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生物制药公司Lantern Pharma在开发用于肿瘤临床试验的患者选择和分层的分子诊断方法方面取得重要里程碑

Lantern Pharma Achieves Key Milestone Towards Development of Molecular Diagnostic for use in Oncology Clinical Trials for Patient Selection and Stratification with Drug Candidate LP-184

Lantern Pharma 等信源发布 2024-07-10 08:30

可切换为仅中文


DALLAS--(BUSINESS WIRE)--

达拉斯--(商业新闻)--

Lantern Pharma (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging artificial intelligence (AI) and machine learning to transform the cost, pace, and timeline of oncology drug discovery and development, today announced a significant advancement towards the development of a diagnostic for its drug candidate LP-184.

Lantern Pharma(NASDAQ:LTRN)是一家临床阶段的生物制药公司,利用人工智能(AI)和机器学习来改变肿瘤药物发现和开发的成本,速度和时间表,今天宣布在开发候选药物LP-184的诊断方面取得了重大进展。

The diagnostic is currently based on qRT-PCR (quantitative real-time polymerase chain reaction) technology and is focused on quantifying the amount of PTGR1 RNA in patient tumor samples to assess the potential for sensitivity to Lantern’s drug candidate LP-184. The company plans to further develop and validate the assay for its use as a potential tool for patient selection in later stage clinical trials across a broad range of solid tumors that have shown sensitivity to LP-184..

该诊断目前基于qRT-PCR(定量实时聚合酶链反应)技术,重点是定量患者肿瘤样品中PTGR1 RNA的量,以评估对Lantern候选药物LP-184的敏感性。该公司计划进一步开发和验证该检测方法,将其用作对LP-184敏感的广泛实体瘤后期临床试验中患者选择的潜在工具。。

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Lantern has successfully confirmed PTGR1 as a key biomarker that it intends to use to optimize patient selection based on potential tumor sensitivity to the drug candidate LP-184. LP-184 is a precision oncology drug candidate with the potential to address multiple solid tumors. This confirmation marks a crucial step towards the development of a companion diagnostic and potential stratification tool to assist with targeted patient selection.

Lantern已成功证实PTGR1是一种关键的生物标志物,它打算根据对候选药物LP-184的潜在肿瘤敏感性来优化患者选择。LP-184是一种精确的肿瘤候选药物,具有解决多种实体瘤的潜力。这一确认标志着朝着开发伴随诊断和潜在分层工具的关键一步,以帮助有针对性的患者选择。

Lantern plans on further validations and development of the assay using qRT-PCR and partnering with central labs and cancer centers for eventual use in patient selection and stratification. In a key publication on the utility and value of biomarkers in oncology trials among some of the most common cancers, titled Does biomarker use in oncology improve clinical trial failure risk? A large‐scale analysis by Parker, et al., 2021 in Cancer Medicine found success of clinical trials to be significantly correlated to the incorporation of biomarkers.

Lantern计划使用qRT-PCR进一步验证和开发检测方法,并与中央实验室和癌症中心合作,最终用于患者选择和分层。在一些最常见的癌症中,生物标志物在肿瘤学试验中的效用和价值的关键出版物中,题为“生物标志物在肿瘤学中的使用是否会改善临床试验失败的风险?”?Parker等人2021年在癌症医学中进行的一项大规模分析发现,临床试验的成功与生物标志物的掺入显着相关。

In particular, the Parker, et al. publication stated that:.

特别是,Parker等人的出版物指出:。

“…Our overall analysis of these four cancers, independent of indication, revealed a fivefold benefit of hazard ratios from the Markov models, suggesting a substantial benefit from biomarker use. The hazard ratio analysis of the Markov biomarker models examined how likely clinical trial success was associated with biomarker use versus no biomarker use.

“…我们对这四种癌症的总体分析,与适应症无关,揭示了马尔可夫模型的风险比的五倍益处,表明生物标志物使用具有实质性益处。马尔可夫生物标志物模型的风险比分析检查了临床试验成功的可能性与生物标志物使用与不使用生物标志物相关。

Hazard ratios indicated that for biomarker‐based drugs clinical trial success was largest for breast cancer (12‐fold) followed by melanoma (eightfold) and lung cancer (sevenfold) …Our data provide the most extensive look at biomarker use to date in oncology, with an advanced statistical method. Our findings indicate that biomarkers provide a statistically significant benefit, despite the fact our study includes biomarkers not yet FDA approved.”.

危险比表明,对于基于生物标志物的药物,乳腺癌的临床试验成功率最高(12倍),其次是黑色素瘤(八倍)和肺癌(七倍)。我们的数据提供了迄今为止在肿瘤学中使用生物标志物的最广泛的视角,采用了先进的统计方法。我们的研究结果表明,生物标志物提供了统计学上显着的益处,尽管我们的研究包括尚未获得FDA批准的生物标志物。”。

By incorporating the PTGR1 biomarker into LP-184's development strategy, Lantern Pharma is aligning with best practices in precision medicine and aiming to increase the likelihood of successful clinical outcomes in future clinical trials. PTGR1 levels have been measured to be higher in certain cancer cells than in normal cells, and Lantern is leveraging this biological activity to target the cancer indications believed most likely to respond to drug candidate LP-184.

通过将PTGR1生物标志物纳入LP-184的发展战略,Lantern Pharma正在与精准医学的最佳实践保持一致,并旨在提高未来临床试验成功临床结果的可能性。已经测量到某些癌细胞中的PTGR1水平高于正常细胞,Lantern正在利用这种生物活性来靶向据信最有可能对候选药物LP-184产生反应的癌症适应症。

In the October 2023 paper in Molecular Cancer Therapeutics, Lantern along with collaborators from Fox Chase Cancer Center published clear evidence that higher potency of LP-184 (measured in IC50 values) was directly correlated with higher expressions of PTGR1 and that cancer cell lines that did not have PTGR1 expression remained stable in the presence of LP-184 (see figure 1)..

在2023年10月发表在《分子癌症治疗学》上的论文中,Lantern与Fox Chase癌症中心的合作者一起发表了明确的证据,证明LP-184的更高效力(以IC50值衡量)与PTGR1的更高表达直接相关,并且没有PTGR1表达的癌细胞系在LP-184存在下保持稳定(见图1)。。

'This milestone represents a significant leap forward in our precision oncology approach and in ensuring that we enrich our future LP-184 clinical trials with the patients we believe will be most likely to benefit,' said Panna Sharma, CEO of Lantern Pharma. 'By working to develop a companion diagnostic for LP-184, we're not just advancing a drug candidate; we're paving the way for more personalized and effective cancer treatments for patients that have the highest likelihood of benefitting from the therapy.

Lantern Pharma首席执行官潘娜·夏尔马(Panna Sharma)说:“这一里程碑标志着我们精准肿瘤学方法的重大飞跃,并确保我们未来对我们认为最有可能受益的患者进行LP-184临床试验。”通过开发LP-184的伴随诊断,我们不仅仅是在推进候选药物;我们正在为最有可能从该疗法中受益的患者铺平道路,以实现更个性化和更有效的癌症治疗。

The planned use of biomarkers like PTGR1 in our clinical trials exemplifies our commitment to data-driven, patient-centric drug development.'.

在我们的临床试验中计划使用PTGR1等生物标志物,证明了我们对数据驱动,以患者为中心的药物开发的承诺。”。

These steps toward development of this companion diagnostic align with Lantern Pharma's commitment to leveraging cutting-edge technology in drug development. By combining AI-driven insights with advanced diagnostic tools, the company aims to accelerate the drug development process and improve patient outcomes..

这些开发这种伴随诊断的步骤与Lantern Pharma在药物开发中利用尖端技术的承诺相一致。通过将人工智能驱动的见解与先进的诊断工具相结合,该公司旨在加速药物开发过程并改善患者预后。。

Lantern Pharma plans to implement this assay in upcoming clinical trials for LP-184, potentially streamlining the development process and increasing the likelihood of successful outcomes. LP-184— a novel therapeutic in clinical development for the potential treatment of malignant gliomas, pancreatic cancer, and atypical teratoid rhabdoid tumors (ATRT)— has also been granted an Orphan Drug Designation by the FDA, along with a Rare Pediatric Disease Designation..

Lantern Pharma计划在即将进行的LP-184临床试验中实施这种检测方法,可能会简化开发过程并增加成功结果的可能性。LP-184是一种临床开发中用于潜在治疗恶性胶质瘤,胰腺癌和非典型畸胎样横纹肌样肿瘤(ATRT)的新型治疗药物,也被FDA授予孤儿药称号,以及罕见的儿科疾病称号。。

About Lantern Pharma:

关于Lantern Pharma:

Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 60 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development.

Lantern Pharma(纳斯达克股票代码:LTRN)是一家AI公司,它改变了肿瘤药物发现和开发的成本、速度和时间表。我们专有的人工智能和机器学习(ML)平台RADR®利用了600多亿个以肿瘤学为中心的数据点和200多个先进的ML算法库,帮助解决肿瘤学药物开发中数十亿美元的现实问题。

By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies that span multiple cancer indications, including both solid tumors and blood cancers and an antibody-drug conjugate (ADC) program.

通过利用人工智能的力量以及世界级科学顾问和合作者的投入,我们加速了跨越多种癌症适应症(包括实体瘤和血癌)以及抗体-药物偶联物(ADC)计划的不断增长的治疗渠道的发展。

On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0 - 2.5 million per program..

平均而言,我们新开发的药物计划在2-3年内从最初的人工智能见解发展为首次人体临床试验,每个计划约为100万至250万美元。。

Our lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials. We have also established a wholly-owned subsidiary, Starlight Therapeutics, to focus exclusively on the clinical execution of our promising therapies for CNS and brain cancers, many of which have no effective treatment options.

我们的潜在客户开发计划包括2期临床计划和多个1期临床试验。。

Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD and have the potential to provide life-changing therapies to hundreds of thousands of cancer patients across the world..

据估计,我们由人工智能驱动的创新产品候选渠道的年市场潜力合计超过150亿美元,并有可能为全球数十万癌症患者提供改变生活的疗法。。

Please find more information at:

Website: www.lanternpharma.com

网址:www.lanternpharma.com

LinkedIn: https://www.linkedin.com/company/lanternpharma/

LinkedIn: https://www.linkedin.com/company/lanternpharma/

X: @lanternpharma

X: @lanternpharma

Forward-looking Statements:

前瞻性声明:

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others.

本新闻稿包含经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所指的前瞻性声明。这些前瞻性报表除其他事项外,还包括与以下事项有关的报表:未来事件或我们未来的财务业绩;我们的RADR®平台在识别可能对候选药物产生反应的候选药物和患者人群方面的潜在优势;我们推进候选药物和抗体-药物偶联物(ADC)开发计划发展的战略计划;关于我们候选药物和ADC开发计划的开发时间的估计;关于临床试验时间和患者登记的期望和估计;我们的内部药物发现计划的研究和开发工作以及利用我们的RADR®平台来简化药物开发过程;我们打算利用人工智能,机器学习和基因组数据来简化和改变肿瘤药物发现和开发的速度,风险和成本,并确定可能对候选药物产生反应的患者人群;关于患者人群,潜在市场和潜在市场规模的估计;我们对候选药物的销售估计以及我们发现和开发候选药物的计划,并通过自己或与他人合作推进这些候选药物来最大限度地发挥其商业潜力。

Any statements that are not statements of historical fact (including, without limitation, statements that use words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' .

任何不属于历史事实陈述的陈述(包括但不限于使用诸如“预期”、“相信”、“沉思”、“可能”、“估计”、“预期”、“打算”、“寻求”、“可能”、“可能”、“可能”、“计划”、“潜力”、“预测”、“项目”、“目标”等词语的陈述)。

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Source: Lantern PharmaReleased July 10, 2024

资料来源:Lantern Pharma于2024年7月10日发布