Discovery of Pirtobrutinib Recognised with Plaque

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 pirtobrutinib¹, 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 UK Headquarters Caitlin Pearson, Head of Communications  [e-mail] Lisa Anson, Chief Executive Officer	T: [phone]
US Office Peter Collum, Chief Financial Officer
FTI Consulting	T: [phone]
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. 

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