On February 25, 2016 The Bayer Group reported that they had a very successful year in 2015, both strategically and operationally (Press release, Bayer, FEB 24, 2016, View Source [SID:1234509183]).

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"Operationally it was another record year for Bayer. Sales reached the highest level in the company’s history, exceeding EUR 46 billion. Clean EBITDA substantially rose by about 18 percent and also set a new record of more than EUR 10 billion," Management Board Chairman Dr. Marijn Dekkers said on Thursday at the Financial News Conference in Leverkusen. "Strategically we have taken all the necessary steps to make Bayer a pure Life Science company," said Dekkers. The Bayer CEO explained that the company had floated the former MaterialScience subgroup on the stock market under the name Covestro and implemented a reorganization to set the course for Bayer’s successful further development. Dekkers forecasted further growth in sales and earnings in 2016.

Group sales advanced by 12.1 percent to EUR 46,324 million (2014: EUR 41,339 million). After adjusting for currency and portfolio effects (Fx & portfolio adj.), the increase was 2.7 percent. EBITDA before special items increased by 18.2 percent to EUR 10,266 million (2014: EUR 8,685 million). The good business development was accompanied by higher R&D expenses (a year-on-year increase of around EUR 740 million). Positive currency effects buoyed earnings by about EUR 680 million. EBIT increased by 15.8 percent to EUR 6,250 million (2014: EUR 5,395 million) after net special charges of EUR 819 million (2014: EUR 438 million). The special charges mainly comprised expenses for the consolidation of production sites, integration costs for acquired businesses and expenses connected with the carve-out and stock market flotation of Covestro. A special gain from a litigation in connection with a breach of contract and patent infringement had a positive effect. Net income climbed by 20.0 percent to EUR 4,110 million (2014: EUR 3,426 million), and core earnings per share from continuing operations by 16.0 percent to EUR 6.83 (2014: EUR 5.89).

Gross cash flow from continuing operations rose by 4.4 percent to EUR 6,999 million (2014: EUR 6,707 million) and was thus substantially above the gross cash flow hurdle of approximately EUR 5.7 billion. "In 2015, Bayer far exceeded the minimum return and reproduction requirements and thus created value. All subgroups contributed to this performance," stressed Chief Financial Officer Johannes Dietsch. Net cash flow (total) rose by 18.6 percent to EUR 6,890 million (2014: EUR 5,810 million). Net financial debt declined by EUR 2.2 billion between the end of 2014 and December 31, 2015, to EUR 17.4 billion.

Substantial sales and earnings growth at HealthCare

Sales of the HealthCare subgroup rose by 19.9 percent (Fx & portfolio adj. 8.1 percent) to EUR 22,874 million (2014: EUR 19,075 million). "This encouraging growth was driven by the recently launched pharmaceutical products," explained Dekkers. "Business also expanded in all divisions of the Consumer Health segment." The considerable reported sales growth was chiefly attributable to the products acquired from Merck & Co., Inc., United States, and to currency effects.

Sales of the Pharmaceuticals segment climbed by a substantial 9.9 percent (Fx & portfolio adj.) to EUR 13,745 million. The recently launched products – the anticoagulant Xarelto, the eye medicine Eylea, the cancer drugs Stivarga and Xofigo, and Adempas to treat pulmonary hypertension – posted combined sales of EUR 4,231 million (2014: EUR 2,908 million). Sales of Xarelto were up by a significant 34.2 percent (Fx adj.), mainly as a result of expanded volumes in Germany and Japan. A strong sales gain was also registered in the United States, where Xarelto is marketed by a subsidiary of Johnson & Johnson. Following its approval in additional indications, sales of Eylea posted even more substantial growth of 57.4 percent (Fx adj.).

Among Bayer’s established top products, the hormone-releasing intrauterine devices of the Mirena product family and the cancer drug Nexavar in particular were successful. Sales of these products rose by 5.7 and 7.4 percent (Fx adj.), respectively. Increased competition caused sales of our multiple sclerosis drug Betaferon/Betaseron to decline by 8.1 percent (Fx adj.). In addition, business with YAZ/Yasmin/Yasminelle oral contraceptives declined by 4.7 percent (Fx adj.) due to generic competition in Europe and the United States. Overall, the Pharmaceuticals business registered encouraging growth in all regions on a currency-adjusted basis. Business developed especially well in Germany, Japan and the United States.

Sales of the Consumer Health segment advanced by 5.1 percent (Fx and portfolio adj.) to EUR 9,129 million. Consumer Care achieved sales of EUR 1,770 million with the products acquired from Merck & Co., Inc., United States. The skincare product Bepanthen/ Bepanthol posted considerable growth of 11.5 percent (Fx adj.). Business with the antifungal product Canesten showed pleasing development in all regions (Fx adj. plus 17.3 percent). Sales of the analgesic Aleve also developed positively (Fx adj. plus 4.8 percent), mainly because of price and volume increases in Latin America/Africa/Middle East. In the Animal Health Division, the Seresto flea and tick collar made a significant contribution to sales growth. By contrast, sales of the Advantage family of flea, tick and worm control products receded slightly (Fx adj. minus 1.3 percent). In the contrast agents and medical equipment business (Medical Care), the MRI contrast agent Gadovist/ Gadavist posted encouraging growth of 17.6 percent (Fx adj.).

EBITDA before special items of HealthCare rose by a substantial 19.8 percent to EUR 6,419 million (2014: EUR 5,357 million). This earnings growth resulted mainly from the very favorable development of business at Pharmaceuticals and Consumer Health – at the latter especially due to the contributions from the acquired businesses. There were also positive currency effects of about EUR 250 million. Earnings were diminished by increased research and development spending at Pharmaceuticals and higher selling expenses at Consumer Health.

CropScience: good business development despite a weaker market environment

Sales of the agriculture business (CropScience) increased in 2015 by 9.2 percent (Fx & portfolio adj. 1.7 percent) to EUR 10,367 million (2014: EUR 9,494 million). "Despite a weaker market environment, sales at CropScience increased further," stressed Dekkers. "We thus grew faster on average than our most important competitors." Both Crop Protection/Seeds and Environmental Science registered growth. In regional terms, business in Europe saw particularly encouraging development. There, CropScience achieved a gain of 8.2 percent (Fx adj.). Sales rose by 1.3 percent (Fx adj.) in Asia/Pacific but declined by 1.6 percent (Fx adj.) in North America. In Latin America/Africa/Middle East, sales were level year on year (Fx adj. minus 0.5 percent).

Crop Protection posted gratifying sales gains at Fungicides (Fx & portfolio adj. plus 9.5 percent) and Herbicides (Fx & portfolio adj. plus 5.4 percent) but a substantial decline at Insecticides (Fx & portfolio adj. minus 14.0 percent) that was mainly attributable to lower pest pressure in Brazil. Sales of SeedGrowth (seed treatments) fell by 10.6 percent (Fx and portfolio adj.). At Seeds, sales improved by 8.8 percent (Fx & portfolio adj.) with soybeans and canola seed developing particularly well. Business in Environmental Science advanced by 4.1 percent (Fx & portfolio adj.).

EBITDA before special items of CropScience improved by 2.4 percent to EUR 2,416 million (2014: EUR 2,360 million). In addition to positive earnings effects due to the satisfactory business development, including higher volumes and slightly improved selling prices, there was a very positive currency effect of about EUR 220 million. On the other hand, there was an increase in the cost of goods sold and in research and development expenses.

Covestro posts strong earnings improvement

Sales of the high-tech polymer materials business (Covestro, formerly MaterialScience) moved forward by 2.8 percent to EUR 11,982 million (2014: EUR 11,651 million). Adjusted for currency and portfolio effects, sales declined by 5.1 percent as a result of lower selling prices in all business units. On the other hand, Covestro expanded volumes in all business units. EBITDA before special items improved by a marked 39.8 percent to EUR 1,659 million (2014: EUR 1,187 million). Considerably lower raw material prices more than offset the decline in selling prices. Furthermore, earnings were buoyed by positive currency effects of about EUR 240 million.

Bayer currently still holds a 69 percent interest in Covestro. As a fully consolidated subsidiary, Covestro continues to be included in the Bayer Group consolidated financial statements. In core earnings per share, however, 31 percent of Covestro earnings are attributable to external stockholders of Covestro. This has the effect of diminishing Bayer’s core earnings per share.

Sales of HealthCare and CropScience rise in the fourth quarter

Group sales rose by 4.9 percent (Fx & portfolio adj. 2.4 percent) in the fourth quarter of 2015 to EUR 11,319 million (Q4 2014: EUR 10,792 million). HealthCare and CropScience contributed to this performance, while sales were down at Covestro. EBITDA before special items improved by 4.0 percent to EUR 1,903 million (Q4 2014: EUR 1,829 million). This good business development, especially at HealthCare, was accompanied by higher R&D and selling expenses. Positive currency effects contributed EUR 200 million to earnings. EBIT improved by a significant 65.4 percent to EUR 908 million (Q4 2014: EUR 549 million). The increase in net income to EUR 613 million was even more substantial (Q4 2014: plus EUR 224 million). Core earnings per share from continuing operations fell to EUR 1.07 (Q4 2014: EUR 1.17), however. In the previous year, they were influenced by tax income.

Bayer targeting further growth in 2016

Dekkers expressed his confidence for fiscal 2016: "We are targeting further growth in both sales and earnings, building on a record year," said the Management Board Chairman. This forecast is based on the new organizational structure introduced with effect from January 1, 2016, and assumes the full-year inclusion of the Covestro business. Also underlying the forecast for fiscal 2016 are the exchange rates at the closing date on December 31, 2015, including a rate of US$1.09 to the euro.

In 2016, the Bayer Group including Covestro is planning sales of more than EUR 47 billion. This corresponds to a low-single-digit percentage increase on a currency- and portfolio-adjusted basis. Bayer plans to increase EBITDA before special items by a mid-single-digit percentage. The company aims to increase core earnings per share from continuing operations by a mid-single-digit percentage as well. This assumption takes account of the fact that only 69 percent of Covestro will be reflected for the full year 2016. From the sale of the Diabetes Care business, Bayer expects core earnings per share of just under EUR 0.40 for discontinued operations.

Sales of approximately EUR 35 billion are planned for the Life Science activities, i.e. the Bayer Group excluding Covestro (2015 pro forma: EUR 34,342 million). This corresponds to a mid-single-digit percentage increase on a currency- and portfolio-adjusted basis. Bayer also plans to increase EBITDA before special items by a mid-single-digit percentage (2015 pro forma: EUR 8,607 million). This planning includes dissynergies of around EUR 130 million from the carve-out of Covestro and from divestments.

Despite declining price developments in some areas, Bayer expects sales of approximately EUR 16 billion (2015 pro forma: EUR 15,308 million) in the Pharmaceuticals Division including the Radiology business. This corresponds to a mid-single-digit percentage increase on a currency- and portfolio-adjusted basis. The company plans to raise sales of the recently launched pharmaceutical products to more than EUR 5 billion. It expects a mid- to high-single-digit percentage increase in EBITDA before special items (2015 pro forma: EUR 4,615 million). Bayer aims to improve the EBITDA margin before special items.

In the Consumer Health Division, Bayer expects sales to come in at more than EUR 6 billion and plans to grow sales by a mid-single-digit percentage on a currency- and portfolio-adjusted basis (2015 pro forma: EUR 6,076 million). EBITDA before special items is also expected to improve by a mid-single-digit percentage (2015 pro forma: EUR 1,456 million).

At Crop Science, Bayer expects sales to be at the prior-year level (2015: EUR 10,367 million). This corresponds to a low-single-digit percentage increase on a currency- and portfolio-adjusted basis. For this division, Bayer plans to increase EBITDA before special items by a low-single-digit percentage (2015: EUR 2,416 million).

At Animal Health, Bayer expects sales slightly above the prior-year level (2015: EUR 1,490 million). This corresponds to a low- to mid-single-digit percentage increase on a currency- and portfolio-adjusted basis. For this business, Bayer also plans an increase in EBITDA before special items by a low- to mid-single-digit percentage (2015 pro forma: EUR 348 million).

For 2016, Covestro is budgeting sales at the prior-year level and a decline in EBITDA after adjustment for special items.

Bayer expects to take special charges in the region of EUR 0.5 billion in 2016, with the integration of the acquired consumer health businesses and charges in connection with the reorganization of the Bayer Group accounting for most of this amount. Bayer intends to increase research and development spending in 2016 to approximately EUR 4.5 billion. The company has budgeted capital expenditures of about EUR 2.5 billion for property, plant and equipment and EUR 0.4 billion for intangible assets. Depreciation and amortization are estimated at about EUR 3.1 billion, including EUR 1.6 billion in amortization of intangible assets. Bayer expects net financial debt to be below EUR 16 billion at the end of 2016.

Dekkers: Europe must become more innovative

Dekkers emphasized at the Financial News Conference that innovation is the foundation of Bayer’s commercial success. The company employs nearly 15,000 people worldwide in research and development and increased its R&D spending last year by 21.0 percent to EUR 4,281 million. "However, we need an environment that supports our innovation efforts if we are to fully exhaust our potential. I am firmly convinced that Europe must become more innovative," said Dekkers.

In the first place, the Bayer CEO sees a need for action in the sociocultural environment. "While everyone is in favor of innovation in theory, concerns quickly gain the upper hand when it comes to specific technologies." Dekkers accepted that it’s right to openly discuss new technologies. However, this debate should be based on scientific facts. Dekkers therefore called on science, politics and industry to strengthen their engagement in public debate.

Secondly, it is important to support technological advances with appropriate regulations, rather than to hinder them. "I’m therefore very much in favor of introducing a European innovation principle – a kind of innovation inspection to examine the effects that regulations would have on industry’s innovation strength," Dekkers said. This could meaningfully supplement the European precautionary principle, he explained. Taken together, the two principles could ensure a more balanced assessment of the benefits and risks of new technologies, remarked the Bayer CEO, adding that this would make it possible to improve regulations – and increase innovation.

"We must also improve the external financing conditions for innovation in order to become more innovative," Dekkers continued. The Management Board Chairman explained that Germany needs a venture capital law that gives young companies easier access to start-up capital.

On February 24, 2016 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new cancer immunotherapies, reported that, following the successful completion of the initial dose cohort, the first patient has been dosed at the succeeding dose level in the Company’s ongoing multicenter Phase 1 study of Ad-RTS-hIL-12 + orally administered veledimex in recurrent or progressive glioblastoma or grade III malignant glioma (Press release, Ziopharm, FEB 24, 2016, View Source [SID:1234509172]). Ad-RTS-hIL-12 + veledimex is a novel viral gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T-cell immune response.

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"This Phase 1 study of Ad-RTS-hIL-12 + veledimex is notable as it is among only a handful of multi-center gene therapy studies ever conducted, involves treatment directly in the brain tumor and addresses an advanced stage of disease where survival outcomes are often dire," said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM. "We are encouraged by the clinical observations to date and look forward to identifying the optimal dose as we continue to enroll additional patients in the trial."

Dr. Lebel added: "Advanced brain cancer is a disease for which there are far too few treatment options. We look forward to presenting follow-up data from this study mid-year, and exploring additional therapy combinations in the clinic starting this year, including the addition of a checkpoint inhibitor to Ad-RTS-IL-12 + veledimex."

At the Society for Neuro-Oncology 20th Annual Scientific Meeting in November 2015, and in subsequent presentations, the Company announced results, including encouraging activity and "on-target toxicity," as well as evidence that veledimex crosses the blood brain barrier, from the first cohort in the study at a dosing regimen of Ad-RTS-hIL-12 2.0×10^11 + veledimex 20mg/day. After a review of tolerability data from this cohort of seven patients by a panel of independent neuro oncology experts, convened as the Data Safety Monitoring Board for the trial, the next dosing cohort of veledimex (40mg/day) was approved.

The ongoing multi-center Phase 1 trial of Ad-RTS-hIL-12 + veledimex examines a gene therapy strategy for recurrent high-grade gliomas, with the goal of generating a localized anti-tumor immune response. The primary objective of the study is to determine the safety and tolerability of a single intra-tumoral Ad-RTS-hIL-12 injection activated upon dosing with oral veledimex. Secondary objectives are to determine the Ad-RTS-hIL-12 + veledimex maximum tolerated dose, the immune responses elicited by Ad-RTS-hIL-12 + veledimex, and assessment of biologic response. The Company anticipates reporting updated results from the study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2016 and preclinical results combining Ad-RTS-hIL-12 + veledimex and checkpoint inhibitors at the American Society of Gene and Cell Therapy Annual Meeting in May 2016.

On February 24, 2016 Asterias Biotherapeutics, Inc. (NYSE:AST) reported the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for AST-VAC1, its investigational therapy targeting acute myeloid leukemia (AML) (Press release, BioTime, FEB 24, 2016, View Source [SID:1234509171]).

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During the meeting, the FDA indicated general agreement with Asterias’ proposed development plan for registration of AST-VAC1 through a single Phase 3 trial to support an accelerated development pathway and Biologics License Application (BLA) filing. In this study, Asterias will assess the impact of AST-VAC1 compared to placebo on the duration of relapse-free-survival as the primary endpoint, and on overall survival as the secondary endpoint in patients who have achieved complete remission using standard therapies. The proposed trial will include AML patients 60 years and older, along with younger individuals who are at high risk for relapse and are not candidates for allogeneic bone marrow transplantation. Pending positive results, this trial could be the basis for accelerated approval of AST-VAC1. Asterias currently plans to submit a request for a Special Protocol Assessment (SPA) to the FDA to confirm the primary endpoint and other design elements of this pivotal Phase 3 trial.

"We are very pleased with the outcome of the End-of-Phase 2 meeting and the feedback from our discussion with the FDA," stated Pedro Lichtinger, President and Chief Executive Officer. "We believe the results from the Phase 2 clinical trial of AST-VAC1 in AML are encouraging. We appreciate the valuable guidance that the FDA has provided us regarding the design and conduct of a Phase 3 registration program and look forward to further discussions in the Special Protocol Assessment process."

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia and has the potential for rapid progression, if untreated. In AML, the bone marrow produces an excess number of immature cells known as blasts. In AML, these blasts fail to mature into normal red and white blood cells. Instead, the blasts proliferate and accumulate in the bone marrow and peripheral blood, leading to deficiencies in normal mature cells. These deficiencies, often referred to as cytopenias, can induce several adverse effects including anemias and susceptibility to infections. Current treatment strategies for AML are associated with significant morbidities and in most instances, AML leads to death.

Approximately 20,500 new cases of AML are diagnosed in the U.S. annually. AML remains a high unmet clinical need, particularly in patients over the age of 60 years who face poor outcomes and have limited therapeutic options. Treatment and prognosis in AML is strongly influenced by a patient’s age and tumor profile. Successful treatment and survival of advanced age patients or those with a high risk profile is very poor, with a four year relapse-free survival of 10% – 20% (Rolig et al, 2011). Detailed characterizations of genetic abnormalities associated with AML have elucidated their high number and relative complexity, making development of targeted therapeutics to these mutations very challenging. For this reason, broad immunotherapy approaches such as autologous cell vaccines are particularly promising.

About AST-VAC1

AST-VAC1 is a cancer immunotherapy, consisting of autologous mature antigen-presenting dendritic cells pulsed with a messenger RNA for the protein component of human telomerase (hTERT) and a portion of a lysosomal targeting signal (LAMP). hTERT is a common protein in tumor cells and is responsible for the increased proliferative lifespan of cancer cells. In AST-VAC1, the dendritic cells present telomerase to the immune system to induce T cells to target and kill hTERT-expressing tumor cells. The LAMP signal allows AST-VAC1 to stimulate both cytotoxic and helper T cell responses to telomerase, critical elements to induce and maintain immune responses that kill tumor cells. In June 2015, Asterias announced long-term follow-up results from a Phase 2 clinical trial in AML patients receiving AST-VAC1. In this trial, twenty-one patients received at least three injections of AST-VAC1, including 19 patients in complete remission (CR). AST-VAC1 showed a strong safety profile in this trial and in a previous study in prostate cancer patients. Eleven of the 19 patients (58 percent) in the trial remain in CR with a median duration of follow-up of 52 months from first vaccination. Four of the seven patients who were at least 60 years old at the time of immunotherapy with AST-VAC1 remained relapse-free 52 to 59 months from first vaccination.

Because of the widespread expression of telomerase in the majority of cancers, AST-VAC1 is a platform immunotherapeutic that could be used alone or in conjunction with other therapeutics such as immune checkpoint inhibitors to target immune-based destruction of tumors.

About Accelerated Approval

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. These studies are known as Phase 4 confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.

On February 24, 2016 Cancer Research UK’s Centre for Drug Development (CDD), in partnership with Amgen Inc., reported that they have launched a new clinical trial to test a drug that could stop a patient’s immune system from protecting tumours (Press release, Cancer Research UK, FEB 24, 2016, http://www.cancerresearchuk.org/about-us/cancer-news/press-release/2016-02-24-cancer-research-uk-launches-trial-for-potential-new-drug-that-could-help-immune-system-fight-cancer [SID:1234509157]).

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Cancer Research UK scientists are studying Amgen’s experimental cancer drug , called AMG319, to find out if it removes the defence shield that hides cancer cells from the immune system. It targets a protein called PI3K delta leading to destruction of the cancer cells when tested in the laboratory.

The Phase II trial, taking place at Poole Hospital, Southampton General Hospital, and the Clatterbridge Cancer Centre/Aintree University Hospital, looks at the effects of giving this drug to patients with a type of head and neck cancer known as squamous cell carcinoma (HNSCC), to determine whether it affects their immune response.

There will be around 54 patients with HPV-negative* HNSCC of the lower and upper parts of the throat (hypopharynx and oropharynx) or mouth in the study. Patients will be randomly assigned to receive either AMG319 or a placebo, during the regular break from treatment to avoid disruption to a patient’s care.

It is the 10th treatment to enter Cancer Research UK’s Clinical Development Partnerships (CDP) scheme.
CDP is a joint initiative between Cancer Research UK’s CDD and Cancer Research Technology, aiming to increase the number of cancer clinical trials and to progress promising anti-cancer agents by working in partnership with pharmaceutical companies.

Professor Christian Ottensmeier, trial lead from the University of Southampton and the Southampton Experimental Cancer Medicine Centre, said: "This is a really exciting trial because we’re using this drug in solid tumours for the first time. It also tries a whole new concept of cancer therapy in solid cancers for the first time. We hope that after taking the drug, patients will have more cancer fighting immune cells in their tumour. We will study in detail how the immune cells behave before and after AMG319 and whether they have become more effective."

Dr Emma King, clinical lead at the Poole Hospital, said: "I am really pleased that this trial gives our head and neck cancer patients and opportunity to get this new drug."

Tony Hoos, Vice president of Medical, Europe at Amgen, said: "The intersection of immunology and oncology represents one of the most promising approaches which may have a significant impact for patients with cancer today.

"We value the work that Cancer Research UK has done to make it possible to develop this promising drug to the next stage. This new trial will give us a better understanding of how AMG319 works, helping us learn more about its potential in patients who might benefit."

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said: "We’re delighted that the collaboration between Amgen and our Centre for Drug Development is moving into Phase II trials. It means we’re getting closer to providing a new treatment for cancer patients.

"Teaching the body’s immune system to fight cancer is a promising area of cancer research and we’re excited to see how this drug may help."