LX-101 / IGF Oncology, Lirum Therap - LARVOL DELTA

Lirum Therapeutics Announces FDA “Study May Proceed” Letter Enabling Inclusion of LX-101 in the RAPID Platform Clinical Trial for Ewing Sarcoma and Desmoplastic Small Round Cell Tumor (GlobeNewswire) - "The RAPID (Rapidly Assess Promising Innovative Drugs), is a patient-centric, multicenter, open-label platform trial...designed to evaluate promising therapies for adolescent and young adult patients, similar to other highly successful platform trials, RAPID employs a master protocol that enables the study of both single-agent and novel drug combinations in patients with relapsed/refractory ES and DSRCT."

IND • Ewing Sarcoma

Lirum Therapeutics’ LX-101 New Positive Data Selected for Presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "These presentations highlight LX-101’s broad activity and promise in a wide array of pediatric and adult cancers with well-established ties to the IGF-1R pathway. In the first presentation, co-authored with investigators from the MD Anderson Cancer Center, LX-101 demonstrated potent activity against Ewing’s Sarcoma in both in vivo and in vitro models, and against desmoplastic small round cell tumor (DSRCT) in in vitro models....The second presentation highlights LX-101’s broad potency against a host of IGF-1R-expressing common adult cancer types including lung, esophageal and stomach representing the potential for further market expansion."

Preclinical • Esophageal Cancer • Ewing Sarcoma • Gastric Cancer • Lung Cancer

LX-101, a novel, clinical stage, payload-bearing targeted therapy directed to the insulin-like growth factor receptor (IGF-1R), demonstrates potent anti-tumor activity in Ewing sarcoma animal models and desmoplastic small round cell tumor (AACR 2025) - "LX-101 is a next-generation, targeted therapy directed to the IGF-1R, consisting of a proprietary IGF-1 variant coupled to a cytotoxic methotrexate payload. These results demonstrate that LX-101 has potent anti-tumor activity against ES, in vivo and in vitro, and DSRCT, in vitro, providing a differentiated approach from previous IGF-1R targeting agents. These data support further clinical development of LX-101 in ES, DSRCT, and other IGF-1R-involved cancers. Phase 2 clinical trials are expected to begin in 2025."

Preclinical • Ewing Sarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • EWSR1 • FLI1 • WT1

LX-101, a novel, clinical stage, payload-bearing targeted therapy directed to the insulin-like growth factor receptor (IGF-1R), demonstrates potent preclinical anti-tumor activity against multiple cancer types with elevated IGF-1R expression (AACR 2025) - "LX-101 consists of a proprietary IGF-1 variant coupled to a cytotoxic methotrexate payload. These results demonstrate that LX-101 has potent preclinical anti-tumor activity against multiple cancer cell lines expressing IGF-1R. These data support further clinical development of LX-101 in IGF-1R-involved cancers. New clinical trials are planned."

Preclinical • Breast Cancer • Esophageal Cancer • Ewing Sarcoma • Gastric Cancer • Lung Cancer • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • IGF1

Lirum Therapeutics Invited to Present at Prestigious Gordon Research Conference (GlobeNewswire) - "This unique invitation highlights the renaissance of IGF-1R targeting in human disease and the excitement around Lirum’s innovative clinical approach in cancer and autoimmune disease. The oral presentation entitled 'LX-101: A Novel Approach to Targeting IGF-1R' will be delivered by Lirum’s VP of Operations, Matt Hoberman."

Clinical • Immunology • Oncology

Lirum Therapeutics Announces Debut of LX-101 Results in Thyroid Eye Disease, Selected for Presentation at the 2025 NANOS Annual Meeting (GlobeNewswire) - "These new results demonstrate the ability of LX-101 to effectively target the underlying processes that drive TED pathogenesis. Principal findings demonstrate that LX-101 can: inhibit TED-derived orbital fibroblasts; decrease production of key inflammatory cytokines; reduce production of pro-fibrotic components of the extracellular matrix; and modulate activity of TED-derived T-cells....The results will be presented by Lirum’s academic collaborator, Collynn F. Woeller, Ph.D., from the Flaum Eye Institute at the University of Rochester."

Preclinical • Thyroid Eye Disease

Lirum Therapeutics Presents Positive Data on LX-101 at the 2025 ESMO Targeted Anticancer Therapies Congress; Highlighting LX-101’s Promise in IGF-1R Prominent Cancers (GlobeNewswire) - "The presentations are entitled: LX-101, a Novel, Clinical Stage, Payload-Bearing Targeted Therapy Directed to the Insulin-Like Growth Factor Receptor (IGF-1R), Demonstrates Potent Anti-Tumor Activity in Ewing Sarcoma Animal Models and Desmoplastic Small Round Cell Tumors; LX-101, a Novel, Clinical Stage, Payload-Bearing Targeted Therapy Directed to the Insulin-Like Growth Factor Receptor (IGF-1R), Demonstrates Potent Preclinical Anti-Tumor Activity Against Multiple Cancer Types with Elevated IGF-1R Expression....Given these promising results, new clinical trials with LX-101 are planned in pediatric indications that carry strong ties to the IGF-1/IGF-1R pathway, including Ewing Sarcoma, DSRCT, rhabdomyosarcoma, and GIST. In addition, Lirum is planning trials in adult patients with cancer types that are naturally enriched for IGF-1R, including certain head and neck indications and others."

New trial • Preclinical • Esophageal Cancer • Ewing Sarcoma • Gastric Cancer • Gastrointestinal Stromal Tumor • Head and Neck Cancer • Lung Cancer • Rhabdomyosarcoma • Solid Tumor

LX-101, a novel, clinical stage, payload-bearing targeted therapy directed to the insulin-like growth factor receptor (IGF-1R), demonstrates potent preclinical anti-tumor activity against multiple cancer types with well-established ties to the IGF-1/IGF-1R pathway (AACR 2024) - "LX-101 consists of a proprietary IGF-1 variant coupled to a cytotoxic methotrexate payload. These results demonstrate that LX-101 has potent preclinical anti-tumor activity against multiple cancer cell lines with well-established ties to the IGF-1/IGF-1R pathway, including with different genetic and epigenetic alterations. These data support further clinical development of LX-101 in IGF-1R-involved cancers. New clinical trials are planned."

Preclinical • Breast Cancer • CNS Tumor • Ewing Sarcoma • Head and Neck Cancer • Neuroblastoma • Oncology • Osteosarcoma • Rhabdomyosarcoma • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • ERG • EWSR1 • FLI1 • IGF1 • PAX3

Lirum Therapeutics to Present Positive Data on LX-101, a Novel Clinical-Stage Targeted Therapy Demonstrating Potent Preclinical Activity Against Adult and Pediatric IGF-Related Cancers, at the 2024 AACR Annual Meeting (GlobeNewswire) - "Lirum Therapeutics, Inc...announced today the upcoming presentation of positive data on LX-101...at the 2024 American Association for Cancer Research (AACR) Annual Meeting being held from April 5-10 in San Diego, California....Lirum’s data covers clinically-tested LX-101’s potent preclinical anti-tumor activity against variety of adult and pediatric cancers, including cancers of the head and neck and breast as well as certain sarcomas and neuroblastoma, all of which have well-established IGF-1R pathway involvement....Given these promising results and the existing clinical data, Lirum is planning new clinical trials with LX-101 focused on oncologic indications, both pediatric and adult, that carry well-established ties to the IGF-1/IGF-1R pathway."

New trial • Preclinical • Breast Cancer • Head and Neck Cancer • Neuroblastoma • Oncology • Sarcoma • Solid Tumor

LX-101, a novel, clinical stage, payload-bearing, IGF-1R targeted therapy, has potent preclinical anti-tumor activity against sarcomas and other IGF-related cancers (Sarcoma-RC 2024) - "Background: LX-101, a next-generation, targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R), consists of a proprietary optimized IGF-1 variant coupled to a cytotoxic methotrexate payload...Background: LX-101, a next-generation, targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R), consists of a proprietary optimized IGF-1 variant coupled to a cytotoxic methotrexate payload... These results demonstrate that LX-101 has potent preclinical anti-tumor activity against sarcoma and other rare cancer cells with well-established ties to the IGF-1R pathway, including those with different oncogenic gene fusions. These data support the clinical development of LX-101 in IGF-1R-related sarcomas and other rare cancers. Clinical trials are planned."

Preclinical • Adrenal Cortex Carcinoma • Ewing Sarcoma • Genito-urinary Cancer • Oncology • Osteosarcoma • Rhabdomyosarcoma • Sarcoma • Solid Tumor • EWSR1 • FLI1 • PAX3

Lirum Therapeutics Announces Positive Data on LX-101, a Novel Clinical-Stage Targeted Therapy Demonstrating Potent Preclinical Activity Against IGF-Related Cancers, Accepted for Presentation at the 2024 ESMO Sarcoma and Rare Cancers Congres (GlobeNewswire) - "Lirum Therapeutics, Inc...announced today the acceptance for presentation of positive data on LX-101...at the 2024 European Society for Medical Oncology ('ESMO') Sarcoma and Rare Cancers Congress being held from March 14-16 in Lugano, Switzerland....Given these promising results and the existing clinical data, Lirum is planning new clinical trials with LX-101 focused on oncologic indications, both pediatric and adult, that carry well-established ties to the IGF-1/IGF-1R pathway." "

New trial • Preclinical • Oncology • Solid Tumor

Lirum Therapeutics Presents Positive Data on LX-101, a Novel Clinical-Stage Targeted Therapy, at the 2024 ESMO Targeted Anticancer Therapies Congress; Highlighting LX-101’s Potential in IGF-1R Prominent Cancers (GlobeNewswire) - P1a | N=19 | "Lirum Therapeutics, Inc...announced today that it will present positive data on LX-101, a novel clinical-stage targeted therapy directed to the insulin growth factor-1 receptor (IGF-1R), in patients with high IGF-1R tumor expression at the 2024 European Society for Medical Oncology (ESMO) Targeted Anticancer Therapies Congress in Paris, France on Monday, February 26^th at 5:15 PM CET (11:15 ET)...Of the 19 patients treated with LX-101, 4 were considered high IGF-1R expressers. Of these 4 patients, 3 were evaluable for response, and 2/3 (67%) of these patients experienced disease control/response, including the one patient who had an objective response at the highest dose....Lirum is planning new clinical trials with LX-101 focused on oncologic indications, both pediatric and adult, that carry well-established ties to the IGF-1/IGF-1R pathway."

P1 data • Oncology • Solid Tumor

LX-101, A NOVEL, CLINICAL STAGE, PAYLOAD-BEARING TARGETED THERAPY DIRECTED TO THE INSULIN-LIKE GROWTH FACTOR RECEPTOR, HAS POTENT PRECLINICAL ANTI-TUMOR ACTIVITY AGAINST PEDIATRIC SARCOMAS (CTOS 2023) - "Objective: LX-101, a next-generation, targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R), consists of a proprietary IGF-1 variant coupled to a cytotoxic methotrexate (MTX) payload. These results demonstrate that LX-101 has potent preclinical anti-tumor activity against pediatric sarcoma cell lines with well-established ties to the IGF-1R pathway, including with different oncogenic gene fusions. These data further support the clinical development of LX-101 in IGF-1R-related pediatric cancers. A clinical trial is planned."

Preclinical • Ewing Sarcoma • Oncology • Osteosarcoma • Rhabdomyosarcoma • Sarcoma • Solid Tumor • ERG • EWSR1 • FLI1 • PAX3

Lirum Therapeutics Presents Positive Data on LX-101, a Novel Clinical-Stage Targeted Therapy, Demonstrating Potent Preclinical Activity Against Pediatric Sarcomas (GlobeNewswire) - "Lirum Therapeutics...announced the presentation of positive data at the 2023 Connective Tissue Oncology Society meeting in Dublin, Ireland. LX-101, a novel clinical-stage payload-bearing targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R), demonstrated potent anti-tumor activity against cell lines with well-established IGF-1R pathway involvement, including pediatric sarcomas. These include cancers with known genetic alterations affecting the IGF-1R pathway and/or with high IGF-1R expression such as Ewing’s and related sarcomas, rhabdomyosarcoma, and osteosarcoma."

Preclinical • Ewing Sarcoma • Osteosarcoma • Rhabdomyosarcoma

IGF-MTX Conjugate in the Treatment of Myelodysplastic Syndrome (clinicaltrials.gov) - P1/2 | N=2 | Terminated | Sponsor: IGF Oncology, LLC | Active, not recruiting ➔ Terminated; Funding

Trial termination • Acute Myelogenous Leukemia • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

IGF-MTX Conjugate in the Treatment of Myelodysplastic Syndrome (clinicaltrials.gov) - P1/2; N=2; Active, not recruiting; Sponsor: IGF Oncology, LLC; Recruiting ➔ Active, not recruiting; Trial completion date: Sep 2020 ➔ Sep 2021; Trial primary completion date: Jun 2020 ➔ Jun 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology