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[PDF]Fujifilm Kyowa Kirin Biologics establishes joint venture with AstraZeneca to develop and commercialise anti-VEGF biosimilar

On July 24, 2015 I FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd. (President and CEO: Hideaki Nomura; hereinafter "Fujifilm Kyowa Kirin Biologics") reported that it has entered into an agreement with AstraZeneca plc (hereinafter "AstraZeneca") to establish a joint venture for the development and commercialisation of FKB238 in development for the treatment of multiple solid tumours (Press release, Kyowa Hakko Kirin, JUL 24, 2015, View Source [SID:1234506617]).

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FKB238 is a biosimilar version of bevacizumab, an anti-VEGF1 humanized monoclonal antibody with established efficacy across a range of cancers including colorectal and non-small cell lung cancer2. Fujifilm Kyowa Kirin Biologics commenced its Phase I clinical trial for FKB238 in Europe in November 2014.

Under the terms of the agreement, the new joint venture that is equally co-funded by the two companies and will use FKB238’s non-clinical, clinical development data compiled by Fujifilm Kyowa Kirin Biologics thus far. Fujifilm Kyowa Kirin Biologics will transfer the rights to FKB238 to the new joint venture, and will receive a lump-sum payment of USD45 million in return.

"Together with Kyowa Hakko Kirin, Fujifilm has been developing high-quality, cost-competitive biosimilars, by adopting to Fujifilm Kyowa Kirin Biologics its technological expertise in precise production control and strict quality assurance, cultivated over the years in photographic film business." said Takatoshi Ishikawa, Director, Senior Vice President, General Manager Pharmaceutical Products Division of Fujifilm. "We hope that FKB238 will help patients as soon as possible by the joint venture accelerating the drug development."

"Since 2012, we have put effort in biosimilar business with Fujifilm through Fujifilm Kyowa Kirin Biologics." said Wataru Murata, Executive Officer, Director, Corporate Strategy & Planning Department of Kyowa Hakko Kirin. "We expect that this joint venture with AstraZeneca will accelerate the global development of FKB238 as a potential companion to other oncology medicines for the treatment of a range of cancers."

Fujifilm Kyowa Kirin Biologics was established by FUJIFILM Corporation (President and CEO: Shigehiro Nakajima; hereinafter "Fujifilm") and Kyowa Hakko Kirin Co., Ltd. (President and CEO: Nobuo Hanai, hereinafter "Kyowa Hakko Kirin") on March 27, 2012 as a company for developing, manufacturing and marketing biosimilars. In its pipeline are FKB238 as well as biosimilar of the fully human anti-TNF-A monoclonal antibody, adalimumab (Development No. FKB327) a drug with dramatic therapeutic effects for rheumatoid arthritis. FKB327 is under Phase III clinical trial in the United States and other countries.

By merging the technologies in advanced production, quality control and analysis which Fujifilm has developed over many years through its photographic film business, with the proprietary technologies and know-how which Kyowa Hakko Kirin has accumulated through its biopharmaceutical R&D and manufacturing, Fujifilm Kyowa Kirin Biologics creates revolutionary production processes and reduces costs for the production of biosimilars. Through this partnership, the company will develop and manufacture reliable, high quality, cost-competitive biosimilar products and commercialize these products in a timely manner. With this strategy, Fujifilm Kyowa Kirin Biologics aims to hold a leading position in the expanding biosimilar market.

* VEGF is an abbreviation for Vascular Endothelial Growth Factor. VEGF is a glycoprotein which promotes mitogenic activity in vascular endothelial cells, which in turn stimulates angiogenesis.
** Lung cancer can be broadly divided into small cell lung cancer and non-small cell lung cancer, with 85% of lung cancers falling into the latter category. Non-small cell lung cancers include squamous cell cancer, adenocarcinoma and large cell carcinoma

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Bristol-Myers Squibb, JUL 23, 2015, View Source [SID:1234506612])

PharmaMar announces license agreement with TTY Biopharm for APLIDIN® (plitidepsin) in hematological cancers

On July 23, 2015 PharmaMar reporrted that it has entered into an exclusive license and commercialization agreement with the pharmaceutical company TTY Biopharm to market and distribute the drug candidate APLIDIN (plitidepsin) in Taiwan(Press release, PharmaMar, JUL 23, 2015, View Source [SID:1234510353]). Under the terms of the agreement, PharmaMar will receive an upfront payment, royalties and additional remunerations for regulatory milestones achieved by APLIDIN (plitidepsin). PharmaMar will retain exclusive production rights and will supply the finished product to TTY Biopharm for commercial use.
APLIDIN (plitidepsin) is PharmaMar´s second anticancer drug candidate obtained from a marine organism and is currently under development for the treatment of multiple myeloma and a type of T cell lymphoma. The company announced in June that patient recruitment of the international pivotal Phase III trial (ADMYRE) for APLIDIN (plitidepsin) in refractory/relapsed multiple myeloma was successfully completedi.
"Thousands of patients are living with this disease, and it is our commitment and dedication to bring a novel and first-in-class therapy to patients in need. For this mission, we are delighted to collaborate in a partnership with one of the long-standing leaders in the field of oncology and hematology in Taiwan." said Heiner Pieper, Vice-President of Business Development & Licensing at PharmaMar.
"Our understanding of the Taiwanese market and our capabilities to market plitidepsin along with the therapeutic value of this innovative compound will be factored into the success of this partnership", said Hsiao Ying-Chun, Chairman of TTY Biopharm. "We are hoping to start contributing to the well-being of these patients by providing clinicians with a novel drug".

Sunesis Pharmaceuticals Announces Regulatory Update

On July 23, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported regulatory updates from its interactions with the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) regarding a potential path toward marketing authorization for vosaroxin as a treatment for acute myeloid leukemia (AML) in Europe and the United States (Press release, Sunesis, JUL 23, 2015, View Source;p=RssLanding&cat=news&id=2070668 [SID:1234506619]).
With respect to Europe, the company recently met separately with the Rapporteur (United Kingdom) and Co-Rapporteur (Netherlands) assigned to provide advice and guide the company through the Marketing Authorization Application (MAA) process.

Based on these substantive discussions, the company was encouraged to proceed with an MAA filing for the indication of relapsed/refractory AML in patients age 60 years and older, a population with the greatest medical need and for whom the greatest benefit was observed in the vosaroxin/cytarabine treatment arm of VALOR, the company’s pivotal Phase 3 study of vosaroxin and cytarabine in adult patients with relapsed or refractory AML.

With respect to the United States, after conducting additional safety and efficacy analyses, the company recently met with the FDA. In light of not reaching statistical significance on the protocol-defined primary analysis of overall survival, Sunesis was informed that the Agency did not support a filing and encouraged the company to provide additional clinical evidence to support a future NDA submission.

Based on feedback from European and U.S. regulators, the company will place near-term focus on the MAA filing, which it will work to complete as expeditiously as possible, and will evaluate and refine its plan to gain marketing approval in the U.S.
"We are at once encouraged by our interactions with European regulators and disappointed with the outcome of our meeting with their U.S. counterparts," said Daniel Swisher, Chief Executive Officer of Sunesis. "Our belief, supported by many in the medical community, is that the VALOR outcomes for patients with high unmet needs were both compelling and an important step forward in addressing the enduring challenges of treating AML. We look forward to moving ahead with the submission of an MAA filing in Europe."

Mr. Swisher added: "Our confidence in vosaroxin stems not only from the outcomes seen in VALOR, but our ongoing investigator sponsored studies. It is our goal to leverage this body of data to determine a clinical and regulatory path forward for vosaroxin that is time and resource efficient, addresses the needs of patients with AML and maximizes our likelihood of regulatory and commercial success."

Damon Runyon cancer grant boosts Davila’s research

On July 23, 2015 Vanderbilt University reported Marco Davila, M.D., Ph.D., assistant professor of Medicine and of Cancer Biology, has received a grant from the Damon Runyon Cancer Research Foundation that will provide $450,000 over three years to help fund his research on therapies for several types of blood disorders, including various forms of leukemia and non-Hodgkin (also known as non-Hodgkin’s) lymphoma (Press release, Vanderbilt University, JUL 23, 2015, View Source [SID:1234506607]).
Davila’s current research focuses on the body’s immune system.

"Some people would argue that cancers that develop are, in part, a failure of the immune system," said Davila.

Normally the body’s immune system defenses should recognize and attack cancer cells, but scientists have discovered mechanisms that throw up a screen, making the cancer cells invisible. The immune system uses white blood cells, or lymphocytes, which originate in the bone marrow. The lymphatic system includes T cells and B cells which have receptors on their surface that can recognize invaders. Davila said B cells have a protein called CD19 which is present in almost all B cell malignancies like leukemia.

Prior to joining Vanderbilt in 2014, Davila and colleagues at Memorial Sloan Kettering Cancer Center in New York created an antigen receptor that would recognize and lock onto CD19.

"By genetically modifying T cells to CD19 we created a huge bulk population of cells that are now going to be reactive to this B cell target," said Davila.

They tested this CAR T antigen receptor in mouse models and in some patients with relapsed ALL (acute lymphocytic leukemia) with remarkable results.

"This is a disease where with standard salvage chemotherapy the survival rate would be 20 to 30 percent. In the patients we treated the complete response rate was nearly 90 percent," Davila said.

However, the CAR T cell therapy was not as effective with CLL (chronic lymphocytic leukemia) or non-Hodgkin diseases. Davila and colleagues believe CLL is immune resistant to CD19-targeted CAR T cell therapies.

"We can see the disease is eradicated in the bone marrow but a lot of times the disease is still residual in the lymph nodes. So we think that within the lymph node the tumor cells themselves or maybe some other cells that they are recruiting in the tumor microenvironment are suppressing the CAR T cells that infiltrate into the lymph node," said Davila.

He is hoping to develop an "armored CAR" third generation that will be resistant to immune suppression within the lymph node or the tumor microenvironment.

"We’re engineering the cells in a way to be able to activate themselves and avoid immune suppression within these lymph nodes in the hostile tumor microenvironments."

Davila said support from the Damon Runyon Cancer Research Foundation is critical for this project and he is excited about the "luminaries of cancer research" working with the foundation who will be monitoring his project and helping him troubleshoot any barriers to the translation of his research.

The foundation is named in honor of Damon Runyon, a journalist and short story writer active in the early part of the last century who was renowned for his humorous sports coverage and creation of colorful characters from the sports, horse racing and gambling worlds. Since 1946, the Foundation has invested more than $287 million dollars in innovative cancer research, supporting the work of more than 3,400 cancer investigators.