Licensing Portfolio - Biological Therapeutics
Pre-Clinical Candidate. TNFα converting enzyme (TACE) is a membrane bound metalloprotease also known as Adam17 which regulates the release of membrane tethered substrates such as EGF family ligands and TNFα. A number of TACE substrates have been linked to the growth and progression of tumours and many of these substrates as well as TACE itself are upregulated in tumours suggesting TACE may be a promising therapeutic target in a range of cancers including breast, prostate and colorectal. This antibody represents the first reported antibody capable of inhibiting TACE and comes with an extensive package of data and attractive properties including: i) high affinity binding (Kd=0.4nM), ii) potent biochemical and cellular inhibition data and iii) demonstration of
in-vivo efficacy and modulation of TACE substrate levels in a xenograft model. The antibody is a fully human IgG1 and could be rapidly moved into formal pre-clinical and clinical testing. In addition to utility in a number of oncology indications, the antibody’s ability to modulate levels of TNFα and the soluble IL-6 receptor make it a promising candidate for the treatment of a number of inflammatory diseases such as rheumatoid arthritis and psoriasis. CRT is seeking a licensee to drive the rapid translation of this antibody into clinical testing.
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Clincal Phase II. A technology platform based on an antigen of choice and an immunoenhancing sequence was developed to significantly promote the immune response. These therapeutic DNA fusion vaccines can be designed to activate antibody and/or T cell responses. Clinical trials in lymphoma, myeloma, prostate cancer and colorectal cancer confirmed the safety and immunogenicity of these vaccines. Phase II testing is currently ongoing. CRT is seeking a suitable partner to develop these DNA fusion vaccines through to the market.
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Clinical Phase II. TA-CIN, a human papillomavirus (HPV) vaccine, has been developed for the prevention and/or treatment of HPV-related diseases including vulval, anal and cervical intraepithelial neoplasias and cervical cancer. TA-CIN is a subunit vaccine comprising L2/E6/E7 proteins from HPV16, designed to generate a strong cellular immune response against HPV-infected cells. A Phase I study showed that TA-CIN is tolerated and immunogenic. In a subsequent Phase II prime boost clinical trial, TA-CIN in combination with the TA-HPV vaccine proved safe and well-tolerated, and some clear clinical responses were demonstrated.
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Clinical Phase I. MFE-23 is a single chain Fv antibody that has high affinity for the tumour specific antigen CEA. Successful preclinical and clinical studies support its potential for use in targeted cancer therapies and as an imaging agent. These include Phase I studies of radiolabelled MFE-23 for use as an imaging agent, for radioimmunoguided surgery and as the tumour-targeting moiety of an antibody directed enzyme prodrug therapy. A Phase I study of autologous T cell therapy is in progress. Humanised MFE-23 and higher affinity variants are also available.
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In vivo Proof-of-Principle. Dendritic cell NK lectin Group Receptor-1 (DNGR-1) is a c-type lectin with expression profile that is highly restricted to a subset of dendritic cells that are known to be highly efficient at MHC class I cross-presentation of foreign and self antigens. In vivo administration of anti-DNGR1 antibody conjugated tumour antigens elicit strong antigen specific cytotoxic T-cell response resulting in potent anti-tumour response in both prophylactic and therapeutic setting. CRT is seeking a commercial partner for further development of this technology for anti-cancer and infectious disease vaccines.
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In vivo Proof-of-Principle. PASD1 is a novel tumour specific cancer testis antigen. It’s wide expression profile in a variety of haematological malignancies and solid tumours (including melanoma, lung, head and neck and colorectal carcinoma), combined with the proven immunogenicity of PASD1 peptides, make it an attractive candidate for cancer vaccine development. CRT and Isis Innovation are seeking a commercial partner for further development of PASD1-based immunotherapy.
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In vivo Proof-of-Principle. This patented platform technology enables generation of potent antibody response to antigen of choice without the requirement of CD4 T cell help. The circumvention of Th cell requirement enables faster and more potent Antibody response to the antigen(s) of choice. In addition, this also allows generation of antibody response to antigens without the need for MHC class II epitopes. The technology relies on enlisting either Galcer/iNKT cell or B cell resident TLRs (or both) for specifically activating only the B cells presenting the antigen cognate B cell Receptor. Faster and more potent antibody response can be utilised for generation of more efficient vaccines and generation of monoclonal antibodies to antigens that do not contain any MHC class II epitopes.
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In vitro Proof-of-Principle. Heparan sulfate and heparin play a central role in a large number of processes including angiogenesis, anti-coagulation, cell growth and migration. Short oligosaccharides which block angiogenesis through inhibition of heparin sulphate-dependent growth factor signalling have been discovered. Efficacy has been demonstrated
in vivo with partially-purified preparations and in vitro with synthetic oligosaccharides. Optimisation of the oligosaccharides is ongoing. A scalable synthesis route has been developed and optimised. CRT is now seeking a commercial partner to progress this programme under a licensing or co-development model.
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In vivo Proof-of-Principle. Peptides which potently and selectively bind to the integrin ανβ6 have been developed. The structural motif required for binding has been elucidated, and the consensus sequence is protected by a patent application. The peptides have utility for targeting tumours in which the integrin is over-expressed (including oral, pancreatic, ovarian, lung, colorectal and breast). The peptides have applications in tumour imaging as well as in cancer therapy via targeting of payloads and functional inhibition of ανβ6. The ability of radiolabelled versions of the peptide to selectively localise to ανβ6-expressing tumours in vivo has been demonstrated by PET and SPECT.
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In vivo Proof-of-Principle. Recent results of clinical trials with MUC1-based agents have attracted considerable interest in MUC1 as potential target antigen for immunotherapy of breast, pancreas, ovarian and other cancers. Studies using a proprietary human MUC1 transgenic mouse have shown that MUC1-based naked DNA immunotherapy elicits an anti-tumour response. An exclusive license to CRT’s MUC1 patent portfolio in the field of naked DNA based therapy and non-exclusive rights to the huMUC1 transgenic mouse model are available.
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Target Validation. Genes specifically expressed in tumour endothelial cells have been identified using an in silico approach. On-going expression and functional analysis indicates that they are potentially good antibody and/or small molecule targets for development of anti-angiogenic/vascular targeting therapeutics.
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Target Validation. A novel interaction of the oncofoetal antigen 5T4 and chemokine receptor CXCR4 has been identified which directly facilitates the biological response to the chemokine CXCL12. 5T4 is required for optimal functional cell surface expression of CXCR4 and CXCL12 mediated chemotaxis and inhibition of CXCL12 chemotaxis by some anti-m5T4 mouse monoclonal antibodies has been shown in murine embryonic stem cells and embryo fibroblasts. In addition to 5T4 being expressed by many different cancers (with expression associated with poor clinical outcome in some), CXCL12 and CXCR4 expression have been associated with tumourigenesis in many cancers, with CXCR4 mediating the CXCL12-directed migration of cancer cells to metastatic sites. Inhibition of CXCL12-mediated chemotaxis through targeting the 5T4-CXCR4 complex offers an exciting therapeutic approach with potential applications in a number of cancer types that would exploit the tumour-specificity of 5T4. CRT has filed a patent application and is seeking a co-development partner or licensee for a therapeutic antibody or small molecule programme.
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Target Validation. A target validation programme is underway to provide
in vivo proof of concept for inhibition of the chemokine receptor CCR4 or its ligands CCL17/22 in the treatment of certain solid tumours where these proteins have been found to be overexpressed and functionally active on tumour cells as well as the immune cell infiltrate. Based on proprietary target validation data, CRT have filed a patent with claims to the use of CCR4 and its ligands as biomarkers for diagnosis and stratification, as well as target claims to CCL17/22, which may be suited to intervention using antibodies. CRT is seeking a co-development partner for a therapeutic antibody programme.
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