Lantern Pharma announces LP-184 trial met all primary endpoints

Lantern Pharma (LTRN) announced the completion of its Phase 1a clinical trial for LP-184. The trial met all primary endpoints, demonstrating a favorable safety and pharmacokinetic profile, and early signs of antitumor activity. Enrollment is complete, with several patients continuing treatment due to ongoing clinical benefit. The open-label, multicenter, non-randomized study evaluated LP-184 in 63 patients with advanced relapsed or refractory solid tumors, including GBM. Primary objectives focused on safety, tolerability, PK, and determining a recommended Phase 2 dose when administered on Days 1 and 8 of a 21-day cycle. LP-184 exhibited a robust safety profile, with no dose-limiting toxicities in the majority of cohorts and low incidence of discontinuations, interruptions, or delays due to drug-related adverse events. Adverse events were predominantly Grade 1 or 2, including manageable nausea and vomiting-consistent with alkylating agents-that resolved without significant intervention. The low rate of Grade 3+ events underscores LP-184’s tolerability, making it well-suited for potential monotherapy or combinations with agents like PARP inhibitors and immunotherapies, where preclinical synergies have been observed. PK data confirmed that therapeutic concentrations were achieved at dose levels 8 and above, aligning with preclinical models and supporting dose optimization for future trials. These observations will help further de-risk LP-184, enabling efficient advancement in biomarker-enriched populations. Promising antitumor activity emerged, particularly at dose levels 8 and above, where therapeutic exposures were attained. Disease control was achieved in 48% of evaluable patients after two cycles, including in heavily pre-treated cases. The median number of prior lines of therapy was 3; some patients had up to 8 prior lines of therapy. Clinical benefit observed in 4 of 16 recurrent GBM patients previously exposed to temozolomide, lomustine, and/or radiation. Marked reductions in target cancer lesions among patients with CHK2, ATM, BRCA1 and STK11/KEAP1 mutations, spanning colon cancer, thymic carcinoma, gastrointestinal stromal tumor, and NSCLC. A NSCLC patient with DNA damage response mutations, refractory to immunotherapy, achieved nearly two years of clinical benefit and remained on treatment. Two patients at dose level 10 maintain disease control beyond six months and continue on therapy.