REG - Poolbeg Pharma PLC - Further data shows POLB001 potential in cancer CRS

Poolbeg PharmaAnnouncement

17/01/2024 07:00

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RNS Number : 9157Z  Poolbeg Pharma PLC  17 January 2024

Poolbeg Pharma plc

 

Further Data Confirms POLB 001's Potential in Cancer Immunotherapy-Induced
Cytokine Release Syndrome (CRS)

Market opportunity estimated to be greater than US$1 billion

 

Key highlights

-      Efficacy demonstrated in reducing cancer immunotherapy-induced CRS
in an in vivo model

-      Data strengthens and facilitates the expansion of patent
applications for POLB 001 in cancer immunotherapy-induced CRS

-      Independent Advisory Board supportive of POLB 001's potential to
both prevent and treat cancer immunotherapy-induced CRS

-      An Investor Meet Company
(https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor)
presentation scheduled at 6pm on 17 January 2024 with Poolbeg management and
Key Opinion Leader, Dr Martin Kaiser

 

17 January 2024 - Poolbeg Pharma (http://www.poolbegpharma.com/)  (AIM:
POLB, OTCQB: POLBF, 'Poolbeg' or the 'Company'), a biopharmaceutical company
focussed on the development and commercialisation of innovative medicines
targeting diseases with a high unmet medical need, today announces promising
in vivo results for POLB 001 in addressing cancer immunotherapy-induced CRS.

 

Positive study results

POLB 001 demonstrated efficacy in reducing cancer immunotherapy-induced CRS in
an in vivo animal model with CRS symptoms significantly improved following
administration of POLB 001. Reductions were seen in all serum proinflammatory
cytokines tested.

 

The results, together with the data from the recent LPS human challenge tria
(https://polaris.brighterir.com/public/poolbeg_pharma/news/rns/story/x5zok8x)
l, further support the Company's strategic expansion of the Phase II ready
POLB 001 to treat and prevent cancer immunotherapy-induced CRS. The data also
strengthens and facilitates the expansion of patent applications for POLB 001
in cancer immunotherapy-induced CRS.

 

Market opportunity estimated at over US$1 billion

Largely due to the CRS risk (which can be life threatening), administration of
cancer immunotherapies, such as bispecific antibodies, is currently restricted
to specialist cancer centres which limits uptake of these effective therapies.
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. The
Company believes that POLB 001 represents a significant market opportunity
estimated at > US$1 billion in Multiple Myeloma, High Grade Lymphoma and
Acute Lymphoblastic Leukaemia alone. Cancer immunotherapies are being widely
developed across a broader range of haematological malignancies, solid tumours
and immune inflammatory diseases, which represents an even greater market
opportunity.

 

In the U.S., the American Cancer Society estimates that there will be 24.6
million cases of cancer by 2030(1,2). Cancer immunotherapies, such as
bispecific antibodies and CAR T cell therapy, are rapidly moving into earlier
lines of treatment in many tumour types, with these markets anticipated to
grow to US$100bn+ (~35% CAGR) by 2030(3).

 

Independent Advisory Board Supportive of POLB 001's Potential

Poolbeg convened an Independent Advisory Board with international Key Opinion
Leaders, healthcare payers and clinical trial experts, which endorsed the
attractiveness of POLB 001's Target Product Profile (TPP) and its potential as
an oral therapy to address the significant unmet medical need of cancer
immunotherapy-induced CRS. POLB 001 has been shown to reduce hyperinflammation
without complete ablation of an effective immune response, which makes it
potentially a very attractive therapy for this disease area.

 

Prof. Gareth Morgan, NYU Langone, United States said "Bispecific antibodies
will only be delivered in specialist cancer centres until there is a way to
make them safer. POLB 001 could make treatment safe enough to extend
bispecifics to a much wider patient population".

 

Dr Martin Kaiser, Reader/Associate Professor in Molecular Haematology at The
Institute of Cancer Research and Haematology Consultant at The Royal Marsden
Hospital said, "Patients undergoing cancer immunotherapy treatment that suffer
with CRS can be critically ill which, alongside a weakened immune system, can
further increase their risk of infection. Preventing CRS in the first instance
would have a significant impact on patient health and wellbeing, as well as
reducing the burden on the healthcare system. Current CRS treatments require
intravenous infusion, which is difficult to deliver out of hospital, and some
can only be used off label in combination with bispecific antibodies. If there
was a therapy that was orally delivered, a whole lot of infrastructure
requirement falls away."

 

David Allmond, Chief Business Officer of Poolbeg Pharma, commented: "POLB 001
has the potential to revolutionise the impact of cancer immunotherapies by
enabling safer and broader use in an outpatient setting, reducing healthcare
resource utilisation and making these next generation cancer treatments more
widely available to the patients that need them. The pharmaceutical sector is
seeking an effective solution for CRS and, as an oral therapy, we believe
there is a significant opportunity for POLB 001 to meet this critical unmet
medical need and have a positive impact on global health."

 

Investor presentation

Poolbeg's management team along with Martin Kaiser, Reader/Associate Professor
in Molecular Haematology at The Institute of Cancer Research and Haematology
Consultant at The Royal Marsden Hospital, will provide a live presentation via
the Investor Meet Company platform on Wednesday 17 January 2024 at 6pm GMT.

 

The presentation is open to analysts and investors, those who already follow
Poolbeg on the Investor Meet Company platform will automatically be invited.
Investors can sign up to Investor Meet for free and add Poolbeg Pharma
plc to their company dashboard via:
https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor
(https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor)

 

References

1.     The American Cancer Society (ACS)
(https://pressroom.cancer.org/FactsandFigures23#:~:text=Based%20on%20ACS%20data%2C%20in,%2C%20available%20on%20cancer.org)
 

2.     The International Agency for Research on Cancer (IARC)
(https://www.iarc.who.int/faq/latest-global-cancer-data-2020-qa/)

3.     CAR T Cell Therapy Market Analysis 2023-2030; Bispecific Antibodies
Market Size, Share & Trends Analysis Report, Grand View Research

 

Enquiries

 

 Poolbeg Pharma Plc                                                      +44 (0) 207 183 1499

 Jeremy Skillington, CEO

 Ian O'Connell, CFO

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

 Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)

 Singer Capital Markets (Joint Broker)                                    +44 (0) 207 496 3000

 Phil Davies, Sam Butcher

 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 Poolbeg Pharma

Poolbeg Pharma plc is committed to the development and commercialisation of
innovative medicines targeting diseases with a high unmet medical need. Its
model focusses upon developing its exciting clinical assets and
commercialising approved and marketed drugs to fund the development of its
robust pipeline of innovative products, thereby driving significant value
creation.

Poolbeg is led by an experienced leadership team with a history of delivering
significant shareholder value. The team has been strengthened by the
appointment of three former members of the Amryt Pharma plc leadership team,
with the intention of repeating Amryt's success and generating near term
revenues.

Poolbeg's clinical programmes target large addressable markets including CRS
induced by cancer immunotherapies, infectious disease, and metabolic
conditions such as obesity with the development of an oral GLP-1R agonist. It
uses a cost-effective development philosophy to generate high quality human
data to support partnering and further development. Its AI-led infectious
disease programmes analyse unique data from human challenge trials to identify
clinically relevant drug targets and treatments, leading to faster development
and greater commercial appeal.

 

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.

 

For more information, please go to www.poolbegpharma.com
(http://www.poolbegpharma.com/)  or follow us on Twitter
(https://twitter.com/PoolbegPharma)  and LinkedIn
(https://www.linkedin.com/company/poolbeg-pharma/)  @PoolbegPharma.

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