Regeneron 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 , Regeneron, FEB 12, 2015, View Source [SID1234501550]).

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On February 11, 2015 Oncolytics Biotech reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN, for the treatment of ovarian cancer (Press release Oncolytics Biotech, FEB 11, 2015, View Source [SID:1234501535]).

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"This is an important regulatory milestone for Oncolytics and will provide us with a number of benefits as we advance the development and commercialization process for REOLYSIN," said Dr. Brad Thompson, President and CEO of Oncolytics. "Ovarian cancer is a devastating disease that represents a significant unmet need, particularly for those patients diagnosed in later stages."

Oncolytics has supported two sponsored clinical studies assessing REOLYSIN in the treatment of ovarian cancer. The first was a Phase 1/2 clinical trial (OSU-07022) for patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous and intraperitoneal administration of REOLYSIN that provided evidence of viral targeting and replication in peritoneal and ovarian cancer cells. The second is an ongoing randomized Phase II trial (GOG186H) of weekly paclitaxel versus weekly paclitaxel with REOLYSIN in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. The second trial completed enrollment in September 2014.

The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.

On February 9, 2015 Aduro Biotech, Inc. reported that it has achieved its first milestone under its collaboration with Janssen Biotech, Inc., by initiating toxicology studies to support an Investigational New Drug Application for ADU-741, an immuno-oncology product candidate for the treatment of prostate cancer (Press release Aduro BioTech, FEB 9, 2015, View Source [SID:1234501616]). The Janssen decision to advance ADU-741 toward clinical trials was based on preclinical data generated in the first eight months of the collaboration. This accomplishment triggered a milestone payment to Aduro.

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In May 2014, Aduro entered into an agreement granting Janssen an exclusive, worldwide license to certain product candidates specifically engineered for the treatment of prostate cancer based on its novel LADD immunotherapy platform. Under the agreement, facilitated by Johnson & Johnson Innovation, California, Aduro is eligible to receive up to a potential total of $365 million in upfront license fees and milestone payments upon achievement of defined development, regulatory and commercialization milestones, if multiple programs advance to commercialization, as well as tiered royalties on worldwide net sales.

"This is an important validation of our ability to rapidly engineer new product candidates from our LADD platform," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We are pleased to earn the associated milestone payment and importantly to see our technology progress toward clinical trials to evaluate its utility in prostate cancer."
About LADD

LADD is Aduro’s proprietary platform of live, attenuated, double-deleted Listeria monocytogenes strains that have been engineered to initiate a powerful innate immune response and drive a targeted, durable adaptive immune response.
About ADU-741

ADU-741 is a multivalent LADD product candidate engineered specifically for the treatment of prostate cancer. In May 2014, Janssen Biotech, Inc. licensed exclusive global development and commercialization rights to ADU-741.

CellCeutix has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing 10-Q , CellCeutix, FEB 9, 2015, View Source [SID1234501516]).

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On February 9, 2015 GenSpera, Inc. (OTCQB: GNSZ) reported a strategic partnership with Phyton Biotech for the manufacture of thapsigargin, which is derived from the thapsia plant and is the key ingredient in the company’s investigational agent mipsagargin (Press release, GenSpera, FEB 9, 2015, View Source [SID:1234508845]). Phyton Biotech will offer its Plant Cell Fermentation (PCF) development expertise to convert the thapsia plant into a preserved, fermentable cell line with a goal of creating a sustainable source of high quality thapsigargin.

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"This partnership will revolutionize the way we obtain thapsigargin to develop our drugs, enabling us to boost supply and reduce the impurities that can arise when it is extracted from naturally grown plants," said Craig Dionne, Ph.D., chief executive officer at GenSpera. "By working with Phyton Biotech, we are leveraging state-of-the-art biotech that has the potential to improve the efficiency of our production process. It is through these kinds of partnerships that we can not only develop new drug candidates, but do so in a way that creates increased product value."

The announcement comes as GenSpera enters a stage of continued development of mipsagargin in hepatocellular carcinoma (HCC) and ongoing trials in glioblastoma (brain cancer) and prostate cancer. This week, GenSpera will present its long-term business growth plans at the BIO CEO & Investor conference being held in New York City. Last month, GenSpera presented positive Phase II study results for mipsagargin in treating HCC at the 2015 Gastrointestinal Cancers Symposium in San Francisco, Calif., demonstrating a proof of concept for its intellectual property.

"Working with an innovative partner like GenSpera, who is committed to developing new treatment options and doing so in a way that maximizes efficiency and quality, is exciting," said Mark Mitchell, president at Phyton Biotech. "Phyton has a proven track record for commercial supply of active pharmaceutical ingredients in the field of oncology using its PCF process. We share GenSpera’s vision of harnessing the power of the thapsia plant and expanding their capacity with the best biotech."