瞄準單株抗體商機，生達與美上市公司結盟
2010/05/25精實新聞 看好單株抗體市場發展，生達(1720)即將與美國公開上市Peregrine製藥公司及Stason製藥公司，宣布結盟，共同發展新型TNT(Tumor Necrosis Therapy，腫瘤壞死療法)生物技術及產品研究，並取得該技術的亞洲授權。生達總經理范滋庭表示，該平台已在美國完成腦癌的PhaseII臨床實驗，未來將引進台灣及大陸等地的合作夥伴，開發更多癌症治療的適應症，共同進軍亞洲市場。美國Stason製藥公司成立近20年，主要發展癌症治療藥品及因癌症治療引起副作用的支持性藥品，擁有癌症用藥全球行銷經驗；美國Peregrine製藥公司亦為美國公開上市公司；生達製藥則為國內通過PIC/S藥廠及40年國際化經驗的製藥廠。三家公司均對TNT腫瘤壞死療法得生物技術平台及產品線前景，深具信心。生達表示，腫瘤壞死療法(TNT, Tumor Necrosis Therapy)技術是一項新型的生物技術平台，平台發展計畫起源於第一代嵌合TNT單株抗體，而美國Peregrine公司從1990年開始，即研發相關技術，原用於腦癌膠質母細胞瘤的臨床試驗，透過該技術平台，提供癌症病患一種新型、可靠的治療方式。美國Stason製藥公司和Peregrine製藥公司已經簽訂合約，取得相關技術智慧財產權，並結合生達全球資源，共同進行第一代嵌合TNT單株抗體的後續開發，並從第一代嵌合型TNT單株抗體，轉換成第二代全人類TNT抗體，未來也將發展至第三代TNT生物製劑，做為GMP級抗體試劑組，此等也將應用於癌症、心血管疾病及其他可能的致死性疾病治療。而目前第一代崁合TNT單株抗體產品，已完成二期臨床，預估二至三年內，將通過FDA快速審查，取得上市核准用於腦癌，未來將再擴展至新的癌症領域，包括肺癌、大腸癌、乳癌、肝癌、前列腺癌及胰臟癌等。范滋庭說，生達已取得美方的亞洲授權，未來將在該平台基礎下，尋求台灣及大陸有意發展新適應症的合作夥伴，甚至不排除尋求新的單株抗體候選人。他也說，台灣學名藥廠的下一步路，可以朝開發美國利基市場，或善用大陸原料藥廠的垂直整合，另外，也可自國外技術移轉，取得發展單株抗體及蛋白質藥物的基礎。他表示，生達接下來也將把單株抗體及生物相似藥(Bio-Similar)列入重點發展。目前TNT結盟計畫，生達也盼扮演初期種子基金的角色，吸引更多有能力、有意願發展新適應症的廠商加入，共同開發亞洲市場。
Reference:
PR 5-3-10: Peregrine & Stason Sign TNT Deal ('Certain APEC Countries')
Peregrine and Stason Enter Into Agreement for Innovative Tumor Necrosis Therapy (TNT) Technologies
• Agreement Includes Exclusive Rights to Develop TNT Products in Certain APEC Countries; Upon Successful Commercialization, Stason Has Option to Acquire Rights to Expand Coverage to Additional Regions
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=465795
TUSTIN & IRVINE, May 3, 2010: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing innovative monoclonal antibodies for the treatment of cancer and viral infections, and Stason Pharmaceuticals [ http://www.stasonpharma.com ], a privately-held U.S.-based pharmaceutical company commercializing products globally since 1994, today announced agreements granting Stason certain exclusive development and commercialization rights to Peregrine's tumor necrosis therapy (TNT) technologies. Peregrine's lead TNT product candidate is Cotara(R), a novel brain cancer therapy currently in Phase II clinical development. 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," commented Steven W. King, president and chief executive officer of Peregrine Pharmaceuticals. "As we advance our clinical-stage pipeline of innovative products for oncology and viral infections, we will continue to pursue select partnering opportunities while retaining future potential value for our products in the major pharmaceutical markets."
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, European Union countries, and other select countries internationally. 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.
Harry Fan, president and 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."
Stason will pursue drug development, clinical trial and commercialization activities in its exclusive APEC territories and both Stason and Peregrine will have the right to initiate new research activities worldwide. Peregrine will receive from Stason upfront fees, annual fees, and milestone payments over the term of the agreements, as well as double-digit royalty payments on net sales. Upon successful commercialization of a product and payment of predetermined royalties to Peregrine within the first 7 years of this agreement, Stason will have a right to negotiate with Peregrine further expansion into other countries worldwide. If commercialization is not achieved within the first 7 years, Stason will lose exclusivity to its APEC territories.
Peregrine's wholly-owned subsidiary Avid Bioservices will initially manufacture TNT products for Stason's research and development activities. Under the terms of the companies' agreement, Avid will be available to provide fee-based services to Stason for developing new processes and manufacturing products under cGMP conditions for clinical trials.
ABOUT TNT TECHNOLOGIES
TNT technologies use monoclonal antibodies to target intracellular tumor antigens in dead or dying (necrotic) tissues. This platform has demonstrated a broad-spectrum potential in solid tumors, including brain, lung, colon, breast, liver, prostate, and pancreatic cancers. Peregrine's lead TNT product Cotara is a monoclonal antibody conjugated with a radioisotope Iodine-131. Cotara is currently being evaluated in a Phase II clinical trial in the U.S. and India for the treatment of patients with glioblastoma multiforme (GBM), the deadliest form of brain cancer. A unique approach to treating brain cancer patients, Cotara targets necrotic cells residing at the core of solid tumors. It transports and binds the radioactive iodine to the center of the tumor, allowing the radiation to destroy the tumor from the inside out. Prior data show that Cotara delivers 300-fold more radiation to the tumor than to normal tissues. Survival benefits for recurrent GBM patients were demonstrated in a prior Phase II trial, with 25% (7/28) of patients surviving over 1 year, 11% (3/28) surviving over 5 years, and 2 patients surviving over 9 years. These data compare favorably to the 5-year survival rate of 3.4% reported by the U.S. Brain Cancer Registry. Cotara has Orphan Drug status in the U.S. and EU and Fast Track designation in the U.S.
ABOUT PEREGRINE PHARMACEUTICALS
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing 3 separate clinical programs in cancer and hepatitis C virus infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house cGMP manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
ABOUT STASON PHARMACEUTICALS
Stason Pharmaceuticals, Inc., established in 1994 and based in Irvine, CA is a privately-held, global pharmaceutical company involved in drug development, manufacturing, importation/exportation, licensing and marketing of both generic and branded products. The company's primary area of development is in the area of oncology, and supportive products for the treatment of side effects related to cancer therapy. Additional therapeutic areas include cardiovascular, central nervous system, autoimmune and endocrine disorders. Additional information about Stason can be found at http://www.stasonpharma.com .
Safe Harbor *snip*
Peregrine Contacts:
• Investors: Amy Figueoroa, Peregrine Pharmaceuticals, 800- 987-8256, info@peregrineinc.com
• Media: Barbara Lindheim, BioCom Partners, 212-918-4650
Stason Contact:
Diana Wood, VP, Business Dev., Stason Pharmaceuticals, Inc., 760-929-0346, diana.wood@stasonpharma.com
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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 e
11-27-07: Exiqon A/S and Oncotech Inc today announce that they have entered into a binding Letter of Intent under which Exiqon will acquire Oncotech, a California based leading supplier of extreme drug resistance diagnostic tests in cancer. The transaction will create a world leader in molecular diagnostic products based on miRNA. The consideration amounts to approximately USD 45 million (approximately DKK 225 million) and will be paid through to approx. 6.2 million newly issued shares in Exiqon A/S as of November 26, 2007.
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1-19-10: PPHM & Stason websites show non-binding agreement to dev. TNT in Asia http://tinyurl.com/ybl92b7
…"Peregrine & Stason Pharm. have entered into a non-binding agreement to pursue a collaboration for developing TNT technologies in certain Asia-Pacific countries. The proposed collaboration would allow Peregrine to establish a regional partner for its proprietary TNT technology platform with an established pharmaceutical company that possesses expertise & experience in developing & marketing cancer therapies throughout the Asia-Pacific region."
Added to bottom of PPHM's Homepage 1-19-10 http://www.peregrineinc.com :
PEREGRINE'S STRATEGIC PARTNER
Peregrine Pharmaceuticals and Stason Pharmaceuticals to Pursue Tumor Necrosis Therapy (TNT) Develop
Peregrine has been actively seeking regional strategic partners for its preclinical and clinical programs that either are not currently in active clinical development or for territories where the company does not plan to pursue clinical development on its own. Ideal regional partners are established pharmaceutical companies with experience in drug development and commercialization. As part of this strategy, Peregrine and Stason Pharmaceuticals, Inc., have entered into a non-binding agreement to pursue a collaboration for developing tumor necrosis therapy (TNT) technologies in certain Asia-Pacific countries. The proposed collaboration would allow Peregrine to establish a regional partner for its proprietary TNT technology platform with an established pharmaceutical company that possesses expertise and experience in developing and marketing cancer therapies throughout the Asia-Pacific region. Stason was established in 1994 as a generic drug manufacturing and marketing company with an oncology and CNS focus. In 2008, Stason launched a Brand Division to develop proprietary branded drugs. It currently has 2 novel proprietary development stage oncology compounds in its portfolio.
ABOUT STASON PHARMACEUTICALS, INC.
Stason Pharmaceuticals, Inc., established in 1994 and based in Irvine, CA, is a privately-held, global pharmaceutical company involved in drug development, manufacturing, importation/exportation, licensing and marketing of both generic and branded products. Stason established a brand division in 2008 to acquire or license new chemical entities, and has offices throughout North America and Asia. The company's primary area of development is oncology, as well supportive products for the treatment of side effects related to cancer therapy. Due to its focus in the area of oncology, Stason specializes in the development of cytotoxic products requiring high containment operations for their production. Stason also provides contract services for non-high containment products. Additional therapeutic areas include cardiovascular, central nervous system, autoimmune and endocrine disorders. For more information on Stason Pharmaceuticals please visit their website at http://www.stasonpharma.com .
http://www.peregrineinc.com/index.php?option=com_content&task=view&id=90
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Versions of TNT (Tumor Necrosis Therapy)
TNT1 - USA, directed against DNA histone H1 complex in the nucleosome (TNT1+I131=CORATA)
TNT3 – China, targets both single & double stranded DNA
TUMOR NECROSIS THERAPY (TNT/COTARA/VEA's) NEWS:
Highlights of Cotara/GBM Trials History 1998-2009: http://tinyurl.com/y8fyl2r
1-19-10: PPHM & Stason websites show non-binding agreement to dev. TNT in Asia http://tinyurl.com/ybl92b7
…"Peregrine & Stason Pharm. have entered into a non-binding agreement to pursue a collaboration for developing TNT technologies in certain Asia-Pacific countries. The proposed collaboration would allow Peregrine to establish a regional partner for its proprietary TNT technology platform with an established pharmaceutical company that possesses expertise & experience in developing & marketing cancer therapies throughout the Asia-Pacific region."
7-1-09 Eur. Patent #1638989 for 'In-Line Labeling' (used in Cotara GBM trials) & JNM Article: http://tinyurl.com/mlgz8p
India (expanded Jan'10 to U.S.) Cotara/Brain Ph.2 Trial (40 patients, 1st relapse):
India's DCGI protocol (init=7-2007): http://clinicaltrials.gov/ct2/show/NCT00677716
1-28-10 U.S. site (Barrow/Phoenix) added formerly India-Only Ph.2 trial: http://tinyurl.com/yk565jy
…Per 3-11-10 QtlyCC, VP/ClinAffairs J.Shan said also exp. UPenn & Univ. of S.Car. http://tinyurl.com/yl4befh
…9-2-09 Interim Ph.2 data (10 pts) presented at AANS Annual Mtg/Boston: http://tinyurl.com/mxzbzm
……P.I. Dr. A.K. Mahapatra: "Most importantly, Cotara has demonstrated promising signs of efficacy."
...8-2-07 1st Patient Dosed in Indian Cotara/Brain Ph.2 Trial: http://tinyurl.com/296mcj
...The obvious desire is to compare Cotara vs. SOC Temodar for GBM therapy: http://tinyurl.com/yttt99
USA Cotara/Brain 'Dosimetry & Dose Confirmation Trial' (originally funded by NABTT):
U.S.A. Cotara Brain Cancer trial protocol (added 8-14-07): http://clinicaltrials.gov/show/NCT00509301
...2-11-10: "Current Cancer Therapy Reviews" article on Cotara/GMB http://tinyurl.com/yg2on8f
......the cases of "2 patients who have survived more than 9 years" are also reviewed.
...12-2-09: U.S. Trial Enrollment Complete http://tinyurl.com/yez7lzd
...6-16-09: Cotara/Brain Oral-Pres. at SNM Annual Meeting http://tinyurl.com/lmhkw2
......Dr. Sui Shen (U-Alabama), "With a mean dose ratio showing 300-fold greater delivery of radiation to the tumor as compared to other organs, Cotara represents a potentially valuable new therapy for GBM patients."
…9-23-08: Article in Cleveland paper – comments by P.I. Dr. Andrew Sloan (Case Western/CLEV) http://tinyurl.com/3mkmas
...5-31-08: Cotara USA Ph.1B data presented at ASCO/2008: http://tinyurl.com/68apro
...8-29-05: NABTT Initiates Cotara/Brain Trial (28 patients/4 sites): http://tinyurl.com/9w3cr
...Orig. NABTT protocol, "6-2007, completed": http://www.clinicaltrials.gov/ct/show/NCT00128635
...The Phil (Marfuta) Bannister Story (NABTT Cotara/GBM patient #1, diag. 2-4-06) - articles & updates: http://tinyurl.com/24gkml
.....Update 12-29-08: Phil posts on iHub that he's doing OK (34 mos. since diag.): http://tinyurl.com/8r5fnz
.....Update 10-14-09: Phil posts on YASG.com that he's doing well, 44 mos. after diagnosis: http://tinyurl.com/yfbpk57
Previous USA Cotara/Brain Ph.1-2 Trials, completed in 2003:
...Slides showing correlation between Cotara dosage levels and MST vs. Temodar(curr.SOC): http://tinyurl.com/26s265
...4-27-08 update: The Jerod Swan Cotara/Brain Success Story (10 years after diag.): http://tinyurl.com/68ofsv
...5-22-07 update: The Freddie Sanford Cotara/Brain Success Story (7 years after diag.): http://tinyurl.com/2du2e5
...6-1-05: Cotara w/CED Brain Delivery pub. in Neurosurgery Jrnl: http://tinyurl.com/anmaa
..."Cotara Holds Promise for Treating Brain Cancer - P1/P2 Data Suggests Extended Survival in a Number of Patients"
TNT3 (Vivatuxin) Lung Cancer Approval/Launch in China:
...Shanghai MediPharm Biotech's TNT/China website: http://www.vivatuxin.com
...1-16-07: Medipharm Launches TNT in China for Lung Cancer http://tinyurl.com/ttlne
...6-19-02: TNT Interim Lung Data from China: http://tinyurl.com/ggcba & http://tinyurl.com/em6da
Peregrine v. CTL Lawsuit – Settled 6-19-09:
...6-19-09: Form 8-K, Peregrine & CTL Settle: http://tinyurl.com/mhgcg7
...3-29-07 CTL countersues PPHM over TNT/China licensing dispute: http://tinyurl.com/39k8sx
...3-30-07 PPHM comments on CTL's 3-29-07 countersuit: http://tinyurl.com/33xzzq
...1-12-07: New China Subsidiary; Suit Filed Against Cancer Therapeutics Labs (CTL) http://tinyurl.com/y4vzbj
Eur. Licensee Merck-KGaA's TNT/Cytokine Fusion Protein Ph.1 Trial:
...4-2009: 2nd SELECTIKINE Ph.1 trial added: SELECTIKINE+RAD/NSCLC: http://tinyurl.com/pzl9j8
...5-2007: 2nd SELECTIKINE Ph.1 site added, Univ. of Lausanne, Switz: http://tinyurl.com/2l933s
...Ph.1 Trial Protocol (Merck KGaA/Germany, PI=Dr. R.Stupp): http://tinyurl.com/2f4u2t
...2-22-07: TNT-based European Cancer Trial initiated by 'Licensee': http://tinyurl.com/2zcjqr
...Clearly, it's Merck-KGaA's 'SELECTIKINE' (NHS-IL2-LT/EMD521873): http://tinyurl.com/yud7pw
VEAs:
...5-1-08 Dr. Missag Parseghian (Dir/R&D) presents VEAs at PEGS/2008: http://tinyurl.com/66onj2
...NOTE: Drs. Parseghian (Dir.R&D) & Luhrs, key PPHM TNT/VEA researchers: http://tinyurl.com/2ahhdp
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
Emerging Biopharm Forefront
Business Overview: TNT Technology Platform
Geographic Area: Biomedical Services
Line of Business: Professional > Science & Research
Products & Services: monoclonal antibodies, biosimilars
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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 e
Stonsa Biopharm's new website (5-2010 deal to dev. TNT in APEC countries)
Stonsa Biopharm, Inc. rolls out new website: http://stonsabio.com
(at least it was nothing like this the last time I checked a few weeks back)…
Recall, Stonsa Biopharm, headed by Dr. Eugene Mechetner, is the spin-off biopharmaceutical company that Stason Pharmaceuticals (a strategic partner of Standard Chem. & Pharm. Co., Ltd) formed "to focus on commercializing TNT technologies", following Stason's 5-3-10-announced licensing from Peregrine of "certain exclusive development & commercialization rights to Peregrine's TNT technologies" for use in "certain Asia-Pacific Economic Cooperation (APEC) countries".
AS STONSA DESCRIBES THEMSELVES ON THEIR "PARTNERSHIPS PAGE"
"In addition to our research collaborations with US and intl. centers of excellence, Stonsa pursues the development & commercialization of the TNT technology platform through partnering with several pharmaceutical and biotechnology companies in the So. California and Asia Pacific regions."
http://stonsabio.com/partnerships.html
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5-3-10: PPHM Licenses TNT rights in "Certain APEC Countries" to STASON (Stonsa Biopharm) http://tinyurl.com/29x433b
...Harry Fan/CEO/Stason, "This agreement represents a unique opportunity to acquire a novel, cutting-edge pharmaceutical technology package and bring innovative & promising treatments to millions of cancer patients in Asia & the Pacific Rim. We will also continue developing new applications & 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 (Stonsa Biopharm Inc.) headed by Dr. Eugene Mechetner will be formed which will focus on commercializing TNT technologies."
…6-2010: More on PPHM-Stason Collab., "TNT For Tumors", Lloyd Dunla, Drug Disc. News http://tinyurl.com/28vmkzm
…5-27-10: Stonsa's CEO Dr. Eugene Mechetner presents TNT at Taiwanese Bio-Seminar http://tinyurl.com/29r7one
...12-16-10: "Stason Inks Deal to use Lonza's GS Gene Expression System with TNT Antibody Platform" http://tinyurl.com/2dzz4b5
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