On July 10, 2024 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, reported a significant advancement towards the development of a diagnostic for its drug candidate LP-184 (Press release, Lantern Pharma, JUL 10, 2024, View Source [SID1234644776]). 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.
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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 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. In particular, the Parker, et al. publication stated that:
"…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. 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."
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. 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).
"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. The planned use of biomarkers like PTGR1 in our clinical trials exemplifies our commitment to data-driven, patient-centric drug development."
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.
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.