LP-284 / Lantern Pharma - LARVOL DELTA

Preclinical Studies Support the Clinical Development of LP-284 in Relapsed and Refractory B-Cell Lymphomas (ASH 2023) - "In preclinical pharmacology studies, the mantle cell lymphoma (MCL) xenograft tumor mouse model derived from JeKo-1, which has mutated TP53 and checkpoint kinase 2 (CHEK2), an HRD score of 46, and was refractory to ibrutinib and bortezomib, showed near complete response after LP-284 treatment. Overall, based on its impressive preclinical anti-tumor efficacy profile, low drug-drug interaction liability, and findings from toxicological studies, a Phase 1 study is currently planned with LP-284 to assess its safety, tolerability, pharmacokinetics, and clinical activity in patients with relapsed or refractory B-cell lymphoma. Clinical development will be informed by an emphasis on patient selection strategy based on DDR/HR biomarkers."

IO biomarker • Preclinical • Ataxia • B Cell Lymphoma • Hematological Malignancies • Immunology • Lymphoma • Mantle Cell Lymphoma • Movement Disorders • Non-Hodgkin’s Lymphoma • Oncology • Primary Immunodeficiency • Solid Tumor • ATM • BCL2 • CHEK2 • HRD • MYC • TP53

Lantern Pharma Reports Complete Response in Heavily Pre-Treated Lymphoma Patient with LP-284 in Phase 1 Clinical Trial (Businesswire) - P1 | N=110 | NCT06132503 | Sponsor: Lantern Pharma Inc. | "Lantern Pharma...announces that a heavily pretreated patient with aggressive Grade 3 non-germinal center B-cell diffuse large B-cell lymphoma (DLBCL) achieved a complete metabolic response in the ongoing Phase 1 clinical trial of LP-284. This represents the first complete response observed with LP-284 and displays profound clinical activity in one of the most therapeutically challenging hematologic cancers...Following enrollment in April 2025, the patient achieved complete metabolic response with non-avid lesions after completing just two 28-day cycles of LP-284 administered on days one, eight, and 15...Lantern plans to continue enrollment in the Phase 1 trial while closely monitoring the responding patient and other potential future patients for durability of response and efficacy signals. The company anticipates providing additional clinical updates as the trial progresses and more patients reach evaluable timepoints."

P1 data • Trial status • Diffuse Large B Cell Lymphoma

Lantern Pharma Secures EU Patent Allowance for LP-284, Bolstering Global IP Position for AI-Developed Cancer Therapy (Businesswire) - "Lantern Pharma...announced that the European Patent Office (EPO) has issued a notice of allowance for a composition of matter patent covering its drug candidate LP-284. This patent, expected to be granted in the coming months with exclusivity through early 2039, strengthens Lantern's global intellectual property (IP) portfolio and supports the development and commercialization path for LP-284, a novel therapy in development for relapsed or refractory non-Hodgkin's lymphoma (NHL), including mantle cell lymphoma (MCL) and high-grade B-cell lymphomas (HGBL).The EU patent complements a composition of matter patent granted in Japan (June 2024) and the U.S. (April 2023), with additional patent allowances grants in India and Mexico, and applications pending in China, Australia, Canada, and Korea....LP-284 is in an active Phase 1 trial in the US focused on lymphomas and other B-cell cancers with a potential completion in late 2025."

Patent • Trial status • B Cell Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma

AI-Powered Drug Development Pipeline Highlights (Businesswire) - "LP-284 continued enrollment in its Phase 1A, first-in-human clinical trial for relapsed/refractory non-Hodgkin’s lymphoma and solid tumors. No dose-limiting toxicities have been observed through cohort 4. LP-284 has shown nanomolar potency in multiple preclinical cancer models, including tumors that are resistant to Ibrutinib and Bortezomib...Lantern plans on sharing data from these early preclinical studies during Q2 of 2025."

P1 data • Preclinical • Non-Hodgkin’s Lymphoma • Solid Tumor

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

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

Phase 1 Clinical Trial of LP-284, a Novel Synthetically Lethal Small Molecule, in Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas and Solid Tumors (SOHO 2024) - P1 | "LP-284 has overcome the resistance to Bruton's tyrosine kinase inhibitors and bortezomib in mantle cell lymphoma (MCL) xenograft mouse models. In addition, a synergistic effect between LP-284 and rituximab has been observed preclinically...Enrollment in dose level 3 commenced in May 2024. After the selection of the MTD and/or RP2D(s), additional patients will be enrolled at two dose levels, as determined by the Safety Review Committee, until at least 10 patients are treated at each dose to confirm the RP2D(s) prior to initiating enrollment in Phase 1b."

Clinical • P1 data • Synthetic lethality • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • TP53

Lantern Pharma Receives Certificate of Patent from Japanese Patent Office (JPO) for Composition of Matter Covering Drug Candidate LP-284 (Businesswire) - "Lantern Pharma Inc...announced that the Japan Patent Office (JPO) has issued a Certificate of Patent for patent application no. 2021-513267 / registration no. 7489966 directed to Lantern Pharma’s drug candidate LP-284 ((+)N-hydroxy-N-(methylacylfulvene)urea). The Certificate of Patent entitled 'Illudin Analogs, Uses Thereof, and Methods for Synthesizing the Same' covers molecule LP-284, including claims covering the new molecular entity. A Certificate of Patent is issued after JPO examinations have confirmed the merits of a patent request. Lantern values the broad protection this latest patent provides."

Patent • Oncology

Lantern Pharma Reports First Quarter 2024 Financial Results and Business Highlights (Businesswire) - P1a | N=110 | NCT06132503 | Sponsor: Lantern Pharma Inc. | "LP-284 – The initial two cohorts of patients have been dosed, and no dose-limiting toxicities have been observed in the Phase 1a clinical trial. The company expects to open additional sites in the US throughout the second quarter with the potential to advance to Phase 1b/2 by the close of 2024....In the US and Europe, MCL, DHL, and HGBLs are diagnosed in 16,000-20,000 patients each year and have an estimated annual market potential of over USD 3+ billion."

New P1/2 trial • P1 data • Sales projection • Trial status • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Phase 1a/1b clinical trial of LP-284, a highly potent TP53 mutation agnostic DNA damaging agent, in patients with refractory or relapsed lymphomas and solid tumors (NCT06132503) (AACR 2024) - P1 | "In a TP53-mutated mantle cell lymphoma (MCL) xenograft model, LP-284 inhibited tumor growth at least 3-fold more than ibrutinib and bortezomib...In a high-grade B-cell lymphoma with MYC and BCL2 rearrangement xenograft model, LP-284 led to 99% tumor growth inhibition when used as a single agent and showed synergistic effect with rituximab...The exploratory objectives are to evaluate the association between tumor response and changes in ctDNA and importantly to identify potential genomic features associated with LP-284 response, particularly those related to DNA damage response pathways.The primary objectives of Phase 1b are to obtain preliminary estimates of clinical activity in adult patients with R/R DLBCL and MCL, and to determine the dose of LP-284 for further development based on exposure-response/safety relationships derived from the totality of the data obtained from both Phase 1a and 1b. Trial (NCT06132503) is open to accrual."

Clinical • IO biomarker • P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sarcoma • Solid Tumor • BCL2 • MYC • TP53

Lantern Pharma Reports Fourth Quarter & Fiscal Year 2023 Financial Results and Business Highlights (Businesswire) - "New data and scientific findings will be presented for LP-284 at AACR (American Association for Cancer Research) during the 2024 Annual Meeting in San Diego from April 5 to 10. Presentation Title: Phase 1a/1b clinical trial of LP-284, a highly potent TP53 mutation agnostic DNA damaging agent, in patients with refractory or relapsed lymphomas and solid tumors (NCT06132503)."

P1 data • Lymphoma • Solid Tumor

Lantern Pharma Announces Initial Patients Dosed in First-In-Human Clinical Trial for AI-Guided Drug-Candidate, LP-284 (Businesswire) - "Lantern Pharma Inc...announced the dosing of the first two patients in the Phase 1 clinical trial evaluating Lantern’s investigational new drug LP-284 in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL), including mantle cell lymphoma (MCL) and double hit lymphoma (DHL) and other high-grade B-cell lymphomas (HGBL) as well as other select solid tumors and sarcomas. Recently, Lantern Pharma’s AI platform, RADR is expected to exceed 100 billion data points during 2024, and has been crucial in uncovering and accelerating indications for LP-284 as well as other drug-candidates that are in development."

Trial status • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sarcoma • Solid Tumor

Lantern Pharma's A.I. Platform, RADR, Surpasses 60 Billion Data Points – Anticipates Reaching 100 Billion Data Points in 2024, Paving the Way for Enhanced Cancer Therapy Innovations and Expedited Development Timelines (Businesswire) - "Lantern Pharma Inc...announced a series of important milestones related to the development, size, and advancement of RADR -- its proprietary AI platform focused on transforming the cost, pace, and timeline of oncology drug development...This strategy has allowed data from thousands of previously siloed sources to be analyzed in a more comprehensive, complete, and productive manner and has aided in the development of new indications for LP-184 and the development of LP-284 in a highly compressed and cost-effective manner while also leading to several conference posters, and scientific publications by Lantern Pharma and our collaborators....The current data-growth campaigns, which plan on the addition of antigen, immune-response, and protein data, are also enabling a more robust and powerful multi-omic analysis that is positioned to guide the use of LP-184, LP-284, and other similar synthetically lethal agents in combination with standard-of-care checkpoint inhibitors."

Clinical • Hematological Malignancies • Oncology • Solid Tumor

A Study of LP-284 in Relapsed or Refractory Lymphomas and Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Lantern Pharma Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2023 ➔ Jan 2023

Enrollment open • Trial initiation date • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

FDA Grants Lantern Pharma Orphan Drug Designation for Drug Candidate LP-284 in High-Grade B-cell Lymphomas (HGBL) (Businesswire) - "Lantern Pharma Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted LP-284 Orphan Drug Designation (ODD) for the treatment of high-grade B-cell lymphoma with MYC and BCL2 rearrangements."

Orphan drug • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of LP-284 in Relapsed or Refractory Lymphomas and Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Not yet recruiting | Sponsor: Lantern Pharma Inc.

New P1 trial • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Lantern Pharma Reports Third Quarter 2023 Financial Results and Operational Highlights (Businesswire) - "In xenograft PDX models of high-grade B cell lymphomas (HGBL), LP-284 showed synergistic and significantly enhanced anti-cancer activity when used in combination with rituximab. In in-vivo PDX models, the combined synergy of rituximab with LP-284 was 63% more effective in destroying HGBL tumors—93% tumor growth inhibition with both rituximab and LP-284 versus 57% tumor growth inhibition with rituximab alone.... Lantern plans to release additional details and data on this set of results with LP-284 in this setting in the coming month."

Preclinical • Non-Hodgkin’s Lymphoma

Targeting Homologous Recombination Deficiencies in B‑Cell Non‑Hodgkin Lymphomas With the Novel Anti‑Tumor Small Molecule LP‑284 (SOHO 2023) - "As a monotherapy, LP-284 (2 mg/ kg) treatment resulted in 57% TGI, whereas combination treatment with LP-284 (2 mg/kg) and rituximab (10 mg/kg) resulted in 93% TGI. Taken together, our data support further characterization of HRDs in B-NHLs and the development of LP-284 as a targeted B-NHL therapy."

Breast Cancer • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD

Lantern Pharma Receives IND Clearance from FDA Enabling Phase 1 Initiation for Drug Candidate LP-284 in Non-Hodgkin’s Lymphomas (Businesswire) - "Lantern Pharma Inc...today announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for LP-284. LP-284 is being developed for the treatment of relapsed or refractory non-Hodgkin’s lymphoma (NHL), including mantle cell lymphoma (MCL) and double hit lymphoma (DHL) and other high-grade B-cell lymphomas (HGBL). Lantern expects to commence enrollment of patients for the first-in-human Phase 1 trial for LP-284 during the fourth quarter of 2023."

IND • New P1 trial • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Lantern Pharma to Present Data Highlighting the Anti-Tumor Potency of Drug Candidate LP-284 in Non-Hodgkin’s Lymphomas at the Society of Hematologic Oncology Annual Meeting (Businesswire) - "Lantern Pharma Inc...today announced that it will present positive data highlighting the anti-tumor potency of its drug candidate LP-284 for non-Hodgkin’s lymphoma (NHL) at the Society of Hematologic Oncology (SOHO) Eleventh Annual Meeting occurring on Sept. 6 – 9, 2023, at the George R. Brown Convention Center in Houston, Texas."

Preclinical • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Lantern Pharma Expands AI Capabilities of RADR Platform to Accelerate the Clinical Development of Immune Checkpoint Inhibitors (Businesswire) - "Lantern Pharma Inc...announced a substantial increase in the power and capabilities of RADR^® focused on improving the drug development process for immune checkpoint inhibitors (ICIs)....Lantern plans to deploy its new RADR^® ICI predictive module with biopharma partners and to identify potential combinatorial strategies for LP-184 and LP-284, the first of Lantern’s drug candidates developed internally with the assistance of the RADR^® AI platform....Our lead development programs include two Phase 2 clinical programs and multiple upcoming Phase 1 clinical trials anticipated for 2023."

Clinical • New P1 trial • Oncology

Lantern Pharma Reports Second Quarter 2023 Financial Results and Operational Highlights (Businesswire) - "IND-enabling studies for LP-284 have been completed, and Lantern expects to submit the IND application to the FDA in August. The first-in-human Phase 1 clinical trial launch of LP-284 is targeted for Q4 of 2023 for B-cell non-Hodgkin’s lymphomas (NHL), where LP-284 has shown nanomolar potency across multiple in vitro and in vivo studies, including mantle cell lymphoma (MCL), double hit lymphoma (DHL), and other advanced NHL cancer subtypes with DNA damage response deficiencies, notably those with reduced expression of the ataxia-telangiectasia mutated (ATM) gene due to mutations or deletions."

IND • New P1 trial • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Oncotarget Publishes New Data by Lantern Pharma, an AI Company Developing Cancer Therapies, Further Supporting Clinical Advancement of LP-284, a Novel Synthetically Lethal Drug Candidate for Non-Hodgkin’s Lymphomas (Businesswire) - "Lantern Pharma...announced the company has published new findings in Oncotarget demonstrating drug candidate LP-284’s in vitro and in vivo antitumor potency for multiple non-Hodgkin’s lymphomas (NHL), including mantle cell lymphoma (MCL) and double-hit lymphoma (DHL)....Publication highlights in vitro and in vivo results supporting LP-284’s development for mantle cell lymphoma (MCL), an aggressive form of B-cell non-Hodgkin's lymphoma (NHL) with immediate patient needs. Lantern is anticipating filing the IND application with the FDA and initiating a first-in-human Phase 1 trial for LP-284 in NHL, including MCL, during the second half of 2023."

IND • Preclinical • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

LP-284, a small molecule acylfulvene, exerts potent antitumor activity in preclinical non-Hodgkin's lymphoma models and in cells deficient in DNA damage repair. (PubMed, Oncotarget) - "In addition, LP-284 is capable of inhibiting tumor growth of JeKo-1 xenografts that are refractory to bortezomib or ibrutinib. We further showed that LP-284 is particularly lethal in cells with deficient DNA damage response and repair, a targetable vulnerability in NHL."

Journal • Preclinical • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • HRD

Lantern Pharma Receives Notice of Allowance for Composition of Matter Patent Covering Drug Candidate LP-284 (Businesswire) - "Lantern Pharma Inc...today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for U.S. patent application no. 17/192,838 directed to Lantern Pharma’s drug candidate LP-284 ((+)N-hydroxy-N-(methylacylfulvene)urea). The allowed application entitled...covers the molecule LP-284, including claims covering the new molecular entity itself....Lantern expects the resulting LP-284 patent will be Orange Book-listable with an anticipated expiration of early 2039. Lantern intends to continue to prosecute additional patent applications, including patent applications directed to manufacturing methods and methods of use, to further enhance its existing patent estate protecting LP-284. Lantern anticipates receiving similar patent rights for LP-284 in Europe, Japan, India, China, Australia, Canada, and Korea."

Patent • Oncology