On June 10, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported it has initiated patient enrollment and screening in its Phase 1 imaging study evaluating VMT01 for the treatment of metastatic melanoma (Press release, Viewpoint Molecular Targeting, JUN 10, 2021, https://viewpointmt.com/viewpoint-molecular-targeting-commences-patient-enrollment-in-phase-1-imaging-study-for-vmt01-program-for-metastatic-melanoma/ [SID1234585490]).

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Melanoma is a cancer of the skin and the most aggressive form of skin cancer. While a disease that is identified early (when confined to the outer layers of the skin) can be cured by surgery, melanoma that migrates to distant sites in the body (metastatic melanoma) is difficult to treat. Despite the introduction of new treatments for metastatic melanoma, according to the American Cancer Society, the five-year survival is approximately 25%.

"The start of the VMT01 imaging study represents a significant milestone for the Company. The study tests Viewpoint’s investigational imaging agents in subjects with advanced melanoma to accelerate therapeutic drug development and enable image-guided treatment. We are pleased to be working alongside Mayo Clinic to advance this novel theranostic approach to radiopharmaceutical therapy against metastatic melanoma," commented Frances L. Johnson, MD, Chief Executive Officer and Co-Founder of Viewpoint Molecular Targeting. "Based on the extremely encouraging preclinical data seen to date, we believe that our targeted alpha-particle therapies have the potential to significantly enhance treatment responses in 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. Following the results of the imaging trial, the Company plans to initiate a multisite Phase 1/2a therapy study of VMT01 for the treatment of metastatic melanoma.

Viewpoint’s VMT01 program is intended to address an unmet clinical need with the use of a new imaging agent to guide Viewpoint’s radiopharmaceutical therapy against metastatic melanoma. This image-guided approach is often referred to as "theranostics." Using information guided by the low-risk medical imaging scan, a treatment plan utilizing the VMT01 ligand is designed to deliver the power of alpha-particle radiation specifically to melanoma tumors, while minimizing risk to unaffected organs and tissues. VMT01 represents a unique way to treat metastatic melanoma that has been vetted as scientifically sound by rigorous peer review and has the potential to be transformative for melanoma patients.