Harnessing the Immune System to fight Cancer
“Our mission, our ambition. Cancer is a extraordinary complex disease. We are learning that only a massive attack can result in better therapeutic outcomes. At Takis we are developing ground-breaking innovative vaccines based on cutting-edge technologies. Our genetic vectors have the potential to activate a potent, pleiotropic immune response against cancer and other diseases. As scientists, we fully recognize that only a deep and evolving knowledge of cancer biology, immunology and new target discovery will help finding new effective therapies. And we are aware that combination therapies are key to success.
Cancer Immunotherapy is currently facing a spectacular renaissance and we strongly believe that this approach will become an established therapeutic modality for the treatment of cancer within the next decade. We are proud to contribute to this challenging objective.
We invite you to join us in this revolutionary field and offer new perspectives to cancer patients.”
Luigi Aurisicchio, PhD
Takis is a Biotech Company born in 2009 as a spin off from IRBM, a Research Center in near Rome, formerly part of the global network of Merck Research Laboratories (MRL). The group has more than 15 years experience and an established track record in drug discovery in Oncology and is also recognized for the conception and implementation of a number of innovative technologies.
An Innovative Biotech focused on Cancer Immunotherapy
Takis as Biotech pursues the discovery and development of innovative Therapeutic Cancer Vaccines based on a proprietary Adenoviral vector-prime/DNA-boost platform technology. One of the main assets of Takis is the expertise in in vivo electro-gene-transfer, which can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis is actively involved in the generation of humanized monoclonal antibodies for use in Oncology and Infectious Diseases.
Takis’ frontline candidates are three therapeutic cancer vaccines: a) TK-001, against a well-known oncogene and validated target in Oncology; b) TK-002, targeting a tumor stromal antigen recently identified by the group as novel target for cancer immunotherapy; c) TK-004 and TK-005, both targeting Telomerase (TERT), a key molecule in Oncology. The main cancer types suitable for these immunotherapies are: Breast, Lung, Ovarian, Lymphomas and Gastrointestinal cancer. In addition, Takis has developed a family of monoclonal antibodies against ErbB3/HER3 (TK-003MAb), a receptor involved in tumor cell resistance to chemo- and radio-therapies.
Takis business strategy for the next 5 years is: 1) to develop three therapeutic cancer vaccines from advanced regulatory pre-clinical Phase to the achievement of clinical Phase Ib Proof-of-Concept and then to license out to Pharma/large Biotech companies, in exchange for upfront, success-based milestones and royalty fees. 2) to develop TK-004 veterinary cancer vaccine as a marketed product; 3) to develop TK-003MAb from pre-clinical Phase to a clinical Phase I trial. Other R&D projects are under advanced pre-clinical development.
Results achieved thus far
The combined use of Adeno and DNA plasmid vectors in prime-boost vaccination strategies is a Takis competitive advantage, validated in several preclinical species from mice, to dogs and monkeys. Both types of vectors have been approved by regulatory authorities in USA and Italy for human clinical trials. Importantly, Takis’ scientists have recently shown immunogenicity and significant therapeutic efficacy of this technology in pet dogs affected by spontaneous B cell lymphoma with significant improvement of survival and permanent cure in a high proportion of vaccinated subjects. This last result represents a clear proof-of-concept for our technology and enhances our confidence that its translation into a human clinical setting has high probability of success.
Takis’ anti-HER3 antibodies TK-003MAbs have shown significant therapeutic effects in a variety of preclinical models and were capable of reverting tumor resistance to chemotherapy.
Luigi Aurisicchio, Ph D, Master in “Regulatory Affairs, Founder, Chief Executive and Chief Scientific Officer
Giuseppe Roscilli, M.Sc., Partner, Director, Drug Testing and Monoclonal Antibodies
Emanuele Marra, Partner, Director, Infectious Diseases and Biomarkers
Takis competitive advantage is based on 3 distinct elements, which combined together provide an increased probability of success for Clinical Progression of our products and constitute a distinguishing feature of the Company vs others in the field:
1) Access to a new therapeutic modality for cancer, namely therapeutic cancer vaccines, complementary to validated therapeutic modalities such as chemotherapy;
2) Use of an innovative platform technology;
3) Focus on concepts of personalized therapy and pharmaco-genomics.
Takis’ pipeline of genetic cancer vaccines and antibodies offers opportunities for co-development of our candidates. Our expertise in cancer immunotherapy also provides the basis for collaborations for the development of other vaccines.
We intend to bring our core vaccine candidates through to the completion of Phase Ib proof-of-concept trials. Selected immunotherapy candidates outside our core areas may be out-licensed at an earlier stage of development.
We are also seeking partnerships to support registration trials and market our veterinary vaccines worldwide.
Biopharmaceutical companies with a focus on Cancer and the clinical development of active immunotherapies can contact us to explore potential partnerships.
Takis as Contract Research Organization, provides highly specialized services to Pharma/Biotech companies, such as:
- Engineering of Genetic Vectors, viruses and DNA plasmids;
- Evaluation of the immune response elicited by vaccines and immunomodulators;
- Protein Engineering to enhance expression levels and immunogenicity;
- Generation of monoclonal and polyclonal antibodies through classic immunization and by DNA electroporation;
- Medium scale production of antibodies and quality control;
- Validation of novel biomarkers and set up of diagnostic kits;
- Isolation and characterization of Cancer Stem cells to test new drugs and natural products;
- Combination studies: chemotherapy, immunotherapy, radiotherapy, electrochemotherapy, immune checkpoint inhibitors, immunomodulators;
- In vivo studies in Oncology to test drugs and data elaboration for preparation of IND/IMPD;
- Exploratory PK and PD;
- Immunologic evaluation in large animal models;
- In vivo models of Invasive Aspergillosis;
- Evaluation of drug delivery methods: aerosol, per os, i.d., i.m., i.v.
- Generation and characterization of genetically modified murine models: transgenics, knock-out e knock-in
Our Clients include Novartis, Janssen, Sigma-Tau, Glaxo-SmithKline and Menarini Biotech. Takis’ quality system complies with the standard ISO 9001:2008. Most of Takis’ team has a previous experience in the Pharmaceutical Industry and a considerable expertise in Oncology, Immunology and Infectious diseases. All reagents and instrumentation (equipment for plasmid DNA scale up, purification and characterization, standard and 13 colour FACS, animal facility equipped with imaging instruments and skilled personnel, cell culture facilities, BSL-2 rooms) required for the services we provide are available and in place. Takis also has access to general tools and reagents, constructs and a variety of animal models. The Animal core facility ensures the successful execution of in vivo studies. The Animal House at Takis is capable of accommodating up to 20,000 rodents in standard SPF (Specific Pathogen Free) conditions.
For more information, visit: www.takisbiotech.it