Sareum Regulatory News (SAR)

This announcement contains inside information for the purposes of Article 7 of Regulation 596/2014

SAREUM HOLDINGS PLC

("Sareum" or "the Company")

Sareum regains worldwide rights to small molecule Aurora+FLT3 inhibitors in preclinical development targeting haematological cancers

Sareum Holdings plc (AIM: SAR), the specialist cancer drug discovery and development business, announced that it has regained worldwide rights to preclinical-stage small molecule inhibitors of Aurora and FLT3 kinases that have shown potential in acute myeloid leukaemia (AML) and other haematological cancers. The rights have been returned by Hebei Medical University Biomedical Engineering Center (HMUBEC), a pharmaceutical research and development group based in China that has been conducting preclinical development activities.

Aurora+FLT3 kinase inhibitors target two mechanisms that are considered important in the progression of certain cancer types: Aurora kinase is involved in the control of tumour cell mitosis (cell division), and FLT3 kinase over-activation is the most common mutation in AML. The preclinical development candidate to which Sareum regains rights has showed particular promise against a range of haematological cancer models including AML and Acute Lymphoblastic Leukaemia (ALL) with good tolerance of the candidate drug at the predicted therapeutic dose, and no significant side effects being seen.

As part of the reversion package, Sareum will receive all preclinical data generated by HMUBEC and full control over the future preclinical development programme for both intravenous (IV) and oral formulations of candidates. HMUBEC will retain a low-mid single digit percentage of net revenues that Sareum may receive from any future licence agreement or sales of Aurora+FLT3 inhibitors. In regaining the worldwide rights, there is no immediate or material financial impact to Sareum. The company will review the full preclinical data package over the coming months and consider the best way forward with these assets.

The termination of the 2013 agreement with HMUBEC is a result of several factors, including ongoing issues relating to the intravenous (IV) formulation, which are preventing higher doses from being explored to establish maximum-tolerated dose, thereby delaying the completion of toxicity studies, coupled with organisational changes at HMUBEC.

Sareum has been funding formulation specialists in the UK to try and resolve the IV formulation issue to enable preclinical studies to complete. In parallel, Sareum is beginning to explore the potential of orally available formulations of the lead Aurora+FLT3 inhibitor candidate.

Dr Tim Mitchell, CEO of Sareum, commented: "The work done to date by HMUBEC has provided encouraging insights to the potential of the lead Aurora+FLT3 inhibitor candidate in AML and other haematological cancers. We are pleased to regain the worldwide rights to these inhibitors, particularly as recent industry activity suggests a resurgence of interest in Aurora kinase as a target for cancer drugs. In taking back full control, we now have the flexibility to further address the IV formulation issues and fully explore oral routes of administration including the use of novel delivery technologies that have emerged in recent years. We will provide a further update on our plans with these molecules once we have completed a review of the data and our options."

For further information, please contact: 

Notes for editors: 

Sareum is a specialist drug discovery and development company delivering targeted small molecule therapeutics, focusing on cancer and autoimmune disease, and generating value through licensing them to international pharmaceutical and biotechnology companies at the preclinical or early clinical trials stage.

Its most advanced programme, SRA737, is a novel Checkpoint kinase 1 (Chk1) inhibitor licensed to NASDAQ-listed Sierra Oncology and in clinical trials targeting a range of advanced cancers. The key role of Chk1 in cancer cell replication and DNA damage repair suggests that SRA737 may have broad application as a targeted therapy in combination with other oncology and immune-oncology drugs in genetically defined patients.

Sareum is also advancing programmes to develop novel tyrosine kinase 2 (TYK2) inhibitors in autoimmune diseases and cancers, and Aurora+FLT3 inhibitors in haematological cancers, which are in the IND-enabling preclinical and lead optimisation stages.

The Company's drug discovery technology platform (SKIL® - Sareum Kinase Inhibitor Library) is being applied to generate drug research programmes against other kinase targets.

Sareum Holdings plc is listed on the AIM market of the London Stock Exchange, trading under the ticker SAR. For further information, please visit www.sareum.co.uk 

- Ends -