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Phase 1 cross over biodistribution study of [203Pb]VMT01 for single photon emission computed tomography (SPECT) and [68Ga]VMT02 for positron emission tomography (PET) imaging of stage 4 melanoma

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA203430-02A1
Agency Tracking Number: R44CA203430
Amount: $1,982,028.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA18-573
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-20
Award End Date (Contract End Date): 2021-08-31
Small Business Information
1127 WILD PRAIRIE DR
Iowa City, IA 52246-8707
United States
DUNS: 830356262
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 FRANCES JOHNSON
 (319) 321-5582
 frances-johnson@viewpointmt.com
Business Contact
 HEYWARD COLEMAN
Phone: (843) 860-6553
Email: hhcolem@hotmail.com
Research Institution
N/A
Abstract

SIGNIFICANCE: Melanoma incidence is rising faster than any other cancer and metastatic melanoma is typically
fatal. Responses to targeted and immunotherapies can be remarkable, but low response rates, acquired
resistance, and adverse side effects limit long-term quality of life for these patients. The overall response rate to
all therapies remains dismally near 50% and the 5-year survival is andlt;25%. Preclinical studies have identified
radiolabeled peptides that target the melanocortin receptor 1 (MC1R) as a potential therapeutic alternative. While
this approach using -particle emitters has been largely ineffective preclinically, previous publications and our
Phase I data have demonstrated efficacy of Viewpoint’s MC1R-targeted VMT01 -particle therapy in mice
bearing melanoma tumors. Thus, VMT01 is designed to meet the significant unmet medical need to improve
outcomes for these patients (initial indication of progressive stage 4 metastatic melanoma), with potential for
expanded indications in combination with FDA-approved melanoma drugs (e.g., immunotherapies). In this
revised Phase II SBIR project, Viewpoint will complete a Phase 1 first-in-human clinical trial to determine the
safety of its companion diagnostics. It is further expected that the company will have gained a preliminary
understanding of the effectiveness of [68Ga]VMT02 imaging (PET) to identify MC1R positive tumors and the utility
of [203Pb]VMT01 imaging (SPECT) for performing patient dosimetry for personalized [212Pb]VMT01 -therapy.
PREDICATE PHASE I MILESTONES include: efficacy (therapy and imaging) in mice; pharm/tox of lead
VMT01; automated radiopharmaceutical production with GMP kits; exclusive licenses to IP; clinical consortium
with Mayo Clinic and 203Pb supply with Lantheus Medical Imaging; CRO for statistics/clinical data (Compleware,
Inc.); and a radiopharmacy partner (Hotshots Nuclear Medicine) for manufacturing/distribution of [203Pb]VMT01.
EQUITY INVESTMENTS: Viewpoint has secured $650,000 in equity investment to establish manufacturing of
212Pb generators for future clinical therapy trials. The company will complete the following Aims toward its goals.
AIM 1. Secure FDA “safe to proceed” designation to conduct the Phase 1 imaging trial of [203Pb]VMT01
and [68Ga]VMT02 under IND.
AIM 2. Complete a Phase 1 safety and biodistribution study of [203Pb]VMT01 and [68Ga]VMT02 imaging in
human subjects and demonstrate their utility for identifying MC1R positive tumors and performing
patient-specific dosimetry.
OUTCOMES: We expect to demonstrate the clinical safety of [203Pb]VMT01 and [68Ga]VMT02. We further expect
to develop preliminary understanding of the efficacy of [68Ga]VMT02 PET/CT to identify MC1R+ tumors and the
utility of [203Pb]VMT01 SPECT/CT for patient-specific dosimetry for [212Pb]VMT01 -therapy. Thus, we will be
prepared to initiate dosimetry-based trials of [212Pb]VMT01 -particle therapy for metastatic melanoma to be
funded under Phase IIB SBIR studies and Phase III equity investments.This project aims to complete a Phase 1 trial of companion diagnostics that would be used for patient selection
and dosimetry for an radionuclide therapy for metastatic melanoma. No other agents are available for this aim.

* Information listed above is at the time of submission. *

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