Duyuru • Mar 27

Lantern Pharma Inc. and Starlight Therapeutics Announce Fda Clearance of Ind for Planned Phase 1 Pediatric Cns Cancer Trial of Star-001

Lantern Pharma Inc. and its CNS-oncology focused wholly owned subsidiary Starlight Therapeutics announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for STAR-001 in a planned Phase 1 pediatric clinical trial (IND No. 179145). STAR-001 is a precision oncology compound whose CNS and pediatric CNS indications were initially identified using Lantern's proprietary RADR® AI platform. The planned trial will evaluate STAR-001 as a single agent and in combination with spironolactone in pediatric patients with relapsed or refractory central nervous system (CNS) malignancies. The trial is planned to be conducted in collaboration with POETIC — the Pediatric Oncology Experimental Therapeutics Investigators' Consortium — a multicenter network of 14 academic children's cancer centers across the United States, Canada, and Israel. The study protocol, as reviewed and cleared by the FDA, is titled: "A PHASE 1, MULTICENTER, OPEN-LABEL, DOSE ESCALATION STUDY OF STAR-001 (LP-184) AS A SINGLE AGENT AND IN COMBINATION WITH SPIRONOLACTONE IN PEDIATRIC PATIENTS WITH RELAPSED OR REFRACTORY CENTRAL NERVOUS SYSTEM MALIGNANCIES." Pediatric CNS tumors represent one of the most devastating and treatment-resistant categories of childhood cancer. In the United States, an estimated 4,975 new cases of primary brain tumors will be diagnosed in children and adolescents in 2026 alone — making brain tumors the leading cause of cancer-related death among children and adolescents ages 0 to 19. Globally, approximately 47,600 new pediatric CNS tumor cases are diagnosed each year, resulting in an estimated 23,500 deaths annually. Despite advances in molecular profiling and surgical technique over the past two decades, survival outcomes for children with relapsed or refractory high-grade CNS tumors have improved only marginally. For certain diagnoses, the prognosis remains catastrophic. Diffuse Intrinsic Pontine Glioma (DIPG), for instance, carries a median survival of less than 12 months from diagnosis with no approved curative option. For children with relapsed ATRT, GBM, medulloblastoma, and ependymoma, current therapeutic options are equally limited and often associated with severe long-term toxicity. The trial design provides for STAR-001 (LP-184) to be evaluated across a range of these aggressive pediatric CNS malignancies, including: Atypical Teratoid/Rhabdoid Tumor (ATRT), Diffuse Intrinsic Pontine Glioma (DIPG), Glioblastoma (GBM), Medulloblastoma, and Ependymoma. A scientifically distinctive and potentially first-in-class feature of the planned trial is a dedicated combination cohort evaluating STAR-001 alongside spironolactone — exploiting a biological vulnerability in CNS tumor cells that Lantern's RADR® AI platform helped in part to identify as a novel approach to creating synthetic lethality in these brain tumors. STAR-001 operates through a precision bioactivation mechanism: selectively converted into a potent DNA-crosslinking agent within tumor cells that overexpress PTGR1 (Prostaglandin Reductase 1), it induces DNA double-strand breaks that are lethal to the cancer cell — if left unrepaired. By degrading ERCC3, spironolactone removes that option. Lantern's RADR® AI platform identified ERCC3 (Excision Repair Cross-Complementation Group 3) — a key helicase in the nucleotide excision repair (NER) pathway — as a central repair mechanism that could be exploited in high-grade pediatric CNS malignancies including ATRT, medulloblastoma, and diffuse midline glioma, compared to low-grade gliomas. Spironolactone — a brain-penetrant, orally administered agent with a long safety record in pediatric patients — degrades ERCC3 through targeted proteasomal degradation, reducing ERCC3 protein levels by at least 50% across tumor models and confirming direct target engagement. With this repair pathway dismantled, STAR-001-induced DNA damage accumulates unrepaired, driving dramatically enhanced tumor cell death based on preclinical observations. In ATRT orthotopic xenograft models, the combination extended median survival from 27 to 76 days — a 181% improvement over control (p = 0.0018) — with comparable results across medulloblastoma and DMG models showing up to a 3- to 5-fold increase in apoptotic cells versus monotherapy (p < 0.0001). This two-pronged strategy — AI-guided identification of a DNA repair vulnerability, precision bioactivation of a DNA-damaging agent, and pharmacological elimination of the tumor cell's repair escape route — represents a mechanistically coherent and potentially transformative approach to pediatric CNS cancers where conventional chemotherapy has reached its limits. The planned trial will be conducted across approximately 15 academic pediatric oncology centers in collaboration with POETIC (Pediatric Oncology Experimental Therapeutics Investigators' Consortium), a multicenter network of 14 institutions — including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and Lucile Packard Children's Hospital at Stanford — spanning 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. POETIC's established clinical infrastructure provides Starlight with the reach to enroll a geographically and demographically diverse patient population across North America and internationally. STAR-001 is Starlight Therapeutics' CNS oncology compound, co-developed with Lantern Pharma as LP-184. CNS and pediatric CNS cancers were initially identified as priority indications for STAR-001 through Lantern's proprietary RADR® AI platform, which analyzed genomic and molecular data across tumor types to pinpoint the PTGR1 overexpression signature that makes these malignancies particularly susceptible to STAR-001's mechanism of action. STAR-001 is a precision acylfulvene-based agent engineered to exploit elevated PTGR1 (Prostaglandin Reductase 1) expression in tumor cells. Laboratory observations have demonstrated that PTGR1-mediated bioactivation selectively converts STAR-001 into a highly reactive DNA-crosslinking species within cancer cells, while normal tissues with lower PTGR1 activity are largely spared. LP-184/STAR-001 has received multiple FDA orphan and rare pediatric disease designations and has demonstrated encouraging activity in early-stage clinical and preclinical studies. In pediatric CNS cancers — where PTGR1 overexpression has been identified across ATRT, GBM, DIPG, medulloblastoma, and ependymoma — STAR-001 represents a scientifically grounded precision approach to a historically intractable disease.

Duyuru • Dec 03

Lantern Pharma Inc. 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

Lantern Pharma Inc. announced additional details and clinical insights from its completed Phase 1a dose-escalation study of LP-184 as well as highlights from its recent webinar. The clinical trial demonstrated encouraging durable disease control in 63 heavily pre-treated patients with advanced solid tumors, many of which had DNA damage repair (DDR) pathway deficiencies. The clinical trial met all primary endpoints for safety, tolerability, and established a clear recommended phase 2 dose (RP2D). Building on these encouraging Phase 1a results, Lantern is advancing an ambitious precision oncology development strategy featuring multiple biomarker-guided Phase 1b/2 clinical trials in triple-negative breast cancer (TNBC), glioblastoma multiforme (GBM), non-small cell lung cancer (NSCLC), and advanced urothelial carcinoma (bladder cancer). The company and independent industry analysts estimate that the aggregate annual market opportunity for LP-184 across these and additional targeted indications could exceed $10 billion. Phase 1a Trial Successfully Completed with Encouraging Efficacy Signals: 63 heavily pre-treated patients (median 3+ prior therapies) with advanced solid tumors enrolled; trial achieved 54% disease control rate in patients at or above therapeutic dose levels, demonstrating promising activity in DNA damage repair-deficient cancers. Exceptional Durability in Difficult-to-Treat Cancers: Patients with stage 4 squamous lung cancer (BRCA1 mutation), thymic carcinoma (CHEK2 mutation), and gastrointestinal stromal tumor (ATM mutation) remain on treatment with 12+ to 23+ months of ongoing clinical benefit and meaningful tumor reductions after failing multiple prior therapies. Addresses Major Market Opportunity in Precision Oncology: LP-184 targets the estimated 20-25% of solid tumor patients with DDR deficiencies—representing more than 400,000 cases annually and a market potential exceeding $10 billion in annual drug sales. AI-Driven Biomarker Strategy Strengthened: Lantern's RADR platform identified PTGR1 as a key predictive biomarker; >87% of Phase 1a patients (recurrent, advanced solid tumors) exceeded the bioactivation threshold, with a diagnostic-ready molecular assay enabling patient selection and/or stratification. Strong Regulatory Support Accelerates Development: Five FDA designations (3 Orphan Drug, 2 Fast Track) for LP-184 across TNBC, GBM, pancreatic cancer, and rare pediatric tumors provide development advantages and potential expedited pathways to approval. Multi-Indication Phase 1b/2 Program Are Advancing: Biomarker-guided trials are being planned and advancing in markets with high patient need: triple-negative breast cancer (monotherapy + PARP inhibitor combination); drug and IO resistant, PDL-1 low, non-small cell lung cancer (NSCLC); recurrent glioblastoma (GBM) (with +spironolactone); and advanced recurrent DDR deficient bladder cancer. The Phase 1a study enrolled 63 patients with advanced solid tumors who had received a median of three prior lines of therapy. Key findings include: 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. Several patients with DDR pathway alterations in the Phase 1a study achieved exceptional, ongoing responses despite having progressed through multiple prior standard-of-care therapies: A 62-year-old male patient with stage 4 squamous NSCLC harboring a BRCA1 alteration, who had failed radiation and durvalumab, began LP-184 treatment in December 2023 and continues on therapy with more than 23 months of clinical benefit (Cycle 34 ongoing) and 22% target lesion reduction A 50-year-old male patient with stage 4 thymic carcinoma with a CHEK2 alteration, who had progressed through four prior lines including pembrolizumab, started LP-184 in November 2023 and remains on treatment with more than 12 months of benefit (Cycle 17 ongoing) and 26% target lesion reduction. A 62-year-old female patient with stage 4 gastrointestinal stromal tumor (GIST) harboring an ATM alteration, who had failed four prior therapies including sunitinib, initiated LP-184 in November 2023 and continues treatment with more than 12 months of benefit (Cycle 19 ongoing) and 9% tumor reduction These durability signals in heavily pre-treated, genomically-defined patient populations underscore LP-184's potential as a precision oncology therapy and support the company's biomarker-driven development strategy. Lantern's proprietary RADR artificial intelligence platform played a central role in LP-184's development, identifying prostaglandin reductase-1 (PTGR1) overexpression and low expression of multiple DDR genes as strong predictors of LP-184 sensitivity. LP-184 functions as a prodrug that is selectively activated inside cancer cells by PTGR1, which is frequently overexpressed in tumors. Upon activation, LP-184 forms a highly reactive metabolite that breaks apart the DNA of the cancer cell and induces interstrand cross-links and double-strand breaks—damage that cannot be repaired in tumors with deficient DDR pathways, resulting in selective cancer-cell death while sparing normal cells. Critically, LP-184 demonstrates activity across both homologous recombination (HR)-deficient and nucleotide excision repair (NER)-deficient tumors, potentially addressing a broader patient population than PARP inhibitors, which primarily target HR deficiency. Preclinical data show LP-184 is active even in PARP inhibitor-resistant models, highlighting its differentiated mechanism. Lantern has developed a diagnostic-ready RT-qPCR assay for PTGR1 expression in FFPE tumor tissue, enabling patient selection for ongoing and future trials consistent with a precision oncology approach. LP-184 has received six FDA designations recognizing its potential to address serious unmet medical needs: Fast Track Designation for triple-negative breast cancer (TNBC); Fast Track Designation for glioblastoma multiforme (GBM) (granted October 2024); Orphan Drug Designation for malignant gliomas; Orphan Drug Designation for pancreatic cancer; Orphan & Pediatric Rare Disease Drug Designation for atypical teratoid rhabdoid tumors (ATRT).

Toplam Hissedar Getirisi	-4.7%
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Temettü Büyümesi	n/a
Bir sonraki temettü ödeme tarihi	n/a
Eski temettü tarihi	n/a
Hisse başına temettü	n/a
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Segment	Temettü Verimi
Şirket (LTRN)	n/a
Pazarın Alt %25'i (US)	1.4%
Pazarın En İyi %25'i (US)	4.3%
Sektör Ortalaması (Biotechs)	2.4%
Analist tahmini (LTRN) (3 yıla kadar)	n/a

Veri	Son Güncelleme (UTC saati)
Şirket Analizi	2026/05/17 19:47
Gün Sonu Hisse Fiyatı	2026/05/15 00:00
Kazançlar	2026/03/31
Yıllık Kazançlar	2025/12/31

Paket	Veri	Zaman Çerçevesi	Örnek ABD Kaynağı ^*
Şirket Finansalları	10 yıl	Gelir tablosu Nakit akış tablosu Bilanço	SEC Form 10-K SEC Form 10-Q
Analist Konsensüs Tahminleri	+3 yıl	Finansal tahminler Analist fiyat hedefleri	Analist Araştırma Raporları Blue Matrix
Piyasa Fiyatları	30 yıl	Hisse senedi fiyatları Temettüler, Bölünmeler ve Eylemler	ICE Piyasa Verileri SEC Form S-1
Sahiplik	10 yıl	En büyük hissedarlar İçeriden öğrenenlerin ticareti	SEC Form 4 SEC Form 13D
Yönetim	10 yıl	Liderlik ekibi Yönetim Kurulu	SEC Form 10-K SEC Form DEF 14A
Önemli Gelişmeler	10 yıl	Şirket duyuruları	SEC Form 8-K

Analist	Kurum
Chad Messer	Lake Street Capital Markets, LLC
Ashok Kumar	ThinkEquity LLC

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Lantern Pharma Inc. (NasdaqCM:LTRN) announces an Equity Buyback for $7 million worth of its shares.

Recent updates

Lantern Pharma Inc. has filed a Follow-on Equity Offering in the amount of $4.399934 million.

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Lantern Pharma Inc. has filed a Follow-on Equity Offering.

New minor risk - Share price stability

Lantern Pharma Inc. and Starlight Therapeutics Announce Fda Clearance of Ind for Planned Phase 1 Pediatric Cns Cancer Trial of Star-001

Lantern Pharma Inc. to Report Q4, 2025 Results on Mar 30, 2026

Price target decreased by 9.1% to US$20.00

New minor risk - Share price stability

New major risk - Revenue and earnings growth

Lantern Pharma Inc. 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

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Insufficient new directors

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New major risk - Financial position

New major risk - Revenue and earnings growth

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

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