REG - Redx Pharma plc - Redx Presents Poster on RXC004 at ASCO

Redx PharmaAnnouncement

30/05/2022 07:15

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RNS Number : 1639N  Redx Pharma plc  30 May 2022

REDX PHARMA PLC

("Redx" or "the Company")

 

Redx Presents Poster on Phase 2 Clinical Trial of RXC004 'PORCUPINE' at the
American Society of Clinical Oncology (ASCO) Annual Meeting

 

Alderley Park, 30 May 2022, Redx (AIM: REDX), the clinical-stage
biotechnology company focused on discovering and developing novel, small
molecule, highly targeted therapeutics for the treatment of cancer and
fibrotic disease, announces that a poster abstract on RXC004 at the American
Society of Clinical Oncology (ASCO) Annual Meeting (3-7 June 2022, Chicago,
US/virtual) is now available for viewing. A formal presentation of the poster
by the Chief Investigator, Professor Scott Kopetz, The University of Texas MD
Anderson Cancer Center, Houston, TX., will be made at the conference on 4
June 2022.

 

RXC004, a highly potent and selective, orally active once-daily Porcupine
inhibitor, is being developed as a targeted therapy for Wnt-ligand driven
cancer. It is currently being evaluated as monotherapy in Phase 2
proof-of-concept clinical trials in genetically selected patients with
metastatic colorectal cancer and pancreatic cancer, as well as in unselected
patients with biliary cancer. Additionally, RXC004 is in a Phase 1 combination
study with nivolumab, an anti-PD-1 antibody from which a dose for the
combination arm of the Phase 2 colorectal cancer study will be selected later
this year. Data readouts from these Phase 2 studies are expected in 2023.

 

The poster entitled 'A Multi-arm, Phase 2, Open-Label Study to Assess the
Efficacy of RXC004 as Monotherapy and in Combination with Nivolumab, in
Patients with Ring Finger Protein 43 (RNF43) or R-Spondin (RSPO) Aberrated,
Metastatic, Microsatellite Stable Colorectal Cancer, following standard
treatment' details the design of Redx's ongoing PORCUPINE(1) Phase 2 trial of
RXC004 monotherapy, and RXC004 in combination with nivolumab, an anti-PD-1
antibody, in patients with advanced microsatellite stable (MSS) metastatic
colorectal cancer (mCRC) who have progressed following treatment with standard
of care. The PORCUPINE trial will explore the dual mechanism of action of
RXC004 seen in the preclinical models by targeting tumour cells and reversing
immune evasion.

 

Dr Jane Robertson, Chief Medical Officer, Redx Pharma, said: "We continue to
be excited by the potential of RXC004 to tackle a number of Wnt-ligand driven
cancers with high unmet clinical need, including metastatic colorectal cancer.
We look forward to progressing our proof-of-concept Phase 2 studies with this
compound, where we expect to report headline data during 2023."

 

More information on the contents of the poster

The abstract is available on the ASCO website at: http://ASCO.org/abstracts
(http://asco.org/abstracts) and the poster will be made available Company's
website following the presentationat:
https://www.redxpharma.com/scientific-publications/
(https://www.redxpharma.com/scientific-publications/) . The poster describes
the ongoing PORCUPINE study, which is currently open in the USA, UK, Spain and
South Korea. The PORCUPINE study initially opened with the monotherapy arm
(Arm A), whilst the combination arm (Arm B) will be opened once a dose for
RXC004 in combination with nivolumab has been established in the combination
module of the Phase 1 study. To be eligible for this study, patients must have
metastatic microsatellite stable colorectal cancer with a loss of function
RNF43 mutation or an RSPO 2/3 fusion, which has progressed following standard
therapies.

 

(1) ClinicalTrials.gov Identifier: NCT03447470

 

 For further information, please contact:

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

 Caitlin Pearson, Head of Communications ir@redxpharma.com
 (mailto:ir@redxpharma.com)

 UK Headquarters

 Lisa Anson, Chief Executive Officer

 US Office

 Peter Collum, Chief Financial Officer

 SPARK Advisory Partners (Nominated Adviser)                 T: +44 (0)203 368 3550
 Matt Davis/ Adam Dawes

 WG Partners LLP (Joint Broker)                              T: +44 (0)203 705 9330
 Claes Spång/ Satheesh Nadarajah/ David Wilson

 Panmure Gordon (UK) Limited (Joint Broker)                  T: +44 (0)207 886 2500
 Rupert Dearden/ Freddy Crossley/ Emma Earl

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

 

About RXC004

RXC004, a highly potent and selective, orally active once-daily Porcupine
inhibitor is being developed as a targeted therapy for Wnt-ligand driven
cancer. Aberrant Wnt signalling contributes directly to tumour growth and
plays an important role in immune evasion, which has also been linked to
resistance to immune-checkpoint inhibitors (ICIs) such as nivolumab. RXC004
has the potential to both directly inhibit the tumour growth and have an
immune-enhancing effect in patients with tumours that have high Wnt-ligand
dependency, such as tumours with mutations in the RNF43 gene and fusions in
the RSPO gene family.

 

Immune checkpoint inhibitors (ICIs) such as anti-PD-1 antibodies have
revolutionised the treatment of cancer, but do not work in all patients. Wnt
pathway activation can enhance the ability of the tumour to evade destruction
by the immune system and has been linked to lack of response to ICIs in these
tumours. Redx have demonstrated preclinically that RXC004 can block activation
of the Wnt pathway and restore the ability of the immune system to fight the
tumour. Thus, RXC004 offers potential as a monotherapy or combination therapy.

 

About Redx Pharma Plc

Redx Pharma (AIM: REDX) is a clinical-stage biotechnology company focused on
the discovery and development of novel, small molecule, highly targeted
therapeutics for the treatment of cancer and fibrotic diseases, aiming
initially to progress them to clinical proof of concept before evaluating
options for further development and potential value creation. Redx's lead
oncology product candidate, the Porcupine inhibitor RXC004, commenced a Phase
2 programme in November 2021. The Company's selective ROCK2 inhibitor product
candidate, RXC007, is in development for idiopathic pulmonary fibrosis and
commenced a Phase 1 clinical trial in June 2021. Encouraging safety and
pharmacokinetic data has been reported, and a Phase 2 clinical program is
confirmed to start in 2022. Redx's third drug candidate, RXC008, a GI-targeted
ROCK inhibitor for the treatment of fibrostenotic Crohn's disease, is
currently in pre-IND stage, with Phase 1 clinical studies expected to commence
in 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, LOXO-305), a BTK
inhibitor now in Phase 3 clinical development by Eli Lilly following its
acquisition of Loxo Oncology and RXC006, a Porcupine inhibitor targeting
fibrotic diseases including idiopathic pulmonary fibrosis (IPF), which
AstraZeneca is progressing in a Phase 1 clinical study. In addition, Redx has
forged collaborations with Jazz Pharmaceuticals.

 

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(http://www.redxpharma.com/investor-centre/email-alerts/)  

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