QSAM Biosciences, Inc. is developing next generation nuclear medicines for the treatment of cancer and related diseases and conditions.
QSAM’s initial technology is Samarium-153 DOTMP, aka CycloSam®, a clinical-staged bone targeting radiopharmaceutical? developed by IsoTherapeutics Group LLC, leaders in the nuclear medicine space who also developed FDA-approved and commercially available Quadramet® (Samarium-153 EDTMP), indicated for pain palliation. CycloSam was assigned to IsoTherapeutics Group’s subsidiary, IGL Pharma, Inc.
CycloSam® has already demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared successful human trial performed in 2020. This nuclear technology uses low specific activity Samarium-153 (resulting in far less europium) and DOTMP, a chelator which is believed to eliminate off-target migration and targets sites of high bone turn over making it an ideal agent to treat osteosarcoma or other bone metastases. Osteosarcoma is the most common malignant bone tumor among children and adolescents. Because of its ability to deliver radiation to the skeletal system, it is also believed to be an effective agent to perform bone marrow ablation as pre-conditioning for bone marrow transplantation. This drug candidate utilizes an FDA approved radioisotope combined with a novel chelant that has demonstrated increased efficacy and decreased side effects in animal models. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process. Given these factors, management believes there is a strong pathway to commercialization.
CycloSam® is cleared by the FDA under an investigator initiated IND to commence human dosing immediately in patients with osteosarcoma and bone metastasis. CycloSam® was also cleared by FDA and successfully used under a single-patient IND to perform bone marrow ablation prior to allogenic marrow transplantation (BMA/T) in 2020.
The overall market for Radiopharmaceuticals is expected to exceed US$6.1 billion. The rising prevalence of cancer and cardiovascular diseases are the main factors driving the radiopharmaceuticals market.
QSAM Biosciences, Inc. (“QSAM”) is comprised of industry experts formed to acquire the rights to and seek commercialization of Samarium-153 DOTMP, aka CycloSam®, a bone targeting radiopharmaceutical? from IsoTherapeutics Group.
IsoTherapeutics’ scientists, leaders in the development of radiopharmaceuticals, also developed FDA approved and commercially released Quadramet® (Samarium-153 EDTMP), indicated for pain palliation.
CycloSam® shares the same FDA approved radioisotope as Quadramet®, but utilizes a novel chelate that had demonstrated preliminary increased efficacy and decreased side effects in animal models.
CycloSam® is cleared by the FDA under an investigator IND to commence human dosing immediately in patients with osteosarcoma and bone metastasis.
The study protocol, Principal Investigator, 1 clinical site and manufacturing plan are all finalized and the clinical trial is ready to commence. Additional sites are proposed to be coming online in the coming months to participate in the clinical trial.
CycloSam® is also cleared by the FDA under a second single-patient IND to perform bone marrow ablation prior to allogenic marrow transplantation (BMA/T).
Fifteen (15) patents under prosecution in the US and internationally; two of which have been issued.