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Date: 2018-02-01

Type of information: Granting of a patent

Product name: Clevegen® and Clever-1 antibodies

Compound:

Therapeutic area: Cancer - Oncology

Action mechanism:

  • monoclonal antibody. Clevegen® is an antibody designed to prevent tumour growth and metastasis which targets the tumour immune suppressor molecule, Clever-1. Clever-1 is an adhesion, scavenging and signaling molecule involved in cancer growth and is found in lymphatic and vascular endothelium as well as type 2 immunosuppressive macrophages. When Clever-1 is blocked, tumour-associated macrophages (TAM) cannot enter the tumour site and their function in the tumour as an immune suppressive cell is diminished. Both these events change the tumour environment from immune suppression to immune stimulation, allowing the host immune system to fight the tumour cells.

Company: Faron Pharmaceuticals (Finland)

Disease:

Latest news:

Patents:

  • • On February 1, 2018, Faron Pharmaceuticals announced that the European Patent Office has granted Faron a European Patent (No. 2421888) for the use of Clever-1 antibodies, the mechanism behind Clevegen•, for the treatment of cancer. Clevegen, Faron's second wholly-owned pipeline product, is a novel anti-Clever-1 antibody which causes changes in the immune environment of solid tumours by switching immune suppressive M2 macrophages to immune active M1 macrophages. Faron plans to initiate clinical Phase I/II Clevegen development in 2018. The planned initial Phase I/II trial will target patients with liver, melanoma, ovarian and pancreatic cancer as part of an adaptive protocol design, which is currently under review by regulators, with feedback anticipated in 2018.
  • The field of the patent invention is: an agent capable of modulating the Clever-1 receptor on the type 2 macrophage cell, that in addition to the mannose receptor, also expresses the Clever-1 receptor for use in the treatment of cancer. This decision extends the existing patent estate for Clevegen until 2030. Additional IP around Clevegen's mechanism is being sought that could extend protection to the end of 2038.

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

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UE authorization:

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Favourable opinion USA:

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Orphan status UE:

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Pediatric exclusivity UE:

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Other news:

Is general: Yes