News
CuraCell Receives CTA Approval for Phase I/IIa Clinical Trial with Innovative TIL Therapy CC-38
August 13th, 2025
CuraCell today announced that the Paul-Ehrlich-Institut (PEI), the German federal authority for vaccines and biomedicines, has approved the company’s Clinical Trial Application (CTA) to initiate a Phase I/IIa clinical trial evaluating its novel autologous TIL (Tumor-Infiltrating Lymphocyte) therapy, CC-38, in patients with metastatic colorectal cancer and metastatic prostate cancer. The clinical trial is planned to commence in the second half of 2025.
The open-label Phase I/IIa trial will enroll up to 16 patients with advanced solid tumors, including colorectal and prostate cancer (EU-CT-Number: 2025-521227-70-00). The study will be conducted at Krankenhaus Nordwest in Frankfurt. The trial will assess the feasibility of repeated administration, with safety and tolerability as the primary endpoints. Secondary objectives include evaluating preliminary anti-tumor activity and immune responses.
“This CTA approval marks a major milestone for CuraCell and affirms the strength of our science and clinical strategy,” said Jonas Båtelson, CEO of CuraCell. “Our dedicated team, together with our expert collaborators, has worked tirelessly to advance our first TIL therapy from bench to bedside. This is a big step forward in our mission to provide curative treatments for the toughest and most deadly solid tumors.”
CuraCell partners with ScaleReady in cGMP Manufacturing Optimization
April 10th, 2025
CuraCell signes collaboration agreement with ScaleReady under the G-REX Grant Program Initiative aimed to advance state of the art cell and gene-modified cell therapy (CGT) development and manufacturing.
ScaleReady, with support from Wilson Wolf Corporation, Bio-Techne Corporation (NASDAQ: TECH), and CellReady will support CuraCell in process development and manufacturing optimization of CC-38, CuraCell’s Tumor Infiltrating Lymphocytes (TIL) product. ScaleReady’s growing consortium of G-Rex Grant Partners brings best-in-class tools and technologies as well as unparalleled knowledge and expertise in the areas of cGMP manufacturing, quality and regulatory affairs and CGT business operations.
“This collaboration helps us advance a TIL-cell therapy that can help patients suffering from solid tumors with dire prognoses. We are honored to be awarded a ScaleReady G-Rex Grant and appreciate the support that ScaleReady and its partners are giving to help us optimize our processes beyond our Phase I/IIa clinical trial.” said Dr. Lucas Arruda, CSO of CuraCell.
CuraCell to present patient named clinical results at AACR and ISCT 2025 in the USA
April 1st, 2025
CuraCell will present clinical outcomes of patients treated with our Tumor Infiltrating Lymphocytes (TIL)-based therapy this spring at the American Association for Cancer Research (AACR) Annual Meeting and the International Society for Cell & Gene Therapy (ISCT) Annual Meeting, both taking place in the United States. All patients treated, on a patient-named basis, were diagnosed with late-stage solid tumors and refractory to all conventional therapies.
The presentations mark a significant milestone for our team as we share important data highlighting the potential of our TIL-product CC-38 to address the unmet medical need in cold solid tumors.
“We look forward to connecting with the scientific and clinical community during these events and continuing the conversation on advancing durable, personalized cancer immunotherapy.” said Dr. Lucas Arruda, CSO of CuraCell.
CuraCell's CDMO partner Zellwerk-Berlin receives GMP licence
November 11th, 2024
CuraCell’s manufacturing partner Zellwerk-Berlin GmBH, a specialized contract development & manufacturing organization (CDMO), receives GMP authorization of its manufacturing site in Brandenburg, Germany. The GMP authorization of Zellwerk-Berlin’s site in Brandenburg is a key milestone for CuraCell in its progress towards filing for the first-in-human clinical trial.
CuraCell holds final advice meeting with German regulator PEI
January 17th, 2024
CuraCell today held its second advice meeting with the German regulator PEI (Paul-Erlich Institut). The first meeting was held on the 27th of October, focused on non-clinical questions related to the company’s first product, CC-38. Today’s meeting was dedicated to the study protocol.
The feedback received supports CuraCell to move ahead and prepare the fist-in-human clinical trial application (phase 1/2a). The trial is planned to include advanced prostate and colorectal cancer patients.
CuraCell selects IKF as CRO partner for its phase 1/2a trial
August 22nd, 2023
CuraCell has signed a partnership agreement with the German Clinical Research Organisation, IKF, located in Frankfurt, Germany. IKF will support CuraCell in the preparation of the upcoming phase 1/2a trial and coordinate clinical operations throughout the trial.
IKF is specialized in investigator-initiated and industry-academia collaborative cancer research. Founded by oncologists, with more the 20 years of operations, the company has been involved in oncology trials across 300 centers world-wide.
CuraCell signes collaboration agreement with Zellwerk-Berlin
October, 2022
Takura’s affiliate CuraCell signes collaboration agreement with Zellwerk-Berlin, a Specialized Contract Development & Manufacturing Organization (CDMO) with engagements in Tumor Infiltrating Lymphocytes (TIL), Natural Killer (NK) cells and Mesenchymal Stromal Cells (MSC), an affiliate of Hiper Group. CuraCell acquires intellectual property rights from Zellwerk Berlin associated with CuraCell’s TIL product, CC-38.
CC-38 has been used in patient named treatments in Germany demonstrating promising clinical results. The two companies will now join forces in optimizing and validating CC-38 for upcoming clinical trials. Through the collaboration CuraCell gets access to process engineering capabilities of Zellwerk Berlin’s R&D team and secures manufacturing capacity for its first clinical phase.