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TESARO and Zai Lab Announce Collaboration, Development and License Agreement

On September 29, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, and Zai Lab (Shanghai) Co., Ltd., a biopharmaceutical company based in China, reported a collaboration to support the development and commercialization of niraparib for patients in China and the potential to advance two immuno-oncology programs outside of China (Press release, TESARO, SEP 29, 2016, View Source [SID:SID1234515493]). This partnership reflects the commitment of both companies to develop novel therapeutic approaches for people living with cancer around the world.

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Within this collaboration, TESARO has granted to Zai Lab an exclusive license for the development of niraparib specifically for the China market, which includes an option for TESARO to participate in the commercialization of niraparib in greater China. The companies will establish a joint steering committee to review and oversee all development and commercialization plans. In addition, TESARO has the option to license two novel, discovery-stage immuno-oncology programs from Zai Lab.

"TESARO is devoted to providing transformative therapies for people bravely facing cancer, and this partnership will enable us to globalize our mission," said Lonnie Moulder, CEO of TESARO. "The Zai Lab team has a track record of regulatory and development successes in China, and we are excited to work with them to quickly advance new treatment options for patients."

Samantha Du, Chairman and CEO of Zai Lab, added, "We are delighted to partner with TESARO, a leader in global oncology drug development. Ovarian and other cancer types that niraparib is being evaluated in are areas of large unmet medical need in China, with very limited treatment options. Our collaboration with TESARO will bring this exciting new product candidate quickly to the Chinese patients, and we look forward to working with TESARO."

In addition to an upfront payment, TESARO will be eligible to receive milestone payments contingent upon Zai Lab achieving certain specified development and commercial goals. Should TESARO elect not to participate in the commercialization of niraparib in China, TESARO will be eligible to receive tiered, double-digit royalty payments on annual net sales from Zai Lab. Additional financial details were not disclosed.

About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in four ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial in patients with recurrent ovarian cancer (the NOVA trial); a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial); a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); and a Phase 3 trial for the treatment of patients with BRCA-mutant breast cancer (the BRAVO trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab and bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. TESARO has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA, and intends to complete this submission during the fourth quarter. The Marketing Authorization Application (MAA) for niraparib is planned for submission to the European Medicines Agency (EMA) in the fourth quarter.

bluebird bio and Medigene Establish Strategic T Cell Receptor (TCR) Alliance in Cancer Immunotherapy

On September 29, 2016 Medigene AG (MDG1, Frankfurt, Prime Standard), Germany, and bluebird bio, Inc. (Nasdaq: BLUE), USA, reporteded the signing of a strategic research and development collaboration and licensing agreement encompassing T cell receptor (TCR) immunotherapies against four targets (Press release, bluebird bio, SEP 29, 2016, View Source [SID:SID1234515487]).

"We are delighted to collaborate with bluebird bio, a leader in the field of cell and gene therapy, including cancer immunotherapy," said Dolores J. Schendel, chief executive officer and chief scientific officer, Medigene. "With its T cell immunotherapy expertise and outstanding gene delivery and genome editing capabilities, bluebird bio is an ideal partner for us to jointly discover and develop a new generation of T cell therapeutics to treat unmet oncology indications."

"Medigene’s proprietary technology to generate highly active natural TCRs makes them an ideal partner, enabling us to broaden our pipeline with TCR-based product candidates against four new targets and continue to build our leadership in immuno-oncology," said Rick Morgan, Ph.D., vice president of immunotherapy, bluebird bio. "This agreement exploits our core expertise in lentiviral gene transfer, genome editing and synthetic biology, and leverages our manufacturing and clinical development capabilities to build a broad, fully integrated immuno-oncology franchise."

"Our first commercial agreement based on Medigene’s TCR technology is testimony to our rapid progress as an immuno-oncology company," added Dave Lemus, chief operating officer, Medigene. "Furthermore, the agreement provides Medigene with significant additional financial resources for both the short term and potentially the long term as we participate in the value creation of the cell therapeutics that we jointly create."

Under the terms of the agreement, Medigene will be responsible for the generation and delivery of the TCRs using its TCR isolation and characterization platform. Following the collaborative preclinical development, bluebird bio will assume sole responsibility for the clinical development and commercialization of the TCR product candidates and will receive an exclusive license for the intellectual property covering the resulting TCRs.

Medigene will receive an upfront payment of USD 15 million as well as potential preclinical, clinical, regulatory and commercial milestone payments, which together could total over USD 1 billion in the aggregate for the four potential TCR products across several indications. Additionally, Medigene will receive R&D funding for all work performed in the collaboration and is eligible for tiered royalty payments on net sales up to a double-digit percentage.

Contractual parties to the agreement are Medigene Immunotherapies GmbH, a wholly owned affiliate of Medigene AG, and bluebird bio, Inc.

Press and analysts’ conference call: Medigene will hold a press and analysts conference call (in English) today at 3:00 pm CEST / 9:00 am EDT and will webcast the call live via Medigene’s website, www.medigene.com.

About Medigene’s TCR technology: The TCR technology aims at arming the patient’s own T cells with tumor-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient’s tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient’s T cells outside the body (ex-vivo).

TCR therapy is developed to detect a greater number of potential tumor antigens than other T cell-based immunotherapies, such as chimeric antigen receptor T cell (CAR T) therapy. Medigene is preparing the clinical development of its first TCR candidates and is establishing a library of recombinant T cell receptors, and has established Good Manufacturing Practice (GMP)-compliant processes for their combination with patient-derived T cells. The start of a clinical Phase I TCR investigator-initiated trial (IIT) with Medigene participation is expected in 2017. Medigene plans to commence its own first clinical TCR trial in 2017 and a second trial in 2018.

Medigene’s TCR technology for adoptive T-cell therapy is one of the company’s three highly innovative and complementary immunotherapy platforms in immuno-oncology.

Current Report

On September 28, 2016 Mirna Therapeutics, Inc. (the "Company") reported that it received verbal notice from the U.S. Food and Drug Administration (the "FDA") that the Company’s Investigational New Drug ("IND") for MRX34, its investigational microRNA therapy for multiple cancers, has been placed on full clinical hold ((Press release, Mirna Therapeutics, SEP 28, 2016, View Source [SID1234515521]). The Company anticipates that it will receive a formal clinical hold letter from the FDA within 30 days. This follows the Company’s announcement on September 20, 2016 that it was voluntarily stopping its Phase 1 trial for MRX34

AbbVie Opens First Phase of its Global Manufacturing Facility in Singapore to Support the Growth of its Pipeline

On September 28, 2016 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported that it has strengthened its manufacturing capabilities by opening the small molecule active pharmaceutical ingredient (API) facility of its Singapore manufacturing site (Press release, AbbVie, SEP 28, 2016, View Source [SID:SID1234515496]). This facility supports the growth of AbbVie’s oncology and women’s health pipeline and reflects progress from AbbVie’s two previous announcements for manufacturing investment in Asia in 2014.

The new 120,000 square-meter site – located in the Tuas Biomedical Park – is AbbVie’s first manufacturing facility in Asia and will also include a biologics manufacturing facility that is expected to be fully operational by the end of 2018. Combined, the API and biologics facilities represent a $320 million (more than S$400 million) investment in Singapore that will employ more than 250 new employees, the majority of whom will be hired locally in Singapore, including skilled positions across manufacturing, technical operations, administration, quality, information technology and supply chain.

"Our goal as AbbVie is to assure patients around the world have access to new and innovative medicines when they need them and where they need them," said Azita Saleki-Gerhardt, Ph.D., senior vice president, operations, AbbVie. "Today, with the opening of the first phase of our Singapore facility, we will further strengthen our manufacturing capabilities and continue to enhance our support of AbbVie’s pipeline in the therapeutic areas of oncology and women’s health for patients around the world."

Speaking at the opening ceremony, Site Director Marc O’Donoghue, Ph.D., added, "Singapore is recognized as a leader in the biopharmaceutical industry and AbbVie is excited to open its facility and begin operations. Singapore has a robust infrastructure, a highly educated and skilled workforce and provides a supportive environment for manufacturing. Our presence in Singapore establishes AbbVie’s footprint in Asia and provides geographic balance in AbbVie’s manufacturing network to ensure continuity of supply."

"AbbVie’s choice of Singapore for its first in Asia manufacturing facility is testament to our capabilities as a high-quality, global biopharmaceutical manufacturing hub. Given our track record of providing a world-class business environment and skilled talent pool to companies, we enable companies such as AbbVie to develop and manufacture innovative products to deliver value for patients worldwide," said Ms. Weng Si Ho, director, biomedical sciences, Singapore Economic Development Board (EDB). "EDB will continue to commit strong investments in talent, infrastructure and technology to support the strong growth in the biopharmaceutical industry."

AbbVie’s manufacturing network now includes 13 locations across the United States, Europe, Asia and Puerto Rico, as well as strategic partnerships with third-party manufacturers.

ICLUSIG® Tablets 15 mg Approved in Japan for Patients with Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

On September 28, 2016 Otsuka Pharmaceutical Co., Ltd. reported that it has received regulatory approval in Japan for manufacture and sales of ICLUSIG Tablets 15 mg (ponatinib hydrochloride), a tyrosine kinase inhibitor (TKI) indicated to treat patients with chronic myeloid leukemia (CML) who are resistant or intolerant to previous treatments and patients with recurrent or refractory Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) (Press release, Otsuka, SEP 28, 2016, View Source;date=2016-09-28 [SID:SID1234515492]).*2

Although TKIs are used as a first-line treatment for CML and Ph+ ALL, mutation of BCR-ABL genes can develop during the treatment period and indicates resistance to the currently used TKI. In addition, intolerance to the side effects of existing TKI treatments can lead to a discontinuation of treatment.

ICLUSIG, discovered in the U.S. by ARIAD Pharmaceuticals, Inc., is a TKI that targets BCR-ABL expressed in CML and Ph+ ALL. This drug is a new chemically synthesized oral TKI, and is specifically designed to inhibit mutated TK caused by a T315I mutation which induces resistance to the currently used TKI. ICLUSIG demonstrates efficacy in CML patients with resistance to or with intolerance to currently available TKIs. ICLUSIG was approved in the U.S. in 2012, in Europe in 2013, and in 2014 Otsuka obtained the rights to commercialize and develop ICLUSIG in ten Asian countries and regions.*1 ICLUSIG was designated as an orphan drug in Japan and a new drug application (NDA) was submitted in January 2016. NDAs have been submitted in Korea and Taiwan as well.