The Department of Clinical and Molecular Medicine of Sapienza University of Rome, Takis and Tethis start a collaboration to advance HER3-targeted therapies and diagnostics

ROME and MILAN, Oct. 3, 2025 /PRNewswire/ -- The Department of Clinical and Molecular Medicine of Sapienza University of Rome (DMCM), Takis S.r.l. and Tethis S.p.A. today announce a joint initiative, to accelerate research on HER3-targeted therapies and advance the development of companion diagnostics for lung cancer patients.

Within the framework of the HERCART project, funded by the Italian Ministry of Enterprises and Made in Italy, Takis and DMCM are developing innovative antibody-based therapies, including a bispecific T-cell engager based on Rever3mAb, which binds the HER3 receptor. In parallel, DMCM has signed a service agreement with Tethis to implement a liquid biopsy analysis with Tethis' proprietary See.d^® instrument and SmartBioSurface^® slides to detect HER3-positive circulating tumor cells (CTCs).

Following a successful proof-of-concept using model cells, the collaboration now moves into a clinical phase. Blood samples from lung cancer patients will be collected at Sant'Andrea Hospital in Rome and processed at DMCM where Tethis' See.d instrument has been installed. The instrument will produce cytology slides containing cells, including CTCs. These slides will then be sent to Tethis, where they will be stained with Takis' HER3-specific antibody, enabling the identification of HER3-positive CTCs. This combined effort represents a crucial step toward developing both HER3-targeted therapies and non-invasive companion diagnostics to select patients most likely to benefit from HER3-targeted treatment, advancing the promise of personalized medicine.

"The bispecific T-cell engager developed by Takis redirects T cells to kill tumor cells that overexpress the HER3 receptor," said Giuseppe Roscilli, CTO of Takis. "Innovation in cancer therapeutics and diagnostics must go hand in hand—new therapies require relevant diagnostics for patient selection, while diagnostics only gain value when they guide treatment choices."

"Our See.d instrument automates the preparation of cytology slides without bias - avoiding cell selection based on morphology or marker expression," said Holger Neecke, CEO of Tethis. "By capturing cells comprehensively, this approach not only ensures more representative detection of circulating tumor cells but also holds significant potential for developing companion diagnostics especially for drugs targeting specific protein biomarkers."

"Detecting and characterizing HER3-positive cells in blood samples from lung cancer patients could lay the groundwork for developing new therapeutic solutions such as antibodies, antibody-drug conjugates, and CAR-T therapies that target HER3 as a specific molecular target," said Claudia De Vitis, Researcher, Department of Clinical and Molecular Medicine, Sapienza University of Rome.

" This collaboration between an academic center, a hospital, a biotech company and a diagnostic company demonstrates how combining cutting-edge research with technological innovation can accelerate the development of targeted therapies and companion diagnostics for precision oncology for the benefit of patients. " said Rita Mancini, Full Professor, Department of Clinical and Molecular Medicine, Sapienza University of Rome.

The See.d^® instrument and SmartBioSurface^® slides are for Research Use Only and are not intended for use in diagnostic procedures.

About the Department of Clinical and Molecular Medicine of Sapienza University of Rome

The Department of Clinical and Molecular Medicine (https://dmcm.web.uniroma1.it/it/english), established on 10 April 2009 (Rectoral Decree No. 167 of 2009), operates at the Sant'Andrea University Hospital in Rome and brings together professors from the Faculty of Medicine and Psychology with the primary objective of promoting and coordinating translational and multidisciplinary research activities. The affiliated professors belong to scientific disciplines related to molecular and cellular medicine, diagnostics, clinical medicine and surgery. The research activities, which are aimed at meeting the growing demand for excellent and modern medicine, are developed in an integrated manner and are closely linked to the clinical and assistance activities of the Sant'Andrea Hospital and the teaching activities of the Faculty of Medicine and Psychology.

Takis (www.takisbiotech.com) is a Rome-based biotech company focused on the development of vaccines and therapeutic antibodies for solid tumors and infectious diseases. Founded by scientists formerly of Merck Research Laboratories (MRL), the company brings over 15 years of experience in oncology drug discovery and is recognized for the conception and implementation of a number of innovative technologies, including DNA delivery. Takis is actively advancing humanized monoclonal antibodies and bispecifics for oncology and infectious diseases, including COVID-19. The company has also developed COVID-eVax, a DNA-based vaccine against SARS-CoV-2, and continues to apply its electroporation expertise to vaccine development and somatic gene therapy.

About Tethis

Tethis (www.tethis-lab.com) is a pioneering life sciences and diagnostic company developing an innovative workflow to integrate liquid biopsy into clinical practice, offering precise cancer management. Tethis' technology focuses on standardizing the preparation of blood samples to ensure the highest quality and integrity of liquid biopsy specimens. This approach facilitates comprehensive analysis of all clinically relevant biomarkers. The company's nanocoated SmartBioSurface^® slides, in conjunction with the See.d^® instrument, enable the identification and characterization of immune cells and rare cells, such as circulating tumor cells, with unparalleled sensitivity, even in early-stage settings. The company is headquartered in Milan, Italy.

Media Contacts

For Department of Clinical and Molecular Medicine of Sapienza University of Rome: DMCM@uniroma1.it

For Takis: marketing@takisbiotech.it

For Tethis: media@tethis-lab.com 

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