This week, Pfizer Inc (NYSE:PFE) revealed a new collaboration to unlock new therapeutic approaches. Its smaller European industry peer specialized in early detection of cancer, Mainz Biomed N.V. (NASDAQ:MYNZ) applied for Breakthrough Device Designation to the US Food and Drug Administration (FDA) for its revolutionary colorectal cancer (CRC) screening test, which subject to the review, would significantly accelerate the approval process.
Pfizer Enter A Drug Discovery Collaboration
Pfizer entered a multi-year partnership with Evotec to work together to advance scientific discovery for diseases with unmet need. Together with Evotec, Pfizer will focus on research for metabolic and infectious diseases. Everest chief business officer tated the company is honored to join Pfizer in focusing on diseases with severe unmet medical needsthat impact millions across the globe whose vital mechanism has been disrupted. Everest is excited to explore innovative therapies by supporting Pfizer with research and development activites at its facilities in France, a country praised for developing a strong biopharmaceutical ecosystem. Biopharmaceuticals are the new generation of complex medicines whose active substance is derived from a living source by using cutting-edge methods. In addition to its high quality research infrastructure, France ranks second in Europe for its development pipeline that consists of 584 products, according to France Biolead.
Mainz Biomed Seeking Breakthrough Device Designation
Mainz Biomed developed a non-invasive CRC test, ColoAlert. Prior to the FDA application, Mainz Biomed reported positive results from its clinical studies ColoFuture and eAArly Detect, as well as data from a pooled study including both the European and the US data, that showed sensitivity of 97% for CRC, as well as 88% for advanced adenomas which are precancerous lesions, with a specificity of 93%. ColoAlert is already being marketed across Europe, but the next-generation test includes novel mRNA biomarkers that will be used in the pivotal registration study titled ReconAAsense.
Along with its proprietary portfolio of mRNA biomarkers, Mainz Biomed complemented the Fecal Immunochemical Test (FIT) with an advanced AI and machine learning algorithm.
Besides providing an easy, non-invasive, at-home solution for CRC screening that is often avoided due to the inconvenience of colonoscopy, Mainz Biomed also went a step further by providing the opportunity to prevent CRC altogether by allowing the treatment of advanced adenoma before they advance to a cancerous state.
All in all, the above stories are examples of embracing emerging technology for good, which will undoubtedly also do good to their financials, if successful.
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本周,辉瑞公司(纽交所:PFE)揭示了一项新合作来解锁新的治疗方法。其较小的欧洲行业同行Mainz Biomed N.V. (纳斯达克:MYNZ)专门从事癌症早期检测,已向美国食品和药物管理局(FDA)申请“突破性设备认定”,用于其革命性的结直肠癌(CRC)筛查测试,如果经过审查,将显着加快批准进程。
辉瑞进入药物发现合作关系
辉瑞已与Evotec建立了多年的合作伙伴关系,共同推进未满足需求的疾病的科学发现。与Evotec一起,辉瑞将专注于代谢和传染病研究。 Everest首席业务官表示,该公司很荣幸能够加入辉瑞公司,专注于那些对全球数百万人造成严重不满足的医疗需求的疾病,其重要机制已被破坏。 Everest很高兴能够探索创新疗法,通过在法国设施开展研究和开发活动来支持辉瑞,法国因发展强大的生物制药生态系统而备受赞誉。生物制药是复杂药物的新一代,其活性物质是通过使用先进方法从来源于生命的衍生物中提取的。除了其高质量的研究基础设施外,根据France Biolead的数据,法国在其由584种产品组成的开发管道中排名欧洲第二。
Mainz Biomed寻求突破性设备认定
Mainz Biomed开发了一种非侵入性结直肠癌测试ColoAlert。在申请FDA之前,Mainz Biomed报告了来自其临床研究ColoFuture和eAArly Detect以及包括欧洲和美国数据在内的汇总研究的积极结果,这些结果显示在CRC方面的敏感性为97%,在癌前病变的先驱性癌症中为88%,具有93%的特异性。 ColoAlert已在欧洲市场上销售,但下一代测试包括新的mRNA生物标志物,将用于名为ReconAAsense的关键注册研究中。
除了其专有的mRNA生物标志物组合外,Mainz Biomed还将先进的AI和机器学习算法与Fecal Immunochemical Test(FIT)相结合。
除了提供一种易于非侵入性的在家CRC筛查解决方案,Mainz Biomed还更进一步,提供了通过治疗先进的癌前病变阻止CRC的机会。
总的来说,以上故事是采用新兴技术为良好事物所做的例子,如果成功,无疑也将有益于其财务情况。
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