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Saturday, 07/31/2010 9:16:10 AM

Saturday, July 31, 2010 9:16:10 AM

Stason spin-off for TNT/APEC Dev: Stonsa Biopharm, Inc.

Recall the 5-3-10 Stason Licensing from Peregrine of “certain exclusive development & commercialization rights to Peregrine's tumor necrosis therapy (TNT) technologies” for use in “certain Asia-Pacific Economic Cooperation (APEC) countries”. Recall also that in the 5-3-10 PR ( http://tinyurl.com/29x433b ), Stason CEO Harry Fan stated, “We will also continue developing new applications and bioproducts based on TNT technologies to complement Peregrine's activities in the glioblastoma arena and will aggressively pursue new, diverse biotechnology markets. To advance these efforts, a new spin-off biopharmaceutical company headed by Dr. Eugene Mechetner will be formed which will focus on commercializing TNT technologies." (A followup 6-2010 article in Drug Discovery News states that the name of the spin-off is: Stonsa Biopharm, Inc. - see below).

Well, about 3 weeks later, on 5-27-10, this Seminar occurred in Taiwan…

5-27-10 Seminar in Taiwan:
"Introduction of applications of new TNT bio-technology platform for the diseases treatment and medical imaging"
Sponsored by:
• MOEA Biotechnology & Pharmaceutical Industry Development
• U.S. Stason Pharmaceuticals, Inc.
• Standard Chem Pharmaceutical Co., Ltd.
http://blog.biopharm.org.tw/bpipo/?p=522
GOOGLE TRANSLATE ( http://tinyurl.com/2u59coo ):
TNT bio-technology platform development project originated in the first generation of chimeric TNT monoclonal antibody (Peregrine product Cotara ®) for the brain cancer glioblastoma clinical trial, the safety & efficacy of products have been in previous clinical trials was confirmed when the drugs used in the treatment of brain cancer were full approval, it will immediately implement clinical trials of other solid tumors.
Currently Stason and Peregrine Pharmaceuticals has signed a contract, the contract in addition to the first generation of chimeric TNT antibodies to the follow-up development, but also from the first generation of chimeric TNT antibody into the second generation of humanity TNT antibody, and the future TNT will be the development of biological agents to third-generation antibody reagents for the GMP level group, which will be applied to cancer, cardiovascular disease and other lethal diseases of possible treatment and imaging. To achieve these goals and challenges, we will actively seek to develop innovative biological agents of the partnership, and the technology is widely used in Taiwan and other Asia-Pacific countries patients.
AGENDA (5-27-10):
"Introduction of applications of new TNT bio-technology platform for the diseases treatment and medical imaging"
9:30-9:40: Welcome/opening remarks: Dr. Chen Qixian, BPIPO/Biomedical promote group
9:40-10:15: Missag Parseghian, Senior Director of Scientific Affairs, Peregrine Pharmaceuticals, Inc. “TNT biotechnology platform and its applications in therapeutics and diagnostics”
HOST: Harry Fan, CEO of Stason Pharmaceuticals, Inc.
10:30-11:00: Missag Parseghian, “TNT product pipelines, FDA standards, and commercialization strategies”
11:00-11:30: Q&A - Questions and note discussions
• Eugene Mechetner, CEO of Stonsa Biopharm, Inc.
• Missag Parseghian, Senior Director of Scientific Affairs, Peregrine Pharmaceuticals
• Debbie Harris, Director of Product Dev. of Stonsa Biopharm, Inc.

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Stonsa Biopharm, Inc.
2453 Impala Drive
Carlsbad CA 92008
Phone: 760-268-2018, Fax: 760-268-0566
Web: http://www.stonsabio.com
Emerging Biopharm Forefront
Business Overview: TNT Technology Platform
Geographic Area: Biomedical Services
Line of Business: Professional > Science & Research
Products & Services: monoclonal antibodies, biosimilars

= = = = = = = =
5-3-10: PPHM Licenses TNT rights in “Certain APEC Countries” to STASON http://tinyurl.com/29x433b
...”Stason is acquiring from Peregrine exclusive rights to Peregrine's TNT tech’s in Asia-Pacific countries. Peregrine retains exclusive rights to its TNT tech’s in the U.S. & EU countries, and other select countries internationally. The agreements also include certain non-excl. licenses for Peregrine's proprietary radiolabeling technologies and its fully-human NHS76 TNT antibody… Peregrine will receive from Stason upfront fees, annual fees, and milestone payments, as well as double-digit royalty payments on net sales… Harry Fan, CEO of Stason, stated, "This agreement represents a unique opportunity to acquire a novel, cutting-edge pharmaceutical technology package and bring innovative and promising treatments to millions of cancer patients in Asia and the Pacific Rim. We will also continue developing new applications and bioproducts based on TNT technologies to complement Peregrine's activities in the glioblastoma arena and will aggressively pursue new, diverse biotechnology markets. To advance these efforts, a new spin-off biopharmaceutical company headed by Dr. Eugene Mechetner will be formed which will focus on commercializing TNT technologies."

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6-2010: “TNT For Tumors”
By Lloyd Dunla, Drug Discovery News
http://www.drugdiscoverynews.com/index.php?newsarticle=3924
IRVINE, Calif.—Stason Pharmaceuticals has been granted certain exclusive development and commercialization rights to Peregrine Pharmaceutical’s tumor necrosis therapy (TNT) technologies. Peregrine’s lead TNT product candidate is Cotara, a novel brain cancer therapy currently in Phase II clinical trials in the United States and India for the treatment of patients with glioblastoma multiforme, an especially deadly form of brain cancer. The company’s TNT-based immunocytokines technology has also been licensed to Merck KGaA.

“Stason’s focus on oncology products for growing Asian markets expands the development of our TNT technologies to reach patients in this region who urgently need new options for the treatment of cancer,” says Steven W. King, Peregrine’s president and CEO.

Under the terms of the agreements, Stason is acquiring from Peregrine exclusive rights to Peregrine’s TNT technologies in certain Asia-Pacific Economic Cooperation (APEC) countries. Peregrine has retained exclusive rights to its TNT technologies in the United States, Europe and other select countries. The agreements also include certain non-exclusive licenses for Peregrine’s proprietary radiolabeling technologies and its fully-human NHS76 TNT antibody to enable and accelerate Stason's development of TNT products.

Citing the two companies’ close proximity in South Central Orange County as a trust-building factor in closing the deal, Harry Fan, president and CEO of Stason, states, “this agreement represents a unique opportunity to acquire a novel, cutting-edge pharmaceutical technology package and bring innovative and promising treatments to millions of cancer patients in Asia and the Pacific Rim. We will also continue developing new applications and bioproducts based on TNT technologies to complement Peregrine's activities in the glioblastoma arena and will aggressively pursue new, diverse biotechnology markets.”

To advance these efforts, Stonsa Biopharm, a new spin-off biopharmaceutical company headed by Dr. Eugene Mechetner, was created in May to concentrate on the development, validation and commercialization of TNT technologies in the territories stipulated by the deal. Stonsa will also work closely with Peregrine and Stason on the creation of new TNT products.

Discussions between the two companies regarding Cotara and the potential of the TNT technologies began while Peregrine was advancing their Phase II clinical-oncology pipeline. Due to Stason’s manufacturing and marketing presence within the rapidly growing Asia Pacific region, both companies realized the synergies and potential to further Peregrine’s Cotara development efforts and bring TNT based drugs to the bedside of patients within this region. Peregrine will receive from Stason upfront fees, annual fees, and milestone payments over the seven-year term of the agreements, as well as double-digit royalty payments on net sales.

Peregrine’s tumor necrosis therapy uses monoclonal antibodies attracted to the dead and dying cells found at the necrotic core of solid tumors. When these antibodies are attached to therapeutic agents such as radioisotopes, they carry the anti-cancer agent into the tumors to kill them from the inside out. Cotara is a monoclonal antibody conjugated to Iodine-131, a therapeutic radioisotope, to deliver a toxic payload to neighboring viable cancer cells, resulting in their death.

TNT antibodies are potentially capable of carrying a variety of therapeutic agents into the interior of solid tumors including radioisotopes, chemotherapeutic agents and biosimilars. The radioisotope can be tracked by imaging devices to document that it is entering the tumor and not dispersing in healthy tissues.

Overall, Cotara has been administered to a total of more than 120 patients with brain, colon or liver cancer. Survival benefits for recurrent GBM patients were demonstrated in a prior Phase II trial, with 25 percent of patients surviving over 1 year, 11 percent surviving over 5 years, and two patients surviving over 9 years. These data compare favorably to the 5-year survival rate of 3.4 percent reported by the U.S. Brain Cancer Registry. Cotara has orphan drug status in the United States and Europe and fast-track designation in the United States.
Code: E061022

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EUGENE MECHETNER'S BIOGRAPHY (Ph.D)
• Director of Scientific & Clinical Trials at Oncotech Inc. - 2006
• Adjunct Associate Professor at University of California - to 2007
Eugene Mechetner joined Oncotech as Senior Dir. of Scientific, Clinical, and New Product Dev. His general research interests are focused on the areas of experimental and clinical oncology, imaging, biotechnology, and immunology, with a specific emphasis on multiple drug resistance in normal and tumor cells and new methods of biomarker detection using monoclonal antibodies. Dr. Mechetner has authored over 60 peer-reviewed scientific publications and several US and intl. patents. He has over 12 years of extensive experience in a variety of industries, including biotechnology, drug development, bioreagents, and clinical laboratory testing. In addition to his responsibilities at Oncotech, Dr. Mechetner holds a position of Adjunct Associate Professor with the College of Medicine, Univ. of California - Irvine.
http://www.spoke.com/info/p7DsYM9/EugeneMechetner
PUBS: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=search&db=pubmed&orig_db=pubmed&term=Mechetner%20e