VMT-01 / Perspective Therap - LARVOL DELTA

MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=264 | Recruiting | Sponsor: Perspective Therapeutics | Trial completion date: Jun 2027 ➔ Dec 2029 | Trial primary completion date: Jun 2025 ➔ Dec 2027

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • BRAF

MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=264 | Recruiting | Sponsor: Perspective Therapeutics | N=52 ➔ 264

Combination therapy • Enrollment change • Metastases • Monotherapy • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • BRAF

FDA Grants Fast Track Designation to VMT01 for Unresectable/Metastatic MC1R+ Melanoma (OncLive) - "The FDA has granted fast track designation to the development of the targeted alpha-particle therapy (212Pb) VMT01 for the diagnosis and treatment of patients with unresectable or metastatic melanoma, as well as those who have demonstrated melanocortin 1 receptor (MC1R) expression, Perspective Therapeutics announced in a news release....VMT01 was previously evaluated in a completed pilot imaging study at the Mayo Clinic, in Rochester, Minnesota, and is currently being evaluated in a phase 1/2a study (NCT05655312)."

Evidence highlight • Fast track • Melanoma • Oncology • Skin Cancer • Solid Tumor • MC1R

Low-dose [212Pb]VMT01 targeted alpha-particle therapy cooperates with immune checkpoint inhibitors to induce robust tumor responses in a heterogeneous melanoma model in mice. (SNMMI 2024) - "Strong cooperative anti-tumor effect between [212Pb]VMT01 α-TRT and ICIs was observed in single and heterogeneous murine melanoma allograft models. Induction of this cooperative effect can be observed with 2 Gy of alpha-ration in tumor. Ongoing studies are focused on analyzing dynamic changes in innate and adaptive immunity, as well as T-cell populations in response to [212Pb]VMT01 treatments."

Checkpoint inhibition • Heterogeneity • Preclinical • Melanoma • Oncology • Solid Tumor • CTLA4 • PD-1

A phase I/IIa of [ 212 Pb]VMT01 targeted a-particle therapy for unresectable or metastatic melanoma. (ASCO 2024) - P1/2 | "An interim futility evaluation may be performed after ~10 participants in the dose escalation phase for participants who have completed their first post-treatment response assessment. The trial is open for recruitment."

Metastases • P1/2 data • Genetic Disorders • Melanoma • Oncology • Solid Tumor • MC1R

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

Dosing Complete in First Phase of Trial Evaluating [212Pb]VMT-α-NET for NETs (Targeted Oncology) - "'We are grateful to our collaborator, Nikolaos Trikalinos, MD...ensures that patients can access our potentially life-changing therapeutic. With both of our investigational therapies, [212Pb]VMT-alpha;-NET and [212Pb]VMT01, now having completed their first cohorts, we look forward to generating data at higher doses early in 2024,' added Puhlmann in a press release."

Media quote

Perspective Therapeutics Announces Clinical Collaboration Agreement with Bristol Myers Squibb to Evaluate [(212)Pb]VMT01 in Combination with Nivolumab in MC1R-Positive Metastatic Melanoma (GlobeNewswire) - "Perspective Therapeutics...today announced a clinical trial collaboration agreement with Bristol Myers Squibb...to evaluate the safety and tolerability of Perspective’s targeted alpha-particle therapy [212Pb]VMT01 in combination with Bristol Myers Squibb’s nivolumab in patients with histologically confirmed melanoma and positive melanocortin 1 receptor (MC1R) imaging scans. This combination study is an amendment to the Company’s ongoing Phase1/2a study of [212Pb]VMT01 in patients with metastatic melanoma. The study has completed enrollment in the first cohort and has commenced dosing in the second cohort. Under the terms of the collaboration, Perspective will sponsor and fund the combination study and Bristol Myers Squibb will provide nivolumab for use in the study."

Enrollment status • Licensing / partnership • Melanoma

Perspective Therapeutics Completes Recruitment for First Patient Cohort in Phase 1/2a Dose Escalation Trial of VMT01 in Malignant Melanoma (GlobeNewswire) - "Perspective Therapeutics, Inc...today announced the completion of recruitment for the first patient cohort in its Phase 1/2a dose escalation study of 212Pb-VMT01...its targeted alpha-particle therapy, in development for the treatment of MC1R-positive metastatic melanoma."

Enrollment closed • Melanoma • Oncology • Skin Cancer • Solid Tumor

Perspective Therapeutics Begins Dosing in Phase 12a Trial of VMT01 for MC1RPositive Metastatic Melanoma (Best Stocks) - "Perspective Therapeutics...has recently made a groundbreaking announcement on August 11, 2023. They have successfully administered the first dose of VMT01, their innovative targeted alpha-particle therapy (TAT), to a patient participating in the Phase 1/2a dose escalation trial. This trial aims to revolutionize the treatment of MC1R-positive metastatic melanoma, a challenging and life-threatening form of cancer."

Trial status • Melanoma • Oncology • Skin Cancer • Solid Tumor

MC1R-targeted Alpha-particle Therapy Trial in Adults With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=52 | Recruiting | Sponsor: Viewpoint Molecular Targeting | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • BRAF

Perspective Therapeutics Initiates Phase 1/2a Clinical Trials for Two Targeted Alpha Therapy Oncology Product Candidates (GlobeNewswire) - "Perspective Therapeutics, Inc...announced that it has initiated clinical trial sites and commenced the enrollment period for its 212Pb-labeled therapeutic product candidates, VMT-α-NET and VMT01....Investigators at Fortis Memorial Research Institute (FMRI) located in Gurgaon, India are excited about initial patient experiences in their investigator initiated compassionate use of VMT-α-NET, results of which are expected to be presented at a major medical meeting in Q3 of 2023....Preliminary results from the initial cohorts for both trials are expected to be available by the end of 2023."

P1/2 data • Trial status • Eye Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Mucosal Melanoma • Neuroendocrine Tumor • Ocular Melanoma • Oncology • Pancreatic Cancer • Skin Cancer • Solid Tumor • Uveal Melanoma

MC1R imaging and histology in the targeted imaging of melanoma for alpha-particle radiotherapy (TIMAR1) trial (AACR 2023) - "A subgroup of advanced melanoma patients were identified to express MC1R using new MC1R-targeted imaging agents. Full concordance between imaging and IHC of positive scans, but not with negative scans, suggests that IHC is a more sensitive biomarker detection method. Additional testing is needed to establish frequency of positive MC1R imaging in stage IV melanoma and its correlation to histological findings and treatment outcomes."

Melanoma • Oncology • Solid Tumor • MC1R

MC1R-targeted Alpha-particle Therapy Trial in Adults With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=52 | Not yet recruiting | Sponsor: Viewpoint Molecular Targeting | Initiation date: Dec 2022 ➔ Jun 2023

Trial initiation date • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • BRAF

Perspective Therapeutics and PharmaLogic announce collaboration for the development and production of theranostics for cancer care (PRNewswire) - "PharmaLogic Holdings Corp...announces the signature of a Master Services Agreement with Viewpoint Molecular Targeting, Inc., a wholly-owned subsidiary of Perspective Therapeutics, Inc...for the development and production of theranostic candidates VMT-01 and VMT-α-NET....Under the terms of the agreement, PharmaLogic will produce and supply doses of VMT-01 and VMT-α-NET for use in Perspective's early-stage clinical trials."

Licensing / partnership • Melanoma • Neuroendocrine Tumor • Oncology • Skin Cancer • Solid Tumor

MC1R-targeted Alpha-particle Therapy Trial in Adults With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=52 | Not yet recruiting | Sponsor: Viewpoint Molecular Targeting

Metastases • New P1/2 trial • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • BRAF

Dosimetry of [Pb]VMT01, a MC1R-Targeted Alpha Therapeutic Compound, and Effect of Free Tl on Tissue Absorbed Doses. (PubMed, Molecules) - "Absorbed doses from free Tl result in a percent increase of no more than 1.2% over [Pb]VMT01 in any organ or tissue. This latter finding indicates that free Tl in the [Pb]VMT01 injectate will not substantially impact estimated tissue absorbed doses in humans."

Journal • Melanoma • Oncology • Solid Tumor

Viewpoint Molecular Targeting(R) Presents Preclinical Data from VMT-𝛼-NET, Theranostic in Development for the Treatment and Diagnosis of Neuroendocrine Tumors, at the Pacifichem 2021 Congress (Yahoo Finance) - "[212Pb]VMT-alpha-NET therapy was effective and well-tolerated in mice (renal injury biomarkers NGAL' CREA), achieving a 70% complete response rate in tumor bearing mice....The Company plans to move forward with a Phase 1/2a therapy study of VMT-𝛼-NET for the treatment of neuroendocrine tumors."

New P1/2 trial • Preclinical • Neuroendocrine Tumor • Oncology

Targeted Alpha-Particle Radiotherapy and Immune Checkpoint Inhibitors Induces Cooperative Inhibition on Tumor Growth of Malignant Melanoma. (PubMed, Cancers (Basel)) - "Enhanced tumor infiltrating CD3, CD4, CD8 lymphocytes were observed following injection of 1.4 MBq [Pb]VMT01. Overall, we demonstrated anti-tumor cooperation between α-TRT and ICIs in melanoma that is mediated by tumor specific immunity."

Checkpoint inhibition • Journal • Immune Modulation • Immunology • Inflammation • Melanoma • Oncology • Solid Tumor • CD4 • CD8

Viewpoint Molecular Targetin(TM) Commences Patient Enrollment in Phase 1 Imaging Study for VMT01 Program for Metastatic Melanoma (Issuer Direct) - “Viewpoint Molecular Targeting…announced it has initiated patient enrollment and screening in its Phase 1 imaging study evaluating VMT01 for the treatment of metastatic melanoma…The Phase 1 first-in-human, crossover design study of Positron Emission Tomography (PET) and Single-Photon Emission Computerized Tomography (SPECT) scanning will enroll approximately 10 subjects with Stage III/IV unresectable melanoma. The primary endpoint of the study is safety and biodistribution. Secondary endpoints of the study are molecular target validation and image quality. The current VMT01 Phase 1 imaging study is being conducted at Mayo Clinic in Rochester, MN, and a future therapy study is planned. Provisional results for the imaging study are targeted for Q4 2021.”

Enrollment status • P1 data • Melanoma • Oncology • Skin Cancer

TIMAR1: Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: Viewpoint Molecular Targeting

New P1 trial • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

Viewpoint Molecular Targeting(TM) Presents Positive Preclinical Results of VMT01 at the 10th World Congress of Melanoma (Issuer Direct) - “Viewpoint Molecular Targeting…announced additional positive preclinical results from its [212Pb] VMT01 program currently in development for the treatment of metastatic melanoma. These results were presented at the virtual 10th World Congress of Melanoma held April 15 - 17, 2021…The data from the study demonstrated high expression of MC1R in human melanoma biopsy samples as well as in melanoma cancer cell lines. The expression of MC1R in normal tissues is largely absent…Combination of [212Pb] VMT01 and immune checkpoint inhibitors induced a synergistic anti-tumor effect and 43% (3/7) complete tumor response. Animals with complete tumor responses also developed anti-tumor immunity to reject further tumor cell challenge (i.e., subcutaneous naïve cancer cell implants).”

Preclinical • Melanoma • Oncology • Skin Cancer

Viewpoint Molecular Targeting(TM) Presents Positive Preclinical Results of VMT01 at the 2021 American Association for Cancer (AACR) Annual Meeting (Issuer Direct) - “Viewpoint Molecular Targeting…announced positive preclinical results…at the American Association for Cancer Research (AACR) Annual Meeting, being held virtually from April 10 - 15, 2021…The results from this study indicate that MC1R-targeted therapies, such as peptide receptor radionuclide therapies (PRRT), are a promising alternative to current therapies for metastatic melanoma…these results give us confidence in our specialized MC1R targeting peptide as we prepare to launch our Phase 1 imaging study of VMT01…Provisional results for the VMT01 imaging study are targeted for Q4 2021. Following the results of the imaging trial, the Company plans to initiate a Phase 1/2a therapy study of VMT01 for the treatment of metastatic melanoma.”

New P1/2 trial • P1 data • Preclinical • Melanoma • Oncology • Skin Cancer • Solid Tumor