TIDMONC
Oncimmune Holdings PLC
28 October 2020
28 October 2020
Oncimmune Holdings plc
("Oncimmune" or the "Company")
Clinical study initiated by Biodesix to further support adoption
of EarlyCDT(R) Lung in US market
Oncimmune Holdings plc (AIM: ONC.L), the leading global
immunodiagnostics group, is pleased to note the initiation of a
study by Biodesix Inc ("Biodesix") using Oncimmune's EarlyCDT (R)
Lung blood test, which is marketed in the US by Biodesix as Nodify
CDT(TM) .
Biodesix have initiated the "ALTITUDE" clinical utility study
designed to evaluate the performance of Nodify Lung(TM) (Nodify
XL2(TM) and Nodify CDT in combination) in a randomised controlled
study. The study "A Multicenter, Randomized Controlled Trial,
Prospectively Evaluating the Clinical Utility of the Nodify XL2
Proteomic Test in Incidentally Discovered Low to Moderate Risk Lung
Nodules" seeks to further demonstrate the efficacy of the Nodify
XL2 and Nodify CDT tests. A secondary focus of the study will be to
further understand the economic impact of the tests in guiding
treatment choices and the potential impact of our tests in reducing
overall healthcare costs in the US.
The ALTITUDE study objectives are to evaluate how the addition
of the Nodify Lung test result impacts the clinical decision making
for patients with new, incidentally identified solid lung nodules
assessed as low to moderate risk of lung cancer. A total of 2,000
patients are expected to be enrolled in the study.
The trial has an adaptive study design with a blinded standard
of care arm and 2:1 randomisation for open-label results for Nodify
XL2. The first patients will be enrolled before the end of 2020,
with Phase 1 of the study including only Nodify XL2, expected to
enrol 500 patients. Phase 2 of the adaptive study design will
include an open-label arm for Nodify CDT, which is aligned with
Biodesix's commercial testing algorithm.
Oncimmune's EarlyCDT Lung blood test is marketed in the US under
Biodesix's Nodify Lung brand as Nodify CDT. The Nodify CDT test
assists physicians in identifying patients with lung nodules at
high risk of lung cancer and is partnered with Biodesix's existing
Nodify XL2 test, which is designed to help identify lung nodules
with a very low risk of cancer. Both tests are offered in
combination as the Nodify Lung Nodule Risk Assessment strategy,
giving physicians the ability to order both tests from a single
blood draw.
Biodesix has a direct US national sales force who sell direct
into pulmonologists and corporately into national hospital
systems.
Dr Adam M Hill, CEO of Oncimmune commented: "Oncimmune is
committed to producing further evidence that supports both adoption
and reimbursement decisions in the markets where EarlyCDT Lung is
available. Part of our agreement with Biodesix in June 2019 was to
continue to deliver high quality evidence in the US market with
EarlyCDT Lung. The ALTITUDE study will build upon the data
presented last week at the American College of Chest Physicians
from the PANOPTIC study, whilst adding to the substantial evidence
base already underpinning the use of our product globally."
For further information:
Oncimmune Holdings plc
Adam Hill, Chief Executive Officer
Matthew Hall, Chief Financial Officer
contact@oncimmune.co.uk
Zeus Capital Limited (Nominated Adviser and Joint Broker)
Andrew Jones, Daniel Harris, Victoria Ayton
+44 (0)20 3829 5000
N+1 Singer (Joint Broker)
Aubrey Powell, Harry Gooden, Iqra Amin, James Fischer
+44 (0)20 7496 3000
WG Partners (Joint Broker)
David Wilson, Chris Lee
+44 (0)20 3705 9321
Media enquiries:
FTI Consulting
Ben Atwell, Michael Trace, Alex Davis
Oncimmune@fticonsulting.com
+44 (0)20 3727 1000
About Oncimmune
Our intimate understanding of the human immune system enables us
to harness its sophisticated response to disease to detect cancer
earlier and to support the development of better therapies.
The key to improving cancer survival is early detection and
better selection for therapy. As a company, we are driven by our
passion to improve cancer survival and to give people extra time.
Oncimmune's immunodiagnostic test, EarlyCDT, can detect and help
identify cancer on average four years earlier than standard
clinical diagnosis.
The unique combination of our core technology and understanding
of the immune system powers our ImmunoINSIGHTS service - a
proprietary platform that enables life science organisations to
optimise drug development and delivery, leading to more effective,
targeted as well as safer treatments for patients.
Oncimmune was founded in 2002 and launched its platform
diagnostic technology in 2009, followed by the launch of its first
commercial tests, EarlyCDT Lung and EarlyCDT Liver. To date, over
200,000 tests have been performed for patients worldwide. EarlyCDT
Lung was also used in what is believed to be the largest randomised
controlled trial for the early detection of lung cancer using
biomarkers, the successful National Health Service (NHS) Early
detection of Cancer of the Lung (ECLS) trial of 12,208 high-risk
smokers in Scotland. This trial demonstrated that EarlyCDT Lung
reduced the incidence of patients with late-stage lung cancer or
unclassified presentation at diagnosis, compared to standard
clinical practice.
Oncimmune, headquartered at its laboratory facility in
Nottingham, UK, has a discovery research centre in Dortmund,
Germany and a partner representative office in Shanghai, China.
Oncimmune joined the AIM Market of the London Stock Exchange in May
2016 under the ticker ONC.L
What is EarlyCDT Lung?
EarlyCDT is a simple blood test that detects the elevated
presence of autoantibodies generated by the body's immune system as
a natural defence against cancer cells.
EarlyCDT Lung is the world's most thoroughly validated blood
test for the detection of lung cancer and requires only a small
volume of blood which can be taken using a test in the home or
community setting as well as a doctor's surgery. Shown to detect
lung cancer on average four years earlier compared to current
standard clinical diagnosis, EarlyCDT Lung can also provide an
effective assessment of cancer risk in indeterminate pulmonary
nodules (IPNs).
For more information, visit www.oncimmune.com
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