VHIO'S TRANSVERSAL CLINICAL TRIALS CORE SERVICES & UNITS

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Jordi Rodón
Director

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Summary
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Inaugurated in June 2010, thanks to the support received from the Fundació Bancària “la Caixa”, the Research Unit for Molecular Therapy of Cancer (UITM) - “la Caixa”, is dedicated to complex clinical trials with drugs in early development (Phase I and early Phase II trials), focusing on novel targets. Occupying a total surface area of 1000 m2 our Unit is located within the General Area of the Vall d’Hebron University Hospital. Due to such a privileged environment with direct access to patients, coupled with VHIO’s translational approach to research and superb scientific framework, our Unit has rapidly established itself as one of the few comprehensive facilities in Europe to rapidly transform latest discovery into benefits for patients.

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UITM promotes tight connectivity between health care and research which enables us to establish new treatment models for patients with highly selective drugs, expanding the knowledge of tumor diseases and how to treat them in an individualized way - getting the right drug to the right patient at the right time. As the figures show, we are gradually doing so for an increasing number of patients. In 2015, 106 phase I clinical trials were performed at the Unit with a total of 370 patients enrolled. It is thanks to the Unit’s facilities coupled with our multidisciplinary clinical teams that we continue to expand our portfolio of phase I trials.

Research carried out at our Unit by VHIO’s Early Clinical Drug Development Group, focuses on the development of new drugs based on the molecular profile of each tumor as well as the optimization of treatment regimes using combinations of new drugs with those already existing. In line with VHIO’s translational model, research is also linked with other research areas carried out by VHIO groups, connecting molecular biology and optimal tumor models with pharmacology and innovative clinical research. VHIO scientists also collaborate closely in the trials to facilitate biomarker development, a profound understanding of the mechanism of action, as well as research into mechanisms of resistance.

In partnership with VHIO’s Molecular Oncology, and Translational Cancer Genomics groups, we perform molecular analysis of the patients’ tumors to select the best possible treatment with the experimental therapeutics available. Thanks to additional technology platforms implemented by VHIO’s Cancer Genomics and Translational Cancer Genomics groups – including MiSeq, HiSeq2500, and nCounter Nanostring, we continue to drive faster, more precise mutational analysis of tumorsuppressor genes as well as translocations and gene amplifications.

UITM incorporates a multidisciplinary team comprised of medical oncologists, clinical trial coordinators and data managers, nurses and nurse technicians, pharmacists, as well as administrative personnel. Excellent patient treatment and care as well as pioneering research is also made possible thanks to the collaboration with many other oncology professionals including clinical research oncolgy nurses, pathologists from Vall d’Hebron’s Molecular Pathology Department, radiologists and interventional radiologists, as well as the Clinical Trials Office, Database Management, and healthcare specialists (dermatologists, cardiologists, ophthalmologists).

Research Unit for Molecular Therapy of Cancer (UITM) - “la Caixa”

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Director
Jordi Rodón

Co-Director
Josep Tabernero

Executive Team
Jordi Rodón
Gemma Sala
Ángeles Peñuelas

Medical Coordinator
Jordi Rodón

Associate Investigators
SENIOR CONSULTANTS
Judith Balmaña
Joan Carles
Enriqueta Felip
Ana Oaknin
Cristina Saura
Josep Tabernero

PHASE I INVESTIGATORS
Maria Alsina
Analía B. Azaro
Irene Braña
Cristina Cruz
María Elena Élez
Ana Garrido Castro
Patricia Gómez
Julieta Grasselli
Cinta Hierro
Teresa Macarulla
Juan Martín
Álex Martínez
María Ochoa de Olza
Mafalda Oliveira
José Manuel Pérez
Alejandro Navarro
Tamara Saurí
Cristina Suárez
Claudia Valverde
Helena Verdaguer
Esther Zamora

Head, Clinical Trials Office
Gemma Sala

Study Coordinators
Meritxell Baño
Marta Beltrán
Lluïsa Carbonell
Maria Herranz
Sonia Martínez
Lidia Martínez de Arenzana
Laura Maynés
Adelaida Piera
Josep Roman
Elisabet Sicart

Data Entries
Laia Cano
Gloria García
Isabel Rico
Montserrat Pujadas
Cristina Viaplana

Pharmacy
FOUITM
Maria Josep Carreras Soler
USIFO
Laura Maños

Nurse Supervisor
Ángeles Peñuelas

Nurse Coordinators
Sonia Valverde
Lydia Vélez

Nurses
Meritxell Cucurell
Elisabet Hernández
Margarida Marcos
Isabel Muñoz
Tania Sánchez

Nursing Assistants
Alicia López
María Martín

Nurse Supervisor’s Assistant
Juan Manuel García

Secretary
Teresa Mendoza

Strategic Goals / Research Unit for Molecular Therapy of Cancer (UITM) - “la Caixa”

  1. Early drug development and translational research led by UITM physician-researchers and VHIO scientists: Expansion of our broad portfolio of promising novel anticancer therapies, across a balanced spectrum of studies, with special focus on first-in-human studies, novel-novel combinations, best-in class compounds, and a new class of drugs.
  2. Perform complex trials such as organ dysfunction trials, Octopus trials, Basket trials, link clinical research at UITM with VHIO’s preclinical and translational research groups, and collaborate with the different partners involved in drug development and translational research.
  3. Genomic medicine trials in early drug development: perform molecular analysis of patient tumors in order to select the best possible treatment with the experimental treatments available, co-develop medical informatics applied to genomic medicine, and integrate preclinical and clinical research by incorporating novel drugs, new insights and study designs together with customized molecular diagnostics.
  4. Immunotherapy: UITM Task Force in early drug development of immunotherapeutics and cell signaling (with sepcia focus on cytokines, immunomodulatory agents and immune checkpoint inhibitors) and translational research in immune-oncology.

Highlights 2015 / Research Unit for Molecular Therapy of Cancer (UITM) - “la Caixa”

  1. We have performed some of the most complex phase I trials, including those focused on molecularly-selected patient populations (more than a dozen trials in molecularly-selected patient populations Basket/Octopus trials as well as trials in immuno-oncology. One such phase II novel basket trial carried out at UITM showed the efficacy of vemurafenib as therapy against multiple tumor types that share the BRAFV600 mutation – results which were published in the prestigious journal The New England Journal of Medicine (Hyman DM et al. 2015. N Engl J Med. 373:726-736).
  2. We have expanded our expertise in drugs targeting developmental pathways, cell signaling (PI3K, BRAF, MET, FGFR), and immunotherapy (PD1/PDL1, OX40, CD40, engineered antibodies).
  3. In collaboration with VHIO’s Cancer Genomics and Translational Cancer Genomics Groups, we benefit from cutting-edge technology platforms including the MiSeq, Hiseq 2500 NextGen sequencers, and the nCounter Nanostring. We also co-develop molecular tests for VHIO’s Pre-screening Program (disease-oriented mutation panels for our NGS platforms).