PolTREG S.A., a leader in cell therapies based on T-regulatory lymphocytes (TREG), is expanding its cGMP capabilities with the announcement of the completion of the first stage investment and its Research and Development Center for the development and production of current and next generation TREG drugs for innovative therapies in autoimmune diseases.

Ultimately, the company will have 2,100 sq m. of laboratory space and 15 production lines, with a maximum throughput of up to 700 batches of therapy per year. PolTREG S.A. new manufacturing facility will be one of the most modern plants in Europe for the production of cell therapies.

Currently, PolTREG is in the process of installing laboratory equipment and obtaining relevant decisions and consents, including GMP (Good Manufacturing Practice) certification, from the Main Pharmaceutical Inspectorate and the National Center for Tissue and Cell Banking issued for a new manufacturing site for the production of TREG as ATMP (advanced therapy medicinal product). Which will enable the Company to produce its own cell therapies for the purposes of clinical trials and offering therapies under the hospital exception procedure, and will allow it to conduct research and development work on next generations of innovative therapies for autoimmune diseases

The production of cell and gene therapies is complex, therefore the strategic value of our facility is very high for several reasons. Having a modern and scalable facility will enable us to produce our own therapies on a larger scale, which, combined with our current and future clinical programs portfolio constitute a complete set of R&D and manufacturing assets for the development of cell therapies for autoimmune diseases. We believe that these factors will have a positive impact on the process of commercialization of our technology, which, according to the assumptions, we will intensify in the coming monthssaid prof. Piotr Trzonkowski, CEO and co-founder of PolTREG S.A.

At the same time, the second stage of investment in this new manufacturing plant for the production of cell therapies as part of the project “Implementation on the market and dissemination in Poland of an innovative method of treating type 1 diabetes by purchasing infrastructure for culturing T-regulatory cells” is under implementation.

A few days ago, PolTREG concluded a cooperation agreement with IQVIA, a leading global supplier of advanced analytical solutions, technological solutions and clinical trials for the life science industry. The company also concluded the first agreement for conducting market analyses and forecasts and for preparing materials confirming the strategic value and advantages of products developed by PolTREG, which will support its global Business Development and Alliance Management activities lead by PolTREG’s new Chief Business Development Officer also hired a few weeks ago, in negotiations with industry partners. As part of the cooperation, IQVIA will identify opportunities to establish strategic partnerships with global pharmaceutical companies.

Establishing cooperation with IQVIA is part of the Company’s strategy, whose elements supporting the conclusion of the partnering agreement are: development of an analytical report estimating the commercial potential of the developed therapies, building a registration path with the FDA and building an Advisory Board composed of global Key Opinion Leaders. In recent quarters, a visible increase in interest in cell therapies has been observed on the global market.

This is confirmed by several partnering transactions. In January, TRex Bio licensed-out to Eli Lilly three preclinical projects. TRex Bio will receive a $55 million upfront payment, up to $1.1 billion in milestone payments and sales royalties payments. Regeneron has partnered with Sonoma Biotherapeutics to develop TREG therapy in autoimmunity. The value of upfront payments amounted to USD 75 million and the value of potential milestones is USD 45 million. In June, Quell Therapeutics signed a collaboration and licensing agreement with AstraZeneca to develop, manufacture and commercialize modified TREG cell therapies for autoimmune diseases. Quell will receive $85 million in upfront payments and is eligible to receive more than $2 billion for further development and commercialization as well as royalties from potential sales.