Lantern Pharma Reports AI-Guided LP-184 Meets Phase 1a Endpoints in Solid Tumors
Lantern Pharma, an oncology-focused company that applies artificial intelligence to drug development, has completed its Phase 1a trial of LP-184 in 63 patients with relapsed or refractory solid tumors, including glioblastoma. The study met all primary objectives, showing a favorable safety profile, consistent pharmacokinetics, and early antitumor activity, while establishing a recommended Phase 2 dose.
LP-184 is a next-generation acylfulvene small molecule prodrug activated by the PTGR1 (prostaglandin reductase 1) enzyme, which is overexpressed in certain cancers. Once activated, it produces cytotoxic metabolites that form DNA adducts, leading to irreparable DNA damage.
The open-label, multicenter trial enrolled 63 patients with relapsed or refractory solid tumors, evaluating safety, tolerability, pharmacokinetics, and dose selection. Adverse events were mostly mild (Grade 1–2 nausea and vomiting typical of alkylating agents), with few serious events and no dose-limiting toxicities in most cohorts. Therapeutic drug levels were reached from 0.25 mg/kg, supporting dose optimization. Based on safety and pharmacokinetic data, the review committee set the recommended Phase 2 dose at 0.39 mg/kg, with provisions for intra-patient escalation.
Clinical benefit was observed in 48% of evaluable patients treated at therapeutic exposures. Several patients continued on therapy beyond six months, and one NSCLC patient with DNA damage response (DDR) mutations remained on treatment for nearly two years after failing immunotherapy. Benefit was reported across multiple tumor types, including glioblastoma, gastrointestinal stromal tumor, thymic carcinoma, colon cancer, and NSCLC.
See also: Lantern Pharma Reports on Q2: Clinical Trials & New AI Prediction Tools
Lantern used its proprietary RADR platform to guide patient selection and biomarker analyses in the trial. RADR integrates more than 200 billion oncology-focused data points and over 200 machine learning algorithms to identify populations most likely to respond to treatment. Insights from RADR highlighted activity in DNA damage response–mutated tumors, including those with CHK2, ATM, BRCA1, and STK11/KEAP1 alterations, helping to de-risk LP-184 development in biomarker-enriched groups.
Beyond LP-184, Lantern applies RADR to a pipeline spanning solid and hematologic cancers as well as an antibody–drug conjugate program. The company reports that the platform supports accelerated development timelines by combining preclinical models, clinical datasets, and machine learning–driven predictions to prioritize indications and therapeutic combinations.
Lantern plans to advance LP-184 into targeted Phase 1b/2 studies:
- Triple-negative breast cancer in combination with the PARP inhibitor olaparib, with ctDNA as a potential biomarker.
- NSCLC with STK11/KEAP1 co-mutations, with or without immunotherapy.
- Bladder cancer through an investigator-led trial in Denmark for patients with DDR mutations.
The data cutoff was August 26, 2025. Full trial results are expected in peer-reviewed publications and at upcoming oncology conferences.
Topic: AI in Bio
