Our Pipeline

A focused portfolio of differentiated oncology programs with Best-in-Class AND First-in-Class ADCs

Adcendo is advancing a pipeline of first- and best-in-class ADC candidates across solid epithelial tumors and cancer with mesenchymal origin, with three programs in clinical development and additional discovery assets progressing toward IND-studies.

Pipeline Asset Preclinical Phase 1 / 2 Pivotal Study
ADCE-T02
Target: Tissue Factor
Indications: HNSCC, PDAC, CRC, NSCLC, CC
Information: Optimized monoclonal antibody; next generation and clinically validated Topo I Linker/payload; Phase I study ongoing in Australia; US IND clearance obtained
ADCE-D01
Target: uPARAP
Indications: Mesenchymal tumors, soft tissue sarcoma
Information: Monoclonal antibody designed to not interfere with natural ligand of uPARAP; next generation and clinically validated Topo I Linker/Payload; US IND clearance obtained; Phase I study planned in US and EU
ADCE-B05
Target: Undisclosed
Indications: Squamous cell solid tumors
A0401
Target: Undisclosed
Indications: Undisclosed solid tumors

Our Programs

ADCE-T02

ADCE-T02 is a potential best-in-class ADC that combines an optimized Tissue Factor (TF) targeting monoclonal antibody with a next generation linker and exatecan payload technology, aiming to deliver better efficacy and improved tolerability.

TF is a clinically validated ADC target overexpressed in numerous solid tumor indications and associated with poor prognosis. Unlike the first-generation TF targeting ADC, ADCE-T02 has been optimized to avoid interference with the coagulation pathway and deliver a potent exatecan payload using an optimized hydrophilic, cleavable linker. ADCE-T02 has demonstrated strong anti-tumor activity in in vivo studies across a range of solid tumors with both high and low TF expression as well as excellent tolerability in toxicity studies. The combination of an optimized monoclonal antibody with a clinically validated topoisomerase I based linker-payload technology makes ADCE-T02 a promising candidate for improving cancer treatment outcomes over existing options.

ADCE-T02 is being investigated in a multicenter Phase I study (NCT06597721) that aims to assess its safety, tolerability, and optimal dose selection in patients with advanced cancers at clinical trial sites across the United States and Australia.

Enrolment is ongoing in the cohort expansion portion of Tiffany-01 study across multiple solid tumor indications. The expansion cohorts are designed to evaluate two go-forward dose levels in a randomized setting, supporting dose optimization and enabling additional assessments of safety, anti-tumor activity, and durability of response. These data are expected to provide further clinical proof of concept and better inform the potential therapeutic profile of ADCE-T02 across multiple solid tumor indications.

Stage

Indications

  • Range of solid tumors expressing TF

Technology

  • Optimized TF targeting mAb that avoids coagulation pathway interference
  • Exatecan (topoisomerase I) based payload
  • Hydrophilic, cleavable linker

 

ADCE-D01

ADCE-D01 is a first-in-class ADC targeting uPARAP, an endocytic receptor overexpressed on a wide spectrum of cancers of mesenchymal origin, including soft tissue sarcomas, osteosarcoma, GIST, mesothelioma, and glioblastoma.

uPARAP is an ideal ADC target due to its rapid internalization and constitutive recycling, as well as its highly differentiated expression profile between tumor and healthy tissues. ADCE-D01 combines a uPARAP binding antibody designed to avoid interference with the natural receptor ligand, collagen, paired with a clinically validated protease-cleavable linker and potent deruxtecan payload. Preclinical studies have demonstrated strong anti-tumor activity across a range of in vivo models, as well as a highly encouraging toxicology profile, positioning ADCE-D01 as a potential first- and best-in-class ADC for patients with mesenchymal cancers of high unmet medical need.

ADCE-D01 is being investigated in a multicenter Phase I/II study (NCT06797999) to assess its safety, tolerability, and optimal dose selection in patients with patients with soft tissue sarcoma at clinical trial sites across the United States and Europe.

ADCE-D01 received Fast Track Designation and Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of soft tissue sarcoma.

Stage

Indications

  • Mesenchymal cancers, including soft tissue sarcomas, osteosarcoma, GIST, mesothelioma

Technology

  • First-in-class uPARAP binding antibody
  • Exatecan-derivative topoisomerase I payload
  • Hydrophilic, cleavable linker

 

ADCE-B05

ADCE-B05 is a first-in-class ADC (target undisclosed) using a clinically validated linker-payload.

ADCE-B05 has demonstrated strong anti-tumor activity in in vivo studies across a range of squamous cell tumors and exhibited excellent tolerability in pre-clinical toxicity studies.

ADCE-B05 is being investigated in a multicenter phase I study (NCT07362888) that aims to assess its safety, tolerability, and optimal dose selection in patients with advanced cancers at clinical trial sites across the United States and Australia.

Stage

Indications

  • Squamous solid tumors

Technology

  • First-in-class ADC (target undisclosed)
  • Exatecan-derivative topoisomerase I payload
  • Hydrophilic, cleavable linker