Yimufeng's Nanobody-Based CLDN18.2 CAR-T Therapy IMC002 Receives FDA Orphan Drug Designation for Pancreatic Cancer
Immunofoco
Developer of Novel Therapeutics for Solid Tumors
On October 12, 2024, Immunofoco, an outstanding company invested by Daoyuan Capital and dedicated to the development of immune cell therapy products for breaking through solid tumor treatments, announced that its self-developed autologous CAR-T product IMC002 targeting CLDN18.2 has recently received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer patients. This marks the second ODD for IMC002, following its first ODD granted in July 2022 for the treatment of gastric cancer.
- The FDA's Orphan Drug Designation recognizes the significant potential of IMC002 in the field of pancreatic cancer treatment.
- IMC002 has completed the dose escalation of Phase I clinical trial in China, demonstrating good safety and efficacy.
The orphan drug designation not only highlights the significant potential of IMC002 in the field of pancreatic cancer treatment but also brings new hope for patients.According to GLOBOCAN 2022 statistics, pancreatic cancer ranks 12th in global cancer incidence and 6th in mortality, with mortality closely approaching incidence (510,570 new cases and 466,983 deaths globally in 2022). In China, there were 118,672 new cases and 106,295 deaths from pancreatic cancer in 2022, ranking 10th in cancer incidence and 6th in mortality. Known as the "king of cancers" due to its high mortality and extremely poor prognosis, pancreatic cancer urgently demands new treatment approaches and drugs.
Immunofoco's deep cultivation in the field of pancreatic cancer treatment reflects the company's commitment to providing innovative treatment solutions for patients worldwide. The company will continue to advance the clinical research of IMC002, with the hope of bringing more effective treatment options to pancreatic cancer patients as soon as possible.
IMC002
IMC002 is an autologous CAR-T product based on highly specific VHH nanobodies that selectively target CLDN18.2.This highly specific VHH antibody is expected to enhance the tolerability of IMC002 and expand its clinical dosage range, while also broadening its application in frontline treatment, combination/sequential therapy, and other scenarios, ultimately overcoming the challenges of solid tumor treatment.CLDN18.2 is highly expressed in a variety of tumors, including pancreatic cancer and gastric cancer, making it an ideal target for CAR-T cell therapy.
IMC002 obtained clinical approval from the U.S. FDA in March 2023 and received clinical implied permission from China's CDE in April 2023. Recently, IMC002 has completed the dose escalation of Phase I registered clinical trials in China. Preliminary data indicates that IMC002 has demonstrated good safety and efficacy in patients with advanced gastric cancer and pancreatic cancer who have failed all standard treatments. Notably, one patient with advanced pancreatic cancer, who had failed two lines of prior anti-tumor treatments and presented with multiple liver, lung, peritoneal metastases, as well as ascites, showed significant shrinkage of pancreatic lesions upon first tumor assessment after infusion of IMC002, achieving partial response.
About Immunofoco
Immunofoco is a biotechnology company dedicated to breaking through solid tumor treatments and bringing long-term survival benefits to patients worldwide. The company, established by scientists and industry elites, commenced operations in September 2020. Its core team successfully advanced the first CAR-T drug's market application in China, boasting extensive experience in cell drug development and industrialization.
Immunofoco, starting from the pain points of solid tumor treatment and clinical benefits, has proposed the clinical strategy of "transforming solid tumors into hematological tumors" for the first time globally. Based on this, it developed the Peri Cruiser® technology platform and also created other technology platforms such as SNR and T-Booster, aiming to enhance the safety of CAR-T products, counteract tumor heterogeneity, and improve their expansion and tumor infiltration capabilities.
The company has always been oriented towards clinical value, with a rich product pipeline. Among them, IMC002 (CLDN18.2 CAR-T) has received two Orphan Drug Designations (ODD) from the U.S. FDA for gastric cancer and pancreatic cancer, and its IND application was approved by both China and the U.S. in April 2023; IMC001 (EpCAM CAR-T) has conducted two IIT clinical studies, demonstrating good tolerable safety and preliminary efficacy. It received ODD designation from the U.S. FDA in August 2023, and its IND application was approved by both China and the U.S. in February 2024; IMC008 (SNR CAR-T) has rapidly advanced to the IIT clinical research stage, receiving two ODD designations from the U.S. FDA in August 2023 for the treatment of gastric cancer and pancreatic cancer.
Shenzhen Immunofoco Biotechnology Co., Ltd. adheres to the development philosophy of "collective efforts make tasks easier, unity realizes aspirations, and courage leads to new heights," gathering industry talents to jointly develop innovative drugs that can bring long-term survival benefits to patients with solid tumors.
About Daoyuan Capital
Daoyuan Capital is a leading private equity investment institution focused on the healthcare sector, dedicated to helping outstanding healthcare companies grow rapidly by leveraging capital and industry resources, providing better medical products and services to society, and promoting human health.
Currently, Daoyuan Capital manages 19 RMB funds and 4 USD funds, with investments in 90 outstanding projects, including 16 IPO projects (one of which has received registration approval from the CSRC). These include Prayes Ophthalmology (301239), Jinxin Fertility (HK.1951), Sinomed Medical (688108), Innovax Biotech (688253), Tinavi Medical Technologies (688277), Viva Biotech (HK.1873), Anbiping (688393), and Angenesis (688581), among others. As of the latest date in 2024, two companies have filed for IPOs, and more than 10 invested companies are expected to enter the IPO process within the next three years.
