On 25 August 2026, a meeting took place between representatives of the Ludwik Hirszfeld Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences and experts from the European Medicines Agency (EMA), organised as part of the preparations for the Scientific Advice procedure for the CAR-T cell therapy investigational medicinal product being developed at the Institute. The meeting concerned the B(e)CAME project and the product IDC-SHMAB-07 being developed under it, which is intended for further clinical development in the treatment of relapsed and refractory multiple myeloma.
The meeting was led on behalf of the Institute by Karol Szczudło and Emilia Jaskuła, PhD. Also in attendance were Prof. Andrzej Gamian – Director of the IIET PAS – and experts representing various areas of research, pre-clinical and clinical work: Mateusz Chmielarz, PhD; Beata Orzechowska, PhD, DSc; Elżbieta Pajtasz-Piasecka, PhD, DSc; Agnieszka Szczygieł, PhD; Prof. Joanna Wietrzyk and Jarosław Dybko, PhD, from the Lower Silesian Centre for Oncology, Pulmonology and Haematology, a consortium partner in the project. Representing the EMA at the meeting were experts from the Scientific Advice Office: Myriam Chapelin, Ragini Shivji, Rhys Whomsley and Joana Portela.
The aim of the meeting was to discuss the documentation currently being prepared and the scope of the issues to be submitted for assessment by the Scientific Advice Working Party and experts from the Biologics Working Party and the Committee for Advanced Therapies (CAT). The discussion covered key areas of the product’s further development: quality and manufacturing process, the pre-clinical research programme, and the design of the planned first-in-human (FIH) clinical trial. The meeting also enabled the identification of elements of the documentation requiring further clarification before the EMA experts commence their formal assessment.
The next stage involves updating and submitting the documentation in accordance with the agreements reached at the meeting. Subsequently, the formal assessment under the Scientific Advice procedure will commence, with completion scheduled for the fourth quarter of 2026.
This is an important stage in the preparations for the further development of the academic CAR-T therapy being developed at the IIET PAS and its future application in clinical trials.
Participation in the Scientific Advice procedure represents a further step in preparing the therapy being developed at the Institute for the clinical trial phase and brings the B(e)CAME project closer to achieving its translational goal – translating the results of academic research into solutions available to patients.
