SolaranRx, a privately held biotechnology company developing a new class of precision medicine for the treatment of metastatic melanoma, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health. SolaranRx and the NCI will work together to advance SolaranRx’s Precision Theranostic Platform™ that employs radiopharmaceutical therapies and companion imaging agents for metastatic melanoma, the most lethal form of skin cancer and highly resistant to current therapies.

Under the CRADA, the two parties will jointly evaluate SRX-1177, SolaranRx’s proprietary lead compound in preclinical mouse models of metastatic melanoma. SolaranRx’s technology precisely targets deadly melanoma tumors with its novel radiolabeled peptide that specifically binds to melanocortin-1 (MC1) receptors over-expressed in about 80 percent of human melanomas.

NCI’s Center for Advanced Preclinical Research (CAPR)’s group will work with SolaranRx to achieve the CRADA goals. SolaranRx CEO Les Stewart will serve as the collaborator principal investigator. CAPR conducts comprehensive preclinical studies to evaluate efficacy of therapeutics and diagnostics for human cancers.

“We are very pleased to be working in conjunction with the research team at CAPR led by Dr. Zoe Weaver Ohler, an expert in preclinical cancer models useful for translation to human studies,” Stewart said. “Combining our expertise with that of the NCI through the CRADA will help SolaranRx accelerate the development of our Precision Theranostic Platform for metastatic melanoma.”

Stewart added, “Current immunotherapy treatments for malignant melanoma are effective in only a subset of patients, and a significant number of patients must stop treatment due to side effects. Thus, new therapeutic modalities like SolaranRx’s Precision Theranostic Platform that may be effective in a broader melanoma patient population are greatly needed.”

SolaranRx’ own preclinical studies have yielded promising results, demonstrating proof-of-concept. Studies in mice show highly specific targeting of melanoma metastases and clear visualization of tumor location. Combining therapeutic and diagnostic radionuclides with its lead peptide has demonstrated superior tumor uptake, no off target effects and reduced renal retention in melanoma mouse models. The merger of therapy and diagnostics creates a unique theranostic product for metastatic melanoma.

NCI CAPR has adapted and optimized a novel Genetically Engineered Mouse-Derived Allograft (GDA) for preclinical study of therapies for primary and metastatic melanoma. This GDA model exhibits melanoma markers and progression pattern relevant to human disease, and allows monitoring of growth and therapeutic responses in primary and metastatic melanoma in the context of a normal immune system. Therefore, it can be used in testing therapies that target cancer cells and/or immune cells in intervention or adjuvant settings.