Adela Announces Clinical Validation Results for Head & Neck Cancer MRD Test Simultaneously Published in Annals of Oncology and Presented at ESMO 2024

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

SOURCE Adela