FAP-2286 and Clovis' Targeted Radionuclide Therapy Development Program

In September 2019, Clovis and 3B Pharmaceuticals GmbH (3BP) entered into a global licensing and collaboration agreement with an initial focus on developing FAP-2286, a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). 

FAP-2286, is Clovis Oncology’s peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) and is the lead candidate in the Company’s targeted radionuclide therapy development program. FAP-2286 is a clinical candidate under investigation as a PTRT and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. FAP is highly expressed in cancer-associated fibroblasts (CAFs) which are found in the majority of cancer types, at varying levels, potentially making it a suitable target across a wide range of tumors. High FAP expression has been shown in multiple tumor types including pancreatic ductal adenocarcinoma, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous NSCLC, and head and neck cancers as well as in cancers of unknown primary. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade.[i] The Phase 1/2 LuMIERE study of FAP-2286 is open for enrollment. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel. FAP-2286 is an unlicensed medical product.

Clovis also has global rights to three additional discovery-stage compounds in its targeted radionuclide development program.

[i] Kwan T et al. Pan-Cancer Analysis of Fibroblast Activation Protein Alpha (FAP) Expression to Guide Tumor Selection for the Peptide-Targeted Radionuclide Therapy FAP-2286. Virtual Presentation 2021 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, 2021.

FAP-2286 Scientific Presentations

<sup>177</sup>Lu-FAP-2286 in patients with advanced or metastatic solid tumours: updated data from a phase 1/2 study investigating safety, pharmacokinetics, dosimetry, and preliminary antitumour activity (LuMIERE)

Oral Presentation 2022 EANM Annual Congress

First-in-human evaluation of <sup>68</sup>Ga-FAP-2286, a fibroblast activation protein targeted radioligand

Oral Presentation 2022 SNMMI Annual Meeting

<sup>177</sup>Lu-FAP-2286 in patients with advanced or metastatic solid tumors: initial data from a phase 1/2 study investigating safety, pharmacokinetics, dosimetry, and preliminary antitumor activity (LuMIERE)

Oral Presentation 2022 SNMMI Annual Meeting

Imaging of Solid Tumors Using <sup>68</sup>Ga-FAP-2286

Poster Presentation 2022 ASCO Annual Meeting

Comparative Biodistribution and Radiotherapeutic Efficacy of the Fibroblast Activation Protein (FAP)-Targeting Agents FAP-2286 and FAPI-46

Poster Presentation 2022 AACR Annual Meeting

LuMIERE: A Phase 1/2 Study Investigating Safety, Pharmacokinetics, Dosimetry, and Preliminary Antitumor Activity of <sup>177</sup>Lu-FAP-2286 in Patients With Advanced or Metastatic Solid Tumors

Poster Presentation 2022 AACR Annual Meeting

Preclinical evaluation of FAP-2286, a peptide-targeted radionuclide therapy to fibroblast activation protein alpha

Poster Presentation 2020 ESMO Virtual Meeting