zirdafulven (LP-184) / Lantern Pharma, Starlight Therapeutics - LARVOL DELTA

Quantitative characterization of platelet count and alanine aminotransferase dynamics to inform personalized dosing in the first-in-human LP-184 trial. (PubMed, Cancer Chemother Pharmacol) - P1/2 | "Integration of in-depth data analytics in FIH studies facilitates earlier safety signal detection and informs safety monitoring and dose selection in later studies."

First-in-human • Journal • P1 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Lantern Pharma to Advance EMA-Cleared Phase 1b/2 Trial of LP-184 (Zirdafulven) in Biomarker-Selected Advanced Bladder Cancer (Businesswire) - "The study will be conducted at Rigshospitalet in Copenhagen — Denmark’s national referral center for urologic cancers — in collaboration with Professor Helle Pappot, MD, DMSc, a leading authority in the treatment of urothelial cancer...The trial is designed to test a novel, biomarker-guided approach in patients with advanced or metastatic urothelial carcinoma who have progressed on or are ineligible for current standard-of-care regimens."

New P1/2 trial • Bladder Cancer • Urothelial Cancer

Lantern Pharma…announced that the United States Patent and Trademark Office has issued a Notice of Allowance for U.S. Patent Application No. 17/230,821, titled 'Methods for the Treatment of Solid Tumor Cancers Using Illudins and Biomarkers' (Businesswire) - "The allowed claims cover methods of selecting and treating patients with ovarian, primary liver, kidney, or thyroid cancer with LP-184 (zirdafulven) based on measured elevated expression of each of three genes - PTGR1, PTPN14, and ASPH - in a patient tumor sample....LP-184 is planned to be evaluated in multiple precision oncology Phase 1b/2 trials in advanced aggressive and rare cancers during 2026. Lantern Pharma intends to continue expanding its patent portfolio through additional filings covering further indications and biomarker-guided applications of LP-184."

New P1/2 trial • Patent • Hepatocellular Cancer • Ovarian Cancer • Renal Cell Carcinoma • Thyroid Gland Carcinoma

A first-in-human phase 1a study of LP-184, a tumor-site activated novel alkylating agent, in patients with advanced solid tumors. (PubMed, Invest New Drugs) - P1/2 | "The maximum tolerated dose (MTD) of LP-184 is 0.49 mg/kg. Registry: ClinicalTrials.gov, TRN: NCT05933265, Registration date: June 23, 2023."

First-in-human • Journal • P1 data • Fatigue • Hepatology • Liver Failure • Oncology • Solid Tumor • PTGR1

Chemotherapeutic induction of cytosolic single-stranded DNA accumulation sensitizes triple-negative breast cancer to immunotherapy. (PubMed, J Immunother Cancer) - "These findings establish cytosolic ssDNA-driven immune programs as a mechanistic link between DNA damage and antitumor immunity, providing both a predictive biomarker and a therapeutic axis for chemoimmunotherapy. Pharmacologic induction of ssDNA represents a rational strategy to enhance ICB efficacy and expand immunotherapy responsiveness in TNBC."

IO biomarker • Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • TREX1

A first-in-human phase 1a study of LP-184, a tumor site–activated novel alkylating agent, in patients with advanced solid tumors. (ASCO 2026) - P1/2 | "LP-184 demonstrates a manageable safety profile with encouraging antitumor efficacy in tumors harboring key DDR alterations. The MTD is 0.49 mg/kg IV administered on days 1 and 8 every 21 days."

Clinical • First-in-human • Metastases • P1 data • Hematological Disorders • Hepatology • Liver Failure • Oncology • Solid Tumor • BRCA • PTGR1

LTRN184-1AST23-1: Study of LP-184 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=64 | Active, not recruiting | Sponsor: Lantern Pharma Inc. | Recruiting ➔ Active, not recruiting | N=175 ➔ 64 | Trial completion date: Sep 2025 ➔ Jul 2026 | Trial primary completion date: Feb 2025 ➔ Jul 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • PTGR1

Data-driven characterization of platelet count and alanine aminotransferase dynamics in the first-in-human LP-184 dose escalation trial (AACR 2026) - P1/2 | "Data-driven analysis in the LP-184 trial identified risk windows for PLT decrease (cycle 2) and ALT increase (cycle 1). Baseline PLT and dose arekey predictors, enabling modeling of ≥ grade 2 decrease in PLT. Our study supports the integration of in-depth data analytics in Phase 1 studies to facilitate earlier safety signal detection and inform more proactive safety monitoring and dose selection in later studies."

First-in-human • P1 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • PTGR1

Identification of biomarkers for drug candidate LP-184 in precision oncology applications (AACR 2025) - "A retrospective biomarker validation will be performed using established NGS assays to analyze liquid biopsy and/or tissue samples from the ongoing Phase 1a LP-184 trial. Future directions include determining associations between biomarker expression or mutation and clinical outcomes, refining PTGR1 expression threshold, and utilizing emerging biomarkers to guide patient selection in subsequent expansion studies."

Biomarker • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ATRX • BRAF • BRCA1 • BRCA2 • CDC37 • CDKN2B • EGFR • ERCC3 • GAPDH • HSP90AA1 • MAD2L2 • PTGR1

Novel acylfulvene LP184 shows single agent and combinatorial efficacy with PARP inhibitors in atypical teratoid rhabdoid tumors (AACR 2024) - "The dual therapy also demonstrates cytostatic and cytotoxic effects as confirmed by immunofluorescence and western blots (BT37 BrdU = 0.0004, BT37 CC3 = 0.0002, CHLA06 BrdU = 0.0033, CHLA06 CC3 = 0.0117 compared to control). Further studies in vivo are being conducted to test single agent and combination therapies of LP-184 and Rucaparib in ATRT, as our data indicates that the two could provide a compelling treatment option for patients with this poor prognosis brain tumor."

Clinical • Brain Cancer • CNS Tumor • Glioma • High Grade Glioma • Oncology • Rhabdoid Tumor • Sarcoma • Solid Tumor • SMARCB1

Lantern Pharma and Starlight Therapeutics Announce FDA Clearance of IND for a Planned Phase 1 Pediatric CNS Cancer Trial of STAR-001 (Businesswire) - "The Planned Multicenter Phase 1 Trial Will Evaluate STAR-001 as Monotherapy and in Combination with Spironolactone in Children with Relapsed or Refractory CNS Malignancies, Including ATRT, DIPG, GBM, Medulloblastoma, and Ependymoma...The trial is planned to be conducted in collaboration with POETIC — the Pediatric Oncology Experimental Therapeutics Investigators' Consortium — a multicenter network of 14 leading academic children's cancer centers across the United States, Canada, and Israel...The planned trial is subject to obtaining additional funding and it is designed to enroll approximately 18 to 42 pediatric patients aged 1 to 17 years."

IND • New P1 trial • Diffuse Intrinsic Pontine Glioma • Ependymoma • Glioblastoma • Medulloblastoma • Rhabdoid Tumor

A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Objective Response of STAR-001 (LP-184) in Combination With Spironolactone in Supratentorial Glioblastoma at First Progression (clinicaltrials.gov) - P1/2 | N=68 | Not yet recruiting | Sponsor: Lantern Pharma Inc.

New P1/2 trial • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Lantern Pharma to Present at the 7th Glioblastoma Drug Development Summit in Boston on February 17-19, 2026 (Businesswire) - "In his presentation on Day Two (Thursday, February 19, 2026, at 10:30 a.m. ET), Mr. Sharma will highlight how Lantern applied RADR to: Elucidate the mechanism of action of STAR-001 Identify patient biomarkers to inform clinical use; Select optimal cancer indications; Discover novel combination therapies in neuro-oncology."

Clinical • Glioblastoma • Rhabdoid Tumor

Lantern Pharma Reports Additional Positive LP-184 Phase 1a Results Showing Durable Disease Control in Heavily Pre-Treated Advanced Cancer Patients as Company Advances Precision Oncology Program into Multiple Biomarker-Guided Phase 1b/2 Trials (Businesswire) - "Established Recommended Phase 2 Dose (RP2D): 0.39 mg/kg administered intravenously on Days 1 and 8 of a 21-day cycle; Favorable Safety Profile: Main adverse events included reversible transaminitis, nausea/vomiting, and thrombocytopenia—all clinically manageable and consistent with the alkylating agent class; High Therapeutic Index: Therapeutic plasma concentrations achieved three dose levels below RP2D, indicating a wide therapeutic window (~2.45-fold); Encouraging Disease Control: 54% disease control rate and 8% clinical benefit rate at ≥6 months in DDR-altered tumors; Biomarker Validation: More than 87% of Phase 1a patients exceeded the PTGR1 bioactivation threshold, confirming the biomarker's utility for patient selection."

P1 data • Solid Tumor

Targeting DNA repair mechanisms with spironolactone to enhance LP-184 CNS pharmacodynamics and efficacy (SNO 2025) - P1/2 | "Machine learning approaches also associate spironolactone-induced GBM cell sensitization to LP-184 with down-regulation of the TC-NER complex endonuclease ERCC1 and the DNA damage sensor CETN2. These findings provide a rationale and framework for a planned Phase 1b/2a trial to evaluate LP-184 + spironolactone therapy against recurrent GBM."

Clinical • PK/PD data • Brain Cancer • Solid Tumor • Targeted Protein Degradation • ERCC1 • ERCC3

Targeting DNA repair mechanisms with spironolactone to enhance LP-184 CNS pharmacodynamics and efficacy (WFNOS 2025) - P1/2 | "Machine learning approaches also associate spironolactone-induced GBM cell sensitization to LP-184 with down-regulation of the TC-NER complex endonuclease ERCC1 and the DNA damage sensor CETN2. These findings provide a rationale and framework for a planned Phase 1b/2a trial to evaluate LP-184 + spironolactone therapy against recurrent GBM."

Clinical • PK/PD data • Brain Cancer • Solid Tumor • Targeted Protein Degradation • ERCC1 • ERCC3

Upcoming Milestones and Corporate Developments: Early 2026 Catalysts (Businesswire) - "Q1 2026: Planned Pediatric CNS cancer trial initiation through Starlight Therapeutics subsidiary (IND amendment submission); Q1 2026: Planned initiation of LP-184 Phase 1b/2 trials in TNBC and NSCLC (subject to funding); H1 2026: Investigator-led bladder cancer trial initiation in Denmark; 2026: Additional HARMONIC trial data readouts and potential partnership announcements."

New P1/2 trial • New trial • P2 data • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

KOL-hosted scientific webinar on LP-184 Phase 1a results scheduled for November 20, 2025 at 4:30 p.m. ET, providing insights from key opinion leader at Fox Chase Cancer Center along with additional clinical data and future plans from Lantern management. (Businesswire)

P1 data • Non Small Cell Lung Cancer • Pancreatic Adenocarcinoma • Triple Negative Breast Cancer

Lantern Pharma’s LP-184 Phase 1a Clinical Trial Achieves All Primary Endpoints with Robust Safety Profile and Promising Antitumor Activity in Multiple Advanced Solid Tumors (Businesswire) - "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....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 (GIST), and NSCLC."

Biomarker • P1 data • Bladder Cancer • Colorectal Cancer • Gastrointestinal Stromal Tumor • Glioblastoma • Non Small Cell Lung Cancer • Thymic Carcinoma • Triple Negative Breast Cancer

Lantern Pharma Announces Completion of Type C Meeting with FDA, Providing Clarity on Regulatory Pathway for Pediatric CNS Cancer Trial (Businesswire) - "The agency confirmed the potential incorporation of spironolactone as a combination agent, to allow for the assessment of spironolactone’s synergistic effects with Lantern's lead investigational therapy, LP-184/STAR-001 in enhancing the potential efficacy in CNS cancers....The company plans to submit an Investigational New Drug (IND) application amendment incorporating the FDA's guidance in the coming months, with planned trial initiation targeted for Q1 2026."

FDA event • IND • CNS Tumor • Rhabdoid Tumor

LP-184: Successful Completion of Enrollment for Phase 1a & Advancing Toward Phase 1b/2 Studies (Businesswire) - "Lantern successfully completed enrollment of its LP-184 Phase 1a first-in-human trial with 65 patients across multiple solid tumor indications. The trial established both the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), positioning LP-184 for advancement of planned Phase 1b/2 studies in indications with large multi-billion dollar annual market potential, including recurrent TNBC and recurrent bladder cancer."

Trial status • Bladder Cancer • Triple Negative Breast Cancer

Lantern Pharma's Subsidiary, Starlight Therapeutics, Announces U.S. Food and Drug Administration Clearance of IND for Phase Ib/2a Glioblastoma Multiforme (GBM) Trial (Businesswire) - "Starlight Therapeutics...today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase Ib/2a clinical trial to evaluate STAR-001 (LP-184) in combination with spironolactone for patients with glioblastoma multiforme (GBM) at first progression...The planned Phase Ib/2a clinical trial (IND 178511) is designed to investigate the safety, tolerability, and preliminary efficacy of STAR-001 in combination with spironolactone in patients with recurrent GBM, one of the deadliest and most aggressive forms of brain cancer....Starlight is targeting commencement of the Phase Ib/2a trial in late 2025 or early 2026, subject to additional funding, and plans to provide regular updates on trial preparation, patient enrollment progress, and preliminary data as they become available."

IND • New P1/2 trial • Glioblastoma

Lantern Pharma's LP-184 Shows Promising In Vivo Activity in Atypical Teratoid Rhabdoid Tumors (ATRT) at SNO Pediatric Conference, Further Validating Rare Pediatric Disease Designation and Pathway to Clinical Trials (Businesswire) - "The data demonstrated that LP-184, a next-generation acylfulvene clinical-stage drug candidate, significantly extended survival in mouse models of ATRT. In the CHLA06 model, median survival increased from 20 days in the control group to 89 days in the LP-184 treatment group, representing a 345% improvement (p<0.0001). In the BT37 model, median survival increased from 68 days to 98 days (p=0.0422)....The company highlighted that the pediatric Phase I trial for LP-184 in brain tumors is targeted to open in winter 2025 or early 2026, following completion of the ongoing Phase I trial in adult solid tumors (NCT05933265) and obtaining future funding and approvals from the pediatric consortium."

New trial • Preclinical • Brain Cancer

Lantern Pharma Secures FDA Clearance for Planned Phase 1b/2 Trial of LP-184 in Biomarker-Defined, Treatment-Resistant NSCLC Patients with High Unmet Clinical Need (Businesswire) - "Lantern Pharma Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared the amendment to its Investigational New Drug (IND) application to initiate a Phase 1b/2 clinical trial of LP-184 in a genomically defined patient population of non-small cell lung cancer (NSCLC) where there is a need to improve patient outcomes...The biomarker focused Phase 1b/2 clinical trial is designed to target high-risk NSCLC subtypes by evaluating LP-184 in combination with the immune checkpoint inhibitors nivolumab and ipilimumab in patients with advanced NSCLC harboring KEAP1 and/or STK11 mutations and low PD-L1 expression—a population with limited response to existing first-line therapies. The study is designed to assess safety, preliminary efficacy, and biomarker correlations, potentially paving a path toward accelerated development in this genetically defined patient segment that is treatment resistant to many existing approved chemo and immunotherapies."

IND • New P1/2 trial • Non Small Cell Lung Cancer

Lantern Advances Drug Candidate LP-184 with IND Clearance for Phase 1b/2 Clinical Trial in Triple Negative Breast Cancer (TNBC) (Businesswire) - "Lantern Pharma...announced that it has received clearance of its Investigational New Drug Application (IND) from the U.S. Food and Drug Administration (FDA) for a Phase 1b/2 clinical trial for LP-184 in Triple Negative Breast Cancer....The innovative dual-approach in the clinical trial is designed to evaluate LP-184 in recurrent, advanced-stage TNBC patients through: (i) Monotherapy Arm: An open-label study involving approximately 30 patients with advanced-stage TNBC, focusing on dose optimization to evaluate, enhance and optimize safety and potential efficacy for TNBC patients; (ii) Combination Therapy: Evaluation of LP-184 in combination with olaparib in second-line settings for patients with advanced-stage TNBC harboring BRCA1 or BRCA2 alterations, with primary endpoints including safety and efficacy parameters that could potentially support a pathway to regulatory approval."

IND • New P1/2 trial • Triple Negative Breast Cancer