TNT for tumors

Peregrine grants Stason rights to develop TNT products in APEC countries

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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.

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