March 2018 – Page 12 – 1stOncology™: Cancer Intelligence Service

10-K/A [Amend] – Annual report [Section 13 and 15(d), not S-K Item 405]

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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Celsion has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Celsion, 2018, MAR 27, 2018, View Source [SID1234524998]).

FENNEC PHARMACEUTICALS RECEIVES BREAKTHROUGH THERAPY DESIGNATION BY FDA FOR PEDMARK™

On March 27, 2018 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted PEDMARK (a unique formulation of sodium thiosulfate) Breakthrough Therapy designation for prevention of cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB) (Press release, Fennec Pharmaceuticals, APR 27, 2018, View Source [SID1234525799]).

"The decision by the FDA to grant PEDMARK the first Breakthrough Therapy designation for the prevention of cisplatin ototoxicity reflects a recognition of the promising efficacy and safety data generated from SIOPEL 6 and COG ACCL0431 studies. We believe the recent receipt of Fast Track designation, and today, Breakthrough Therapy designation highlights the current lack of safe and effective treatments and overwhelming need to address this serious condition," said Rosty Raykov, President and Chief Executive Officer of Fennec. "This designation is another significant milestone for the advancement of PEDMARKTM, as we work closely with the Agency to expedite the NDA filing."

According to FDA, Breakthrough Therapy designation is given when preliminary clinical evidence has been provided to show that a treatment effect may represent substantial improvement over available therapies for the treatment of a serious condition. The designation includes all of the Fast Track program features, as well as more intensive FDA guidance on an efficient drug development program. Additional information is available under the FDA guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics:

View Source

About PEDMARK (Sodium Thiosulfate (STS))

Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients, and are particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe there is estimated that over 10,000 children may receive platinum based chemotherapy. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

STS has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies are completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Nagoya City University, Chubu University, Daiichi Sankyo and Mitsubishi UFJ Capital Announce Open Innovation Research on New Cancer Hyperthermia Therapy in Japan

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]).

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

Daiichi Sankyo’s HER2-Targeting Antibody Drug Conjugate DS-8201 Receives SAKIGAKE Designation for Gastric Cancer from Japan MHLW

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]).

"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

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Month: March 2018

10-K/A [Amend] – Annual report [Section 13 and 15(d), not S-K Item 405]

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

FENNEC PHARMACEUTICALS RECEIVES BREAKTHROUGH THERAPY DESIGNATION BY FDA FOR PEDMARK™

Nagoya City University, Chubu University, Daiichi Sankyo and Mitsubishi UFJ Capital Announce Open Innovation Research on New Cancer Hyperthermia Therapy in Japan

Daiichi Sankyo’s HER2-Targeting Antibody Drug Conjugate DS-8201 Receives SAKIGAKE Designation for Gastric Cancer from Japan MHLW