Poolbeg presents POLB 001 data at 66th ASH Meeting

Poolbeg Pharma

09/12/2024 07:00

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RNS Number : 2475P  Poolbeg Pharma PLC  09 December 2024

REACH

 

Poolbeg Pharma plc presents POLB 001 pre-clinical study data at the 66th
American Society of Hematology (ASH) Annual Meeting

 

All doses of POLB 001 significantly reduced clinically observed Cytokine
Release Syndrome scores

 

POLB 001 treatment showed statistically significant reductions in key
cytokines

 

Positive results reinforce the use case for POLB 001 in the prevention and
treatment of cancer immunotherapy-induced CRS

 

9 December 2024 - Poolbeg Pharma (https://www.poolbegpharma.com/)  (AIM:
POLB, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company
focused on the development and commercialisation of innovative medicines
targeting diseases with a high unmet medical need, today announces key
insights from its poster presentation at the 66th American Society of
Hematology ('ASH') Annual Meeting and Exposition, San Diego, California.

 

The poster, which detailed POLB 001 as a promising preventative therapy for
Cytokine Release Syndrome (CRS) associated with cancer immunotherapies, was
presented by the Company's Chief Executive Officer, Jeremy Skillington,
PhD on Saturday 7 December.

 

The study was designed to evaluate the effect of POLB 001 on CRS compared to
Adalimumab, an anti-TNF antibody which is a gold standard potent inhibitor of
CRS in humanised tumour-bearing mouse models. Mice were treated twice daily
with either placebo or POLB 001 at low, medium, or high doses for five days.

 

Key Highlights:

 l  POLB 001 effectively reduced CRS and demonstrated superior cytokine inhibition
    compared to Adalimumab
 l  In a model of anti-CD28 induced CRS, POLB 001 was shown to dose dependently
    reduce clinical CRS scores
 l  POLB 001 reduced peak serum levels of TNF, IL-4, IL-6, IL-8 and MIP-1α and
    the results were statistically significant
 l  All other cytokines tested, including IFN-γ, IL-8, IL-10 and IL-2,
    demonstrated trends of reduced peak serum levels
 l  Other immunological and malignancy-related endpoints were monitored with no
    harmful effects of POLB 001 observed
 l  Positive results reinforce the use case for POLB 001 in the prevention and
    treatment of cancer immunotherapy-induced CRS

 

Mark Sumeray, MD, Consultant Clinical Advisor for Poolbeg, commented:
"Addressing cancer immunotherapy-induced CRS holds the potential to greatly
impact the treatment of hematological malignancies - enhancing safety and
reaching more patients. These data presented at ASH are promising,
demonstrating statistically significant cytokine inhibition and a dose
dependent reduction in clinical CRS. The results of this animal study support
development of POLB 001 in a Phase 2 clinical study as a prophylactic for the
prevention of immunotherapy-induced CRS. The previous successful LPS trial in
healthy human volunteers also provides ratification."

 

Poster Presentation Details:

 

Title: POLB 001, an Oral p38 MAPK Inhibitor, Reduces Cytokine Release Syndrome
(CRS) in a Mouse Model of Immunotherapy-Induced CRS

Session Name: 703. Cellular Immunotherapies other than CAR-T Cells: Basic and
Translational: Poster I

Session Date and Time: Saturday, 7 December 2024, 5:30 PM - 7:30 PM PST

Location: San Diego Convention Center, Halls G-H

Authors:  Liam Tremble, PhD, MSc, BSc, Paula Maguire, PhD, Jiwon Yang, PhD,
James G Keck, Laura Maher, MSc, Mark Graham, Martin F Kaiser, MD, FRCP,
FRCPath, Emma Searle, MD, PhD and Mark Sumeray, MD

Abstract Number: 2061

 

Enquiries

 

 Poolbeg Pharma Plc                                                  +44 (0) 207 183 1499

 Jeremy Skillington, CEO                                             ir@poolbegpharma.com

 Ian O'Connell, CFO

  
 Cavendish Capital Markets Ltd (NOMAD & Joint Broker)                +44 (0) 207 220 0500

 Geoff Nash, Camilla Hume, 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, Isobel Jones (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, Vici Rabbetts, Elena Bates                             poolbeg@optimumcomms.com (mailto:poolbeg@optimumcomms.com)

  

 

About POLB 001

CRS can occur in >70%(1) of patients treated with T cell engaging
bispecific antibodies, or CAR T cell therapies. CRS of any grade can lead to
prolonged hospital stays and mortality risk. The administration of these
cancer immunotherapies is therefore restricted only to specialist cancer
centres, which has created a "bottleneck" in providing seamless,
cost-efficient access to these treatments for the patients who need them.

 

There are currently very few approved therapies for the management of CRS and
no approved therapies for the prevention of CRS. As an oral therapy to prevent
or treat CRS, POLB 001 has the potential to enable broader use of cancer
immunotherapies in an outpatient setting to reduce the risk of a bottleneck
occurring, and to make these life-saving therapeutics more readily accessible
to patients.

 

Independent research commissioned by Poolbeg confirmed a market potential for
POLB 001 of c.US$10 billion in Multiple Myeloma and Diffuse Large B-Cell
Lymphoma alone due to the significant advances in bispecific antibody and CAR
T-cell therapies for these indications.(2) Cancer immunotherapies are being
widely developed across a broader range of hematological malignancies
(including many rare or orphan cancers) and solid tumours, which Poolbeg
believe will expand the opportunity for POLB 001 far beyond the estimate
of c.US$10 billion.

 

1. Average rate from Summary of Product Characteristics (SmPCs) for Yescarta,
Tecartus, Abecma, Kymriah, Carvykti, Breyanzi, Elrexfio, Columvi, Epkinly,
Tecvayli and Talvey. 2. Independent research commissioned by Poolbeg.

 

About Poolbeg Pharma plc

Poolbeg Pharma plc is a clinical-stage biopharmaceutical company focussed on
acquiring, developing and commercialising innovative medicines that will help
improve the lives of patients with rare and orphan diseases and where there is
a high unmet medical need. Poolbeg comprises a strong and growing portfolio of
development assets. For more information, please go to www.poolbegpharma.com
(https://www.poolbegpharma.com)  or follow us on Twitter
(https://twitter.com/PoolbegPharma/)  and LinkedIn
(https://www.linkedin.com/company/poolbeg-pharma/)  @PoolbegPharma.

 

Forward-Looking Statements

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cause the actual results, performance or achievements to be materially
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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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