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REVER3MAB: "An ambitious project for the development of an innovative biological drug"?

15 June 2018

IBI collaborates in the development of an innovative biological drug to revert resistance to conventional cancer treatments: project: REVER3MAB (EU, State and Region)

The project aims to develop studies on an innovative biological drug to reverse resistance to conventional cancer treatments. The acronym "REVER3MAB" identifies a monoclonal antibody, directed against the ErbB3 protein able to block the proliferation of tumor cells in vitro and in vivo, with potential use as a therapeutic agent in the clinic.

As a whole, REVER3MAB has very ambitious objectives: the development of Rever3mAb for clinical trials, the optimization of treatment protocols to be applied in humans, the set up of the ImmunoAvatar model and the molecular and immunological characterization of melanoma and NSCLC tumors functional to the project, with the creation of a tissue biobank - samples from patients - unique in Lazio, which can be very useful for future studies. The development of methods for the industrial scale production of Rever3mAb is also planned.

The design idea and the related investment program are the result of the active collaboration of two industrial companies, a Large and a Micro Enterprise of the biotechnological/pharmaceutical sector, respectively IBI - Istituto Biochimico Lorenzini Spa and Takis srl and a Research Organization, Hospital Physiotherapeutic Institutes - Regina Elena Institute IRCCS.

The partners are geographically located exactly in the center of the DTB Technological District of the Lazio Biosciences area, created in 2008. All three partners contribute to the implementation of the Integrated Project, as required by the Call. The project started on 1 September 2017 and will finish by the first half of July 2019.

The REVER3MAB Project is coordinated by Takis in the persons of Dr. Luigi Aurisicchio - Head of Administration and Science and of Dr. Giuseppe Roscilli - Director of the Antibodies department with his team. Takis developed the antibody and obtained important preclinical evidence of its effectiveness and its mechanism of action.

 

The project managers for IBI are: Dr. Loredana Cecchetelli - Director of Research and Development; Dr. Stefano Franceschini - Head of the Biotechnology Department. The IBI will have the task of developing an industrial production process of the Rever3mAb antibody, dealing with the development of the cell line, the selection of the clone, the optimization of the up and down-stream phases and the analytical characterization of the final product. A production process in GMP will be achieved, adequate for the production of the drug to be used for the preclinical and for the phase I clinical trial.

 

The project managers for IFO-IRE are Dr. Paola Nisticò - UOSD Immunology and Tumor Immunotherapy, Department of Research, Advanced Diagnostics and Technological Innovation and Dr. Maurizio Fanciulli - UOSD SAFU Department of Research, Advanced Diagnostics and Technological Innovation. For the realization of the project, IFO-IRE will provide the equipment for immunohistochemical analysis, available at the Pathological Anatomy Unit, as well as the equipment necessary for cell biology procedures, immunological monitoring including cytofluorimetry platform and the Luminex platform. In addition, Illumina and Thermo Fisher equipment will be available for DNA sequencing, nucleic acid analysis equipment, a Nanostring platform and several real time PCRs.

Purposes

The REVER3MAB project represents the tool to drive the development of this drug through that phase which is called the "Death Valley" of the development of biotechnological drugs. The tasks foreseen by the project will allow an advancement of the knowledge to support the industrialization of the involved realities and the innovative product studied. They can act as a motor to obtain further funding or they will be functional to a strategic alliance with other companies, in order to continue the development of antibodies as therapeutic, with the preparation of regulatory documentation (IMPD and / or IND) and the execution of a phase 1 clinical study. The drug trial may lead to its possible sale to large pharmaceutical groups on the international market.

Results

The REVER3MAB project has ambitious objectives: the development of the antibody for clinical trials, the optimization of treatment protocols to be applied in humans, the set up of the ImmunoAvatar model and the molecular and immunological characterization of melanoma and NSCLC tumors.

Takis will characterize REVER3MAB in the laboratory and will perform preclinical efficacy and combination studies with other drugs to identify the best therapeutic protocol to propose for a clinical study.

IBI, thanks to its experience in the production of active biotechnology and injectable finished products, will contribute to the project by developing a production process according to GMP requirements. An antibody will be obtained at the end of all activities, usable for preclinical tests on animals and ready for Phase I trials in humans.

IFO-IRE will contribute to the project by providing samples of tumor tissues, peripheral blood lymphocytes, serum / plasma of patients with NSCLC and melanomas, detailed characterized by phenotypic and molecular analysis, thus allowing the production of innovative tumor models with wide applicability in the field biomedical, the ImmunoAvatar by Takis.

Financial support received

The total investment of the project admitted to the contribution is equal to Euro 1,216,490.00, on which expenditure Lazio Innova has granted a non-repayable loan of Euro 847,742.00. The funding resources are based on the public notice "LIFE 2020" no. G08726 of 29.07.16, project code A0112E0114, CUP: F87H18000370007.

Part of the activities foreseen by the project will be carried out with the financial support of the proponents, partners of the ATS.

www.europa.eu

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