0001102624-14-001713.txt : 20141027 0001102624-14-001713.hdr.sgml : 20141027 20141027165524 ACCESSION NUMBER: 0001102624-14-001713 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20141023 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20141027 DATE AS OF CHANGE: 20141027 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Stellar Biotechnologies, Inc. CENTRAL INDEX KEY: 0001540159 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 0831 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-54598 FILM NUMBER: 141174992 BUSINESS ADDRESS: STREET 1: 332 EAST SCOTT STREET CITY: PORT HUENEME STATE: CA ZIP: 93041 BUSINESS PHONE: (805) 488-2800 MAIL ADDRESS: STREET 1: 332 EAST SCOTT STREET CITY: PORT HUENEME STATE: CA ZIP: 93041 8-K 1 stellar8k.htm STELLAR BIOTECHNOLOGIES, INC. 8-K stellar8k.htm
 


 

 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM 8-K
 
 
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
 
 
Date of Report (Date of earliest event reported) October 23, 2014
 
 
STELLAR BIOTECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
 
 
British Columbia, Canada
 
000-54598
 
N/A
(State or other jurisdiction
 
(Commission
 
(I.R.S. Employer
of incorporation)
 
File Number)
 
Identification No.)
 
 
32 E. Scott Street
Port Hueneme, California 93041
(Address of principal executive offices) (Zip Code)

 
(805) 488-2800
(Registrant’s telephone number, including area code)
 
 
Not applicable.
(Former name or former address, if changed since last report)
 
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 
 

 

 
Item 8.01                      Other Events.

On October 23, 2014, Stellar Biotechnologies, Inc. (the “Company”) issued a press release announcing its entry into a definitive supply agreement with Biovest International, Inc. (“Biovest”). The Company will provide cGMP-compliant Stellar KLH™ to Biovest for use as an active component in Biovest’s BiovaxID®, an active immunotherapy vaccine to treat follicular non-Hodgkin’s lymphoma. The supply agreement has an initial three-year term, and may be renewed upon Biovest’s written request for additional one-year periods.

The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 
Item 9.01                      Financial Statements and Exhibits.

Exhibit No.
 
Description
     
 
Press release issued by Stellar Biotechnologies, Inc. dated October 23, 2014.


 
 

 

 
SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
  Stellar Biotechnologies, Inc.
   
Date: October 27, 2014 By: /s/ Kathi Niffenegger                    
 
Name: Kathi Niffenegger
 
Title: Chief Financial Officer
 

 
 

 

 
EXHIBIT INDEX

Exhibit No.
 
Description
     
 
Press release issued by Stellar Biotechnologies, Inc. dated October 23, 2014.

 

 


EX-99.1 2 exh99_1.htm EXHIBIT 99.1 exh99_1.htm
 


Exhibit 99.1
 
 
Logo
 
 
Stellar Biotechnologies and Biovest International Sign KLH Supply Agreement for BiovaxID Immunotherapy for Follicular Non-Hodgkin’s Lymphoma
 
PORT HUENEME, CA, (October 23, 2014) -- Stellar Biotechnologies, Inc. ("Stellar" or “the Company”) (OTCQB: SBOTF) (TSX-V: KLH) and Biovest International, Inc. (“Biovest”) today announced that 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. ”
 
About Biovest International, Inc.
 
Biovest International, Inc. is a pharmaceutical company focused in the field of active personalized immunotherapy development targeting life-threatening cancers of the blood system, marketing state-of-the-art bioreactors, and providing a full range of custom biomanufacturing services.  Biovest’s lead personalized cancer vaccine candidate BiovaxID® is an autologous active immunotherapy (personalized cancer vaccine) that targets follicular non-Hodgkin’s lymphoma, mantle cell lymphoma, and potentially other B-cell malignancies.  BiovaxID® has undergone three clinical trials conducted in collaboration with the U.S. National Cancer Institute (NCI) that have demonstrated BiovaxID®’s ability to increase the duration of cancer remission following chemotherapy and to induce immune responses which correlate highly with long-term survival.  Biovest is currently in the process of pursuing European marketing approval for BiovaxID®.
 
Visit www.biovest.com
 
About Stellar Biotechnologies, Inc.
 
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX-V: KLH) is a leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH), an important immune-stimulating protein used in wide-ranging therapeutic and diagnostic markets. KLH is both an active pharmaceutical ingredient (API) in many new immunotherapies targeting cancer, immune disorders, Alzheimer’s, and inflammatory diseases as well as a finished product for measuring immune status. Stellar Biotechnologies is unique in its proprietary methods, facilities, and KLH technology.  We are committed to meeting the growing demand for commercial-scale supplies of GMP grade KLH, ensuring environmentally sound KLH production, and developing KLH-based active immunotherapies.
 
Visit www.stellarbiotech.com and the KLH knowledge base www.klhsite.org.
 
Stellar Biotechnologies, Inc. Company Contact:
 
Mark A. McPartland
Vice President of Corporate Development and Communications
Phone: +1 (805) 488-2800 ext. 103
markmcp@stellarbiotech.com
www.stellarbiotech.com
 
Biovest International, Inc. Company Contact:
 
David Moser
Biovest International
8500 Evergreen Blvd.
Minneapolis, MN 55433
813-864-2567 (direct)
www.biovest.com
 
 
 
 

 
 
 
Forward Looking Statements
 
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include, but may not be limited to: general economic and business conditions; technology changes; competition; changes in strategy or development plans; governmental regulations and the ability or failure to comply with governmental regulations; the timing of anticipated results; and other factors referenced in the Company's filings with securities regulators. For a discussion of further risks and uncertainties related to the Company's business, please refer to the Company's public company reports filed with the TSX Venture Exchange and the U.S. Securities and Exchange Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such statements. This press release does not constitute an offer or solicitation of an offer for sale of any securities in any jurisdiction, including the United States. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of the information contained in this press release.
 

 
###
 

 


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