Array BioPharma Announces Clinical Data Presentations At The 2015 European Cancer Congress

On September 11, 2015 Array BioPharma Inc. (NASDAQ: ARRY) reported presentations on encorafenib and binimetinib at the 2015 European Cancer Congress (ECC), which will be held September 25 – 29, 2015 in Vienna, Austria (Press release, Array BioPharma, SEP 11, 2015, View Source;p=RssLanding&cat=news&id=2087227 [SID:1234507455]). These products are currently advancing in a total of three pivotal trials, with top-line results expected over the next year from the NEMO (binimetinib monotherapy in NRAS mutant melanoma) and COLUMBUS (binimetinib and encorafenib in BRAF mutant melanoma) Phase 3 trials.

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Array BioPharma
Ron Squarer, Chief Executive Officer of Array, noted, "We are encouraged to see two ECC abstracts reporting clinical data from binimetinib and encorafenib. Importantly, the LOGIC2 presentation at ECC will provide a further opportunity to demonstrate the safety and clinical activity profile of this combination in a larger, independent data set."

The following is a summary of the presentations that will be given at ECC.

ORAL PRESENTATION

Title: A phase 1b/2 study of ribociclib (LEE011; CDK4/6 inhibitor) in combination with binimetinib (MEK162; MEK inhibitor) in patients with NRAS-mutant melanoma naive to BRAFi treatment (Abstract #3300)
Presenter: Carla van Herpen, MD
Date: Monday, September 28, 9 – 9:15 a.m. CEST (Oral Presentation)
Updated data will be provided at the conference, beyond what is included in the abstract.

POSTER PRESENTATION WITH SPOTLIGHT SESSION

Title: LOGIC2: Phase 2, multi-center, open-label study of sequential encorafenib/binimetinib combination followed by a rational combination with targeted agents after progression, to overcome resistance in adult patients with locally-advanced or metastatic BRAF V600 melanoma (Abstract #3310)
Presenter: Reinhard Dummer, MD
Date: Sunday, September 27, 4:45 – 6:45 p.m. CEST
Abstract #3310 will also be included in the Poster Spotlight Session on Sunday, September 27, 5:15 – 6:15 p.m.
Updated data will be provided at the conference, beyond what is included in the abstract.

All abstracts can be accessed through the ECC website, View Source

– See more at: View Source;p=RssLanding&cat=news&id=2087227#sthash.FMOn4AWQ.dpuf

Merck KGaA, Darmstadt, Germany and Pfizer to Present Updates for Avelumab at the European Cancer Congress 2015

On September 11, 2015 Merck KGaA, Darmstadt, Germany and Pfizer reported that six abstracts on studies evaluating the potential role of programmed death-ligand 1 (PD-L1) inhibition and the safety and efficacy of the investigational cancer immunotherapy avelumab* will be presented at this year’s ECC in Vienna, Austria, September 25–29, 2015 (Press release, Pfizer, SEP 11, 2015, View Source [SID:1234507453]).

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New data will be presented in urothelial (e.g. bladder), mesothelioma and gastric/gastroesophageal cancers. Additional NSCLC and ovarian cancer data from Phase Ib trials build on those previously presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).1–10 As the promise of immuno-oncology continues to grow, these new data help to further the understanding of the potential role of avelumab for patients suffering from cancers with high unmet need.

Despite continued progress in bringing new treatments to patients, there remains a significant unmet need across many types of cancer. For example, the incidence of gastric cancer remains a major public issue in Western and Asian countries, and there is a continued need to better understand the disease biology to provide patients with the most appropriate and effective treatment.11 For some cancer types, such as mesothelioma, the incidence rates are rising worldwide,12 with limited treatment options currently available for patients.

"Our clinical program for avelumab continues to accelerate, and we remain on-target to initiate up to six pivotal trials this year," said Dr Luciano Rossetti, Global Head of Research & Development of the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. "As we investigate avelumab across a broad range of tumor types, Merck KGaA, Darmstadt, Germany and Pfizer are working together diligently to analyze and present data at important congresses like ECC, to share the latest knowledge and understanding of this immune-checkpoint inhibitor with the medical community."

Currently, more than 1,000 cancer patients have been treated with avelumab in the Phase I/Ib clinical program (JAVELIN Solid Tumor), and more than 15 tumor types are under investigation.

"This is an exciting time for the Merck KGaA, Darmstadt, Germany and Pfizer alliance. Working together, we have made substantial progress in advancing the clinical evaluation of avelumab as both a single agent and as part of combination therapy in patients with difficult-to-treat cancers," said Dr Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology. "We believe that the talent, resources, pipeline products, and commitment that each partner brings to this collaboration position us well to become potential leaders in the field of immuno-oncology."

Avelumab is under clinical investigation and has not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.

Data to be presented at ECC are part of the JAVELIN clinical trial program, an extensive international program exploring the use of PD-L1 inhibition with avelumab to treat multiple types of cancer.

The JAVELIN clinical trial program includes a Phase III open-label, multicenter trial to investigate avelumab versus docetaxel in patients with Stage IIIb/IV or recurrent NSCLC that has progressed after platinum-based chemotherapy (JAVELIN Lung 200); an international Phase II trial to investigate avelumab in patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200); a Phase Ib, open-label, multicenter, multiple-dose trial designed to estimate the maximum tolerated dose and select the recommended Phase II dose of avelumab in combination with axitinib in patients with previously untreated advanced renal cell carcinoma (JAVELIN Renal 100); an international Phase I trial to investigate avelumab in patients with metastatic or locally advanced solid tumors (JAVELIN Solid Tumor); and a Phase I trial to investigate avelumab in Japanese patients with metastatic or locally advanced solid tumors, with an expansion cohort in Asian patients with gastric cancer (JAVELIN Solid Tumor Japan). The clinical development program for avelumab now includes more than 1,000 patients treated across more than 15 tumor types, including NSCLC, breast cancer, gastric cancer, ovarian cancer, urothelial cancer, esophageal cancer, head and neck cancer, renal cell carcinoma, Merkel cell carcinoma, melanoma and mesothelioma.

In the United States and Canada, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, operates as EMD Serono.

*Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (MSB0010718C)

Cancer Research UK and MedImmune launch ground-breaking biotherapeutics research centre in Cambridge

On September 11, 2015 Cancer Research UK and MedImmune reported a new laboratory that will focus on the discovery and development of novel biologic cancer treatments and diagnostics has been opened this week in Cambridge by life sciences minister George Freeman MP (Press release, Cancer Research Technology, SEP 11, 2015, View Source [SID1234523202]).

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The state-of-the-art CRUK-MEDI Alliance Laboratory, located on Granta Park, is an innovative collaboration between Cancer Research UK, its commercial arm Cancer Research Technology, and MedImmune, the global biologics research and development arm of AstraZeneca.

In this important partnership, both Cancer Research UK and MedImmune scientists will work together in the laboratory and collaborate closely to share knowledge and expertise to discover and develop novel biologics to treat and diagnose cancer. The alliance will bring together MedImmune’s world-class human antibody phage display libraries and protein-engineering expertise with Cancer Research UK’s cancer biology expertise.

Cancer Research UK has provided the equipment and operational funding for the laboratory and will contribute a portfolio of novel drug targets through its extensive network of principal investigators. MedImmune will manage the drug discovery process for accepted projects.

Dr Maria Groves, head of the CRUK-MEDI Alliance Laboratory and associate director at MedImmune, said: "This laboratory is truly a collaborative approach and its success will depend on three key factors: the application of our high-quality and diverse phage display libraries; designing a drug discovery process that will enable us to find specific potent antibodies with the right mechanism against the disease target and, finally, building a network of principal investigators who will have the opportunity to generate novel ideas for oncology therapeutics.

"We are driven to engineer the best antibodies and identify which components of cancer make the best targets for treatment. There’s a lot of ground to cover and we’re delighted to be working in partnership to advance this exciting field."

Life Sciences Minister George Freeman said: "This pioneering new laboratory in Cambridge highlights the vital role that Cancer Research UK and other charities play in funding exciting medical research which has the potential to help many patients. This ambitious project unites academia and industry to translate world-leading research from the laboratory into crucial new treatments for patients. The UK is already leading the way in cancer research, and collaborations such as this help to ensure that we convert that science into new medicines."

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said: "Increasing investment in biotherapeutic treatment forms a key part of Cancer Research UK’s research strategy.

"We’re delighted to embark on this exciting new initiative, which will give leading Cancer Research UK scientists access to the latest antibody-engineering technologies and expertise. This will create opportunities to translate breakthroughs in our understanding of cancer biology into urgently needed new cancer treatments."

Arrowhead Nominates ARC-HIF2 As First RNAi Therapeutic Candidate Using Extrahepatic DPC™ Delivery System

On September 11, 2015 Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, reported that it has nominated ARC-HIF2 as its first therapeutic candidate delivered using a new Dynamic Polyconjugate (DPC) designed to target tissues outside of the liver (Press release, Arrowhead Research Corporation, SEP 11, 2015, View Source [SID:1234507456]). Arrowhead believes that ARC-HIF2, which uses RNA interference to silence transcription factor hypoxia-inducible factor 2α (HIF-2α), is a promising new candidate for the treatment of clear cell renal cell carcinoma (ccRCC).

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The company will present preclinical data at the European Cancer Congress 2015 (ECC2015) in Vienna on September 27 in a session starting at 16:45 CEST. In a poster titled "HIF-2α targeting with a novel RNAi delivery platform as therapy for renal cell carcinoma," (abstract #353), Arrowhead scientists will show data suggesting that HIF-2α inhibition through RNA interference may significantly impact late stage ccRCC progression. The company is in the process of manufacturing scale up to allow for initiation of IND-enabling studies. Timing for anticipated regulatory submission will be announced in the future.

"Preclinical data using our new extrahepatic DPC delivery system has been very promising. We think the ability to target tissues outside of the liver, including tumors, opens additional opportunities for Arrowhead to develop differentiated RNAi-therapeutics that address numerous diseases without adequate treatment options," said Christopher Anzalone, Ph.D., Arrowhead’s president and chief executive officer. "This is an important milestone for Arrowhead and we look forward to continued development of the DPC delivery platform and product candidates based on it."

ARC-HIF2 is designed to inhibit the production of HIF-2α, which has been linked to tumor progression and metastasis in ccRCC. ARC-HIF2 employs a novel extrahepatic-targeted DPC that comprises a membrane active polymer to promote RNAi trigger endosomal release, an active ligand that targets the DPC to tumor cells, reversible masking to prevent polymer activity prior to cellular uptake, and an RNAi trigger to HIF-2α conjugated directly to the DPC.

Using ARC-HIF2 in a preclinical ccRCC tumor model, mice treated with weekly injections led to greater than 80% knockdown of HIF-2α mRNA in tumors. Furthermore, tumors from treated mice exhibited statistically significant reductions in size and weight, extensive tumor cell death, reduction in the tumor-expressed VEGF-A biomarker, and destruction of the blood vessels feeding the tumors.

Therapies for metastatic ccRCC including agents that target the VEGF/VEGFR or mTor signaling pathways, which are validated cancer targets, have become the standard-of-care and have improved patient outcomes. However, since emergence of resistance to these agents is common, novel therapies targeting alternative pathways are needed for patients with resistant tumors. Arrowhead believes that HIF2α is an attractive target for intervention because over 90% of ccRCC tumors express a mutant form of the Von Hippel-Landau protein that is unable to degrade HIF-2α, leading to its accumulation during tumor hypoxia and promoting tumor growth.

An abstract of the data to be presented at ECC2015 is available on the conference website at www.europeancancercongress.org/.

Kite Pharma Receives Positive Opinion for Orphan Drug Designation in the European Union for KTE-C19, Kite’s Lead Cancer T-Cell Immunotherapy

On September 11, 2015 Kite Pharma, Inc. (Kite) (Nasdaq:KITE) reported that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending KTE-C19 for designation as an orphan medicinal product for the treatment of PMBCL and MCL (Press release, Kite Pharma, SEP 11, 2015, View Source [SID:1234507454]). KTE-C19 is an investigational therapy in which a patient’s T cells are genetically engineered to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. No other product candidate currently has orphan drug designation for the treatment of PMBCL in the EU. Kite previously received orphan drug designation for KTE-C19 for the treatment of diffuse large B‑cell lymphoma (DLBCL) in both the US and the EU.

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"The positive opinion for EU orphan designation for PMBCL and for MCL aligns with Kite’s leadership in and broad commitment to delivering innovative therapies that have the potential to transform the lives of cancer patients around the world," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer of Kite. "We are conducting a Phase 1/2 clinical trial of KTE-C19 in patients with refractory, aggressive non-Hodgkin lymphoma, including DLBCL and PMBCL, and plan to report initial topline results from the Phase 1 portion of the trial later this year."

The COMP adopts an opinion on the granting of orphan drug designation, after which the opinion is submitted to the European Commission for endorsement of the opinion. Orphan drug designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU, and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.