A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer

Summary

Participation Requirements

Description

Investigational Medicinal Product, IMU-201, consists of drug substance, APi2568, which is a B-cell epitope (amino acids 92-110 from PD-1) linked to a promiscuous T-cell epitope (amino acid residues 288-302 from measles virus fusion protein) via a 4-amino acid linker (Gly-Pro-Ser-Leu), and combined w...

Investigational Medicinal Product, IMU-201, consists of drug substance, APi2568, which is a B-cell epitope (amino acids 92-110 from PD-1) linked to a promiscuous T-cell epitope (amino acid residues 288-302 from measles virus fusion protein) via a 4-amino acid linker (Gly-Pro-Ser-Leu), and combined with Water for Injection (WFI) forms the drug product, IMU-201, which becomes PD1-Vaxx when emulsified with excipient Montanide ISA 720 VG. It is hypothesized that a polyclonal induced B-cell antibody response will be more effective or as effective with improved safety over current monoclonal antibody therapy. This phase 1 study is designed to assess the safety, tolerability, and immunogenicity of IMU-201 (PD1-Vaxx) as monotherapy in patients with PD-L1 expressing non-small cell lung cancer (NSCLC). The monotherapy dose-escalation of IMU-201 (PD1-Vaxx) will establish the optimal biological dose. Once established, the dose cohort will be expanded to a total of 10 participants. Once the monotherapy optimal biological dose is established and expansion complete, the protocol will be modified to include a combination dose escalation with standard of care treatment.

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