FutureChem to apply for cond approval of Ludotadipep in KOR

Chan-soo Park, Executive Director of Development, FutureChem

Ludotadipep confirms comparable safety to PSMA-617 and strong tumor uptake

The albumin binder structure extends half-life and minimizes normal organ exposure

Shows confidence over the Korean radioligand therapy’s entry into the global stage

Results for FutureChem's next-generation radioligand therapy (RLT) ‘Ludotadipep (FC705)’, presented at the European Society for Medical Oncology (ESMO 2025), are drawing significant attention.

 

In a multiple-dose clinical trial for patients with metastatic castration-resistant prostate cancer (mCRPC), the cumulative radiation dose to major organs was found to be below international safety standards, and tolerability was maintained even with repeated administration.

 

DailyPharm met with Chansoo Park, Executive Director of Development at FutureChem, in Berlin to discuss the significance of these results and the company's future development strategy.

 

ESMO2025 Poster Presentation by Chan-soo Park, Executive Director of Development, FutureChem

" “Albumin-binding structure extends …alleviates safety concerns" Director Park stated, “This data proves that the albumin-binding structure extends the substance’s half-life in the body while enhancing tumor accumulation without increasing exposure to normal organs.” The study, a Phase II clinical trial that was conducted in Korea, analyzed a total of 68 treatment cycles in 20 mCRPC patients.

 

At the first dose, the highest absorbed doses were observed in the salivary glands (1.22±0.53 Gy/GBq) and kidneys (0.674±0.33 Gy/GBq), while the lowest dose was in the bone marrow (0.053±0.011 Gy/GBq).

 

After repeated administration, the salivary gland dose decreased significantly (p<0.001), while kidney, liver, and bone marrow showed only minor changes.

 

Director Park explained, “The cumulative kidney dose after 6 cycles was 18.1 Gy, and the bone marrow dose was 1.28 Gy, both below safety thresholds (kidney 23 Gy, bone marrow 2 Gy).

 

This confirms sufficient safety even with prolonged circulation.” “1.6 to 2 times higher tumor uptake rate compared to Pluvicto...

 

PSA response rate 73%” FC705 shares the same PSMA-targeting mechanism as Novartis's Pluvicto (¹⁷⁷Lu-PSMA-617), but incorporates an albumin binder to maximize accumulation efficiency within tumors.

 

Chan-soo Park, Executive Director of Development, FutureChem

Director Park stated, “Pluvicto showed a tumor uptake rate of approximately 9.5% ID/g at 72 hours post-administration, while FC705’s was about 5 times higher at 51% ID/g.

 

The difference in the radiation dose reaching the tumor itself leads to a difference in treatment efficacy.” In the domestic Phase II clinical trial, FC705’s PSA response rate (PSA reduction of 50% or more) was 73.3%, higher than that of Pluvicto (approximately 46%).

 

The radiological objective response rate (ORR) was 60% (CR 13.3%, PR 46.7%).

 

PSA-PFS was 6.6 months, and overall survival (OS) was 14.4 months, both showing superior results compared to the competitor.

 

He stated, " We’ve achieved comparable safety with superior efficacy.

 

Ludotadipep has strong potential to become a best-in-class PSMA therapy.” The main point of the ESMo presentation was the results of its dosimetry analysis, the quantitative analysis of radiation dose.

 

In radiopharmaceuticals, dosimetry is a key indicator corresponding to the plasma concentration–pharmacodynamic (PK/PD) relationship, enabling objective prediction of safety and efficacy.

 

Director Park stated, “The fact that the dosimetry results were well within international standards attracted the attention of overseas pharmaceutical companies.

 

“Ludotadaipep quantitatively demonstrated its structural advantages over existing PSMA agents.” He further explained, “High protein binding rates in the blood can lead to variations in bone marrow dose per patient.

 

This study precisely estimated actual radiation exposure by applying hematocrit correction and an SPECT/CT-based RMBLR model.” “Conditional approval application planned within the year…Phase III trial in IRB stage in major hospitals” Ludotadipep has been designated as an orphan drug and fast-track candidate by the Ministry of Food and Drug Safety (MFDS), and the company aims to apply for its conditional approval within this year.

 

Major institutions, including Seoul St.

 

Mary's Hospital, Seoul National University Hospital, Samsung Medical Center, Severance Hospital, and the National Cancer Center, have confirmed participation in the Phase III trial, with patient enrollment scheduled to begin in November.

 

Director Park stated, “For domestic clinical trials, we have completed all MFDS approval procedures, and recruitment for the US Phase II trial is also complete.

 

Results in the first half of next year will serve as key data for global licensing negotiations.” He further explained, “Our domestic direct manufacturing system minimizes the burden on hospitals and patients.

 

Unlike imported drugs requiring 2-3 weeks' advance orders, our same-day production and supply system reduces risks.” Finally, Director Park emphasized that this outcome has bolstered confidence within the company regarding both development and global expansion.

 

He added, “The dosimetry data provide evidence on both safety and efficacy.

 

We are confident that domestically developed RLT technology has ample potential to compete successfully on the global stage.”