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A novel human epidermal growth factor receptor-3 targeting antibody-drug conjugate for treatment of cancer

Country of Origin: Italy
Reference Number: TOIT20191114001
Publication Date: 25 November 2019

Summary

An Italian SME specialized in drug discovery has developed and patented a novel human epidermal growth factor receptor-3 (HER-3) targeting antibody-drug conjugate (ADC) for treating cancer. This molecule has shown potent therapeutic efficacy combined with a good safety profile. 
The company is looking for pharmaceutical companies or investors for financial or license agreement to further develop the product in clinical trials. A research cooperation agreement is also foreseen.

Description

HER-3 plays an important role in the growth, progression and development of drug resistance in several cancers. HER-3 is kinase impaired, therefore its inhibition can only be obtained through use of a neutralizing antibody. 
Several “naked” monoclonal antibodies targeting HER-3 have been developed, however the results from the clinic have revealed a modest effect in several types of cancer. It is conceivable that a substantial improvement over this immunotherapeutic approach could rely on an anti-HER3 based ADC.

An Italian SME located in Central Italy, specialized in drug discovery, has developed and patented an anti-HER3 monoclonal antibody which has been used as a building block of a HER-3 targeting ADC. This molecule has shown potent therapeutic activity against several types of cancer and has good safety profile combined with a favorable pharmacokinetics.
The product is in pre-clinical stage of development. In order to submit the application for phase 1 trial, the following steps have to be performed: (i) generation of a stable antibody producing cell line and a master cell bank (ii) production of drug substance batch and performing a toxicology study (iii) production of clinical drug substance batches.

Pharmaceutical companies or investors for financial or license agreement to further develop the product in clinical trials are sought. The company is also interested in a research cooperation agreement.

Advantages and Innovations

The company has generated a novel ADC by coupling its proprietary anti-HER3 humanized monoclonal antibody with a potent cytotoxic antitumor drug through a linker.  

Compared with the naked antibody, the resulting ADC displays a potent, long lasting remission of several types of cancer. Also, the product shows a good safety profile in animals combined with favorable pharmacokinetics.

HER-3 is overexpressed in more than 50% of human cancers. Therefore, possible indications in oncology are manifold and include, among others: lung cancer, colorectal cancer, ovarian cancer, prostate cancer, breast cancer resistant to anti-HER2 drugs and melanoma.
ADC is one of the fastest growing segments of the global pharmaceutical industry, with six ADCs approved and more than 80 in clinical development.

Stage Of Development

Under development/lab tested

Requested partner

The company is looking for pharmaceutical companies or investors (VC, Banks, Private Investors) interested in financial or license agreement to further develop the product in clinical trials. A research cooperation agreement with a technological partner (pharmaceutical company, R&D Institutions) with expertise and interest in therapeutic antibody or/and ADC technology could also  be considered. During the cooperation, the partner is expected to set-up and upscaling manufacturing process of the anti-HER3 antibody in accordance with good manufacturing practice (GMP) and regulatory, among others.

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