Lantern Pharma (NASDAQ: LTRN), a clinical-stage, AI-driven precision oncology company, has received regulatory and Institutional Review Board approvals in Taiwan to open Part 2 of its Phase 2 HARMONIC trial of LP-300, according to a press release. The lead Taiwan site is now open to accrual and actively screening patients, with the company anticipating IRB approval at two additional sites during the fourth quarter. In the United States, a central IRB has approved the amended protocol, and clinical sites have begun identifying patients with the EGFR exon 21 L858R mutation.
The approvals matter because they expand the geographic reach of a trial targeting a specific, hard-to-treat population: patients with the L858R mutation who have progressed after tyrosine kinase inhibitor treatment. Part 2 will enroll these patients and allow LP-300 to be administered for up to eight cycles in combination with carboplatin and pemetrexed, up from six cycles previously. This extended dosing could potentially deepen or prolong responses, though the company cautions that findings to date are preliminary, exploratory, and based on small patient numbers.
Preliminary data showed median progression-free survival of 8.9 months among nine L858R patients who completed six cycles, compared with 8.3 months among all 16 L858R patients evaluated. While the difference is modest and the sample size small, it suggests a signal that warrants further study. For investors, the Taiwan approvals represent a tangible step forward for Lantern’s pipeline and its RADR artificial intelligence platform, which integrates large-scale genomic and biological data to identify patients most likely to benefit from its therapies.
Lantern’s pipeline includes LP-184 (zirdafulven), LP-300, and LP-284, along with its central-nervous-system-focused subsidiary, Starlight Therapeutics, and its AI subsidiary, Open-Medicine AI. The company’s approach aims to transform the cost, pace, and precision of oncology drug development. For more details, the full press release is available at https://ibn.fm/CqeDR, and ongoing updates can be found in the company’s newsroom at https://ibn.fm/LTRN.
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