AMLo Biosciences publish pivotal data for diagnostic biomarker technology AMBLor® in identifying melanomas at low risk of metastasis

• Large-cohort international validation study, confirming that the combined biomarkers, AMBRA1 and loricrin (AMBLor® histochemical test) can be used to reliably stratify stage I and II melanomas at low risk of metastasis.
• Independent prognostic biomarker AMBLor can segment melanomas that will not progress to advanced disease at the point of excision.
• Low risk melanoma patients may not need subsequent invasive diagnostic procedures, lengthy follow-up or unnecessary therapy, thereby lowering the risk of patient complications, reducing impact on healthcare systems and offering a more personalised approach to disease management.

AMLo Biosciences publish pivotal data for diagnostic biomarker technology AMBLor® in identifying melanomas at low risk of metastasis


Wednesday 3rd January 2024 – AMLo Biosciences Ltd (Newcastle upon Tyne, UK) announce the publication of a large-cohort international validation study, confirming that the combined biomarkers, AMBRA1 and loricrin (AMBLor® histochemical test) can be used to reliably stratify stage I and II melanomas at low risk of progression. Clinically, this information may reduce the need for subsequent invasive diagnostic procedures, lengthy follow-up or unnecessary therapy, thereby easing pressure on health systems and offering patients a personalised approach to disease management. The results are published in the British Journal of Dermatology.

The retrospective analysis evaluated the clinical value of combined biomarker AMBRA1/loricrin expression in 840 American Joint Committee on Cancer (AJCC) stage I and II non-ulcerated melanoma tissue samples in two distinct cohorts1. AMBLor status was compared with up to 12 years clinical outcomes of each cohort. The combined multivariate model showed that the estimated effect of AMBLor was statistically significant with a hazard ratio of 3.469 (p=0.007) and an overall negative predictive value (NPV) of 96.5%1. The multivariate analysis of both cohorts also showed significantly reduced recurrence-free survival (RFS) rate in 698 AMBLor-stratified at-risk melanomas compared with 142 AMBLor-stratified low-risk melanomas (RFS 80.4% vs 96.2% p<0.001) independently of Breslow depth1. Clinically, this means that AMBLor can reliably segment melanomas that will not progress to advanced disease at the point of excision.

Prof. Penny Lovat, Newcastle University Centre for Cancer, Chief Scientific Officer, AMLo Biosciences and the senior author of the publication commented, “These robust data from such a large international cohort reinforce the reliability of AMBLor biomarker technology. AMBLor offers accurate, clinically validated, prognostic information relating to tumour progression and will enable physicians to offer reassurance to low-risk patients along with a more personalised approach to disease management.”

Only around 20% of patients with early AJCC stage I or II melanomas will progress to metastatic disease but currently there is no accurate predictor for low-risk melanoma recurrence. As a result, disease management guidance recommends the same treatment route and follow-up regimen for all early-stage melanoma patients. Patients may be recommended to undergo sentinel lymph node biopsy to inform subsequent therapy and follow-up options. This is an invasive procedure with potential for complications including seroma, wound infection, lymphoedema, and haematoma2. There is an urgent need for improved prognostic tests in early-stage melanoma and risk-predication models should incorporate biomarkers for improved accuracy3.

Mr Aidan Rose, NIHR Clinical Lecturer (FRCSEd Plast PhD), Newcastle University, added, “With the increasing number of melanoma diagnoses, there is a clear need for a simple, reliable, low-cost prognostic biomarker with the potential to streamline the care of patients with melanoma and reduce strain on UK skin cancer services.”

This validation study demonstrates the clinical role of the AMBLor biomarker technology to reliably identify subsets of patients at low risk of melanoma progression supporting their need for fewer diagnostic procedures and reduced follow-up. This has the potential to reduce patient anxiety relating to diagnosis and allow a more personal approach to disease management.

Dr Zainab Laftah, Consultant Dermatologist and British Skin Foundation spokesperson said: “Thrilled to see the data behind this innovative British Skin Foundation funded project showing the combined biomarkers, AMBRA1 and loricrin (AMBLor® histochemical test) as a reliable predictor of low risk of melanoma progression. This will help offer patients a more personalised approach to disease management, reduce unnecessary invasive procedures and ease pressure on health systems.”
ENDS.



Contact
AMLo Biosciences
Jane Meaney, AMLo Biosciences: j.meaney@amlo-biosciences.com

About AMLo Biosciences Ltd.
AMLo Biosciences Ltd (AMLo) is an innovative medical device company that specialises in the early detection of skin cancers with metastatic potential. Its goal is to improve the management of skin cancers through risk stratification, enabling targeted and personalised cancer management.

AMLo is a spin-out from Newcastle University in the UK. The discovery and validation of the novel biomarkers that comprise these new devices emerged from the Newcastle University laboratory of Penny Lovat, Professor of Cellular Dermatology and Oncology supported by a National Institute for Health Research (NIHR) Invention for Innovation (i4i) grant (project reference 20993) in association with AMLo Biosciences Ltd. AMLo has collaborated with medical teams in the USA, Europe, and Australia to provide evidence for significantly improved disease-free survival compared to current treatment pathways.

There are almost 288,000 worldwide cases of melanoma diagnosed each year4, representing a significant market opportunity for accurate prognostic markers.

AMLo is also developing a prognostic test for cutaneous squamous cell carcinomas (cSCC); the second most common form of skin cancer. In addition, it is working on a product for oropharyngeal squamous cell carcinoma (OPSCC) which will enable precision management to reduce unnecessary treatment-associated toxicities.
www.amlo-biosciences.com

About AMBLor
AMBLor technology evaluates protein biomarkers found in the epidermis. In normal skin, these proteins are clearly expressed but original research5 led Professor Penny Lovat (CSO) found that they are absent or reduced in early-stage cutaneous melanomas that become metastatic and form secondary, often fatal, cancers.
Confirmatory studies in >400 Stage l and ll melanoma samples from the UK, USA, Australia, and Europe, followed up for over seven years, was published at the Society for Melanoma Research in 20216.
This recent prospective observational study to demonstrate clinical utility was conducted in 840 samples of non-ulcerated AJCC stage I and II melanomas across two geographically distinct cohorts. The discovery cohort (n=540) showed a recurrence-free survival (RFS) rate of 95.5% (p<0.001) and a negative predictive value (NPV) of 96%1. The validation cohort (n=300) demonstrated a RFS rate of 97.6% (p<0.001) and a NPV of 97.6%1.
The data show that a low risk AMBLor score will be assigned to 17% of non-ulcerated Stage l and Stage ll patients and will predict that a melanoma will not spread in 97.1% cases6. In addition, the high sensitivity of the test shows that AMBLor has the potential in identifying truly high-risk patients, confirmation of which is the subject of ongoing research. The combined data sets involving >1,100 patients suggest that AMBLor has superior prognostic value to current AJCC staging criteria as the current standard of care.
Melanoma is diagnosed in nearly 100,000 people each year in the USA and is implicated in nearly 25,000 deaths7. It is the 5th most common cancer in the UK with about 19,000 new cases each year and is the main cause of cancer death in the under 45s8. Incidence is increasing worldwide due to greater sun exposure and an ageing population9. The vast majority of melanomas are classed as low risk, early-stage Stage l (70%) or Stage ll (20%) melanoma10 and at-risk type surveillance is currently the only form of management for these patients. As more than 97% of Stage l and 82% Stage ll melanomas do not progress further11, placing everyone on an at-risk investigation and surveillance pathway places a significant burden on healthcare budgets. Surveillance regimens can last up to 5 years, placing extraordinary stress on patients and costs to NHS and private insurers. Potentially releasing around 1 in 5 people from this burden would have a significant impact on resource savings.
In September 2022, AMLo Biosciences Ltd and Avero Diagnostics LLC entered a license agreement allowing Avero Diagnostics to develop, market, and distribute AMBLor technology across the US. AMBLor has been developed in the USA by Avero Diagnostics and is available through a CLIA laboratory service. AMBLor technology fits into the existing histological analysis of melanoma specimens with local pathology teams sending samples to Avero Diagnostics for analysis. The technology is available in the UK via a UKAS accredited referral service.

About The British Journal of Dermatology
The British Journal of Dermatology (BJD) is a top-ranked international dermatology journal, publishing the highest-quality research to advance the understanding and management of skin disease to improve patient outcomes. The BJD is one of the journals of the British Association of Dermatologists, the professional membership body for dermatologists in the UK.
Oxford University Press (OUP) is BAD's publishing partner. OUP publishes over 500 academic and research journals covering a broad range of subject areas, two-thirds of which are published in collaboration with learned societies and other international organizations. OUP has been publishing journals for more than a century and, as the world’s largest university press, has more than 500 years of publishing expertise. For more information, visit www.academic.oup.com

References
1. Ewen T, et al. Validation of Epidermal AMBRA1 and Loricrin (AMBLor) as a prognostic biomarker for non-ulcerated AJCC stage I/II cutaneous melanoma. Br J Dermatol 2023; In press. https://doi.org/10.1093/bjd/ljad459
2. Moody JA, et al. Complications of sentinel lymph node biopsy for melanoma – A systematic review of the literature. Eur J Surgical Oncol 2017;43(2):270–277. https://doi.org/10.1016/j.ejso.2016.06.407
3. Kunonga TP, et al. Predictive accuracy of risk prediction models for recurrence, metastasis and survival for early-stage cutaneous melanoma: a systematic review. BMJ Open 2023;13:e073306. http://dx.doi.org/10.1136/bmjopen-2023-073306
4. American Cancer Society. Key Statistics for Melanoma Skin Cancer. Available at: https://www.cancer.org/cancer/melanoma-skin-cancer/about/key-statistics.html Accessed October 2023.
5. Ellis R et al, British Journal of Dermatology (2020) 182, pp156–165 https://onlinelibrary.wiley.com/doi/full/10.1111/bjd.18086
6. Ewen T, et al. Validation of AMBLor as a prognostic biomarker for non-ulcerated cutaneous AJCC stage l/ll Melanoma. Presented at the 18th International Congress of the Society for Melanoma Research Congress. 28–31 October 2021. Pigment Cell Melanoma Res. 2022;35(1):97–184.
7. GLOBCAN 2020. US factsheet. Available at: https://gco.iarc.fr/today/data/factsheets/populations/840-united-states-of-america-fact-sheets.pdf. Accessed October 2023.
8. GLOBCAN 2020. UK factsheet. Available at: https://gco.iarc.fr/today/data/factsheets/populations/826-united-kingdom-fact-sheets.pdf Accessed October 2023.
9. Global Coalition for Melanoma Patient Advocacy. Fighting Melanoma Together’. 2020. Available at: https://www.melanomauk.org.uk/2020-melanoma-skin-cancer-report Accessed October 2023.
10. National Cancer Registration and Analysis Service. Routes to diagnosis of cancer by stage 2012-2013 workbook (link is external). London: NCRAS; 2016 accessed via www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/melanoma-skin-cancer/incidence#ref-11 Accessed October 2023.
11. Gershenwald JE, et al. Melanoma staging: Evidence-based changes in the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer J Clin. 2017;67:472–492.



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