On May 22, 2017 FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd. (President & CEO: Hideaki Nomura; "Fujifilm Kyowa Kirin Biologics") reported that on May 18, 2017, the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for FKB327, an adalimumab biosimilar candidate to the fully human anti-TNF-α*1 monoclonal antibody, Humira (Press release, Fujifilm Kyowa Kirin Biologics, MAY 22, 2017, View Source [SID1234519287]).

(Press release, Fujifilm Kyowa Kirin Biologics, MAY 22, 2017, View Source [SID1234519287])

In December 2014, Fujifilm Kyowa Kirin Biologics began a Phase 3 global clinical study of FKB327 at sites in the US, Europe and other countries to compare the efficacy and safety profile of FKB327 with Humira(reference product) in patients with moderate to severe rheumatoid arthritis*2. In this study, FKB327 met the primary endpoint and prespecified criteria for equivalence, and there were no significant differences in the rate of adverse events between FKB327 and Humira. Based on the top-line results, announced on October 19, 2016, Fujifilm Kyowa Kirin Biologics decided to file the MAA for FKB327 to EMA in April 2017.

"We are delighted that EMA has accepted the application," said Hideaki Nomura, President & CEO of Fujifilm Kyowa Kirin Biologics. "The acceptance of this filing brings us one step closer to meeting the demand for high quality and affordable biopharmaceuticals."

Fujifilm Kyowa Kirin Biologics was established by FUJIFILM Corporation (President & COO: Kenji Sukeno; "Fujifilm") and Kyowa Hakko Kirin Co., Ltd. (President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") on March 27, 2012 as a company for the development, manufacture, and marketing of biosimilars.

Fujifilm Kyowa Kirin Biologics creates revolutionary production processes and reduces the production cost of biosimilars 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 accumulated by Kyowa Hakko Kirin through its biopharmaceutical R&D and manufacture. As the results of this partnership, the goal of Fujifilm Kyowa Kirin Biologics is to develop and manufacture reliable, high quality, cost-competitive biosimilar products that it will commercialise in a timely manner. Through this strategy, Fujifilm Kyowa Kirin Biologics aims to attain a leading position in the expanding biosimilar market. For more information about Fujifilm Kyowa Kirin Biologics, please visit View Source

*1 TNF-α (tumor necrosis factor alpha) is a cytokine that is involved in inhibition of tumorigenesis and defense against infection. Overexpression of TNF-α is implicated in a range of inflammatory diseases, including rheumatoid arthritis and psoriasis.
*2 Rheumatoid arthritis is an inflammatory autoimmune disorder that affects the joints, in particular arms and legs. It typically results in painful joints and joint degeneration, leading to deterioration of the daily functional activities. The disease may also cause malaise as one of the general symptoms.

On May 22, 2017 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) posted briefing documents on its website in preparation for the May 24 Oncologic Drugs Advisory Committee (ODAC) meeting scheduled to review PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer (Press release, Puma Biotechnology, MAY 22, 2017, View Source [SID1234519257]).

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ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes appropriate recommendations to the FDA. Its comments are not binding, but are considered by the FDA in its decision-making process.

On May 22, 2017 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported multiple presentations discussing clinical and non-clinical studies relating to their oral rigosertib plus azacitidine combination therapy for which a Phase 3 trial is being designed (Press release, Onconova, MAY 22, 2017, View Source [SID1234519256]). In addition, SymBio, Onconova’s partner in Japan and Korea, will present Phase 1 data evaluating intravenous rigosertib in Japanese patients with recurrent/relapsed or refractory Myelodysplastic Syndromes.

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DETAILS OF THE PRESENTATIONS:

Combination Therapy with Rigosertib Plus Azacitidine

Oral Rigosertib Combined With Azacitidine in Patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS): Effects in Treatment of Naive and Relapsed/Refractory Patients

Format: Oral presentation

Date: June 24, 2017

Presenter: Shyamala Navada, M.D., Assistant Professor, Mount Sinai School of Medicine

Abstract: S488


Rigosertib Combined with Azacitidine Epigenetically Modulates Chromatin and Hematopoietic Stem Cell Populations in the Myelodysplastic Syndromes (MDS)

Author: Pratima Chaurasia, Ph.D., Assistant Clinical Professor, Mount Sinai School of Medicine

Shyamala C. Navada, M.D., Assistant Professor, Mount Sinai School of Medicine

Abstract: E1170


Oral Rigosertib as a Single Agent

A Multicenter, Open-label, Phase 1 Cinical Study: Safety, Efficacy, and Pharmacokinetics of Oral Rigosertib in Japanese Patients with Recurrent/Relapsed or Refractory Myelodysplastic Syndromes

Format: E Poster Presentation

Author: Kenichi Ishizawa, M.D., Ph.D.

Abstract: E1199


Another abstract of Phase 1 Data Demonstrating Intravenous Rigosertib as a Single Agent from SymBio collaborators will be published as an abstract only:

Safety, Efficacy and Pharmacokinetics of Intravenous Rigosertib in Japanese Patients with Recurrent/Relapsed or Refractory Myelodysplastic Syndromes (MDS): A Multicenter, Open-label, Phase 1 Study

Format: Publication only

Author: Michinori Ogura, M.D., Ph.D.

Abstract: PB1919

About IV Rigosertib

The intravenous form of rigosertib has been employed in Phase 1, 2, and 3 clinical trials involving more than 800 patients, and is currently being evaluated in the randomized Phase 3 international INSPIRE trial for patients with higher-risk MDS, after failure of hypomethylating agent, or HMA, therapy. This formulation is intended for patients with advanced disease, provides long duration of exposure, and ensures dosing under a controlled setting.

About INSPIRE

The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the U.S. Food and Drug Administration and European Medicines Agency and derives from the findings of the ONTIME Phase 3 trial. INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first 9 months or nine cycles over the course of one year after initiation of HMA treatment. This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).

About Oral Rigosertib

The oral form of rigosertib was developed to provide more convenient dosing for use where the duration of treatment may extend to multiple years. This dosage form also supports many combination therapy modalities. To date, 368 patients have been treated with the oral formulation of rigosertib. Initial studies with single-agent oral rigosertib were conducted in hematological malignancies, lower-risk MDS, and solid tumors. Combination therapy of oral rigosertib with azacitidine and chemoradiotherapy has also been explored. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients with higher-risk MDS who require HMA therapy. A Phase 2 trial of the combination therapy has been fully enrolled and the preliminary results were presented in 2016. This novel combination is the subject of an issued US patent with earliest expiration in 2028.

On May 22, 2017 Nektar Therapeutics (NASDAQ: NKTR) reported that Takeda Pharmaceutical Company Limited (TSE: 4502) and Nektar have entered into a research collaboration to explore the combination of Nektar’s lead immuno-oncology candidate, the CD122-biased agonist NKTR-214, with five oncology compounds from Takeda’s cancer portfolio (Press release, Nektar Therapeutics, MAY 22, 2017, View Source [SID1234519255]). The two companies will explore the anti-cancer activity of NKTR-214 with five different targeted mechanisms in preclinical tumor models of lymphoma, melanoma and colorectal cancer.

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"We look forward to collaborating with Takeda to explore a range of combination therapy approaches in models of both liquid and solid tumors," said Jonathan Zalevsky, PhD, Senior Vice President of Biology and Preclinical Development. "Importantly, this research collaboration will allow us to understand the potential of NKTR-214 with key compounds in the Takeda oncology portfolio, including a SYK-inhibitor and a proteasome inhibitor, and identify which combination treatment regimens show the most promise for possible advancement into the clinic."

"We see significant potential in Nektar’s unique CD122-biased agonist in particular the ability to stimulate tumor-killing T-cells in the tumor micro-environment itself," said Phil Rowlands, PhD, Head, Oncology Therapeutic Area Unit, Takeda. "Research partnerships are an important part of helping us advance our aspiration of curing cancer. Working together with Nektar will enable us to identify combinations with exciting preclinical activity and help us achieve Takeda’s goal of developing innovative, targeted therapies to treat people with cancer."

Under the terms of the collaboration, the companies will share costs related to the preclinical studies and each will contribute their respective compounds to the research collaboration. Nektar and Takeda will each maintain global commercial rights to their respective drugs and/or drug candidates.

NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting CD8+ effector T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. NKTR-214 targets CD122 specific receptors found on the surface of these cancer-fighting immune cells in order to stimulate their proliferation. In clinical and preclinical studies, treatment with NKTR-214 resulted in expansion of these cells and mobilization into the tumor micro-environment.1,2,3 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.

Takeda signed the research collaboration agreement with Nektar Therapeutics through its wholly-owned subsidiary, Millennium Pharmaceuticals, Inc.