Regen Acquires Issued Patent and Preclinical Data Package for Targeting Cancer Stem Cell; Sigma-Aldrich announced SAFC Commercial Entered a Contract with BeiGene Print E-mail
By William Kent   
Wednesday, 11 March 2015 19:20
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 11, 2015.
Regen BioPharma Inc. (OTCBB: RGBP) (OTC PINK: RGBP) announced successful closing of a transaction resulting in acquisition of issued US patent #8,263,571, and associated preclinical data package. The intellectual property covers specific therapeutic agents that gene silence CTCFL. CTCFL, otherwise known as Brother of the Regulator of Imprinted Sites (BORIS) is a gene that is critical for cancer stem cells to survive, in part by inducing expression of telomerase, a protein that creates cellular immortality. 
Thomas Ichim, Ph.D., Chief Scientific Officer of Regen is co-inventor of the patent, which was filed in October 2007 by Vendevia Group. Through a private transaction, Dr. Ichim obtained assignment of the patent and preclinical package, which was subsequently assigned by Dr. Ichim to Regen. 
"Having co-authored the peer-reviewed publication dating back to 2008 in which potent inhibition of breast cancer was demonstrated by gene silencing of CTCFL2, and having assigned my own gene silencing/immunotherapy patent to Regen3, I am highly enthusiastic that this very promising approach to killing cancer stem cells has now been brought under the Regen umbrella." Stated Dr. Wei-Ping Min, Professor of Immunology at the University of Western Ontario and Member of Regen's Scientific Advisory Board. "The use of RNA interference to kill cancer stem cells adds another powerful weapon in Regen's arsenal on the war on cancer."
CTCFL, also termed Brother of the Regulator of Imprinted Sites (BORIS) is a key protein that was originally discovered by Dr. Victor Lobanenkov at the NIH4, which acts as a "master orchestrator" of numerous genes needed for cancer to maintain the properties of cancer5. Dr. Ichim previously co-authored papers with NIH and other academic groups demonstrating that immunotherapy targeting CTCFL results in regression of breast cancer, leukemia, and glioma6.
"Having worked for several years on developing the CTCFL gene-silencing therapeutic approach, and witnessing first-hand the promise of this technology in terms of specifically targeting tumor stem cells, I am excited that we identified a mechanism of bringing this highly complementary technology into Regen," said Dr. Ichim. "Currently Regen is using gene silencing to block NR2F6 in cancer stem cells. The acquisition of the CTCFL intellectual property allows for performing experiments in parallel, thus significantly reducing developmental costs while doubling the probability of success."
"The possession of an issued US patent in this rapidly evolving space allows for a wide range of possibilities ranging from internal development, to co-development, to outright licensing," said David Koos, Chairman and CEO of Regen. "We have initiated discussions with entities in this industry in order to most rapidly optimize value of this asset."
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Sigma-Aldrich® Corporation (NASDAQ: SIAL) announced that SAFC® Commercial, its custom manufacturing services business unit, has entered a commercial sales and service contract with leading biopharmaceutical company, BeiGene. Located in Beijing, the innovative oncology company purchased SAFC's off-the-shelf, turnkey CHOZN cell line production platform and cell line engineering services to support discovery and commercial development of BeiGene's targeted oncology drug.
"The CHOZN Platform offers us a great deal of value through the ability to maximize the production of monoclonal antibodies and other recombinant-proteins used in our targeted oncology treatments," said Dr. Kang Li, Head of Biologics from BeiGene. "Reducing timelines are critical to every oncology development project. Our objective in selecting SAFC's CHOZN Platform and services was to shorten bioproduction times in early development and to obtain a manufacturing clone quickly with the highest protein quality specifications."
"Following last year's first commercial placement of the GS-/-CHO cell line in the Asian markets, SAFC is seeing significant interest in using our CHOZN recombinant cell line development platforms in the region," said Kevin Gutshall, Global Senior Manager of the CHOZN Platform for SAFC. "The CHOZN Platform supports efficient innovation and the highest quality therapeutics. It offers a turnkey solution that is unmatched in the industry. Users simply identify and clone the genes for their therapeutic protein of interest into the CHOZN expression vector, and then employ the traditional cell line development strategies of transfection, selection and cloning. The CHOZN Platform is designed to deliver a robust producing clone - ready for manufacturing."
Enabled by Sigma-Aldrich's, CompoZr® Zinc Finger Nuclease (ZFN) gene editing technology, the first commercially available glutamine synthetase (GS) knockout CHO line was brought to market in 2011. The full CHOZN Platform includes the CHOZN GS-/- CHO cell line and an optimized set of cGMP-produced and chemically defined media and feeds.  In addition to the cell line, media, and feed, SAFC provides extensive user support, which includes working with customers on protocols - from transfection through to scale-up in bioreactors, as well as comprehensive cell-line safety testing and development history.
 
Also Wednesday:
 
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that the Gynecologic Oncology Group (GOG), now part of NRG Oncology, has enrolled the first patient in Stage 2 of its ongoing Phase 2 open-label clinical study of ADXS-HPV in patients with persistent or recurrent cervical cancer with documented disease progression. 
Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced that it will host a Key Opinion Leader breakfast focused on current advances in tinnitus treatments. 
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced financial results for the fourth quarter and full year ended December 31, 2014, and provided updates on its clinical development programs.
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company today announced that it will host a conference call and audio webcast to discuss fourth quarter and year end results, as well as provide a general business update, on Tuesday, March 17th, 2015 at 4:30pm ET.
EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS), a Boston-based biopharmaceutical company focused on the global development of biosimilar monoclonal antibodies, today announced that it will host a conference call and webcast at 10 a.m. Eastern Time on Tuesday, March 24, 2015 to discuss fourth quarter and fiscal year 2014 financial results, and to discuss the Company's progress. 
eRAD, a division of RadNet, Inc. (Nasdaq:RDNT), an industry leader in Web-based RIS, PACS, and Teleradiology workflow solutions, announced today the company has taken several distributor-based orders from new customers during the fourth quarter of 2014. 
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, today announced that during the first quarter of 2015 certain potential accounting matters were discovered by management, which prompted the Audit Committee, with the assistance of independent advisors, to commence an internal investigation. 
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company, today announced the completion of its previously announced underwritten public offering of 4,750,000 shares of its common stock at a public offering price of $24.00 per share. 
Juno Therapeutics, Inc. (Nasdaq:JUNO) will announce financial results for the fourth quarter and year ended December 31, 2014 on Wednesday, March 18, 2015 after the close of U.S.-based financial markets. 
Ocera Therapeutics, Inc. (Nasdaq:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced updates to its clinical development programs and reported financial results and other business highlights for the quarter and year ended December 31, 2014.
Pazoo, Inc. (OTCQB:PZOO) (German WKN#:A1J3DK) is pleased to report that wholly owned Subsidiary, Harris Lee, LLC., a company created to open and operate best-in-class marijuana testing labs throughout the USA has entered into a License Agreement with Steep Hill Labs, Inc. 
Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today reported financial results for the fourth quarter and year ended December 31, 2014.
Sientra, Inc. (Nasdaq:SIEN), a medical aesthetics company, today announced its financial results for the fourth quarter and full year ended December 31, 2014. 
South Nassau Communities Hospital chose Allscripts (Nasdaq:MDRX) to provide its anesthesia information management system (AIMS). 
Surgical Care Affiliates, Inc. (Nasdaq:SCAI) announced today that it has priced an offering of $250 million aggregate principal amount of its senior unsecured notes due 2023 (the "Notes"). 
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR), an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), announced today that TKM-Ebola-Guinea will be evaluated for efficacy in Ebola virus infected patients in Sierra Leone, West Africa. Patient recruitment has been initiated.
TG Therapeutics, Inc. (Nasdaq:TGTX) today announced its financial results for the fourth quarter and year ended December 31, 2014 and provided recent company developments along with a business outlook for 2015.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today reported its operational highlights and financial results for the quarter and year ended December 31, 2014.



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