MELBOURNE, AUSTRALIA: Telix Pharmaceuticals Limited has entered into an agreement to acquire QSAM Biosciences, Inc. and its lead investigational drug Samarium-153-DOTMP (153Sm-DOTMP).

The purchase price comprises US$33.1 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 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.

QSAM Biosciences 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).

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, 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.

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix said, “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. 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.”

Telix Pharmaceuticals to acquire QSAM Biosciences and its bone cancer therapy