hydroxyureamethylacylfulvene (STAR-001) / Lantern Pharma - LARVOL DELTA

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

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

Lantern’s wholly owned subsidiary, Starlight Therapeutics, made key strides in 2024 toward developing potential therapies for CNS and brain cancers (Businesswire) - "LP-184, referred to as STAR-001 for CNS indications, was highlighted at the Society for Neuro-Oncology (SNO) 2024 conference, with a Phase 1b trial in recurrent GBM anticipated to begin in 2025 subject to successful additional funding."

New P1 trial • Glioblastoma

AI-Powered Drug Development Pipeline Highlights (Businesswire) - "LP-184 continued advancement through a Phase 1a trial in multiple solid tumors, which is targeted to finish enrollment during Q2 of 2025....The trial is now on cohort 11, and early indications of clinical activity have been observed at higher dose levels, consistent with preliminary PK data...Enrollment at dose level 9 and above is focused on inclusion of advanced solid tumor patients that have identified DNA damage repair mutations. A broader clinical data update is slated for Q2 2025 when recruitment for the trial is expected to be finished, and complete safety and dose response data is expected to be available."

P1/2 data • Trial status • Glioblastoma • Non Small Cell Lung Cancer • Pancreatic Cancer • Triple Negative Breast Cancer

Effects of synthetic microbial community fermentation on volatile flavor and quality characteristics of ginger pickle. (PubMed, Food Res Int) - "This study aimed to examine the effects of synthetic microbial communities (SynComs) constructed using Leuconostoc mesenteroides LM187, Weissella cibaria WC014, and Lactiplantibacillus plantarum LP184 on the fermentation dynamics and flavor of ginger pickle...Sensory evaluation demonstrated that the appearance, texture, taste, and flavor of pickle fermented with SynComs were superior to those of other pickles fermented with single lactic acid bacteria (LAB). Therefore, the SynComs constructed using L. mesenteroides, W. cibaria, and L. plantarum are promising inoculants for enhancing the flavor and quality of ginger fermentation."

Journal

LTRN184-1AST23-1: Study of LP-184 in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=175 | Recruiting | Sponsor: Lantern Pharma Inc. | Phase classification: P1 ➔ P1/2 | N=30 ➔ 175 | Trial completion date: Jun 2025 ➔ Sep 2025

Enrollment change • Phase classification • Trial completion date • Breast Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer

Lantern Pharma's Investigational Drug-Candidate, LP-184, Receives Second Fast Track Designation from FDA for Treatment of Triple Negative Breast Cancer (TNBC) (Businesswire) - "Lantern Pharma Inc...announced that the FDA has granted Fast Track Designation for investigational drug candidate, LP-184, for treatment of Triple Negative Breast Cancer (TNBC)....LP-184 is currently in a Phase 1A clinical trial designed to evaluate the safety and tolerability of this synthetically lethal investigational drug candidate in a broad range of solid tumors, including TNBC."

Fast track • Triple Negative Breast Cancer

Lantern Pharma & Starlight Therapeutics Present LP-184 (STAR-001) Phase 1b Trial Design and Preclinical Data in Glioblastoma at Society for Neuro-Oncology (SNO) 2024 Highlighting Novel Synthetic Lethality (Businesswire) - "The Phase 1b clinical trial design presented at SNO2024 combines LP-184 (STAR-001) with spironolactone to potentially enhance therapeutic response in recurrent glioblastoma (GBM) patients; Preclinical data, including in previously published research by Lantern Pharma, demonstrates up to 6-fold increase in GBM cell sensitivity when LP-184 is combined with spironolactone; LP-184 continues to advance through the existing Phase 1a clinical trial to assess safety and establish a maximum tolerated dose (MTD); no dose-limiting toxicities have been observed to date across nine patient cohorts enrolled; The clinical development for LP-184 in CNS cancers is planned to be advanced as STAR-001 by Starlight Therapeutics in later stage human clinical trials."

Clinical protocol • Preclinical • Glioblastoma • Solid Tumor

A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Objective Response of LP-184 alone and in combination with Spironolactone in IDH wild type Glioblastoma at First Progression (SNO 2024) - P1 | "If 1 or more of the first 10 response evaluable subjects achieve an objective response, 19 further subjects may be accrued in the second stage. In each cohort, at least 5 subjects will undergo planned tumor resection and will be treated with LP-184 or the combination the day prior to surgery to evaluate PK/PD."

Clinical • Combination therapy • P1 data • PK/PD data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • ERCC3

Lantern Pharma Reports Third Quarter 2024 Financial Results and Business Updates (Businesswire) - "Highlights of AI-Powered Pipeline:...LP-184 – LP-184 continues to advance through its Phase 1a first-in-human basket trial (NCT05933265) across multiple solid tumor indications....Based on pharmacokinetic analyses, the upcoming cohorts are expected to reach dosage levels where therapeutic concentrations should be attainable, with enrollment projected to complete this year and initial safety and molecular correlation data expected by year-end 2024 or early 2025....Through Lantern's wholly-owned subsidiary Starlight Therapeutics, LP-184 (designated as STAR-001 for CNS indications) is being positioned for a Phase 1b/2a clinical trial in recurrent GBM that is targeted to begin in early 2025."

New P1/2 trial • P1 data • Trial status • Glioblastoma

Starlight Therapeutics Announces Inaugural Members of Scientific Advisory Board (Businesswire) - "Starlight Therapeutics...announced today the formation of a Scientific Advisory Board ('SAB') to support the development of lead compound STAR-001. The inaugural SAB will work closely with Starlight’s management team to provide strategic guidance and critical expert insights into the development of STAR-001 in CNS and brain tumors for both children and adults."

Clinical • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Lantern Pharma to Host & Participate in Two Public Webinars During October (Businesswire) - "Lantern Pharma Inc...announced that they will be participating in and hosting two webinars that are open to the public during October. Lantern expects to discuss in detail how big data and AI are being leveraged to advance the development of multiple indications for drug-candidates LP-184 and LP-284...Lantern will also discuss how their algorithm for blood-brain-barrier (BBB) penetrability played a critical role in supporting the development of LP-184 across multiple CNS cancer indications, including GBM."

Clinical data • Glioblastoma

Current status of LP-184 & STAR-001 in clinical trials & development (Businesswire) - "LP-184 is currently being studied in a phase 1A clinical trial to evaluate the safety, tolerability and maximum tolerated dose (MTD) of the potential therapy in a wide range of tumors...Once the MTD has been established, Lantern has plans to advance the drug-candidate LP-184 as STAR-001 through its wholly owned subsidiary, Starlight Therapeutics, in GBM and other CNS and brain cancers....The proposed goals for the development of Phase 1b/2a clinical studies are targeting a rGBM specific trial to begin in late 2024 or early 2025. This trial is being planned to assess LP-184 in a Phase 1b/2a study as mono-therapy and in combination with spironolactone in rGBM to assess safety, pharmacokinetics and preliminary efficacy. Concurrently, Lantern will conduct a retrospective correlative analysis of multiple key markers of DNA damage as exploratory endpoints."

New P1/2 trial • Pipeline update • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Lantern Pharma’s Investigational Drug-Candidate, LP-184, Receives Fast-Track Designation in Glioblastoma from the FDA (Businesswire) - "Lantern Pharma Inc...announced that the FDA has granted Fast Track Designation for investigational drug candidate, LP-184, for treatment of Glioblastoma. LP-184 is currently in a Phase 1A clinical trial designed to evaluate the safety and tolerability of the synthetically lethal investigational drug candidate in a broad range of solid tumors, including Glioblastoma (GBM)."

Fast track • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Lantern Pharma Announces Three U.S. FDA Rare Pediatric Disease Designations Granted to LP-184 in Multiple Ultra Rare Children’s Cancers (Businesswire) - "Lantern Pharma Inc...announced today that the company has been granted three rare pediatric disease designations (RPDD) by the FDA. Lantern was granted these rare pediatric disease designations in: malignant rhabdoid tumors (MRT), rhabdomyosarcoma (RMS), and hepatoblastoma....LP-184 is currently in a multi-center Phase 1A clinical trial that is expected to enroll approximately 50 to 60 patients across a wide range of solid tumors."

Enrollment status • FDA event • Hepatoblastoma • Oncology • Rhabdoid Tumor • Rhabdomyosarcoma

Lantern Pharma Highlights Promising Preclinical Results of LP-184’s Synergy with Checkpoint Inhibitors & Sensitizing Tumors That are Non-Responsive to Anti-PD1 Therapy in Collaboration with MD Anderson at Immuno-Oncology Summit 2024 (Businesswire) - "Lantern Pharma...announced a significant advancement demonstrating the preclinical synergy of LP-184 with checkpoint inhibitors and the ability of LP-184 to resensitize tumors that have become non-responsive to Anti-PD1 therapies. The company will be presenting preliminary data from the recent work done in conjunction with Drs. Yong Du and Shiaw-Yih (Phoebus) Lin at MD Anderson at The Immuno-Oncology Summit 2024 in Philadelphia....LP-184 seems to potentiate anti-PD1 response in a mouse model of TNBC that is non-hypermutated and resistant to immunotherapy in the absence of LP-184....LP-184 is being investigated in an ongoing first-in-human Phase 1 trial (NCT05933265) in advanced recurrent solid tumors..."

Preclinical • Trial status • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Lantern Pharma Achieves Key Milestone Towards Development of Molecular Diagnostic for use in Oncology Clinical Trials for Patient Selection and Stratification with Drug Candidate LP-184 (Businesswire) - "Lantern Pharma...announced a significant advancement towards the development of a diagnostic for its drug candidate LP-184....The company plans to further develop and validate the assay for its use as a potential tool for patient selection in later stage clinical trials across a broad range of solid tumors that have shown sensitivity to LP-184. Lantern has successfully confirmed PTGR1 as a key biomarker that it intends to use to optimize patient selection based on potential tumor sensitivity to the drug candidate LP-184....Lantern Pharma plans to implement this assay in upcoming clinical trials for LP-184, potentially streamlining the development process and increasing the likelihood of successful outcomes."

Clinical • Brain Cancer • Breast Cancer • CNS Tumor • Gastrointestinal Cancer • Glioma • Lung Cancer • Melanoma • Oncology • Pancreatic Cancer • Rhabdoid Tumor • Skin Cancer • Solid Tumor

Lantern Pharma Reports First Quarter 2024 Financial Results and Business Highlights (Businesswire) - "Five cohorts of patients, comprised of dose levels 1 thru 5, have been enrolled and dosed – in escalating doses – in the ongoing Phase 1A clinical trial...The company has also submitted a dose optimization and expansion protocol (Supplement A) to the FDA related to LP-184 in non-CNS solid tumors, including TNBC (triple negative breast cancer) with DDR alterations. Additionally, the company in collaboration with Starlight Therapeutics, has also submitted to the FDA a dose optimization and expansion protocol in recurrent IDH wild-type high grade gliomas (Supplement B)...AI and preclinical studies are ongoing to further refine drug combination studies supporting the use of LP-184 to improve the durability or overall response rates in combination with FDA approved drugs that are widely used in cancer treatment. Globally, the aggregate annual market potential of LP-184’s target indications is estimated to be approximately $12+ billion..."

FDA event • Sales projection • Trial status • Brain Cancer • Breast Cancer • CNS Tumor • Oncology • Solid Tumor • Triple Negative Breast Cancer

Lantern Pharma Launches “Webinar Wednesdays” Featuring World-Class Physician Scientists & Key Opinion Leaders Discussing Critical Areas of Oncology Drug Development (Businesswire) - "Lantern Pharma Inc...announced today that – the company has launched Webinar Wednesdays, a webinar series that focuses on areas of high oncology drug development interest with leading physicians, scientists and Lantern collaborators in drug development and artificial intelligence.... These sessions provide a deep dive into the company’s research, collaborations, clinical trials and expected goals for the drug or AI development initiatives. The series kicks off today, Wednesday April 24, focusing on LP-300, a novel therapeutic for the treatment of non-small cell lung cancer in never-smokers presented by Dr. Joseph Treat. Next month Dr. Igor Astsaturov will share his experience, and approach for the treatment of pancreatic cancer and other solid tumors and how synthetically lethal drug candidate, LP-184 fits into an increasingly biomarker driven paradigm for cancer treatments."

Clinical • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor