IMC-001

P2, N=30, Not yet recruiting, ImmuneOncia Therapeutics Inc.

P2, N=23, Active, not recruiting, ImmuneOncia Therapeutics Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Feb 2026 | Trial primary completion date: Dec 2023 --> Jul 2024

P1, N=3, Active, not recruiting, Mayo Clinic | Recruiting --> Active, not recruiting | N=18 --> 3

Clinical trial identification The study had a classic 3+3 design for each indication trial, with separate EpCAM CAR-T cell (IMC001) dose escalations for monotherapy...Conclusions We present valuable insights into the pathophysiology of CRS and suggest that TLR4 on CD36+ monocytes is a promising target for managing CRS, which offers a new strategy for mitigating the side effects of CAR-T therapy. We also highlight the role of innate immune components, particularly CD16+ monocytes, in achieving optimal CAR-T treatment efficacy through antigen processing and presentation.

IMC001 shows a favorable safety profile and reasonable anti-tumor activities at the initial dosage level in patients with refractory EpCAM+ cancers of digestive system. Updated data from open cohorts will be presented.

These results suggest that NK cells induce an ADCC response in combination with anti-PD-L1 mAbs, which helps promote ADCC antitumor activity against PD-L1-positive tumors. This study provides support for NK cell immunotherapy against high PD-L1-expressing tumors in combination with ADCC through anti-PD-L1 mAbs.

"Neoadjuvant IMC-001 seems to be well tolerated and have preliminary immune modulating activity in resectable GC, EC, and HCC pts. The study is ongoing and the updated clinical and immunologic results will be presented. Research Funding: ImmuneOncia Therapeutics, Inc., Asan Institute for Life Sciences, Asan Medical Center"