Adela's tissue-agnostic MRD test has been
clinically validated to predict and surveil for recurrence in
patients with head & neck cancer, regardless of HPV
status
The test identified recurrences in head &
neck cancer up to 14.9 months before standard of care clinical exam
and imaging
FOSTER
CITY, Calif., Sept. 14,
2024 /PRNewswire/ -- Adela, Inc., an innovator in
blood testing for molecular residual disease (MRD) monitoring and
early cancer detection through a proprietary genome-wide methylome
enrichment technology, has successfully completed clinical
validation of its MRD test to predict and surveil for recurrence in
head & neck cancer. Results have been published in Annals of
Oncology1 and are being presented during an Oral
Presentation at the European Society for Medical Oncology (ESMO)
Congress 2024.
"Blood-based MRD testing has the potential to transform
recurrence monitoring for patients with head & neck cancer.
Currently, the majority of recurrences are not detected until
symptoms or physical findings are reported by the
patient2. By identifying signals of disease prior to
clinical presentation or routine imaging with MRD testing,
recurrences can be treated earlier and more effectively," said
Geoffrey Liu, MSc, MD, Medical
Oncologist and Senior Scientist, Princess Margaret Cancer Centre,
University Health Network (UHN). "The clinical validation results
from Adela's MRD test demonstrate that the test identified
recurrences up to 14.9 months earlier than standard of care
clinical exam and imaging."
The ability of Adela's test to quantify cfDNA cancer signal and
predict and surveil for recurrence was evaluated in individuals
diagnosed with stage I-IVB human papillomavirus (HPV)-positive
oropharyngeal and HPV-negative head and neck cancer treated at
Princess Margaret Cancer Centre, University Health Network. This
comprehensive patient cohort, based on rigorous data collection,
provided a strong foundation for evaluating the test's performance.
The full study cohort included >1,100 plasma samples collected
from >300 patients. 484 plasma samples from 149 patients were
included in the validation analysis. In the study, blood draws
occurred before and after curative intent treatment, and in a
subset of patients, at mean 12 and 24 months post-curative intent
treatment.
In the validation analysis, Adela's MRD test demonstrated the
ability to identify recurrences up to 14.9 months before standard
of care clinical exam and imaging, with a mean lead time of 4.1
months. Sensitivity for recurrence in the surveillance setting was
91% at 88% specificity. Significant differences in recurrence-free
survival (RFS) were observed when patients were stratified by MRD
positivity (HR of 35.7 (P<0.001)). MRD status showed significant
association with RFS in both HPV-positive and HPV-negative
disease.
"We are highly encouraged by the validation results of Adela's
MRD test, demonstrating strong test performance without the added
complexity of obtaining a patient's tumor tissue sample or building
an individualized panel," said Dr. Anne-Renee Hartman, Chief Medical Officer of
Adela. "For patients with head and neck cancer, in particular,
tumor tissue samples are often not available. A blood-only,
tissue-agnostic offering such as Adela's is the only way to make
MRD testing universally accessible to those who will benefit."
"These strong validation results exemplify the ability of
Adela's genome-wide methylome enrichment platform to maximize
detection of cancer signal in the blood by efficiently capturing
and preserving the information-rich methylated regions of the
genome. This single liquid biopsy platform can be applied across
cancer types, and we look forward to replicating these promising
results in additional cancer types in the near future," said Dr.
Daniel De Carvalho, Chief Scientific
Officer of Adela and Senior Scientist at Princess Margaret Cancer
Centre, University Health Network.
A Research Use Only (RUO) version of Adela's MRD test is
currently available to biopharmaceutical companies and other
investigators for use in biomarker discovery and drug development.
Adela plans to commercialize the test in 2025 for use in patients
who have received curative intent treatment for head & neck
cancer, regardless of HPV status, to detect recurrence earlier and
help guide treatment decision-making.
Presentation Details
Presentation Number 64O - Clinical validation of a
tissue-agnostic genome-wide methylome enrichment MRD assay for head
and neck cancers
Shao Hui
Huang, MD, MSc, MRT(T) 3
Saturday September 14, 2024 15:35 PM CEST
Salamanca Auditorium, Hall 5
About Adela
Adela is developing best-in-class
technology to accelerate the diagnosis and improve the management
of cancer through blood tests for minimal residual disease (MRD)
monitoring and multi-cancer early detection (MCED). Adela's
genome-wide methylome enrichment platform, which utilizes the
company's patented cfMeDIP-seq platform, efficiently captures
extensive, biologically-relevant genomic information to maximize
test performance and improve treatment decisions. The company's
platform specifically isolates the information-rich (methylated)
regions of the genome through a high-affinity enrichment process,
enabling it to capture and preserve more genomic material for
sequencing compared to other platforms that use enzymatic or
chemical treatment (bisulfite conversion). This comprehensive view
of the methylome significantly increases the opportunities for
Adela's products to detect cancer signals in the blood compared to
approaches that target a smaller set of genomic regions. It also
enables enhanced prognostic and predictive abilities, as well as
dynamic monitoring in patients over time. Adela's approach to MRD
testing is tissue agnostic, eliminating the burden of acquiring a
tumor sample. Adela's investors are F-Prime Capital, OrbiMed,
Deerfield Management, Decheng Capital, RA Capital Management, and
Labcorp. Find more information at adelabio.com.
About UHN
UHN is Canada's No. 1 hospital and the world's No. 1
publicly funded hospital. With 10 sites and more than 20,000
members of TeamUHN, UHN consists of Toronto General Hospital,
Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto
Rehabilitation Institute, The Michener Institute of Education at
UHN and West Park Healthcare Centre. As Canada's top research hospital, the scope of
research and complexity of cases at UHN have made it a national and
international source for discovery, education and patient care.
1 Liu G et al., Clinical validation of a
tissue-agnostic genome-wide methylome enrichment MRD assay for head
and neck malignancies. Annals of Oncology. 2024.
https://doi.org/10.1016/j.annonc.2024.08.2348
2 Agrawal A et al., Role of the physician versus the
patient in the detection of recurrent disease following treatment
for head and neck cancer. Laryngoscope. 2004 Feb;114(2):232-5. doi:
10.1097/00005537-200402000-00011.
3 Princess Margaret Cancer Centre, University Health
Network, Toronto, ON, Canada
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