indusatumab vedotin (TAK-264) / Takeda, Pfizer - LARVOL DELTA

Preclinical Antitumor Activity and Biodistribution of a Novel Anti-GCC Antibody-Drug Conjugate in Patient-Derived Xenografts. (PubMed, Mol Cancer Ther) - P1 | "Collectively, our data suggest that TAK-164 is highly active in multiple GCC positive tumors including those refractory to TAK-264, a GCC-targeted auristatin ADC. A strong relationship between uptake of 89Zr-labeled TAK-164, levels of GCC expression and, most notably, response to TAK-164 therapy in GCC expressing xenografts and PHTX models. These data supported the clinical development of TAK-164 as part of a first-in-human clinical trial (NCT03449030)."

Journal • Colorectal Cancer • Oncology

MLN0264 in Previously Treated Asian Patients With Advanced Gastrointestinal Carcinoma or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Guanylyl Cyclase C (clinicaltrials.gov) - P1/2; N=12; Completed; Sponsor: Millennium Pharmaceuticals, Inc.; Recruiting ➔ Completed; N=95 ➔ 12

Enrollment change • Trial completion • Biosimilar • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology

Takeda: Q3 FY 2015 Results (Takeda) - “Development terminated due to lack of efficacy”

Discontinued • Gastric Cancer • Oncology • Pancreatic Cancer

Dual-isotope Cryo-imaging Quantitative Autoradiography (CIQA): Anvestigating Antibody-Drug Conjugate Distribution And Payload Delivery Through Imaging. (PubMed, J Nucl Med) - "... TAK-264, an investigational ADC targeting anti-guanylyl cyclase C (GCC), was synthesized using tritiated monomethyl auristatin E. The tritiated ADC was then conjugated to diethylenetriaminepentaacetic acid, labeled with In, and evaluated in vivo in animals bearing GCC-positive and GCC-negative tumors...For GCC-positive tumors, a representative section obtained 96 hours post tracer injection showed only 0.8% of the voxels have co-localized signal versus over 15% of the voxels for a GCC-negative tumor section., suggesting successful and specific cleaving of the toxin in the antigen positive lesions. The combination of a veteran established autoradiography technology with advanced image analysis methodologies affords an experimental tool that can support detailed characterization of ADC tumor penetration and pharmacokinetics."

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Evaluation of TAK-264, an Antibody-Drug Conjugate in Pancreatic Cancer Cell Lines and Patient-Derived Xenograft Models. (PubMed, Clin Cancer Drugs) - "TAK-264 has shown suppression activity in pancreatic cancer cell lines and in pancreatic PDX models. These findings support further investigation of ADC targeting GCC."

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