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Akoya Biosciences and NeraCare Enter into an Exclusive Agreement to Enable Personalized Therapy Selection for Early-Stage Melanoma Patients
MARLBOROUGH, Mass. and FRANKFURT, Germany, May 09, 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 patients, announced an exclusive agreement today under which the parties will develop market opportunities for combining Akoya’s PhenoImager HT platform and NeraCare’s Immunoprint assay for patient stratification and therapy selection in early-stage melanoma patients.
Melanoma is the leading cause of skin cancer-related deaths, with over 235,000 new diagnoses globally every year. Recent approvals of immune- and targeted therapies have greatly expanded the available treatment options for adjuvant therapy. Nonetheless, a significant number of early-stage melanoma patients remain at high risk of relapse and mortality without access to such therapies. As the majority of melanoma patients are diagnosed with early stage disease, there is a critical unmet medical need to identify those at-risk patients to potentially enable earlier access to life-saving therapeutic agents.
“NeraCare’s Immunoprint assay has demonstrated robust clinical performance in identifying early-stage melanoma patients at high risk of relapse through multiple, independent, prospective and retrospective clinical studies. The Immunoprint high-risk patient group has a risk of relapse comparable to those patients in later stages with approved adjuvant therapies. Therefore, the Immunoprint high-risk patient group is ideally suited to potentially benefit from these therapeutic options that would usually only be administered in later stages. We believe Immunoprint is in a class of its own in terms of the potential to positively impact patients’ lives,” said Daniel von Janowski, Co-Founder of NeraCare.
At this year's ASCO Annual Meeting, updated clinical data from the MELARISK-001 study in stage IB/IIA will be presented.
"We are pleased to partner with Akoya Biosciences, a leader in spatial biology. The PhenoImager HT platform, with its powerful multiplex immunofluorescence capabilities, is an excellent match for our Immunoprint assay. This combination enables precise and efficient spatial phenotyping while using a minimal number of tissue sections,” said Friedrich Ackermann, Co-Founder of NeraCare.
"We are thrilled to partner with NeraCare in efforts to bring this game changing test to market and drive better patient care. Our collaboration is a testament to the power that spatial multiplexing can bring beyond research and into the clinic,” said Brian McKelligon, CEO of Akoya Biosciences. “Immunoprint has demonstrated unparalleled clinical utility to identify high risk patients, and our collaboration is a critical first step towards helping to serve the unmet need to increase therapeutic intervention for patients with this life-threatening disease."
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 our products and services, our ability to market, sell and achieve market acceptance of our current and planned products and services 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.
Akoya Investor Contact:
Priyam Shah
Sr. Director, Investor Relations
Akoya Biosciences
investors@akoyabio.com
Akoya Media Contact:
Christine Quern
Akoya Biosciences
+1.617.650.8497
media@akoyabio.com
Melanoma is the leading cause of skin cancer-related deaths, with over 235,000 new diagnoses globally every year. Recent approvals of immune- and targeted therapies have greatly expanded the available treatment options for adjuvant therapy. Nonetheless, a significant number of early-stage melanoma patients remain at high risk of relapse and mortality without access to such therapies. As the majority of melanoma patients are diagnosed with early stage disease, there is a critical unmet medical need to identify those at-risk patients to potentially enable earlier access to life-saving therapeutic agents.
“NeraCare’s Immunoprint assay has demonstrated robust clinical performance in identifying early-stage melanoma patients at high risk of relapse through multiple, independent, prospective and retrospective clinical studies. The Immunoprint high-risk patient group has a risk of relapse comparable to those patients in later stages with approved adjuvant therapies. Therefore, the Immunoprint high-risk patient group is ideally suited to potentially benefit from these therapeutic options that would usually only be administered in later stages. We believe Immunoprint is in a class of its own in terms of the potential to positively impact patients’ lives,” said Daniel von Janowski, Co-Founder of NeraCare.
At this year's ASCO Annual Meeting, updated clinical data from the MELARISK-001 study in stage IB/IIA will be presented.
"We are pleased to partner with Akoya Biosciences, a leader in spatial biology. The PhenoImager HT platform, with its powerful multiplex immunofluorescence capabilities, is an excellent match for our Immunoprint assay. This combination enables precise and efficient spatial phenotyping while using a minimal number of tissue sections,” said Friedrich Ackermann, Co-Founder of NeraCare.
"We are thrilled to partner with NeraCare in efforts to bring this game changing test to market and drive better patient care. Our collaboration is a testament to the power that spatial multiplexing can bring beyond research and into the clinic,” said Brian McKelligon, CEO of Akoya Biosciences. “Immunoprint has demonstrated unparalleled clinical utility to identify high risk patients, and our collaboration is a critical first step towards helping to serve the unmet need to increase therapeutic intervention for patients with this life-threatening disease."
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 our products and services, our ability to market, sell and achieve market acceptance of our current and planned products and services 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.
Akoya Investor Contact:
Priyam Shah
Sr. Director, Investor Relations
Akoya Biosciences
investors@akoyabio.com
Akoya Media Contact:
Christine Quern
Akoya Biosciences
+1.617.650.8497
media@akoyabio.com
Published: May 23, 2024 Assay identified 98% of relapses and 100% of cutaneous melanoma-related deaths in stage IB/IIA patients Patients with stage IB/IIA melanoma identified as high-risk had a relapse rate comparable to later-stage patients for whom adjuvant therapy is already approved The prognostic assay may be useful in selecting early-stage melanoma patients for adjuvant trials Assay is being transferred to the Akoya Biosciences’ PhenoImager® HT multiplex platform to enable automation and tissue preservation FRANKFURT, Germany--(BUSINESS WIRE)-- NeraCare, a leading developer of laboratory tests for personalized survival prediction of melanoma patients, today announced publication of an abstract describing the clinical validation of a prognostic seven biomarker immunohistochemistry (7-IHC; Immunoprint) risk categorization assay that stratifies patients with early-stage (IB/IIA) cutaneous melanoma into high-risk or low-risk groups for recurrence and melanoma-specific survival, on the American Society of Clinical Oncology (ASCO) website. Results of the Melarisk-001 study demonstrated that use of 7-IHC identified 98% of relapses and 100% of cutaneous melanoma-related deaths in stage IB/IIA patients. Patients with 7-IHC high-risk had a relapse rate comparable to stage IIB-IV patients for whom adjuvant therapy is approved. Results of the study suggest its utility in selecting early-stage melanoma patients for adjuvant trials. “Anti-PD-1 therapy is a standard of care adjuvant therapy for cutaneous melanoma patients with resected AJCC stages IIB-IV disease.” said Jeffrey Weber, MD, PhD, co-author of the poster and Deputy Director of the Perlmutter Cancer Center and Co-Director of the Melanoma Research Center at NYU Langone Health. “Nonetheless, a smaller subgroup of earlier-stage patients with IB or IIA disease is at high risk of relapse and death, and remains without access to adjuvant therapy. This subgroup accounts for a significant share of overall melanoma-related mortality. While adjuvant clinical trials for these earlier-stage patients that will be destined to relapse may be merited, this subgroup is not detectable via current AJCC staging alone. The ability to identify these patients using 7-IHC may be useful in selecting such high-risk participants for adjuvant trials.” The multicenter MELARISK-001 archival study enrolled 382 patients diagnosed with stage IB/IIA cutaneous melanoma with available formalin-fixed paraffin-embedded primary melanoma tissue sections; 247 (65%) patients were categorized as stage IB and 135 (35%) were stage IIA, all sentinel node-negative. Tissue specimens were analyzed by the 7-IHC assay and patients classified as either high-risk or low-risk. The assay measures the expression of five risk markers (Bax, Bcl-X, CD20, COX-2, PTEN) and two protective markers (MTAP, β-Catenin). Median follow-up for recurrence-free survival (RFS) was 90 months and for melanoma-specific survival (MSS), 98 months. 7-IHC classified 212 patients (55%) as high-risk and 170 (45%) as low-risk 7-IHC high-risk patients had significantly worse survival outcomes than 7-IHC low-risk patients “As the majority of melanoma patients are diagnosed with early-stage disease, there is a critical unmet medical need to identify those at-risk patients to potentially enable earlier access to life-saving therapeutic agents,” said Daniel von Janowski, Co-Founder of NeraCare. “With clinical validation of 7-IHC and the potential for tens of thousands of early-stage melanoma patients to benefit from the test, we are already in the process of transferring the assay from IHC to the Akoya Biosciences’ PhenoImager HT multiplex platform. In doing so, the assay can be fully automated and will require a much smaller tissue sample than is needed for IHC.” said Friedrich Ackermann, Co-Founder of NeraCare. Poster Presentation Details: Title: Clinical validation of a prognostic 7-marker IHC assay (7-IHC) in 382 patients (pts) with stage IB/IIA cutaneous melanoma (CM; MELARISK-001) Presenter: Teresa Amaral, MD, PhD, Skin Cancer Center, Department of Dermatology, Eberhard Karls University of Tübingen Abstract: 9572 Poster Board: 356 Session Title: Melanoma/Skin Cancers Session Location, Date, and Time: Hall A, Saturday, June 1 - 1:30pm CDT ABOUT NERACARE NeraCare is a developer of laboratory tests for individualized survival with offices in Frankfurt and New York. In addition to Immunoprint®, the company markets the gene expression-based assay MelaGenix®, which was used in the phase III NivoMela trial, the first clinical trial in melanoma to select patients for adjuvant treatment based on individualized risk for relapse. The company has raised more than $20 million in venture capital funding led by MIG Capital AG, also a founding investor of German biotech giant BioNTech.
FRANKFURT, GERMANY, NEW YORK, USA – January 19, 2024 : SkylineDx and NeraCare today announced that they will not continue their strategic partnership. The initial intent was to identify and collaborate in areas where the companies would have synergies for further assay development and optimization of NeraCare's IHC assay. After an evaluation phase both companies jointly concluded that they will proceed independently. About SkylineDx SkylinDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient’s response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam. the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego California, USA. To learn more about SkylineDx, please visit www.skylinedx.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.
FRANKFURT , and NEW YORK , 26 April 2023 - NeraCare, a leading developer of laboratory tests for personalized survival prediction of melanoma patients, has announced a strategic partnership with SkylineDx, a biotechnology company that focuses on research and development of molecular diagnostics. The agreement includes an exclusive co-development and licensing agreement for Immunoprint®, a proteomic test used to identify early-stage melanoma patients at high risk of relapse and death. Melanoma is a severe form of skin cancer that can quickly spread, resulting in the majority of skin cancer-related deaths. While recent approvals of immune- and targeted therapies have greatly expanded the available treatment options for adjuvant therapy, a large group of early-stage patients still lack access to these life-saving therapies, accounting for most of melanoma deaths. Immunoprint® has the potential to help solve this problem. The anticipated impact of Immunoprint® was recently highlighted at the 2023 European Association of Dermato-Oncology (EADO) Congress. Across multiple, independent prospective and archival validation studies, Immunoprint showed a significant improvement of individualized risk prediction beyond the current melanoma staging system (AJCC8 )." Immunoprint has the potential to select melanoma patients at high risk of relapse and death, with high precision, and therefore allows a highly personalized adjuvant treatment approach already in early-stage melanoma”," said Dr. Dirk Schadendorf, Director of the West German Comprehensive Cancer Center at University Hospital Essen. Under the agreement, SkylineDx will lead the commercialization of Immunoprint®, while NeraCare will receive royalty payments. "We are thrilled to partner with SkylineDx, given their proven track record in successful R&D programs and a highly capable team to bring innovative diagnostic solutions to market," said Daniel von Janowski and Friedrich Ackermann, Co-Founders of NeraCare. "This partnership marks a significant milestone for SkylineDx as the world continues to move towards personalized care, and away from one-size-fits-all approaches to medicine. The team at NeraCare has made great progress in melanoma risk stratification," commented Jvalini Dwarkasing, CSO of SkylineDx. "Through this collaboration, we anticipate to accelerate the development of precision diagnostics and treatment for patients with this life-threatening disease." With the news of this announcement the combined efforts of NeraCare and SkylineDx will focus on setting up a phase III clinical trial that will randomize high-risk early-stage melanoma patients to receive drug treatment. If successful, this clinical trial could potentially provide access to drug treatment for up to 28,000 early-stage melanoma patients globally every year. This would further add to the already significant breakthroughs in adjuvant melanoma therapy in recent history and provide hope for many patients. ABOUT NERACARE : NeraCare is a developer of laboratory tests for individualized survival with offices in Frankfurt and New York. In addition to Immunoprint®, the company markets the gene expression-based assay MelaGenix®, which was used in the phase III NivoMela trial , the first clinical trial in melanoma to select patients for adjuvant treatment based on individualized risk for relapse. The company has raised close to $15 million in venture capital funding led by MIG Capital AG, also a founding investor of German biotech giant BioNTech. ABOUT SKYLINEDX : is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient’s response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam. the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego California, USA.