RevOpsis and Kemwell Biopharma Enter Into Strategic Manufacturing Partnership to Expedite Development of Novel Multispecific Biologics
RevOpsis and Kemwell Biopharma Enter Into Strategic Manufacturing Partnership to Expedite Development of Novel Multispecific Biologics
- Partnership to accelerate development of lead product candidate, RO-104; a first-in-class tri-specific biologic for treating neovascular age-related macular degeneration.
- Broader collaboration to streamline and expedite therapeutic discovery to IND submission timelines of the proprietary multispecific Rev-Mod Platform.
- 加速開發首款三重特異性生物製品RO-104，用於治療新生血管相關年齡相關性黃斑變性。
- 更廣泛的合作，以加快治療性發現到專利申請提交時間。
SAN CARLOS, Calif. and BANGALORE, India, June 17, 2024 /PRNewswire/ -- RevOpsis Therapeutics, a next-generation biopharmaceutical company spearheading innovation of multispecific ophthalmic therapies, and Kemwell Biopharma, a leading biologics contract development and manufacturing organization (CDMO), announced today a broad strategic manufacturing partnership. This collaboration aims to accelerate the development of RevOpsis' lead candidate, RO-104, a first-in-class tri-specific biologic for the treatment of neovascular age-related macular degeneration (nAMD).
2024年6月17日，加利福利亞州聖卡洛斯和印度班加羅爾 /新華社/ -- RevOpsis Therapeutics，一家下一代生物製藥公司，領導多重特定革新性眼科治療，和Kemwell Biopharma一家領先的生物類似物合同開發和製造組織（CDMO），今天宣佈了廣泛的戰略性製造夥伴關係。該合作旨在加速最先進的三重特異性生物製品RO-104的開發，用於治療新生血管相關年齡相關性黃斑變性（nAMD），此類疾病是全球致盲的主要原因之一。
Under this partnership, Kemwell will manufacture RO-104, a novel tri-specific biologic designed to target the three dominant angiogenic pathways (VEGF-A, VEGF-C, Ang-2) for treating nAMD, a leading cause of blindness worldwide. The unique ability of RO-104 to bind these three validated targets simultaneously positions it as a first-in-class fully human monotherapy biologic, poised to redefine the treatment landscape for retinal vascular diseases.
在此合作中，Kemwell將製造RO-104，這是一種新型三重特異性生物製品，旨在針對治療nAMD的三種主要血管生成通路（VEGF-A，VEGF-C，Ang-2）。 RO-104的獨特能力同時結合這三個已驗證的靶點，使其成爲首個完全人類單一治療生物製品，定位於重新定義視網膜血管疾病的治療方式。
As India's first commercial current Good Manufacturing Practices (cGMP) manufacturing facility, Kemwell is a trusted and respected partner with extensive experience in complex protein manufacturing. This collaboration leverages Kemwell's well-established manufacturing excellence and RevOpsis' innovative Rev-Mod platform to expedite the development of novel multispecific biologics.
作爲印度第一家商業現行良好製造規範（cGMP）製造設施，Kemwell是一家備受信任和尊重的合作伙伴，具有複雜蛋白製造的豐富經驗。該合作利用了Kemwell的成熟製造卓越性和RevOpsis的創新Rev-Mod平台，以加速開發新型多重特異性生物製品。
"Partnering with Kemwell is a pivotal step in accelerating the development of our lead candidate, RO-104, and advancing our pipeline of innovative multispecific biologics," said Ram Bhandari, MD, Co-founder and Interim CEO of RevOpsis. "Kemwell's exemplary track record in high-quality biologics manufacturing and their efficiency in reducing timelines, combined with our proprietary Rev-Mod platform, ensures we can deliver transformative therapies to patients efficiently. This collaboration aligns with our mission to develop groundbreaking treatments expeditiously, and bring our innovation to patients worldwide."
RevOpsis的聯合創始人和臨時首席執行官Ram Bhandari博士表示：“與Kemwell合作是加速開發我們的首席候選藥物RO-104和推動我們創新的多重特異性生物製品流水線的關鍵一步。Kemwell在高質量生物製品製造方面的卓越業績和提高減少時間的效率，再加上我們專有的Rev-Mod平台，確保我們可以高效地將變革性治療帶給患者。該合作符合我們發展突破性治療並將我們的創新帶給全球患者的使命。”
Anurag Bagaria, CEO of Kemwell Biopharma, added, "We are excited to collaborate with RevOpsis to manufacture and commercialize RO-104. Our expertise in complex protein manufacturing, coupled with RevOpsis' innovative therapeutic approaches, holds great promise for advancing the treatment of retinal vascular diseases. This strategic partnership underscores our commitment to delivering high-quality biologics for patients in need."
Kemwell Biopharma的首席執行官Anurag Bagaria表示：“我們很高興與RevOpsis合作製造和商業化RO-104。我們在複雜蛋白製造方面的專業知識，加上RevOpsis的創新治療方法，爲推進視網膜血管疾病治療提供了很大的希望。該戰略合作凸顯了我們致力於爲有需要的患者提供高質量生物製品的承諾。”
This new alliance provides RevOpsis a critical biologics development solution to rapidly transition from pre-clinical activities to first-in-human clinical trials, expediting the development of RO-104 and the broader platform. By integrating RevOpsis' next generation plug-and-play multispecific biologics platform with Kemwell's deep biologics development and manufacturing knowledge, the collaboration aims to accelerate therapeutic discovery to IND submission timelines. This new alliance efficiently connects preclinical efforts, process development, and clinical manufacturing allowing significantly reducing the complexity and timelines of managing early GMP manufacturing process.
這種新的聯盟爲RevOpsis提供了一種關鍵的生物製品開發解決方案，以從臨床前活動迅速過渡到人體第一期臨床試驗，以加速開發RO-104和更廣泛的平台。通過將RevOpsis下一代即插即用多重特異性生物製品平台與Kemwell深厚的生物類似物開發和製造知識相結合，該合作旨在加快治療性發現到專利申請提交時間。這種新的聯盟有效地連接了臨床前工作、工藝開發和臨床製造，顯著降低了管理早期GMP製造過程的複雜性和時間。
About RO-104
Leveraging the proprietary Rev-Mod platform, RO-104 is RevOpsis' current lead candidate. Engineered as a first-in-class fully human modular tri-specific biologic designed to address all three clinically validated dominant angiogenic pathways (VEGF-A, VEGF-C, Ang-2) implicated in retinal vascular disease progression, including neovascular age-related macular degeneration (nAMD). RO-104 represents a significant innovative advancement in the treatment landscape for retinal vascular diseases. Backed by a significant body of preclinical evidence demonstrating intended efficacy and safety in established animal models, RO-104 heralds a transformative approach positioned to redefine the current standard of care for patients with nAMD.
關於RO-104：利用專有的Rev-Mod平台，RO-104是RevOpsis目前主要的候選藥物。作爲一種首個完全人類模塊化三重特異性生物製品，旨在解決所有三種在視網膜血管疾病進展中受到臨床驗證的主要血管生成通路（VEGF-A，VEGF-C，Ang-2），包括新生血管相關年齡相關性黃斑變性（nAMD）。RO-104代表了視網膜血管疾病治療領域的重大創新進步。有大量的動物模型預臨床證據支持RO-104的預期療效和安全性，爲重新定義nAMD患者當前的標準護理打下了堅實的基礎。
關於Rev-Mod平台：Rev-Mod平台採用模塊化的“即插即用”方法，以簡化和加速高效探索和開發多重特異性生物製品，針對一系列慢性、常見和大型疾病，它們是全球導致死亡和殘疾的主要原因。我們專有的平台擁有近300億個完全人類抗體組分的龐大庫存，採用結構化的噬菌體展示系統，便於快速識別和組裝多重特異性產品候選物。以無縫兼容爲特色，Rev-Mod平台能夠快速有效地設計多重特異性生物製品，以滿足眼科、腫瘤、免疫介導疾病等主要治療領域的未滿足需求。
About Rev-Mod Platform
The proprietary Rev-Mod Platform employs a modular 'plug-and-play' approach to streamline and expedite the efficient discovery and development of multispecific biologics targeting a wide spectrum of chronic, prevalent, large diseases, that are the leading causes of death and disability worldwide. Our proprietary platform boasts a vast library of nearly 30 billion fully human antibody components in a structured phage display system, facilitating rapid identification and assembly of multispecific product candidates. With seamless compatibility, the Rev-Mod platform enables swift and efficient design of multispecific biologics to address unmet needs in major therapeutic areas including ophthalmology, oncology, and immune-mediated diseases.
關於RevOpsis Therapeutics：RevOpsis Therapeutics成立於2018年，是一傢俬人持有的下一代生物製藥公司，引領眼科治療的創新。我們由一支領先的醫生、科學家和商業領袖組成的團隊指導，致力於利用我們的專有Rev-Mod平台開發和商業化突破性治療慢性多因素疾病。我們堅定地致力於負責任地推進患者護理，旨在開啓改善疾病管理和延長疾病緩解的新時代。欲了解更多信息，請訪問。
關於Kemwell Biopharma：Kemwell Biopharma是一家領先的生物類似物CDMO，爲全球生物製藥組織提供臨床和商業需要。位於印度班加羅爾的Kemwell爲客戶提供高品質和經濟實惠的端到端服務，包括哺乳動物細胞培養療法蛋白質的開發和製造。Kemwell的設施包括cGMP藥物物質製造套間，超過5000L生物反應器容量，cGMP藥物製品灌裝、配製，以及爲單克隆抗體、多重特異性蛋白質、細胞療法等蛋白質治療方案提供工藝和分析開發的開發實驗室等。 Kemwell目前製造商業藥物物質和藥品，並在衆多新型生物類似物和生物類似物方面參與了大量R&D項目，以支持其客戶在開發和臨床階段中使用。欲了解更多信息，請訪問。
About RevOpsis Therapeutics
Founded in 2018, RevOpsis Therapeutics is a privately held, next-generation biopharmaceutical company spearheading innovation in ophthalmic therapies. Guided by a team of leading physicians, scientists, and business leaders, we are dedicated to leveraging our proprietary Rev-Mod Platform to develop and commercialize groundbreaking treatments for chronic multifactorial diseases. With a steadfast commitment to responsibly advancing patient care, we aim to usher in a new era of improved disease management and extended disease remission. For more information, please visit .
自2018年成立以來，RevOpsis Therapeutics是一傢俬人持有的下一代生物製藥公司，引領眼科治療的創新。我們由一支領先的醫生、科學家和商業領袖組成的團隊指導，致力於利用我們的專有Rev-Mod平台開發和商業化突破性治療慢性多因素疾病。我們堅定地致力於負責任地推進患者護理，旨在開啓改善疾病管理和延長疾病緩解的新時代。欲了解更多信息，請訪問。
RevOpsis Therapeutics成立於2018年，是一傢俬人控股的新一代生物製藥公司，率先推動眼科療法創新。在一支領先的醫生、科學家和商業領袖團隊的指導下，我們致力於利用我們專有的Rev-Mod平台開發和商業化開創性的治療方法，用於治療慢性多因素疾病。我們堅定地致力於推進負責任的患者護理，旨在引領改進疾病管理和延長疾病緩解的新時代。欲了解更多信息，請訪問。
About Kemwell Biopharma
Kemwell Biopharma is a leading biologics CDMO which provides services to global biopharmaceutical organizations for both clinical and commercial needs. Kemwell, located in Bangalore, India, provides customers with high-quality and cost-effective access to end-to-end services in development and manufacturing of mammalian cell culture-based therapeutic proteins. Kemwell's facilities consist of cGMP drug substance manufacturing suites with over 5000L bioreactor capacity, sterile fill and finish for cGMP drug product manufacturing, and development laboratories to support process and analytical development for protein therapeutics such as monoclonal antibodies, multispecific proteins, cell therapies, etc. Kemwell is currently manufacturing commercial drug substances and drug products and has worked on numerous R&D projects to support its customers during the development and clinical phase for both novel biologics and biosimilars. For more information, please visit .
關於Kemwell Biopharma：Kemwell Biopharma是一家領先的生物類似物CDMO，爲全球生物製藥組織提供臨床和商業需要。位於印度班加羅爾的Kemwell爲客戶提供高品質和經濟實惠的端到端服務，包括哺乳動物細胞培養療法蛋白質的開發和製造。Kemwell的設施包括cGMP藥物物質製造套間，超過5000L生物反應器容量，cGMP藥物製品灌裝、配製，以及爲單克隆抗體、多重特異性蛋白質、細胞療法等蛋白質治療方案提供工藝和分析開發的開發實驗室等。 Kemwell目前製造商業藥物物質和藥品，並在衆多新型生物類似物和生物類似物方面參與了大量R&D項目，以支持其客戶在開發和臨床階段中使用。欲了解更多信息，請訪問。
Kemwell Biopharma是一家領先的生物製藥CDMO，爲全球生物製藥組織提供臨床和商業需求服務。位於印度班加羅爾的Kemwell爲客戶提供高質量、經濟實惠的端到端服務，包括哺乳動物細胞培養類治療蛋白的開發和製造等。Kemwell的設施包括具有超過5000L生物反應器容量的cGMP製劑生產套房、cGMP製劑生產的無菌填充和完工、以及支持蛋白質治療劑的過程和分析開發的開發實驗室，如單克隆抗體、多種特異性蛋白和細胞療法等。Kemwell目前正在製造商業製劑和藥品，並已參與許多研發項目，爲其客戶在新型生物製品和仿製生物製品的研發和臨床階段提供支持。欲了解更多信息，請訪問。
SOURCE RevOpsis
消息來源：RevOpsis
譯文內容由第三人軟體翻譯。