The Phase 1b clinical trial design presented at SNO2024 combines LP-184 (STAR-001) with spironolactone to potentially enhance therapeutic response in recurrent glioblastoma (GBM) patients.

SNO2024上提出的1b期临床试验设计将LP-184（STAR-001）与螺内酯相结合，以潜在地增强复发性胶质母细胞瘤（GBM）患者的治疗反应。

Preclinical data, including in previously published research by Lantern Pharma, demonstrates up to 6-fold increase in GBM cell sensitivity when LP-184 is combined with spironolactone.

包括Lantern Pharma先前发表的研究在内的临床前数据表明，当LP-184与螺内酯联合使用时，GBM细胞敏感性增加了6倍。

LP-184 continues to advance through the existing Phase 1a clinical trial to assess safety and establish a maximum tolerated dose (MTD); no dose-limiting toxicities have been observed to date across nine patient cohorts enrolled.

LP-184继续通过现有的1a期临床试验来评估安全性并建立最大耐受剂量（MTD）；迄今为止，在登记的9个患者队列中未观察到剂量限制性毒性。

The clinical development for LP-184 in CNS cancers is planned to be advanced as STAR-001 by Starlight Therapeutics in later stage human clinical trials.

Starlight Therapeutics计划在晚期人类临床试验中将LP-184在中枢神经系统癌症中的临床开发推进为STAR-001。

DALLAS--(BUSINESS WIRE)--

达拉斯--（商业新闻）--

Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence company transforming oncology drug development, and its wholly-owned subsidiary Starlight Therapeutics, focused exclusively on CNS and brain cancers, today announced the presentation of new preclinical data and Phase 1b trial design for LP-184 (to be developed as STAR-001 for CNS indications) in glioblastoma at the Society for Neuro-Oncology (SNO) 2024 Annual Meeting in Houston, Texas..

Lantern Pharma Inc.（纳斯达克股票代码：LTRN）是一家转化肿瘤药物开发的人工智能公司，其全资子公司Starlight Therapeutics专门专注于中枢神经系统和脑癌，今天在德克萨斯州休斯顿举行的神经肿瘤学会（SNO）2024年会上宣布了针对胶质母细胞瘤的LP-184（将被开发为中枢神经系统适应症的STAR-001）的新临床前数据和1b期试验设计。。

The poster presentation highlighted LP-184's unique mechanism of action, brain penetrance properties, and potential enhanced therapeutic effect when combined with spironolactone in glioblastoma multiforme (GBM). LP-184 is currently under investigation in a Phase 1a dose-escalation safety study (NCT05933265) in adult patients with advanced solid tumors including GBM..

海报展示强调了LP-184在多形性胶质母细胞瘤（GBM）中与螺内酯联合使用时的独特作用机制，脑渗透特性和潜在的增强治疗效果。LP-184目前正在对包括GBM在内的晚期实体瘤成年患者进行1a期剂量递增安全性研究（NCT05933265）。。

'The data and trial design presented at SNO2024 further validate and progress LP-184's potential as a promising new treatment option for glioblastoma patients,' said Panna Sharma, President and CEO of Lantern Pharma. 'Through our subsidiary Starlight Therapeutics, we are positioned to advance LP-184 as STAR-001 specifically for brain cancers and CNS indications, where treatment options are limited and often ineffective.

Lantern Pharma总裁兼首席执行官潘娜·夏尔玛（PannaSharma）说，SNO2024上提供的数据和试验设计进一步验证和提高了LP-184作为胶质母细胞瘤患者有希望的新治疗选择的潜力通过我们的子公司Starlight Therapeutics，我们将LP-184提升为STAR-001，专门用于脑癌和中枢神经系统适应症，这些疾病的治疗选择有限且通常无效。

The combination with spironolactone represents an innovative approach, which has been developed with the aid of our AI platform RADR®, to potentially enhance therapeutic response in this devastating disease.'.

与螺内酯的组合代表了一种创新方法，该方法是在我们的AI平台RADR®的帮助下开发的，可以潜在地增强这种毁灭性疾病的治疗反应。”。

The key highlights from the poster presented by Dr. Schreck from Johns Hopkins Medicine and Dr. Kulkarni from Lantern Pharma at SNO2024 include:

约翰·霍普金斯医学公司的Schreck博士和Lantern Pharma公司的Kulkarni博士在SNO2024上发布的海报的主要亮点包括：

LP-184 shows favorable brain penetrance with a brain tumor/plasma concentration ratio of 0.2 compared to 0.1 for the existing standard of care, temzolomide.

LP-184显示出良好的脑外显率，脑肿瘤/血浆浓度比为0.2，而现有的护理标准替莫唑胺为0.1。

Preclinical studies show spironolactone increases GBM cell sensitivity to LP-184 up to 6-fold through ERCC3 degradation – which induces NERD (nucleotide excision repair deficiency) making the cancer cells both more sensitive to LP-184/STAR-001 and largely unable to repair themselves after exposure to the drug-candidate..

临床前研究表明，螺内酯通过ERCC3降解将GBM细胞对LP-184的敏感性提高了6倍，这会诱导NERD（核苷酸切除修复缺陷），使癌细胞对LP-184/STAR-001更敏感，并且在接触候选药物后基本上无法自我修复。。

Multiple time point and dose level experiments show that GBM cells treated with spironolactone showed significant depletion of ERCC3 – including at 25μM of spironolactone which showed up-to 95% depletion of ERCC3 by 24h.

多时间点和剂量水平实验表明，用螺内酯处理的GBM细胞显示出ERCC3的显着消耗，包括25μM的螺内酯，其在24小时内显示出高达95%的ERCC3消耗。

LP-184 is effective in temozolomide-resistant GBM models and is agnostic to MGMT methylation status.

LP-184在替莫唑胺耐药的GBM模型中有效，并且对MGMT甲基化状态不可知。

PTGR1 expression analysis from GTEX normal brain and TCGA GBM highlights that PTGR1 levels are higher in brain tumor tissue (median 5.15) as compared to normal brain tissue (median 3.95).

来自GTEX正常脑和TCGA GBM的PTGR1表达分析强调，与正常脑组织（中位数3.95）相比，脑肿瘤组织中的PTGR1水平更高（中位数5.15）。

ERCC3-dependent TC-NER activity was identified as a determinant of LP-184 synthetic lethality predicting that LP-184’s therapeutic potential will be enhanced in patients with intrinsic or spironolactone-induced NER deficient tumors.

ERCC3依赖性TC-NER活性被确定为LP-184合成致死率的决定因素，预测LP-184在内源性或螺内酯诱导的NER缺陷型肿瘤患者中的治疗潜力将增强。

Phase 1b trial being considered will evaluate LP-184 as both monotherapy and in combination with spironolactone using Simon's 2-stage optimal design in patients with IDH wild type GBM at first progression.

正在考虑的1b期试验将评估LP-184作为单一疗法以及与螺内酯联合使用，使用Simon的两阶段最佳设计对IDH野生型GBM患者进行首次进展。

Following determination of the Maximum Tolerated Dose and/or Recommended Phase 2 Dose from the ongoing Phase 1a study, Starlight Therapeutics plans to initiate a Phase 1b trial evaluating LP-184/STAR-001 in two cohorts of recurrent GBM patients: one arm which anticipates administration of STAR-001 as monotherapy and the other arm which anticipates administration of STAR-001 in combination with spironolactone (200 mg daily)..

根据正在进行的1a期研究确定最大耐受剂量和/或推荐的2期剂量后，星光治疗计划在两组复发性GBM患者中启动一项1b期试验，评估LP-184/STAR-001：一组预期将STAR-001作为单一疗法给药，另一组预期将STAR-001与螺内酯联合给药（每天200毫克）。。

The trial, as currently anticipated and designed, will assess safety, pharmacokinetics, and objective response using RANO 2.0 criteria. Additionally, the study will evaluate biomarkers including PTGR1 expression, ERCC3 levels, and DNA damage markers to help identify patients most likely to respond to treatment.

按照目前的预期和设计，该试验将使用RANO 2.0标准评估安全性，药代动力学和客观反应。此外，该研究将评估生物标志物，包括PTGR1表达，ERCC3水平和DNA损伤标志物，以帮助确定最有可能对治疗有反应的患者。

Lantern has previously reported on achieving significant development milestones in the creation of a molecular diagnostic using quantitative PCR to assess PTGR1 levels from clinical patient samples..

Lantern先前曾报道过使用定量PCR评估临床患者样本中PTGR1水平的分子诊断方法取得了重大的发展里程碑。。

LP-184 (to be developed as STAR-001 for CNS indications) is a fully synthetic small molecule that belongs to the acylfulvene class of alkylating agents. It induces DNA double-strand breaks and has shown promise across a range of solid tumors, including in preclinical GBM models. LP-184 is activated by PTGR1, which is over-expressed in approximately 80% of recurrent GBM tumors.

LP-184（将开发为用于中枢神经系统适应症的STAR-001）是一种完全合成的小分子，属于酰基硫醚类烷化剂。它诱导DNA双链断裂，并在一系列实体瘤中显示出前景，包括在临床前GBM模型中。LP-184被PTGR1激活，PTGR1在大约80%的复发性GBM肿瘤中过表达。

The FDA has granted LP-184 both Orphan Drug and Fast Track designations for the treatment of malignant gliomas / glioblastoma..

FDA已批准LP-184用于治疗恶性胶质瘤/胶质母细胞瘤的孤儿药和快速通道指定。。

ABOUT STARLIGHT THERAPEUTICS

关于星光疗法

Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma, is focused exclusively on the clinical development and commercialization of promising oncology therapies for CNS and brain cancers. Starlight leverages Lantern's RADR® AI platform to advance precision medicine approaches for adult and pediatric patients with CNS cancers, many of which have limited or no treatment options.

Starlight Therapeutics是Lantern Pharma的全资子公司，专注于中枢神经系统和脑癌的有前途的肿瘤疗法的临床开发和商业化。Starlight利用Lantern的RADR®AI平台，为患有中枢神经系统癌症的成人和儿科患者推进精准医学方法，其中许多患者的治疗选择有限或没有。

For more information, please visit – www.starlightthera.com ..

有关更多信息，请访问www.starlightthera.com。。

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 platform, RADR®, leverages billions of 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平台RADR®利用数十亿个以肿瘤学为中心的数据点和200多种先进的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。

For more information, please visit http://www.lanternpharma.com ..

For more information, please visit http://www.lanternpharma.com ..

Please find more information at:

有关更多信息，请访问：

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 STATEMENT:

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有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。

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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 Pharma Inc.Released November 26, 2024

资料来源：Lantern Pharma Inc.于2024年11月26日发布