REG - Redx Pharma plc - Redx and Caris Life Sciences Announce Partnership

Redx PharmaAnnouncement

06/12/2021 07:00

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RNS Number : 5866U  Redx Pharma plc  06 December 2021

REDX PHARMA PLC

("Redx" or the "Company")

 

Redx and Caris Life Sciences Announce Strategic Partnership to Accelerate
Phase 2 Study Recruitment in the U.S.

 

RXC004 Phase 2 IND is open for patients with genetically-defined Wnt-ligand
dependent colorectal cancer

 

Redx will leverage Caris' precision development programme including
comprehensive molecular profiling, trial matching and real-world data

 

Alderley Park, United Kingdom and Irving, Texas, 6 December 2021 - Redx Pharma
(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, and Caris Life Sciences® ("Caris"),
the leading molecular science and technology company actively developing and
delivering innovative solutions to revolutionize healthcare, today announce
that they have entered into a strategic partnership. The partnership will
leverage Caris' comprehensive Whole Transcriptome Sequencing (WTS) and Whole
Exome Sequencing (WES) platform assay, real-world data and its
Right-In-Time™ (RIT) clinical trial solutions to enhance the speed of U.S.
accruals for Redx's Phase 2 trial for the investigational Porcupine inhibitor,
RXC004, in genetically-selected patients with Wnt-ligand dependent
microsatellite stable (MSS) metastatic colorectal cancer (mCRC).

Utilizing Caris' RIT clinical trial solution will help Redx match the right
U.S. patients to the Phase 2 trial based on both the individual patient's
molecular tumour profile and the trial's eligibility requirements, i.e., those
whose cancers carry Ring Finger Protein 43 (RNF43) loss of function mutations
or R-spondin (RSPO) fusions with MSS mCRC, and have progressed following
therapy with current standard of care. Through the nationwide identification
of eligible patients with the required genetic characteristics Caris' flexible
enrolment model will enable rapid initiation of study treatment for RXC004 at
its extensive network of U.S. RIT trial sites, in addition to trial sites
initiated by Redx.

 

Lisa Anson, Chief Executive Officer of Redx Pharma, said: "We are delighted to
be partnering with Caris on several of their innovative technologies and
approaches. Together we aim to greatly enhance the speed of our patient
accrual for the U.S. into PORCUPINE, our RXC004 Phase 2 trial in patients with
Wnt-ligand driven metastatic colorectal cancer who currently have few
treatment options.  The Caris approach will complement our screening
capabilities, and potentially identify new populations where RXC004 may have
utility."

 

"Unlike more limited panels, Caris tests all 22,000 genes in both DNA and RNA,
which minimizes the potential of missing alterations that would inform drug
development decisions," said Brian Lamon Ph.D., Chief Business Officer, Head
of BioPharma Business Development at Caris Life Sciences. "We will
comprehensively deploy all of our precision oncology tools to support and
maximize the success of the RXC004 program."

 

The RXC004 Phase 2 trial in MSS mCRC patients (NCT04907539), known as the
PORCUPINE trial, prospectively selects patients with Wnt-ligand dependence for
treatment with Redx's Porcupine inhibitor, RXC004. The study will recruit
patients from the U.K., U.S., Spain and South Korea. The prevalence of the
upstream Wnt pathway aberrations which drive Wnt-ligand dependence in MSS
mCRC, RNF43 loss of function mutations and RSPO-fusions, is around 8%.  As
such, identification of potentially eligible MSS mCRC patients involves a
significant screening effort. The International Coordinating Investigator in
the U.S. for PORCUPINE, the RXC004 Phase 2 trial in colorectal cancer, is
Professor Scott Kopetz at The University of Texas MD Anderson Cancer Center,
Houston, TX.

 

The strategic partnership between Redx and Caris will also include a
real-world evidence collaboration, using Caris' extensive database of genetic
aberrations, therapeutic interventions and patient outcomes, to understand the
clinical outcomes for MSS CRC patients with these genetic aberrations.
Utilizing Caris' comprehensive data set will allow Redx to further
characterize the target patient population, and potentially identify
additional patient populations in MSS CRC where RXC004 may have efficacy.

 

Financial terms have not been disclosed.

 

 

 

 For further information, please contact:

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

 UK Headquarters

 Lisa Anson, Chief Executive Officer
 Karl Hård, Head of Investor Relations

 k.hard@redxpharma.com (mailto:k.hard@redxpharma.com)

 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/ 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

 Caris Corporate Contact:

 Brian Lamon, Chief Business Officer

 Caris Life Sciences

 blamon@carisls.com (mailto:blamon@carisls.com)

 Caris Life Sciences Media Contact:

Allison Kreutzjans

 Edelman

 Caris@Edelman.com (mailto:Caris@Edelman.com)

 +1 (314) 550-1327

 

About RXC004

RXC004 is a wholly owned, potent, selective, oral, small-molecule inhibitor of
the Porcupine enzyme, a key activator of Wnt ligands in the Wnt-signalling
pathway. The Wnt pathway is well established as a driver of both tumour growth
and immune evasion. 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.
By selecting patients with tumours that have high Wnt-ligand dependency, such
as those with loss of function mutations in the RNF43 gene and fusions in the
RSPO gene family, RXC004 has an opportunity to both directly inhibit the
tumour growth and have an immune-enhancing effect to allow the patient's
immune system to better recognise and attack the tumour.

 

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 scientists have
observed in preclinical studies 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 to address some of the shortcomings of ICI
therapies through increasing both response rates and duration of response,
particularly in patient populations unresponsive to ICI 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 disease, 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. Initial results were
reported in October 2021, with full Phase 1 results expected in 2022.

 

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 the two wholly-owned clinical-stage
product candidates and rapidly expanding pipeline, but also by the four
strategic transactions from which has emerged the most advanced product
candidate pirtobrutinib (RXC005, LOXO-305), a BTK inhibitor now in Phase 3
clinical development by Eli Lilly following its acquisition of Loxo Oncology.
In addition, Redx has forged pre-clinical collaborations with AstraZeneca and
Jazz Pharmaceuticals.

 

Forward-Looking Statements

This press release contains forward-looking statements about our business.
Forward-looking statements are statements that are not historical facts, and
in some cases can be identified by terms such as "may," "will," "could,"
"expects," "plans," "anticipates," and "believes." These statements include,
but are not limited to, statements regarding the clinical development of
RXC004, including in respect of data to be reported therefrom and potential
benefits thereof to patients if approved. Any forward-looking statements are
based on management's current views and assumptions and involve risks and
uncertainties that could cause actual results, performance or events to differ
materially from those expressed or implied in such statements, including
suspensions, delays or other developments in the Company's clinical trials and
regulatory developments. All information in this press release is as of the
date of the release, and the company undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events, or otherwise, except as required by law.

 

About Caris Life Sciences

Caris Life Sciences(®) (Caris) is the leading molecular science and
technology company actively developing and delivering innovative solutions to
revolutionize healthcare and improve patient outcomes. Through comprehensive
molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the
application of advanced artificial intelligence (AI) and machine learning
algorithms, Caris has created the large-scale clinico-genomic database and
cognitive computing needed to analyze and unravel the molecular complexity of
disease. This information provides an unmatched resource and the ideal path
forward to conduct the basic, fundamental research to accelerate discovery for
detection, diagnosis, monitoring, therapy selection and drug development to
improve the human condition.

With a primary focus on cancer, Caris' suite of market-leading molecular
profiling offerings assesses DNA, RNA and proteins to reveal a molecular
blueprint that helps patients, physicians and researchers better detect,
diagnose and treat patients. Caris' latest advancement, which is currently
available within its Precision Oncology Alliance, is a blood-based,
circulating nucleic acids sequencing (cNAS) assay that combines comprehensive
molecular analysis (Whole Exome and Whole Transcriptome Sequencing from blood)
and serial monitoring - making it the most powerful liquid biopsy assay ever
developed.

 

Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Denver
and Basel, Switzerland. Caris provides services throughout the U.S., Europe,
Asia and other international markets. To learn more, please
visit CarisLifeSciences.com (https://www.carislifesciences.com/)  or follow
us on Twitter (@CarisLS (https://twitter.com/carisls) ).

 

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