Strategic expansion of POLB 001 into oncology

Poolbeg Pharma

16/01/2023 07:00

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RNS Number : 7442M  Poolbeg Pharma PLC  16 January 2023

Poolbeg Pharma Plc

 

Poolbeg announces strategic expansion of POLB 001 into oncology

Complements strong initial data from LPS challenge trial and is in line with
stated objective at IPO to expand POLB 001 to additional indications

 

Key Highlights

·      Newly filed patent application to protect use of POLB 001 for new
oncology indication

·    Scientific findings indicate POLB 001 has the potential to dampen the
pro-inflammatory cytokine release syndrome affecting patients receiving CAR T
cell therapies

·      Patent application covers a method of use of all p38 inhibitors
during CAR T cell therapy

·      Progressing towards trial initiation in CAR T cell patients in
2024

 

16 January 2023 - Poolbeg Pharma (http://www.poolbegpharma.com/) (AIM: POLB,
OTCQB: POLBF, 'Poolbeg' or the 'Company'), a leading infectious disease
focused biopharmaceutical company, announces the strategic expansion of POLB
001 into oncology. While investigating the role of cytokine release syndrome
("CRS") in severe influenza, Poolbeg discovered data specific to the overt
immune response in CAR T cell patients that suggest POLB 001 as a potential
treatment option for this severe complication. The Company has submitted a
patent application for the use of POLB 001 in addressing the impact of CRS in
CAR T cell patients.

 

CAR T cell therapies are a form of immunotherapy for cancer that have produced
remarkable results across a range of haematological malignancies, including
cases of complete and durable responses in patients with advanced leukaemia
and lymphoma who failed on previous therapies.  A significant number of
patients suffer treatment related side effects, including CRS which in severe
form can be life threatening. Cell therapies may induce these effects in up to
95% of patients(1). Poolbeg has identified POLB 001 as a potentially valuable
companion therapy to be used in conjunction with existing CAR T cell therapies
to address this significant unmet need. POLB 001's mode of action, reducing
hyperinflammation which is associated with CRS, has the potential to
significantly reduce the serious adverse effects experienced by many CAR T
cell patients.

 

The filed patent application is expected to provide class protection for use
of p38 inhibitors in CAR T cell treatment and opens up a significant new
market opportunity for POLB 001 in addition to severe influenza.

 

A long-term strategic objective for Poolbeg has been and continues to be to
evaluate POLB 001's potential in additional indications to fully unlock the
potential value of the molecule and strengthen Poolbeg's position with a view
to potential partnering and out-licensing. The Company is performing oncology
clinical trial enabling activities to progress towards trial initiation in CAR
T cell patients in 2024. Further oncology-related data, regulatory feedback
and non-clinical development updates are expected in 2023.

 

Prof Brendan Buckley, Scientific Advisory Board member at Poolbeg Pharma,
said: "Hyperinflammation as a driver of disease severity in influenza is also
fundamental to CRS, which can severely complicate CAR T cell therapy of
patients with blood cancers. By reducing runaway inflammation associated with
CRS, POLB 001 has the potential to significantly reduce the serious adverse
effects that many CAR T cell patients suffer. With 18-19 million cases of
cancer diagnosed globally each year, the use of cell therapies is predicted to
expand significantly over the coming years with the CAR T cell market expected
to grow to an estimated $6 billion by 2031. With oncology clinical trial
enabling activities for POLB 001 underway, we look forward to updating the
market as to the progress of this exciting programme."

 

Virtual Company presentation

 

Jeremy Skillington, PhD, Chief Executive Officer, and Professor Brendan
Buckley, Scientific Advisory Board member, will provide a live presentation
via the Investor Meet Company platform on Monday 16 January
2023 at 5:30pm. Click here to register
(https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor) .

 

The presentation is open to all existing and potential shareholders. Investors
can sign up to Investor Meet Company for free and add to meet Poolbeg
Pharma plc here
(https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor) .
The presentation and recording will be available on the Company's website
after the event here
(https://www.poolbegpharma.com/investors/events-presentations/) .

 

1. CARVYKTI package insert, FDA, 2022
(https://www.fda.gov/media/156560/download)

-Ends-

Enquiries

 Poolbeg Pharma Plc                                                +44 (0) 207 183 1499

 Jeremy Skillington, CEO

 Ian O'Connell, CFO

 finnCap 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

 Mary Clark, Nick Bastin, Manel Mateus, Vici Rabbetts              poolbeg@optimumcomms.com (mailto:poolbeg@optimumcomms.com)

 

About Poolbeg Pharma

 

Poolbeg Pharma specialises in the development of innovative medicines to
address the unmet need in prevalent and emerging infectious diseases. Poolbeg
has a disciplined portfolio approach to mitigate risk, accelerate drug
development and enhance investor returns. The Company simultaneously advances
multiple programmes in cost-effective clinical trials, rapidly generating
early human safety and efficacy data to enable early partnering /
out-licensing, with the funds generated reinvested in the pipeline. Poolbeg
also uses AI to interrogate human challenge trial data sets to quickly
identify new targets and drugs, and in-license near or in the clinic
medicines, leading to faster development and greater commercial appeal.

 

The Company is targeting the growing infectious disease market. In the wake of
the COVID-19 pandemic, infectious disease has become one of the fastest
growing pharma markets and is expected to exceed $250bn by 2025.

 

With its initial assets from hVIVO plc (http://www.hvivo.com)
 (formerly Open Orphan plc), an industry leading infectious disease and
human challenge trials business, Poolbeg has access to knowledge, experience,
and clinical data from over 20 years of human challenge trials. The Company is
using these insights to acquire new assets as well as reposition clinical
stage products, reducing spend and risk. Amongst its portfolio of exciting
assets, Poolbeg has a small molecule immunomodulator (POB 001) which offers
significant opportunity across multiple disease areas. The initial data
analysis from its LPS human challenge trial indicates a marked reduction in
both systemic and localised inflammatory response in an LPS human challenge
trial (full data read-out expected in Q2 2023). Its other product candidates
include a first-in-class, intranasally administered RNA-based immunotherapy
for respiratory virus infections (POLB 002); and a vaccine candidate for
Melioidosis (POLB 003). The Company is also developing
two Oral Delivery Programmes and is progressing
two Artificial Intelligence (AI) Programmes to add promising new assets to
its pipeline.

 

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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