CHR2797

This orally active aminopeptidase inhibitor is currently being developed by our partner, CTI BioPharma (CTI). This compound was originally partnered with Chroma Therapeutics (a UK venture capital backed cancer research specialist) who advanced CHR2797 (Tosedostat) through its early clinical development. In 2012, Chroma licensed the compound to CTI for development in the Americas. In October 2014, CTI became world-wide licensee and Chroma no longer has any rights or financial interest in CHR2797 (Tosedostat).

 

Description

Orally active CHR2797 (Tosedostat) has been shown to halt cell growth and cause apoptosis (cell death) in a large number of cancer cell lines, without seeming to have any adverse impact on normal healthy cells.

  • In development by CTI BioPharma
  • Positive data from latest Phase II study announced in June 2015
  • Potential Phase III registration study
  • Granted orphan drug status for AML by both US FDA and the EMEA
  • Royalties due on future sales

Background

CHR2797 (Tosedostat) is a first-in-class, once daily, orally active aminopeptidase inhibitor which has been shown to halt cell growth or cause apoptosis (cell death) in a large number of cancer cell lines without having any impact on normal cells. It is in development by CTI BioPharma, and Vernalis will receive royalties on future sales.

Pre-clinical studies

CHR2797 (Tosedostat) has successfully completed a number of pre-clinical studies that demonstrated proof-of-concept.

Clinical studies

Pre-clinical studies completed. Chroma undertook Phase I and II clinical studies and in December 2008 announced positive data from a Phase II study in the treatment of patients with haematological malignancies. Final results from the OPAL Phase II study were announced in December 2011 which demonstrated a significant response rate in elderly patients with relapsed or refractory acute myeloid leukemia (AML).

In March 2011 Chroma signed a licensing deal for North, Central and South America with Cell Therapeutics, Inc. (CTI) who intend to progress CHR2797 (tosedostat).  In June 2012, CTI initiated a Phase II study for elderly patients with newly-diagnosed AML or high-risk myelodysplastic syndrome (MDS), with positive data being announced in June 2015. Results showed the combination of CHR2797 (Tosedostat) with low dose cytarabine/Ara-C resulted in an overall response rate of 54% in elderly patients with AML, with 45% of patients achieving durable complete responses. CTI have confirmed they are continuing to advance the development of CHR2797 including the potential for a Phase III registration study in primary AML or AML that evolves from MDS.

Project Status

In March 2011, Chroma announced a licensing deal with Cell Therapeutics, Inc., now called CTI BioPharma Corp (CTI), for North, Central and South America along with the news that CHR2797 (Tosedostat) has been granted orphan drug status by the US FDA and EMA. CTI will now be responsible for further development. In June 2012, CTI initiated a Phase II study for elderly patients with newly-diagnosed acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome (MDS), with positive results announced in June 2015. CTI have confirmed they continue to advance the development of CHR2797, including the potential for a Phase III study.  Vernalis will receive royalties on future sales.

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