Self-Depot OncoPDC™ Therapeutics for High-Mortality Cancers

  • Excellamol is a biotechnology company developing next-generation Self-Depot OncoPDC™ therapeutics for hard-to-penetrate and high-mortality cancers, including malignant glioma and pancreatic cancer.

  • The company’s proprietary self-assembling polypeptide-drug conjugate platform is designed to enable multi-week local drug retention, sustained intratumoral exposure, and reduced systemic toxicity following local or intracranial administration.

  • Excellamol is advancing a differentiated oncology platform focused on localized pharmacokinetic engineering for tumors where conventional systemic therapies have shown limited efficacy due to poor tissue penetration, rapid clearance, or dose-limiting toxicities.

  • The company’s development strategy is focused on generating clinically meaningful local drug exposure in tumors where conventional systemic therapies have historically shown limited efficacy.

Platform Differentiation

  • The Self-Depot OncoPDC™ platform is designed to address major limitations of conventional oncology therapeutics, particularly in brain and other difficult-to-penetrate tumors.

  • Potential applicability across multiple payload classes, including topoisomerase inhibitors, immuno-oncology agents, and radiotherapeuticsal investigations demonstrated substantially extended intracranial pharmacokinetic exposure profiles and favorable biodistribution characteristics compared with conventional local therapeutic approaches.

  • Key platform characteristics include:

    (1) Multi-week intracranial and local drug retention

    (2) Sustained tumor exposure following a single administration

    (3) Minimal systemic exposure following local delivery

    (4) Reduced risk of systemic toxicity

    (5) Compatibility with highly potent payloads

Pipeline and Regulatory Momentum

  • Excellamol has three U.S. FDA Orphan Drug Designations (ODD) and expects two additional FDA ODDs in 2026 for:

(1) XM146-MPA-SN38 for pancreatic cancer,

(2) XM147-SN38 for malignant glioma

(3) XM161-SN38 for malignant glioma

(4) XM182-MVCP-Exatecan for malignant glioma

(5) XM199-MVCP-Exatecan for malignant glioma

  • Excellamol has successfully completed two FDA INTERACT meetings and plans to conduct three additional FDA meetings in 2026 to support IND-enabling development and first-in-human clinical trial planning.

  • Notably, these regulatory achievements were accomplished primarily through the company’s internal scientific and regulatory capabilities without reliance on external regulatory consulting firms, reflecting a highly capital-efficient development strategy.

  • The company is currently transitioning from advanced preclinical development into IND-enabling studies for planned first-in-human clinical programs in malignant glioma and pancreatic cancer.

Scientific Validation

  • The company’s scientific findings have been presented and peer-reviewed through internationally recognized neuro-oncology conferences and publications. Highlights include:

    (1) Poster presentation at the 2025 Society for Neuro-Oncology Annual Meeting on the preclinical efficacy of XM147-SN38 and XM161-SN38

    (2) Oral presentation on the pharmacokinetics, biodistribution, and neurotoxicity evaluation of XM182-MVCP-Exatecan

    (3) Peer-reviewed publication in Neuro-Oncology Advances (2025)

  • Preclinical studies demonstrated:

    (1) Sustained intracranial exposure profiles with minimal systemic leakage following local administration

    (2) Favorable neurotoxicity observations following intracranial delivery

    (3) Durable tumor control and prolonged survival in aggressive malignant glioma models

    (4) Encouraging translational pharmacokinetic and biodistribution characteristics supporting localized therapeutic exposure

Intellectual Property

  • Excellamol continues to expand its intellectual property portfolio surrounding the Self-Depot OncoPDC™ platform and therapeutic applications. Current IP status includes:

    (1) 1 registered Japanese patent

    (2) 2 Korean patent applications

    (3) 2 PCT applications

    (4) 2 U.S. patent applications expected by June 2026

Development Strategy and Clinical Readiness

  • Excellamol is currently conducting GLP toxicology and pharmacokinetic studies to support IND submissions and first-in-human clinical trials targeted for the first quarter of 2028. For CMC development and GMP manufacturing, the company has established collaborations with Sterling Pharma Solutions and KBI Biopharma.

  • Clinical development collaborations include: Asan Medical Center for pancreatic cancer clinical studies and UCSF Helen Diller Family Comprehensive Cancer Center as a candidate site for first-in-human malignant glioma clinical trials

  • Excellamol was also selected for the BTR-NTA Program, an international nonprofit initiative supporting translational development strategies for brain tumor therapeutics.

Investment Highlights

  1. Differentiated localized oncology platform with sustained intracranial pharmacokinetic retention

  2. Multiple FDA Orphan Drug Designations and ongoing FDA regulatory engagement

  3. Strong translational positioning in malignant glioma and pancreatic cancer

  4. Multi-asset platform applicability across multiple payload classes

  5. Capital-efficient internal regulatory execution capability

  6. Peer-reviewed scientific validation and international conference presentations

  7. IND-enabling studies underway with planned first-in-human clinical development

  8. Strategic manufacturing and clinical collaborations supporting global development readiness