Lantern Pharma Inc., an AI-driven company specializing in cancer therapies, has secured clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug Application (IND) to proceed with a Phase 1b/2 clinical trial of LP-184 for Triple Negative Breast Cancer (TNBC). This milestone follows a series of regulatory achievements, including Orphan Drug Designation in 2023 and Fast Track Designation in 2024. Panna Sharma, CEO and President of Lantern Pharma, emphasized the significance of this IND clearance, stating, "This clearance represents a pivotal advancement in our mission to bring precisely targeted, AI-developed medicines to patients with aggressive cancers and limited treatment options." Strategic Trial Design to Address Critical Treatment Gaps The Phase 1b/2 trial for LP-184 is designed to evaluate its effectiveness in two phases: as a monotherapy and in combination with a PARP inhibitor. Monotherapy Phase: This part of the trial will focus on dose optimization to ensure both safety and efficacy. It will involve around 30 patients with recurrent, advanced-stage TNBC, using two different dose levels in an open-label study. Combination Therapy Phase: LP-184 will be tested in combination with olaparib, a PARP inhibitor, in a second-line setting. This phase targets patients with advanced-stage TNBC whose tumors have BRCA1 or BRCA2 alterations and who have developed resistance to PARP inhibitors. Preclinical studies have shown that LP-184 can re-sensitize these tumors, making the combination therapy a promising approach. Mechanistic Rationale and Preclinical Findings LP-184 is a synthetic lethal small molecule that triggers DNA double-strand breaks upon activation by the enzyme prostaglandin reductase 1 (PTGR1). Nearly 70% of TNBCs exhibit deficiencies in homologous recombination pathways, making them particularly sensitive to LP-184. Preclinical studies demonstrated significant tumor regression in PARP-resistant and sensitive patient-derived xenograft (PDX) models. Additionally, LP-184 has shown the ability to penetrate the blood-brain barrier (BBB), which is crucial given that up to 46% of TNBC patients develop brain metastasis. Multi-Region Clinical Strategy Lantern Pharma plans to conduct the trials at select centers in the United States, as well as in academic cancer centers and institutions in India and Nigeria, where TNBC incidence rates are higher, comprising nearly 40% of initial breast cancer diagnoses. This strategic site selection aims to leverage established research networks and address regions with significant disease burden and high clinical demand. Future Plans and Market Potential Beyond TNBC, LP-184 shows potential for treating other cancers with DNA damage repair mutations, such as lung, bladder, pancreatic, and ovarian cancers. Multiple additional clinical trials for these indications are in the planning stages. The global TNBC market is estimated at $3-5 billion USD annually, with over 300,000 new cases diagnosed each year. Although initial treatments with PARP inhibitors can be effective, resistance often develops, highlighting the need for novel therapeutic approaches. industry insiders and analysts view the IND clearance for LP-184 as a significant step forward in the development of AI-driven cancer therapies. They underscore the potential of LP-184 to address unmet medical needs in TNBC and other aggressive cancers. Lantern Pharma's integration of AI and machine learning in drug discovery and development is seen as a game-changer, capable of accelerating the process and reducing costs. The company's RADR® platform utilizes over 100 billion oncology-focused data points and more than 200 advanced machine learning algorithms to identify promising drug candidates and patient populations. With its current pipeline, including Phase 2 and multiple Phase 1 clinical trials, Lantern Pharma is well-positioned to make a substantial impact in oncology. The establishment of Starlight Therapeutics, a wholly-owned subsidiary focusing on CNS and brain cancers, further strengthens its commitment to providing life-changing therapies for various cancer types. Industry forecasts estimate that Lantern's AI-driven product candidates have a combined annual market potential of over $15 billion USD, underlining the company's ambitious goals and the significant market opportunities it aims to capitalize on.