FDA clears LP-184 trial for NSCLC patients with specific mutations

Published 12/05/2025, 14:06
FDA clears LP-184 trial for NSCLC patients with specific mutations

DALLAS - Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biotech company with a market capitalization of $43 million and impressive year-to-date gains of nearly 25%, has received U.S. Food and Drug Administration (FDA) approval for an amendment to its Investigational New Drug (IND) application. This approval allows for a Phase 1b/2 clinical trial of LP-184, a novel small molecule drug, in a specific subset of non-small cell lung cancer (NSCLC) patients. The trial will focus on patients with KEAP1 and/or STK11 mutations and low PD-L1 expression, who have historically shown limited response to existing therapies.According to InvestingPro data, Lantern Pharma maintains a strong liquidity position, with liquid assets exceeding short-term obligations by a factor of 5.8x.

LP-184, developed using Lantern Pharma’s RADR® AI platform, is designed to target cancer cells by causing DNA damage in a mechanism dependent on the presence of the enzyme PTGR1, which is overexpressed in certain tumor types. This targeted approach aims to reduce systemic toxicities while maintaining robust anti-tumor activity.

The upcoming clinical trial will evaluate the efficacy and safety of LP-184 in combination with the immune checkpoint inhibitors nivolumab and ipilimumab. The study aims to address the low median overall survival of 15 months for newly diagnosed NSCLC patients with the aforementioned mutations, who are treated with current standard chemo-immunotherapies. With an estimated annual market opportunity exceeding $2 billion, this patient population represents a significant area of unmet medical need.

Lantern Pharma’s approach combines artificial intelligence-driven drug development with an understanding of cancer biology to potentially improve treatment options for patients with limited alternatives. According to Panna Sharma, President and CEO of Lantern Pharma, the FDA clearance for this trial is a pivotal milestone in their mission to develop precise, data-driven cancer therapies.

The company’s RADR® platform has been instrumental in accelerating the development of their product pipeline, which includes multiple cancer indications and an antibody-drug conjugate program. Lantern Pharma’s AI-driven pipeline is estimated to have a combined annual market potential of over $15 billion USD. With an "FAIR" Financial Health score from InvestingPro and analyst price targets ranging from $15 to $26, the company shows potential despite current market challenges. InvestingPro analysis suggests the stock may be undervalued at current levels, with additional insights available in the comprehensive Pro Research Report, part of the extensive coverage of over 1,400 US stocks.

This press release statement serves as the basis for the information reported in this article.

In other recent news, Lantern Pharma reported a net loss of $5.9 million for the fourth quarter of 2024, which is an increase from the $4.2 million loss in the same period the previous year. The company’s research and development expenses rose to $16.1 million for the year, up from $11.9 million in 2023, as it continues to invest in AI-driven drug development. Lantern Pharma’s financial position includes a cash reserve of $24 million as of December 31, 2024. The company is advancing its pipeline with notable progress in trials, particularly in Asia, and expects multiple data readouts in 2025. Lantern Pharma is actively seeking additional funding to support its growth plans, with a focus on leveraging its Agentic AI platform. The company has also established a scientific advisory board with experts in neuro-oncology to guide its development programs. These recent developments reflect Lantern Pharma’s strategic focus on AI and precision oncology, despite the challenges faced in the competitive biotech sector.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers
© 2007-2025 - Fusion Media Limited. All Rights Reserved.