-Two IIT studies of IMC001 indicated for advanced gastric cancer and advanced gastrointestinal malignancies,
respectively
-All 6 subjects passed the Day28 safety evaluation, showing that IMC001 is safe and tolerated
-Five subjects showed stable disease after treatment, with a disease control rate (DCR) of 83.3%, and one subject has
maintained stable disease for more than 7 months
-The dose escalation studies of these two IIT studies of IMC001 will be completed in 2022.
July 19, 2022, Shanghai and Suzhou, China-Immunofoco, a leading company developing innovative cell therapy drugs, today announced the completion of low-dose group study intwo investigator initiated trials (IIT) of its novel cell therapy candidate, IMC001, targeting advanced gastric cancer and advanced gastrointestinal malignancies respectively. There were 3 subjects in the low dose group of each study. All the 6 subjects passed Day 28 safety evaluation without dose-limiting toxicity (DLT). Most of the reported adverse events were mild to moderate in severity. Two subjects experienced cytokine release syndromes (CRS) of grade 1 and 2 after IMC001 infusion, respectively, and no immune effector cell-associated neurotoxic syndromes (ICANS) were observed.
The efficacy evaluation showed that 5 out of the 6 subjects showed stable disease (SD) after IMC001 treatment, and the disease control rate (DCR) was 83.3%. Among them, one subject with gastric cancer who failed multiple lines of treatment, had maintained stable disease status for more than 7 months, and showed continuous reduction of target lesions, sustained response in nontarget lesions (disappearance of ascites, reduction of tumor markers CA125 and CEA to normal levels).

Immunofoco has also established a microfluidic technology-based circulating tumor cells (CTC) detection platform. After treatment, CTCs of these subjects were significantly reduced and maintained below the limit of detection.
IMC001 is an autologous EpCAM-targeted CAR-T product. EpCAM is highly expressed in a variety of epithelial cell-derived tumors, especially in digestive system malignant tumors, and its expression is uniform (90% expression rate), making it an effective target for such advanced tumors. At the same time, EpCAM is also expressed on CTCs. CTCs are the seeds of tumor metastasis. Clearing CTCs helps to block the distant metastasis of tumors.
According to statistics, in 2020, there were 555,000 new cases and 286,000 deaths of colorectal cancer, 479,000 new cases and 374,000 deaths of gastric cancer in China. The number of new cases and deaths is highest in the world, and it still shows an increasing trend. Recurrence and metastasis are the main causes of death for cancer patients. Liver metastasis occurs in 40%-50% of colorectal cancers, and peritoneal metastasis occurs in more than 50% of gastric cancer patients. The effectiveness of existing drug therapy is limited and insufficient to meet the clinical needs of patients.
Professor Tianhang Luo, Chief Physician of Gastrointestinal Surgery, Changhai Hospital, Naval Medical University, and the principal investigator of the CT-03 study of IMC001, said: "We are very excited about the safety and efficacy of IMC001 observed in the low-dose group. Although the patients can only be rated as stable disease (SD) according to the RECIST1.1, but from the improvement of non-target lesions, the patients actually benefited significantly. For example, when the ascites completely disappeared, target lesions were in a state of disease control for a long time, then tumor-bearing survival could be achieved. And because of the control of non-target lesions, patients may also get the opportunity to surgically removal of target lesions. This is more meaningful than short-term PR or even CR.”
Professor Fang Weijia, chief physician of the Medical Oncology, the First Affiliated Hospital of Zhejiang University, and the principal investigator of the CT-04 study of IMC001, said: "The safety and efficacy data makes me look forward to the results of medium and high doses grups. And we will combine IMC001 with ablation to treat patients with liver metastasis of gastrointestinal cancers. We believe that combination of CAR-T and ablation may bring long-term survival benefits to these patients.”
"We are pleased to see the good safety and efficacy of IMC001 at low dose group in these IIT trials. Although EpCAM, as a tumor-associated antigen, like other CAR-T targets for solid tumors, has potential ‘on-target off-tumor’ toxicity risks, IMC001 has already shown a dosage window with acceptable safety and efficacy,. Combined with our clinical strategy-‘Curing the Solid Tumors by Treating Them as Hematologic Malignancies’, it is expected to bring significant clinical benefits to patients. We will continue to promote the enrollment of patients in the medium and high dose groups of the IMC001 IIT trials, and plan to complete the dose escalation study in this year, "said Crystal Sun, the Founder and CEO of Immunofoco, “How to solve the risk of on-target off-tumor toxicity is the key point of whether CAR-T therapy can break through the treatment of solid tumors. After solving the safety problem, we have many ways to improve the effectiveness of CAR-T therapy. In addition to our clinical strategy, we have developed Peri Cruiser® technology platform which can improve the safety of CAR-T therapy and expand its dosage window. We believe that this technology can bring a real breakthrough for CAR-T treatment of solid tumors.”
About Immunofoco
Immunofoco is a clinical-stage biotech company, devoted to bringing revolutionary immune cell drugs to patients with solid tumors. The operation started in September 2020, with the founding members combined the mavens from the industry, academia, business, and medical professions, and the executive committees had their hands on all the critical activities in advancing the NDA approval of the first CAR-T drug in China.
We draw our attention to the clinical barriers of the solid tumors, and have established our competitive, patented R&D pipelines. To overcome the toxicity risks in solid tumor treatments, we have adopted firstly the strategy of “curing the solid tumors by treating them as hematologic malignancies” and have established the Peri Cruiser® platform to further reduce the potential toxicity risks of CAR-T treatment. Based on that, additional technology platforms been used to further armor the CAR-T or as combination therapy to enhance the efficacy, thus we can achieve the breakthrough of solid tumor treatment.
With the mission of pursuing breakthroughs in solid tumor treatments with immune cell therapies, we are working with internal and external industry talents, to bring survival benefits to patients with solid tumors.