Sareum Regulatory News (SAR)

(AIM: SAR) 16 May 2019

Sareum Holdings PLC

("Sareum" or the "Company")

Sareum notes that Sierra Oncology has provided an update on its clinical data presentations at ASCO 2019 with SRA737 (a Chk1 inhibitor) in subjects with advanced cancer

Sareum Holdings plc (AIM: SAR), the specialist small molecule drug development business, notes that Sierra Oncology (the licence holder for Chk1 inhibitor SRA737) has provided further information relating to presentations of preliminary clinical data from its Phase 1/2 SRA737 monotherapy study and its Phase 1/2 study of SRA737 in combination with low dose gemcitabine (SRA737+LDG) at the upcoming 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, USA (31 May-4 June 2019).

Two abstracts (published late yesterday) will be presented in poster presentations on Saturday, 1 June.

ASCO 2019 Poster Presentations

Title: A first-in-human phase I/II trial of SRA737 (a Chk1 Inhibitor) in subjects with advanced cancer

Abstract: 3094

Poster #: 86

Poster Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)

Date and Time: Saturday, 1 June, 8:00 - 11:00 am CT

Location: McCormick Place, Event room: Hall A

The published abstract can be accessed by clicking here and its conclusions are as follows:

In this first-in-human trial of SRA737 monotherapy, the MTD (maximum tolerated dose) was 1000 mg/day and based on overall tolerability and PK (pharmacokinetics), the recommended Phase 2 dose is 800 mg/day. The successful enrolment of prospectively-selected genetically-defined subjects will allow response data to be correlated with genomic profiles hypothesized to confer sensitivity to Chk1 inhibition.

Title: A phase I/II first-in-human trial of oral SRA737 (a Chk1 inhibitor) given in combination with low-dose gemcitabine in subjects with advanced cancer

Abstract: 3095

Poster #: 87

Poster Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)

Date and Time: Saturday, 1 June, 8:00 - 11:00 am CT

Location: McCormick Place, Event room: Hall A

The published abstract can be accessed by clicking here and its conclusions are as follows:

The combination of LDG and SRA737 has been well tolerated. This first-in-human clinical study provides proof-of-concept that sub-therapeutic LDG effectively potentiates SRA737. This novel replication stress-targeted therapy warrants further evaluation in genetically pre-defined solid tumors.

Both posters will be available on 1 June at www.sierraoncology.com 

Dr Nick Glover, President and CEO of Sierra Oncology, commented "We look forward to presenting preliminary data for these first-in-human studies of SRA737 and SRA737+LDG at ASCO, and to discussing the potential opportunities for further advancement of our differentiated Chk1 inhibitor that these clinical data provide.

"The two studies have enrolled patients across a range of tumor indications including a variety of prospectively selected genetic contexts, allowing us to broadly survey the cancer landscape for activity signals in response to administration of SRA737 alone and in combination with non-cytotoxic low dose gemcitabine. These preliminary data have also enabled us to correlate clinical findings with tumor origin and genetic signature, ascertain whether the exogenous induction of replication stress via low dose gemcitabine can enhance SRA737's activity, and determine potential next steps in the development path for SRA737."

SRA737 Analyst & Investor Event

In addition, Sierra Oncology will be hosting an Analyst and Investor Event from 6:00 - 7:00 am CT on Monday, 3 June to discuss these clinical findings and potential next steps in the development strategy for SRA737. The event will feature presentations by two distinguished oncologists:

· Professor Johann de Bono, Regius Professor of Cancer Research, Head of the Division of Clinical Studies and Professor in Experimental Cancer Medicine at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust; and

· Dr Rebecca Kristeleit, Clinical Senior Lecturer and Honorary Consultant Medical Oncologist at University College London (UCL) Cancer Institute & UCLH Dept. of Oncology, a leading expert in gynaecological malignancies.

Location: History event room, Marriot Marquis Hotel, 2121 S Prairie Ave, Chicago, IL, USA. Event registration and webcast information are available at www.sierraoncology.com, and an archive of the presentation will be accessible after the event through the Sierra Oncology website.

The full announcement from Sierra Oncology can be found by clicking here.

For further information, please contact: 

Notes for editors: 

Sareum is a specialist drug development company delivering targeted small molecule therapeutics, to improve the treatment of cancer and autoimmune disease. The Company generates value through licensing its candidates to international pharmaceutical and biotechnology companies at the preclinical or early clinical trials stage.

Sareum's leading clinical-stage programme, SRA737, a novel Checkpoint kinase 1 (Chk1) inhibitor licensed to NASDAQ-listed Sierra Oncology, is in Phase 2 clinical trials targeting ovarian and other 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 internal programmes focused on distinct dual tyrosine kinase 2 (TYK2) /Janus kinase 1 (JAK1) inhibitors through preclinical development as therapies for autoimmune diseases (SDC-1801) and cancers (SDC-1802). TYK2 and JAK1 have roles in pro-inflammatory responses in autoimmune diseases (e.g. psoriasis, rheumatoid arthritis, inflammatory bowel diseases and lupus) and tumour cell proliferation in certain cancers (e.g. T-cell acute lymphoblastic leukaemia and some solid tumours). The Company is targeting first human clinical trials in each indication in 2020.

The Company also has an Aurora+FLT3 inhibitor targeting haematological cancers, which is at the preclinical development stage.

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

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