1stOncology™: Cancer Intelligence Service – Page 15630 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Celgene and Juno Announce Celgene Exercised Option to Develop and Commercialize CD19-directed Product Candidates

On April 11, 2016 Celgene Corporation (NASDAQ: CELG) and Juno Therapeutics, Inc. (NASDAQ: JUNO) reported that Celgene exercised its option to develop and commercialize the Juno CD19 program outside North America and China(Press release, Juno, APR 11, 2016, View Source [SID:1234510661]).

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!

With the exercise of this option, Celgene will pay Juno a fee of $50 million and the companies will now share global development expenses for products in the CD19 program. Celgene has commercial rights outside of North America and China and will pay Juno a royalty at a percentage in the mid-teens on any future net sales of therapeutic products developed through the CD19 program in Celgene’s territories. Juno retains commercialization rights in North America and China.

This Smart News Release features multimedia. View the full release here: View Source

Juno currently has three CD19-directed product candidates in clinical development, including JCAR015, JCAR017, and JCAR014. JCAR015 is in a Phase II trial for adults with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL). JCAR017 is in two separate Phase I trials, one in pediatric patients with r/r ALL and another in patients with r/r non-Hodgkin lymphoma (NHL).

JCAR014 is in a Phase I trial in three different indications, adult r/r/ ALL, r/r NHL, and r/r chronic lymphocytic leukemia (CLL), as well as a trial in combination with AstraZeneca’s investigational programmed death ligand 1 (PD-L1) immune checkpoint inhibitor, durvalumab.

"Our CD19-directed portfolio of drug candidates has shown encouraging efficacy and manageable toxicity in trials to date across a range of B cell malignancies, and we are pleased that Celgene has decided to opt in to the CD19 program. Celgene’s development and commercial expertise, particularly in hematologic malignancies, make them our ideal partner and will accelerate our global development capabilities for patients with ALL, CLL, and NHL," said Hans Bishop, Juno’s President and Chief Executive Officer. "The long-term collaboration with Celgene is an important component of our plan to develop our engineered T cell platform rapidly and effectively for the benefit of patients around the world, and we are encouraged by the progress we are making together."

"Our decision to move forward with the Juno CD19 program underscores our commitment to the long-term collaboration with Juno and our strong desire to deliver important new treatment options to patients with serious hematologic malignancies," said Robert Hershberg, M.D., Ph.D., Chief Scientific Officer for Celgene. "CD19-based CAR T therapies hold great promise in B cell malignancies including acute lymphoblastic leukemia, non-Hodgkin lymphoma, and chronic lymphocytic leukemia. Further, the lessons learned from CD19 will inform additional targets and approaches as the Celgene-Juno collaboration evolves."

NanoString Technologies and HalioDx Enter Into Collaboration Agreement to Jointly Develop and Commercialize Novel Gene Expression Assays in Immuno-oncology

On April 11, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, and HalioDx SAS, a diagnostic company in immuno-oncology, reported they have entered into an agreement to jointly develop and commercialize advanced gene expression assays for assessing the response to immunotherapies (Press release, NanoString Technologies, APR 11, 2016, View Source [SID:1234510648]).

Under this collaboration agreement, NanoString and HalioDx will jointly develop innovative immune gene expression assays on the NanoString nCounter Analysis System based on discoveries of Dr. Jérôme Galon, Research Director at the Institut National de la Santé et de la Recherche Médicale (Inserm) and his team (Inserm UMRS1138) at Cordeliers Research Center. NanoString and HalioDx will jointly offer products and associated services to academic, pharmaceutical and biotechnology customers worldwide.

The products and services to be developed under the collaboration will enable researchers and drug developers to use assays to assess responses to immunotherapies and select patients who are most likely to benefit from the therapies. This collaboration expands both companies’ leadership in precision immuno-oncology and offers the potential for companion diagnostic collaborations with biopharmaceutical partners in the future.

"HalioDx is very excited to jointly develop with NanoString our innovative predictive and prognostic immune gene expression signatures on the nCounter platform, one of the best multi-analyte testing platforms for translating gene expression signatures to routine diagnostic use. At HalioDx, we want to develop diagnostic solutions that can be easily used in routine clinical practice settings and we selected the nCounter platform because of its robustness, turn-around time, and compatibility with formalin-fixed-paraffin-embedded tissue samples. Our co-developed immune gene expression assays will complement the breakthrough Immunoscore IHC assay, to foster the development of more precise immunotherapies," said Vincent Fert, co-founder and CEO of HalioDx.

"This collaboration with HalioDx adds another powerful tool to the nCounter immuno-oncology toolkit to support our customers’ efforts in developing clinically validated predictive biomarkers for cancer immunotherapies. With the ability to process small tissue samples with minimal hands-on time, NanoString’s nCounter technology provides a powerful solution to researchers and drug developers who are in search of biomarkers for precision oncology, and is ideally suited to answering complex questions in translational research in the field of immuno-oncology," said Brad Gray, President and Chief Executive Officer of NanoString Technologies.

ARIAD Announces Initiation of Randomized, First-Line Phase 3 Trial of Brigatinib in Treatment of ALK-Positive Non-Small Cell Lung Cancer

On April 11, 2016 ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) reported the initiation of a randomized, first-line Phase 3 clinical trial of brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, in adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously been treated with an ALK inhibitor (Press release, Ariad, APR 11, 2016, View Source [SID:1234510646]).

The ALTA 1L (ALK in Lung Cancer Trial of BrigAtinib in 1st Line) trial is designed to assess the efficacy of brigatinib in comparison to crizotinib based on evaluation of the primary endpoint of progression free survival (PFS).

"We are pleased to be advancing brigatinib into a pivotal Phase 3 trial as a potential new therapy for patients with ALK+ NSCLC who have not yet received an ALK inhibitor," said Tim Clackson, Ph.D., president of research and development and chief scientific officer of ARIAD. "We believe that the encouraging results shown in our preclinical and ongoing Phase 1/2 studies suggest brigatinib has the potential to improve outcomes for ALK+ NSCLC patients as compared to treatment with crizotinib."

Trial Design

The ALTA 1L trial is a randomized, open-label, multicenter, international study that is designed to compare the efficacy and safety of brigatinib to crizotinib in adult patients with ALK+ NSCLC who have not previously received an ALK inhibitor. The trial is expected to be conducted at approximately 150 investigational sites in North America, Europe and the Asia Pacific region. Patients in the trial must be at least 18 years of age, have stage IIIB or stage IV NSCLC with ALK rearrangement, have received no more than one regimen of systemic anticancer therapy in the locally advanced or metastatic setting, and have not received prior therapy with an ALK inhibitor.

Approximately 270 patients are expected to be randomized one-to-one to receive brigatinib (90 mg given orally once daily for seven days followed by escalation to 180 mg once daily) or crizotinib (250 mg given orally twice daily). ARIAD expects to complete patient enrollment in the ALTA 1L trial in 2018.

The primary endpoint of the trial is progression free survival (PFS), per RECIST criteria as assessed by a blinded Independent Review Committee (BIRC). Tumor response assessments will be performed every eight weeks. Key secondary endpoints include objective response rate (ORR), intracranial ORR, intracranial PFS, duration of response, overall survival (OS), safety and tolerability. Health related quality of life data will also be assessed.

"This head-to-head study will directly test brigatinib against crizotinib in the TKI-naïve ALK+ setting – where innovative therapies are needed to improve response rates and to delay progression that can occur through the emergence of secondary resistance mutations in ALK and progression in the central nervous system," said D. Ross Camidge, M.D., Ph.D., director of thoracic oncology at the University of Colorado. "In patients who have experienced crizotinib failure, brigatinib has already exhibited very impressive progression free survival and marked activity in patients with CNS metastases – features that suggest that in the ALK TKI-naive setting, it could potentially change patients’ natural history by better suppressing ALK+ disease from the beginning."

About Brigatinib

Brigatinib is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. It is in development for the treatment of patients with ALK+ NSCLC. Brigatinib received Breakthrough Therapy designation from the FDA in October 2014 for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib on the basis of an ongoing Phase 1/2 trial. Brigatinib is currently being evaluated in the global Phase 2 ALTA trial in ALK+ NSCLC patients who have progressed on crizotinib, which is anticipated to form the basis for a new drug application planned for submission later in 2016.

Kyoto University and Sumitomo Dainippon Pharma Launch Second Stage of Joint Research Project for Innovative Oncology Therapeutics (DSK Project)

On April 11, 2016 Kyoto University (Kyoto, Japan; President: Juichi Yamagiwa) and Sumitomo Dainippon Pharma Co., Ltd. (Osaka, Japan; President: Masayo Tada) ("Sumitomo Dainippon Pharma") reported the launch of second stage of the DSK Project, a framework for joint research aimed at discovering innovative anti-cancer drugs, diagnostic tools and therapeutic methods (Press release, Dainippon Sumitomo Pharma, APR 11, 2016, View Source [SID:1234510640]).

In this new stage of the DSK Project, Kyoto University and Sumitomo Dainippon Pharma will conduct unique drug discovery research focusing on the regulatory mechanisms of interactions with cancer cells, immune cells, and stroma cells in tumor microenvironment by the approaches of molecular/cellular biology and clinical aspects.

Kyoto University is strongly committed to collaborative projects between industry and academia on the institutional level through its Medical Innovation Center (MIC) – The first open innovation laboratory in Japan. The mission of the MIC is to discover innovative medicines and therapeutic methods as well as to develop researchers in related fields. For instance, the University provides intensive, advanced cancer treatments at its Kyoto University Cancer Center and is engaged in state-of-the-art basic research through its Graduate School of Medicine as it seeks to develop new diagnostic tools and groundbreaking therapeutic methods for fighting cancer.

Sumitomo Dainippon Pharma pursues extensive research and development (R&D) approaches including its internal research expertise, in-licensed technologies, and joint research with venture companies and universities in a quest for innovative pharmaceutical products. The Company focuses on the therapeutic areas of psychiatry & neurology and oncology. Within oncology, Sumitomo Dainippon Pharma aims to develop innovative products under the integrated global R&D system between the DSP Cancer Institute of Sumitomo Dainippon Pharma in Japan and Boston Biomedical, Inc. in the United States.

Kyoto University and Sumitomo Dainippon Pharma have agreed to establish a joint cancer R&D laboratory within the MIC for the purpose of launching second stage of the DSK Project. Dr. Shinji Uemoto, Dean of the Kyoto University Graduate School of Medicine and Faculty of Medicine, will serve as a project director, and cancer immunology specialist Dr. Nagahiro Minato, Specially Assigned Professor of the Kyoto University Graduate School of Medicine, will work as a project mentor, core cancer research groups at the Graduate School of Medicine and their counterparts at 2 the research groups at Sumitomo Dainippon Pharma will work closely to develop unique and innovative anti-cancer drugs, diagnostic tools and therapeutic methods from the new perspective of "cancer and host response."

* Initial stage of the DSK Project was announced on March 15, 2011.

Summary

Second stage of DSK Project:

Purpose: Development of unique and innovative anti-cancer drugs, diagnostic tools, and therapeutic strategies through discovering novel regulatory mechanisms of cancers cells interacted with immune and stroma cells in tumor microenvironment.

* Stroma cells are non-cancerous cells that exist in cancer tissues, such as fibroblasts, immune cells, pericytes, endothelial cells and inflammatory cells.

Term:

5 years from April 2016

Organization: The Alliance Management Committee, Research Promotion Committee, and Intellectual Property Committee constitute the leadership structure of the DSK Project, with each committee having an equal number of members from Kyoto University and Sumitomo Dainippon Pharma.

Under the overall management by Dr. Shinji Uemoto, Dean of the Kyoto University Graduate School of Medicine and Faculty of Medicine, and research activity coordination by Dr. Nagahiro Minato, Specially Assigned Professor of the Kyoto University Graduate School of Medicine, Kyoto University’s core research groups (immunology, gastroenterology, genome informatics) and Sumitomo Dainippon Pharma’s satellite research groups will conduct the Project in the Medical Innovation Center, University Hospital, West Campus.

FDA grants priority review for Roche's cancer immunotherapy atezolizumab in specific type of lung cancer

On April 11, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy (Press release, Hoffmann-La Roche , APR 11, 2016, View Source [SID:1234510637]).

"In a study of atezolizumab in people with previously treated advanced lung cancer, PD-L1 expression correlated with how well they responded to the medicine," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone."

Atezolizumab was granted Breakthrough Therapy Designation by the FDA in February 2015 for the treatment of people whose NSCLC expresses PD-L1 and whose disease progressed during or after standard treatments (e.g., platinum-based chemotherapy and appropriate targeted therapy for EGFR mutation-positive or ALK-positive disease). Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure that people have access to them through FDA approval as soon as possible. The BLA submission for atezolizumab is based on results from clinical trials including the Phase II BIRCH study, and the FDA will make a decision on approval by Oct. 19, 2016. A Premarket Application (PMA) is also under review by the FDA for a companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics.

This is the second BLA acceptance and priority review for atezolizumab. On 15th March, Roche announced that the FDA had accepted the company’s BLA and granted Priority Review for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Atezolizumab is also being studied in a number of other cancers.

About the BIRCH study

BIRCH is an open-label, multicenter, single-arm Phase II study that evaluated the safety and efficacy of atezolizumab in 667 people with locally advanced or metastatic NSCLC whose disease expressed PD-L1. PD-L1 expression was assessed for both tumor cells and tumor-infiltrating immune cells with an investigational IHC test based on the SP142 antibody. People in the study received a 1200-mg intravenous dose of atezolizumab every three weeks. The primary endpoint of the study was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included duration of response (DOR), overall survival, progression-free survival and safety.

About non-small cell lung cancer

Lung cancer is the leading cause of cancer death globally. Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day. Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.

About atezolizumab

Atezolizumab (also known as MPDL3280A; anti-PDL1) is an investigational monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1). Atezolizumab is designed to directly bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells. Atezolizumab may also affect normal cells.

About personalised cancer immunotherapy

The aim of personalised cancer immunotherapy (PCI) is to provide individual patients with treatment options that are tailored to their specific needs. Our PCI research and development programme comprises more than 20 investigational candidates, eight of which are in clinical trials. All studies include the prospective evaluation of biomarkers to determine which people may be appropriate candidates for our medicines. In the case of atezolizumab, PCI begins with the PD-L1 (programmed death ligand-1) IHC assay based on the SP142 antibody developed by Roche Tissue Diagnostics. The goal of PD-L1 as a biomarker is to identify those people most likely to experience clinical benefit with atezolizumab as a single agent versus those who may benefit more from combination approaches; the purpose is to inform treatment strategies which will give the greatest number of patients a chance for transformative benefit.The ability to combine atezolizumab with multiple chemotherapies may provide new treatment options to people across a broad range of tumours regardless of their level of PD-L1 expression.

Personalised Cancer Immunotherapy is an essential component of how Roche deliver on the broader commitment to personalised healthcare. For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.