RCS - Redx Pharma plc - Discovery of Pirtobrutinib Recognised with Plaque

Redx PharmaAnnouncement

12/05/2023 10:00

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RNS Number : 2533Z  Redx Pharma plc  12 May 2023

REDX PHARMA PLC

("Redx" or the "Company")

 

Redx's Discovery of Pirtobrutinib Recognised with Unveiling of Commemorative
Plaque at Alderley Park

 

Pirtobrutinib, originally discovered by Redx scientists, received FDA approval
in January 2023

 

Pirtobrutinib is one of five molecules originating from the Redx drug
discovery platform that have progressed into clinical development

 

Alderley Park, UK, 12 May 2023 Redx (AIM:REDX), the clinical-stage
biotechnology company focused on discovering and developing novel, small
molecule, targeted therapeutics for the treatment of cancer and fibrotic
disease confirms that a commemorative plaque has been unveiled by Bruntwood
SciTech at their Alderley Park campus, where Redx is headquartered, in
recognition of the team's discovery of pirtobrutinib(1), the active
pharmaceutical ingredient (API) in Eli Lilly's ("Lilly" NYSE:LLY)
Jaypirca™(2).

 

On 27 January 2023, Lilly announced the approval of pirtobrutinib by the US
Food and Drug Administration (FDA) for the treatment of adult patients with
relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of
systemic therapy, including a BTK inhibitor. More recently, in April 2023, the
drug also received a positive opinion from the European Committee for
Medicinal Products for Human Use (CHMP). Pirtobrutinib, is a highly selective
kinase inhibitor and is the first and only FDA approved non-covalent
(reversible) BTK inhibitor available.

 

Pirtobrutinib, formerly known as RXC005, was discovered by Dr. Nicolas Guisot,
Vice President, Drug Discovery and the team at Redx. RXC005 was successfully
nominated as a drug candidate by the Company in October 2016 and was
progressed through early development, before being divested to Loxo Oncology
in July 2017.

 

Steve Bates OBE, Chief Executive Officer, UK BioIndustry Association,
commented: "The approval of pirtobrutinib is a testament to the potential of
the UK biotech industry to discover important new treatments for unmet medical
needs. The team at Redx should be incredibly proud to have originated a
molecule that has made it to market given that fewer than 5% of preclinical
projects currently achieve this milestone. It also serves to highlight that an
FDA approval is the culmination of years of work, requiring significant
investment, which often forces the UK biotech community to secure partnerships
and investment from outside the UK so their research can become reality. With
its world-class innovation capabilities, of which pirtobrutinib offers a
shining example, the UK can be a real force in the global biotech market and
greater financial and political support from within will help ensure more of
the ultimate returns are captured by the UK economy."

 

Redx has a strong track record of discovering new drug candidates through its
core strengths in medicinal chemistry and translational science, enabling the
Company to discover and develop potential best-in-class, or first-in-class
therapeutics. Pirtobrutinib is one of five molecules originating from the Redx
drug discovery platform that are currently approved or in a clinical phase of
development. The Company's lead asset, RXC007, a next-generation selective
ROCK2 inhibitor, is currently in Phase 2a clinical trials for idiopathic
pulmonary fibrosis (IPF) and also has potential in a number of other fibrotic
indications. Redx is also developing RXC004 which is in a phase 2 programme in
Wnt-ligand driven cancer, expected to report at the end of 2023, and is
progressing a potential new novel treatment for fibrostenotic Crohn's disease,
RXC008, where no therapeutic treatment options currently exist, towards a
Phase 1 clinical trial expected to commence in 2024.

 

Lisa Anson, Chief Executive Officer, Redx Pharma, commented: "As the
originators of pirtobrutinib, the approval of Jaypirca™ by the US FDA
demonstrates the world-class capabilities of Redx's scientists placing the
team amongst the few UK biotechs who have successfully discovered an FDA
approved drug. This achievement showcases what the UK biotech industry is
capable of and the need to nurture and support innovation. We are proud to be
headquartered at Alderley Park, the largest single-site life science park in
the UK, and delighted that this achievement has been commemorated with the
unveiling of a plaque on the Park's 'Wall of Discovery'. I would particularly
like to congratulate Dr. Nicolas Guisot, Vice President, Drug Discovery and
Dr. Richard Armer, Chief Scientific Officer, both of whom were instrumental in
the discovery of pirtobrutinib, along with the team at Redx.  We look forward
to continuing to deliver on our vision of discovering targeted medicines that
impact patients."

 

At the event which took place last night, Redx CEO, Lisa Anson, was joined by
CSO, Dr. Richard Armer, and Dr. Kath Mackay, Director of Life Sciences,
Bruntwood SciTech, who all spoke prior to the unveiling of the plaque.  Also,
in attendance were a number of the Redx scientific team and peers from across
the UK Northwest biotech industry. Dr. Nicolas Guisot, VP, Drug Discovery at
Redx and discoverer of pirtobrutinib, was invited to unveil the commemorative
plaque, the first since Bruntwood SciTech took ownership of the premises in
2014.

(L-R: Lisa Anson Chief Executive Officer, Redx Pharma, Dr. Nicolas Guisot, VP
Drug Discovery, Redx Pharma, Dr. Kath Mackay, Director of Life Sciences,
Bruntwood SciTech, Dr. Richard Armer, Chief Scientific Officer, Redx Pharma)

 

1the asset was subsequently sold outright to Loxo Oncology, now part of Eli
Lilly, Redx has no remaining economic interest

2 Jaypirca™ is a trademark owned or licensed by Eli Lilly and Company, its
subsidiaries, or affiliates.

 

 

 For further information, please contact:

 Redx Pharma Plc                                T: +44 (0)1625 469 918

 UK Headquarters

 Caitlin Pearson, Head of Communications

 ir@redxpharma.com (mailto:ir@redxpharma.com)

 Lisa Anson, Chief Executive Officer

 US Office

 Peter Collum, Chief Financial Officer

 FTI Consulting                                 T: +44 (0)203 727 1000
 Simon Conway/ Ciara Martin

 

About Redx Pharma Plc

 

Redx Pharma (AIM: REDX) is a clinical-stage biotechnology company focused on
the discovery and development of novel, small molecule, targeted therapeutics
for the treatment of cancer and fibrotic disease and the emerging area of
cancer-associated fibrosis, aiming initially to progress them to clinical
proof of concept before evaluating options for further development and
potential value creation. The Company's lead fibrosis product candidate, the
selective ROCK2 inhibitor RXC007, is in development for interstitial lung
disease being evaluated in a Phase 2a trial for idiopathic pulmonary fibrosis
(IPF) with topline data expected in Q1 2024. Redx's lead oncology product
candidate, the Porcupine inhibitor RXC004, is being developed as a targeted
treatment for Wnt-ligand dependent cancers, is expected to report Phase 2 data
in combination with anti-PD-1 by end 2023.  Redx's third drug candidate,
RXC008, a GI-targeted ROCK inhibitor for the treatment of fibrostenotic
Crohn's disease, is progressing towards a CTA application in H2 2023.

 

The Company has a strong track record of discovering new drug candidates
through its core strengths in medicinal chemistry and translational science,
enabling the Company to discover and develop differentiated therapeutics
against biologically or clinically validated targets. The Company's
accomplishments are evidenced not only by its two wholly-owned clinical-stage
product candidates and rapidly expanding pipeline, but also by its strategic
transactions, including the sale of pirtobrutinib (RXC005, REDX08608,
LOXO-305), a non-covalent (reversible) BTK inhibitor now approved by the US
FDA for adult patients with mantle cell lymphoma previously treated with a
covalent BTK inhibitor, and AZD5055/RXC006, a Porcupine inhibitor targeting
fibrotic diseases including IPF, which AstraZeneca is progressing in a Phase 1
clinical study. In addition, Redx has forged collaborations with Jazz
Pharmaceuticals, which includes JZP815, a pan-RAF inhibitor developed by Redx
which Jazz is now progressing through Phase 1 clinical studies, and an early
stage oncology research collaboration.

 

To subscribe to Email Alerts from Redx, please visit:
www.redxpharma.com/investor-centre/email-alerts/
(http://www.redxpharma.com/investor-centre/email-alerts/)

 

 

 

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