TIDMSAR
RNS Number : 8467A
Sareum Holdings PLC
03 June 2019
(AIM: SAR) 3 June 2019
This announcement contains inside information for the purposes
of Article 7 of regulation 596/2014
Sareum Holdings PLC
("Sareum" or the "Company")
Sareum notes that positive preliminary efficacy data from Phase
1/2 clinical trials with SRA737 in advanced cancer were presented
at ASCO 2019 - potential path to registration outlined
-- 30% response rate for SRA737 + low dose gemcitabine (LDG) in anogenital cancer
-- Anti-cancer activity demonstrated across multiple indications and genetic profiles
-- Sierra Oncology to discuss clinical findings and next steps
for SRA737 at Analyst & Investor Event and live webcast today
at 12:00 BST
Sareum Holdings plc (AIM: SAR), the specialist small molecule
drug development business, notes that Sierra Oncology (the licence
holder for Chk1 inhibitor SRA737) reported positive preliminary
clinical data from its two first-in-human Phase 1/2 studies of
SRA737 as monotherapy and as SRA737+LDG (SRA737 potentiated by low
dose gemcitabine) at the 2019 Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Chicago, IL. Anti-cancer
activity was demonstrated across multiple indications and genetic
contexts, with SRA737+LDG specifically achieving a notable 30%
response rate in anogenital cancer patients.
The data and further analyses can be found in the announcement
made on Saturday 1 June by Sierra Oncology (click here) and in both
posters, which are available here. A live webcast of the Analyst
& Investor Event taking place today at 12:00 BST can be
accessed by clicking here.
Dr Tim Mitchell, CEO of Sareum Holdings, said: "We are extremely
encouraged by the preliminary clinical data that Sierra announced
from its clinical programme with SRA737 at ASCO over the weekend.
The results demonstrate the exciting potential of SRA737 in
patients whose cancer type and genetic profile may confer and
enhance sensitivity to this novel drug candidate, and open pathways
for its advancement into the next stages of development towards
registration. We look forward to providing updates on this exciting
prospect as further progress is made and important development
milestones are reached."
SRA737 was discovered and initially developed by scientists at
The Institute of Cancer Research, London, UK in collaboration with
Sareum, and with funding from Cancer Research UK. SRA737 was
licensed to Sierra Oncology for up to $328.5 million plus royalties
by co-investment partner, CRT Pioneer Fund. Sareum is eligible to
receive up to $88 million in milestone payments, plus sales
royalties as SRA737 advances.
Commenting further on the clinical results, Dr Mitchell, added:
"Sierra has designed its clinical trials with SRA737 to make use of
the most advanced concepts in tumour evaluation with the goal of
identifying indications and gene mutations most likely to sensitise
tumours to SRA737, and thereby guide patient selection in future
registration-oriented trials.
"The most striking efficacy findings from these initial clinical
trials were in patients receiving the SRA737+LDG combination, where
sub-therapeutic LDG was shown to potentiate the activity of SRA737,
as hypothesised. In this trial, a clear efficacy signal was
observed across patients with anogenital/cervical cancer, with the
most pronounced anti-tumour activity seen in anogenital cancer
patients. Second-line metastatic anogenital cancer represents a
significant unmet medical need with no approved therapies. Based on
the results, the authors suggest SRA737+LDG could represent a
potentially efficacious treatment option for these patients and
warrants additional registration-intent studies.
"In the SRA737 monotherapy study, there was evidence of
anti-tumour activity (tumour reduction) in subjects with high-grade
serous ovarian cancer (HGSOC), colorectal, prostate and non-small
cell lung cancer, with HGSOC appearing to be the most sensitive
tumour type. Durable responses (stable disease >= 4 months) were
observed in all expansion cohorts except head and neck cancer.
"In both reported trials, recommended doses of SRA737 and
SRA737+LDG were shown to be safe and well tolerated, highlighting
the class-leading safety profile of SRA737. The emerging insight to
the correlation between clinical response with genetic profile also
demonstrates the potential for patient selection and combining
SRA737 with other therapeutic approaches under consideration for
further investigation, such as PARP inhibitors and immune
checkpoint blockade."
Professor Udai Banerji, Deputy Director of the Drug Development
Unit at The Institute of Cancer Research, London and The Royal
Marsden NHS Foundation Trust, said: "These studies have shown the
potential of SRA737 as a possible future treatment for a range of
cancer types, with some encouraging results in combination with
low-dose chemotherapy in anogenital cancers.
"It's a pleasure to see a drug discovered here at the ICR and
progressed through development with our partners show potential as
a future treatment. Hopefully, further trials will firmly establish
the effectiveness of the drug and provide a new option for patients
for whom new options are urgently needed.
"Now that the dose and schedules of administration have been
established in cancer patients, it will be possible to explore
further combinations of SRA737 with other drugs across different
cancers where very interesting preclinical data has been seen."
Professor Paul Workman, Chief Executive of The Institute of
Cancer Research, London, said: "At the ICR, we believe that the
future of cancer treatment is precision medicines, increasingly
used as part of drug combinations, that exploit genetic weaknesses
within cancer to overcome or delay drug resistance. The Chk1
inhibitor SRA737, which was discovered at the ICR with our partners
Cancer Research UK and Sareum and is now being taken forward by
Sierra Oncology, is an excellent example of such an innovative,
highly targeted treatment. I am delighted to see the presentation
of these results which indicate that SRA737 has the potential as
part of combination therapy to benefit some patients with cancers
of the anus and genitals - a group of diseases for which there are
few therapeutic options."
An announcement on the results by the ICR can be found here
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
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
Both posters can be accessed here.
SRA737 Analyst & Investor Event
Sierra Oncology will host an Analyst and Investor Event today
from 12:00-13:00 BST to discuss the 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.
Details for joining the live webcast are available here and an
archive of the presentation will be accessible after the event
through www.sierraoncology.com.
For further information, please contact:
Sareum Holdings plc
Tim Mitchell 01223 497 700
WH Ireland Limited (Nominated Adviser)
Chris Fielding / James Sinclair-Ford 020 7220 1666
Hybridan LLP (Nominated Broker)
Claire Noyce 020 3764 2341
Citigate Dewe Rogerson (Media enquiries)
Shabnam Bashir/ Mark Swallow/ David
Dible 020 7638 9571
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
- Ends -
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END
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