Samarium-153-DOTMP

Australian biotech Telix will attempt to make it through the seemingly shrinking IPO window, which has only seen one successful exit so far this quarter. But fresh off an M&A spree and with three cancer treatments in mid- to late-stage testing, the radiopharma hopes to reinvigorate investor enthusiasm. For more financial analysis, see Vital Signs: Taking the temperature on a cooling IPO cycle.Telix filed its intent on Friday to make its NASDAQ debut. The filing provides a glimpse at the firm’s pipeline of radiopharmaceuticals – one of the more popular areas of dealmaking the past few years – and its recent spending to bulk out its isotope manufacturing capabilities. Along with its therapeutic and diagnostic portfolio – one of its imaging agents has already secured FDA approval – Telix has a radioisotope supplier agreement with Bayer. For more, see - Vital Signs: Mapping the slim pickings in radiopharmaceuticals.Pipeline programmes In the past two months, Telix has signed away about $98.6 million in combined cash and stock deals to acquire IsoTherapeutics Group, ARTMS, and QSAM Biosciences to pad its production capacity, as well as its pipeline. Through its takeout of the latter, Telix gained Samarium-153-DOTMP, a kit-based, bone-seeking targeted radiopharmaceutical intended to manage pain in paediatric patients with bone metastases or those who are receiving osteosarcoma therapy. According to ClinicalTrials.gov, the candidate is expected to complete a Phase I trial by November. Within Telix’s internal pipeline, its lead programme is TLX591 (177Lu rosopatamab tetraxetan), a radio antibody-drug conjugate (rADC) in the pivotal Phase III ProstACT GLOBAL study. The trial is expected to enrol 430 patients with PSMA-positive, metastatic castration-resistant prostate cancer, and report initial interim data in the first half of 2025.The biotech’s second rADC, TLX250 (177Lu-DOTA-girentuximab), is in a pair of investigator-sponsored Phase II trials in patients with advanced metastatic kidney cancer. The company is also developing TLX101, a systemic and blood-brain barrier-penetrant small molecule radiotherapeutic that targets the LAT1 receptor to treat glioblastoma. In addition to a Phase I safety study, the candidate is being evaluated in the investigator-led Phase II IPAX Linz trial, which is expected to read out in the first half of 2025.Telix’s final portfolio programme is TLX300, a preclinical antibody-directed, targeted radiation candidate directed against PDGFRα, which is intended to treat soft tissue sarcoma. A first-in-human study is expected to start this half.

Lutathera is a peptide receptor radionuclide therapy that uses high-dose radiation to target and destroy cancer cells. Image Credit: JHVEPhoto / Shutterstock. Novartis has received a US Food and Drug Administration (FDA) approval for the label expansion of its peptide receptor radionuclide therapy (PRRT), Lutathera (lutetium Lu 177 dotatate). The therapy is approved in paediatric patients aged 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumours (GEP-NETs). The US FDA first approved Lutathera as a combination therapy with a long-acting octreotide for the same indication in the adult population in 2018. Lutathera is a peptide receptor radionuclide therapy that uses high-dose radiation to target and destroy cancer cells. Novartis added Lutathera to its portfolio as part of the $3.9bn acquisition of Advanced Accelerator Applications in 2017. The radionuclide therapy is one of the top 20 brands for Novartis; it generated $169m in sales in Q1 this year, per the company’s financials . Sales for Lutathera are expected to increase to over $879m in 2030, as per GlobalData analysis. GlobalData is the parent company of Pharmaceutical Technology . See Also: FDA approves Utility Therapeutics’ Pivya tablets for UTIs Novartis reports 25% increase in net income in Q1 2024 The US FDA approval decision was based on the data from the open-label Phase II NETTER-P trial (NCT04711135). The trial enrolled 11 patients aged 12–18 years with either GEP-NETs or pheochromocytoma and paraganglioma (PPGL), which are neuroendocrine tumours of the adrenal glands and paraganglia, respectively. Novartis did not disclose the detailed results of the trial but noted that the safety profile was consistent with the results of NETTER-1 study (NCT04954820) that studied adults with this same condition. The company said that the “estimated radiation absorbed dose in paediatric patients was within established organ thresholds for external beam radiation and comparable to that in adults for the approved dose”. There has been an increased interest in the development of radiopharmaceuticals. Last month, AstraZeneca signed a $2.4bn deal to acquire Fusion Pharmaceuticals , which specialises in radioconjugates. Fusion’s lead candidate, FPI-2265 is a radioconjugate that targets prostate-specific membrane antigen (PSMA). It is being evaluated as a treatment for metastatic castration-resistant prostate cancer (mCRPC) in a Phase II trial (NCT05219500). Telix Pharmaceutical also expanded its radiopharmaceutical pipeline with the acquisition of QSAM Biosciences . QSAM’s lead candidate, CycloSam (samarium-153-DOTMP), has received an orphan drug designation and rare paediatric disease designation from the US FDA for the treatment of paediatric osteosarcoma.