QSAM Biosciences Inc., a clinical stage biotechnology company developing next-generation therapeutic radiopharmaceuticals, and RLS (USA) Inc., the third-largest nuclear medicine pharmacy network in the U.S., entered into a commercial supply and clinical dose preparation agreement for the therapeutic radiopharmaceutical drug candidate CycloSam (Samarium-153 DOTMP), a promising clinical-stage treatment for metastatic and primary bone cancer in adults and children.

QSAM is actively enrolling patients with metastatic bone cancer in a Phase I clinical trial for CycloSam across three clinical sites in the U.S. with additional sites planned. The RLS agreement allows for the rapid and efficient preparation of CycloSam doses, under strict industry quality control systems, for patient administration in the current and future clinical trials with an option to expand to commercial scale if CycloSam is ultimately approved by the FDA.

“We believe the short half-life of Samarium-153 with respect to patient exposure, toxicity and tolerability makes it an ideal drug to treat bone cancers,” said Douglas Baum, CEO and co-founder of QSAM. “The ability to meet the potential demand requires a pharmacy network capable of preparing and timely delivering patient doses for administration. The RLS network of 31 radiopharmacies across 18 states adds significant geographic coverage and infrastructure to our supply chain, along with an unprecedented level of on-the-ground expertise and credibility as the only accredited radiopharmacy network in the country.”

Baum added, “Choosing RLS as a partner will not only bolster our current and near-term clinical trials, but it may also provide the initial groundwork for eventual commercial supply and distribution.”

Samarium-153 (Sm-153) is a beta-emitting radioisotope that carries radiation designed and intended to disrupt tumor cell metabolism and cause cancer cell death. With a short 46-hour radiation half-life, Sm-153, in combination with the bone-seeking chelant DOTMP that significantly limits unwanted off-target migration of radiation to nearby healthy tissues, represents a potentially highly effective bone cancer treatment.

The RLS agreement is expected to support QSAM’s clinical research and potential future commercial use of CycloSam.

Stephen Belcher, CEO of RLS, said, “RLS is proud to partner with the talented management team at QSAM in support of these important clinical trials. With this announcement, we are deepening our commitment to building a world-class CDMO and clinical trial business and serving as a trusted, reliable partner for companies like QSAM developing the next generation of nuclear therapies.”