First FDA Breakthrough Therapy Designation for KLH-Conjugate Immunotherapy; Halozyme Reports Selection Of First Product Candidate Under Janssen Collaboration Print
By Marilyn Mullen   
Tuesday, 10 March 2015 19:47
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 10, 2015.
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH), is encouraged that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for a KLH-based immunotherapy compound in the treatment of adult patients with EGFRvIII-positive glioblastoma being developed by Celldex Therapeutics, Inc.

This important designation by the FDA is a first for a KLH-based immunotherapy. Stellar KLH™ is not being used by Celldex, however, there are a number of KLH-conjugate immunotherapies that are currently in clinical trial development in the U.S., Europe, or Asia for a variety of disease indications including cancers, autoimmune disorders, Alzheimer's, and inflammatory diseases, which are using Stellar KLH™.

"We believe this represents an important validating event for the KLH-conjugate approach in immunotherapy," said Frank Oakes, President and CEO of Stellar Biotechnologies. "This fast track designation provides a positive signal from the FDA for companies developing immunotherapies that use the KLH molecule as a carrier protein component."

Stellar developed the proprietary ability to sustainably produce KLH while protecting its natural marine source and the Company is strategically focused on ensuring long-term, scalable supply of this essential molecule for pharmaceutical use. Stellar believes that, should the pipeline of KLH-based immunotherapies lead to approved new drug products, the Company will be positioned to take advantage of the emerging KLH market opportunity.


 
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Halozyme Therapeutics, Inc. (NASDAQ: HALO)
reported today that Genmab A/S announced plans for a Phase 1 clinical trial of a subcutaneous formulation of the anti-CD38 antibody daratumumab using the ENHANZE™ technology. In December 2014, Janssen Biotech, Inc. (Janssen) entered into an agreement with Halozyme Therapeutics for the purpose of developing and commercializing products combining proprietary Janssen compounds with Halozyme's ENHANZE technology. This agreement has the potential to lead to the development of a subcutaneous formulation of daratumumab. Daratumumab is being developed under a collaboration between Janssen and Genmab A/S since August 2012 when Genmab granted Janssen an exclusive worldwide license to develop, manufacture, and commercialize daratumumab.

About Daratumumab -- Daratumumab, a human monoclonal antibody that targets CD38 on the surface of multiple myeloma cells, is in clinical development as a single agent and in combination with standard of care therapies in several settings of multiple myeloma. Daratumumab may also have potential in other hematologic malignancies in which CD38 is expressed, including non-Hodgkins lymphoma and various leukemias. 

About ENHANZE™ -- ENHANZE™ is Halozyme's proprietary drug delivery platform based on the Company's patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections.


 

Also Tuesday:



 
3D Systems (NYSE:DDD)
today announced that more than 10,000 disabled dogs are now able to run faster, jump higher and play harder thanks to 3D printed metal orthopedic knee implants that the Company manufactured for Rita Leibinger Medical.

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that it will issue its financial results for the fourth quarter and twelve months ended December 31, 2014 on Thursday, March 19, 2015, prior to the market open.

Alphatec Holdings, Inc. (Nasdaq:ATEC)
, the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, announced today that the Company's President and Chief Executive Officer, Jim Corbett, will participate in the Canaccord Genuity Musculoskeletal Conference on Tuesday, March 24, 2015 at 11:30 AM Pacific Time at the MGM Grand Hotel, Las Vegas, Nevada.

Analogic Corporation (Nasdaq:ALOG)
, enabling the world's medical imaging and aviation security technology, today announced results for its second quarter ended January 31, 2015.

Anavex Life Sciences Corp. (OTCQX:AVXL)
a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer's disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced that Christopher U. Missling, PhD, President and Chief Executive Officer, will present at 'The Physiopathology of Sigma-1 Receptors' symposium being held at the Nice Sophia Antipolis University in Nice, France.

Auris Medical Holding AG (NASDAQ: EARS)
, a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced the completion of the planned interim analysis in the post-acute tinnitus stratum of the TACTT3 trial ("Stratum B") with AM-101 and that enrollment could continue since the pre-specified futility threshold was not reached.

Bacterin International Holdings, Inc. (NYSE MKT:BONE)
, a leader in the development of bone graft material, today announced it has signed a national distribution agreement with Spartan Medical, Inc., a service-disabled, veteran-owned, small business focused on distribution to government medical facilities.

Biocept, Inc. (Nasdaq:BIOC)
, a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs), today announced the launch of its EGFR mutation detection testing utilizing a patient's blood-based liquid biopsy.

Capricor Therapeutics, Inc. (Nasdaq:CAPR)
, a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that Linda Marbán, Ph.D., Chief Executive Officer, is scheduled to present at the 27th Annual ROTH Conference on March 11, 2015 at 10:30 PT a.m. at The Ritz Carlton in Dana Point, California.

Connecture, Inc. (Nasdaq:CNXR)
, a provider of web-based information systems used to create health insurance marketplaces, today announced financial results for the fourth quarter and full year ending December 31, 2014.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, will report its fourth quarter and full year 2014 financial results on Tuesday, March 17, 2015, after the U.S. financial markets close.

Foamix Pharmaceuticals Ltd. (Nasdaq:FOMX)
, a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced that it will release fourth quarter and fiscal year 2014 financial results and host a conference call and webcast on Wednesday, March 18, 2015.

Heat Biologics, Inc. (Nasdaq:HTBX)
, a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced that it intends to offer for sale shares of its common stock in an underwritten public offering.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
today announced the appointment of Mr. Greg Madison, the Company's President and Chief Operating Officer and incoming Chief Executive Officer, to its Board of Directors, effective March 10, 2015.

Merit Medical Systems, Inc. (Nasdaq:MMSI)
, a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will participate at Sidoti & Company's Annual Small-Cap Equity Conference being held March 16-17, 2015 at The Grand Hyatt New York.

MRI Interventions, Inc. (OTCQB:MRIC)
today announced that a team led by Dr. Brad Elder, Associate Professor, Neurological Surgery at the Ohio State University (OSU) Wexner Medical Center, has utilized the company's ClearPoint® neuro navigation system to enable the first brain biopsy within the OSU Arthur G. James Cancer Hospital's new GE 3-T intraoperative magnetic resonance imaging (MRI) scanner.

Novavax, Inc. (Nasdaq:NVAX)
, a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the appointment of Brian Rosen to the position of Vice President, Government Affairs and Policy.

Oncothyreon Inc. (Nasdaq:ONTY)
today reported financial results for the year and quarter ended December 31, 2014.

StemCells, Inc. (Nasdaq:STEM)
announced today that Management will make a presentation on the Company's programs and operations at the Wall Street Analyst Forum 25th Annual Institutional Investor Conference. Management is scheduled to speak at 10:35 a.m. Eastern Daylight Time on Thursday, March 19, at The University Club located at 1 West 54th Street in NYC.

TG Therapeutics, Inc. (Nasdaq:TGTX)
, today announced that a conference call will be held on Thursday, March 12, 2015 at 8:30am ET to discuss results for the fourth quarter and year-end 2014, and provide a business outlook for 2015.

Tornier N.V. (Nasdaq:TRNX)
, a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the Simpliciti™ Shoulder System, which is a unique, bone sparing total shoulder arthroplasty system designed to treat patients experiencing severe shoulder joint pain, compromised range of motion, loss of strength and functionality.

TRACON Pharmaceuticals (Nasdaq:TCON)
, a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, age-related macular degeneration and fibrotic diseases, today announced its financial results for the year ended December 31, 2014.

Zogenix, Inc. (Nasdaq: ZGNX)
, a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, announced today that it has entered into a definitive agreement to sell its Zohydro® ER (hydrocodone bitartrate) business to Pernix Therapeutics (Nasdaq:PTX) for $100 million plus regulatory and sales milestones up to $283.5 million.



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