ActiTrexx GmbH Company Profile

Background

ActiTrexx GmbH, established in 2020 as a spin-off from the University Medical Center Mainz, is a biotechnology company dedicated to developing innovative cell therapies aimed at restoring immune tolerance in patients with autoimmune and autoinflammatory diseases. The company's mission is to address the root causes of these conditions by leveraging activated regulatory T cells (Tregs) to modulate the immune system effectively. ActiTrexx's work is particularly significant in the field of transplant medicine, where it seeks to prevent complications such as Graft-versus-Host Disease (GvHD) following allogeneic hematopoietic stem cell transplantation.

Key Strategic Focus

ActiTrexx's strategic focus centers on the development of its lead product, Actileucel, an allogeneic Treg therapy designed to prevent and treat GvHD. This therapy utilizes activated regulatory T cells from unmatched third-party donors, offering a universal treatment option without the need for tissue matching. The company's proprietary activation process enhances the suppressive capabilities of Tregs, aiming to rebalance the immune system and provide curative treatments for conditions with high unmet medical needs.

Financials and Funding

In March 2021, ActiTrexx secured €3.5 million in Series A financing. The funding round was led by LBBW Venture Capital GmbH, with participation from MediVentures GmbH, High-Tech Gründerfonds (HTGF), and Investitions- und Strukturbank Rheinland-Pfalz (ISB). These funds are intended to optimize and clinically test Actileucel, particularly focusing on its application in preventing GvHD in leukemia patients undergoing stem cell transplantation.

Pipeline Development

ActiTrexx's lead product, Actileucel, is currently undergoing a Phase Ib/II clinical trial to evaluate its safety, feasibility, and efficacy in preventing GvHD. The study involves ten leukemia patients who have recently received blood stem cell transplants. These patients are treated early after transplantation in three cohorts with increasing doses of Actileucel, followed by a six-month follow-up period. The primary endpoint is to assess the safety and tolerability of Actileucel, while secondary endpoints include evaluating the frequency and severity of GvHD and the feasibility of Actileucel manufacturing. The trial is being conducted at two sites in Germany: the III. Medical Clinic of the University Medical Center Mainz and the University Hospital Carl Gustav Carus in Dresden.

Technological Platform and Innovation

ActiTrexx's innovation lies in its proprietary process for activating regulatory T cells ex vivo. This method significantly enhances the suppressive function of Tregs, enabling them to effectively modulate the immune response. Unlike traditional approaches that require tissue matching, Actileucel's allogeneic nature allows it to be derived from any healthy third-party donor, streamlining the manufacturing process and broadening its applicability. The company's technology aims to provide a curative treatment by addressing the underlying immune dysregulation in autoimmune and autoinflammatory diseases.

Leadership Team

Prof. Dr. Andrea Tüttenberg, CEO: Co-founder of ActiTrexx, Prof. Tüttenberg brings extensive experience from her tenure at the University Medical Center Mainz, where she has been instrumental in advancing cell therapy research.

Dr. Helmut Jonuleit, CSO: As Chief Scientific Officer and co-founder, Dr. Jonuleit has a robust background in immunology and cell therapy, contributing significantly to the development of ActiTrexx's proprietary Treg activation process.

Michael Kring, CFO: Serving as Chief Financial Officer, Michael Kring oversees the company's financial strategy and operations, ensuring fiscal responsibility and supporting ActiTrexx's growth objectives.

Competitor Profile

Market Insights and Dynamics

The market for cell therapies targeting autoimmune and autoinflammatory diseases is expanding, driven by the increasing prevalence of these conditions and the demand for more effective treatments. The global GvHD treatment market, in particular, is projected to grow significantly, reflecting the urgent need for innovative therapies that can improve patient outcomes and quality of life.

Competitor Analysis

Key competitors in the field include companies developing Treg-based therapies and other cell-based immunomodulatory treatments. While specific competitors are not detailed in the available information, the landscape is characterized by a focus on enhancing the efficacy and safety of cell therapies, reducing manufacturing complexities, and expanding the applicability of these treatments across various autoimmune and autoinflammatory conditions.

Strategic Collaborations and Partnerships

ActiTrexx collaborates with leading medical institutions, including the University Medical Center Mainz and the University Hospital Carl Gustav Carus in Dresden, to conduct clinical trials and advance the development of Actileucel. These partnerships are crucial for validating the safety and efficacy of the therapy and for facilitating its eventual integration into clinical practice.

Operational Insights

ActiTrexx's competitive advantage lies in its proprietary Treg activation technology, which enables the use of allogeneic cells from unmatched donors, simplifying the manufacturing process and broadening the potential patient population. This approach positions the company favorably against competitors that may require autologous cells or complex matching procedures.

Strategic Opportunities and Future Directions

Looking ahead, ActiTrexx aims to expand the application of its activated Treg technology beyond GvHD to other autoimmune and autoinflammatory diseases with high unmet medical needs. The company's focus on developing curative treatments that restore immune tolerance aligns with the broader industry trend toward personalized and regenerative medicine. Continued clinical validation and strategic partnerships will be key to achieving these objectives.