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Lantern Pharma Unveils Groundbreaking AI-Powered Module to Predict Activity and Efficacy of Combination Regimens in Clinical Cancer Treatment
Lantern Pharma Unveils Groundbreaking AI-Powered Module to Predict Activity and Efficacy of Combination Regimens in Clinical Cancer Treatment

Business Wire

time6 days ago

  • Business
  • Business Wire

Lantern Pharma Unveils Groundbreaking AI-Powered Module to Predict Activity and Efficacy of Combination Regimens in Clinical Cancer Treatment

DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), a pioneering artificial intelligence (AI) company transforming oncology drug discovery and development, today announced the launch of an innovative AI-powered module within its proprietary RADR ® platform, designed to predict the activity and efficacy of combination regimens involving DNA-damaging agents (DDAs) and DNA damage response inhibitors (DDRis) in clinical cancer treatment. With the global market for combination cancer therapies projected to exceed $50 billion by 2030, growing at a CAGR of 8.5%, this module represents a significant advancement in precision oncology, enabling faster, more cost-effective development of tailored therapeutic regimens. Leveraging this AI-driven framework, Lantern Pharma has successfully architected and achieved FDA clearance for a Phase 1B/2 clinical trial in triple-negative breast cancer (TNBC), focusing on a novel DDA-DDRi combination regimen with promising preclinical efficacy. This AI-powered module is a transformative step in our mission to deliver personalized cancer treatments. By leveraging our RADR® platform to analyze complex multi-omics and clinical trial data, we identified optimal DDA-DDRi combinations that guided... Share In a peer-reviewed study published in Frontiers in Oncology, Clinical outcomes of DNA-damaging agents and DNA damage response inhibitors combinations in cancer: a data-driven review, Lantern Pharma researchers systematically analyzed 221 DDA-DDRi combination-arm clinical trials, involving 22 DDAs and 46 DDRis, to develop this module. The study categorized DDAs into eight subclasses (e.g., alkylating agents, interstrand cross-linkers) and DDRis into 14 subclasses (e.g., PARP, ATR, WEE1 inhibitors). From these, 89 trials with interpretable outcomes were scored for clinical effectiveness, safety, and biomarker-driven responses, providing a robust dataset to train the AI module. 1 Transforming Cancer Combination Therapy Development The new AI module represents a paradigm shift in precision oncology, leveraging machine learning to predict which drug combinations will be most effective for specific patient populations while minimizing toxicity risks. This data-driven approach has already demonstrated its value by successfully guiding the design of Lantern's FDA-cleared Phase 1B/2 clinical trial combining LP-184 with olaparib in triple-negative breast cancer (TNBC). "This AI-powered module is a transformative step in our mission to deliver personalized cancer treatments," said Panna Sharma, CEO & President of Lantern Pharma. "By leveraging our RADR ® platform to analyze complex multi-omics and clinical trial data, we identified optimal DDA-DDRi combinations that guided the development of our TNBC trial. We believe this approach could reduce combination therapy development timelines and costs by one-third compared to traditional methods." The module integrates genomic, transcriptomic, and clinical data to predict synergistic drug interactions, optimize therapeutic outcomes, and identify biomarker-defined patient subpopulations likely to respond to specific combinations. This data-driven approach directly informed the design of Lantern's FDA-cleared Phase 1B/2 trial in TNBC for LP-184 and olaparib, with potential to improve response rates and reduce toxicity. Key insights from the study powering the AI module include: Non-PARP Inhibitor Promise: Non-PARP DDRi combinations, particularly WEE1 inhibitors like adavosertib with platinum agents, showed an 80% positive outcome rate in interstrand cross-linker trials, with strong efficacy in TP53-mutated cancers, directly informing future trial design. Biomarker-Driven Success: Biomarkers such as TP53 mutations and HRD signatures were critical predictors of response, enabling patient stratification to maximize efficacy. Toxicity Mitigation: The use of novel formulations like liposomal doxorubicin in combination regimens reduced cardiotoxicity, providing a safer backbone for combination strategies. Emerging Trends: The analysis emphasizes the patterns in treatment effectiveness, safety, and emerging trends across various cancer types and discusses the potential of biomarkers to guide treatment selection and improve patient outcomes. The module's multi-agentic framework integrates specialized AI agents for data aggregation, drug classification, predictive modeling, biomarker identification, and optimization, creating a dynamic system that is planned to evolve along with new data. The system's continuous learning capability ensures adaptability, enabling Lantern to refine regimens and accelerate future trials across diverse cancer indications. The company is exploring licensing and commercialization opportunities to expand the application of this technology, further revolutionizing combination therapy development. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI-driven biotechnology company focused on accelerating and optimizing the discovery, development, and commercialization of cancer therapies. Its RADR ® platform leverages artificial intelligence and machine learning to uncover novel therapeutic opportunities, accelerate drug development, and improve patient outcomes. Please find more information at: Forward-Looking Statements 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. 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," "model," "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that our research and the research of our collaborators may not be successful, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR ® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025. You may access our Annual Report on Form 10-K for the year ended December 31, 2024 under the investor SEC filings tab of our website at or on the SEC's website at Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. 1 Fontenot R, Biyani N, Bhatia K, Ewesuedo R, Chamberlain M and Sharma P (2025) Clinical outcomes of DNA-damaging agents and DNA damage response inhibitors combinations in cancer: a data-driven review. Front. Oncol. 15:1577468. doi: 10.3389/fonc.2025.1577468

Lantern Pharma Unveils Groundbreaking AI-Powered Module to Predict Activity and Efficacy of Combination Regimens in Clinical Cancer Treatment
Lantern Pharma Unveils Groundbreaking AI-Powered Module to Predict Activity and Efficacy of Combination Regimens in Clinical Cancer Treatment

Yahoo

time6 days ago

  • Business
  • Yahoo

Lantern Pharma Unveils Groundbreaking AI-Powered Module to Predict Activity and Efficacy of Combination Regimens in Clinical Cancer Treatment

The AI module, trained on 221 clinical trials, will be incorporated as part of Lantern's AI platform, RADR ®, and will initially focus on tailored combinations of DNA damaging agents and DNA repair inhibitors Addresses $50+ billion combination cancer therapy market projected to grow 8.5% annually through 2030 Over 60% of cancer patients received DNA damaging agents or DNA repair inhibitors as part of their clinical treatment and unique AI-powered module will focus on predicting the efficacy, safety and biomarker signatures associated with those potential treatments Platform successfully guided FDA-cleared Phase 1B/2 trial design for LP-184 + olaparib in triple-negative breast cancer DALLAS, July 15, 2025--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), a pioneering artificial intelligence (AI) company transforming oncology drug discovery and development, today announced the launch of an innovative AI-powered module within its proprietary RADR® platform, designed to predict the activity and efficacy of combination regimens involving DNA-damaging agents (DDAs) and DNA damage response inhibitors (DDRis) in clinical cancer treatment. With the global market for combination cancer therapies projected to exceed $50 billion by 2030, growing at a CAGR of 8.5%, this module represents a significant advancement in precision oncology, enabling faster, more cost-effective development of tailored therapeutic regimens. Leveraging this AI-driven framework, Lantern Pharma has successfully architected and achieved FDA clearance for a Phase 1B/2 clinical trial in triple-negative breast cancer (TNBC), focusing on a novel DDA-DDRi combination regimen with promising preclinical efficacy. In a peer-reviewed study published in Frontiers in Oncology, Clinical outcomes of DNA-damaging agents and DNA damage response inhibitors combinations in cancer: a data-driven review, Lantern Pharma researchers systematically analyzed 221 DDA-DDRi combination-arm clinical trials, involving 22 DDAs and 46 DDRis, to develop this module. The study categorized DDAs into eight subclasses (e.g., alkylating agents, interstrand cross-linkers) and DDRis into 14 subclasses (e.g., PARP, ATR, WEE1 inhibitors). From these, 89 trials with interpretable outcomes were scored for clinical effectiveness, safety, and biomarker-driven responses, providing a robust dataset to train the AI module.1 Transforming Cancer Combination Therapy Development The new AI module represents a paradigm shift in precision oncology, leveraging machine learning to predict which drug combinations will be most effective for specific patient populations while minimizing toxicity risks. This data-driven approach has already demonstrated its value by successfully guiding the design of Lantern's FDA-cleared Phase 1B/2 clinical trial combining LP-184 with olaparib in triple-negative breast cancer (TNBC). "This AI-powered module is a transformative step in our mission to deliver personalized cancer treatments," said Panna Sharma, CEO & President of Lantern Pharma. "By leveraging our RADR® platform to analyze complex multi-omics and clinical trial data, we identified optimal DDA-DDRi combinations that guided the development of our TNBC trial. We believe this approach could reduce combination therapy development timelines and costs by one-third compared to traditional methods." The module integrates genomic, transcriptomic, and clinical data to predict synergistic drug interactions, optimize therapeutic outcomes, and identify biomarker-defined patient subpopulations likely to respond to specific combinations. This data-driven approach directly informed the design of Lantern's FDA-cleared Phase 1B/2 trial in TNBC for LP-184 and olaparib, with potential to improve response rates and reduce toxicity. Key insights from the study powering the AI module include: Non-PARP Inhibitor Promise: Non-PARP DDRi combinations, particularly WEE1 inhibitors like adavosertib with platinum agents, showed an 80% positive outcome rate in interstrand cross-linker trials, with strong efficacy in TP53-mutated cancers, directly informing future trial design. Biomarker-Driven Success: Biomarkers such as TP53 mutations and HRD signatures were critical predictors of response, enabling patient stratification to maximize efficacy. Toxicity Mitigation: The use of novel formulations like liposomal doxorubicin in combination regimens reduced cardiotoxicity, providing a safer backbone for combination strategies. Emerging Trends: The analysis emphasizes the patterns in treatment effectiveness, safety, and emerging trends across various cancer types and discusses the potential of biomarkers to guide treatment selection and improve patient outcomes. The module's multi-agentic framework integrates specialized AI agents for data aggregation, drug classification, predictive modeling, biomarker identification, and optimization, creating a dynamic system that is planned to evolve along with new data. The system's continuous learning capability ensures adaptability, enabling Lantern to refine regimens and accelerate future trials across diverse cancer indications. The company is exploring licensing and commercialization opportunities to expand the application of this technology, further revolutionizing combination therapy development. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI-driven biotechnology company focused on accelerating and optimizing the discovery, development, and commercialization of cancer therapies. Its RADR® platform leverages artificial intelligence and machine learning to uncover novel therapeutic opportunities, accelerate drug development, and improve patient outcomes. Please find more information at: Website: LinkedIn: X: @lanternpharma Forward-Looking Statements 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. 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," "model," "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that our research and the research of our collaborators may not be successful, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025. You may access our Annual Report on Form 10-K for the year ended December 31, 2024 under the investor SEC filings tab of our website at or on the SEC's website at Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. 1 Fontenot R, Biyani N, Bhatia K, Ewesuedo R, Chamberlain M and Sharma P (2025) Clinical outcomes of DNA-damaging agents and DNA damage response inhibitors combinations in cancer: a data-driven review. Front. Oncol. 15:1577468. doi: 10.3389/fonc.2025.1577468 View source version on Contacts Investor Contact Investor Relationsir@ +1-972-277-1136

Here's Why We're Watching Lantern Pharma's (NASDAQ:LTRN) Cash Burn Situation
Here's Why We're Watching Lantern Pharma's (NASDAQ:LTRN) Cash Burn Situation

Yahoo

time31-05-2025

  • Business
  • Yahoo

Here's Why We're Watching Lantern Pharma's (NASDAQ:LTRN) Cash Burn Situation

Just because a business does not make any money, does not mean that the stock will go down. For example, biotech and mining exploration companies often lose money for years before finding success with a new treatment or mineral discovery. But while history lauds those rare successes, those that fail are often forgotten; who remembers So should Lantern Pharma (NASDAQ:LTRN) shareholders be worried about its cash burn? In this report, we will consider the company's annual negative free cash flow, henceforth referring to it as the 'cash burn'. Let's start with an examination of the business' cash, relative to its cash burn. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. A company's cash runway is the amount of time it would take to burn through its cash reserves at its current cash burn rate. When Lantern Pharma last reported its March 2025 balance sheet in May 2025, it had zero debt and cash worth US$20m. Importantly, its cash burn was US$19m over the trailing twelve months. Therefore, from March 2025 it had roughly 12 months of cash runway. While that cash runway isn't too concerning, sensible holders would be peering into the distance, and considering what happens if the company runs out of cash. Depicted below, you can see how its cash holdings have changed over time. View our latest analysis for Lantern Pharma Lantern Pharma didn't record any revenue over the last year, indicating that it's an early stage company still developing its business. So while we can't look to sales to understand growth, we can look at how the cash burn is changing to understand how expenditure is trending over time. Over the last year its cash burn actually increased by 40%, which suggests that management are increasing investment in future growth, but not too quickly. However, the company's true cash runway will therefore be shorter than suggested above, if spending continues to increase. Clearly, however, the crucial factor is whether the company will grow its business going forward. For that reason, it makes a lot of sense to take a look at our analyst forecasts for the company. While Lantern Pharma does have a solid cash runway, its cash burn trajectory may have some shareholders thinking ahead to when the company may need to raise more cash. Issuing new shares, or taking on debt, are the most common ways for a listed company to raise more money for its business. Commonly, a business will sell new shares in itself to raise cash and drive growth. By looking at a company's cash burn relative to its market capitalisation, we gain insight on how much shareholders would be diluted if the company needed to raise enough cash to cover another year's cash burn. Lantern Pharma's cash burn of US$19m is about 57% of its US$34m market capitalisation. That's high expenditure relative to the value of the entire company, so if it does have to issue shares to fund more growth, that could end up really hurting shareholders returns (through significant dilution). On this analysis of Lantern Pharma's cash burn, we think its cash runway was reassuring, while its cash burn relative to its market cap has us a bit worried. After looking at that range of measures, we think shareholders should be extremely attentive to how the company is using its cash, as the cash burn makes us uncomfortable. On another note, we conducted an in-depth investigation of the company, and identified 6 warning signs for Lantern Pharma (3 make us uncomfortable!) that you should be aware of before investing here. Of course, you might find a fantastic investment by looking elsewhere. So take a peek at this free list of companies with significant insider holdings, and this list of stocks growth stocks (according to analyst forecasts) Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Here's Why We're Watching Lantern Pharma's (NASDAQ:LTRN) Cash Burn Situation
Here's Why We're Watching Lantern Pharma's (NASDAQ:LTRN) Cash Burn Situation

Yahoo

time31-05-2025

  • Business
  • Yahoo

Here's Why We're Watching Lantern Pharma's (NASDAQ:LTRN) Cash Burn Situation

Just because a business does not make any money, does not mean that the stock will go down. For example, biotech and mining exploration companies often lose money for years before finding success with a new treatment or mineral discovery. But while history lauds those rare successes, those that fail are often forgotten; who remembers So should Lantern Pharma (NASDAQ:LTRN) shareholders be worried about its cash burn? In this report, we will consider the company's annual negative free cash flow, henceforth referring to it as the 'cash burn'. Let's start with an examination of the business' cash, relative to its cash burn. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. A company's cash runway is the amount of time it would take to burn through its cash reserves at its current cash burn rate. When Lantern Pharma last reported its March 2025 balance sheet in May 2025, it had zero debt and cash worth US$20m. Importantly, its cash burn was US$19m over the trailing twelve months. Therefore, from March 2025 it had roughly 12 months of cash runway. While that cash runway isn't too concerning, sensible holders would be peering into the distance, and considering what happens if the company runs out of cash. Depicted below, you can see how its cash holdings have changed over time. View our latest analysis for Lantern Pharma Lantern Pharma didn't record any revenue over the last year, indicating that it's an early stage company still developing its business. So while we can't look to sales to understand growth, we can look at how the cash burn is changing to understand how expenditure is trending over time. Over the last year its cash burn actually increased by 40%, which suggests that management are increasing investment in future growth, but not too quickly. However, the company's true cash runway will therefore be shorter than suggested above, if spending continues to increase. Clearly, however, the crucial factor is whether the company will grow its business going forward. For that reason, it makes a lot of sense to take a look at our analyst forecasts for the company. While Lantern Pharma does have a solid cash runway, its cash burn trajectory may have some shareholders thinking ahead to when the company may need to raise more cash. Issuing new shares, or taking on debt, are the most common ways for a listed company to raise more money for its business. Commonly, a business will sell new shares in itself to raise cash and drive growth. By looking at a company's cash burn relative to its market capitalisation, we gain insight on how much shareholders would be diluted if the company needed to raise enough cash to cover another year's cash burn. Lantern Pharma's cash burn of US$19m is about 57% of its US$34m market capitalisation. That's high expenditure relative to the value of the entire company, so if it does have to issue shares to fund more growth, that could end up really hurting shareholders returns (through significant dilution). On this analysis of Lantern Pharma's cash burn, we think its cash runway was reassuring, while its cash burn relative to its market cap has us a bit worried. After looking at that range of measures, we think shareholders should be extremely attentive to how the company is using its cash, as the cash burn makes us uncomfortable. On another note, we conducted an in-depth investigation of the company, and identified 6 warning signs for Lantern Pharma (3 make us uncomfortable!) that you should be aware of before investing here. Of course, you might find a fantastic investment by looking elsewhere. So take a peek at this free list of companies with significant insider holdings, and this list of stocks growth stocks (according to analyst forecasts) Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

EXCLUSIVE: FDA Clears Lantern Pharma's Planned Phase 1b/2 Trial of LP-184 In Treatment-Resistant Lung Cancer Patients
EXCLUSIVE: FDA Clears Lantern Pharma's Planned Phase 1b/2 Trial of LP-184 In Treatment-Resistant Lung Cancer Patients

Yahoo

time12-05-2025

  • Business
  • Yahoo

EXCLUSIVE: FDA Clears Lantern Pharma's Planned Phase 1b/2 Trial of LP-184 In Treatment-Resistant Lung Cancer Patients

The U.S. Food and Drug Administration (FDA) on Monday cleared the amendment to Lantern Pharma Inc.'s (NASDAQ:LTRN) Investigational New Drug (IND) application for the Phase 1b/2 trial of LP-184 in a genomically defined patient population of non-small cell lung cancer (NSCLC). The biomarker-focused Phase 1b/2 trial is designed to target high-risk NSCLC subtypes by evaluating LP-184 in combination with Bristol-Myers Squibb & Co.'s (NYSE:BMY) immune checkpoint inhibitors, Opdivo (nivolumab) and Yervoy (ipilimumab) in patients with advanced NSCLC harboring KEAP1 and/or STK11 mutations and low PD-L1 study is designed to assess safety, preliminary efficacy, and biomarker correlations, potentially paving a path toward accelerated development. Lantern Pharma expects to prepare an application for a Fast Track or Accelerated Approval Designation for this patient population based on data from the planned trial and ongoing analysis from existing models. The company said the median overall survival for newly diagnosed, advanced NSCLC with KEAP1 and/or STK11 mutations treated with checkpoint inhibitors and chemotherapy is estimated to be 15 months, and this population presents an annual market opportunity of over $2 billion. In December 2024, the FDA granted Fast Track Designation for LP-184 for Triple-Negative Breast Cancer (TNBC). This marked the second Fast Track Designation received for LP-184 in 2024, following its designation for Glioblastoma in October. LP-184 has demonstrated significant preclinical efficacy in TNBC models, including those resistant to PARP inhibitors, and recent data shows promising synergy with checkpoint inhibitors in TNBC. In November 2024, Lantern Pharma and its wholly-owned subsidiary Starlight Therapeutics announced the presentation of new preclinical data and Phase 1b trial design for LP-184 in glioblastoma. Following the 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 anticipates administration of STAR-001 as monotherapy and the other arm anticipates administration of STAR-001 in combination with spironolactone (200 mg daily). The trial 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. Price Action: LTRN stock traded lower by 3.02% to $3.86 premarket at the last check on Monday. Read Next:UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article EXCLUSIVE: FDA Clears Lantern Pharma's Planned Phase 1b/2 Trial of LP-184 In Treatment-Resistant Lung Cancer Patients originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

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