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The first research centre in Romania and Eastern Europe, with state-of-the-art equipment for basic and applied research in the field of gene therapies. The Centre has basic and applied research facilities, with 15 compartments including a GMP facility and laboratories endowed with high performance equipment.
Romania-Serbia Joint Initiative against Cancer in Cross-Border Region: Improved Diagnosis and Treatment of Malignant Tumors
Colectivul de cercetători de la OncoGen Timișoara angrenat în proiectul CAR-NK a reușit, de curând, punerea la punct a tehnologiei CAR-T (chimeric antigen receptor – T cell) și CAR-NK (chimeric antigen receptor – Natural Killer cell). Scopul acestui proiect a fost elaborarea celor mai noi tehnologii în tratamentul cancerului, având ca obiectiv final aplicarea terapiilor personalizate la pacienți.
Echipa Centrului de terapii genice și celulare în tratamentul cancerului OncoGen a câștigat, în anul 2016, proiectul „Terapie în cancer cu celule Natural Killer purtătoare de receptori himerici de antigen – CAR-NK”, finanțat prin Programul Operaţional Competitivitate 2014-2020, cu un buget de circa 2 milioane de euro. Proiectul se derulează până la sfârșitul lunii august 2020, în colaborare cu Universitatea Tehnică din Dresda și Universitatea Goethe din Frankfurt.
”Rezultatele obținute până acum în cadrul acestui proiect ne permit trecerea în faza următoare, și anume producerea acestor celule imune modificate genetic, în vederea tratamentului pacienților afectați de leucemia limfatică acută cu limfocite B. Cu cât mai repede vom operaționaliza producția acestor vaccinuri personalizate, cu atât vom reuși să salvăm un număr mai mare de pacienți, copii și adulți, care, altfel, pierd lupta cu această boală letală”.
În momentul de față, Centrul de la Timișoara are pregătirea și dotările necesare pentru a duce aceste noi terapii către pacienți. Însă, pentru a finaliza procesul, este nevoie de îndeplinirea unor condiții de fabricare, asemănătoare cu cele din producția de vaccinuri sau de medicamente, impuse atât de către Agenția Europeană a Medicamentului (EMA), cât și de către Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România (ANMDMR).
”Cele două autorități impun operaționalizarea și autorizarea GMP (Good Manufacturing Practice) a unităților de producție sau, în cazul modificărilor genetice, autorizarea BSL (Biosecurity Level 2) – o facilitate care permite să lucrezi cu vectori fără pericol de contaminare a personalului sau a mediului”, a mai explicat prof. dr. Virgil Păunescu.
În prezent, pacienții români nu au acces la astfel de terapii, deoarece costul lor, la nivel internațional, este cuprins între 500.000 și 800.000 de dolari de persoană.
La sfârșitul anului 2017, Food and Drug Administration – FDA (Agenția Medicamentului din Statele Unite) a aprobat punerea pe piață a primelor terapii personalizate pentru leucemia limfatică acută cu limfocite B, cu rezultate spectaculoase. Circa 80% – 90% dintre pacienții suferinzi de această boală, care nu mai au nicio șansă terapeutică, se vindecă în urma aplicării acestui tratament.
Romania-Serbia Joint Initiative against Cancer in Cross-Border Region: Improved Diagnosis and Treatment of Malignant Tumors” – ROSECAN
On October 25th 2019, OncoGen Research Center hosted the third press conference for the strategic project entitled “Romania-Serbia Joint Initiative against Cancer in Cross-Border Region: Improved Diagnosis and Treatment of Malignant Tumors – ROSECAN”, financed as part of the Interreg-IPA CBC Romania – Serbia programme.
The OncoGen Center acquired all equipment indicated in the project for personalized cancer diagnosis using genome sequencing. As of right now, the center’s acquisition procedure for the development of a software dedicated to diagnosis and treatment of cancer patients is ongoing. This software will be implemented in the Romania-Serbia cross-border region.
Next-generation sequencing (NGS) is a modern method for precise diagnosis and orienting treatment of cancer, used in the case of solid tumors, as well as haematological malignancies. Genome sequencing provides us with information regarding mutations that might appear in cancer cells during tumor development and proliferation. Based on a patient’s gene mutation panel, he/she becomes a unique entity, with a personalized molecular diagnosis, and benefits from a personalized treatment. All data acquired is interpreted using dedicated computer software such as Oncomine, IonReporter or VariantStudio. Following this methodology, new molecular targets present in tumors can be identified, allowing for the development of therapeutic strategies such as personalized vaccines or cell immunotherapy.
Genome sequencing involves no risk for the patients. This method uses DNA extracted from parafilm-enclosed tissue, after the histopathological diagnosis of the tumor is established.
Through the genome sequencing programme, OncoGen aligns to the diagnosis and anti-tumor therapy standards at the international level. As part of the ROSECAN project, 3 NGS machines have been purchased: the system for whole genome sequencing with an automatic sample preparation station (Ion Torrent Studio S5 + Ion Chef – ThermoFisher), the system for targeted DNA sequencing (Personal Genome Machine (PGM) – ThermoScientific) and the MiSeq sequencing system for validation (Illumina). These systems were used to analyze over 80 samples this year, as follows:
– 32 samples were analyzed using the PGM system; results identified gene mutations in 207 hotspots of 50 genes involved in tumorigenesis;
– 30 samples were analyzed using the Illumina MiSeq system, which provided us with data regarding the patient’s immune response to cancer, i.e. the amount and type of cytotoxic T lymphocyte clones, these being the cells that have the ability of destroying cancerous cells;
– 20 samples were analyzed using the Ion Torrent Studio S5 system and the automatic sample preparation station, identifying over 89 gene mutations in over 30 genes investigated from patients with solid tumors; the sample preparation station proved to be extremely useful for shortening processing and preparation time for sequencing samples, which meant that it only took 7 days from receiving the samples to releasing the results;
– circulating free DNA (cfDNA) from peripheral blood samples from 8 cancer patients was analyzed, identifying mutations in 25 oncogenes.
Currently, at the OncoGen Centre it is possible to perform approximately 100 additional genome sequencing analyses.
This successfully concluded phase brings us closer to achieving our goal of offering cancer patients a personalized diagnosis and therapeutic orientation for the purpose of treating malignant tumors.
In the context of the “Educated Romania” project and the designation of Timisoara as European Capital of Culture in 2021, the President of Romania, Mr Klaus Iohannis, attended a series of events held under the motto “Timisoara – Academic, Cultural and Scientific Centre”, which included the visit of Centre for Gene and Cellular Therapies in the Treatment of Cancer – OncoGen. The President has thus conveyed “a mark of encouragement for medical research, openness to researchers in the medical field, support for EU-funded research projects and also a message of encouragement for accessing new projects devoted to medical research.”
The President was welcomed by Prof. Virgil Paunescu, MD, PhD, the coordinator of OncoGen and the leadership of Pius Brinzeu Emergency County Clinical Hospital Timisoara. Mrs Diana Loreta Paun, state adviser, Department of Public Health, as well as local public officials and leading researchers in the Banat region had also attended the visit: Prefect of Timis County, Mircea Bacala, President of Timis County Council, Sorin Grindeanu, Mayor of Timisoara, Nicolae Robu, representatives in the leaderships of main universities in Timisoara and of local research centres. The meeting was also attended by the representatives of the West Regional Office Timisoara within the National Authority for Scientific Research and Innovation, who have supported the project through which OncoGen was built and equipped.
Prof. Paunescu presented the cutting-edge laboratories and equipment of OncoGen, after which the President was invited to a discussion on Romanian medical research, when he was informed on the results of OncoGen researchers, the research strategy and the projects we are currently running. During the meeting, both young and recognised researchers from Timisoara have had the opportunity to discuss with the President on various Romanian research issues. At the end of discussions, the idea of Timisoara reaching the status of excellence pole in biotechnologies by cooperation between all research capacities on interdisciplinary themes in order to reach the critical mass and to exploit human and material potential in the area has emerged.
In his address at the end of the visit, the President stated that “higher education is not to be reasonably imagined without research” and that OncoGen proves Timisoara is a place of innovation.
Pius Branzeu Clinical Emergency Hospital
300723 Timisoara, Romania
156, Liviu Rebreanu Boulevard