On November 19, 2015 Moffitt Cancer Center and Ignyta, Inc. (NASDAQ: RXDX) reported that they have entered into a research collaboration relating to RXDX-106, Ignyta’s small molecule, pseudo-irreversible inhibitor of TYRO3, AXL, Mer (TAM) and cMET that is in late stage preclinical development (Press release, Ignyta, NOV 19, 2015, View Source [SID:1234508295]).\

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The collaboration, which will be conducted in the labs of Eric B. Haura, M.D., director of the Lung Cancer Center of Excellence and leader of the Chemical Biology and Molecular Medicine Program at Moffitt, will explore and develop novel protein based diagnostic assays that can assess RXDX-106 signaling activity in relevant solid tumors and associated tumor microenvironments.

"This exciting collaborative partnership with Ignyta will lead to a better understanding of the potential mechanisms of action of RXDX-106 by employing our expertise in cancer proteomic technology," said Haura.

"We continue to work diligently to progress RXDX-106 and the other product candidates we acquired from Teva earlier this year," said Robert Wild, Ph.D., Ignyta’s Chief Scientific Officer and Senior Vice President, Research. "Ignyta’s vision is to be a guiding biotechnology company in precision medicine. We are pleased to be able to collaborate with a world class investigator such as Dr. Haura and his team on the exciting biology relating to RXDX-106."

On November 19, 2015 Genmab A/S (OMX: GEN) reported it has achieved a USD 45 million milestone in its DARZALEX (daratumumab) collaboration with Janssen Biotech, Inc. (Janssen) (Press release, Genmab, NOV 19, 2015, View Source [SID:1234508294]). The milestone payment was triggered by the first commercial sale of DARZALEX in the United States.

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"Today marks a significant moment in the history of Genmab — the day DARZALEX, our second approved antibody therapeutic, is commercially available. We are very pleased to have brought two differentiated antibody products to the market since our inception in 1999," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
This milestone was included in the updated financial guidance for 2015, which was published on November 16, 2015.

About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat multiple myeloma. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. It is believed to induce rapid tumor cell death through programmed cell death, or apoptosis,1,2 and multiple immune-mediated mechanisms, including complement-dependent cytotoxicity,1,2 antibody-dependent cellular phagocytosis3,4 and antibody-dependent cellular cytotoxicity.1,2

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. Five Phase III clinical studies with daratumumab in relapsed and frontline settings are currently ongoing, and additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin’s lymphoma.

On November 20, 2015 Chugai Pharmaceutical Co., Ltd. (Chugai) (TOKYO: 4519) reported that it obtained a supplemental approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) on November 20, 2015, for the anti-cancer agent, capecitabine (brand name: Xeloda Tablets 300) (Xeloda) for the indication of "postoperative adjuvant chemotherapy for gastric cancer" (Press release, Chugai, NOV 19, 2015, View Source [SID:1234508292]).

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With this approval, the indication of Xeloda has been changed into "gastric cancer," covering the current indication of "advanced or recurrent gastric cancer, which is not amenable to curative resection."

"With the approval of the combination therapy of Xeloda and oxaliplatin showing preventive efficacy for postoperative recurrence, we hope the patients will receive the anti-cancer treatment in a positive frame of mind." said Chugai’s Director and Executive Vice President, Dr. Yutaka Tanaka. "We are extremely pleased that Xeloda can contribute to the treatment of patients."

In December 2014, Chugai and Yakult Honsha Co., Ltd. filed an application for approval with the MHLW based on the results of overseas Phase III study (The CLASSIC study) and a Japanese Phase II study.

In The CLASSIC study which was conducted in 1,035 patients with Stage II/III gastric cancer who had received surgical resection, patients were randomized to receive either combination therapy of Xeloda and oxaliplatin (combination group) or surgery alone with follow-up (follow-up group). Disease-free survival (DFS) was evaluated as the primary endpoint. As a result, the three-year DFS rate was 74% in the combination group and 59% in the follow-up group, demonstrating statistically significant prolongation of DFS in the combination group (hazard ratio: 0.56, 95% confidence interval: 0.44 to 0.72, Wald test, p<0.0001). Moreover, for overall survival, a secondary endpoint, five-year survival rate was 78% in the combination group and 69% in the follow-up group, showing significant prolongation in the combination group (hazard ratio: 0.66, 95% confidence interval: 0.51 to 0.85, Wald test, p=0.0015). The safety profile shown in the combination group was comparable to those which have been reported for the two drugs.

The Japanese Phase II study investigated the combination therapy of Xeloda and oxaliplatin, setting Dose Intensity (cumulative dose of each drug actually administered / cumulative planned dose when eight courses of treatment were completed without treatment interruption or dose reduction) as the primary endpoint. The results showed the average of Dose Intensity is 67.2% in the Xeloda and 73.4% in the oxaliplatin respectively, and the tolerability in the Japanese patients was confirmed as both drugs also exceeded threshold which was defined by the study protocol.

Gastric cancer is prevalent in Asian countries including Japan, South Korea and China as well as in South America. In Japan, the number of patients newly diagnosed with gastric cancer continues to rise each year and is estimated to become, on annual average, approximately 142,900 during 2015-2019*.

Chugai strongly believes that Xeloda will make a contribution to patients as a treatment option for "postoperative adjuvant chemotherapy for gastric cancer." Chugai will continue the efforts to contribute to cancer treatment.

* Tomotaka Sobue, et al. "Cancer White Paper 2012 – For data-based cancer control" (Shinoharashinsha Inc.)

About Xeloda
Xeloda was developed by Nippon Roche K.K. (currently Chugai) and approved in 1998 for the first time in the US, Switzerland and Canada, in 2001 in the EU and has been approved in more than 100 countries worldwide. In Japan, Xeloda is marketed by Chugai and it received approval for "inoperable or recurrent breast cancer" in June 2003, "the overseas dosage and administration" and "postoperative adjuvant chemotherapy for colon cancer" in December 2007, "advanced or refractory colorectal cancer, which is not amenable to curative resection" in September 2009 and "advanced or recurrent gastric cancer, which is not amenable to curative resection" in February 2011. It has been authorized for the indication of "gastric cancer" in more than 90 countries.

About oxaliplatin
Oxaliplatin is a platinum complex, anti-cancer agent of which the development and distribution rights in Japan were obtained by Yakult Honsha Co., Ltd. in 1997 from Debiopharm International SA (Switzerland). Oxaliplatin is marketed by Yakult Honsha Co., Ltd. under the brand name of "Elplat I.V. Infusion Solution 50mg" (Elplat). Elplat was approved in March 2005 for an indication of "advanced or recurrent colorectal cancer, which is not amenable to curative resection" and started to be marketed in April 2005. It was approved for additional indications of "postoperative adjuvant chemotherapy for colon cancer" in 2009, "pancreatic cancer, which is not amenable to curative resection" in 2013 and "advanced or recurrent gastric cancer, which is not amenable to curative resection" in 2015.

On November 19, 2015 Amgen (NASDAQ: AMGN) reported that the European Commission (EC) granted marketing authorization for Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (Press release, Amgen, NOV 19, 2015, View Source [SID:1234508291]). Kyprolis is the first irreversible proteasome inhibitor approved in the European Union (EU) for use in combination treatment of patients with relapsed multiple myeloma.

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"The approval of Kyprolis in combination provides physicians and patients across Europe with an important new treatment option for relapsed multiple myeloma, helping to address a real unmet need for this rare blood cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Multiple myeloma is a complex blood cancer that often becomes resistant to treatment, which is why there is a need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing."

Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.2 It is a rare and very aggressive orphan disease that accounts for approximately one percent of all cancers.3-5 In Europe, approximately 39,000 patients are diagnosed with multiple myeloma each year and 24,000 patient deaths are reported on an annual basis.3

"In clinical studies, approximately one out of three patients achieved a complete response or better on the Kyprolis in combination with lenalidomide and dexamethasone arm, which is three times more frequent than in the lenalidomide and dexamethasone arm," said Prof. Meletios A. Dimopoulos, M.D., Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine. "In addition, the regimen provided patients with more than two years without disease progression. These results are significant for patients with relapsed multiple myeloma, who are faced with worse outcomes each time they experience a relapse."

The EC approved Kyprolis based on data from the pivotal Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial. The study showed that patients treated with Kyprolis in combination with lenalidomide and dexamethasone (regimen referred to as KRd) had increased median time to progressive disease (PD) or death by 8.7 months compared to patients treated with lenalidomide and dexamethasone (regimen referred to as Rd). The median progression-free survival (PFS) was 26.3 months in the KRd arm compared to 17.6 months in the Rd arm (HR: 0.69; 95 percent CI: 0.57 to 0.83; p=0.0001). The most common adverse events (AEs) in the Kyprolis arm included pneumonia (1 percent), myocardial infarction (0.8 percent) and upper respiratory tract infection (0.8 percent). Discontinuation of treatment due to AEs occurred in 15 percent of patients in the KRd arm versus 18 percent of patients in the Rd arm.

Kyprolis received an accelerated assessment from the European Medicines Agency (EMA), and orphan drug designation in 2008, given to medicines intended for the treatment, prevention or diagnosis of a disease that is life threatening and has a prevalence in the EU of no more than five in 10,000 people.

Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.

Amgen plans to submit data from the Phase 3 ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial for potential authorization of Kyprolis in combination with dexamethasone in the EU. This data also serves as the basis of the supplemental New Drug Application of Kyprolis in combination with dexamethasone for patients with relapsed multiple myeloma, which has been accepted for priority review by the U.S. Food and Drug Administration (FDA).

About ASPIRE
The international, randomized Phase 3 ASPIRE trial evaluated Kyprolis in combination with lenalidomide and dexamethasone, versus lenalidomide and dexamethasone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens. The primary endpoint of the trial was PFS, defined as the time from randomization to disease progression or death due to any cause, whichever is earlier. Secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DOR), disease control rate, health-related quality of life (HR-QoL) and safety. Patients were randomized to receive Kyprolis (20 mg/m2 on days 1 and 2 of cycle one, escalating, if tolerated, to 27 mg/m2 subsequently), in addition to a standard dosing schedule of lenalidomide (25 mg per day for 21 days on, 7 days off) and dexamethasone (40 mg per week in 4 week cycles), versus lenalidomide and dexamethasone. In the Kyprolis arm, patients were given a 10 minute infusion on days 1, 2, 8, 9, 15 and 16. Kyprolis was omitted on days 8 and 9 during cycles 13-18 and not administered beyond 18 cycles. The study randomized 792 patients at sites in North America, Europe and Israel.

While the data for median OS were not yet mature at the time of primary analysis, the analysis showed a trend in favor of KRd compared with Rd (HR=0.79; 95 percent CI: 0.63-0.99; p=0.02 [1-sided]). Patients continue to be monitored for OS. The ORR was 87.1 percent with KRd and 66.7 percent with Rd. Median DOR was 28.6 months for patients receiving KRd (95 percent CI, 24.9 to 31.3 months) and 21.2 months for patients receiving Rd (95 percent CI, 16.7 to 25.8 months). In the KRd and Rd groups, 32 percent versus 9 percent of patients achieved a complete response or higher (stringent complete response [sCR] or complete response [CR]), a measurement indicating depth of response.

The rate of death due to AEs within 30 days of the last dose was balanced between the KRd arm and the Rd arm. The most common causes of death not due to PD occurring in patients in the KRd arm compared to the Rd arm included cardiac disorders (3 percent versus 2 percent), infection (2 percent versus 3 percent), renal (0 percent versus less than 1 percent) and other AEs (2 percent versus 3 percent). Serious AEs (SAEs) were reported in 60 percent of the patients in the KRd arm and 54 percent of the patients in the Rd arm. The most common SAEs reported in the KRd arm compared to the Rd arm were pneumonia (14 percent versus 11 percent), respiratory tract infection (4 percent versus 2 percent), pyrexia (4 percent versus 2 percent) and pulmonary embolism (3 percent versus 2 percent). Discontinuation of treatment due to AEs occurred in 15 percent of patients in the KRd arm versus 18 percent of patients in the Rd arm. AEs leading to discontinuation of Kyprolis occurred in 12 percent of patients and the most common events included pneumonia (1 percent), myocardial infarction (1 percent) and upper respiratory tract infection (1 percent).

The ASPIRE data were presented at the 56th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) and published in The New England Journal of Medicine in December 2014.1

About Kyprolis (carfilzomib)
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.6 Kyprolis has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.7 In some cells, Kyprolis can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.7 The irreversibility of Kyprolis’ binding has also been shown to offer a more sustained inhibition of the targeted enzymes.8

Kyprolis is currently approved in the U.S. in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.

Kyprolis is also indicated under FDA accelerated approval as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.

Kyprolis is also approved in Argentina, Israel, Kuwait, Mexico, Thailand and Colombia. Additional regulatory applications for Kyprolis are underway and have been submitted to health authorities worldwide.

Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx Pharmaceuticals is a subsidiary of Amgen and holds development and commercialization rights to Kyprolis globally, excluding Japan.

Important EU Product Safety Information

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Kyprolis treatment should be supervised by a physician experienced in the use of anti-cancer therapy. The most serious side effects that may occur during Kyprolis treatment include: cardiac toxicity, pulmonary toxicities, pulmonary hypertension, dyspnoea, hypertension including hypertensive crises, acute renal failure, tumour lysis syndrome, infusion reactions, thrombocytopenia, hepatic toxicity, posterior reversible encephalopathy syndrome (PRES) and thrombotic thrombocytopenic purpura/haemolytic uremic syndrome (TTP/HUS). The most common side effects are anaemia, fatigue, diarrhoea, thrombocytopenia, nausea, pyrexia, dyspnoea, respiratory tract infection, cough and peripheral oedema.

Please refer to the Summary of Product Characteristics for full European prescribing information.

Important U.S. Product Safety Information

Cardiac Toxicities
New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of Kyprolis. Death due to cardiac arrest has occurred within a day of Kyprolis administration.

Withhold Kyprolis for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart Kyprolis based on a benefit/risk assessment.

Adequate hydration is required prior to each dose in Cycle 1. Monitor all patients for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate in patients with baseline cardiac failure or who are at risk for cardiac failure.

Patients > 75 years, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, and conduction abnormalities may be at greater risk for cardiac complications.

Acute Renal Failure
Cases of acute renal failure and renal insufficiency adverse events (renal impairment, acute renal failure, renal failure) have occurred in patients receiving Kyprolis. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received Kyprolis monotherapy. This risk was greater in patients with a baseline reduced estimated creatinine clearance. Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.

Tumor Lysis Syndrome
Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have occurred in patients receiving Kyprolis. Patients with multiple myeloma and a high tumor burden should be considered at greater risk for TLS. Adequate hydration is required prior to each dose in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly. Withhold Kyprolis until TLS is resolved.

Pulmonary Toxicity
Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred in patients receiving Kyprolis. Some events have been fatal. In the event of drug-induced pulmonary toxicity, discontinue Kyprolis.

Pulmonary Hypertension
Pulmonary arterial hypertension (PAH) was reported in patients treated with Kyprolis. Evaluate with cardiac imaging and/or other tests as indicated. Withhold Kyprolis for PAH until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment.

Dyspnea
Dyspnea was reported in patients treated with Kyprolis. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop Kyprolis for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart Kyprolis based on a benefit/risk assessment.

Hypertension
Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis. Some of these events have been fatal. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold Kyprolis and evaluate. Consider whether to restart Kyprolis based on a benefit/risk assessment.

Venous Thrombosis
Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed with Kyprolis. Thromboprophylaxis is recommended and should be based on an assessment of the patient’s underlying risks, treatment regimen, and clinical status.

Infusion Reactions
Infusion reactions, including life-threatening reactions, have occurred in patients receiving Kyprolis. Symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration of Kyprolis. Premedicate with dexamethasone to reduce the incidence and severity of infusion reactions. Inform patients of the risk and of symptoms of an infusion reaction and to contact a physician immediately if they occur.

Thrombocytopenia
Kyprolis causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Thrombocytopenia was reported in patients receiving Kyprolis. Monitor platelet counts frequently during treatment with Kyprolis. Reduce or withhold dose as appropriate.

Hepatic Toxicity and Hepatic Failure
Cases of hepatic failure, including fatal cases, have been reported during treatment with Kyprolis. Kyprolis can cause increased serum transaminases. Monitor liver enzymes regularly. Reduce or withhold dose as appropriate.

Thrombotic Thrombocytopenic Purpura /Hemolytic Uremic Syndrome (TTP/HUS)
Cases of TTP/HUS including fatal outcome have occurred in patients receiving Kyprolis. Monitor for signs and symptoms of TTP/HUS. Discontinue Kyprolis if diagnosis is suspected. If the diagnosis of TTP/HUS is excluded, Kyprolis may be restarted. The safety of reinitiating Kyprolis therapy in patients previously experiencing TTP/HUS is not known.

Posterior Reversible Encephalopathy Syndrome (PRES)
Cases of PRES have occurred in patients receiving Kyprolis. PRES was formerly known as Reversible Posterior Leukoencephalopathy Syndrome. Consider a neuro-radiological imaging (MRI) for onset of visual or neurological symptoms, such as seizure, headache, lethargy, confusion, blindness, and altered consciousness, along with hypertension.. Discontinue Kyprolis if PRES is suspected and evaluate. The safety of reinitiating Kyprolis therapy in patients previously experiencing PRES is not known.

Embryo-fetal Toxicity
Kyprolis can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals.

Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis and the potential hazard to the fetus if Kyprolis is used during pregnancy.

ADVERSE REACTIONS

The most common adverse events of all grades occurring in at least 20 percent of patients treated with Kyprolis in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, decreased platelets, dyspnea, diarrhea, decreased lymphocyte, headache, decreased hemoglobin, cough, edema peripheral.

The most common adverse events of all grades occurring in at least 20 percent of patients treated with Kyprolis in the combination therapy trial: decreased lymphocytes, decreased absolute neutrophil count, decreased phosphorus, anemia, neutropenia, decreased total white blood cell count, decreased platelets, diarrhea, fatigue, thrombocytopenia, pyrexia, muscle spasm, cough, upper respiratory tract infection, decreased hemoglobin, hypokalemia.

On November 19, 2015 Aduro Biotech, Inc. (Nasdaq:ADRO) reported that it has established European subsidiary headquarters at the BioNovion site in Oss, Netherlands now called Aduro Biotech Europe (Press release, Aduro BioTech, NOV 19, 2015, View Source [SID:1234508289]). On October 30, 2015, Aduro acquired BioNovion, a biopharmaceutical antibody discovery and development company, to broaden its technology portfolio and increase its immunotherapy capabilities.

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"In addition to expanding our pipeline with complementary technologies, we are pleased that this acquisition allows us to integrate a highly experienced scientific team and expand our clinical development presence abroad," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "With our new base in Europe, we look forward to collaborating with the local European medical and business communities as we initiate international clinical research programs."

In addition to Aduro’s established LADD and CDN technologies, Aduro’s new combined offerings include the B-select monoclonal antibodies (B-select) platform, which is designed to produce first- and best-in-class agonist and antagonist monoclonal antibodies (mAbs) that may be used to create a deep pipeline of products focused on harnessing the immune system of cancer patients. Aduro is an immuno-oncology company that has multiple therapeutic platforms with the potential to yield powerful immunotherapy combinations.

Monoclonal antibody expertise will remain in the Aduro Biotech Europe office in the Netherlands, which will operate as a subsidiary. Andrea van Elsas, Ph.D. and Hans van Eenennaam, Ph.D, chief scientific officer and chief operating officer of BioNovion respectively, will retain their roles and titles at Aduro Biotech Europe.

Near term clinical development plans include the initiation of a global Phase 3 trial to evaluate the combination of CRS-207, a LADD-based immunotherapy, and standard-of-care chemotherapy in patients with unresectable malignant pleural mesothelioma (MPM). Clinical trial sites in Europe will open in 2016. MPM – a rare, difficult to treat cancer that is commonly associated with asbestos exposure – is still a significant health problem throughout Europe, with the highest MPM related mortality rate globally and over 50,000 MPM related deaths between 1994-2008.1,2

The integration of Aduro’s newly acquired B-select technology provides a new platform for Aduro to continue to build a strong oncology research and development pipeline. Aduro’s broad portfolio of immunotherapy candidates positions the company to potentially offer patients around the globe novel therapeutic options and combinations that are alternatives to traditional therapies.