1) How and when did your company start, and where are you located?
TxCell was founded in 2001 as a spin-off from the Institut National de la Santé et de la Recherche Médicale (INSERM). TxCell is located in the South of France in Sophia Antipolis, near Nice.
2) How many employees do you have, and how do you find and attract them?
TxCell has 49 employees as of end April 2016. We recruit technicians, engineers and support staff mostly locally. For scientists, medical, regulatory or business positions, we have to look beyond our region. We are using our network and search firms. We give attractive package and we find many persons interested to relocate in the sunny French Riviera, where we are located.
3) What are the main focus and platform technology(ies) of your company?
TxCell develops innovative, personalized cell immunotherapies using regulatory T-cells (Treg) for severe chronic inflammatory and autoimmune diseases. The Company is developing 2 technology platforms, both based on Treg cells:
TxCell's first platform, ASTrIA (Antigen Specific Treg for Inflammation and Autoimmunity), is composed of autologous antigen specific Type 1 Regulatory T cells (Ag-Treg). Ovasave®, the first drug candidate from the ASTrIA platform, is being developed for refractory Crohn's Disease and in currently in Phase IIb.
TxCell's second platform, ENTrIA (Engineered Treg for Inflammation and Autoimmunity) is composed of Chimeric Antigen Receptor engineered FoxP3+ Regulatory T cells (CAR-Treg).
4) Can you provide a short overview of your product pipeline?
Ovasave®, the first drug candidate from the ASTrIA platform, has been developed for the treatment of Inflammatory Bowel Disease and is composed of ovalbumin-specific Type 1 Treg cells. Ovasave is currently in a European Phase IIb clinical study in moderate to severe refractory Crohn's Disease, entitled CATS29.
Col-Treg, the second drug candidate from the ASTrIA platform, is composed of type-2 Collagen-specific Type 1 Treg cells. Col-Treg is in preclinical development for the treatment of steroid-refractory non-infectious uveitis.
TxCell is also conducting several research programs, both with its first platform ASTrIA and with its second platform ENTrIA. In April 2016, TxCell initiated its first ENTrIA development program in collaboration with the San Raffaele Hospital in Milan, for CAR-Tregs in Lupus Nephritis.
5) Who is your competition, and what advantage(s) do your products / technology offer?
We are a first mover in the space of antigen-specific Treg-based cellular immunotherapy. And we have no real competition as this is a novel field. Actually, we would welcome competition as it would create a larger base of scientific and medical validation!
6) What were the “highlights” in your recent product development?
We have made significant progress toward the resumption of CATS29, our Phase IIb study with our lead drug-candidate, Ovasave, in patients with refractory Crohn's disease. In particular, we successfully concluded the most important milestone in the transfer of our manufacturing technology to MaSTherCell, our European contract manufacturing organization (CMO). MaSTherCell successfully completed the manufacturing of a series of contractually defined validation runs of Ovasave, which are an industry-defined marker of the successful transfer of technology to a CMO. We received the authorization from European regulatory authorities to restart the CATS29 study in May 2016, through the Voluntary Harmonized Procedure (VHP).
In addition, we have made significant progress with our second technology platform, ENTrIA, which is composed of CAR-Tregs. We notably signed a strategic R&D collaboration with Ospedale San Raffaele (OSR), a leading gene and cell therapy institution, for the development of CAR-Tregs in Lupus Nephritis.
7) What have been the most critical problems in developing products in your field, and how can your company's technology help overcome these problems?
Manufacturing is always challenging in the cellular immunotherapy field, but most problems can be overcome technically. We are convinced that manufacturing of cell therapy products will be commoditized within the next 5 to 10 y.
8) What is your company's value proposition?
TxCell is positioning itself as a pioneer and expert in the field of cell immunotherapy based on regulatory T cells. A growing number of companies work in the cell immunotherapy field with effector T cells, which stimulate the immune system and are therefore used to fight cancer. TxCell's positioning in cell immunotherapy is unique. Through regulatory T cells, which control the immune system instead of stimulating it, TxCell targets auto-immunity and inflammation. Auto-immunity and inflammation together represent more than 80 disease types and a global market of over 100 billion dollars per year, with a CAGR of over 5% per year over the next 5 years.
9) What business development strategy do you pursue?
We intend to out-license our technology platforms for large indications, while retaining rights in niche/orphan indications. We expect to be entering into strategic collaborations with both academic institutions and pharma or biotech companies. With pharma/biotech partners, these could start as R&D collaborations with further product opt-in rights.
10) How does your company attract partners?
TxCell has a unique expertise as a pioneer in the regulatory T cells field, supported by a robust patent estate with over 125 issued patents. TxCell also brings to its partners a deep understanding of auto-immune and inflammatory diseases.
11) Who are your most important partners?
TxCell entered into a strategic R&D collaboration with the San Raffaele Hospital in Milan (Ospedale San Raffaele, OSR), one of the most prestigious research institutions in Europe in the field of cell and gene therapy. This collaboration includes a development arm focused on CAR-Tregs for Lupus Nephritis, as well as a research program dedicated to CAR-Treg biology.
12) How do you balance performing work in-house vs out-sourcing?
We like to work both in-house and with external parties. This enables us to focus on our areas of strongest expertise. In areas where we believe an external company or academic institution would bring a stronger expertise than ours, we choose to collaborate or to out-source.
13) What are your product development goals for the next 3 years?
Our objective for the next 3 years is to bring one product per year into clinical development.
For more information visit http://txcell.com