PSV359 / Perspective Therap - LARVOL DELTA

Perspective Therapeutics Announces Clinical Collaboration and Supply Agreement with Merck to Evaluate [212Pb]PSV359 in Combination with Keytruda (Pembrolizumab) in FAP-α Positive Solid Tumors (GlobeNewswire) - "The agreement supports the evaluation of Perspective’s targeted alpha-particle therapy [212Pb]PSV359 in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy. This combination will be evaluated under an amendment to the Company’s ongoing Phase 1/2a study of [212Pb]PSV359 in patients with certain types of non-small cell lung cancer and colorectal cancer that express fibroblast activation protein alpha (FAP-α) (clinicaltrials.gov identifier NCT06710756). The study has completed enrollment in the first three monotherapy dose cohorts."

Licensing / partnership • Trial status • Colorectal Cancer • Non Small Cell Lung Cancer

Cancer-associated fibroblast activation protein in Appalachian women with uterine cervix cancer. (PubMed, Front Oncol) - P1/2 | "Cancer-associated fibroblast FAP immunoreactivity in this series indicates that [212Pb]Pb-PSV-359 radiopharmaceutical therapy might have usefulness in women with persistent, recurrent or metastatic uterine cervix cancer. A phase I clinical trial inclusive of metastatic uterine cervix cancer patients is underway (NCT06710756)."

Journal • Cervical Cancer • Oncology • Solid Tumor • Uterine Cancer • FAP

A phase I/IIa, image-guided, alpha-particle therapy study of [ 203 Pb]Pb-PSV359 and [ 212 Pb]Pb-PSV359 in patients with solid tumors that are known to be fibroblast activation protein (FAP)–positive. (ASCO 2026) - P1/2 | "The dose levels of 2.5 and 5 mCi [²¹²Pb]Pb-PSV359 were found to be safe without DLTs. Dose-escalation is ongoing."

Clinical • First-in-human • P1/2 data • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • FAP

Lead-it-EAZY 2.0 - GMP-compliant synthesis of [212Pb]Pb-PSV-359 and challenges in quality control (SNMMI 2026) - "The Lead-it-EAZY (LAZY) process demonstrated stability and robustness over six radiosyntheses, yielding sterile [212Pb]Pb-PSV-359 in high purity for cell experiments and patient application. The in vitro study of the synthesized compound exhibited a high degree of specificity in binding and internalizing on U-87MG cells. In addition, a dose-dependent increase in double-strand breaks and a decrease in overall survival were observed."

Nephrology • Renal Disease • FAP

Lead-it-EAZY 2.0 - GMP-compliant synthesis of [212Pb]Pb-PSV-359 and challenges in quality control (SNMMI 2026) - "The Lead-it-EAZY (LAZY) process demonstrated stability and robustness over six radiosyntheses, yielding sterile [212Pb]Pb-PSV-359 in high purity for cell experiments and patient application. The in vitro study of the synthesized compound exhibited a high degree of specificity in binding and internalizing on U-87MG cells. In addition, a dose-dependent increase in double-strand breaks and a decrease in overall survival were observed."

Nephrology • Renal Disease • FAP

Clinical Highlights: PSV359 (GlobeNewswire) - "Two patients in Cohort 1 had been treated with [²¹²Pb]PSV359 at 2.5mCi and one patient in Cohort 2 had been treated at 5.0mCi, for a total of three patients as of October 31, 2025. Activation activities are underway for additional sites."

Trial status • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Mesothelioma • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Sarcoma

A FAP-Directed Theranostic Approach Using [ 203 Pb]/[ 212 Pb]Pb-PSV359: Design of a First-in-Human Phase I/IIa Clinical Trial (EANM 2025) - No abstract available

Clinical • First-in-human • P1/2 data • Oncology

Perspective Therapeutics…announced that the first patient was treated with [212Pb]PSV359 in a second cohort of the Company’s Phase 1/2a dose-finding trial to determine safety and preliminary anti-tumor activity of the radiopharmaceutical [212Pb]PSV359 in patients with solid tumors that express fibroblast activation protein alpha (FAP-α) (GlobeNewswire) - "Patients in this cohort are receiving [212Pb]PSV359 at 5.0 mCi for up to four doses every eight weeks. The Safety Monitoring Committee (SMC) recommended evaluating [212Pb]PSV359 at a higher dose based on its review of two patients dosed with [212Pb]PSV359 at 2.5 mCi alone."

DSMB • Trial status • Solid Tumor

Preclinical evaluation and first-in-human case of [68Ga]Ga-PSV377, a novel cyclic radiopeptide targeting fibroblast activation protein, for positron emission tomography (PET) imaging of multiple cancers (SNMMI 2025) - P1/2 | "Superior binding affinity of PSV377 to FAP (Ki=0.17 nM) was observed in vitro. In HT1080-FAP cells, compared with [68Ga]Ga-FAPI04, significantly higher uptake of [68Ga]Ga-PSV377 was found at all time points (3.3-fold at 0.5 h,11.9-fold 4 h), with minimal uptake in FAP-negative HT1080WT, indicating high binding specificity of [68Ga]Ga-PSV377. The ex vivo biodistribution study of [67Ga]Ga-PSV377 demonstrated rapid and high uptake of the tracer in HT1080-FAP xenografts in mice with sustained tumor retention (15.1 %ID/g at 1 h and 13.8 %ID/g at 24 h). Micro-PET/CT imaging of [68Ga]Ga-PSV377 demonstrated high tumor uptake, with fast clearance from background, and minimal retention in kidneys (and other organs). In FIH case, compared with standard 18F-FDG, [68Ga]Ga-PSV377demonstrated higher uptake in most primary and metastatic lesions, with minimal absorption in kidneys, the most common dose-limiting organ..."

P1 data • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FAP

Preclinical evaluation and first-in-human case of [68Ga]Ga-PSV377, a novel cyclic radiopeptide targeting fibroblast activation protein, for positron emission tomography (PET) imaging of multiple cancers (SNMMI 2025) - P1/2 | "Superior binding affinity of PSV377 to FAP (Ki=0.17 nM) was observed in vitro. In HT1080-FAP cells, compared with [68Ga]Ga-FAPI04, significantly higher uptake of [68Ga]Ga-PSV377 was found at all time points (3.3-fold at 0.5 h,11.9-fold 4 h), with minimal uptake in FAP-negative HT1080WT, indicating high binding specificity of [68Ga]Ga-PSV377. The ex vivo biodistribution study of [67Ga]Ga-PSV377 demonstrated rapid and high uptake of the tracer in HT1080-FAP xenografts in mice with sustained tumor retention (15.1 %ID/g at 1 h and 13.8 %ID/g at 24 h). Micro-PET/CT imaging of [68Ga]Ga-PSV377 demonstrated high tumor uptake, with fast clearance from background, and minimal retention in kidneys (and other organs). In FIH case, compared with standard 18F-FDG, [68Ga]Ga-PSV377demonstrated higher uptake in most primary and metastatic lesions, with minimal absorption in kidneys, the most common dose-limiting organ..."

P1 data • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FAP

Preclinical evaluation and first-in-human case of [68Ga]Ga-PSV377, a novel cyclic radiopeptide targeting fibroblast activation protein, for positron emission tomography (PET) imaging of multiple cancers (SNMMI 2025) - P1/2 | "Superior binding affinity of PSV377 to FAP (Ki=0.17 nM) was observed in vitro. In HT1080-FAP cells, compared with [68Ga]Ga-FAPI04, significantly higher uptake of [68Ga]Ga-PSV377 was found at all time points (3.3-fold at 0.5 h,11.9-fold 4 h), with minimal uptake in FAP-negative HT1080WT, indicating high binding specificity of [68Ga]Ga-PSV377. The ex vivo biodistribution study of [67Ga]Ga-PSV377 demonstrated rapid and high uptake of the tracer in HT1080-FAP xenografts in mice with sustained tumor retention (15.1 %ID/g at 1 h and 13.8 %ID/g at 24 h). Micro-PET/CT imaging of [68Ga]Ga-PSV377 demonstrated high tumor uptake, with fast clearance from background, and minimal retention in kidneys (and other organs). In FIH case, compared with standard 18F-FDG, [68Ga]Ga-PSV377demonstrated higher uptake in most primary and metastatic lesions, with minimal absorption in kidneys, the most common dose-limiting organ..."

P1 data • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FAP

Lead-212 PSV359 Therapy for Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=112 | Recruiting | Sponsor: Perspective Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Perspective Therapeutics Announces First Patient Dosed with PSV359 in a Phase 1/2a Study in Patients with FAP-α Positive Solid Tumors (GlobeNewswire) - "Perspective Therapeutics, Inc...announced today that the first patient was treated with ^[212Pb]PSV359 in a Phase 1/2a dose-finding trial to determine safety and preliminary anti-tumor activity of the radiopharmaceutical ^[212Pb]PSV359 in patients with solid tumors that express fibroblast activation protein alpha (FAP-α)."

Trial status • Oncology • Solid Tumor

Perspective Therapeutics Provides Recent Business Highlights and Reports Full Year 2024 Results (GlobeNewswire) - "The FDA has completed its review of the investigational new drug application (IND) for PSV359, and issued a 'study may proceed' letter in 1Q 2025. Site activation activities are underway, with the study expected to initiate dosing in mid-2025."

IND • New trial

Lead-212 PSV359 Therapy for Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=112 | Not yet recruiting | Sponsor: Perspective Therapeutics

New P1/2 trial • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

[212Pb]Pb-PSV359 (GlobeNewswire) - "The findings of the study demonstrated that [212Pb]Pb-PSV359 exhibits strong binding affinity (Kd=1.8 nM, Ki=0.4 nM) and selectivity for hFAP. Preclinical biodistribution and imaging studies revealed strong tumor uptake of [212Pb]Pb-PSV359 with fast renal clearance and low background in off-target tissues. Furthermore, strong anti-tumor efficacy of [212Pb]Pb-PSV359 was found in both HT1080-hFAP (FAP on cancer cells) and U87MG (FAP in stromal tissues) xenograft models."

Preclinical • Oncology • Solid Tumor

Preclinical evaluation and first-in-human imaging of [203/212Pb]Pb-PSV359, a novel cyclic peptide targeting fibroblast activation protein-alpha (FAP) (EANM 2024) - "A novel radiopharmaceutical targeting FAP, PSV359, exhibits superior binding affinity, binding specificity, and in vivo tumor targeting in preclinical and clinical settings. Strong anti-tumor efficacy of [212Pb]Pb-PSV359 was found in both HT1080-hFAP and U87MG xenograft models."

P1 data • Preclinical • Lung Adenocarcinoma • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • FAP

Perspective Therapeutics Announces Pricing of $80 Million Underwritten Offering of Common Stock and Pre-Funded Warrants (GlobeNewswire) - "Perspective Therapeutics, Inc...announced the pricing of an underwritten offering of 51,515,880 shares of its common stock at an offering price of $1.51 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 1,464,252 shares of its common stock at a price of $1.509 per pre-funded warrant....Perspective intends to use the net proceeds that it will receive from the offering for: (i) the continued clinical development of VMT-α-NET, VMT-01/02 and PSV359; (ii) the continued development of PSV40X and additional preclinical product candidates as well as broader development platform; and (iii) the build out, operation and expansion of manufacturing facilities, as well as for working capital and other general corporate purposes."

Financing • Oncology • Solid Tumor

Perspective Therapeutics to Present at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting 2024 (GlobeNewswire) - "The Company will present preclinical data for [212Pb]VMT01, a targeted α-particle radionuclide therapy (α-TRT) targeting the melanocortin 1 receptor ('MC1R'), used in combination with immune checkpoint inhibitors ('ICIs') in diverse murine melanoma models with high (B16-F10), mid (YUMM-D3) and low (YUMMwt) expressions of MC1R....The final presentation will introduce [203/212Pb]-PSV-359, a novel cyclic peptide developed to target fibroblast activation protein alpha ('FAP'), a protein abundantly expressed by cancer-associated fibroblasts in tumor lesions and involved in promoting disease progression."

Preclinical • Melanoma • Oncology • Skin Cancer • Solid Tumor