Stellar Biotechnologies and Biovest International Sign KLH Supply Agreement for BiovaxID Immunotherapy for Follicular Non-Hodgkin's Lymphoma Print E-mail
By David Fowler   
Thursday, 23 October 2014 18:13
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 23, 2014.

Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH)
and Biovest International, Inc. announced the companies have executed a definitive supply agreement to meet Biovest's requirements for Keyhole Limpet Hemocyanin (KLH) for use in Biovest's BiovaxID® active immunotherapy to treat follicular non-Hodgkin's lymphoma.

Stellar is a leader in sustainable manufacture of KLH, an immune-stimulating protein widely used as a carrier molecule in active immunotherapy drugs in development for certain cancers and other diseases. Stellar manufactures its KLH products under the brand Stellar KLH™.

Biovest is a biotechnology company developing and commercializing BiovaxID® (dasiprotimut-T), an active immunotherapy to treat follicular non-Hodgkin's lymphoma. BiovaxID® combines autologous heterohybridoma-derived tumor idiotype protein coupled to KLH as the carrier molecule. BiovaxID® has successfully completed Phase 2 and Phase 3 clinical trial development and is currently the subject of a Marketing Authorization Application (MAA) under review by the European Medicines Agency (EMA).

The purpose of the supply agreement is to establish the terms for the production and supply of Stellar KLH™ to Biovest, for use as an active component in BiovaxID® immunotherapy vaccine in both commercial distribution as well as for future clinical trials.

The supply agreement requires Stellar to deliver Stellar KLH™ to Biovest compliant with cGMP standards required for Biovest's ongoing development and as an anticipated commercial supply. Biovest is obligated to purchase Stellar KLH™ at agreed forecasted quantities and prices. The supply agreement has an initial three-year term, which may be renewed by Biovest for additional one-year periods.

The supply agreement provides for Stellar and Biovest to consummate a separate quality agreement, within three months, to list the quality aspects and procedures relating to manufacture and release of the cGMP-compliant Stellar KLH™. Biovest will appoint Stellar as exclusive supplier of KLH in connection with the potential future commercialization of BiovaxID®, subject to negotiation and execution of commercial production and supply terms.

"Stellar's key growth initiative is to leverage our Stellar KLH™ technology into multiple clinical pathways and the BiovaxID® program is a good example of the value of our core business for this purpose," said Frank Oakes, President and CEO of Stellar Biotechnologies, Inc. "There are many new KLH-based immunotherapies advancing in clinical trials and we are positioning Stellar to be the leading company capable of delivering the scalable, sustainable supplies of KLH that will be needed by these pharmaceutical pipelines."

"We are pleased to collaborate with Stellar Biotechnologies to continue the clinical progress of our active immunotherapy (BiovaxID) and are proud to work with Stellar in anticipation of our future commercial success," said Carlos Santos, Chief Executive Officer of Biovest. "BiovaxID immunotherapy has demonstrated ability in long-running clinical trials to elicit potent anti-tumor immune responses and extend remission duration in patients suffering from follicular non-Hodgkin's lymphoma. If approved, we anticipate that this product will offer an innovative adjuvant/consolidation vaccine strategy for patients with this disease."

 

Also Thursday:



Akers Biosciences, Inc. (Nasdaq:AKER) (LSE:AKR)
, a leading designer and manufacturer of rapid diagnostic screening and testing products, has signed a Joint Venture Agreement with Hainan Savy Investment Management Ltd and Mr. Thomas Knox, the Company's Non-executive Co-Chairman, to research, develop, produce and sell certain Akers' rapid diagnostic screening and testing products in China.

Amedica Corporation (Nasdaq:AMDA)
, a biomaterial company that has developed silicon nitride ceramics as a material platform to manufacture and commercialize orthopaedic implants, announced today that it will release financial results for its third quarter 2014 on Thursday, November 6, 2014, at approximately 9:00 a.m. Eastern Time.

Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced that it will present data from its ongoing Phase I/II clinical trial (NCT02049190) evaluating investigational lead compound onapristone in men with advanced castration-resistant prostate cancer (CRPC) after failure of abiraterone or enzalutamide at the 21st Annual Prostate Cancer Foundation (PCF) Scientific Retreat, being held October 23-25, 2014 at the La Costa Hotel in Carlsbad, California.

Celator Pharmaceuticals, Inc. (Nasdaq:CPXX)
, a pharmaceutical company developing new and more effective therapies to treat cancer, today announced the pricing of an underwritten public offering of 6,611,150 shares of common stock and warrants to purchase up to 661,115 shares of its common stock.

Chembio Diagnostics, Inc. (Nasdaq:CEMI)
, which develops, manufactures, markets and licenses point-of-care diagnostic tests, announced today that the Company will release financial results for the third quarter of 2014, before the opening of the market on Thursday, November 6, 2014.

Cerner Corporation (Nasdaq:CERN)
today announced results for the 2014 third quarter that ended September 27, 2014, delivering strong levels of bookings, revenue, earnings and cash flow.

Diversicare Healthcare Services, Inc. (Nasdaq:DVCR)
today announced that it is scheduled to report financial results for its third quarter ended September 30, 2014, on Thursday, November 6, 2014, after the market closes. Diversicare will also hold a conference call at 8:30 a.m. ET, 7:30 a.m. CT, on Friday, November 7, 2014.

SoldierSocks, a non-profit foundation focused on helping veterans, announced today that the VA North Texas Health Care System is the next recipient of an Ekso Bionics™ suit (OTCQB:EKSO).

Fibrocell Science, Inc., (Nasdaq:FCSC)
, an autologous cell therapy company focused on developing first-in class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today announced the company was honored with a 2014 Marcum Innovator of the Year Award.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, today announced an expansion of its respiratory disease research collaboration with GSK that was established in 2012 to identify first-in-class agents and new mechanisms for the treatment of refractory asthma and chronic obstructive pulmonary disease (COPD).

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
today announced  that two Ferric Citrate-related abstracts have been accepted for presentation at the upcoming American Society of Nephrology (ASN) Kidney Week 2014 annual meeting in Philadelphia, PA from November 11-16, 2014.

LHC Group, Inc. (Nasdaq:LHCG)
, a national provider of post-acute care services, announced today details for the release of its results for the third quarter and nine months ended September 30, 2014.

Merit Medical Systems, Inc. (Nasdaq:MMSI)
, a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, today announced revenues of $128.8 million for the quarter ended September 30, 2014, an increase of 12% over revenues of $115.2 million for the third quarter of 2013.

Nature's Sunshine Products, Inc. (Nasdaq:NATR)
, a leading natural health and wellness company engaged in the manufacture and direct selling of nutritional and personal care products, today announced that it will report third quarter 2014 financial results for the period ended September 30, 2014, on Wednesday, November 5, 2014, at 4:00 p.m. Eastern Time.

Novavax, Inc. (Nasdaq:NVAX),
a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that Gregory Glenn, M.D., Senior Vice President, Research and Development at Novavax will present new immunogenicity data from Novavax' RSV F-Protein Nanoparticle vaccine candidate (RSV F vaccine) clinical trials at the 8th Vaccine & ISV Congress to be held October 26-28, 2014 in Philadelphia, PA at the Hilton Philadelphia City Avenue Hotel.

Pacific Biosciences of California, Inc. (Nasdaq:PACB)
today reported a 178% increase in revenue to $20.6 million for the third quarter ended September 30, 2014, compared to $7.4 million for the third quarter of 2013.

Radius Health, Inc. (Nasdaq:RDUS)
announced today it is a sponsor of The Cancer Support Community's symposium, "The Patient Voice: The First Year of the Cancer Experience Registry," in recognition of National Breast Cancer Awareness Month. Radius is pleased to help be a sponsor of this patient-focused event.

Raptor Pharmaceutical Corp. (Nasdaq:RPTP)
today announced that it has strengthened its leadership team with the hiring of two new executives: David Happel, Chief Commercial Officer, who will oversee Raptor's global commercial operations, and Kimberly Lee, D.O., Vice President, Corporate Strategy and Communications, who will lead strategy development, investor relations and media communications.

Repligen Corporation (Nasdaq:RGEN)
today announced that it will report third quarter 2014 financial results on Thursday, November 6, 2014.

Rich Pharmaceuticals, Inc. (OTCQB:RCHA)
, a clinical-stage biotechnology company focused on developing innovative therapies in oncology, announced today that it has submitted an investigational new drug (IND) application to conduct a Phase 2 clinical trial for its lead compound RP-323 in Acute Myelocytic Leukemia (AML) and Myelodysplastic Syndrome (MDS) with the U.S. Food and Drug Administration (FDA).

SAGE Therapeutics (Nasdaq:SAGE)
today announced dose initiation of the first patient in a single-center Phase 2a clinical trial of SAGE-547, an allosteric modulator of GABAA receptors, in patients with essential tremor.

The Spectranetics Corporation (Nasdaq:SPNC)
today reported financial results for the three and nine months ended September 30, 2014.

Star Bulk Carriers Corp. (Nasdaq:SBLK)
, a global shipping company focusing on the transportation of dry bulk cargoes, will visit the Nasdaq MarketSite in Times Square.

Trinity Biotech plc (Nasdaq:TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced results for the quarter ended September 30, 2014.

Vical Incorporated (Nasdaq:VICL) today announced that the company will report financial results for the three and nine months ended September 30, 2014, before the opening of trading on Thursday, October 30, and conduct a conference call and webcast to discuss the financial results and provide a company update at noon Eastern Time on Thursday, October 30.

Vitae Pharmaceuticals, Inc. (Nasdaq:VTAE), a clinical-stage biotechnology company, today announced positive top-line results from clinical trials in treatment and prevention of Alzheimer's disease as part of the collaboration with Boehringer Ingelheim, one of the world's 20 leading pharmaceutical companies.



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