Akoya Biosciences and NeraCare Enter into an Exclusive Global License Agreement for the Development and Commercialization of the Immunoprint Test for Early-Stage Melanoma Patient Treatment Decisions

Rhea-AI Summary

Akoya Biosciences (NASDAQ: AKYA) has entered into an exclusive global license agreement with NeraCare to develop and commercialize the Immunoprint test for early-stage melanoma patient treatment decisions. The test will be developed on Akoya's multiplexed immunofluorescent platform, specifically the PhenoImager HT platform.

The Immunoprint assay addresses a critical need by identifying high-risk early-stage melanoma patients who could potentially benefit from therapeutic options typically reserved for later-stage patients. This is particularly significant as melanoma sees over 235,000 new diagnoses annually, with 80% being early-stage cases (IA/IB/IIA).

The agreement grants Akoya exclusive rights for clinical research, diagnostic development, and patient clinical testing following regulatory approval.

Positive

• Exclusive global rights secured for Immunoprint test development and commercialization
• Large addressable market with 235,000 new melanoma diagnoses annually
• Potential to expand therapeutic options for early-stage melanoma patients (80% of cases)
• Multiple revenue streams possible: laboratory testing and distributable diagnostics

Negative

• Regulatory approval required before clinical use
• Development and commercialization costs and timeline uncertainties

Insights

Medical Research Analyst

This exclusive licensing deal represents a significant strategic advancement in melanoma diagnostics. The Immunoprint test addresses a important gap in early-stage melanoma treatment by identifying high-risk patients who might benefit from adjuvant therapies typically reserved for later stages. With 80% of the 235,000 annual melanoma diagnoses being early-stage cases, this test could potentially revolutionize treatment protocols. The test's ability to identify patients at high risk of relapse in early stages (IA/IB/IIA) could lead to earlier therapeutic interventions, potentially improving survival rates. The integration with Akoya's PhenoImager HT platform adds technical credibility and scalability to the diagnostic solution.

Financial Analyst

This exclusive global licensing agreement significantly strengthens Akoya's position in the precision diagnostics market. The deal expands their clinical test portfolio and creates multiple revenue streams through both laboratory testing and diagnostic kit distribution. With a substantial addressable market of approximately 188,000 early-stage melanoma patients annually, this represents a meaningful commercial opportunity. The partnership also enhances Akoya's relationship with pharmaceutical companies developing melanoma therapies, potentially leading to additional collaboration opportunities. This strategic move could drive long-term value creation by establishing Akoya as a key player in melanoma diagnostics.

Akoya expands clinical test menu, exclusively licensing the global rights to develop and commercialize NeraCare's Immunoprint test for prognostication of disease recurrence in early-stage melanoma patients to better guide treatment decisions and potentially increase access to life saving therapies for those patients at high risk of developing metastatic disease

MARLBOROUGH, Mass. and FRANKFURT, Germany, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Akoya Biosciences, Inc. (Nasdaq: AKYA), The Spatial Biology Company, and NeraCare, a leading developer of laboratory tests for the prognosis of melanoma, today announced an exclusive global license agreement to develop and commercialize NeraCare’s Immunoprint test on Akoya's multiplexed immunofluorescent platform. Building on the research collaboration between the companies announced earlier this year, the license agreement grants Akoya the exclusive right to develop, market and commercialize the test for clinical research, diagnostic development or, following regulatory approval, patient clinical testing as both a laboratory test or a distributable diagnostic on Akoya's PhenoImager HT platform.

Melanoma, the leading cause of skin cancer, sees over 235,000 new diagnoses every year, 80% of which are in early-stage disease (IA/IB/IIA). While these early-stage patients undergo surgery and subsequent monitoring, they are ineligible to receive effective adjuvant therapies approved for later stage melanoma. NeraCare’s Immunoprint assay addresses this critical unmet need by identifying early-stage melanoma patients at high risk of relapse, comparable to later-stage patients, making them ideally suited to potentially benefit from therapeutic options.

"The agreement builds on the complementary expertise of both companies: Akoya’s market-leading multiplex immunofluorescence technology and NeraCare’s innovative development and rigorous clinical validation of Immunoprint. Together, we aim to expand access to life-saving therapies for early-stage melanoma patients worldwide," said Friedrich Ackermann, Co-Founder of NeraCare.

“Our collaboration is a testament to the versatility of Akoya’s PhenoImager HT platform and the clinical impact spatial biology can deliver. Immunoprint has proven unparalleled in identifying high-risk melanoma patients through multiple clinical studies, and our partnership aims to offer a platform to address the unmet need for earlier therapeutic intervention,” added Daniel von Janowski, Co-Founder of NeraCare.

“Our exclusive partnership with NeraCare for Immunoprint is a significant advancement of our clinical strategy providing Akoya and our pharmaceutical partners the opportunity to transform melanoma patient care We are honored to be partnering with NeraCare to help bring this test to market and serve a critical unmet need," said Brian McKelligon, CEO of Akoya Biosciences.

Forward-Looking Statements

This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements concerning our expectations about the potential, utility and safety of Immunoprint, our ability to develop, achieve regulatory approval, commercialize and achieve market acceptance of Immunoprint, the potential impact of Immunoprint on patient treatment and outcomes, and other matters regarding our business strategies, future performance, collaborations and plans and objectives for future operations.

In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

About Akoya Biosciences

As The Spatial Biology Company^®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to therapy. Akoya offers a full continuum of spatial phenotyping solutions to serve the diverse needs of researchers across discovery, translational and clinical research: PhenoCode™ Panels and PhenoCycler^®, PhenoImager^® Fusion and PhenoImager HT Instruments. To learn more about Akoya, visit www.akoyabio.com.

About NeraCare

NeraCare is a developer of laboratory tests for individualized survival prediction of melanoma patients with offices in Frankfurt, Germany and New York, USA. The current portfolio includes two assays: (i) immunoprint^®, an immunohistochemistry-based assay which identifies patients with early-stage melanoma who are at high-risk of relapse and death and (ii) MelaGenix^®, a gene-expression-based assay which was used as an inclusion criterion in the NivoMela trial. NivoMela is the first clinical trial in melanoma to select patients for adjuvant treatment based on individualized risk for relapse. To date, NeraCare has raised $20+ million in venture capital financing.

Investor Contact:

Priyam Shah
investors@akoyabio.com

Media Contact:

Christine Quern
cq@christinequern.com

FAQ

What is the purpose of Akoya Biosciences' (AKYA) Immunoprint test license agreement?

The agreement allows Akoya to develop and commercialize NeraCare's Immunoprint test globally for identifying high-risk early-stage melanoma patients who could benefit from therapeutic interventions typically reserved for later-stage patients.

What is the market size for Akoya's (AKYA) melanoma test?

The market includes over 235,000 new melanoma diagnoses annually, with 80% being early-stage cases (IA/IB/IIA), representing a significant commercial opportunity.

How will Akoya Biosciences (AKYA) commercialize the Immunoprint test?

Akoya will develop the test on their PhenoImager HT platform and commercialize it as both a laboratory test and a distributable diagnostic, subject to regulatory approval.