Right Patient. Right Therapy. Right Now.
4TEEN4 Pharmaceuticals is a German biopharmaceutical company, focused on developing innovative therapies for critical care.
Their flagship product, invobenitug (procizumab, AK1967), is a first-in-class antibody therapy designed to treat life-threatening shock (e.g., cardiogenic and septic shock) by blocking the harmful effects of the biomarker cDPP3.
4TEEN4 approached Abingdon Health to develop a companion diagnostic (CDx), DPP3 InvoSelect, in parallel with their clinical program, aiming to identify patients most likely to benefit from this targeted therapy.
Challenges
- Unmet Medical Need: Currently, there is no approved therapy targeting cDPP3 in shock, making rapid and accurate patient identification critical.
- Biomarker Complexity: cDPP3 serves as a therapeutic target and a biomarker. Not all patients in shock are eligible for treatment with invobenitug (procizumab, AK1967); only those exceeding a specific cDPP3 threshold are likely to benefit. This necessitates a highly sensitive and specific diagnostic tool. DPP3 is a biomarker with dual functionality, serving as both a predictive and a prognostic marker. While the CDx project is primarily focused on its predictive use, we aim to leverage the synergy between these roles to support future development of DPP3 as a prognostic marker as well.
- Urgency of Diagnosis: Shock is a life-threatening condition that demands immediate intervention. To ensure timely identification of eligible patients, a point-of-care solution is essential. Such a solution should be easy to use, deliver rapid results, and provide clear, straightforward interpretations to support swift clinical decision-making.
- Flexibility of Environment: Shock is a heterogeneous disease, and hospital workflows differ widely across institutions. This variability presents a significant challenge: any diagnostic test must be adaptable enough to function effectively in both the ICU and the hospital laboratory.
- Manufacturing Considerations: As this test is intended for a global market, there is an expectation for high demand and large-scale distribution. Therefore, the test must be designed with scalability in mind, ensuring consistent quality.
- Regulatory Considerations: 4TEEN4 is a biotech company with a Quality Management System (QMS) designed for GxP oversight. In this project, the drug is leading in terms of protocol development and regulatory strategy. Accordingly, the development of the companion diagnostic must be closely aligned with the drug development.
- Timeline: The timeline for this project is dictated by the drug development and is not flexible. Given the high unmet medical need, the objective is to bring both the drug and companion diagnostic to market as quickly as possible in order to save lives.
Solution
4TEEN4 has established a clear strategy to bring its drug to market efficiently. Abingdon Health acts as the legal manufacturer of the CDx, ensuring full compliance with regulatory requirements and facilitating timely market entry. Our collaboration is exceptionally close and structured, enabling seamless synchronization between drug development and CDx development.
A key focus is maintaining aligned communication with regulatory agencies, even when national agencies operate separately. Both Abingdon Health and 4TEEN4 bring strong project management and scientific expertise to the implementation, ensuring robust execution at every stage.
The CDx system, DPP3 InvoSelect, features a reader for DPP3 quantification, offering a customized display that provides clear and unambiguous results. The lateral flow assay (LFA) is scalable and easy to use, allowing rapid diagnostic results in any environment, whether in the ICU or the hospital laboratory, without additional workload for healthcare personnel.
We actively engage with regulatory agencies for technical advice throughout the process. Key opinion leaders (KOLs) from 4TEEN4 have been involved from the start of the CDx development, ensuring alignment with clinical needs and expectations.
In parallel, development is underway to establish DPP3 as a prognostic marker, leveraging strong synergies with the DPP3 InvoSelect project while tailoring progress to the specific requirements of prognostic applications.
Results & Impact
The primary aim of this project is to bring a lateral flow CDx to market in parallel with the drug, ensuring both are available as quickly as possible to address urgent clinical needs. This integrated CDx and drug co-development approach is designed to meet the expectations of KOLs, hospital staff, and most importantly to improve patient outcomes and save lives.
4TEEN4’s product is engineered to be easy to use, scalable for widespread adoption, and scientifically robust to ensure accurate results. 4TEEN4 has recently signed off on the critical milestone of design freeze, having already engaged with regulatory agencies and preparing for further interactions. In parallel with the ongoing design work, 4TEEN4 is preparing the performance evaluation, which will be conducted alongside the pivotal clinical trial.
“The technical expertise and regulatory support provided by Abingdon Health have been invaluable in advancing our companion diagnostic project. Their commitment and collaborative approach have brought us significantly closer to delivering a life-saving therapy for patients in critical shock.”
- Head of CDx, 4TEEN4 Pharmaceuticals
Chris Yates, Co-Founder & CCO at Abingdon Health had this to say:
“We’re honoured that 4TEEN4 chose Abingdon Health to provide comprehensive CDMO and regulatory support in this complex project, which is at the forefront of companion diagnostics, providing an effective diagnostic device to work alongside 4TEEN4’s critically important cDPP3 therapy in an area of significant unmet need.”
Why 4TEEN Chose Abingdon Health
Abingdon Health stood out among numerous applicants for the role as legal manufacturer for our CDx development, having successfully passed our rigorous, controlled vendor selection process. They offer all the essential qualities and capabilities for success under one roof. Abingdon Health provides a complete package including regulatory support, technical expertise, commitment, and manufacturing. Their integrated approach combines everything 4TEEN4 expects from a professional CDMO, enabling us to run this project successfully and in full alignment with our drug development strategy.
