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Biotecnol to present latest Investigational New Drug Application enabling results of its pan-cancer multi-specific T-cell engager

07 January, 2015. Biotecnol presents results of its pan-cancer Tribody™ programme Tb535.The product has shown a remarkable efficacy both in-vitro and in-vivo, in Malignant Mesothelioma, an untreatable and highly-aggressive cancer which is caused by past occupational exposure to asbestos. It’s estimated to affect about 30 cases per million people in Australia, USA, Belgium, and Great Britain and is worryingly rising in countries like Russia, India, Japan, Brazil and China due to the continuous production of Asbestos in these countries.

Tb535 is a bispecific antibody based on its proprietary Tribody™ format, combining binding to the pan-carcinoma marker, 5T4 oncofetal antigen also known asWnt-Activated Inhibitory Factor 1, which is completely absent from normal tissue, and a monovalent CD3 binder which activates T-cells only when accumulated at cancer cells. Preclinical studies indicated efficient tumour cell-killing on a variety of tumour types, including Pleural Malignant Mesothelioma, Triple Negative Breast Cancer and KRAS mutated Colorectal Cancer.

In-vivo studies in subcutaneous and orthotopic models of Malignant Mesothelioma have shown that low-doses Tb535 has a remarkable efficacy in killing the tumours and prolonging survival of the animals. Also, preclinical work indicated a high-degree of tolerability and absence of off-target and even on-target toxicity, especially regarding cytokine release.Biotecnol used its Trisomatechnology platform to generate a highly-stable Tb535 product candidate which will be now be entering in clinical development work in 2015. Biotecnol will continue developing the product and is actively seeking for territorial partners for co-developing and co-marketing the product in selected indications.

Biotecnol will be presenting updated results at the Biotech Showcase, on Tuesday the 13th January 2015 at 1.45 PM, which takes place during the next J.P. Morgan 33rd Annual Healthcare Conference in San Francisco, CA 12-15 of Jan 2015.

About the Tribody™ format

Tribody™ molecules are multi-specific antibodies, produced by established recombinant DNA technology methods, which utilize the natural in vivo heterodimerization of Fab fragments to form a scaffold, upon which additional functionality can be incorporated. As a result Tribodies are characterized by an unsurpassed versatility; they can incorporate up to three different binding sites and can combine different functions, such as the ability to engage and redirect potent immune-effector cells like T-cells or NK-cells whilst retaining the ability to target more than one epitope in a tumour target, or more than one target in the same tumour, all in one single molecule.

About Biotecnol Limited

Biotecnol Limited is an immuno-oncology company developing innovative immune-function activating and immune-function modulation approaches for treating cancer. These approaches seek to recruit or to modulate the body’s own immune defences such as T cells and NK cells to kill tumours. Biotecnol multi-specific antibody products are based on its proprietary Tribody™ and Trisoma® platforms, which are comprised of a variety of formats with key properties. Under the Trisoma® platform, Biotecnol has developed a novel format known as Targeted T-cell Engaging Agonistic Response Modifiers or iChecks™.These products aim at improving tumour cell dependent T-cell or NK-cell activation. The iCheck™ formats are expected to achieve a more localized immune-function activation and obtain less or no systemic toxicity, whilst having an increased therapeutic index.These are potentially safer and more effective drugs for treating highly-heterogeneous and highly-aggressive solid tumours.

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