Telix Announces Proposed Acquisition of QSAM Biosciences and Its Lead Therapy Candidate, CycloSam®

Melbourne (Australia) | 14 November 2023

Telix today announces it has signed a conditional Term Sheet to acquire QSAM Biosciences, Inc. (QSAM) and its lead asset, CycloSam® (Samarium-153-DOTMP). QSAM is a United States (U.S.) based clinical stage company developing therapeutic radiopharmaceuticals for primary and metastatic bone cancer.

CycloSam® is highly synergistic with Telix’s existing therapeutic development activity in both prostate cancer and sarcoma. The proposed acquisition, subject to customary completion terms, will further enhance and differentiate Telix’s innovation position to provide a continuum of care to patients from diagnosis and staging, systemic treatment of metastatic disease, to palliative care.

With the broad success of immunotherapies and the more recent clinical impact of radiopharmaceutical therapies in diseases like prostate cancer, there is an unmet need to cost-effectively and safely manage pain from bone metastases in very late-stage patients. This unmet need is further exacerbated by the quality-of-life issues associated with metastatic pain management, particularly opioid administration. In the U.S. alone, there are an estimated 400,000 patients up-staged with malignant bone metastasis primarily from prostate, breast and lung cancer[1].

In addition to near-term opportunities in metastatic disease management, the proposed acquisition may also broaden the Company’s pipeline depth in osteosarcoma, a disease that mostly affects children and young adults, where QSAM has received Orphan Drug[2] and Rare Pediatric[3] Disease Designations (RPDD) from the FDA. The RPDD designation may enable CycloSam to be brought to market more rapidly through additional incentives, including eligibility for a Priority Review Voucher (PRV) under which the FDA may reduce the review period for a drug candidate to six months.

Douglas Baum, QSAM CEO and Co-Founder said, “CycloSam® is a novel, de-risked clinical asset that has the potential to deliver tangible improvements of prior bone-seeking agents with established efficacy, safety and commercial utility. By joining forces with Telix we are accessing a specialised commercial team, distribution network and development expertise, with the goal of realising the full potential of this asset.”

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix continued, “We are pleased to announce our intention to acquire QSAM. This acquisition will bring a validated therapeutic candidate with the potential to accelerate development under the Orphan Drug and Rare Pediatric Disease designations, and a highly experienced team that has completed numerous FDA approvals.

With CycloSam® we plan to leverage Telix’s extensive experience and success in distributing short-life radiopharmaceuticals using a cold kit product from a nuclear pharmacy. Given these factors, we see a strong pathway to commercialisation.”

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[1] Cleveland Clinic Journal of Medicine July 2022

[2] QSAM media release 18 August 2021.

[3] QSAM media release 2 February 2022.