Clinical Trials
5
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
20.0%
Not yet recruiting
1
20.0%
Recruiting
3
60.0%
No approval data available
- Lantern Pharma formally created Open-Medicine AI (OMAI) as a wholly-owned subsidiary to commercialize its withZeta.ai multi-agent AI platform, with plans for external funding and a potential public listing. - OMAI executed commercial licensing agreements granting access to Lantern's withZeta.ai-related models, data, algorithms, and personnel, positioning it for independent growth across oncology and broader disease areas. - The global AI drug discovery and development market is projected to exceed $10 billion by 2030, with oncology representing the largest therapeutic segment and compound annual growth rates above 30 percent. - Lantern established an AI Center of Excellence in Bengaluru, India, in Q1 2026 to accelerate development of the platform alongside its Dallas headquarters.
- The USPTO issued a Notice of Allowance for patent claims covering a three-gene expression signature — PTGR1, PTPN14, and ASPH — to identify patients for LP-184 (zirdafulven) treatment. - LP-184 demonstrated a 45% disease control rate among 29 patients with recurrent or refractory advanced cancers treated at or above the effective therapeutic dose in a completed 63-patient Phase 1a trial. - The allowed claims cover methods for selecting and treating patients with ovarian, primary liver, kidney, or thyroid cancer based on elevated expression of the three-gene biomarker. - Lantern Pharma plans to advance LP-184 into multiple precision oncology Phase 1b/2 clinical trials in advanced aggressive and rare cancers during 2026.
- Lantern Pharma has launched withZeta.ai, the world's first multi-agentic AI co-scientist platform specifically designed for rare cancer drug discovery and development, now commercially available through subscription tiers. - The platform integrates a proprietary rare cancer ontology spanning 438 cancer types with multi-database querying capabilities, enabling researchers to complete work in minutes that previously took weeks or months. - withZeta.ai offers three research modes and specialized capabilities including blood-brain barrier penetration prediction at 94.1% accuracy and generative molecular design via the ether0 24-billion parameter AI model. - The platform addresses the economic challenge of rare cancer drug development, where $1-2 billion development costs cannot be recouped for diseases affecting fewer than 200,000 patients each in the United States.
- The FDA has cleared an IND application for STAR-001, a precision oncology compound targeting pediatric CNS malignancies including ATRT, DIPG, GBM, medulloblastoma, and ependymoma. - The planned Phase 1 trial will evaluate STAR-001 as monotherapy and in combination with spironolactone across 15 leading academic pediatric oncology centers. - Preclinical data shows the STAR-001/spironolactone combination extended median survival by 181% in ATRT models by targeting DNA repair mechanisms. - The trial addresses a critical unmet need, as pediatric CNS tumors cause approximately 23,500 deaths annually worldwide with limited treatment options.
- Lantern Pharma completed a Type C meeting with the FDA, receiving critical guidance on the regulatory pathway and trial design for a planned pediatric CNS cancer trial targeting Atypical Teratoid Rhabdoid Tumor (ATRT). - The FDA confirmed the potential incorporation of spironolactone as a combination agent with LP-184/STAR-001 to assess synergistic effects in enhancing efficacy against CNS cancers. - The company's ATRT program has received both Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA, highlighting the urgent unmet medical need. - Lantern plans to submit an IND application amendment based on FDA guidance, with trial initiation targeted for Q1 2026.
- Lantern Pharma achieved complete responses in two separate clinical trials, with LP-300 showing complete tumor response in a 70-year-old never-smoker lung cancer patient and LP-284 demonstrating complete metabolic response in a heavily pretreated lymphoma patient. - The company successfully completed enrollment of 65 patients in its LP-184 Phase 1a trial and established maximum tolerated dose and recommended Phase 2 dose, positioning the drug candidate for advancement to Phase 1b/2 studies. - Lantern narrowed its Q2 2025 GAAP net loss to $0.40 per share from $0.46 per share in Q2 2024, while maintaining disciplined cost management with $15.9 million in cash providing runway through mid-2026.
- Lantern Pharma successfully enrolled 10 never-smoker NSCLC patients ahead of schedule across five Japanese clinical sites, including the National Cancer Center in Tokyo. - The HARMONIC trial targets a significant unmet medical need, as never-smoker NSCLC represents a $4 billion annual market opportunity with no specifically approved therapies. - Early trial results showed promising efficacy with an 86% clinical benefit rate and 43% objective response rate in the initial US safety cohort. - Japan's higher prevalence of never-smoker NSCLC cases (35-40%) compared to Western populations (15%) makes it a strategically important enrollment region for the global 90-patient trial.
- Lantern Pharma's LP-284 achieved complete metabolic response in a heavily pretreated diffuse large B-cell lymphoma patient after just two treatment cycles. - The 41-year-old patient had previously failed three aggressive treatment regimens including CAR-T therapy and bispecific antibody therapy over 18 months. - LP-284 was developed using Lantern's RADR® AI platform in under three years at approximately $3 million, demonstrating computational efficiency in drug development. - The synthetic lethal therapy targets cancer cells with DNA damage repair deficiencies while preserving healthy tissue function.
- Lantern Pharma received European Patent Office allowance for LP-284, a next-generation acylfulvene targeting relapsed or refractory non-Hodgkin's lymphoma with patent exclusivity through early 2039. - The AI-developed drug candidate achieved clinical trial readiness in under three years at approximately $1.5-2.0 million cost and is currently in Phase 1 trials for aggressive NHL subtypes. - LP-284 has earned FDA Orphan Drug Designations for mantle cell lymphoma and high-grade B-cell lymphomas, addressing a $4 billion annual global blood cancer market. - The European patent strengthens Lantern's global intellectual property portfolio alongside existing patents in the US, Japan, India, and Mexico, positioning LP-284 for worldwide commercialization.
- A 70-year-old never-smoker with advanced non-small cell lung cancer achieved complete response with LP-300 plus chemotherapy after failing three prior treatment lines including Keytruda, radiation, and Tagrisso. - The patient experienced 57% initial tumor reduction followed by complete resolution of lung and adrenal lesions, remaining progression-free for nearly two years across 21 treatment cycles. - The sustained response demonstrates LP-300's potential to address critical unmet needs in never-smoker NSCLC patients who have exhausted targeted kinase therapy options. - Never-smoker NSCLC represents 15-20% of U.S. lung cancer cases with significantly higher rates in Asian populations, yet no therapies are specifically approved for this patient subset.
