Regulatory Advancement Toward Clinical Development (June 29, 2026)

FDA has scheduled an INTERACT meeting to provide regulatory feedbacks on the IND-enabling safety pharmacology and toxicokinetics strategies for Excellamol’s lead OncoPDC drug candidate, supporting its advancement toward clinical development.

FDA grants ODD to Excellamol’s two OncoPDCs for the treatment of malignant glioma (May. 18, 2026)

The US FDA has granted Orphan Drug Designation (ODD) to Excellamol’s two flagship OncoPDC candidates, XM182-MVCP-Exatecan (targeting IL13Rα2) and XM199-MVCP-Exatecan (targeting IL4Rα), for the treatment of malignant glioma. These highly aggressive brain tumors are associated with poor prognosis and severely limited therapeutic options. With this latest milestone, Excellamol now holds five FDA-designated orphan drug pipelines — four for malignant glioma and one for pancreatic cancer — further validating the clinical utility and therapeutic potential of its proprietary Self-Depot™ OncoPDC platform technology (https://www.medicopharma.co.kr/news/articleView.html?idxno=68126).

FDA grants ODD to Excellamol’s leading OncoPDC for the treatment of pancreatic cancer (Apr. 16, 2026)

The US FDA has granted Orphan Drug Designation (ODD) to a PD-L1-targeting OncoPDC, for the treatment of pancreatic cancer, a malignancy associated with poor prognosis and limited therapeutic options. It is developed using Excellamol’s proprietary Self-Depot™ OncoPDC platform, which comprises a target-binding peptide conjugated to a cytotoxic payload. This platform is designed to enhance tumor-selective drug accumulation while minimizing systemic exposure and associated toxicities (https://www.medicopharma.co.kr/news/articleView.html?idxno=67809), (https://www.yna.co.kr/view/AKR20260417072700017).

IND submission strategy solified following U.S. FDA INTERACT (Nov. 13, 2025)

Excellamol has successfully completed two FDA INTERACT meetings for its preclinical candidates targeting glioblastoma. The constructive regulatory feedback received provides clear alignment on development strategy, preclinical requirements, and CMC pathways. This regulatory engagement meaningfully de-risks the programs and positions Excellamol for an efficient and well-prepared IND submission. The outcomes of these meetings further validate the Company’s development approach in this high-unmet-need brain tumor indication.

Received a promising review from the BTR-NTA Committee (Aug. 12, 2025)

Excellamol was honored to be selected for the BTR-NTA program (www.tessajowellbraincancermission.org/strategic-programmes/btr-nta), held on May 21, 2025, in Edinburgh, Scotland. The company showcased its Self-Depot™ OncoPDC platform and XM161-SN38, an FDA Orphan Drug Designated therapy for brain cancers, and engaged with eighteen leading experts across the therapeutic development pathway. Feedback on preclinical progress, manufacturing, regulatory strategy, biomarkers, and trial design will help guide Excellamol’s next steps in advancing therapies for patients with brain cancer.

FDA grants ODD to Excellamol’s OncoPDCs for malignant glioma (Apr. 16, 2025)

The FDA’s Orphan Drug Designation for XM147-SN38 and XM161-SN38 in malignant glioma marks an important regulatory milestone and underscores the strong scientific foundation of Self-Depot™ OncoPDC technology. Advancing innovative therapies for patients with rare and hard-to-treat solid tumors remains central to Excellamol’s mission. Supported by data expected from our upcoming Phase 1 study, we will assess the most effective path forward for clinical development, including potential expansion into rare pediatric brain tumor indications (www.koreabiomed.com/news/articleView.html?idxno=27334).