EO-1001 Program

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EO-1001 Program

EO-1001 (APL-122): A First-in-Class Irreversible Pan-ErbB TKI with CNS Penetration

Overview Of The EO-1001 Program

EO-1001 is an investigational, first-in-class, orally bioavailable, irreversible tyrosine kinase inhibitor that targets multiple members of the ErbB receptor family – EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4). Its most notable feature is central nervous system (CNS) penetration, positioning it uniquely for ErbB-driven tumors with brain involvement.

Key Differentiators

  • Broad Mechanism of Action: Irreversibly inhibits EGFR, HER2, and HER4, including resistance-associated mutations such as EGFR T790M, L858R, exon 19 deletions, and EGFRvIII, which is particularly relevant in glioblastoma.
  • CNS Penetration: Demonstrated ability to cross the blood-brain barrier in preclinical models addressing a critical unmet need in treating brain metastases and primary CNS tumors.
  • Favorable Preclinical Profile: Shows promising pharmacokinetics, safety, and efficacy in patient-derived xenograft models of ErbB-driven cancers. (Such as, lung, breast, and brain)

EO-1001 Clinical Trial​

Current Trial:

  • Phase 1/2a First-in-Human Trial: Taking place in Australia (ANZCTR ref. ACTRN12620000583943)
  • Indications: Advanced/metastatic ErbB-positive solid tumors, including EGFR+ NSCLC, HER2+ breast cancer, glioblastoma, and others
  • Enrollment: Up to 50 patients 
  • Design:
    • Accelerated dose-escalation (single-patient cohorts → 3+3 design)
    • Expansion at maximum tolerated dose (MTD)
    • Evaluation of safety, PK, tolerability, and early signs of efficacy
  • Status: Currently enrolling Phase 2a expansion cohort at and below the MTD

CNS Eligibility: Inclusion of patients with brain metastases and glioblastoma underscores EO-1001’s differentiating feature—CNS activity.

Target Indications & Rationale

Indication
Target
Rationale
HER2+ Breast Cancer
ErbB2
15-20% of cases – aggressive but targetable
EGFR-Mutant NSCLC
ErbB1
Common mutations include L858R, exon 19 del; high prevalence in Asia
HER2+ Gastric/GEJ Cancer
ErbB2
Up to 20% of gastric cancers are HER2+
Colorectal Cancer
EFGR/ErbB1
Targetable in KRAS/NRAS wild-type tumors
HNSCC
EFGR/ErbB1
EGFR overexpression in 80-90% of cases
Glioblastoma (GBM)
EGFRvIII, HER2
EFGRvIII in ~40% of GBMs; HER2 also implicated
CNS Metastases
EGFR+ NSCLC, HER2+ BC
Frequent in advanced cancers, Blood Brain Barrier is challenging

Market Opportunity

Market
2023 Est. Size
Growth Drivers
EGFR Inhibitors
~$9B
NSCLC, colorectal, HNSCC
HER2 Therapies
~$7B+
Breast, gastric,
CNS-Penetrant TKIs
Significant
High unmet need in brain mets, GBM

Strategic Collaboration

  • Edison Oncology licensed global rights (ex-China/HK/Taiwan) to Apollomics Inc.
  • Apollomics is funding Edison Oncology’s Phase 1-2a trial and will be responsible for further development and commercialization in licensed territories.
  • Edison Oncology received an upfront cash payment and is eligible to receive development and commercial milestones and royalties on sales.

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