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HUMANIZED MONOCLONAL ANTIBODIES

3 mAbs (hematological malignancies and/or solid tumors)

ONCOLOGY

Current development phase: Phase preclinical

preclinical
phase i
phase ii
phase iii
preregistration.

In 2012, Menarini initiated a partnership with the British Company Oxford BioTherapeutics, for the development of 5 innovative monoclonal antibodies for the treatment of cancer. 

New humanized monoclonal antibodies (mAbs), against newly identified antigen oncology targets, acting through Antibody Dependent Cell Cytotoxicity (ADCC) or as Antibody Drug Conjugated (ADC-antibody linked to a toxin) will be developed.

Selective and high affinity mAbs are being generated by OBT. Characterization of these mAbs in terms of binding characteristics, in vitro efficacy (ADCC, cytotoxicity, internalization), in vivo efficacy (xenograft models) and exploratory toxicology are ongoing. 

The antibodies have been designed to bind specifically the cancer cells. They can act either as "intelligent missiles" in order to deliver the toxins to destroy the cancer cells (ADC, Antibody Drug Conjugate, mechanism of action), or as death "mediator" of cancer cells through the activation of "killer" cells of the immune system (ADCC, Antibody-Dependent Cellular Toxicity, mechanism of action). 

Menarini will be responsible for: (i) development and commercial manufacturing, (ii) regulatory non-clinical development, (iii) clinical development phase I to phase III and (iv) regulatory submission to main Regulatory Agencies

For two antibodies the preclinical/clinical development has already started:

  • MEN1112, an ADCC in clinical phase I for acute myeloid leukemia 
  • MEN1309, an ADC in clinical phase I for B-Non-Hodgkin lymphoma and solid tumors like some subpopulations of  breast cancer

Press Release 29/10/2012

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