Telix Pharmaceuticals Ramps Up Its Cancer Therapy Program

Biopharmaceutical player Telix traded at higher levels after the company unveiled the strategy update for its Prostate Cancer Therapy Program.

Telix Pharmaceuticals Limited (ASX:TLX) stated that the data analysis and independent monitoring by a third-party Clinical Research Organization has been in favor of taking its proprietary engineered huJ591 into a Phase III study under certain dosing conditions. Subject to regulatory approvals, if the transition goes through, Telix would be potentially able to accelerate its antibody-directed prostate cancer radiotherapy program by approximately two years.

This comes after Telix completes the acquisition of Atlab Pharma SAS in September 2018. Telix engaged a third-party Clinical Research Organization (CRO) to audit and monitored clinical data acquired by Weill Cornell Medical Centre (WCMC) for 177Lu (lutetium)-huJ591. The findings revealed that Lu-huJ591 is well tolerated, particularly with fractionated dosing at or below 45mCi/m. The report stated that the survival benefit of 177Lu-huJ591 in chemotherapy naïve (pre-chemo) patients is approximately twice that of patients that received end-stage chemotherapy. Telix possesses certain commercial radiotherapy rights to huJ591 which is a one of the most widely studied targeting agents in radionuclide therapy for prostate cancer.

Telix CEO Dr. Christian Behrenbruch stated “Given the considerable momentum around prostate radiotherapy, Telix believes it is prudent to pursue a strategy that enables the company to get to Phase III as soon as possible. Based on the detailed data Telix believe that huJ591, with a fractionated dosing regimen, can potentially outperform its competition while the company continues to develop a second-generation product aimed at alpha nuclide therapy.”

Also, Telix is manufacturing both a proprietary huJ591 variant and the “original” huJ591 for clinical use that intends to support comparability studies. The company stated that its proprietary engineered huJ591 (previously denoted as TLX591) would continue to be developed as a “second generation” program for use with an alpha-emitting radionuclide.

On the capital requirement front, Telix stated that it has adequate funding to prepare the necessary documentation to engage with the relevant regulatory authorities, but it does not currently have sufficient capital to execute a Phase III trial. The company’s budgeted activities include the completion of manufacturing of huJ591 as well as the commencement of US-based Phase II study of the re-engineered huJ591 in approximately 120 patients.

Telix intends to submit an information package to the US Food and Drug Administration (FDA), summarizing the entirety of the clinical data for 177Lu-huJ591 by March 2019. Whereas, FDA meeting request to obtain guidance on proposed Phase III clinical trial protocol is expected to take place in May or June 2019. The release of radiolabeled material suitable to potentially support early patient recruitment in Australia is indicated to happen in August or September 2019. Following the completion of all these activities, the company aims to file Phase III Investigational New Drug (IND) application by the fourth quarter of 2019.

With this update, Telix’s shares jumped up 9.924% to last trade at $0.720 on 8 January 2019. Even in the past 12 months, the stock has gone up by 2.34% with a positive performance change of 3.97% achieved last month.

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