Telix Signs Agreement to Acquire QSAM Biosciences and Its Bone Cancer Targeting Platform

MELBOURNE, Australia, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has entered into an agreement to acquire QSAM Biosciences, Inc. (U.S. OTC: QSAM) and its lead investigational drug Samarium-153-DOTMP (¹⁵³Sm-DOTMP). QSAM is a United States (U.S.) based company developing therapeutic radiopharmaceuticals for primary and metastatic bone cancer.

¹⁵³Sm-DOTMP is a novel kit-based bone-seeking targeted radiopharmaceutical candidate that uses a “next generation” chelating agent to deliver a proprietary formulation of Samarium-153 radioisotope. With two major potential applications – pain management of bone metastases and osteosarcoma therapy, including in paediatric patients – ¹⁵³Sm-DOTMP is highly aligned with Telix’s existing therapeutic focus areas in urologic oncology (prostate cancer), neuro-oncology (glioma), and musculoskeletal oncology (sarcoma).

¹⁵³Sm-DOTMP has shown in pre-clinical and early clinical trials evidence of safety, efficacy and future commercial utility, and has the potential to deliver significant improvements on prior bone-seeking agents in the treatment and management of late-stage metastatic disease. This includes a much-improved safety profile (myelotoxicity and renal toxicity), more targeted delivery (reduced off-target irradiation) and a streamlined production system (flexible supply chain and lower COGS).¹ The potential commercialisation of this asset would build on a well-established reimbursement pathway for this class of drugs, offering a potential cost-effective and quality of life-enhancing alternative to standard-of-care (bisphosphonates, steroids, opioids).

Recent pre-clinical and clinical data have yielded encouraging evidence for ¹⁵³Sm-DOTMP to enable the pain management of prostate cancer bone metastases,² where there remains a significant unmet patient need particularly after progression from other forms of radionuclide and radiation therapy. Telix believes that ¹⁵³Sm-DOTMP may benefit patients with metastatic lung and breast cancer, where many patients develop brain and bone metastases, and disease management often focusses on quality-of-life palliative care.

¹⁵³Sm-DOTMP has also been granted Orphan Drug³ and Rare Pediatric Disease⁴ Designations (ODD/RPDD) by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. This designation broadens Telix’s portfolio to include potential treatment for a disease that mostly affects children and young adults, building upon Telix’s established focus in musculoskeletal oncology (the targeted alpha program – TLX300 / olaratumab). The RPDD designation may enable ¹⁵³Sm-DOTMP to be brought to market more rapidly through regulatory incentives, including eligibility for a paediatric rare disease Priority Review Voucher (PRV) that may be applied to this or other Telix programs.