1stOncology™: Cancer Intelligence Service – Page 15995 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Cancer Research UK invests £15 million to unite finest minds across UK to develop better treatments

On October 7, 2015 Cancer Research UK reported that it has invested £15 million to inspire collaborative cancer research between scientists across the UK through a new awards scheme launched today (Press release, Cancer Research UK, OCT 7, 2015, View Source [SID:1234507659]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"Effective partnerships are crucial for delivering the greatest science and boosting advancements in fighting cancer." – Dr David Scott

The Cancer Research UK Centres Network Accelerator Award is a new initiative which provides infrastructure support to research centres in order to encourage collaboration between different organisations and boost ‘bench to bedside’ science.

Four centres – Queens University Belfast (link is external), the University of Leicester (link is external), the Francis Crick Institute (link is external), and the University College London (link is external)– have each received a five-year grant.

Queens University Belfast* received £3.9 million to develop new pathology and image analysis techniques for solid tumours. This includes research to improve cancer diagnosis through tissue imaging, biomarker discovery, and clinical trials. The award will also invest in the next generation of scientists with a Clinical Fellowship programme in molecular pathology.

The University of Leicester** received £1.7 million to set up facilities to study structural biology among centres to improve drug development. The award will focus on research to translate the understanding of structural biology into drugs that could treat patients.

The Francis Crick Institute*** received £4.2 million to support more experimental cancer research and create Clinical Research Fellowships to help unite different research centres in London. This will help turn innovation in the laboratory into tangible benefits for patients – to save more lives from the disease in the future.

University College London**** received £5 million to help advance immunotherapy research – a field of cancer research which has shown promise for a long time and recently provided exciting breakthroughs in cancer treatments. The award will fund research to understand how patients develop immune responses – and why they stop responding to treatments. The award will also help scientists develop new therapies, and safe ways to give treatments.

Professor David Waugh, Director of the Centre for Cancer Research and Cell Biology at Queens University Belfast, said: "This award will allow us to accelerate the development of clinically-robust diagnostic tests that assist in personalizing cancer therapy. The network will help us set technology standards for this increasingly important and fast growing area of cancer research."

Professor Catrin Pritchard, science director at the Cancer Research UK Leicester Centre, said: "Personalised medicine is the future of cancer treatment, and by collaborating with centres across the UK, we look forward to accelerating research underpinning drug development."

Dr Richard Treisman, a research director at the Francis Crick Institute, said: "Thinking outside the box and collaborating across different disciplines and institutions is what we need to invigorate more innovative cancer research."

Professor Henning Walczak, scientific director of the Cancer Research UK – UCL Centre, said: "There has been great progress in the field of cancer immunotherapy and by collaborating with centres across London our Accelerator Network aims to bring successful cancer immunotherapies to more patients and to overcome some of the hurdles in this field."

Dr David Scott, Cancer Research UK’s director of science funding, said: "Effective partnerships are crucial for delivering the greatest science and boosting advancements in fighting cancer. We’re proud to invest in collaborative and innovative research across the UK with the new Centres Network Accelerator awards. It’s through working together and uniting expertise that we will do better research and save more lives."

Kite Pharma Commends Steven A. Rosenberg, M.D., Ph.D., on the Prestigious Medal of Honor Award From the American Cancer Society

On October 7, 2015 Kite Pharma, Inc. (Kite) (Nasdaq:KITE) reported that Steven A. Rosenberg, M.D., Ph.D., Chief of Surgery at the National Cancer Institute (NCI) and a special advisor to Kite, has received three significant awards for his achievements and career dedicated to advancing cancer research (Press release, Kite Pharma, OCT 7, 2015, View Source [SID:1234507657]). The American Cancer Society (ACS), the largest voluntary health organization in the United States, awarded Dr. Rosenberg its Medal of Honor for his pioneering leadership in cancer immunotherapy. The Medal of Honor is the ACS’ highest honor and was presented to Dr. Rosenberg at a ceremony held in Washington, DC, on September 30, 2015. Additional recent awards include:

Dr. Rosenberg has been awarded the Samuel J. Heyman Service to America Medal for career achievement by the Partnership for Public Service. The "Sammies" are bestowed upon individuals to highlight excellence in the federal workforce and inspire other talented and dedicated individuals to go into public service. Dr. Rosenberg will receive his award during a gala and ceremony that is taking place tonight, October 7, in Washington, DC.

Susan G. Komen, the world’s largest breast cancer organization, awarded Dr. Rosenberg the Betty Ford Lifetime Achievement Award for his four decades of work in fighting cancer at the NCI. This award recognizes individuals who have committed their lives to engaging the public in the fight against breast cancer, advocating for meaningful change, and educating communities to support women and men facing the disease. Dr. Rosenberg was recognized during the Honoring the Promise gala, which took place in Washington, DC, on September 24, 2015.

In 2012, Kite partnered with Dr. Rosenberg and the NCI under a Cooperative Research and Development Agreement (CRADA) to further the research and development of multiple chimeric antigen receptor (CAR) and T cell receptor (TCR) based product candidates for the treatment of advanced solid and hematological malignancies. Many of these product candidates are now being assessed in clinical trials and Kite has since exclusively licensed intellectual property related to certain of these product candidates.

"We have always appreciated the great honor of being able to advance cancer therapies with Steve and are thrilled that three of the most prominent awards in medicine and public service have been made in recognition of the pivotal role Steve has played in cancer care and research on the national stage," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer of Kite. "During his long and successful career, Steve’s insights time and again have had an astounding impact on the direction of cancer research. His contributions, including to the exciting field of cancer immunotherapy, have been immense, and we are elated for Steve to receive these awards."

Merck and Pfizer Announce Investigational Immunotherapy Avelumab Receives FDA Fast Track Designation for Metastatic Merkel Cell Carcinoma

On October 7, 2015 Merck and Pfizer reported that the US Food and Drug Administration (FDA) has granted avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer (Press release, Merck KGaA, OCT 7, 2015, View Source [SID:1234507663]).1,2

This announcement builds on the recent FDA Orphan Drug designation that was granted for avelumab on September 21, 2015 for the treatment of MCC. The Fast Track designation is designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and address an unmet medical need.

"We are pleased that the FDA continues to acknowledge the current high unmet needs for patients with metastatic Merkel cell carcinoma through these recent regulatory designations for avelumab," said Dr. Luciano Rossetti, Head of Global Research & Development at Merck’s biopharmaceutical business, Merck Serono. "We look forward to working closely with the FDA on an expedited review process for avelumab, and we hope to be able to provide a potential new treatment option for patients with this difficult-to-treat cancer in the future."

"We look forward to working with our partners at Merck on the development of avelumab in patients with relapsed and refractory Merkel cell carcinoma," said Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology. "Fast Track designation will enable us to coordinate these efforts more closely with the FDA."

The designation relates to the clinical development program for avelumab in metastatic MCC, which includes the Phase II study, JAVELIN Merkel, to assess the safety and efficacy of avelumab in patients with metastatic MCC who have progressed after at least one prior chemotherapy regimen. In this study, the primary endpoint is objective response rate, and secondary endpoints include duration of response, progression-free survival, overall survival and safety. The study, which exceeded its expected enrollment of 84 patients with 88 patients enrolled, is being conducted in sites across Asia Pacific, Australia, Europe and North America.

The clinical development program for avelumab now includes more than 1,000 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastroesophageal cancer, head and neck cancer, MCC, mesothelioma, melanoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (e.g. bladder) cancer.

Nektar Submits Investigational New Drug Application (IND) for NKTR-214 To Treat Solid Tumor Malignancies

On October 7, 2015 Nektar Therapeutics (NASDAQ:NKTR) reported that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NKTR-214, its lead immuno-oncology candidate. NKTR-214 is a CD122-biased immune-stimulatory cytokine that is designed to stimulate the patient’s own immune system to destroy cancer cells (Press release, Nektar Therapeutics, OCT 7, 2015, View Source [SID:1234507662]).

The company plans to initiate a Phase 1/2 clinical study by the end of 2015. The study will evaluate the safety, tolerability and efficacy of NKTR-214 in patients with solid tumor malignancies and will include expansion cohorts that will evaluate NKTR-214 both as a single-agent and in combination with a checkpoint inhibitor.

"As a new cytokine with biased receptor activity and an antibody-like dosing schedule, NKTR-214 could emerge as a differentiated immuno-oncology therapy that specifically stimulates T-cell growth to fight cancer," said Stephen Doberstein, PhD, Senior Vice President and Chief Scientific Officer of Nektar. "In preclinical studies with NKTR-214, we not only observed single-agent efficacy in multiple tumor models, but when administered in combination with a checkpoint inhibitor, we see a dramatic immune-educating vaccine-like effect with NKTR-214. We are excited to start our first-in-human study and we expect to have initial data from the dose-escalation phase of the trial by the second half of 2016."

The Phase 1/2 clinical program will be conducted at multiple clinical sites including MD Anderson Cancer Center and Yale Cancer Center. In addition to the Phase 1/2 clinical program, Nektar and MD Anderson will conduct translational research to identify predictive biomarkers that can be used in the future development of NKTR-214.

About NKTR-214
NKTR-214 is a CD122-biased immune-stimulatory cytokine that is designed to preferentially stimulate the expansion and maintenance of CD8-positive effector T cells, which are tumor-killing cells found naturally in the body. CD122, which is also known as the Interleukin-2 (IL-2) receptor beta subunit, is a key signaling receptor that is known to increase the proliferation of CD8-positive effector T cells.1 These tumor-killing cells comprise a key component of the tumor infiltrating lymphocytes that provide cell-mediated anti-tumor effects.1 By biasing activation to the CD122 receptor, NKTR-214 enhances the generation of CD8-positive T cells in the tumor.

In preclinical studies, a single dose of NKTR-214 resulted in an approximate 400-fold AUC exposure within the tumor compared with an equivalent dose of aldesleukin, an existing IL-2 therapy. This increase potentially enables, for the first time, an antibody-like dosing regimen for a cytokine.2

At the Inaugural CRI-CIMT-EATI-AACR Immunotherapy Conference in New York in September 2015, Nektar presented data demonstrating that NKTR-214 induces durable and specific anti-tumor immunity as a single agent and when combined with checkpoint inhibitors in preclinical models. As a single agent, NKTR-214 demonstrated efficacy in multiple preclinical models. In combination with either anti-CTLA4 or anti-PD-1 checkpoint inhibitor therapies, NKTR-214 produced durable anti-tumor immunotherapeutic effects, which persisted long after the termination of dosing. In a preclinical tumor re-challenge study, sequential dosing of anti-CTLA-4 followed by NKTR-214 resulted in durable and complete responses. At 142 days following the final dose, with no additional treatment, the complete responders demonstrated sustained resistance to multiple tumor re-challenges. In highly-resistant established melanoma tumor models, treatment with NKTR-214 resulted in a controlled, sustained and biased T-cell activating signal and a mean ratio of CD8-positive T cells to CD4-positive regulatory T-cells (which can suppress tumor killing) of 450:1 in the tumor infiltrating lympho

Seattle Genetics Announces Initiation of Phase 1/2 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Combination with Opdivo® (Nivolumab) in Second-line Hodgkin Lymphoma

On October 7, 2015 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that it has initiated a phase 1/2 clinical trial of ADCETRIS (brentuximab vedotin) in combination with Opdivo (nivolumab) for patients with relapsed or refractory Hodgkin lymphoma (HL) after failure of frontline treatment (Press release, Seattle Genetics, OCT 7, 2015, View Source [SID:1234507658]). The trial is being conducted under a previously announced clinical trial collaboration agreement with Bristol-Myers Squibb Company (NYSE:BMY).

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL, which combines the targeting ability of a monoclonal antibody with a highly potent cell-killing agent. Opdivo is a human antibody that targets and inhibits the programmed death receptor-1 (PD-1), resulting in T-cell activation. Opdivo is part of a new class of cancer immunotherapy treatments known as checkpoint inhibitors, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. A second trial under the collaboration is planned to begin later in 2015 for relapsed or refractory B-cell and T-cell non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL).

"This is the first corporate-sponsored clinical trial to evaluate ADCETRIS combined with a checkpoint inhibitor to determine if the combination can improve patient outcomes," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development. "The trial supports our strategy to establish ADCETRIS as the foundation of care for CD30-expressing malignancies, and to test novel combinations that could benefit patients. We are executing a broad clinical program with ADCETRIS to potentially expand into earlier lines of therapy and new indications, including the ECHELON-1 trial in frontline Hodgkin lymphoma, the ECHELON-2 trial in frontline mature T-cell lymphoma, the ALCANZA trial in cutaneous T-cell lymphoma and both ongoing and planned trials in diffuse large B-cell lymphoma."

The phase 1/2 open-label trial will enroll relapsed or refractory HL patients who have failed frontline therapy. The primary objective is to assess the safety and antitumor activity of ADCETRIS in combination with Opdivo. After completion of four cycles of combination therapy, patients are eligible to undergo autologous stem cell transplant (ASCT). Patients at high risk of relapse or progression following ASCT will be eligible to receive ADCETRIS in the commercial setting. All patients will be assessed for progression-free survival after ASCT. The trial is being conducted at multiple centers in the United States and is designed to enroll up to approximately 60 patients.

ADCETRIS is not currently approved for the treatment of second-line, transplant eligible HL or for the treatment of NHL other than relapsed systemic anaplastic large cell lymphoma. Opdivo is currently not approved for the treatment of lymphoma.

About ADCETRIS (Brentuximab Vedotin)

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS for intravenous injection has received approval from the FDA for three indications: (1) regular approval for the treatment of patients with classical HL after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical HL patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Health Canada granted ADCETRIS approval with conditions for relapsed or refractory HL and sALCL.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive HL following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. ADCETRIS has received marketing authorization by regulatory authorities in more than 55 countries. See important safety information below.

Seattle Genetics and Takeda Pharmaceutical Company Limited (Takeda) are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

About Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: HL and NHL. HL is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell generally expresses CD30. NHL is further categorized into indolent (low-grade) or aggressive, including DLBCL. DLBCL is the most common type of NHL.