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 .
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
Akoyaは、初期メラノーマ患者における疾患再発の予測のためのNeraCareのImmunoprintテストを開発・商業化するための世界的権利を独占的にライセンスし、治療選択をより適切に導き、高リスク患者が命を救う治療にアクセスできるようにするために臨床試験メニューを拡大します。
マールボロ、マサチューセッツ州とフランクフルト、ドイツ、2024年12月10日(グローブニュースワイヤー)-- Akoya Biosciences, Inc.(ナスダック:AKYA)、空間生物学会社、およびメラノーマの予後のための臨床検査の主要開発業者であるNeraCareは、Akoyaのマルチプレックス免疫蛍光プラットフォーム上でNeraCareのImmunoprintテストを開発・商業化するための独占的なグローバルライセンス契約を発表しました。 今年初めに発表された両社の研究協力に基づき、このライセンス契約により、Akoyaは臨床研究、診断開発、または規制の承認後に患者の臨床試験用のテストを開発、販売、商業化する独占的権利を付与されます。これは、AkoyaのPhenoImager Htプラットフォーム上の実験室検査または配布可能な診断としても行われます。
メラノーマは皮膚癌の主な原因であり、毎年23.5万人以上の新しい診断が行われ、その80%が初期の病態(IA/IB/IIA)です。 これらの初期患者は手術とその後の監視を受けますが、後期メラノーマのために承認された効果的な補助療法を受ける資格はありません。NeraCareのImmunoprintアッセイは、再発の高リスクにある初期メラノーマ患者を特定することにより、この重要な未充足のニーズに応え、後期患者に匹敵するため、治療オプションの利得が期待できます。
「この契約は、Akoyaの市場をリードするマルチプレックス免疫蛍光テクノロジーとNeraCareのImmunoprintの革新的な開発と厳密な臨床検証という両社の相補的な専門知識に基づいています。私たちは共に、世界中の初期メラノーマ患者に対する命を救う治療へのアクセスを拡大することを目指しています」と、NeraCareの共同創業者であるフリードリヒ・アッカーマンは述べています。
"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.
将来の見通しに関する記述
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.
いくつかのケースでは、"may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" という言葉や、その否定形、またはそれに類似する用語によって前向きな声明を特定することができますが、すべての前向きな声明がこれらの言葉を含むわけではありません。これらの声明は、実際の結果、活動のレベル、パフォーマンス、または成果が、これらの前向きな声明で表明または暗示された情報と大きく異なる原因となり得るリスク、不確実性、その他の要因を含んでいます。これらのリスク、不確実性、その他の要因については、"リスク要因、" "経営陣による財務状況および業績の分析"、および随時提出する証券取引委員会への文書内で説明しています。前向きな声明は、私たちが現在知っている事実と要因の組み合わせおよび未来についての予測に基づいているため、確実ではありません。その結果、前向きな声明が正確であるとは限りません。このプレスリリースにおける前向きな声明は、ここに記載する日時点における私たちの見解を表しています。法的に必要な場合を除き、いかなる理由でも前向きな声明を更新する義務は負いません。
アコーヤバイオサイエンシーズについて
空間生物学企業として、アコーヤバイオサイエンシーズのミッションは、空間表現型化の力を通じて生物学と人間の健康の世界に文脈をもたらすことです。同社は、研究者が空間的文脈でセルを表現型化し、病気の進行や治療への反応にどのように組織され、相互作用するかを可視化することを可能にする包括的な単一細胞イメージングソリューションを提供しています。アコーヤは、発見、翻訳、および臨床研究における研究者の多様なニーズに応えるため、PhenoCodeパネルとPhenoCycler、PhenoImager Fusion、およびPhenoImager Ht装置を含む、空間表現型化ソリューションの完全な連続体を提供しています。アコーヤについて詳しく学ぶには、訪問してください。
NeraCareについて
NeraCareは、ドイツのフランクフルトと米国のニューヨークにオフィスを持つ、メラノーマ患者の個別化された生存予測のための検査を開発している企業です。現在のポートフォリオには、(i)免疫印刷、再発と死亡のリスクが高い早期メラノーマ患者を特定するための免疫組織化学に基づくアッセイと(ii)MelaGenix、NivoMela試験の選定基準として使用された遺伝子発現に基づくアッセイが含まれています。NivoMelaは、個別化された再発リスクを基に患者を選択するメラノーマにおける最初の臨床試験です。これまでに、NeraCareはベンチャーキャピタルの資金調達で2000万ドル以上を調達しています。
投資家コンタクト:
プリヤム・シャー
investors@akoyabio.com
メディア連絡先:
CHRISTINE
cq@christinequern.com