Telix Pharmaceuticals Ltd (ASX: TLX) shares are catching the eye on Tuesday.
In morning trade, the radiopharmaceuticals company's shares are up 14% to $11.62.
Image source: Getty Images
Why are Telix shares jumping?
Investors have been bidding the company's shares higher this morning after it released the results from part one of the ProstACT Global Phase 3 study. This is the safety and dosimetry lead-in for its therapeutic candidate, TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan).
According to the release, the company has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed.
In addition, key findings include a tolerability profile supported by dosimetry and low-grade non-hematologic events, lesion dosimetry that indicates no difference in absorbed dose profile across cohorts, no adverse drug-drug interactions observed in TLX591-Tx combinations, and hematologic events are in line with expectations, transient, and manageable, with similar rates of recovery across all patient cohorts.
Telix highlights that the results from part 1 are consistent with prior clinical studies of this first-in-class lutetium radio antibody-drug conjugate (rADC) therapy.
The patient population comprised prostate-specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer (mCRPC) patients previously treated with one androgen receptor pathway inhibitor (ARPI).
Telix advised that it has already advanced the study into Part 2, which is a 2:1 randomised treatment expansion, in jurisdictions where the clinical trial has obtained approval from health authorities.
Part 1 data will be presented to the United States (U.S.) Food and Drug Administration (FDA) to seek an Investigational New Drug (IND) amendment to progress part 2 in the U.S.
Commenting on the news, Telix's group chief medical officer, David N. Cade, MD, said:
Despite advances in clinical practice, men with advanced prostate cancer still need improved first and second line treatment options. These results build on prior findings and highlight the potential for TLX591-Tx in combination with contemporary standard of care, to become a new first-line option for patients facing this aggressive disease. We are encouraged by the data and look forward to engaging with the FDA at the earliest opportunity, while continuing to advance enrollment in Part 2 in regions where clinical trial initiation has already been approved.
Neeraj Agarwal from the Huntsman Cancer Institute in Salt Lake City, and the ProstACT Global Principal Investigator, said:
These results reinforce the feasibility of integrating TLX591-Tx with current standard of care therapies for mCRPC, including ARPIs such as enzalutamide or abiraterone, or docetaxel. Hematologic events align with those typically seen in this patient population and therapeutic class, and these cases resolved quickly. The dosimetry profile, along with the low-grade nature of non-hematologic adverse events, further supports the tolerability profile of this investigational therapy.
