REG - Poolbeg Pharma PLC - Poolbeg Announces POLB 001 TOPICAL Site Activation

Poolbeg PharmaAnnouncement

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RNS Number : 8479H  Poolbeg Pharma PLC  11 June 2026

 

Poolbeg Pharma plc

 

Poolbeg Pharma Announces Successful Site Activation for POLB 001 TOPICAL
Clinical Trial

Major operational milestone achieved with interim data on track for summer
2026

 

11 June 2026- Poolbeg Pharma
(https://protect.checkpoint.com/v2/r02/___https:/www.poolbegpharma.com/___.YXAxZTpzaG9yZWNhcDpjOm86MmI2OWFmYmU2ZGVmOGFmMjRjZjIwYTZhMWI0YzUzOTI6Nzo2M2Q2OjY1YTk2ZTY1YWRmZjg0ODYzZmE1YmExZmY4OTc5NjgwNzMxMTZlYjlhZmI1YzRhMzdhZjYyODA5YWE1NDFkNTU6cDpGOk4)
 (AIM: POLB, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical
company with a core focus on transforming the cancer immunotherapy field,
announces the first site activation for the first-in-patient POLB 001 TOPICAL*
clinical trial has occurred. This follows the successful completion of the
site initiation visit, with patient recruitment underway and interim data
expected in summer 2026.

 

The trial, being conducted by specialist blood cancer trials
organisation Accelerating Clinical Trials Limited
(https://url.avanan.click/v2/r02/___https:/www.act4patients.com/___.YXAxZTpzaG9yZWNhcDphOm86OWFkMzdlZmEzMTY3NzNiMWFkZWZmYWU1YWRhN2YzMzI6NzplYzBhOjE1ZDU3OGY4YTU3NDIzOGU2OGJmZTFkNTY2NDdlZjhlNzhkNDQwM2JjMzA1YWFhOTY2OWZmYzkwNTRlZTYxNGQ6cDpGOk4)
 ("ACT"), is investigating POLB 001 as a potential preventative for Cytokine
Release Syndrome ("CRS") in approximately 30 relapsed/refractory multiple
myeloma patients that are receiving the approved bispecific antibody,
teclistamab. This acute condition occurs within days to weeks of initiating
bispecific antibody treatment, consequently, the TOPICAL trial is expected to
generate a rapid read out of data.

 

The Company believes that the strong engagement and enthusiasm demonstrated by
investigators and clinical teams reflects both the significant unmet medical
need in cancer immunotherapy-induced Cytokine Release Syndrome and the
potential of POLB 001 to prevent this condition.

 

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said:
"The successful site activation marks a significant milestone for Poolbeg and
our lead programme, POLB 001. We believe POLB 001 has the potential to
transform the cancer immunotherapy field through the prevention of CRS. This
could not only improve patient quality of life but also expand the number of
patients that can receive these life-saving cancer immunotherapies. We look
forward to receiving the first insights from the study and sharing these with
prospective partners, the market, and the wider scientific community in due
course."

 

Dr Paul Sherrington, CEO of Accelerating Clinical Trials Ltd said: "Site
initiation and activation marks an important operational milestone for the
study, as we now move forward to patient recruitment. We are pleased with the
progress made to date and look forward to supporting efficient patient accrual
recruitment and high-quality trial delivery as the study advances."

 

*TOPICAL: Trial of Prevention of ImmunoCytokine Adverse events in Myeloma. A
single-arm, open-label trial investigating POLB 001 as a potential
preventative for CRS in relapsed/refractory multiple myeloma patients
receiving the approved bispecific antibody, teclistamab, provided by Johnson
and Johnson at no cost to Poolbeg.

 

Enquiries

 Poolbeg Pharma Plc                                           +44 (0) 207 183 1499

ir@poolbegpharma.com (mailto:ir@poolbegpharma.com)
 Jeremy Skillington, CEO

 Ian O'Connell, CFO

 Cavendish Capital Markets Ltd (NOMAD & Joint Broker)         +44 (0) 207 220 0500
 Geoff Nash, Trisyia Jamaludin (Corporate Finance)
 Nigel Birks (Life Science Specialist Sales)
 Harriet Ward (ECM)

 Shore Capital Stockbrokers Ltd (Joint Broker)                +44 (0) 207 408 4090
 David Coaten, Harry Davies-Ball (Corporate Advisory)
 Malachy McEntyre (Corporate Broking)

 J&E Davy (Joint Broker)                                      +353 (0) 1 679 6363
 Anthony Farrell, Niall Gilchrist

 Optimum Strategic Communications                             +44 (0) 208 078 4357
 Nick Bastin, Katie Flint, Elena Bates
poolbeg@optimumcomms.com (mailto:poolbeg@optimumcomms.com)

 

About Poolbeg Pharma plc

Poolbeg Pharma plc (AIM: POLB) is a clinical-stage
biopharmaceutical company with a core focus on transforming the cancer
immunotherapy field. The Company's lead asset, POLB 001, has the potential to
expand administration of cancer immunotherapies from centralised specialist
cancer centres into community hospitals by making the treatments safer through
the prevention of the life-threatening side effect, Cytokine Release Syndrome
(CRS). As such, POLB 001 could increase the number of patients that can
receive these life-saving treatments, thereby increasing the market
opportunity. Poolbeg is also advancing the development of a patient-friendly
therapy for obesity with an oral encapsulated GLP-1, offering a differentiated
approach within one of the world's largest markets. With multiple near-term
clinical value inflection points, and an experienced team with a proven track
record, Poolbeg is focussed on partnering its high value programmes that are
targeting large markets and addressing critical unmet medical needs.

 

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Forward-Looking Statements

This announcement may contain forward-looking statements and the words
"expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast",
"project" and similar expressions (or their negative) identify certain of
these forward-looking statements. The forward-looking statements in this
announcement are based on numerous assumptions and Poolbeg's present and
future business strategies and the environment in which Poolbeg expects to
operate in the future. Forward-looking statements involve inherent known and
unknown risks, uncertainties and contingencies because they relate to events
and depend on circumstances that may or may not occur in the future and may
cause the actual results, performance or achievements to be materially
different from those expressed or implied by such forward-looking statements.
These statements are not guarantees of future performance or the ability to
identify and consummate investments. Many of these risks and uncertainties
relate to factors that are beyond Poolbeg's ability to control or estimate
precisely, such as future market conditions, currency fluctuations, the
behaviour of other market participants, the outcome of clinical trials, the
actions of regulators and other factors such as Poolbeg's ability to obtain
financing, changes in the political, social and regulatory framework in which
Poolbeg operates or in economic, technological or consumer trends or
conditions. Past performance should not be taken as an indication or guarantee
of future results, and no representation or warranty, express or implied, is
made regarding future performance. No person is under any obligation to update
or keep current the information contained in this announcement or to provide
the recipient of it with access to any additional relevant information.

 

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