On March 27, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), has received SAKIGAKE Designation for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labour and Welfare (MHLW) (Press release, Daiichi Sankyo, MAR 27, 2018, View Source [SID1234525386]).

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"There are no HER2-targeting treatment options currently available for patients with HER2-positive gastric cancer whose tumors are no longer controlled by trastuzumab," said Koichi Akahane, PhD, MBA, Executive Officer, Head of Oncology Function, R&D Division, Daiichi Sankyo. "We look forward to working closely with the Japan Ministry of Health, Labour and Welfare under the terms of the SAKIGAKE program to accelerate the development of DS-8201 particularly since Japan has one of the highest incidence rates of gastric cancer worldwide."

The SAKIGAKE Designation System promotes R&D in Japan, driving early practical application for innovative pharmaceutical products, medical devices and regenerative medicines. As a designated medicine under the SAKIGAKE Designation system, DS-8201 will have prioritized consultation, a dedicated review system to support the development and review process, as well as reduced review time from the normal 12 to 6 months.

"We are pleased that DS-8201 has received SAKIGAKE Designation for advanced HER2-positive gastric cancer, which follows the Breakthrough Therapy and Fast Track designations granted by the U.S. FDA for HER2-positive metastatic breast cancer," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "These three designations for DS-8201 underscore our commitment to active and close collaborations with health authorities in order to potentially bring DS-8201 as a new treatment option to patients with different types of HER2-expressing cancers worldwide as quickly as possible."

SAKIGAKE Designation was granted based on the results of an ongoing phase 1 study assessing the safety, tolerability and preliminary efficacy of DS-8201. Updated preliminary results of DS-8201 from a subgroup analysis of HER2-positive advanced gastric cancer previously treated with trastuzumab and chemotherapy were recently presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium.1

Unmet Need in Gastric Cancer
Gastric cancer is the fifth most common cancer worldwide, with nearly one million new cases reported in 2012.2 Approximately half of all gastric cancer cases occur in eastern Asia, with Japan having the third highest incidence rate worldwide.2,3 Gastric cancer is the third leading cause of cancer-related death worldwide, and the second leading cause of cancer-related death in Japan.2,4

Approximately one in five gastric cancers overexpress HER2, a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells.5 HER2-expressing gastric cancer is an area of unmet medical need as advances in the treatment of the disease have been limited, largely due to its genetic complexity and heterogeneity.6 Currently, there are no approved HER2-targeting therapy options for patients with HER2-positive advanced gastric cancer after treatment with trastuzumab.

About DS-8201
DS-8201 is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, DS-8201 is a smart chemotherapy comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

DS-8201 is currently in pivotal phase 2 clinical development for HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to T-DM1 (DESTINY-Breast01), pivotal phase 2 development for HER2-positive advanced gastric cancer resistant or refractory to trastuzumab (DESTINY-Gastric01), phase 2 development in advanced colorectal cancer and phase 1 development for other HER2-expressing advanced/unresectable or metastatic solid tumors.

DS-8201 has been granted Breakthrough Therapy designation for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1), and Fast Track designation for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including T-DM1 by the U.S. Food and Drug Administration (FDA). DS-8201 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: DS-8201, an antibody drug conjugate (ADC) for HER2-expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/
refractory acute myeloid leukemia (AML) with FLT3-ITD mutations; and pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com

On March 27, 2018 Public University Corporation Nagoya City University (Chairman: Kenjiro Kohri; Nagoya, Aiichi Prefecture; hereinafter, "Nagoya City University"), Chubu University, Incorporated Educational Institution Chubu University (President: Osamu Ishihara; Kasugai, Aichi Prefecture; hereinafter, "Chubu University"), Daiichi Sankyo Company, Limited (Representative Director, President and COO: Sunao Manabe; head office: Chuo-ku, Tokyo; hereinafter, "Daiichi Sankyo") and Mitsubishi UFJ Capital Co., Ltd. (President: Muneki Handa; head office: Chuo-ku, Tokyo; hereinafter "Mitsubishi UFJ Capital") reported that they will commence open innovation research ("the research") on a new cancer hyperthermia therapy*1 (Press release, Daiichi Sankyo, MAR 27, 2018, View Source [SID1234525387]).

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Based on results of joint research under TaNeDS*2, an open competition joint discovery research grant program operated by Daiichi Sankyo, the research aims to find and optimize magnetic nanoparticles with high capacity for delivery into tumors, and then study their practical application as a new hyperthermia therapy for cancer treatment by researching an alternating magnetic field generating device for efficiently heating the particles.

To carry out the research, a new company called OiDE RYO-UN, Inc. (head office: Chuo-ku, Tokyo; hereinafter "RYO-UN") has been established and will be wholly funded by the OiDE Fund Investment Limited Partnership ("OiDE Fund") operated by Mitsubishi UFJ Capital.

If the pre-agreed goals of the three-year joint research are achieved, Daiichi Sankyo will purchase all of the stock of RYO-UN in order to continue research and development for the project on its own. Then, at the time of achieving its own goals and after a successful product launch, Daiichi Sankyo will pay considerations to Nagoya City University and Chubu University in the form of royalties.

The research on a new cancer hyperthermia treatment is the third OiDE Fund*3 investment, and Daiichi Sankyo and Mitsubishi UFJ Capital plan to continue to carry out open innovation projects to develop new drug discovery platforms using the OiDE Fund.

*1 New cancer hyperthermia therapy
Cancer hyperthermia therapy makes use of the characteristic that cancer cells have weaker heat resistance than normal cells. This therapy selectively kills cancer cells through heating and there are expectations that it can be combined with radiotherapy, chemotherapy and cancer immunotherapy. The new cancer hyperthermia therapy aims to achieve high safety and efficacy by specifically heating cancer cells at a constant temperature.

*2 TaNeDS
TaNeDS (Take a New Challenge for Drug diScovery) is a collaborative drug discovery initiative being pursued by Daiichi Sankyo in open innovation. This is an open competition joint discovery research grant program whose scope covers research from the exploratory stage to the pre-practical application stage.

*3 OiDE (Open innovation for the Development of Emerging technologies) Fund
A fund jointly established by Mitsubishi UFJ Capital and Daiichi Sankyo in 2013, and operated by Mitsubishi UFJ Capital

(Filing, Annual, Compugen, 2017, MAR 27, 2018, View Source [SID1234525031])

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On March 26, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the Phase III IMpower150 study met its co-primary endpoint of overall survival (OS) at this interim analysis and showed that initial (first-line) treatment with the combination of TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) helped people with advanced non-squamous non-small cell lung cancer (NSCLC) live significantly longer compared with Avastin plus carboplatin and paclitaxel (Press release, Hoffmann-La Roche, MAR 26, 2018, View Source [SID1234525397]). A survival benefit was observed across key subgroups, including those with varying levels of PD-L1 expression. Safety for the TECENTRIQ and Avastin plus carboplatin and paclitaxel combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combinations. These data will be presented at an upcoming oncology congress.

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"We are pleased that the IMpower150 study demonstrated a clinically meaningful survival benefit for people receiving their initial treatment for this type of advanced lung cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "These results add to the growing body of evidence supporting the role of combining TECENTRIQ with Avastin. We will submit these additional data to global health authorities and hope to bring this potential treatment option to patients as soon as possible."

At this interim analysis, the study found that substituting Avastin with TECENTRIQ in the combination with carboplatin and paclitaxel did not show a statistically significant OS benefit in people with advanced NSCLC compared to a combination of Avastin plus carboplatin and paclitaxel. The study will continue as planned to the final analysis. Safety in the TECENTRIQ plus carboplatin and paclitaxel arm appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.
Previously reported results from the IMpower150 study showed that the combination of TECENTRIQ and Avastin plus carboplatin and paclitaxel reduced the risk of disease worsening or death (progression-free survival; PFS), a co-primary endpoint, by 38 percent (HR=0.62; p<0.0001, 95 percent CI: 0.52-0.74) compared to Avastin plus carboplatin and paclitaxel in the first-line treatment of people with advanced non-squamous NSCLC. This PFS benefit was observed across key subgroups, including those with varying levels of PD-L1 expression.
IMpower150 is one of eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines. Following the positive IMpower150 and IMpower131 studies, three more Phase III lung cancer studies are expected to report this year.

About the IMpower150 study
IMpower150 is a multicenter, open-label, randomised, controlled Phase III study evaluating the efficacy and safety of TECENTRIQ in combination with carboplatin and paclitaxel with or without Avastin in people with stage IV non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. It enrolled 1,202 people, of which those with ALK and EGFR mutations were excluded from the primary intention-to-treat (ITT) analysis. People were randomised (1:1:1) to receive:
TECENTRIQ plus carboplatin and paclitaxel (Arm A), or
TECENTRIQ and Avastin plus carboplatin and paclitaxel (Arm B), or
Avastin plus carboplatin and paclitaxel (Arm C, control arm)

During the treatment-induction phase, people in Arm A received TECENTRIQ administered intravenously at 1200 mg in combination with intravenous infusion of carboplatin and paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. Following the induction phase, people received maintenance treatment with TECENTRIQ (1200 mg every 3 weeks) until loss of clinical benefit or disease progression.
People in Arm B received induction treatment with TECENTRIQ (1200 mg) and Avastin administered intravenously at 15 mg/kg in combination with intravenous infusion of carboplatin and paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. People then received maintenance treatment with the TECENTRIQ and Avastin regimen until disease progression (Avastin) or loss of clinical benefit/disease progression (TECENTRIQ).
People in Arm C received induction treatment with Avastin administered intravenously at 15 mg/kg plus intravenous infusion of carboplatin and paclitaxel on Day 1 of a 3-week treatment cycle for 4 or 6 cycles. This was followed by maintenance treatment with Avastin alone until disease progression.
The co-primary endpoints were PFS and OS, as determined by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). The co-primary OS endpoint in IMpower150 was assessed in all randomised people without an ALK or EGFR genetic mutation (intention-to-treat wild-type). Key secondary endpoints included investigator-assessed PFS and OS, safety in the ITT population and in EGFR and ALK mutation subgroups.
The primary analysis of the co-primary PFS endpoint in IMpower150 was assessed in two populations: all randomised people without an ALK or EGFR genetic mutation (intention-to-treat wild-type) and in a subgroup of people who had a specific biomarker (T-effector "Teff" gene signature expression ). IMpower150 met its PFS co-primary endpoint per study protocol for both populations assessed.

About NSCLC
Lung cancer is the leading cause of cancer death globally.1 Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.2 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.2 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.
About TECENTRIQ (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.
TECENTRIQ is already approved in the European Union, United States and more than 60 countries for people with previously treated metastatic NSCLC and for people with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.
About Avastin (bevacizumab)
Avastin is a biologic cancer treatment approved in combination with chemotherapy for the first-line treatment of advanced NSCLC and, to-date, has helped over 500,000 patients lead longer lives. Avastin is considered a standard of care for the first-line treatment of advanced NSCLC and has been proven to significantly extend overall survival (OS). Avastin is currently approved in combination with any platinum-based chemotherapy in Europe, and with paclitaxel/carboplatin in the US, in first-line non-squamous NSCLC, based on results of the pivotal Phase III E4599 study. Avastin was the first medicine to help people with previously untreated advanced, non-squamous NSCLC live longer (OS) than one year when added to chemotherapy.
About the TECENTRIQ (atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support combining TECENTRIQ and Avastin. The TECENTRIQ and Avastin regimen may enhance the potential of the immune system to combat a broad range of cancers, including first-line advanced NSCLC. Avastin, in addition to its established anti-angiogenic effects, may further enhance TECENTRIQ’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens.
About Roche in cancer immunotherapy
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.
By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.
To learn more about the Roche approach to cancer immunotherapy please follow this link:
View Source

Ablynx has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, Ablynx, 2018, MAR 26, 2018, View Source [SID1234524997]).

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