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 NexImmune, an emerging leader in the field of antigen-directed immunotherapy, reported that Scott Carmer has been appointed Chief Executive Officer (Press release, NexImmune, MAR 27, 2018, View Source [SID1234554957]). Mr. Carmer has served as NexImmune’s Chief Operating Officer since 2015. In addition, Kristi Jones has been promoted to Chief Operating Officer, and Alan Roemer has been appointed as Chairman of the Board of Directors.

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"I am pleased to congratulate Scott and Kristi, both respected and valued leaders within the organization, on their well-deserved promotions," said Alan Roemer, Chairman of NexImmune. "They have each played an integral role advancing the company’s immuno-oncology programs towards the clinic and closing our $24 million Series A Financing. I look forward to working with the leadership team and Board of Directors to bring NexImmune’s antigen-specific AIM adoptive cellular therapy to patients in need."

Scott P. Carmer
Scott Carmer joined NexImmune in February 2014 as the Company’s first Chief Business Officer and was promoted to Chief Operating Officer in July 2015. Prior to joining NexImmune, Mr. Carmer served as Executive Vice President, Commercial Operations at MedImmune from 2010 through 2013, where he was responsible for all sales, marketing, Medical Affairs, Managed Markets, Global Marketing & Alliances, and commercial analytics functions. He was previously Genentech’s Vice President, Immunology from 2006-2010, responsible for the US launches of Rituxan and ACTEMRA. Prior to Genentech, Mr. Carmer held several leadership roles of increasing responsibility at Amgen, most recently as Executive Director of global marketing, Immunology and Oncology and at GlaxoSmithKline, where he held key roles in global brand management, business development, commercial operations, managed care and field sales. Scott received his B.S. in Biology from the University of Kentucky.

Kristi Jones
Kristi Jones joined NexImmune in 2017 where she served as the Chief Business Officer. She served as NexImmune’s interim CBO in 2016. Prior to joining NexImmune, Ms. Jones was Vice President of Portfolio Strategy and Management at Astra Zeneca, where she played an instrumental role in building a scientifically innovative, diverse portfolio creating new value for the company. Prior to that she served at MedImmune, as Vice President of Global Strategic Marketing and payor planning where she focused driving value through differentiating products, establishing to market strategies and preparing MedImmune for multiple product launches. Previously, Ms. Jones held multiple leadership roles with increasing responsibility at Genentech, where she worked for 16 years, including Head of Immunology and Ophthalmology Pipeline Development – Global Portfolio and Product Strategy, Commercial Operations and Endocrine and Respiratory Franchise leadership. Kristi has held global and US roles in commercial, operations, strategy and business development. She received her B.S. in Biology from Texas Tech University Health Sciences Center and a pharmacy degree from The University of Texas at Austin.

Alan S. Roemer
Alan Roemer has served on NexImmune’s Board of Directors since 2017. Mr. Roemer is also a founding leadership team member of Roivant Sciences and has served as Senior Vice President, Corporate Development since July 2016. He previously served as Roivant’s Senior Vice President, Finance & Operations from the company’s inception through June 2016 and Chief Financial Officer of Axovant Sciences in 2015. From 2009 to 2014, Mr. Roemer was a Managing Director for the Trout Group, where he provided financing, strategic advisory and investor relations services for life sciences clients. He previously served as Chief Financial Officer & Treasurer of Zelos Therapeutics and was a Vice President at Pharmasset (acquired by Gilead) from 1999 to 2008. Prior to Pharmasset, Mr. Roemer was a healthcare consultant for Booz-Allen & Hamilton and Deloitte Consulting, and he held various operational roles at Bank of America. Mr. Roemer currently serves as a trustee of the Helene Fuld College of Nursing. He received his B.S. in Business Administration from Georgetown University and his M.B.A. and M.P.H. degrees from Emory University’s Goizueta Business School and Rollins School of Public Health.

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

On March 27, 2018 STORM Therapeutics, the drug discovery company focused on the discovery of small molecule therapies modulating RNA epigenetics, reported that it has won the Life Science Innovation Award at the Business Weekly Awards ceremony (Press release, STORM Therapeutics, MAR 27, 2018, View Source [SID1234561045]). Held at Queen’s College, Cambridge, the Awards Dinner attracts entries from across the East of England and is the longest-running B2B competition in the UK. The Awards pride themselves on early identification of world-leading businesses.

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STORM Therapeutics was recognised by the judges for leading the field in a highly innovative area of drug discovery which has the potential to target novel disease mechanisms through the inhibition of RNA modifying enzymes.

Commenting on the award, Keith Blundy, CEO of STORM Therapeutics said: "We are very pleased to have been recognized for the Life Science Award, voted for by our peers in Cambridge. It is a credit to the team and our Investors, and a strong endorsement of STORM’s pioneering drug discovery programmes. As the first company tackling disease through harnessing the power of RNA epigenetics, we believe we are well positioned to build a world leading company."

On March 27, 2018 i2020 Accelerator reported that Stelvio Therapeutics has joined its early drug discovery ecosystem (Press release, Stelvio Therapeutics, MAR 27, 2018, View Source [SID1234555715]). i2020 aims to accelerate research programs with differentiated biology and established development paradigms towards advanced leads and clinical candidates. The i2020 Accelerator deploys a world-wide network of well-established R&D resources, financial and BD&L capabilities to help Stelvio Therapeutics advance its proprietary epigenetic platform for glioblastoma therapies.

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i2020 received a startup funding commitment of $30 million from the specialty life science investor, Torrey Pines Investment. "With the risk of taking on projects at early development stages being very significant, i2020 has to be reasonably selective with the programs it supports," comments Nikolay Savchuk, Managing Director at Torrey Pines. "Stelvio Therapeutics’ AI-driven epigenetic signature-based platform, which identifies compounds that trigger differentiation of cancer stem cells into benign cell types, matches i2020’s target profile well. It is a first-in-class project with strong clinical hypothesis, a well-defined product profile and clear development milestones."

"i2020 aligns well with our overall goals, since it provides a robust network of relevant R&D, business strategy and scientific resources, together with an agile business model and flexible partnering options," comments Attila Hajdu, CEO at Stelvio Therapeutics. "This exciting partnership is a tremendous step towards our shared mission of delivering innovative medicines of value to the patients that need them. With our combined technology and resources, the traditional approaches of chemo and radiotherapy would be toppled and we could see a cure for glioblastoma within our lifetime."