IMC001 / Immunofoco - LARVOL DELTA

The world's first new indication application for EpCAM CAR-T was accepted [Google translation] (bydrug.pharmcube.com) - "On December 25, Yimufeng Biotech announced that its self-developed clinical trial application for the new indication of EpCAM autologous CAR-T cell injection product (IMC001) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (acceptance number: CXSL2400901), which is intended to be used for the treatment of epithelial advanced solid tumors."

New trial • Solid Tumor

Efficacy of EpCAM CAR-T IMC001 in advanced gastric cancers. (ASCO 2024) - "This phase I study in advanced gastric cancer resulted in durable response with a favorable safety and efficacy profile especially for the recommended dose of 1M/kg, demonstrate a promising of EpCAM CAR-T therapy in advanced GC pts. Further expanding of this dose with larger patient population and longer follow-up shall bring the hope to this unmet medical need."

Clinical • IO biomarker • Metastases • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • EPCAM

Immunofoco Biotech to Unveil Solid Tumor CAR-T Programs Clinical Trial Data at 2024 ASCO Meeting (PRNewswire) - P1 | N=11 | ChiCTR2100047129 | "An exciting phase I clinical trial was presented, showcasing the innovative application of CAR-T cell therapy targeting EpCAM for the treatment of advanced gastrointestinal (GI) cancers....Between August 18, 2021, and May 8, 2023, a total of 11 patients underwent IMC001 CAR-T cell infusion. As of the cutoff date (March 31st, 2024), infusions of low- and middle-dose IMC001 demonstrated a favorable safety profile. Among 10 evaluable patients, the disease control rate was 90%, with one patient in the low-dose group (1/3, 33.3%) and two in the middle-dose group (2/5, 40%) achieved a partial response (PR). The middle-dose was determined as the Recommended Dose, the median progression-free survival (PFS) was 18.1 weeks (95% CI 7.97, --) and the median overall survival (OS) was 55.1 weeks (95% CI 23.78, --) for this group; within the middle-dose group, 3/5 patients survived for more than 10 months."

P1 data • Gastric Cancer

Immunofoco Announces the Dual Approval of IND Applications by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors (PRNewswire) - "Immunofoco...announced a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T cell product for infusion, it also received the IND approval from the U.S. FDA, for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ)."

IND • New trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Immunofoco’s EpCAM CAR-T Cell Therapy IND Application Receives Acceptance from CDE (Immunofoco Press Release) - "Immunofoco, a cell therapy product development company dedicated to advancing treatments for solid tumors, announced that its independently developed, EpCAM-targeting autologous CAR-T cell product for infusion (IMC001) has officially received formal acceptance from the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) in China for its clinical trial application, the acceptance Number is CXSL2300792, this approval is granted for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ)."

New trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Orphan Designation: Treatment of gastric cancer (FDA) - Date Designated: 08/16/2023

Orphan drug • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase I Trial to Evaluate the Safety of IMC002 in Advanced Digestive System Tumors (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Suzhou Immunofoco Biotechnology Co., Ltd

Metastases • New P1 trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18 • IL10 • IL2 • IL6

EpCAM CAR T (IMC001) for the treatment of advanced GI cancers. (ASCO 2023) - P1 | "This is the first CAR-T therapy ever tested in humans targeting the EpCAM. IMC001 showed a favorable safety profile and reasonable anti-tumor activities at the low and middle dosage levels in patients with advanced EpCAM+ GI cancers, especially in gastric cancer. In addition, our trial has successfully provided a surgical treatment opportunity after CAR-T therapy downstaging of unresectable gastric cancers."

IO biomarker • Metastases • Colorectal Cancer • Dermatology • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Oncology • Pruritus • EPCAM • IFNG • IL15 • IL6

Peri Cruiser CAR-T: An innovative platform to reduce on-target off-tumor toxicity of CAR-T therapy. (ASCO 2023) - "To determine the toxicity in vivo, the anti-mouse EpCAM CAR-T cells were administered to non-tumor bearing NSG mice, and the body weight and T cell infiltration in normal tissues was evaluated... The Peri Cruiser CAR-T platform can significantly improve the safety of CAR-T cells without compromising their efficacy to eliminate tumor cells in primary site and metastasis. This technology opens another avenue to safely target a variety of other TAA by CAR-T even when there is the potential of on-target off-tumor toxicity in normal tissues for those antigens."

Oncology • Solid Tumor • CCR7 • IFNG

EpCAM-targeted CAR-T cell therapy in patients with advanced colorectal and gastric cancers (ESMO 2022) - P1 | "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."

CAR T-Cell Therapy • Clinical • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • EPCAM