LP-184 gains FDA fast track for triple negative breast cancer

DALLAS - Lantern Pharma Inc. (NASDAQ: LTRN), a micro-cap biotech company valued at $34 million utilizing artificial intelligence (AI) in cancer therapy development, has announced the Fast Track Designation by the FDA for LP-184 as a treatment for Triple Negative Breast Cancer (TNBC). According to InvestingPro data, the company maintains a strong financial position with more cash than debt and a healthy current ratio of 8.31, though analysts note the company is rapidly burning through its cash reserves. This follows a similar designation for Glioblastoma in October 2024 and marks a significant milestone in addressing the needs of aggressive cancers.

TNBC, representing around 20% of breast cancer cases, affects nearly 29,000 patients annually in the U.S. The prognosis is notably poor, with over half of the patients experiencing relapse within the first three to five years. Current treatments are limited, especially for patients resistant to existing therapies. While Lantern Pharma's stock has experienced significant volatility, trading at $3.16 and down about 49% over the past six months, Wall Street analysts maintain optimistic price targets ranging from $15 to $26, suggesting potential upside if the company's clinical trials succeed. For deeper insights into biotech stock analysis and valuation metrics, InvestingPro subscribers can access comprehensive research reports covering over 1,400 US stocks.

Preclinical studies have shown LP-184 to be effective in both PARP inhibitor-resistant and sensitive TNBC tumors, with complete tumor regression observed in tested models. The drug is activated by Prostaglandin Reductase 1 (PTGR1), an enzyme often elevated in TNBC tumors, suggesting a targeted approach to treatment. LP-184 is currently in a Phase 1A clinical trial (NCT05933265) evaluating its safety and tolerability across various solid tumors, including TNBC.

Panna Sharma, President and CEO of Lantern Pharma, expressed that the Fast Track Designation reinforces the potential of LP-184 in meeting critical needs for TNBC patients, especially those with limited therapeutic options. The recent data, presented at the Immuno-Oncology Summit, also indicated LP-184's ability to sensitize TNBC tumors to checkpoint inhibitors, potentially broadening treatment options.

LP-184's development leveraged Lantern's RADR® AI platform, which has played a role in validating mechanisms for clinical use and identifying targeted patient populations. The drug candidate is part of Lantern Pharma's broader pipeline, which aims to address various cancer indications and has received Orphan Drug and Rare Pediatric Disease Designations for other cancers.

The Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill unmet medical needs. The designation for LP-184 reflects its potential to provide a significant therapeutic advance for TNBC patients. With an overall Financial Health score of "FAIR" from InvestingPro, investors can access additional ProTips and detailed financial metrics to better evaluate the company's potential in the competitive biotech landscape. The Pro Research Report provides comprehensive analysis of key performance indicators and growth prospects, essential for making informed investment decisions in the biotechnology sector.

This report is based on a press release statement from Lantern Pharma Inc.

In other recent news, Lantern Pharma disclosed its Q3 2024 financial results and updates on clinical trials. The biotechnology company reported a net loss of $4.5 million for the quarter, with revenue increasing to $1.5 million, primarily due to increased clinical trial activities. Despite the net loss, the company's cash position of $28.1 million is projected to support operations until late 2025.

In terms of drug development, Lantern Pharma's LP-184 received FDA Fast Track designation for glioblastoma, and the Harmonic (NASDAQ:HLIT) trial for non-small cell lung cancer is being expanded into Asia. The company's AI-driven RADR platform has advanced 14 drug programs since its IPO in 2020.

In other developments, Lantern Pharma's subsidiary, Starlight Therapeutics, is planning Phase Ib and II trials for recurrent glioblastoma. The company is also exploring collaborations with larger biotech firms and has ongoing partnerships, including one with Oregon Therapeutics. These are the recent developments in the company's operations.

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