Australian Biotech's Novel Antibody-Based PSMA Therapy


ProstACT - Telix Pharmaceuticals

Enters Pivotal Trial Phase, Challenging Pluvicto's $1.4 Billion Market

BLUF (Bottom Line Up Front)

Telix Pharmaceuticals has advanced its investigational prostate cancer treatment TLX591 into the randomized expansion phase of a global Phase 3 trial, marking the first study to combine an antibody-based PSMA radioligand with standard therapies from the outset. The Australian company is positioning this antibody approach—which offers potentially reduced side effects and simpler dosing versus Novartis's blockbuster Pluvicto—to capture a share of the rapidly expanding radioligand therapy market. With U.S. sites now enrolling patients and preliminary safety data forthcoming, TLX591 enters a competitive landscape where Pluvicto generated $1.39 billion in 2024 sales and recently secured FDA approval for earlier-line use. The trial's outcome could determine whether antibody-based radioligand therapy can challenge the dominance of small-molecule approaches in advanced prostate cancer treatment.

Novel Antibody Approach Enters Advanced Testing

On December 8, 2025, Telix Pharmaceuticals dosed the first patient in Part 2 of its ProstACT Global Phase 3 trial at the Australian Prostate Centre in Melbourne, launching the randomized expansion phase for TLX591 (lutetium-177 rosopatamab tetraxetan). This milestone represents more than routine clinical trial progress—it signals the most advanced test yet of whether antibody-based PSMA targeting can offer advantages over the small-molecule approach that has dominated the field.

TLX591 belongs to a class called radioantibody-drug conjugates (rADCs), using a full monoclonal antibody—rosopatamab—to deliver radioactive lutetium-177 to cancer cells bearing prostate-specific membrane antigen (PSMA). This differs fundamentally from Novartis's Pluvicto (lutetium-177 PSMA-617), which uses a small peptide molecule to achieve the same goal. While both target the same protein, their different molecular architectures create distinct pharmacological profiles that could translate into different clinical outcomes.

The Pluvicto Benchmark: A Market TLX591 Aims to Penetrate

To understand what's at stake, consider Pluvicto's commercial trajectory. FDA-approved in March 2022 for metastatic castration-resistant prostate cancer (mCRPC) patients who had received prior hormone therapy and chemotherapy, Pluvicto achieved blockbuster status in 2024 with $1.39 billion in global sales—representing 42% growth over 2023. This made it the first nuclear medicine product to cross the billion-dollar threshold.

In March 2025, the FDA expanded Pluvicto's indication to include patients who haven't yet received chemotherapy, tripling its addressable patient population based on the PSMAfore trial. That study showed Pluvicto reduced radiographic progression risk by 59% compared to switching androgen receptor pathway inhibitors (median progression-free survival: 9.3 versus 5.6 months). Market analysts project Pluvicto could reach peak sales exceeding $5 billion with this earlier-line approval, particularly as Novartis expands manufacturing capacity across the U.S., Japan, and China.

Novartis has built formidable infrastructure: over 590 treatment sites in the U.S. alone, with 350 actively ordering. The company expects to administer 250,000 radioligand therapy doses annually. This established market presence represents both validation of PSMA radioligand therapy's potential and the competitive hurdle TLX591 must clear.

What Makes Antibodies Different: The Scientific Rationale

The distinction between antibody-based and small-molecule PSMA targeting involves more than academic classification—it has practical implications for how treatments work in patients' bodies.

Size and circulation: TLX591's antibody component weighs approximately 150 kilodaltons versus PSMA-617's roughly 1 kilodalton. This size difference creates longer circulation time—antibodies typically remain in the bloodstream for days rather than hours. Longer circulation can mean more sustained tumor exposure, but also more time for radiation exposure to normal tissues.

Binding and internalization: Antibodies bind to PSMA's extracellular domain, while small molecules target the enzyme's active site. After binding, both undergo internalization into cancer cells, but their different entry mechanisms may affect how efficiently radiation reaches tumor DNA. Telix claims TLX591 demonstrates "longer retention, internalization, and potential therapeutic benefits" compared to small molecules.

Biodistribution patterns: This represents perhaps the most clinically significant difference. Small-molecule PSMA agents like Pluvicto are cleared primarily through the kidneys, leading to potential kidney toxicity. The Pluvicto label warns that patients with moderate renal impairment face 14% risk of grade 3-4 renal toxicity. Small molecules also accumulate in salivary and lacrimal glands, causing the dry mouth and dry eyes that affect over 40% of Pluvicto patients—the most common quality-of-life issue.

TLX591, by contrast, clears through the liver. Telix reports that in long-term follow-up of patients treated with TLX591, "significant acute or delayed kidney toxicity has not been observed." Due to its larger size, TLX591 demonstrates "minimal salivary and lacrimal gland uptake," potentially reducing xerostomia and xerophthalmia that plague current radioligand therapies.

Radiation exposure: Perhaps most strikingly, TLX591's two-dose regimen delivers approximately 152 mCi cumulative radiation versus up to 1,200 mCi with Pluvicto's six-dose course—nearly an eight-fold difference in total radiation burden.

These pharmacological differences don't guarantee superior clinical outcomes, but they establish a scientifically plausible hypothesis that antibody-based targeting might offer therapeutic advantages. The Phase 3 trial will test whether these laboratory and early-trial observations translate into meaningful benefits for patients.

The ProstACT Global Trial Design: Testing Combination From the Start

ProstACT Global's design breaks from the conventional radioligand therapy playbook in a significant way: it tests TLX591 in combination with standard treatments rather than as monotherapy after other options have failed.

The trial enrolled patients with progressive mCRPC who have received prior androgen receptor pathway inhibitor therapy and are PSMA-positive on PET imaging. Part 1, the safety run-in with 30 patients, evaluated TLX591 combined with physician's choice of abiraterone (Zytiga), enzalutamide (Xtandi), or docetaxel chemotherapy. Data from this cohort will be submitted to the FDA to support U.S. site expansion.

Part 2, now underway, will randomize approximately 490 patients 2:1 to receive either TLX591 plus standard care or standard care alone. The primary endpoint is radiographic progression-free survival; overall survival serves as a key secondary endpoint.

This first-line combination strategy mirrors Pluvicto's evolution. Initially approved as post-chemotherapy monotherapy, Pluvicto demonstrated greater benefit when used earlier, in combination with standard treatments. The PSMAddition trial (presented at ESMO 2024) showed adding Pluvicto to standard care in earlier mCRPC significantly improved progression-free survival. Similarly, the PSMAfore data that supported Pluvicto's label expansion came from combination use before chemotherapy.

By testing combination therapy from the outset, Telix attempts to leap directly to where the field is heading: integration of PSMA radioligands with existing treatments rather than sequential use after other options fail.

Geographic Expansion and U.S. Market Entry

The trial is currently recruiting in Australia, New Zealand, and Canada. U.S. enrollment began in February 2025, with the Biogenix Molecular Research Center in Miami dosing the first American patient. This Miami site administered TLX591's two-dose regimen (given 14 days apart) and continues recruiting eligible patients as part of a broader U.S. rollout.

Telix's strategy for U.S. expansion required careful regulatory navigation. The company filed its investigational new drug (IND) application with the FDA in late 2023 and will submit Part 1 safety data before broadly activating American sites. The FDA has agreed to review this preliminary data to enable U.S. expansion, with public disclosure of Part 1 results aligned to regulatory engagement.

Additional regulatory approvals are in place or pending for China, Japan (with a required Japan-specific 9-patient safety cohort per PMDA requirements), Singapore, South Korea, Turkey, and the United Kingdom. Telix plans to file a clinical trial application with the European Medicines Agency to enable EU site activation.

This global footprint matters for more than enrollment speed—it positions TLX591 for regulatory submissions in major markets if Phase 3 results prove positive. The U.S. alone represents the world's largest pharmaceutical market, where over 34,000 men die annually from prostate cancer. Entry into this market would pit TLX591 directly against Pluvicto's established infrastructure.

Clinical Data Supporting the Phase 3 Trial

ProstACT Global builds on 242 patients treated across eight Phase 1 and 2 studies. The most informative early data comes from a Phase 2 trial testing TLX591 with fractionated dosing plus docetaxel chemotherapy, which reported median overall survival of 42.3 months—striking for such an advanced population, though without a control arm, this figure must be interpreted cautiously.

The recently completed ProstACT SELECT study provided the immediate foundation for Phase 3 advancement. In SELECT, 28 evaluable patients received two doses of TLX591 14 days apart. Results showed PSA reduction in 64% of patients, with 27% achieving ≥30% reduction and 18% achieving ≥50% reduction. The study confirmed TLX591's "high PSMA tumor antigen specificity with low rates of off-target organ exposure" and validated the two-dose regimen.

Safety data from SELECT showed 25% of patients experienced grade 3 thrombocytopenia and 25% had grade 4 thrombocytopenia—significant hematologic toxicity but generally manageable. Critically, the study demonstrated minimal kidney and salivary gland uptake, confirming the theoretical advantages of antibody-based targeting.

The Competitive Landscape: Beyond Pluvicto

While Pluvicto dominates current attention, the PSMA radioligand therapy field includes multiple competitors pursuing different strategies:

Actinium-225 approaches: Several companies are developing alpha-emitting radioligands using actinium-225 instead of lutetium-177. Alpha particles deposit more energy over shorter distances than lutetium's beta particles, potentially killing cancer cells more efficiently. Fusion Pharmaceuticals (acquired by AstraZeneca for $2.4 billion) is developing actinium-based PSMA therapies. Bristol Myers Squibb acquired RayzeBio for $4.1 billion, gaining an alpha-emitting radiopharmaceutical platform. Early studies of actinium-225-PSMA-617 show impressive PSA responses, with an 89% pain control rate in patients with bone metastases, though longer-term toxicity data remain limited.

Alternative small molecules: Point Biopharma (acquired by Eli Lilly) is developing PNT2002, another lutetium-177 PSMA small molecule in Phase 3 trials. Other small-molecule approaches include PSMA I&T, MIP-1095, and various compounds in earlier development.

Other antibody approaches: Beyond TLX591, radiolabeled monoclonal antibody J591 has been tested clinically. A comparative study at Johns Hopkins found that J591 and PSMA-617 showed different biodistribution and dosimetry, with J591 demonstrating "minimal salivary gland uptake" similar to what Telix reports for TLX591. However, J591's development has proceeded more slowly than small-molecule competitors.

The intense commercial activity—major pharma acquisitions totaling over $6 billion in the past two years—reflects industry conviction that PSMA radioligand therapy represents a fundamental advance in prostate cancer treatment. The question is which molecular approach will prove most effective.

Market Implications and Commercial Pathway

If ProstACT Global succeeds, TLX591 would enter a market with established proof of concept but room for differentiation. Pluvicto's commercial success validates payer willingness to reimburse PSMA radioligand therapy, with coverage established through Medicare and major private insurers. Treatment costs range from $20,000-$45,000 per cycle, with Pluvicto's six-cycle course totaling $120,000-$270,000. TLX591's two-dose regimen could offer cost advantages, though pricing ultimately depends on Telix's commercial strategy.

The company has already established U.S. market presence through Illuccix, its FDA-approved PSMA PET imaging agent (the same 68Ga-PSMA-11 compound used to select patients for radioligand therapy). Telix has distribution agreements with Cardinal Health and PharmaLogic covering over 140 nuclear pharmacies, reaching more than 85% of PET imaging sites. This existing infrastructure could facilitate TLX591 commercialization if approved.

Manufacturing represents a critical consideration. Radioligand therapies require specialized facilities and cold-chain distribution due to short radioisotope half-lives (lutetium-177: 6.6 days). Novartis invested heavily to build manufacturing capacity, including facilities in Indianapolis, New Jersey, and sites in Japan and China. Telix operates manufacturing through its Telix Manufacturing Solutions division but would need to scale significantly to meet potential demand.

What This Means for Patients Now

For men currently battling metastatic castration-resistant prostate cancer, several points merit consideration:

TLX591 remains investigational: It has not received regulatory approval anywhere and is available only through clinical trial participation. The trial website (telixpharma.com/prostact) and ClinicalTrials.gov (NCT06520345) provide information about eligibility and participating sites.

Current treatment options: Patients needing treatment now should focus on approved therapies. For PSMA-positive mCRPC, options include:

  • Pluvicto: Now approved for use after androgen receptor pathway inhibitor therapy, whether or not patients have received chemotherapy
  • Hormone therapies: Abiraterone, enzalutamide, apalutamide, darolutamide
  • Chemotherapy: Docetaxel, cabazitaxel
  • Bone-targeted therapy: Radium-223 (for bone-predominant disease)
  • PARP inhibitors: Olaparib, rucaparib (for patients with BRCA1/2 or other DNA repair mutations)

Timeline considerations: Phase 3 trials typically require 2-4 years from first patient dosed to final results. With approximately 490 patients to enroll globally, completion depends on recruitment pace. Even if results are positive, regulatory review adds 6-12 months. Realistically, TLX591 approval (if it occurs) likely won't come before 2027-2028.

Clinical trial participation: Men interested in ProstACT Global should discuss with their oncologists whether they meet eligibility criteria (progressive mCRPC, prior androgen receptor pathway inhibitor therapy, PSMA-positive on PET scan) and whether trial sites are accessible. Clinical trial participation offers access to investigational treatments but requires understanding that outcomes are uncertain.

The Broader Scientific Question

Beyond TLX591's commercial prospects, ProstACT Global tests a fundamental scientific question: Do antibody-based radioligand therapies offer clinically meaningful advantages over small molecules?

The theoretical benefits—reduced kidney and salivary gland toxicity, simplified dosing, lower total radiation exposure—are compelling. Early clinical data support these advantages. But only a randomized Phase 3 trial can determine whether these differences translate into improved survival, better quality of life, or both.

The scientific community has historically viewed antibodies as inferior to small molecules for PSMA targeting due to slower tumor uptake and longer systemic circulation. A 2023 review in the journal Frontiers in Oncology noted that "monoclonal antibodies have generally been considered inferior to PSMA small molecule binders because of their larger size, slower tumor uptake, and longer half-lives which lead to more systemic radiation exposure and hematotoxicity."

Yet this conventional wisdom derives largely from older antibody constructs. Modern antibody engineering has produced smaller variants (minibodies, diabodies) with faster clearance while retaining beneficial properties. TLX591's apparently favorable toxicity profile in early trials suggests the field may need to reassess assumptions about antibody-based radioligand therapy.

Looking Ahead: Key Milestones

The prostate cancer community will watch several critical junctures:

Near-term (2025): Public disclosure of Part 1 safety data aligned with FDA engagement. This will provide the first comprehensive look at TLX591's safety profile when combined with standard therapies and inform U.S. site activation.

Mid-term (2026-2027): Completion of Part 2 enrollment and interim analyses (if planned). Enrollment pace across multiple continents will determine when the study reads out.

Longer-term (2027-2028): Final results, regulatory submissions, and potential approvals. If results are positive, TLX591 could join Pluvicto as an approved PSMA radioligand therapy, potentially with differentiation based on toxicity profile and dosing convenience.

Parallel developments in the broader PSMA landscape will also influence TLX591's prospects. Pluvicto is being tested in earlier disease stages through the PSMAddition trial (hormone-sensitive prostate cancer; results expected late 2025). Success there would further expand Novartis's market. Actinium-225 therapies are advancing through trials. The competitive landscape remains dynamic.

Conclusion: A Pivotal Test for Antibody-Based Radioligand Therapy

The advancement of TLX591 into randomized Phase 3 testing represents more than one company's clinical trial progress. It marks the most rigorous evaluation yet of whether antibody-based PSMA targeting can challenge the small-molecule paradigm that has shaped radioligand therapy development.

The stakes are substantial. Prostate cancer remains the second-leading cause of cancer death among American men, with over 35,000 deaths annually. For men with advanced disease that has stopped responding to hormone therapy, treatment options remain limited and survival measured in months. PSMA radioligand therapy has already demonstrated the capacity to extend survival—Pluvicto added four months of overall survival in the VISION trial, a meaningful improvement for such advanced disease.

If TLX591 can match Pluvicto's efficacy while delivering on its promise of reduced toxicity and simpler dosing, it would represent genuine therapeutic advance. If the antibody approach proves inferior, the result still generates valuable knowledge about optimal radioligand therapy design.

For now, patients and clinicians await Part 1 safety data and the multi-year process of Phase 3 trial completion. The work continues, driven by the same imperative that has animated prostate cancer research for decades: finding better ways to help men live longer, with fewer side effects, when facing this challenging disease.

Sources

  1. Telix Pharmaceuticals Limited. "ProstACT Global Phase 3 Update: First Patient Dosed in Randomized Treatment Expansion, Part 1 Readout Plans Confirmed." ASX/NASDAQ announcement, December 8, 2025. https://telixpharma.com

  2. Telix Pharmaceuticals Limited. "First Patient Dosed in Phase III ProstACT GLOBAL Study of Antibody-based Prostate Cancer Therapy Candidate, TLX591." Company announcement, January 10, 2024. https://telixpharma.com/news-views/first-patient-dosed-in-phase-iii-prostact-global-study-of-antibody-based-prostate-cancer-therapy-candidate-tlx591/

  3. Telix Pharmaceuticals Limited. "Recruitment Spotlight: Phase 3 Clinical Trial of Novel Prostate Cancer Radiopharmaceutical Now Active in Miami." Globe Newswire, February 25, 2025. https://www.globenewswire.com/news-release/2025/02/25/3031912/0/en/Recruitment-Spotlight-Phase-3-Clinical-Trial-of-Novel-Prostate-Cancer-Radiopharmaceutical-Now-Active-in-Miami.html

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  19. "Phase 3 study launches exploring TLX591 in mCRPC." Urology Times, November 13, 2023. https://www.urologytimes.com/view/phase-3-study-launches-exploring-tlx591-in-mcrpc

  20. Telix Pharmaceuticals. "ProstACT Global Clinical Trial Information." https://telixpharma.com/prostact/

Medical Disclaimer: TLX591 (lutetium-177 rosopatamab tetraxetan) is an investigational therapy that has not been approved by any regulatory authority. It is available only through participation in clinical trials. This article is for informational purposes only and should not be considered medical advice. Patients should discuss all treatment options, including clinical trial opportunities, with their oncology care team.

 

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