TIDMSAR
RNS Number : 1399K
Sareum Holdings PLC
27 August 2019
(AIM: SAR) 27 August 2019
The information contained within this announcement is deemed by
the Company to constitute inside information under the Market Abuse
Regulation (EU) No. 596/2014
Sareum Holdings PLC
("Sareum" or the "Company")
Pre-Close Trading Statement
Sareum Holdings plc (AIM: SAR), the specialised small molecule
drug development business, provides the following trading update
ahead of its full year results for the year ended 30 June 2019.
Sareum expects to report its full audited annual results by
mid-October 2019.
Operational Highlights
Selective TYK2/JAK1 Inhibitors in Autoimmune Diseases and
Cancer
-- Advancing two distinct molecules selected from our
proprietary dual tyrosine kinase 2 (TYK2) / Janus kinase 1 (JAK1)
programmes as potential therapies for autoimmune diseases
(SDC-1801) and cancers (SDC-1802)
-- Programmes continue to attract interest from international pharmaceutical companies
o Both molecules demonstrate high selectivity for TYK2 and JAK1
kinases as well as compelling activity in relevant disease
models
o Drug candidates have the potential for once-daily oral dosing
and have shown a good early safety profile
o Data arising from some of this work are being prepared for
publication via peer-reviewed journal and conference
presentations
-- Formal preclinical development continues to progress well
o SDC-1801 has demonstrated excellent tolerability in toxicology
studies in rodents (as reported in June 2019), with doses up to 30
times the level that displayed good responses in efficacy
studies
o Dosing in two short-term dose range finding studies has now
completed and laboratory analysis of the data obtained is on-going.
These studies have been designed to identify low, medium and high
doses to use in specific longer-term toxicology studies, which
would form part of the regulatory documentation needed to apply to
begin human trials
o A robust manufacturing route has been developed for SDC-1801
to produce active ingredient for both preclinical and clinical
studies and the product required for the next round of toxicology
studies has been delivered. Research is ongoing to find the most
reliable manufacturing process for the best solid form of the
molecule to progress into clinical studies
o Activities continue to confirm an optimal route of synthesis
for SDC-1802. Enough material is in hand to initiate short-term
toxicology studies in rodents
o Additional research to refine the Company's clinical plans,
including prioritisation of indications, is continuing, with
detailed profiling of SDC-1801 in human tissue, and of SDC-1802 in
immune-competent mouse models of cancer. Human clinical trials are
targeted to start in late-2020, subject to successful progress and
financing
SRA737 - Promising Data Presented at International Cancer
Congresses
-- In June 2019, Sierra Oncology ("Sierra"), the licence holder
of SRA737 (an oral selective Chk1 inhibitor), announced promising
preliminary efficacy and safety data at the annual meeting of the
American Society of Clinical Oncology (ASCO) from two ongoing Phase
1/2 clinical trials. These trials were evaluating SRA737 across
multiple indications, as a monotherapy and as a combination,
potentiated by non-cytotoxic low-dose gemcitabine (LDG)
-- The studies delivered highly encouraging results:
o SRA737 demonstrated notable anti-cancer activity in multiple
indications including a 30% Overall Response Rate (ORR) in
evaluable patients with anogenital cancer treated with SRA737+LDG.
Anogenital cancer is an indication for which the second-line
metastatic setting represents a significant unmet medical need,
with there being no approved therapies and a very poor life
expectancy for patients
o Additionally, evaluable subjects whose tumours harboured
distinct genetic profiles (RAS wild type with FA/BRCA gene network
mutations) displayed favourable outcomes across multiple
indications, with an ORR of 25%
-- Sierra has also presented evidence highlighting the potential
of combining SRA737 with other novel therapeutic approaches that
are gaining traction as mainstays of targeted cancer treatment,
including PARP inhibition (PARPi) and immune checkpoint
blockade
o At the DNA Damage Response (DDR) Therapeutics Summit in
January 2019, Sierra noted promising data demonstrating that Chk1
inhibition, with agents such as SRA737, could address the
significant and growing clinical problem of acquired resistance to
PARP inhibitors
o In addition, at the American Association of Cancer Research
(AACR) conference in April 2019, Sierra showed that SRA737+LDG
induced significant anti-tumour activity when combined with
anti-PD-L1 immunotherapy. These data demonstrated durable tumour
regressions in a mouse model of small cell lung cancer (SCLC)
o At an analysts' meeting held during ASCO, Sierra presented
similarly striking data with the SRA737+LDG anti-PD-L1 combination
in a mouse model of colorectal cancer, with 80% regressions
observed following three treatment cycles
SRA737 Development Update
-- In June 2019, following its ASCO presentation, Sierra
announced it was exploring non-dilutive strategic options to
support the next stages of development of SRA737, as it had decided
to prioritise the development of its Phase 3 myelofibrosis
candidate, momelotinib
-- The ongoing SRA737 monotherapy and SRA737+LDG combination
Phase 1/2 studies continue with completion expected in the first
half of 2020
Sareum's Potential Financial Returns from SRA737 - Partial
Details Disclosed for the First Time
-- In its most recent Form 10-Q filing with the US Securities
and Exchange Commission (dated 8 August 2019), Sierra revealed the
following, previously confidential, details of its licensing
agreement with CRT Pioneer Fund ("CPF") in relation to the future
near-term clinical milestones due from the remaining US$319.5
million:
o US$7.5 million would be due upon the dosing of the first
patient in the first Phase 1 trial of SRA737 in the United
States
o US$12.0 million would be due upon the dosing of the first
patient in a randomised Phase 2 trial of SRA737
o US$19.5 million would be payable in the event the milestone
for Phase 2 is achieved but no milestone payment for Phase 1 has
been paid
-- 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
-- CPF licensed SRA737 to Sierra in 2016 for up to US$328.5
million, including an upfront payment of US$7 million and US$321.5
million payable upon the achievement of certain developmental,
regulatory and commercial milestones, plus royalties on future
sales
-- CPF has a Co-investment and Partnership agreement with
Sareum. Under this agreement Sareum is eligible to receive 27.5% of
all payments made to CPF as SRA737 advances, equivalent to up to a
total of US$88 million in future milestone payments, plus sales
royalties
-- CPF is responsible for the on-going relationship with Sierra,
and the Company is in regular dialogue with CPF to ensure that it
is kept informed of developments. While Sareum must ensure
compliance with the confidentiality restrictions in both the
licensing agreement between CPF and Sierra, and the Partnership
agreement between CPF and Sareum, the Company is committed to
keeping the market updated as and when it can
Financial highlights (subject to audit)
-- Raised GBP850,000 before expenses in November 2018, through a
placement of 130,769,231 new ordinary shares at 0.65p per share, to
progress its drug development programmes as well as for working
capital purposes
-- Raised GBP781,484 before expenses in June 2019, through a
placement and offer of 195,371,000 new ordinary shares at 0.4p per
share to progress the Company's TYK2/JAK1 drug development
programmes as well as for working capital purposes
-- Loss on ordinary activities (after taxation) of GBP1.45m (2018: loss of GBP1.47m)
-- Cash at bank as at 30 June 2019 was GBP0.92m (excluding the
GBP0.78m raised in the June 2019 placing) (GBP1.54m as at 31
December 2017; GBP1.38m as at 30 June 2018)
Dr Tim Mitchell, CEO of Sareum, commented:
"We believe our two TYK2/JAK1 inhibitors have the potential to
address unmet needs in autoimmune diseases and cancer, through a
novel mechanism that is clearly gaining increasing interest from
both the pharmaceutical industry and financial investors.
"Given this positive background, we remain focused on applying
our available resources as efficiently as possible to advance our
first TYK2/JAK1 inhibitor towards clinical trials in 2020 and are
continuing activities to determine the priority indications.
"The preliminary clinical data presented by Sierra on SRA737 at
ASCO, alongside other evidence on the use of SRA737 or Chk1
inhibition in combination with PARPi and immuno-oncology
approaches, have been very encouraging. These findings give us
confidence that SRA737 has the potential to become an attractive
new therapeutic option for patients in several important and
underserved cancer indications. However, it is now clear that the
next stages of development of SRA737 are dependent on Sierra being
successful in securing a non-dilutive strategic option to enable
its planned clinical and preclinical programmes to advance.
"We continue to believe, based on the very promising clinical
data that has been generated to-date, that Sierra should have every
chance of finding a suitable solution to progress the development
of SRA737, which in due course would lead to Sareum receiving the
milestones set out in the CPF/Sierra licensing agreement."
For further information, please contact:
Sareum Holdings plc
Tim Mitchell 01223 497 700
Strand Hanson Limited (Nominated Adviser)
James Dance / Richard Tulloch 020 7409 3494
Hybridan LLP (Nominated Broker)
Claire Noyce / John Beresford-Peirse 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 aims to generates value
through licensing its candidates to international pharmaceutical
and biotechnology companies at the preclinical or early clinical
trials stage.
Sareum is 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). The Company is targeting first
human clinical trials in each indication in 2020.
Sareum also has an economic interest in SRA737, a clinical-stage
oral, selective Checkpoint kinase 1 (Chk1) inhibitor that targets
cancer cell replication and DNA damage repair mechanisms.
Preliminary data suggest SRA737 may have broad application 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 in
collaboration with Sareum, and with funding from Cancer Research
UK. SRA737 was licensed by CRT Pioneer Fund (CPF) to Sierra
Oncology, in a $328.5m plus royalties licence deal, with Sareum
eligible to receive 27.5% of all payments to CPF under the
agreement.
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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