Celldex's Rindopepimut (Rintega(R)) Receives FDA Breakthrough Therapy Designation for the Treatment of Adult Patients with EGFRvIII-positive Glioblastoma

HAMPTON, N.J., Feb. 23, 2015  -- Celldex Therapeutics, Inc. (CLDX) today announced that the U.S. Food and Drug Administration (FDA) has granted rindopepimut (Rintega(R)) Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma (GBM).

This application was based on data from the Phase 2 ReACT study in recurrent GBM, the Phase 2 ACT III study in newly diagnosed GBM and additional supportive Phase 2 studies. An international Phase 3 study of rindopepimut, called ACT IV, in newly diagnosed GBM completed enrollment (n=745) in December of 2014.

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Rigel and Bristol-Myers Squibb Announce Research and Development Collaboration for TGF Beta Receptor Kinase Inhibitors for Use in Immuno-Oncology Related Indications

SOUTH SAN FRANCISCO, Calif. and NEW YORK, February 23, 2015 -- Rigel Pharmaceuticals, Inc. (RIGL) and Bristol-Myers Squibb Company (BMY) today announced that they have entered into a collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel's extensive portfolio of small molecule TGF beta receptor kinase inhibitors. TGF beta can promote tumor growth, broadly suppress the immune system and increase the ability of tumors to spread in the body. The collaboration will focus on developing a new class of therapeutics aimed at increasing the immune system's activity against various cancers either as monotherapy or in combination with immune checkpoint inhibitors, including Bristol-Myers Squibb's Opdivo (nivolumab) and Yervoy (ipilimumab).

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Oncolytics Biotech® Inc. Announces Completion of Enrollment in Randomized Phase II Colorectal Cancer Study

CALGARY, Feb. 18, 2015 - Oncolytics Biotech® Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that enrollment has been completed in a randomized Phase II study of REOLYSIN® in patients with advanced or metastatic colorectal cancer (IND 210). The trial is being sponsored and conducted by the NCIC Clinical Trials Group (NCIC CTG) at Queen's University in Kingston, Ontario.

"Colorectal cancer continues to account for a significant portion of both new cancer cases and deaths in North American men and woman, highlighting the need for ongoing research in this indication," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are grateful to our colleagues at the NCIC CTG for their efforts in completing enrollment in this study in such a timely manner."

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Capnia Announces First U.S. Commercial Sales of CoSense(R)

REDWOOD CITY, Calif., Feb. 17, 2015 -- Capnia, Inc. (CAPN) , focused on the development of novel products based on its proprietary technologies for precision metering of gas flow, today announced the first U.S. commercial sales of the Company's CoSense End-Tidal Carbon Monoxide (ETCO) Monitors and single-use sampling sets to leading academic, research and healthcare institutions. CoSense is a portable, non-invasive device that rapidly and accurately measures carbon monoxide in exhaled breath. The measurement of carbon monoxide is the gold standard for measuring hemolysis, a condition that, if left untreated, may lead to elevated levels of bilirubin in the blood and a range of neurodevelopmental disorders in newborns.

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Oncolytics Biotech® Inc. Announces Receipt of Orphan Drug Designation from the U.S. FDA for Pancreatic Cancer

CALGARY, Feb. 17, 2015  - Oncolytics Biotech® Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY), a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN®, for the treatment of pancreatic cancer.

"This is the second indication for which we have received Orphan Drug Designation in the United States," said Dr. Brad Thompson, President and CEO of Oncolytics. "The prognosis for pancreatic cancer is typically poor, and it is critical to expand the range of treatment options available to these patients."

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