Headed by Rodrigo Dienstmann, Principal Investigator of VHIO’s Oncology Data Science (ODysSey) Group, under the co-leadership of Ana Vivancos, Principal Investigator of VHIO’s Cancer Genomics Group, Paolo Nuciforo, Principal Investigator of our Molecular Oncology Group, and Elena Garralda, who leads VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, as well as Early Clinical Drug Development, our Molecular Prescreening Program, is supported through our institutional Advanced Molecular Diagnostics Program (DIAMAV), powered by one of our patrons and Institutional Supporters, the FERO Foundation.
Serving as a Core VHIO Service, our expert team focuses on the clinical implementation of advanced molecular diagnostics to optimize the selection of therapies for patients being considered for enrolment in clinical trials, as well as continued medical education on emerging cancer biomarkers for precision cancer therapy. By advancing molecular profiling in patients, personalized treatment strategies based on the genomic or pathologic profile of each individual patient can be more effectively matched to the molecular makeup of their respective disease.
Our researchers and clinical investigators identify specific molecular risk factors and better predict the potential efficacy of specific agents tailored to each particular tumor. Additionally, this knowledge better guides our multidisciplinary teams to assess and establish patients’ suitability for inclusion in early phase clinical trials led by VHIO’s Research Unit for Molecular Therapy of Cancer (UTIM) – CaixaResearch.
It is thanks to the backing received from FERO that our Molecular Prescreening Program continues to establish itself as a reference in prescreening and oncogenomics in Europe, and continues to extend its enabling technologies and platforms to an increasing number of individuals. In 2020, our researchers and clinical investigators performed molecular profiling in over 1,100 cancer patients as potential candidates for inclusion in our clinical studies. In total, 150 patients were treated with biomarker-matched innovative therapies as a result of these efforts.
In short, this Program enables us to lead one of the few centers in Europe to run such a comprehensive program, ensure that more of our patients can ultimately benefit from our powerful technology programs and approaches, further advance research into the more effective and less invasive tracking of cancer by liquid biopsy, as well as develop cancer diagnostics for the early detection of disease.
Cancer is the second leading cause of death globally, with around 18 million new cases diagnosed and more than 9.6 million cancer-related deaths each year. While cancer survival rates continue to improve, there are still many tumor types with no effective treatments. Clinical trials are crucial to identifying and developing novel therapies against cancer and are only possible at VHIO thanks to the continued support received from the ”la Caixa” Foundation; one of our Institutional Supporters and Patrons.
Building on the successes of the two previous VHIO-”la Caixa” Institutional 3-year Programs, our CaixaResearch Advanced Oncology Research Program (2020-2023) launched this year to further spur the development of more potent and precise anti-cancer medicines, fortify existing research lines as well as initiate new projects to lead frontier research in some of the most relevant and rising focus fields in precision oncology; those areas showing particular promise in solving the multiple questions that stand in the way of more effectively combating cancer.
Marking the tenth anniversary of our Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch -also supported by ”la Caixa” Foundation, this program enables us to pursue our transformative research lines aimed at unpicking the complex role that the microbiome plays in cancer development, driving ‘big data’-derived insights, developing and integrating cutting-edge platforms incorporating bioinformatics, biostatistics and machine learning applications in cancer prognosis and prediction, as well as harnessing the potential of Artificial Intelligence (AI) in the development of individually matched therapies.
In parallel with our plans to expand VHIO’s portfolio of clinical trials performed at our Unit, that have led and/or contributed to the approval of some 30 anti-cancer agents by the U.S. Food and Drug Administration (FDA), our CaixaResearch Advanced Oncology Research Program will allow us to further advance and apply novel anti-cancer approaches and armory including liquid biopsy, RNA expression analysis, immune-based therapies, bispecific antibodies, oncolytic virus, and intratumoral therapy.
These efforts are driven thanks to the expertise of several VHIO groups and teams including our Early Clinical Drug Development, Cancer Genomics), Molecular Oncology, Oncology Data Science (ODysSey) Groups, led by Elena Garralda, Ana Vivancos, Paolo Nuciforo, and Rodrigo Dienstmann, respectively.
Within the scope of this CaixaResearch Advanced Oncology Research Program, Elena Garralda's team has performed several clinical trials with patients selected on molecular alterations: mutations in AKT1, EGFR, IDH1, ALK, ROS1, BRAF, NRAS, KRAS, FGFR1 and 2, MET, HER2, HER3, RET; ATM; BRCA, amplifications in HER2, AKT 1, 2, and 3, FGFR1, MET, NOTCH1-4, rearrangements of NTRK1-3 ROS1, ALK, BRAF, RSPO2/3, RET, NRG and FGFR1-3.
The matched dedication of our clinical and translational investigators across all VHIO groups, as well as our Clinical Trial Office, headed by Marta Beltran, Clinical Trials Support Office, managed by Susana Muñoz, Clinical Research Oncology Nurses, spearhead by Nines Peñuelas, Clinical Research Oncology Pharmacy Unit –an additional Facility supported by the ”la Caixa” Foundation, led by Maria Queralt Gorgas, and Quality & Processes Unit, led by Gemma Sala, has also made the past decade’s total of over 1,300 Phase I plus Basket studies, and 1076 Phase II insightful studies possible. Over the last ten years more than 7,800 patients have been enrolled in clinical trials at VHIO.
Considering the successes of the very first VHIO-BBVA Foundation Program on Tumor Biomarkers Research that launched back in 2011, VHIO and the BBVA Foundation renewed their agreement in in 2018. Building on the achievements of the first program, our 4-year Comprehensive Program of Cancer Immunotherapy & Immunology (CAIMI), centers on advancing research into the natural mechanisms governing how T lymphocytes react to cancer and how to use these antitumor responses to develop more personalized and potent immune-based therapies and treatment strategies.
Represents an important forward step in advancing agents that inhibit checkpoint regulation of the immune system, this VHIO Institutional Program aims at achieving a deeper understanding of mechanisms of resistance and response to these therapies, and prioritizes the early clinical drug development of those therapies and combinations that show most promise. Under the leadership of our Director, Josep Tabernero, CAIMI counts on the expertise of VHIO’s Elena Garralda, Principal Investigator of VHIO’s Early Clinical Drug Development Group, and Director of our Research Unit for Molecular Therapy of Cancer (UITM) - CaixaResearch who heads up the program’s clinical research, and Alena Gros, Principal Investigator of our Tumor Immunology and Immunotherapy Group, who leads its translational research.
These efforts also rely on our Molecular Prescreening Program, headed by Rodrigo Dienstmann, Principal Investigator of VHIO’s Oncology Data Science (ODysSey) Group, under the co-leadership of Ana Vivancos, Principal by VHIO’s Cancer Genomics Group, Paolo Nuciforo, Principal Investigator of our Molecular Oncology Group, and Elena Garralda.
Over the past two years, CAIMI has enabled the development of various translational projects linked to the early clinical development phases of immunotherapy. Just some focus areas include the development of cell-based therapies such as killer T cells for non-responders to current immunotherapies, characterizing hyperprogressive disease with immunotherapy to advance insights into this phenomenon, as well as establishing a radiomic signature to predict response to immunotherapy, led by Raquel Perez-Lopez, Principal Investigator of our Radiomics Group. Concerning the latter, we are now exploring how this correlates with the genomic evolution in patients.
Importantly, this year, Alena Gros and Elena Garralda’s teams have worked together to finalize the clinical grade validations of tumor-infiltrating lymphocytes expansion for the treatment of certain cancer patients at the Vall d’Hebron University Hospital HUVH).
Most recently, Alena’s group filed an investigational new drug (IND) application to the AEMPS Spanish Regulatory Agency towards treating patients with metastatic epithelial or immunotherapy refractory tumors with neoantigen-reactive TILs. By enriching for neoantigen-reactive lymphocytes, the aim is to fortify the efficacy of TIL therapy in epithelial cancers.
Accelerating progress through team science, VHIO’s multidisciplinary teams, coordinated by our VHIO’s Scientific Area, also work together as established Task Forces that have been created based on VHIO’s strategic vision and core research priorities.
These comprehensive teams are comprised of preclinical and translational researchers, clinical investigators and medical oncologists, oncologists, pathologists, other MD disciplines, clinical research nurses, data curators as well as study coordinators, and project managers, among others.
Covering breast, colorectal, gastroesophageal, kidney, melanoma, neuroendocrine/rectal, pancreatic, prostate, and gynaecological cancers, as well as onco-imaging, VHIO’s task forces regularly convene to synergize efforts, boost collaborations among groups and between specialists, and continuously revise patients and samples’ circuits and ethics toward advancing cancer science and precision medicine.
The internal organization of each dedicated task force varies depending on its size, workflow, participants, and level of action. Each have an appointed Chair and are coordinated by an allocated project manager for the setting of agendas, writing of meeting minutes, follow up of action points/ tasks, and establishing alignments, interactions and synergies across our various task forces.
Illustrative of VHIO’s commitment to team science in more effectively tackling the complexity of cancer malignancies, clinical researchers from other medical specialties across Vall d’Hebron and/or other local hospitals in Catalonia, as well as other investigators from the Vall d’Hebron Barcelona Hospital Camps and other research institutions, actively contribute to the activities of our dedicated task forces.
We aim to create new task forces for pathologies that do not currently have specific, allocated task teams, as well as other transversal areas. In addition, we hope to set up a new task force devoted to patients, their families and caregivers, to further involve patients in our research, in alignment with ongoing policies and activities of the Vall d’Hebron University Hospital.