Penitrium Bio has received approval to amend the trial protocol for its ongoing Phase 1 clinical trial of the 'Penetrium™' combination therapy in patients with refractory and relapsed solid tumors who have exhausted all prior treatments.

According to a disclosure on the 17th, the Ministry of Food and Drug Safety (MFDS) approved the protocol amendment for the Phase 1 clinical trial of the combination therapy of pembrolizumab and Penetrium™. The approval date for the amendment is June 16, 2026.

■ Trial Design and Evaluation Criteria

This trial is an open-label, dose-escalation, multi-center Phase 1 study that evaluates the safety and maximum tolerated dose (MTD) of the combination treatment of pembrolizumab and Penetrium™. The trial is being conducted at Ajou University Medical Center, and the target indications are non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).

The primary objective is to determine the MTD and dose-limiting toxicity (DLT) of Penetrium™. The secondary evaluations will assess the objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), and ECOG performance status at 6 and 12 weeks, while also confirming pharmacokinetic characteristics, the occurrence of new metastases, and overall survival (OS). The recommended Phase 2 dose will also be derived in the future.

■ Reasons for Amendment, Schedule, and Scale

The company explained that the reason for the amendment approval was a "change in the manufacturer and formulation." The clinical trial period is approximately 24 months from the date of MFDS approval, and the target number of subjects ranges from a minimum of 3 to a maximum of 24. The expected completion date is June 16, 2028.

■ Intellectual Property and Licensing

Intellectual property rights, including patents related to the formulation and manufacturing of Penetrium™, are held by C& Pharm. Penitrium Bio acquired and is using the exclusive license for the breast and lung cancer anticancer drug sector from Hyundai Bioscience.

■ Investment Risk Notice

The company explained that both the amendment approval date and the date of occurrence are based on the date of the MFDS notification regarding the clinical trial protocol amendment. The company stated, "The probability of a clinical trial drug ultimately receiving final approval as a pharmaceutical product is statistically known to be around 10%. Results that do not meet expectations may arise during the clinical trial and product approval process, and accordingly, there remains a persistent possibility that our company may change or abandon its commercialization plans." They also added, "Investors are advised to invest prudently by comprehensively considering the disclosed investment risks through periodic disclosures and business reports."