IM-3050 / Immunome - LARVOL DELTA

Clinical Evaluation of 177Lu-FAP-VG11 Injection in Patients With Fibroblast Activation Protein -Positive Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=7 | Recruiting | Sponsor: Shandong Cancer Hospital and Institute

New P1 trial • Oncology • Solid Tumor • FAP

Immunome Announces First Patient Dosed in Phase 1 Trial Evaluating IM-3050, an FAP-Targeted Radioligand Therapy, in Patients with FAP-Expressing Advanced Solid Tumors (Businesswire)

Trial status • Solid Tumor

Bladder RadioMolecularIncubator Theranostics: Safety and Efficacy of Intravesical 177Lu-FAP (3BP-3940) and 177Lu-CXCR4 and Systemic 177Lu/225Ac-3BP-3940 in High-Grade Muscle-Invasive Bladder Cancer (SNMMI 2026) - "Histologies ranged from conventional urothelial carcinoma to poorly differentiated locally advanced, plasmacytoid variant, or metastatic (lymph nodal, peritoneal, osseous); prior treatments: TURBT (all), platinum CHT (all), pembrolizumab (2 patients), and sacituzumab govitecan (1 patient). This study highlights the feasibility and preliminary efficacy of CXCR4- and FAP-targeted radioligand therapy in refractory bladder cancer, leveraging tumor stroma for precision delivery. Intravesical RLT exploits the bladder's "radioincubator" potential for precise, high-dose tumor irradiation with limited off-target effects and addresses anatomical constraints, while extension to FAP/CXCR4 dual targeting and alpha/beta tandem RLT may enhance efficacy in selected patients with disseminated disease. This real-world experience demonstrates favorable tolerability and promising early signals of efficacy, with improvements in quality of life and a potential new option for..."

Clinical • IO biomarker • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Thrombosis • Urothelial Cancer • CXCR4 • FAP

Pipeline Highlights:…IM-3050 (Businesswire) - "In March 2026, Immunome initiated the first clinical trial site for a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors."

Trial status • Solid Tumor

Fibroblast Activation Protein-Targeted Radioligand Therapy (FAP RLT) in Gastroenteropancreatic Malignancies: Biological Rationale, Clinical Evidence, and Future Directions. (PubMed, World J Nucl Med) - "Overall, 177 Lu-FAP RLT remains investigational but represents a biologically compelling but still clinically unproven biomarker-driven strategy, whose current role is best confined to investigational settings and highly selected patients. Future progress requires optimized ligand design, standardized imaging and dosimetry, and prospective clinical trials to define its clinical role."

Journal • Review • Colorectal Cancer • Gastric Cancer • Hematological Disorders • Oncology • Pancreatic Cancer • Solid Tumor

A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer (clinicaltrials.gov) - P1 | N=105 | Recruiting | Sponsor: Immunome, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Oncology • Solid Tumor

A novel lutetium-177 radioligand therapy targeting FAP has potent antitumor activity in xenograft cancer model (AACR 2024) - "Screening this library for binding, biodistribution and pharmacology properties identified a 177Lu-FAP RLT lead molecule...The treatment was well-tolerated, with no significant weight loss or deaths. The outstanding antitumor activity and high selectivity for FAP support further evaluation of this investigational RLT in patients with solid tumors."

Preclinical • Oncology • Solid Tumor

IM-3050: (Businesswire) - "Immunome previously received IND clearance for IM-3050 and plans to initiate a Phase 1 study in early 2026 after delivery of third-party diagnostic radiotracer supply."

IND • New P1 trial • Solid Tumor

Pipeline Highlights:…IM-3050 (Businesswire) - "Immunome received IND clearance for IM-3050 in April 2025 and plans to initiate a Phase 1 study in early 2026 after delivery of third-party diagnostic radiotracer supply."

New P1 trial • Solid Tumor

Immunome Reports Second Quarter 2025 Financial Results and Provides Business Update (Businesswire) - "Pipeline Highlights:... (i) IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with patients recently dosed at the third dose level. The trial is an open-label, multicenter dose-escalation and expansion study that is expected to include participants with advanced B-cell lymphomas and advanced solid tumors; (ii) IM-3050: Immunome received IND clearance for IM-3050 in April 2025 and expects to initiate a Phase 1 clinical trial before the end of 2025."

New P1 trial • Trial status • B Cell Non-Hodgkin Lymphoma • Solid Tumor

Immunome Reports First Quarter 2025 Financial Results and Provides Business Update (Yahoo Finance) - "Pipeline Highlights: (i) Varegacestat:...Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025...; (ii) IM-3050: Immunome received IND clearance for IM-3050 in April 2025 and expects to initiate a Phase 1 clinical trial in the second half of 2025."

IND • New P1 trial • P3 data: top line • Desmoid Tumors • Solid Tumor

Immunome Reports Full Year 2024 Financial Results and Provides Business Update (Businesswire) - "Pipeline Highlights:...IM-3050: Immunome recently submitted an IND for IM-3050 and expects to initiate a clinical trial for the program in the second half of 2025."

IND • New trial • Solid Tumor

Immunome Provides Pipeline Update in Advance of Presentation at the 43rd Annual J.P. Morgan Healthcare Conference (Businesswire) - "The presentation will cover Immunome’s pipeline of targeted therapeutics, including varegacestat (formerly known as AL102), a once-daily oral gamma secretase inhibitor in the Phase 3 RINGSIDE clinical trial for the treatment of desmoid tumors. Immunome expects to report topline data in the second half of 2025....Immunome also announced the FDA clearance of its IND submission for IM-1021, a ROR1-targeted ADC. Immunome anticipates submitting an IND for IM-3050, its FAP-targeted radioligand therapy, by the end of the first quarter of 2025."

IND • P3 data: top line • Desmoid Tumors

Immunome Reports Third Quarter 2024 Financial Results and Provides Business Update (Businesswire) - "Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing additional manufacturing and pharmacology work required to support a new drug application filing for AL102. Immunome also anticipates submitting INDs for IM-1021 and IM-3050 in the first quarter of 2025, as previously disclosed."

IND • P3 data • Desmoid Tumors

Prolonged disease-free survival and bladder preservation in a patient with chemotherapy-resistant Muscle Invasive Bladder Cancer (MIBC) after first-in-human 177Lu-FAP radioligand treatment - the RadioMolecularIncubator Experience within the Bladder BRIDGister. (EANM 2024) - "Three cycles Gemcitabin/Cisplatin chemotherapy were applied; however, the patient denied planned cystectomy...The second PTRT in 05/23 included intravesical application via transurethral catheter of 2.9 GB 177Lu-3BP-3940 followed by i.v. application of 3.9 GBq 177Lu-3BP-3940 plus 200 mg Pembrolizumab infusion as radiosensitizer 3h after radioligand therapy... To the best of our knowledge this is the first molecularly stratified, theranostic application of FAP radioligand therapy (RLT) by transurethral intravesical instillation plus systemic administration in combination with immune checkpoint inhibitor therapy after initial immune-sensitizing RLT. Remarkably, complete response of chemotherapy-resistant MIBC was achieved. A phase I/II study is currently initiated."

Clinical • IO biomarker • P1 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FAP • KRT20 • KRT5 • NECTIN4 • PPARG

Impact of molar mass of FAPI on 68Ga/177Lu-FAPI PET imaging and radiotherapy for targeting murine FAP in wildtype tumor cell line derived xenograft (EANM 2024) - "The administration molar mass of 68Ga/177Lu-FAPI-04 shall apparently influence FAP-targeted imaging results and therapeutic effect. It's never careful enough to take it in consideration when apply radiolabeled FAP ligands to FAP-targeted PET imaging and radiotherapy in preclinical situation."

Preclinical • Tumor cell • Oncology • FAP

The first case of 99m Tc-FAPI Uptake in Optic Nerve sheath Meningioma (EANM 2024) - "Nonetheless, FAPI avidity may offer hope for future treatment planning with 177Lu-FAPI in patients who are refractory to 177Lu-Dotatate treatment. Overall, this study highlights the potential use of FAPI-ligand uptake as a diagnostic and therapeutic tool for optic nerve sheath meningioma patients who have not responded well to traditional treatments. Further research is needed to explore this potential further and optimize treatment strategies using FAPI-ligands."

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

Enhanced Diagnostic and Therapeutic Potentials of 68Ga-LNC1013 and 177Lu-LNC1013 in Cancer Imaging and Radionuclide Therapy: A Comparative and Preclinical Study (EANM 2024) - "This tracer demonstrated superior tumor growth inhibition compared to 177Lu-FAPI-46 and control groups in CDXs, suggesting effective radionuclide therapy potential. 68Ga-LNC1013 outperforms 18F-FDG in the diagnostic imaging of diverse cancer types, providing higher contrast and detection sensitivity. The theranostic potential of this tracer series is further highlighted by the promising therapeutic outcomes of 177Lu-LNC1013 in preclinical models, setting the stage for advanced FAP-targeted theranostics in oncology."

Preclinical • Oncology

Localized in vivo prodrug activation using radionuclides. (PubMed, bioRxiv) - "RAiDER was evaluated in syngeneic mouse models of cancer using fibroblast activation protein inhibitor (FAPI) agents 99m Tc-FAPI-34 and 177 Lu-FAPI-04, the prostate-specific membrane antigen (PSMA) agent 177 Lu-PSMA-617, combined with caged-MMAE or caged-exatecan. This proof-of-concept study shows that RAiDER is compatible with multiple radionuclides commonly used in nuclear medicine and has the potential to improve the efficacy of radiopharmaceutical therapies to treat cancer safely. RAiDER thus shows promise as an effective strategy to treat disseminated malignancies and broadens the capability of radiopharmaceuticals to trigger diverse biological and therapeutic responses."

Journal • Preclinical • Oncology

Immunome Reports Second Quarter 2024 Financial Results and Provides Business Update (Businesswire) - "...Immunome continues to expect to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing additional manufacturing and pharmacology work required to support a new drug application filing for AL102. Immunome also anticipates submitting INDs for IM-1021 and IM-3050 in the first quarter of 2025, as previously disclosed."

Commercial • IND • P3 data • Desmoid Tumors

Clinical translation of a novel FAPI dimer [68Ga]Ga-LNC1013 (SNMMI 2024) - "The lead compound, 68Ga -LNC1013, was then labeled with 177Lu in a biodistribution study against the FAPI monomer, 177Lu-FAPI-46, measured with a γ-counter. Dimerization is an effective strategy to produce FAPI derivatives with favorable tumor uptake, long tumor retention, and imaging contrast over their monomeric counterparts. We demonstrated that LNC1013, the lead compound without piperazine moiety, had superior diagnostic potential when labeled with 68Ga over 68Ga-FAPI-46 and 18F-FDG. A preliminary experiment with 177Lu suggests extended retention of dimer in HT-1080 tumor-bearing mice model and implies its potential for radioligand therapy of FAP-positive cancers."

Clinical • Esophageal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Pancreatic Cancer • Solid Tumor • FAP

Clinical translation of a novel FAPI dimer [68Ga]Ga-LNC1013 (SNMMI 2024) - "The lead compound, 68Ga -LNC1013, was then labeled with 177Lu in a biodistribution study against the FAPI monomer, 177Lu-FAPI-46, measured with a γ-counter. Dimerization is an effective strategy to produce FAPI derivatives with favorable tumor uptake, long tumor retention, and imaging contrast over their monomeric counterparts. We demonstrated that LNC1013, the lead compound without piperazine moiety, had superior diagnostic potential when labeled with 68Ga over 68Ga-FAPI-46 and 18F-FDG. A preliminary experiment with 177Lu suggests extended retention of dimer in HT-1080 tumor-bearing mice model and implies its potential for radioligand therapy of FAP-positive cancers."

Clinical • Esophageal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Pancreatic Cancer • Solid Tumor • FAP

Clinical translation of a novel FAPI dimer [68Ga]Ga-LNC1013 (SNMMI 2024) - "The lead compound, 68Ga -LNC1013, was then labeled with 177Lu in a biodistribution study against the FAPI monomer, 177Lu-FAPI-46, measured with a γ-counter. Dimerization is an effective strategy to produce FAPI derivatives with favorable tumor uptake, long tumor retention, and imaging contrast over their monomeric counterparts. We demonstrated that LNC1013, the lead compound without piperazine moiety, had superior diagnostic potential when labeled with 68Ga over 68Ga-FAPI-46 and 18F-FDG. A preliminary experiment with 177Lu suggests extended retention of dimer in HT-1080 tumor-bearing mice model and implies its potential for radioligand therapy of FAP-positive cancers."

Clinical • Esophageal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Pancreatic Cancer • Solid Tumor • FAP

Clinical translation of a novel FAPI dimer [68Ga]Ga-LNC1013 (SNMMI 2024) - "The lead compound, 68Ga -LNC1013, was then labeled with 177Lu in a biodistribution study against the FAPI monomer, 177Lu-FAPI-46, measured with a γ-counter. Dimerization is an effective strategy to produce FAPI derivatives with favorable tumor uptake, long tumor retention, and imaging contrast over their monomeric counterparts. We demonstrated that LNC1013, the lead compound without piperazine moiety, had superior diagnostic potential when labeled with 68Ga over 68Ga-FAPI-46 and 18F-FDG. A preliminary experiment with 177Lu suggests extended retention of dimer in HT-1080 tumor-bearing mice model and implies its potential for radioligand therapy of FAP-positive cancers."

Clinical • Esophageal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Pancreatic Cancer • Solid Tumor • FAP

Preclinical Evaluation of 68Ga/177Lu labeled novel FAP-targeted peptide for tumor radionuclide imaging and therapy (SNMMI 2024) - "In therapeutic studies, 177Lu-FAP-HXN showed significant antitumor activity in HEK-293-FAP tumors at well-tolerated doses, which also exhibited longer tumor retention and better tumor growth delay in comparison to FAP-2286. Preclinical studies show that radiolabeled FAP-HXN had high tumor uptake and retention, as well as potent efficiency in HEK-293-FAP tumors. FAP-HXN has the potential as a novel theranostic tracer for clinical translation in FAP-positive tumors."

Preclinical • Oncology • FAP