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

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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Company to Partner with Phyton Biotech for Manufacture of the Key Ingredient in Mipsagargin

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."

Aduro Meets Development Milestone in Immuno-Oncology Collaboration with Janssen for Treatment of Prostate Cancer

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.

Cellular Biomedicine Group Acquiring Chinese PLA General Hospital’s CAR-T (CD19/CD20/CD30/EGFR) Immuno-Oncology Technology and Clinical Data

On Feb 9, 2015 Cellular Biomedicine Group reported its acquisition of Chinese PLA General Hospital’s (“PLAGH”, Beijing, also known as “301 Hospital”) Chimeric Antigen Receptor T cell (CAR-T) therapy, its recombinant expression vector CD19, CD20, CD30 and Human Epidermal Growth Factor Receptor’s (EGFR or HER1) Immuno-Oncology patents (all pending), and Phase I/II clinical data of the aforementioned therapies and manufacturing knowledge (Press release Cellular Biomedicine Group, FEB 9, 2015, View Source [SID:1234501528]).

“This CAR-T cell technology acquisition further accelerates CBMG’s growth in the Immuno-Oncology segment. We look forward to working with PLAGH as a long-term partner as we evaluate paths to commercialization,” commented Dr. William (Wei) Cao, Chief Executive Officer of Cellular Biomedicine Group.

CAR-T cell therapy involves engineering cancer patients’ own immune cells to recognize and attack their tumors. Wei Dong Han, MD, PhD, head of PLAGH’s Biotherapy Department, is a renowned key opinion leader in the cancer immunotherapy field. Professor Han’s team has conducted several preliminary clinical studies of various CAR-T constructs targeting CD19-positive acute lymphoblastic leukemia, CD20-positive lymphoma, CD30-positive Hodgkin’s lymphoma and EGFR-HER1-positive advanced lung cancer. PLAGH is a top-ranking medical center in China, holding to the highest academic standards. The hospital consists of 125 clinical, medical and technological departments and 4,000 patient beds, with annual volumes of approximately 4 million patients and more than 65,000 surgeries.

Prior to acquiring PLAGH’s technology, the Company has made progress with recent acquisitions of Agreen Biotech Co. Ltd. and its T-Cell Memory technology (Tcm), T Cell Receptor clonality analysis technology, as well as another third generation CAR-T, anti-PD-1, CD19 and aAPC cancer immunotherapy technologies from Persongen Biotechnology Ltd. Together with PLAGH’s technology, CBMG’s state-of-the art infrastructure and clinical platform, along with these acquired technologies will enable improvement of cancer immune cell therapies and strategic combination therapies which will boost the Company’s Immuno-Oncology presence, and pave the way for future partnerships.

“We are very impressed by the quality of the work done by Dr. Han and his team at PLAGH, and are excited by the safe and efficacious profile of these novel T cell therapies for cancerous diseases, which we deem necessary to be a leader in this field while providing alluring prospective therapies for other cancers. This is the beginning of a long-term strategic partnership between CBMG and PLAGH. Together, we will expeditiously continue our quest in developing safer and more effective cancer immunotherapy programs with leading hospitals and other partners,” said Dr. William (Wei) Cao, Chief Executive Officer of Cellular Biomedicine Group.

Oncolytics Biotech® Inc. Announces Filing for Orphan Drug Designation with the U.S. FDA for High Grade Gliomas in Pediatric Patients

On February 9, 2015 Oncolytics Biotech reported that it has submitted an application for Orphan Drug Designation to the U.S. Food and Drug Administration (“FDA”) for REOLYSIN for the treatment of high grade gliomas (HGG) in pediatric patients (Press release Oncolytics Biotech, FEB 9, 2015, View Source [SID:1234501512]). Oncolytics has conducted three previous clinical studies in brain cancers including gliomas, and has found that REOLYSIN can infect a variety of brain tumors when delivered intravenously.

“High grade gliomas are typically a very aggressive form of cancer. They remain difficult to treat, particularly in pediatric patients, and are associated with poor survival outcomes,” said Dr. Brad Thompson, President and CEO of Oncolytics. “While surgical resection, radiotherapy and chemotherapy may be treatment options, REOLYSIN may offer these patients an alternative, more targeted therapeutic approach to treatment.”

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. For more information, please visit: View Source

According to the US Central Brain Tumor Registry an estimated 4,620 new cases of primary malignant and non-malignant brain and central nervous system tumors will be diagnosed in pediatric and adolescent patients in 2015. In patients between zero and 19 years old, the overall total incidence of HGG (including anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, mixed glioma, and malignant glioma) is approximately 0.8 per 100,000.