Shanghai, Suzhou, Chengdu, October 12 --Immunofoco Biotech, a company dedicated to developing cell therapy products for solid tumors, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to IMC002, a novel CAR-T therapy targeting CLDN 18.2, for the treatment of pancreatic cancer. This recognition follows a similar designation for IMC002 in July 2022 for the treatment of gastric cancer, further underscoring the huge potential of IMC002 to meet the unmet medical needs of multiple solid tumors.
The FDA grants orphan drug designation to IMC002 that may provide a significant therapeutic advantage over existing treatments and target conditions that affect fewer than 200,000 people in the United States. GLOBOCAN 2022 data indicates that pancreatic cancer is the 12th most diagnosed cancer and the 6th leading cause of cancer-related deaths globally, with an almost identical incidence-to-mortality ratio. In 2022, there were an estimated 510,570 new cases and 466,983 deaths worldwide. In China, the disease affected 118,672 people, with 106,295 fatalities, emphasizing the severity of pancreatic cancer and the urgent need for effective treatments.
IMC002, the first CAR-T product utilizing a highly specific VHH nanobody, is an autologous CAR-T product targeting CLDN18.2. The highly specific VHH nanobody has equipped the CAR-T with a better safety profile and wider clinical dose window, and may expand the use of IMC002 in earlier-line, combo or sequential treatment. CLDN18.2 is highly expressed in a variety of tumors, including pancreatic and gastric cancer, making it an ideal target for CAR-T cell therapy.
IMC002 has received IND approval from the U.S. FDA and, in April 2023, obtained tacit approval from China's CDE. Recently, IMC002 has completed the Phase I dose-escalation trial with low, medium, and high dose groups in China. Preliminary data suggests that in patients with advanced gastric and pancreatic cancer who have failed standard-of-care treatments, IMC002 has demonstrated excellent safety and efficacy. For example, one advanced pancreatic cancer patient who had previously failed previous two-lines anti-tumor therapies and accompanied by multiple liver, lung, and peritoneal metastases and abdominal effusion achieved partial response at the first tumor evaluation after IMC002 infusion with significant reduction of tumor lesions including pancreatic lesions.
The dedication to the field of pancreatic cancer treatment demonstrates the company's commitment to providing innovative treatment solutions to patients globally. Immunofoco will continue to advance the clinical development of IMC002, aiming to bring more effective treatment options to pancreatic cancer patients as soon as possible.
About Immunofoco
Immunofoco has pioneered a clinical strategy focused on "curing the solid tumors by treating them as hematologic malignancies", addressing the challenges in solid tumor treatment, and the clinical advantages of treating hematologic malignancies. To improve the safety of CAR-T products, counteract tumor heterogeneity, and to enhance their effectiveness in tumor amplification and infiltration, we have developed innovative platforms such as Peri Cruiser®, SNR, and T-Booster. Driven by the clinical outcomes, our company maintains an extensive spectrum of product pipeline. Notably, our IMC002 (CLDN18.2 CAR-T) product obtained gastric ODD and pancreatic ODD from the U.S. FDA, and its IND application has been approved in both the U.S. and China in April 2023. Similarly, our IMC001 (EpCAM CAR-T) product obtained ODD from the U.S. FDA in August 2023, and its IND application has been approved in both the U.S. and China in February 2024. The IMC008 (SNR CAR-T) product has rapidly moved to the IIT stage and received two ODD approval from the U.S. FDA in August 2023, for the treatment of gastric cancer and pancreatic cancer, respectively. Embodying the ethos of "collaboration, aspiration, and dedication for the best clinical results," our company brings together industry talents and experts to develop innovative cell therapies that offer enduring survival benefits for patients with solid tumors. For further details about Immunofoco, please visit our website at www.immunofoco.com.
