PharmaMar’s research efforts have been recognized through grants from public entities for several projects, both individual and in cooperation with public centers and private companies. These collaborative projects aim to make the maximum use of human and technical resources, searching for synergies that permit a greater progress in innovation.

The public funding comes mainly from the Centro de Desarrollo Tecnológico Industrial (CDTI) and the State Secretariat for Research, Development and Innovation (part of the Ministry of Economy and Competitiveness) as well as from the Framework Programs of the European Union.

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UNDERLIPIDS

UNDERLIPIDS: Solid Lipid Nanoparticles for Subcutaneous Administration of Antitumour Marine Compounds. Reference: RTC-2015-3303-1.

This consortium is headed by PharmaMar and comprises also of the Institute of Material Science of Barcelona (ICMAB) and the University of the Basque Country. The project seeks to develop a suitable and effective formulation for subcutaneous administration of an antitumor drug as a solid dispersion. Duration: 2015-2018.

 

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INMUNOTOP

INMUNOTOP: Discovery of Innovative Antitumour Drugs against Oncology Targets: Topoisomerase System and Immune Answer Regulation. Reference: RTC-2016-4611-1.

This consortium is headed by PharmaMar and also comprises the Autónoma University of Madrid, the University of Seville and the University of La Coruña. The project aims to discover new potential antitumour molecules by two means: On the one hand, the reactivation of the immune answer through small molecules that improve the monoclonal antibodies in current clinical use and on the other hand through the inhibition of the topoisomerase system with compounds that improve the mechanism of action of the inhibitors already known, increase their efficacy and lower the possibility of resistance. Duration: 2016-2019.

 

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DESPOL

DESPOL: Biotechnology Applied to the Activation of Nonribosomal Polyketides and Peptides that Are Bioactive in Marine Bacteria. Reference: RTC-2016-4892-1.

This consortium is headed by PharmaMar and also comprises The Spanish National Research Council (CSIC) and the University of Oviedo. The project aims to develop different biotechnological tools to activate silenced bacterial genes involved in the production of bioactive compounds that are not expressed in standard culture conditions. Duration: 2016-2019.

Multifun

Consorcio MULTIFUN: Multifunctional Nanotechnology for selective detection and Treatment of cancer. Referencia: 262943. Convocatoria FP7 NMP.

Liderado por Atos. El proyecto se centra en el desarrollo y validación de sistemas nanotecnológicos novedosos y mínimamente invasivos para mejorar el diagnóstico del cáncer y su tratamiento en base a nanopartículas magnéticas. Duración: 2011-2015.

 

Micro B3

Consorcio MICRO B3: Marine Microbial Biodiversity, Bioinformatics and Biotechnology. Referencia: 287589. Convocatoria FP7 OCEAN.

Liderado por la Universidad Jacobs de Bremen. El objetivo del proyecto es el desarrollo de métodos bioinformáticos innovadores, así como de un marco jurídico que permita un mayor nivel de integración de los datos disponibles sobre biología de ecosistemas marinos. Duración: 2011-2015.

 

MaCuMBA

Consorcio MACUMBA: Marine Microorganisms: Cultivation Methods for Improving their Biotechnological Applications. Referencia: 311975. Convocatoria FP7 KBBE.

Liderado por el Real Instituto Holandés de Investigación Marina (NIOZ). El proyecto busca mejorar la tasa de aislamiento y la eficiencia de crecimiento de microorganismos marinos mediante el uso de métodos innovadores y procedimientos automatizados de alto rendimiento. Duración: 2012-2016.

 

BLUEPHARMTRAIN

Consorcio BLUEPHARMTRAIN: Co-Cultivation of Sponge Cells & Microorganisms. Referencia: 607786. Convocatoria FP7 PEOPLE.

Liderado por la Universidad de Wageningen. En el marco de un proyecto conjunto de formación de jóvenes investigadores se aplicarán tecnologías –ómicas pioneras para impulsar otras disciplinas más tradicionales con el objetivo de obtener compuestos bioactivos a partir de esponjas y los microorganismos que albergan. Duración: 2013-2017.

 

INMARE

Consorcio INMARE: Industrial Applications of Marine Enzymes: Innovative screening and expression platforms to discover and use the functional protein diversity from the sea. Referencia: 634486. Convocatoria H2020-BG.

Liderado por la Universidad de Bangor. El proyecto pretende utilizar enzimas y metabolitos microbianos recientemente descubiertos para diversas aplicaciones industriales como la producción de fármacos antitumorales o el desarrollo de plataformas de limpieza medioambiental. Duración: 2015-2019.

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Estudios de eficacia en el tratamiento de tumores sólidos avanzados seleccionados con el compuesto antitumoral de origen marino lurbinectedina. IDI-20150006

Se trata de un estudio fase II internacional para evaluar la eficacia y la seguridad del antitumoral en desarrollo PM1183 (lurbinectedina) en pacientes con varios tipos de tumores en fase avanzada. Este ensayo “Basket” incluye pacientes con tumores del tipo cáncer microcítico de pulmón, cáncer de cabeza y cuello, tumores neuroendocrinos, carcinoma de vías biliares, cáncer de endometrio, cáncer de mama asociado a mutaciones BRCA1/2, tumores de células germinales, tumores de Ewing y otros tumores de origen primario desconocido.

Este estudio incluye un sub-estudio de seguridad cardiaca con el fin de evaluar si la administración de lurbinectedina tiene algún efecto sobre los parámetros electrocardiográficos del paciente y así ampliar el conocimiento del perfil de seguridad del compuesto. Duración: 2015-2017.

Estudio de fase I del compuesto antitumoral PM060184 en combinación con gemcitabina. IDI-20150007

Se trata de un estudio prospectivo, abierto, de escalado de dosis, no controlado con el objetivo de  evaluar el perfil de seguridad, estudiar las características farmacocinéticas y determinar la actividad antitumoral preliminar de la combinación PM060184/gemcitabina tras su administración intravenosa a pacientes con tumores sólidos avanzados para los que no existe una alternativa terapéutica. Duración: 2014-2017.

Spanish Partnerships

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UNDERLIPIDS

UNDERLIPIDS: Solid Lipid Nanoparticles for Subcutaneous Administration of Antitumour Marine Compounds. Reference: RTC-2015-3303-1.

This consortium is headed by PharmaMar and comprises also of the Institute of Material Science of Barcelona (ICMAB) and the University of the Basque Country. The project seeks to develop a suitable and effective formulation for subcutaneous administration of an antitumor drug as a solid dispersion. Duration: 2015-2018.

 

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INMUNOTOP

INMUNOTOP: Discovery of Innovative Antitumour Drugs against Oncology Targets: Topoisomerase System and Immune Answer Regulation. Reference: RTC-2016-4611-1.

This consortium is headed by PharmaMar and also comprises the Autónoma University of Madrid, the University of Seville and the University of La Coruña. The project aims to discover new potential antitumour molecules by two means: On the one hand, the reactivation of the immune answer through small molecules that improve the monoclonal antibodies in current clinical use and on the other hand through the inhibition of the topoisomerase system with compounds that improve the mechanism of action of the inhibitors already known, increase their efficacy and lower the possibility of resistance. Duration: 2016-2019.

 

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DESPOL

DESPOL: Biotechnology Applied to the Activation of Nonribosomal Polyketides and Peptides that Are Bioactive in Marine Bacteria. Reference: RTC-2016-4892-1.

This consortium is headed by PharmaMar and also comprises The Spanish National Research Council (CSIC) and the University of Oviedo. The project aims to develop different biotechnological tools to activate silenced bacterial genes involved in the production of bioactive compounds that are not expressed in standard culture conditions. Duration: 2016-2019.

International Partnership

BLUEPHARMTRAIN

Co-Cultivation of Sponge Cells & Microorganisms. Reference: 607786. Call FP7 PEOPLE.

Headed by Wageningen University, the project belongs to a young scientist training programme. It will adopt cutting-edge -omic technologies to give a new boost to the more traditional disciplines with the aim of obtaining a wide variety of bioactive compounds from distinct sponges and their microbes. Duration: 2013-2017.

INMARE

Industrial Applications of Marine Enzymes: Innovative screening and expression platforms to discover and use the functional protein diversity from the sea. Reference: 634486. Call H2020-BG.

Headed by Bangor University, the project will mine for and use newly discovered microbial enzymes and metabolites, in particular for the targeted production of anti-cancer drugs or environmental clean-up technologies. Duration: 2015-2019.

ITCC-P4

ITCC-P4: Innovative Therapies for Children with Cancer – Pediatric Preclinical POC Platform. Reference: 116064. Call: IMI2-2015-07-05 “A comprehensive ‘pediatric preclinical POC platform’ to enable clinical molecule development for children with cancer”

The project aims to establish a preclinical study platform that increases therapeutic success of oncology drugs in children with solid malignancies. It is leaded by the Deutsches Krebsforschungszentrum (DKFZ). Duration: 2017-2021.

Individual Projects

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Clinical and pharmacokinetic, open-label, dose-scalation Phase I study of PM14 after intravenous administration to patients with advanced solid tumors. IDI-20170558

The project includes a clinical, open-label and dose-scalation Phase I study for PM14. It is the first clinical study for this compound. The primary goal of the study is to determine the limiting toxicities, maximum tolerated dose and recommended dose of PM14 after intravenous administration to patients with advanced solid tumors. Besides, the project aims to assess the safety and tolerability of PM14, define its pharmacokinetic profile, make pharmacogenomic analysis and obtain preliminary information about the antitumour activity of this compound. Duration: 2017-2020.

Preclinical model platform for the optimization in the search for pediatric oncology drugs. (ITCC-P4). IDI.20161003

The project aims to set the basis to generate a series of preclinical models that are useful for the study of the pediatric cancers, the evaluation of the efficacy of standard treatments in this models, the monitoring of patients and the possible prediction of an specific treatment efficacy. The ITCC-P4 platform has been created to achieve these goals, with the participation of PharmaMar beside 20 other European entities. The project is framed in the IMI-2 program. Duration: 2017-2019.

Clinical and pharmacokinetic, multicentre, open-label Phase I study of PM1183 in combination with Irinotecan in previously treated patients with advanced solid tumors. IDI-20160110

This project includes a Phase I clinical trial to increase the clinical data of the compound lurbinectedin and also to evaluate the safety, the pharmacological and even, the antitumor activity when administered in combination with another antitumor agent, irinotecan. Duration: 2016-2018

Controlled, randomized and open-label Phase II study of PM060184 in patients with hormone-receptor positive, HER2-negative, locally advanced and/or metastatic breast cancer, in third or fourth line. IDI-20151119

The aims of this project are to obtain sufficient evidence on the efficacy of PM060184 in the treatment of advanced breast cancer (hormone-receptor positive, HER2-negative in third or fourth line) and to evaluate its role in this indication. Also, to increase the knowledge on tolerability and the readiness of the compound in this subpopulation of oncological patients is pretended. Duration: 2015-2016

Efficacy studies in the treatment of selected advanced solid tumors with the marine-origin antitumor compound lurbinectedin. IDI-20150006

It is an international Phase II study to evaluate the efficacy and safety of the under development antitumor compound PM1183 (lurbinectedin) in patients with different kinds of advanced stage tumors. This “basket” trial includes patients with tumors such as small-cell lung cancer, head and neck cancer, neuroendocrine tumors, carcinoma of bile ducts, endometrial cancer, breast cancer associated with BRCA1/2 mutations, germ cell tumors, Ewing tumors and other unknown primary origin tumors.

This study includes a heart safety sub-study in order to evaluate if the administration of lurbinectedin has any effect on the patient’s electrocardiographic parameters and thus, widen the knowledge of the compound’s safety profile. Duration: 2015-2017.

Phase I study of the antitumor compound PM060184 combined with gemcitabine. IDI-20150007

It is a prospective, open-label, dose-escalation study with the aim of evaluating the safety profile, studying the pharmacokinetics characteristics and determining the preliminary antitumor activity of the PM060184/gemcitabine combination after intravenous administration to patients with advanced solid tumors for which there are no alternative therapeutic options. Duration: 2014-2017.

Finished Projects

Spanish Partnerships

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  • MARINMAB: Development of a New Generation of Anticancer Therapies: Antibody-Marine Drug Conjugates. Reference: IPT-2012-0198-090000
  • ORALBEADS: Development of solid/nanostructural pathways for the oral administration of antitumoral marine compounds. IPT-2011-0754-900000
  • BIOKETIDO: Marine Poliketides in oncology. Development of bioprocesses for the supply of marine anti-tumoral compounds based on biotechnology. IPT-2011-0752-900000
  • POLYSFERA: Polymeric nanocapsules for the controlled and targeted liberation of antitumoral drugs. IPT-090000-2010-1

 

International Partnerships

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  • MULTIFUN: Multifunctional Nanotechnology for selective detection and Treatment of cancer. Reference: 262943. Call FP7 NMP.
  • MICRO B3: Marine Microbial Biodiversity, Bioinformatics and Biotechnology. Reference: 287589. Call FP7 OCEAN.
  • MACUMBA: Marine Microorganisms: Cultivation Methods for Improving their Biotechnological Applications. Reference: 311975. Call FP7 KBBE.
  • DENDREAMERS: Functional Liquid Crystal Dendrimers: Synthesis of New Materials, resource for New Applications. FP7-P-2007-1-1-ITN
  • MULTIFUN: Multifunctional Nanotechnology for selective detection and Treatment of cancer. FP7-NMP-2010-262943
  • NANOTHER: Integration of novel nanoparticle based technology for therapeutics and diagnosis of different types of cancer. FP7-NMP-2007- 213631
  • MAMBA: Marine metagenomics for new biotechnological Application. FP7-KBBE-2008-3-2-2007
  • OPTATIO: OPtimizing TArgets and Therapeutics In high risk and refractOry Multiple Myeloma. FP7-H-2011-278570-2
  • METAFIGHT: Understanding and fighting metastasis via dissection of the Core Invasive Machinery. FP7-H-2007-201862

 

Individual Projects

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  • The incorporation of novel technology for the production of trabectedin. RCI-010000-2013-15
  • More industrialized, optimal and sustainable processes re-engineering for obtaining PM1183. SEI-010000-2012-195
  • New high capacity, sustainable, safe and efficient processes focused on innovative products and therapies in the treatment against cancer. SEI-010000-2011-102

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  • The evaluation of systems administration through the inhalatory route for lung cancer studies in rodent models. PPT-300000-2009-004
  • New antitumor metabolites produced by marine fungi. PPT-090000-2009-003

 

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  • Technical development of the synthesis, escalation and formulation for the manufacture of the marine antitumoral compound, lurbinectedin (PM1183). IDI-20130950
  • Evaluation of the marine antitumoral compound (PM1183) in patients with Non Small Cell Lung Cancer in combination with paclitaxel in patients with advanced solid tumors. IDI-20130938
  • Lurbinectedin: Study of the pharmacological and clinical behavior in combination with capecitabine, and an evaluation of the antitumoral activity in Breast Cancer. IDI-20130013

 

Proyectos_finalizados-logo_ministerio_ciencia_innovacion

  • Identification of the molecular markers of the drug response to antitumoral drugs. IAP-570000-2008-64
  • Research and clinical development of new antitumoral compounds. IAP-570000-2008-3
  • Research and development of the antitumoral compounds: Zalypsis and Aplidin. IAP-560200-2008-67
  • Molecular markers. CIT-09100-2007-20
  • Industrial development of antitumoral compounds, Zalypsis and Aplidin. FIT-320100-2007-48
  • Development and scaling of the manufacturing process for Aplidin. FIT-320100-2006-92
  • Bioprospecting at PharmaMar 2006. The discovery of innovative drugs of marine origin against cancer. FIT-320100-2006-78
  • Clinical R&D program for new antitumoral drugs from PharmaMar 2007. FIT-090100-2007-15
  • Clinical R&D program for new antitumoral drugs from PharmaMar 2006. FIT-090100-2006-72

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