Australian biopharma announces new acquisition

Biotech News: Melbourne-based Telix Pharmaceuticals is advancing its position in the field of radiopharmaceuticals by entering into an agreement to acquire QSAM Biosciences, a U.S.-based company specialising in the development of therapeutic radiopharmaceuticals for primary and metastatic bone cancer.

The centerpiece of this strategic acquisition is QSAM’s lead investigational drug, Samarium-153-DOTMP (153Sm-DOTMP), a bone-seeking targeted radiopharmaceutical candidate. Utilising a “next generation” chelating agent, the proprietary formulation of Samarium-153 radioisotope in 153Sm-DOTMP shows promise in two major applications – pain management of bone metastases and osteosarcoma therapy, including in paediatric patients.

Telix, known for its focus on urologic oncology, neuro-oncology, and musculoskeletal oncology, sees this alignment with 153Sm-DOTMP as a natural progression in their therapeutic focus areas. The drug has exhibited evidence of safety, efficacy, and future commercial utility in pre-clinical and early clinical trials, presenting potential improvements in the treatment and management of late-stage metastatic disease.

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix, emphasised the transformative potential of the acquisition, stating, “The acquisition of QSAM provides Telix with an additional near-term therapeutic pipeline asset, further differentiating our innovation position in radiopharmaceuticals and building depth in Telix’s key disease focus areas of urological and musculoskeletal oncology.”

153Sm-DOTMP stands out with a significantly improved safety profile, reduced off-target irradiation through more targeted delivery, and a streamlined production system, offering a cost-effective and quality of life-enhancing alternative to standard-of-care treatments. Telix envisions its potential commercialisation as a milestone that builds on an established reimbursement pathway for this class of drugs.

Recent pre-clinical and clinical data support the use of 153Sm-DOTMP in the pain management of prostate cancer bone metastases, addressing a critical unmet patient need after progression from other radionuclide and radiation therapies. Telix is optimistic about the broader application of the drug in metastatic lung and breast cancer, where patients often face brain and bone metastases, underscoring the potential for enhanced quality-of-life palliative care.

Further adding to the significance of this acquisition, 153Sm-DOTMP has received Orphan Drug and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. This expands Telix’s portfolio to include a potential treatment for a disease predominantly affecting children and young adults, aligning with Telix’s established focus in musculoskeletal oncology.

Dr Behrenbruch added “Samarium is a highly optimal radionuclide for treating bone metastases, and the combination of ODD and PRDD status with Telix’s demonstrated experience in pharmacy-based cold-kit distribution has strong potential for a rapid pathway to commercialisation of this asset.”

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