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Peregrine, Biotecnol sign pact on fusion proteins
Tustin, California | Tuesday, December 19, 2006, 08:00 Hrs  [IST]

Peregrine Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing targeted therapeutics for the treatment of cancer and hepatitis C virus (HCV) infection, and Biotecnol SA announced a collaboration for the development of novel targeted immunocytokine agents for the treatment of cancer and other disease indications. The collaboration will apply technology from Peregrine's Vascular Targeting Agent (VTA) platform with Biotecnol's Tribody technology to engineer novel agents that fuse Peregrine's anti-phospholipid targeting agents to one or more cytokines in a Tribody format.

In September 2006 Peregrine reported new research showing that a novel fusion protein combining two proprietary Peregrine technologies--its anti- phospholipid and VTA platforms--with an immunostimulatory cytokine showed significant anti-tumour activity. The fusion protein reduced tumour growth in animal models by more than 90 per cent, without showing evidence of the cytokine- induced toxicity that has limited the widespread therapeutic use of immunostimulatory cytokines such as interferon and interleukin. By fusing these cytokines with Peregrine's anti-phospholipid technology that directly targets tumour blood vessels, the combined fusion protein is expected to reduce both systemic toxicity and dosing frequency, while generating significant anti-tumour effects.

Under the collaboration, Biotecnol will engineer novel fusion proteins using one or more of Peregrine's anti-phospholipid antibodies or other targeting agents. The work will be performed as part of a research and development collaboration and is expected to result in a license agreement from Biotecnol to Peregrine for development and commercialization of the resulting agent or agents. Further details of the collaboration were not disclosed.

"This collaboration is an important step in developing clinical candidates that capitalize on the striking results we saw in tests of our fusion protein technology in animal cancer models," said Steven W. King, president and CEO of Peregrine. "Our anti-phospholipid platform is an ideal vehicle for targeting tumour blood vessels and delivering a cytokine payload with the goal of producing a very robust immune response while reducing systemic adverse events. We believe that Biotecnol's unique Tribody technology will contribute significantly to our ability to produce fusion protein drug candidates, and we therefore expect this collaboration to further broaden the potential of our proprietary VTA and anti-phospholipid platforms."

Biotecnol's Tribody technology uniquely allows engineering of multifunctional recombinant antibody derivatives, which utilize the natural in vivo heterodimerization of Fd fragments and light chains of a Fab fragment to form a scaffold upon which additional functions can be incorporated, such as additional binders, or cytokines, chemokines, growth factors, enzymes or protein toxins.

"This collaboration has great potential for designing superior immunocytokines based on the characteristics of our unique Tribody antibody engineering platform," said Pedro de Noronha Pissarra Ph.D., CEO of Biotecnol. "We believe that Peregrine has the proprietary technology and expertise to generate several antibody candidates for development as fusion proteins using our platform, with potential applications in oncology and infectious diseases. We are pleased to have the opportunity to contribute to the success of this project by providing a novel way to engineer these fusion protein candidates with unique properties and potentially safer profiles."

Peregrine's lead anti-phospholipid agent bavituximab is currently being studied In reply to phase l clinical trials in the US for the treatment of solid cancers and chronic hepatitis C infection. In clinical data collected to date, bavituximab appears safe and well tolerated, and the company has reported promising signs of anti-viral activity in a phase I HCV trial. Patient enrolment in a Phase Ib HCV trial has been completed, and a Phase lb solid cancer trial combining bavituximab and commonly-used chemotherapy regimens is now underway in India.

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