On September 9, 2021 Viewpoint Molecular Targeting, Inc., a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application (IND) to commence a Phase I imaging study of VMT–NET for imaging of neuroendocrine tumors (NETs) (Press release, Viewpoint Molecular Targeting, SEP 9, 2021, https://viewpointmt.com/viewpoint-molecular-targetingtm-receives-fda-clearance-of-investigational-new-drug-application-for-phase-1-imaging-study-for-vmt-a-net-for-neuroendocrine-tumors/ [SID1234587507]). The Phase I imaging study is an investigator-initiated study that will be conducted at the University of Iowa Hospitals and Clinics.

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The Phase I imaging study will evaluate [203Pb]VMT–NET as an agent for imaging somatostatin receptor subtype 2 (SSTR2)-positive neuroendocrine tumors. The images obtained will inform future therapeutic trials of [212Pb]VMT–NET alpha-particle therapy for this tumor type. In parallel to this investigator initiated imaging trial, the Company plans to move forward with a Phase I/IIa therapy study of VMT–NET for the treatment of neuroendocrine tumors.

"We are incredibly pleased that our second product has received IND clearance from the FDA, allowing our collaborators at the University of Iowa to proceed with another first-in-human Phase I imaging study. We continue to be encouraged by the preclinical results demonstrated to date, that show the promise of treating this disease with targeted alpha-particle therapy. With this milestone now achieved, Viewpoint together with the team at the University of Iowa is excited to progress toward enrollment and provisional results in our imaging study over the remainder of this year," commented Frances L. Johnson, MD, Chief Executive Officer and Co-Founder of Viewpoint Molecular Targeting.

Preclinical data seen to-date provides strong evidence that the VMT–NET image-guided approach can be an effective therapy with a promising toxicity profile. Supported by over $4 million in the form of Small Business Innovation Research grants and R01 academic research grants from the NCI to advance this treatment, VMT–NET is well-positioned to apply the new transformative power of alpha-particle treatment to NET tumors and other cancers that express the SST2R biomarker.

Neuroendocrine tumors are rare forms of cancers that occur most commonly in the pancreas or other areas of the gut such as the stomach, small intestine, rectum, colon, or appendix. A neuroendocrine tumor may grow slowly or aggressively and spread to other parts of the body. Diagnosis and treatment of neuroendocrine tumors depend on the type of tumor, its location, whether it produces excess hormones, how aggressive it is and whether it has spread to other parts of the body. Some approaches may include surgery, radiation, and chemotherapy.