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Female-led AMLo Biosciences snaps £2.45M for early-stage skin cancer test

AMLo Leadership
Image credits: AMLo

Newcastle University spin-out, AMLo Biosciences, is today announcing it has successfully secured £2.45M from investors including Future Planet Capital, topping its previous seed funding round.

The innovative med-tech startup specialises in the early detection of skin cancer. AMLo’s “rule-out” prognostic test for early-stage skin cancer can accurately identify genuinely low risk, early-stage melanomas. The startup’s funding will facilitate the completion of essential clinical studies. The goal is to provide the evidence required to gain inclusion in Clinical Guidelines in key markets and to support the launch of AMBLor in the UK &US in 2022, with Australia following in 2023.

The round included a new investment from Ascension’s Life Fund and Conduit’s EIS Impact Fund, on top of re-investment from NorthStar Ventures, Future Planet Capital’s BIF Opportunities Fund, Esperante, and a cohort of Angel Investors, highlighting the continued confidence in the technology and leadership of the business.

The global prevalence of skin cancer

Melanoma is the 5th most common cancer worldwide. The condition is diagnosed in nearly 100,000 people each year in the US, causing nearly 25,000 deaths and about 19,000 new cases each year in the UK. Skin cancer has grown to be the main cause of cancer death in the under 45s, with incidences increasing globally due to greater sun exposure and an ageing population.

The vast majority of melanomas are classed as low risk, early-stage, Stage l (70%) and Stage ll (20%) melanoma. Currently, the only form of management for these patients is at-risk type surveillance. Because more than 97% of Stage l and 82% of Stage ll melanomas do not progress further, placing everyone on an at-risk investigation and surveillance pathway places a significant strain on healthcare budgets. Surveillance regimens easily last up to 5 years, placing an extraordinary burden on patients and expense to the NHS and private insurers. Potentially releasing around 1 in 5 people from this burden would have a significant impact on resource savings.

AMLo’s “rule-out” prognostic test

AMLo’s solution comes in the form of its patented “rule-out” prognostic test, AMBLor. AMBLor contains two novel antibodies which can stratify early-stage melanomas into standard-risk and low-risk metastasis, the latter with high accuracy. People with low-risk lesions could potentially be spared unnecessary surveillance and the resulting anxiety. Standard risk tumour identification will therefore justify the consequent investment into enhanced investigation and surveillance with the potential to perform early targeted drug therapy, to reduce mortality rates.

AMBLor will be launched in the US in 2022 via CLIA laboratory partners North West Pathology. Following the UKCA mark, it will simultaneously be launched in the UK NHS and private medicine markets in 2022 with plans to commercialise in Australia in 2023, where melanoma management is high profile, underway.

Female-led and founded

Professor Penny Lovat MPhil PhD, an academic professor at Newcastle University with over 25 years of experience in international translational research co-founded AMLo with Dr Marie Labus who has over 16 years of business management experience and Jane Meany who bears 25+ years of biopharma marketing experience. This wonder team clearly exudes experience and industrial expertise.

An FDA pre-sub application for AMBLor’s reagent kit was submitted in February 2022. A service using the AMBRA1 and loricrin antibodies has been available & accessible in the UK since late 2021. The UKCA marked reagent kit for pathology labs will be included in routine onco-dermatology diagnostic pathways starting from July 2022. AMLo is developing in its pipeline a prognostic device for cutaneous squamous cell carcinomas (cSCC), the second most occurring form of skin cancer. The startup is also working on a product for oropharyngeal squamous cell carcinoma (OPSCC) which will enable precision management thereby reducing unnecessary treatment-associated toxicities.

AMLo’s CEO Dr Marie Labus said, “This funding allows AMLo to embark on the next step of our journey with the resources to potentially relieve countless people with early-stage melanoma from the anxiety and follow-up burden that should be reserved for those with higher risk disease. I am delighted to welcome several new investors, and especially to see such strong additional commitment from our previous partners. Our levelling up from an academic spin-out to commercial success is critical to ensure we have the resources to further drive innovation in medical devices across our markets.”

Guy Pengelley, Portfolio Manager at Future Planet Capital, added, “Already in this relatively short period, the firm has achieved significant milestones including scientific validation and a successful pilot launch in the UK. We look forward to supporting them during the next stage of their expansion as the company scales up to become a commercial success, with the further launch in the UK & US imminent.”

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