TIDMSAR
RNS Number : 0336C
Sareum Holdings PLC
13 June 2019
(AIM: SAR) 13 June 2019
This announcement contains inside information for the purposes
of Article 7 of regulation 596/2014
Sareum Holdings PLC
("Sareum" or the "Company")
Portfolio Update
Sareum Holdings plc (AIM: SAR), the specialist small molecule
drug development business, follows the Company's recent
announcements on SRA737 with an update on other developments within
its active preclinical portfolio.
The Company's active development portfolio comprises candidates
being developed internally (SDC-1801 and SDC-1802) and a partnered
programme (SRA737) that is out-licensed to Sierra Oncology.
These potent and selective small molecules target important
mechanisms in cancer and autoimmune diseases and provide
potentially high-value opportunities to develop new therapies for
patients.
Selective TYK2/JAK1 Inhibitors in Autoimmune Diseases and
Cancer
Sareum's internal programmes focus on distinct dual tyrosine
kinase 2 (TYK2) /Janus kinase 1 (JAK1) inhibitors, which are
progressing through preclinical development as therapies for
autoimmune diseases (SDC-1801) and cancers (SDC-1802). The Company
is targeting first-in-human clinical trials in 2020.
Both Sareum programmes have progressed well since candidate
nomination in September 2018, building on the compelling efficacy
seen in disease models, the potential for once-daily oral dosing
and good early safety profiles. Data arising from some of this work
are being prepared for submission to a peer-reviewed publication
and a conference presentation.
Sareum's recent activities have focused on toxicology studies
designed to gain insight to the maximum-tolerated doses (MTD) of
SDC-1801 and SDC-1802 in rodents. SDC-1801 is further advanced and
currently demonstrating excellent tolerability with doses up to 30
times the level that gave good responses in efficacy studies; an
MTD has yet to be reached.
Multiple dose-finding studies are now ongoing to identify doses
to use in specific toxicology studies, which are intended to form
part of the applications for initial human trials. Additional
research to refine the clinical plans, including prioritisation of
potential target indications, is continuing.
In addition, the Company has been exploring robust manufacturing
routes to produce each candidate for preclinical and clinical
studies. Such a route has been developed for SDC-1801 and
activities continue to confirm a route of synthesis for
SDC-1802.
Dr Tim Mitchell, CEO of Sareum Holdings, commented: "We believe
there is a clear opportunity to generate significant value for our
shareholders over the next 12 months, given recent progress with
both our clinical and preclinical programmes.
"The potential for our two preclinical TYK2/JAK1 inhibitors in
autoimmune diseases and cancer is gaining increasing clinical
validation and we are convinced that SDC-1801 and SDC-1802
represent strong and well-differentiated candidates to address
diseases within these areas. We are focused on advancing these
exciting preclinical candidates towards human trials as quickly as
possible, aiming for first-in-man studies to begin in 2020.
"With respect to SRA737, the Phase 1/2 data that were presented
at the recent ASCO meeting by Sierra Oncology give us increasing
confidence in its potential to become an attractive new therapeutic
option for cancer patients. Sierra has proposed a
registration-intent Phase 2 trial as a route to market in
anogenital cancers for this exciting prospect, with potential for
accelerated approval and payments due to Sareum linked to the
achievement of certain milestones. Registration-intent Phase 2
trials represent an efficient approach to accelerate time to market
for drugs intended to treat life-threatening diseases where no
effective treatment exists.
"Anogenital cancer represents a distinct and substantial market
opportunity as there are currently no 2(nd) -line therapies
approved once chemotherapy becomes ineffective and these patients
have a very poor life expectancy. The striking anti-tumour activity
reported in the SRA737+Low Dose Gemcitabine (LDG) trial is a
notable result, considering the advanced state of the cancers and
the extent of previous treatments that patients received.
"Both Sierra and Sareum believe that SRA737 is competitively
positioned as potentially one of the leading clinical assets in its
class. In both trials, the treatments were safe and well tolerated,
with the majority of adverse events being only mild or moderate.
The safety profiles of SRA737 monotherapy and SRA737+LDG were
markedly superior to those of recently discontinued molecules from
Lilly (prexasertib) and Genentech/Roche (GDC-0575).
"Additionally, we continue to seek other opportunities to which
the Company could add value and grow the business, and our recently
expanded Board is instrumental in this search."
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 multiple
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.
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 our co-investment partner, CRT Pioneer Fund. Sareum is eligible
to receive up to $88 million in milestone payments, plus sales
royalties as SRA737 advances.
Notable highlights from the Phase 1/2 preliminary results
reported by Sierra at ASCO were:
SRA737 + low dose gemcitabine (LDG) combination
-- Striking anti-tumour activity was observed in patients with
anogenital cancer, including examples where metastatic disease was
cleared from liver and lung.
-- Tumour size decreased by more than a third in 30% of the
evaluable anogenital cancer patients and a further 30% had durable
stable disease.
-- Sierra outlined a potential route to market for SRA737+LDG in
anogenital cancer via a registration-intent Phase 2 trial.
SAR737 monotherapy
As expected, high-grade serous ovarian cancers (HGSOC) appeared
to be the most sensitive tumour to SRA737, with the disease being
controlled (stable disease) in 54% of evaluable 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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