http://www.taigabiotech.com/index.php/site/index/ en info@xigent.com Copyright 2010 2010-10-18T19:41:00-05:00 http://www.taigabiotech.com/index.php/site/investors/ http://www.taigabiotech.com/index.php/site/investors/#When:19:41:00Z Since the company’s founding in 2006, Taiga Biotechnologies has received private seed financing and non-dilutive capital from public and private sources, including multiple SBIR grants. Contact us for more information. Team 2010-10-18T19:41:00-05:00 http://www.taigabiotech.com/index.php/site/platform/ http://www.taigabiotech.com/index.php/site/platform/#When:16:08:00Z The keystone of Taiga Biotechnologies’ proprietary technologies, and the underlying basis for each of the company’s product programs, is Taiga’s platform for the unlimited expansion and purification of undifferentiated hematopoetic stem cells (HSCs) in a laboratory setting.  This technology involves the transduction of primary HSCs with specific genes (or proteins, which are gene products) and their subsequent expansion in culture.  The expanded HSCs are fully functional stem cells, as demonstrated by their ability to repopulate bone-marrow depleted mice with functional cells of all hematopoietic lineages. Taiga’s accomplishment marks the first time that long-term repopulating, self-renewing HSCs have been expanded to such an extent.  Recent attempts in the field by others have succeeded in expanding a more differentiated, short-term HSC.  Platform 2010-10-08T16:08:00-05:00 http://www.taigabiotech.com/index.php/site/management/ http://www.taigabiotech.com/index.php/site/management/#When:19:57:00Z Yosef Refaeli, Ph.D. – Chief Executive Officer, Co-Founder Dr. Refaeli is an expert in the genetic manipulation of cells, regulation of gene expression and transformation in hematopoetic lineages. His research interests focus on three broad area: 1) the contribution of antigen receptor signaling to lymphoid neoplasica; 2) the role of role of proto-oncogenes in the regulation of lymphoid tolerance and disease; and 3) the role of MYC in the regulation of stem cell proliferation, survival, self-renewal and differentiation.  Dr. Refaeli is Associate Professor, Charles C. Gates Program in Regenerative Medicine and Stem Cell Biology, Department of Dermatology, University of Colorado Denver School of Medicine.  He received his Ph.D. from Harvard University and his A.B. degree from the University of Pennsylvania. Brian Turner, Ph.D., M.H.S. – President and Chief Scientific Officer, Co-Founder Dr.  Turner has extensive experience in the areas of molecular biology and genetics, biochemistry and the genetic manipulation of viruses and various hematopoietic cell types, including stem cells, mature lymphoid and myeloid cells. In addition to his role at Taiga, Dr. Turner is Research Instructor, Charles C. Gates Program in Regenerative Medicine and Stem Cell Biology, Department of Dermatology, University of Colorado Denver School of Medicine.  He received his Ph.D. from the University of Colorado Health Sciences Center, holds a Masters in Public Health from the Johns Hopkins School of Public Health and received his A.B. degree from Cornell University. Gregory Bird, Ph.D. – Director Molecular Biology Dr. Bird is coordinating the basic science and genetic engineering of the blood stem cells used to generate human antibodies.  Prior to joining Taiga Biotechnologies, Dr. Bird spent eight years as a scientist at biotechnology companies Cytokine Sciences and Sangamo BioSciences. He received his Ph.D. from the University of Colorado Health Sciences Center and his B.A. from the University of Colorado, Boulder. James Posada, Ph.D., MBA – Business Advisor Dr. Posada is currently CEO and Co-founder of Resolve Therapeutics, LLC, a Seattle-based private biotechnology company developing a novel biologic compound for the treatment of lupus. Dr. Posada is also the owner of Posada & Associates, Inc. a consulting practice focused on assisting biotechnology clients with business strategy and partnering. Dr. Posada’s previous industry experience includes Chief Business Officer at GlycoFi, Senior Director of Business Development at PDL BioPharma, and Manager of Biotechnology R&D at Eli Lilly and Company. He received his Ph.D. from the University of Vermont College of Medicine, holds a Masters in Business Administration from the University of Vermont and received his B.S. from Eastern Connecticut State University. Team 2010-09-21T19:57:00-05:00 http://www.taigabiotech.com/index.php/site/red_blood_cell_pharming/ http://www.taigabiotech.com/index.php/site/red_blood_cell_pharming/#When:18:52:00Z Taiga Biotechnologies is currently developing technologies to meet the challenges of generating red blood cells (RBCs) for clinical applications.  Using its proprietary hematopoetic stem cell technology the company has adapted culture conditions to generate functional RBCs in a simple two-step process without the need for viruses, animal serum, or animal “feeder” cells. Taiga believes its approach has the potential to provide a supply of RBCs that is safe, effective and universally applicable to all patients requiring RBC transfusion. Red blood cell (RBC) transfusion is routinely used for many clinical and surgical applications. On average, 39,000 units of blood are needed every day and data from 2004 indicate that 29 million units of blood were transfused in one year (source http://www.aabb.com).  This procedure has singe-handedly saved many lives over the past 60 years, and demand continues to increase with advances in medical treatments and an aging population. In spite of the wide range of clinical applications that have benefited from RBC transfusion, the supply has steadily decreased for three main reasons. First, the number of infectious agents that have been shown to be transmitted through blood transfusions have continuously increased, forcing more extensive testing of the donated supply to prevent iatrogenic infections. Second, the chronic use of Erythropoeitin (Epo) has recently been associated with increased risk of developing erythroid leukemias, embolisms as well as cardiac complications. Third, the performance of stabilized and recombinant hemoglobins and oxygen transporters (perflourocarbons) has been disappointing and these approaches will have to overcome important development hurdles before replacing RBC transfusions in the clinic. Taiga is developing a novel method that uses its conditionally-transformed long-term repopulating hematopoietic stem cells as the source of a continuous and defined supply for the production of RBCs. This technology can either provide mature RBCs for immediate transfusion or RBC progenitors for transfer and short-term reconstitution of the RBC compartment in patients. Furthermore, the enucleation of mature RBCs should alleviate concerns of any genetic modification. One of the company’s ultimate goals for this project is to engineer a RBC product having a sufficiently longer shelf life to enable its distant transport to patients who don’t have access to RBC therapy currently. Ready access to a continuous supply of RBC progenitors that could generate a defined RBC product for transfusion would alter clinical practice and render blood transfusion a safer and more extensively used procedure. Products 2010-09-21T18:52:00-05:00 http://www.taigabiotech.com/index.php/site/vaccine_adjuvants/ http://www.taigabiotech.com/index.php/site/vaccine_adjuvants/#When:18:23:01Z Taiga Biotechnologies’ expertise in the regulation of cytokine-dependent responses in lymphocytes and the regulation of immune function has enabled the company to pursue a novel approach to molecular advjuvants for use in improved vaccines against viral diseases and cancers. The operative principle for Taiga’s adjuvant is the transient relaxing of what is termed “immunological tolerance,” (a mechanism that prevents the immune system from targeting the host) thus allowing the development of antibodies to targets that are normally hidden from the antibody response. Taiga’s initial focus includes the use of this technology for improved vaccines against influenza and other viruses and with vaccines to combat cancers such as melanoma and leukemia. An important challenge in vaccine design involves the selection of targets that are readily accessible to the immune system. For antiviral vaccines, a majority of such targets are highly variable and unless a vaccine can overcome this diversity, the virus can simply change its expression patterns, thus limiting vaccine effectiveness. Similarly, in cancers like melanoma, the specific challenges to vaccine design include the selection of antigens that are required for tumor cell maintenance as well as the ability for the immune system to respond to self-antigens expressed by the tumor cells. Taiga has developed a proprietary molecular antigen TBI4000 that, in animal models, improves the response to antiviral or anti-melanoma vaccines through the simultaneous enhancement of immune function and the transient modulation of self-tolerance. Based on the transient modulation of specific growth gene(s) in lymphoid cells, Taiga’s TBI4000 adjuvant appears to accelerate vaccine responses, generate cross-reactive antibodies, and allow significant (100X) “dose-sparing”. Products 2010-09-21T18:23:01-05:00 http://www.taigabiotech.com/index.php/site/therapeutic_monoclonal_antibodies/ http://www.taigabiotech.com/index.php/site/therapeutic_monoclonal_antibodies/#When:19:01:00Z Taiga Biotechnologies has developed a novel method of generating fully human monoclonal antibodies (MAbs) based on its proprietary platform for conditionally immortalized human HSCs. Taiga believes its approach can overcome existing obstacles to efficient antibody discovery and development and recognize antigenic specificities that would normally be difficult to generate with current technologies. Taiga’s approach can also generate antibodies 3-4 times faster than current antibody production methods, potentially making it suitable for the rapid generation of antibodies for emerging infectious diseases. In recent years, monoclonal antibody (MAb) therapeutics have emerged as highly successful treatments for cancer and other illnesses. MAbs work by binding to the cancer cell or pathogen and targeting it for destruction, or by blocking the binding of viral surface proteins to cellular receptors. Despite the success of antibody therapies in the clinic, the overall approach and ability to apply MAb therapies to many diseases is limited by the difficulty in generating antibodies to certain protein targets. The difficulty arises because those proteins do not elicit an efficient reaction by the immune system due to a phenomenon called immune dominance. Traditional methods for generating MAbs limit the possible target specificity at several stages: Certain regulatory mechanisms prevent antibody formation against the host’s “self” proteins. Development of an antibody-producing cell line requires that the B cell of interest reside in a specific point of growth to “fuse” with another cell. Cell line development and humanization constraints.  Even if an antibody can be generated against a specific target, producing a therapeutic product can take years because of the extensive testing required to identify the one cell that makes the antibody of interest and the elaborate process of changing a mouse antibody into a human antibody. Taiga’s scientific team discovered that they could force mice to generate antibodies to a “self” target (“auto-antibodies”) by over-expressing a particular growth gene in antibody-producing B cells that are derived from the proprietary stem cell lines. In doing so, responsive B-cells overcome regulatory mechanisms that normally prevent antibody formation against the host’s “self” proteins, become activated, and produce copious amounts of auto-antibodies. Such mice also developed B-cell tumors that Taiga can grow in the laboratory for many months, suggesting that the company has overcome the challenge of developing an antibody cell line by having to “fuse” an antibody-producing with another cell. Recently, Taiga has refined its method of generating antibodies to generate specific human antibodies in 6-8 weeks.  In theory, the company believes it could generate antibodies against new targets in a very short amount of time, bypassing the extensive testing required to identify the one cell that makes the antibody of interest and the elaborate process involved in engineering a mouse antibody into a human antibody. Using this technology, Taiga believes it can develop antibodies against any conceivable target for clinical applications in a variety of disease indications. The company’s ability to quickly generate specific antibodies without the need and problems related to humanizing antibodies makes Taiga’s approach unique in the field of MAb production. Products 2010-09-20T19:01:00-05:00 http://www.taigabiotech.com/index.php/site/intellectual_property/ http://www.taigabiotech.com/index.php/site/intellectual_property/#When:20:17:00Z The co-founders have developed several pieces of intellectual property in their academic institutions (UCHSC and NJMRC). The co-founders are the co-inventors on the various patents that have been filed to protect the intellectual property that describes the key technologies upon which Taiga Biotechnologies was founded. NJMRC and UCHSC have filed a broad set of patents in the U.S. and more broadly through the patent cooperation treaty covering the technologies developed by Taiga’s co-founders. Taiga maintains exclusive global licenses to all IP associated with the stem cell technology, the novel antibody technologies and small molecule screening platforms. Investor Relations, Team 2007-11-27T20:17:00-05:00 http://www.taigabiotech.com/index.php/site/medical_needs/ http://www.taigabiotech.com/index.php/site/medical_needs/#When:20:05:00Z With the triad of the Stem cell product, Therapeutic Antibodies and Small Molecules, Taiga will initially focus on the markets for cancer therapeutics. The cancer market has grown at double-digit rates for the past 5 years, driven by the growth in new innovative and targeted therapies. By focusing initially on blood cancer therapeutics, Taiga will address a subset of the overall global cancer market. Stem cell transplant The unmet medical need for stem cell transplantation in each specific hematology indication is presented in Table 1. We have also assumed that the number of transplants per year in the U.S. will remain stable in the next 10 years and will not grow or decline significantly. In fact, if we're successful with our Universal stem cell product, we expect an increase in the number of transplants in these indications due to the future use of transplant in patients who today aren’t eligible due to lack of a matching donor. Therapeutic Antibodies The dynamics of the antibody market are highly attractive for innovative small companies such as Taiga. Significant unmet needs remain in infectious disease and nearly all cancer indications; regulatory pathways involving accelerated approval can be achieved for innovative therapeutics that demonstrate meaningful early clinical results; the sales and marketing organizations required to launch and market new therapeutics are small relative to other therapeutic areas and are therefore feasible for small companies to build; and the pricing environment remains very attractive for products that genuinely improve on current standards of care. Table 1: Annual U.S. market potential for Taiga’s stem cell product, by tumor (Taiga estimate)   Annual Transplants Acute lymphocytic leukemia (ALL) 2,837 Acute myeloid leukemia (AML) 4,621 Chronic myeloid leukemia (CML) 2,475 Hodgkin’s disease 5,030 Non-Hodgkin’s lymphoma 13,124 Multiple myeloma 2,978 Total   31,065 The use of antibody therapy for the treatment of disease has drawn approval by the Food and Drug Administration (FDA). Over the past 10 years or so, the US FDA has approved several monoclonal antibodies for the treatment of certain cancers (source: American Cancer Society). Small molecule therapEutics As with antibody therapeutics the dynamics of the small molecule therapeutics market are highly attractive to small companies such as Taiga. Major unmet medical needs remain in nearly all blood cancer indications. Accelerated and subsidized regulatory pathways to approval can be achieved for novel therapeutics that demonstrate promising early clinical results. Also, as with antibody therapeutics, the sales and marketing organizations required to launch and market new treatments are feasible for small companies with or without large pharmaceutical partnerships and the pricing environment remains very attractive for products that genuinely improve on current standards of care. Taiga's initial indication for its three small molecule candidates is AML (Acute Myelogenous Leukemia), which represents an even larger potential market than CML (13,410 new cases of AML are expected to be diagnosed in 2007 in the United States vs. 4,570 new cases of CML-source: Leukemia and Lymphoma Society). Investor Relations 2007-11-27T20:05:00-05:00 http://www.taigabiotech.com/index.php/site/cell_therapy/ http://www.taigabiotech.com/index.php/site/cell_therapy/#When:19:27:00Z Overview Stem-cell therapeutics and red blood cell production for the treatment of hematological malignancies via hematopoietic stem cell transplant or any medical procedure requiring red blood cell transfusion. A stem cell is an extraordinary type of cell that has the ability to self-renew over time and can also give rise to all of the different cell types present in blood. Development and testing of our long-term hematopoietic stem cells has demonstrated the effectiveness of these cells in treatment of a variety of cancers in animal models. Transitioning into the clinical setting, the lead indications for this program include acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and chronic myeloid leukemia (CML). Taiga is also leveraging its patented stem cell technology to develop a safer and more efficient method to produce large amounts of red blood cells for medical use. THE HEMATOPOIETIC STEM CELL (HSC) TRANSPLANTATION OPPORTUNITY Table 1: Estimated U.S. HSC transplants by cancer type, 2006 (Source: DaVinci Oncology Specialists)   2006 Transplants Acute lymphocytic leukemia (ALL) 2,837 Acute myeloid leukemia (AML) 4,621 Chronic myeloid leukemia (CML) 2,475 Hodgkin’s disease 5,030 Non-Hodgkin’s lymphoma 13,124 Multiple myeloma 2,978 Total   31,065 HSC transplants have been performed by physicians for decades to treat a variety of deadly diseases, in particular cancer. Patients are initially treated with high dose chemotherapy drugs that ablate existing bone marrow cells, including HSCs. The subsequent treatment of these patients with healthy HSCs restores the patient’s hematopoietic system. The success of HSC transplant in specific cancers has led to significant use. As described in Table 1, >30,000 HSC transplants were performed in the U.S. in 2006 among leukemia and lymphoma patients alone. Though HSC transplantation has become a successful approach and is standard of care for many cancers, the technology currently employed in HSC transplantation has not been adapted to address the significant problems associated with the procedure that limit both its effectiveness and the breadth of its use. The specific technical hurdles limiting the use and the effectiveness of HSC transplant are: Cell numbers. Obtaining a sufficient number of HSCs to ensure successful engraftment of the HSC transplant. Often the optimal number of cells needed for an adult HSC transplant is not available and results in a failure to engraft. Ensuring sufficient cell numbers in HSC transplant for cancer indications has significant clinical benefits, including increased survival, improved bone marrow function, and a lower incidence of subsequent Myelodysplastic Syndrome. Cases that require multiple rounds of bone marrow (HSC) transplantation pose a particularly difficult challenge, in terms of procuring a sufficient number of stem cells. Cell purity. Achieving sufficient cell purity to allow HSC transplant into non-matched transplant recipients. Because HSCs harvested from either bone marrow or peripheral blood are contaminated with donor immune cells, HSC transplants are only successful when the donor and recipient are matched (histocompatible). Obtaining pure HSCs allows the transfer of donor cells into ANY recipient. Taiga has proprietary solutions to the two key technical hurdles associated with HSC transplantation that provide the opportunity to fundamentally transform the therapy of many life-threatening cancers. TAIGA’S SOLUTION FOR HSC TRANSPLANTATION Taiga has addressed the technical hurdles associated with HSC transplant by developing patented technologies that allow for the unlimited expansion and purification of undifferentiated HSCs ex vivo. The expanded HSCs are fully functional stem cells, as demonstrated by their ability to repopulate bone-marrow depleted mice with functional cells of all hematopoietic lineages. This is the first time that long-term repopulating, self-renewing HSCs have been expanded to such an extent. Using these technologies, Taiga’s goal is to develop a single Universal HSC product for broad use in HSC transplant. A universal product would have several critical benefits over current approaches that would make it an attractive therapy for use in the clinic: Removes the need for donor / recipient histocompatibility, greatly expanding the population of patients eligible for HSC transplant. Creates a single standard for the preparation and transfer of donor HSC cells (current protocols for HSC harvest and preparation vary widely and perform inconsistently in practice). RED BLOOD CELL DEMAND AND OPPORTUNITY Transfusion of red blood cells (RBC) is commonly needed in many clinical and surgical practices. On average, 39,000 units of blood are needed every day and data from 2004 indicate that 29 million units of blood were transfused in one year (source http://www.aabb.com). This procedure has singe-handedly saved many lives over the past 60+ years, and demand continues to increase with advances in medical treatments and an aging population, but is increasingly difficult to provide for the following reasons: The supply of blood components available from transfusion has steadily decreased over the past number of years, and will continue to do so, with more complex and thorough diagnostic testing for blood borne infectious diseases. The performance of stabilized and recombinant hemoglobins and oxygen transporters (perflourocarbons) has been disappointing and these approaches will have to overcome important development hurdles before replacing RBC transfusion in the clinic. Increasing reports of potential unwanted side-effects of long-term exposure to recombinant erythropoietin (EPO) suggest that additional studies of this widely used product may be warranted. While some initial attempts have been made to derive RBCs from hematopoietic stem cells in vitro (bone marrow, cord blood and peripheral blood), they are expensive and labor intensive, and suffer from the absence of a defined and continuous supply of RBC progenitor cells. Ready access to a continuous supply of RBC progenitors that could generate a defined RBC product for transfusion would alter the practice in the clinics and render blood transfusion a safer and more extensively used procedure. TAIGA'S SOLUTION FOR RBC PRODUCTION Taiga is currently developing a novel method that uses our conditionally-transformed long-term repopulating hematopoietic stem cells as the source of a continuous and defined supply for the production of RBCs. This technology can either provide mature RBCs for immediate transfusion, or RBC progenitors for transfer and short-term reconstitution of the RBC compartment in patients. Furthermore, the enucleation of mature RBCs should alleviate concerns of any genetic modification. One of our ultimate goals for this project is to engineer a RBC product that has a longer shelf life that would enable far enough transport to reach patients who don’t have access to red blood cell therapy currently. Products 2007-11-27T19:27:00-05:00 http://www.taigabiotech.com/index.php/site/biologics/ http://www.taigabiotech.com/index.php/site/biologics/#When:19:25:00Z Overview Biologics are therapeutics whose mode of action is based on naturally occuring interactions within living animals. Therapeutic antibodies. Taiga has also developed an innovative method for rapidly generating monoclonal antibodies for treating cancer and infectious disease. Monoclonal antibodies work in the same way natural antibodies work, by identifying and binding to a specific target in the body. They then alert other cells in the immune system to eliminate the antibody bound substance. Development of fully humanized antibodies for the treatment of disease has become a primary focus of Taiga. THERAPEUTIC ANTIBODY OPPORTUNITY In recent years, the clinical application of Monoclonal Antibodies (MoAbs) has emerged as a major new source of drugs for cancer therapy. Monoclonal antibodies are naturally occurring proteins of the immune system that attack foreign substances in the body and can be grown and purified in a laboratory setting. As a cancer therapy, once the antibody binds its receptors, it marks the cancer cells as targets of the immune system. Despite the success of antibody therapies in the clinic, the overall approach is limited by the difficulty in generating antibodies to certain protein targets. These limitations include the physiological processes that keep the immune system from making antibodies that recognize proteins from the body (self-proteins), as well as the requirement to be able to fuse an antibody-making cell with a myeloma cell line in order to generate large amounts of the specific antibody. These problems specifically impact on our ability to generate novel antibodies that specifically recognize proteins expressed by tumor cells. We have developed a novel method to generate monoclonal antibodies to any protein we would like, without regard to the limitations involved by tolerance to self-proteins. We have also overcome the need to fuse the antibody-producing cells with a myeloma cell line in order to enable us to produce large amounts of a specific antibody. Limitations of current technology: Specificity. Traditional methods used to make MoAbs limit the possible target specificity at several stages. The ability to make an antibody against just any target is limited by regulatory mechanisms that prevent antibody formation against the host’s "self" proteins. The process of generating an antibody-producing cell line requires that the antibody cell reside in a specific point of growth to "fuse" with another cell. These two steps are likely to reduce the number of possible target specificities represented at the end of the process by approximately 90%. Time. If an antibody can be generated against a specific target, producing a therapeutic product can take years because: Extensive testing is required to identify the one cell that makes the antibody of interest. The elaborate process of changing a mouse antibody into a human antibody. This is also the main source of unforeseen complications that have derailed several clinical trials. TAIGA'S SOLUTION FOR THERAPEUTIC ANTIBODY PRODUCTION We have developed a novel method of generating MoAbs that is able to overcome both obstacles and recognize antigenic specificities that would normally be difficult to generate with current technologies. This can be achieved 3-4 times faster than current technologies, which would also enable us to use this approach for the rapid generation of antibodies for emerging infectious diseases. We discovered that we could force mice to generate antibodies to a "self" target (which are called "autoantibodies") by over-expressing a particular gene in our proprietary stem cells. The progeny cells, called B-cells, become activated and produce copious amounts of autoantibody as a result of their ability to overcome the regulatory mechanisms that normally prevent antibody formation against the host's "self" proteins. Using this technology, Taiga has the opportunity to develop antibodies against any conceivable target for clinical applications in a variety of indications. Our ability to quickly generate specific antibodies without the need, and problems related to, humanizing antibodies makes our approach unique in the field Products 2007-11-27T19:25:00-05:00