CycloSam (samarium-153 DOTMP) / Telix - LARVOL DELTA

Telix Doses First Patient in SOLACE Trial for Metastatic Bone Pain (GlobeNewswire) - "SOLACE (Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage bone pain) is an open-label Phase 1 clinical trial enrolling up to 33 patients with advanced cancer that has metastasized to the bony skeleton."

Trial status • Bone Cancer • Solid Tumor

SOLACE: Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

New P1 trial • Musculoskeletal Pain • Oncology • Osteosarcoma • Pain • Solid Tumor

Telix Signs Agreement to Acquire QSAM Biosciences and Its Bone Cancer Targeting Platform (PRNewswire-Asia) - "Telix Pharmaceuticals Limited...announces it has entered into an agreement to acquire QSAM Biosciences...and its lead investigational drug Samarium-153-DOTMP (153Sm-DOTMP)....The purchase price comprises: (i) US$33.1 million (AU$50.8 million) upfront, which is payable in the form of 4,369,914 Telix ordinary shares to be issued at closing, subject to certain cash adjustments (at or after closing) which would be deducted off the upfront value, and (ii) Contingent Value Rights, or performance rights, that represent the right of the holders to receive contingent payments up to US$90 million (AU$138 million) in the aggregate, which are payable in cash and/or in ordinary shares, upon achievement of certain clinical and commercial milestones."

M&A • Solid Tumor

Telix Announces Proposed Acquisition of QSAM Biosciences and Its Lead Therapy Candidate, CycloSam (PRNewswire) - "Telix Pharmaceuticals Limited...announces it has signed a conditional Term Sheet to acquire QSAM Biosciences, Inc. (QSAM) and its lead asset, CycloSam (Samarium-153-DOTMP)....CycloSam is highly synergistic with Telix's existing therapeutic development activity in both prostate cancer and sarcoma.....Upon signing of the Term Sheet, Telix has agreed to pay QSAM an upfront Collaboration and Option Fee of US$2 million (approximately AU$3.1 million) to advance development efforts based on mutually agreed goals and to provide sixty days of exclusivity pending completion of diligence and execution of a definitive acquisition agreement (Purchase Agreement)."

M&A • Prostate Cancer • Sarcoma

A Dose Finding Study to Treat Bone Tumor(s) (clinicaltrials.gov) - P1 | N=17 | Recruiting | Sponsor: QSAM Therapeutics, Inc.

Metastases • New P1 trial • Ewing Sarcoma • Oncology • Osteosarcoma • Prostate Cancer • Sarcoma • Solid Tumor • CD34

Phase I evaluation of CycloSam (Sm-153-DOTMP) bone seeking radiopharmaceutical in dogs with spontaneous appendicular osteosarcoma. (PubMed, Vet Radiol Ultrasound) - "DOTMP (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetramethylene-phosphonate) is a macrocyclic chelating agent with superior binding properties to Sm when compared with EDTMP (Quadramet™, used for palliative treatment of bone cancer)...Carboplatin chemotherapy (300 mg/m2 IV every 3 weeks ×4) started 4 weeks after Sm-DOTMP injection...All dogs completed study monitoring. The recommended dose for CycloSam in dogs is 1.75 mCi/kg, which resulted in some pain control with minimal toxicity and was safely combined with chemotherapy."

Journal • P1 data • Neutropenia • Osteosarcoma • Pain • Palliative care • Sarcoma • Solid Tumor • Thrombocytopenia

QSAM Biosciences Opens Enrollment of the Second Cohort of Patients in its Phase 1 Study of CycloSam Targeting Metastatic Bone Cancer (GlobeNewswire) - "QSAM Biosciences Inc...announces the opening of enrollment into the 2nd grouping of participants (Cohort 2) after completing Cohort 1 in February in its Phase 1 study evaluating CycloSam^® in the treatment of bone cancer."

Enrollment open • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

QSAM Biosciences Completes Enrollment of Initial Cohort in its Phase 1 Study of CycloSam Targeting Metastatic Bone Cancer (GlobeNewswire) - "QSAM Biosciences Inc...announces the completion of enrollment in the first participant grouping 'cohort') of its Phase 1 study evaluating CycloSam^® in the treatment of bone cancer. The last participant dosed was a breast cancer patient with active metastatic bone cancer....The total dosage of the active radioisotope Samarium-153 to be received by the second cohort, expected to commence in early Q2 2023, will be 50% higher."

Enrollment closed • Trial status • Oncology • Osteosarcoma • Solid Tumor

QSAM Biosciences Receives Clearance from FDA to Expand Enrollment Criteria in its Phase 1 Study of CycloSam Targeting Metastatic Bone Cancer (GlobeNewswire) - "QSAM Biosciences Inc...announces that the U.S. Food & Drug Administration (FDA) has cleared the Company’s amended clinical trial protocol increasing the maximum age of participants to 75 years old from the prior age limitation of 65. This amendment to the enrollment criteria significantly expands the population of potential participants in QSAM’s Phase 1 study evaluating CycloSam^® in the treatment of bone cancer."

Clinical protocol • Oncology • Osteosarcoma • Sarcoma

A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Albert Einstein College of Medicine | N=20 ➔ 0 | Suspended ➔ Withdrawn

Enrollment change • Trial withdrawal • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy (clinicaltrials.gov) - P1 | N=20 | Suspended | Sponsor: Albert Einstein College of Medicine | Not yet recruiting ➔ Suspended

Trial suspension • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Dosimetric implications of the potential radionuclidic impurities in Sm-DOTMP. (PubMed, Appl Radiat Isot) - "The effective dose from the impurities in lower-specific-activity Sm is less than 17% of the effective dose from pure Sm-153. It has a background-equivalent radiation time for a dosage of 37 MBq/kg of less than one-half year."

Journal

QSAM Biosciences Announces FDA Clearance of IND for Samarium-153 DOTMP (CycloSam), an Investigational Radiopharmaceutical for the Treatment of Bone Cancer - "QSAM Biosciences Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared QSAM’s investigational new drug (IND) application which allows the Company to commence Phase 1 clinical trials and the dosing of patients with bone cancer....'We expect to commence our Phase 1 open-label dose escalation trial in bone cancer patients by the end of this year.'"

IND • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer