Tavocept (dimesna) / BioNumerik, Lantern Pharma - LARVOL DELTA

LP-300 HARMONIC Trial: Progression-Free Survival Benefit Deepens With Treatment Duration (Businesswire) - "Progression-Free Survival: Median progression-free survival reached 8.9 months among L858R patients who completed six cycles of LP-300 (n=9, of whom three had not progressed at the time of analysis), compared with 8.4 months across the overall L858R cohort (n=16). The L858R subgroup corresponded to a hazard ratio of 0.37 (95% CI 0.15–0.89)...More than 70% of evaluable L858R patients experienced a reduction in target-lesion size, including a complete response and multiple partial responses among the deepest responders, with certain responses sustained beyond two years and a clinical benefit rate of 77%...Comparable safety profiles were observed across patients receiving four or six cycles of LP-300, with no evidence of increased adverse events with longer treatment duration."

P2 data • Non Small Cell Lung Cancer

The FDA has raised no objections to major protocol modifications for the ongoing phase 2 HARMONIC trial (NCT05456256), which evaluates the investigational small molecule LP-300 (formerly known as biosustained disodium succinate) in never-smokers with advanced non–small cell lung cancer (NSCLC) adenocarcinoma. (Targeted Oncology) - "The protocol amendments alter both the patient population and the dosing schedule. Future enrollment will focus entirely on the EGFR exon 21 L858R mutation subset...Additionally, the FDA raised no objections to extending the maximum duration of LP-300 administration from 6 to 8 cycles when given alongside a standard chemotherapy backbone of carboplatin and pemetrexed."

Clinical protocol • FDA event • Non Small Cell Lung Cancer

Lantern Pharma In....announced it has scheduled a Type C meeting with the U.S. Food and Drug Administration (FDA) for mid-May 2026 to seek feedback on proposed protocol amendments to its ongoing Phase 2 HARMONIC clinical trial evaluating LP-300. (Businesswire) - "Preliminary clinical data from the HARMONIC trial, with a data cutoff of April 13, 2026, have revealed a differentiated and consistent progression-free survival profile for LP-300 in patients harboring the EGFR Exon 21 L858R mutation — accounting for approximately 40% of all EGFR-mutant NSCLC cases globally, and a subgroup with a notably inferior prognosis following frontline TKI (including osimertinib) therapy compared with Exon 19 deletion patients...L858R patients completing 6 cycles of LP-300 showed a mPFS = 8.9 months (n=9, 3 patients had not yet progressed at the time of analysis)...L858R patients with 2 prior systemic therapies: mPFS = 13.5 months (n=5; 3 patients had not yet progressed at the time of analysis)."

FDA event • P2 data • Non Small Cell Lung Cancer

HARMONIC: A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Lantern Pharma Inc. | Trial completion date: Jun 2026 ➔ Jun 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • NTRK

Three Proposed Protocol Amendments (Businesswire) - "Lantern is seeking FDA feedback and concurrence on these proposed amendments as part of the mid-May Type C meeting...Focus Future Trial Enrollment to EGFR Exon 21 L858R Patients...Convert to a Phase 2 Single-Arm Simon Two-Stage Study Design...Increase LP-300 Treatment Cycles from 6 to 8."

Clinical protocol • FDA event • Non Small Cell Lung Cancer

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

LP-300 preliminary Phase 2…clinical and patient data planned for a webinar in December. (Businesswire)

P2 data • Non Small Cell Lung Cancer

LP-300 HARMONIC Trial: Complete Response Observed Demonstrating Clinical Activity… (Businesswire) - "The Phase 2 HARMONIC trial continues to advance with enrollment across the United States and expansion sites in Asia. A remarkable complete response was observed in a 70-year-old never-smoker patient with advanced NSCLC who had exhausted three prior treatment regimens....Additional clinical data and findings are anticipated in September 2025, including initial safety and response evaluations from the Asian expansion cohort."

P2 data • Trial status • Non Small Cell Lung Cancer

Lantern Pharma Completes Targeted Enrollment for Lung Cancer Phase 2 Harmonic Clinical Trial in Japan for LP-300 (Businesswire) - "Lantern Pharma...announced the successful completion of targeted enrollment for its Phase 2 HARMONIC clinical trial in Japan. The company enrolled 10 patients ahead of schedule across five clinical sites in Japan, including the National Cancer Center Japan. The HARMONIC trial is evaluating LP-300 in combination with carboplatin and pemetrexed in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs)....The completion of Japanese enrollment represents an important milestone in the global HARMONIC trial, which is designed to enroll approximately 90 patients across multiple regions....Lantern is scheduled to provide further clinical and outcome data from the HARMONIC trial later this quarter, with updates covering both Asian and U.S. patient cohorts."

P2 data • Trial status • Non Small Cell Lung Cancer

Phase II Trial of LP-300 in Combination With Carboplatin and Pemetrexed in Never Smoker Patients With Relapsed Advanced Primary Adenocarcinoma of the Lung After Treatment With Tyrosine Kinase Inhibitors. (PubMed, Clin Lung Cancer) - P2 | "This phase II trial is accruing patients at sites in the U.S, Japan, and Taiwan. Patient accrual is expected to be completed in the Fall of 2026."

Journal • P2 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • NTRK • ROS1

Lung Cancer Patient in Lantern Pharma’s Harmonic Trial Shows Durable Complete Response in Target Cancer Lesions with Survival Continuing for Nearly Two Years (Yahoo Finance) - P2 | N=90 | HARMONIC (NCT05456256) | Sponsor: Lantern Pharma Inc. | "The patient, who had previously failed three lines of prior therapy including Keytruda (pembrolizumab) with chemotherapy, radiation therapy, and the EGFR inhibitor Tagrisso (osimertinib), initially demonstrated a partial response with a 57% reduction in tumor volume after completion of the HARMONIC™ lead-in cohort enrollment in Q3 of 2024. The patient subsequently demonstrated a complete response in the target cancer lesions, specifically the lung and adrenal gland lesions by Q1 of 2025. This type of complete response in the target cancer lesions is atypical for this advanced and recurrent NSCLC after multiple rounds of therapy....Notably, the patient has shown no clinically significant adverse drug reactions or dose-limiting toxicities (DLTs) over 21 cycles of treatment....The company anticipates providing an additional data update from the randomized expansion phase in the second half of 2025."

P2 data • Lung Adenocarcinoma • Non Small Cell Lung Cancer

Design, Synthesis, and Evaluation of Camptothecin-Based Antibody-Drug Conjugates with High Hydrophilicity and Structural Stability. (PubMed, Molecules) - "In the subcutaneous model of SHP-77 NOD scid gamma mice, when the ADC dose was 5 mg/kg, 7300-LP3004 showed the highest tumor inhibition rate with a tumor growth inhibition (TGI) of 106.09%, which was superior to that of the positive control 7300-Deruxtecan, which had a TGI of 103.95%. In conclusion, 7300-LP3004 demonstrated strong antitumor activity and high physicochemical stability, highlighting the need for further research and development of ADC drugs."

Journal • Oncology • CTSB

AI-Powered Drug Development Pipeline Highlights (Businesswire) - "Lantern’s Phase 2 HARMONIC trial for LP-300 continued to expand globally in 2024 with sites opened in Japan and Taiwan, including at the National Cancer Center Japan. Patient enrollment was initiated in Taiwan and Japan during Q4 of 2024 and is expected to accelerate during 2025...Lantern plans on sharing additional results, which will include data from patients enrolled in Taiwan and Japan from the expansion cohort, during Q2 of 2025."

P2 data • Trial status • Non Small Cell Lung Cancer

Lantern Pharma Announces First Patient Enrolled in Taiwan for Phase 2 HARMONIC Clinical Trial of LP-300 in Never-Smoker NSCLC Patients (Businesswire) - "Lantern Pharma Inc...today announced that the first patient has been enrolled and dosed in Taiwan for its Phase 2 HARMONIC clinical trial evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs)....The Phase 2 HARMONIC™ trial is actively screening in multiple cancer centers in the US, Japan and Taiwan and is expected to enroll up to 90 patients across two treatment arms....Lantern plans to review, and share the interim data from, the Phase 2 trial for PFS and OS (co-primary endpoints) after 30 clinical events have been observed."

P2 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Lantern Pharma Announces First Patient Dosed in Japan for The Expansion Cohort in The Phase 2 HARMONIC Clinical Trial of LP-300 in Never-Smoker NSCLC Patients (Businesswire) - "The HARMONIC trial is evaluating LP-300 in combination with carboplatin and pemetrexed in never-smoker NSCLC patients who have recurrent NSCLC and have stopped responding to tyrosine kinase inhibitor (TKI) based therapies....Ten clinical trial sites across Japan and Taiwan are actively screening patients, with additional sites expected to also begin patient enrollment in the coming months. U.S. clinical sites continue to actively screen and dose patients in both the LP-300 combination arm and the standard-of-care control arm of the Harmonic trial."

Trial status • Non Small Cell Lung Cancer

Lantern Pharma Reports Third Quarter 2024 Financial Results and Business Updates (Businesswire) - "Highlights of AI-Powered Pipeline: (i) LP-300: The Harmonic Phase 2 Clinical Trial:...The study's co-primary endpoints are progression-free survival (PFS) and overall survival (OS), with planned interim analysis after 31 patients have experienced disease progression which is expected by mid 2025...; (ii) LP-284 - The fourth cohort of patients are being dosed, and no dose-limiting toxicities have been observed in the LP-284 Phase 1a clinical trial. We are in the process of opening additional hematology-focused sites later this year, with the potential to advance to Phase 1b or 2 by early to mid 2025."

New trial • P2 data • Trial status • Lymphoma • Non Small Cell Lung Cancer

HARMONIC: A Study of LP-300 with Carboplatin and Pemetrexed in Never Smokers with Advanced Lung Adenocarcinoma (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Lantern Pharma Inc. | Trial completion date: May 2025 ➔ Jun 2026 | Trial primary completion date: Nov 2024 ➔ Dec 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • NTRK

Lantern Pharma Announces Positive Clinical Update from Ongoing Phase 2 HARMONIC Clinical Trial for Never Smokers with Advanced NSCLC, Including an 86% Clinical Benefit Rate in the Initial Patient Cohort (Businesswire) - P2 | N=90 | HARMONIC (NCT05456256) | Sponsor: Lantern Pharma Inc. | "Of the 7 patients enrolled in the Phase 2 lead-in stage of the Harmonic trial: The clinical benefit rate (CBR) or disease control rate (DCR) was 86% with 6 of the 7 patients receiving clinical benefit to date; The preliminary objective response rate (ORR) was 43%, with 3 of the 7 patients having a partial response and 3 patients having stable disease; The 3 partial responses include complete disappearance of metastatic lesions and/or normalization of lymph nodes that were abnormal at baseline and the patients experienced an average of 51% reduction in tumor sizes as measured by RECIST criteria; In the 3 patients achieving stable disease, there was an average of 13% reduction in tumor size with two patients having distal lesions reduced by 40% in tumor size."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Lantern Pharma Reports First Quarter 2024 Financial Results and Business Highlights (Businesswire) - "LP-300 – The phase 2 Harmonic clinical trial sites in the US are continuing to screen for patients and have also increased the pace of enrollment. This past quarter we also received approval to proceed with the Phase 2 clinical trial in Japan and Taiwan...Dr. Yashushi Goto...will be leading the phase 2 trial in Japan, where the incidence of non-small cell lung cancer (NSCLC) in never-smokers is double or more than that of the United States...The Harmonic trial is assessing the effect of LP-300 in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) in LCINS patients with relapsed NSCLC....In the US it is estimated that LP-300 has an annual market potential of $1.5 billion, and a global estimated annual market potential of over $2.6 billion."

New P2 trial • Sales projection • Trial status • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

Lantern Pharma Receives Regulatory Approval to Expand Harmonic Clinical Trial for Non-Small Cell Lung Cancer in Never-Smokers into Japan and Taiwan (Businesswire) - "Lantern Pharma Inc...announced today that – the company has received regulatory approval to expand its Harmonic trial, a Phase 2 clinical study evaluating LP-300 in non-small cell lung cancer (NSCLC) in never-smokers in both Japan and Taiwan....The approval to proceed with the Phase 2 clinical trials in Japan and Taiwan are expected to accelerate the collection of patient and response data needed for the next-stage of evaluation and development of LP-300, a therapeutic for the treatment of relapsed and inoperable primary adenocarcinoma of the lung given in combination with chemotherapy."

Trial status • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Lantern Pharma Reports Fourth Quarter & Fiscal Year 2023 Financial Results and Business Highlights (Businesswire) - "LP-300 – Twelve sites for the Phase 2 Harmonic trial have been activated in the US, and 3 Asian countries are in various phases of regulatory allowance for clinical trial commencement. This strategy should increase the potential for dosing additional patients in the Phase 2 Harmonic trial during 2024, which should help address the patient enrollment challenges Harmonic has faced in the US. In these Asian countries, Japan, South Korea and Taiwan, the incidence of never-smokers with NSCLC (non-small cell lung cancer) is double or higher than that of patients in the US. The Harmonic trial is assessing the effect of LP-300 in combination with standard-of-care chemotherapy in never-smoker patients with relapsed NSCLC."

Trial status • Non Small Cell Lung Cancer

A randomized multiplex CRISPRi-Seq approach for the identification of critical combinations of genes. (PubMed, Elife) - "lpg2888 and lpg3000 were particularly fascinating for their apparent redundant functions during L. pneumophila human macrophage infection, while lpg3000 alone was essential for L. pneumophila virulence in the amoeban host Acanthamoeba castellanii. Thus, MuRCiS provides a method for rapid genetic examination of even large groups of redundant genes, setting the stage for application of this technology to a variety of biological contexts and organisms."

Journal • Infectious Disease

Phase II Trial of LP-300 + Pemetrexed/Carboplatin in Patients Who Never Smoked with Lung Adenocarcinoma After TKI Progression (IASLC-WCLC 2023) - "The prior phase III trial evaluating LP-300 with paclitaxel/cisplatin demonstrated a marginal increase in survival in the overall study population. Patients who received TKIs as a prior therapy must have disease progression or treatment intolerance. Enrollment for this trial began in March of 2023."

Clinical • P2 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • GLRX • MET • NTRK • ROS1

Dr Kim on the HARMONIC Trial of LP-300 in Advanced Lung Cancer (OncLive) - P2 | N=90 | HARMONIC (NCT05456256) | Sponsor: Lantern Pharma Inc. | "Edward S. Kim...discusses the investigation of LP-300 plus chemotherapy in the phase 2 HARMONIC trial (NCT05456256) in patients with advanced lung adenocarcinoma....After patients complete 6 cycles of carboplatin and pemetrexed with or without LP-300, both arms will have the option to receive pemetrexed maintenance. Additionally, blood and biopsy specimens will be collected throughout the trial to monitor any changes on biomarkers, Kim says."

P2 data • Video