Die Hoffotografen GmbH

Solid tumours meet their match

Solid tumours pose major obstacles for cell therapies, but German-American biotech T-knife is tackling them head-on. CEO Tom Soloway and CTO Elisa Kieback share how their “supercharged” TCR-Ts are engineered to overcome these challenges.

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EuroBiotech_How do you see the current sentiment for cell therapy in the US compared to Europe?
Thomas Soloway_The sentiment remains strong on both sides of the Atlantic, with substantial progress as the field advances the power of cell therapy beyond haematological malignancies. In Europe, and especially in Germany, we benefit from exceptional scientific rigour and deep expertise in immunology. Based in Berlin, T-knife leverages a robust European ecosystem that has pioneered innovations in target selection, construct design, manufacturing, and clinical trials.

EuroBiotech_What opportunities and challenges do you see for cell therapies in solid tumours?
Soloway_Unlike blood cancers, solid tumours are heterogeneous, including in terms of antigen expression, which makes targeting difficult. Therapeutic T cells also face limited engraftment and persistence, and the immunosuppressive tumour microenvironment (TME) further reduces efficacy.
At T-knife, we aim to achieve deep and durable responses by combining validated targets with advanced T-cell engineering that precisely addresses these challenges.

EuroBiotech_What distinguishes your next-generation “supercharged” approach?
Dr Elisa Kieback _Each programme begins with an analysis of advanced tumours expressing shared antigens to identify the specific barriers T cells must overcome. We then integrate proprietary engineering to enhance engraftment, persistence, and functionality within the TME.
Our lead candidate, TK-6302, targets PRAME-positive cancers, including ovarian, endometrial, lung, breast, and melanoma. We plan to submit a clinical trial application (CTA) in the coming weeks, with first dosing expected in mid-2026 at multiple European sites. We also have an earlier-stage pipeline addressing other unmet needs.

EuroBiotech_How do cell therapies compare with other modalities such as ADCs or checkpoint inhibitors?
Kieback_Each modality has unique advantages and strengths. Checkpoint inhibitors and ADCs have advanced cancer care, but many patients do not respond or eventually relapse. Cell therapies can deliver lasting responses in a single, potentially curative infusion, which reduces patient burden and long-term healthcare costs. Carvykti® (ciltacabtagene autoleucel) illustrates this potential, with five-year progression-free survival in one-third of multiple myeloma patients.

EuroBiotech_What is needed to make cell therapy more scalable and accessible?
Kieback_Conventional cell therapy manufacturing is labour-intensive, costly, and complex. The field has made significant progress through automation and improved analytics that simplify product release. At T-knife, we use a non-viral gene-editing process that improves scalability and cost-efficiency while producing high-quality, fit cells. Together, these innovations pave the way for more efficient, reliable, and accessible cell therapies.

EuroBiotech_How important is a transatlantic setting for your financing and growth?
Soloway_Our dual presence in Berlin and San Francisco provides access to two complementary ecosystems. It allows us to engage with a broad investor base, align with both European and US regulatory frameworks, and recruit top global talent. This transatlantic setup also reflects the global nature of biotech – success depends on integrating the best cross-border resources, talent, and infrastructure.

This interview was originally published in the Special CDMOs & CROs as part of European Biotechnology Magazine Autumn 2025.

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