diseases, reported that it has identified a lead compound in its second discovery programme with GSK (Press release, Immunocore, MAY 8, 2017, View Source [SID1234518893]). This novel ImmTAC lead molecule is relevant in a number of cancers including triple negative breast cancers, oesophageal, gastric and ovarian cancers. The identification of this new ImmTAC has triggered an undisclosed milestone payment to Immunocore.

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Immunocore is now working on two ImmTAC programmes under the discovery collaboration agreement with GSK. The first ImmTAC programme under Immunocore’s GSK collaboration is on track to be submitted as an IND this year and will enter Phase I clinical studies during early 2018, with potential application in Non-Small Cell Lung Cancer (NSCLC), bladder cancer, synovial sarcoma, melanoma and ovarian cancer.

Immunocore and GSK announced their collaboration in 2013, and Immunocore will receive up to a total of £142 million in pre-clinical milestone payments. In addition, for each product that reaches the market, up to £200 million is due to Immunocore in development and commercial milestone payments, plus up to double digit royalties. Immunocore will be responsible for all pre-clinical development and for the initial clinical trial in patients for the first two programmes. GSK will be responsible for the remaining development and commercialisation of the products.

Dr Bent Jakobsen, Chief Scientific Officer at Immunocore, commented: "Our discovery collaboration with GSK is generating novel ImmTAC molecules which are relevant across multiple solid tumours and the disease targets are all intracellularly located, which are hard for other biologic platforms to reach. Our ImmTAC technology is continuing to demonstrate its versatility across a wide range of cancer types showing an ability to tackle solid ‘cold’, low mutation rate tumours – the majority of tumours and across other diseases. We are growing increasingly confident about our opportunity to help patients with some of the most intractable cancers and major diseases."

Dr Axel Hoos, Senior Vice President Therapeutic Area Head, Oncology R&D Head, at GSK, added: "Our collaboration with Immunocore is progressing extremely well and we have identified novel and promising ImmTAC molecules with potential utility across a broad range of cancer types. We look forward to continued progress in both programmes."

On May 8, 2017 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported operating results for the first quarter 2017 and reiterated timelines for its upcoming data presentations (Press release, Epizyme, MAY 8, 2017, View Source [SID1234518890]).

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Upcoming Tazemetostat Clinical Data Presentations

Phase 2 in Molecularly Defined Solid Tumors: Interim efficacy and safety data from study cohorts in Epizyme’s ongoing Phase 2 clinical trial of tazemetostat in adult patients with molecularly defined solid tumors that have reached futility assessment by the Independent Data Monitoring Committee will be reported in two poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2017 in Chicago. The Company will host a conference call to discuss the data on Thursday, May 18 at 8:30 a.m. ET, after ASCO (Free ASCO Whitepaper) abstracts have been released.

To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 12186629. The webcast, and accompanying slides for the call, will be accessible under "Events and Presentations" in the Investor Relations section of the Company’s website at www.epizyme.com.

Phase 2 in Non-Hodgkin Lymphoma: Interim efficacy and safety data from all five monotherapy study cohorts in Epizyme’s ongoing Phase 2 study of tazemetostat in patients with relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) has been selected for a plenary session on Wednesday, June 14, 2017 at 2:00 p.m. CET (8:00 a.m. ET) at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. Data from a 62-gene panel biomarker study of tazemetostat in patients with NHL will also be presented in a poster session during ICML. The Company plans to hold a conference call to discuss these clinical findings on Wednesday, June 14 at 10:30 a.m. ET.

To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 15855261. The webcast, and accompanying slides for the call, will be accessible under "Events and Presentations" in the Investor Relations section of the Company’s website at www.epizyme.com.
"Already in 2017, we have made progress in our novel epigenetic pipeline, led by tazemetostat," stated Robert Bazemore, president and chief executive officer. "We have continued to advance tazemetostat in multiple clinical trials in a range of solid tumors and hematological malignancies, and as both a monotherapy and in combination with other anti-cancer agents. We look forward to reporting interim data from our Phase 2 study in molecularly defined solid tumors in our conference call next week and from our Phase 2 study in relapsed or refractory FL and DLBCL in June."

Recent Achievements

In May 2017, the Company earned a $10 million milestone payment from GlaxoSmithKline (GSK). The milestone payment follows GSK’s initiation of GLP toxicology studies for a first-in-class methyltransferase inhibitor discovered by Epizyme and licensed to GSK.
In April 2017, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to tazemetostat for the treatment of patients with relapsed or refractory FL, including patients whose tumors have wild type EZH2 or EZH2 activating mutations. Fast Track designation is intended to provide expedited processes for the development and FDA review of drugs that may reduce development time and costs associated with bringing a drug to market.
In March 2017, Epizyme initiated clinical investigation of tazemetostat in combination with prednisolone in relapsed or refractory patients with DLBCL, based on observed preclinical synergy of the agents. This combination regimen is being conducted as the sixth cohort in the ongoing Phase 2 NHL study.
In January 2017, Epizyme completed enrollment of all wild type EZH2 cohorts in its ongoing Phase 2 study of tazemetostat in patients with relapsed or refractory FL and DLBCL.
First Quarter 2017 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $211.2 million as of March 31, 2017, as compared to $242.2 million as of December 31, 2016.
Revenue: No revenue was recognized in the first quarter of 2017, compared to $0.5 million for the first quarter of 2016.
R&D Expenses: Research and development (R&D) expenses were $24.7 million for the first quarter of 2017, compared to $17.7 million for the first quarter of 2016. The increase is primarily due to the expansion of the tazemetostat clinical program and advancement of our proprietary research pipeline.
G&A Expenses: General and administrative (G&A) expenses were $8.3 million for the first quarter of 2017, compared to $5.8 million for the first quarter of 2016. The increase is primarily due to higher pre-commercial, intellectual property, business development and product planning expenses.
Net Loss: Net loss was $32.5 million for the first quarter of 2017, compared to $22.9 million for the first quarter of 2016.
2017 Guidance
Epizyme believes, based on its current operating plan, that its cash, cash equivalents and marketable securities of $211.2 million as of March 31, 2017 will be sufficient to fund the Company’s planned operations into at least the third quarter of 2018.

About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma, as well as in combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of patients with relapsed or refractory FL, either wild type EZH2 or with EZH2 activating mutations, and for relapsed or refractory DLBCL with EZH2 activating mutations, as well as Orphan Drug designation for malignant rhabdoid tumors.

On May 5, 2017 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three months ended March 31, 2017(Press release, Eagle Pharmaceuticals, MAY 8, 2017, View Source [SID1234518888]). Highlights of and subsequent to the first quarter of 2017 include:

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Business Highlights:

Bendeka total market share rose to 95%, as of March 31, 2017;
Received a $25 million sales milestone payment from Teva related to cumulative Bendeka sales reaching $500 million;
Eight new patents allowed by the U.S. Patent and Trademark Office for Eagle’s Bendeka portfolio bringing the total to 14 issued or allowed, with 13 listed in the Orange Book;
Ryanodex sales increased to $4.4 million during the first quarter;
Granted Priority Review by the U.S. Food and Drug Administration (FDA) for the Company’s NDA for Ryanodex for Exertional Heat Stroke (EHS) with a PDUFA target date of July 23, 2017;
Appointed Richard A. Edlin to the Company’s Board of Directors, and as a member of the Board’s Nominating and Corporate Governance Committee;
NDA for Pemetrexed Injection for non-small cell lung cancer and mesothelioma accepted for filing; PDUFA target date of October 30, 2017; and,
By the end of the quarter, Eagle had purchased $51 million in Eagle common stock as part of its $75 million Share Repurchase Program. Since commencing this program approved by the Board in August 2016, Eagle has purchased 756,000 shares.
Financial Highlights:

First Quarter

Total revenue for the first quarter of 2017 grew 160% to $76.8 million compared to $29.6 million in the first quarter of 2016;
Product sales increased to $15.3 million compared to $14.1 million in Q1 2016;
Royalty revenue increased to $36.5 million compared to $9.5 million in Q1 2016;
License and other revenue increased to $25.0 million compared to $6.0 million in Q1 2016;
Sales of Ryanodex grew 132% to $4.4 million during the first quarter of 2017 compared to $1.9 million in Q1 2016;
Q1 2017 income before income tax provision was $32.7 million;
Q1 2017 net income was $22.9 million, or $1.50 per basic and $1.42 per diluted share, compared to a net loss of $0.9 million, or $0.06 per basic and $0.06 per diluted share in Q1 2016; and,
Cash and cash equivalents were $27.7 million and accounts receivable were $84.7 million as of March 31, 2017.
"This was another strong quarter for Eagle, driven by Bendeka and Ryanodex, with sequential and year-over-year growth in revenue and profitability. We are executing our strategy and remain confident that it will be another transformative year for Eagle with ongoing progress," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"With Priority Review granted by the FDA for our Ryanodex NDA for Exertional Heat Stroke and a PDUFA date of July 23, 2017, we are preparing for launch and are scaling our commercial organization accordingly. With multiple opportunities in place including our Pemetrexed PDUFA date in October, continued progress on fulvestrant and a potential third indication for Ryanodex for Ecstasy and methamphetamine intoxication, we expect the momentum to continue. We are also investing in our product pipeline, with up to four clinical trials anticipated this year and look forward to reporting on our progress," added Tarriff.

First Quarter 2017 Financial Results

Total revenue for the three months ended March 31, 2017 was $76.8 million, as compared to $29.6 million for the three months ended March 31, 2016. A summary of total revenue is outlined below:


Three Months Ended March 31,
2017 2016

Revenue:
Product sales $ 15,286 $
14,122

Royalty revenue 36,507 9,469
License and other revenue 25,000 6,000
Total revenue 76,793 29,591

Product sales increased to $15.3 million on net product sales in Bendeka, Ryanodex, docetaxel injection non-alcohol formulation, and Argatroban. Royalty revenue increased to $36.5 million, as a result of the increased sales of Bendeka. License and other revenue increased to $25.0 million due to the milestone payment from Teva triggered by cumulative sales of Bendeka of $500 million.

Research and development expenses increased to $7.5 million in the three months ended March 31, 2017, compared to $5.5 million in the prior year quarter. The increase was largely due to continued spending on our R&D pipeline.

SG&A expenses increased to $18.6 million in the first quarter of 2017 compared to $12.1 million in the three months ended March 31, 2016. Sales and marketing pre-launch related expenses accounted for the bulk of the increase as the Company prepares for the commercial launch of Ryanodex for EHS, if approved.

An income tax provision of $9.7 million was recorded during the first quarter.

Net income for the first quarter of 2017 was $22.9 million, or $1.50 per basic share and $1.42 per diluted share, compared to net loss of $896,000, or $0.06 per basic and $0.06 per diluted share in the three months ended March 31, 2016, due to the factors discussed above.

Liquidity

As of March 31, 2017, the Company had $27.7 million in cash and cash equivalents and $84.7 million in net accounts receivable, $71 million of which was due from Teva. This represents an increase of $17.4 million in cash and cash equivalents and net accounts receivable compared to December 31, 2016. The Company had no outstanding debt.Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three months ended March 31, 2017. Highlights of and subsequent to the first quarter of 2017 include:

Business Highlights:

Bendeka total market share rose to 95%, as of March 31, 2017;
Received a $25 million sales milestone payment from Teva related to cumulative Bendeka sales reaching $500 million;
Eight new patents allowed by the U.S. Patent and Trademark Office for Eagle’s Bendeka portfolio bringing the total to 14 issued or allowed, with 13 listed in the Orange Book;
Ryanodex sales increased to $4.4 million during the first quarter;
Granted Priority Review by the U.S. Food and Drug Administration (FDA) for the Company’s NDA for Ryanodex for Exertional Heat Stroke (EHS) with a PDUFA target date of July 23, 2017;
Appointed Richard A. Edlin to the Company’s Board of Directors, and as a member of the Board’s Nominating and Corporate Governance Committee;
NDA for Pemetrexed Injection for non-small cell lung cancer and mesothelioma accepted for filing; PDUFA target date of October 30, 2017; and,
By the end of the quarter, Eagle had purchased $51 million in Eagle common stock as part of its $75 million Share Repurchase Program. Since commencing this program approved by the Board in August 2016, Eagle has purchased 756,000 shares.
Financial Highlights:

First Quarter

Total revenue for the first quarter of 2017 grew 160% to $76.8 million compared to $29.6 million in the first quarter of 2016;
Product sales increased to $15.3 million compared to $14.1 million in Q1 2016;
Royalty revenue increased to $36.5 million compared to $9.5 million in Q1 2016;
License and other revenue increased to $25.0 million compared to $6.0 million in Q1 2016;
Sales of Ryanodex grew 132% to $4.4 million during the first quarter of 2017 compared to $1.9 million in Q1 2016;
Q1 2017 income before income tax provision was $32.7 million;
Q1 2017 net income was $22.9 million, or $1.50 per basic and $1.42 per diluted share, compared to a net loss of $0.9 million, or $0.06 per basic and $0.06 per diluted share in Q1 2016; and,
Cash and cash equivalents were $27.7 million and accounts receivable were $84.7 million as of March 31, 2017.
"This was another strong quarter for Eagle, driven by Bendeka and Ryanodex, with sequential and year-over-year growth in revenue and profitability. We are executing our strategy and remain confident that it will be another transformative year for Eagle with ongoing progress," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"With Priority Review granted by the FDA for our Ryanodex NDA for Exertional Heat Stroke and a PDUFA date of July 23, 2017, we are preparing for launch and are scaling our commercial organization accordingly. With multiple opportunities in place including our Pemetrexed PDUFA date in October, continued progress on fulvestrant and a potential third indication for Ryanodex for Ecstasy and methamphetamine intoxication, we expect the momentum to continue. We are also investing in our product pipeline, with up to four clinical trials anticipated this year and look forward to reporting on our progress," added Tarriff.

First Quarter 2017 Financial Results

Total revenue for the three months ended March 31, 2017 was $76.8 million, as compared to $29.6 million for the three months ended March 31, 2016. A summary of total revenue is outlined below:


Three Months Ended March 31,
2017 2016

Revenue:
Product sales $ 15,286 $
14,122

Royalty revenue 36,507 9,469
License and other revenue 25,000 6,000
Total revenue 76,793 29,591

Product sales increased to $15.3 million on net product sales in Bendeka, Ryanodex, docetaxel injection non-alcohol formulation, and Argatroban. Royalty revenue increased to $36.5 million, as a result of the increased sales of Bendeka. License and other revenue increased to $25.0 million due to the milestone payment from Teva triggered by cumulative sales of Bendeka of $500 million.

Research and development expenses increased to $7.5 million in the three months ended March 31, 2017, compared to $5.5 million in the prior year quarter. The increase was largely due to continued spending on our R&D pipeline.

SG&A expenses increased to $18.6 million in the first quarter of 2017 compared to $12.1 million in the three months ended March 31, 2016. Sales and marketing pre-launch related expenses accounted for the bulk of the increase as the Company prepares for the commercial launch of Ryanodex for EHS, if approved.

An income tax provision of $9.7 million was recorded during the first quarter.

Net income for the first quarter of 2017 was $22.9 million, or $1.50 per basic share and $1.42 per diluted share, compared to net loss of $896,000, or $0.06 per basic and $0.06 per diluted share in the three months ended March 31, 2016, due to the factors discussed above.

Liquidity

As of March 31, 2017, the Company had $27.7 million in cash and cash equivalents and $84.7 million in net accounts receivable, $71 million of which was due from Teva. This represents an increase of $17.4 million in cash and cash equivalents and net accounts receivable compared to December 31, 2016. The Company had no outstanding debt.

On May 8, 2017 AVEO Oncology (NASDAQ: AVEO) reported that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. patent application number 14/653,684, entitled "notch binding agents and antagonists and methods of use thereof." Allowed under the application are composition of matter and method of use claims related to the Company’s humanized anti-Notch 3 antibodies, including AV-353. The U.S. patent scheduled to issue from this application will expire December 19, 2032, with the potential for extension to December 19, 2037.

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AV-353 is a potent inhibitory antibody specific to Notch 3, a pathway implicated in multiple diseases, including Pulmonary Arterial Hypertension (PAH). In preclinical studies, AV-353 has demonstrated the ability to potentially reverse the PAH disease phenotype, which would represent a potential disease-modifying approach to treatment. PAH is a rare and life-threatening disorder that affects approximately 250,000 people worldwide and is caused by enlargement of the arterial walls in small arteries between the heart and the lungs, resulting in restricted blood flow.

"AV-353’s disease modifying properties have the potential to transform the future treatment of PAH, a debilitating disorder for which current therapies target only symptoms," said Michael Bailey, president and chief executive officer of AVEO. "AV-353’s selectivity and high affinity to Notch 3, which are unique from other approaches targeting the Notch pathway, have enabled us to build an increasingly broad patent estate around the program. Consistent with our strategic focus on oncology, we continue to engage with potential partners around the worldwide development of this important therapeutic candidate."

On May 8, 2017 Array BioPharma Inc. (Nasdaq: ARRY) reported that it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the United States and Canada) to investigate the safety and efficacy of Array’s MEK inhibitor, binimetinib, with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in metastatic colorectal cancer patients with microsatellite stable tumors (MSS CRC) (Press release, Array BioPharma, MAY 8, 2017, View Source [SID1234518886]).

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The companies are entering into this collaboration based on the growing body of preclinical and clinical evidence that the immune activity of an anti-PD-1 therapy, such as KEYTRUDA, can be enhanced when combined with a MEK inhibitor, such as binimetinib.

"Array is excited to announce this partnership with Merck, an established leader in the field of immuno-oncology," said Ron Squarer, Chief Executive Officer, Array BioPharma. "Given the synergistic activity we have seen with our MEK inhibitor when combined with anti-PD-1 therapy in preclinical models, and based on emerging clinical data, we are optimistic that this combination holds great potential for cancer patients."

Under the terms of the agreement, Array and Merck will collaborate on a clinical trial to investigate the safety and efficacy of the combination of binimetinib with KEYTRUDA, in MSS CRC patients. The trial is expected to establish a recommended dose regimen of binimetinib and KEYTRUDA, as well as explore the preliminary anti-tumor activity of several novel regimens. The study is expected to begin in the second half of 2017. Results from this first study will be used to determine optimal approaches to further clinical development of these combinations.

The collaboration agreement is between Array BioPharma and Merck, through a subsidiary. Under the agreement, the trial will be sponsored by Merck. Additional details of the collaboration were not disclosed.

About Colorectal Cancer
Worldwide, colorectal cancer is the third most common type of cancer in men and the second most common in women, with approximately 1.4 million new diagnoses in 2012. Of these, nearly 750,000 were diagnosed in men, and 614,000 in women. Globally in 2012, approximately 694,000 deaths were attributed to colorectal cancer. In the U.S. alone, an estimated 135,430 patients will be diagnosed with cancer of the colon or rectum in 2017, and approximately 50,000 are estimated to die of their disease. There is wide variation in 5-year survival rates across the globe, with 5-year survival expected to be around 65% in the developed world and dropping to around 20% in some developing countries. The incidence of microsatellite stability in colorectal tumors varies by stage, with nearly 80% of early stage, resectable tumors and approximately 67% of advanced, metastatic tumors exhibiting MSS.

About Binimetinib
MEK is a key protein kinase in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as melanoma, colorectal and thyroid cancers. Binimetinib is a late-stage small molecule MEK inhibitor which targets key enzymes in this pathway.

Binimetinib is being studied in clinical trials in advanced cancer patients, including the Phase 3 COLUMBUS trial in patients with BRAF-mutant melanoma and the Phase 3 BEACON CRC trial in patients with BRAF V600E-mutant colorectal cancer.