In a significant breakthrough for pancreatic cancer treatment, a patient with advanced pancreatic cancer who had previously failed two lines of anti-cancer therapy has experienced sustained remission following Immunofoco IMC002 CAR-T cell therapy at the First Medical Center of the General Hospital of the Chinese People's Liberation Army (Beijing 301 Hospital). This case marks a pivotal moment in the application of CAR-T cell therapy for solid tumors, particularly pancreatic cancer, which is often referred to as the "king of cancers" due to its high mortality rate and poor prognosis.
According to GLOBOCAN 2022 statistics, pancreatic cancer ranks 12th in global cancer incidence and 6th in mortality, with a striking proximity between incidence and mortality rates. In China, there were 118,672 new cases and 106,295 deaths in 2022, highlighting the urgent need for new treatment methods and drugs.
The patient, diagnosed with moderately differentiated pancreatic adenocarcinoma with liver metastasis in March 2024, underwent a pancreatoduodenectomy followed by first and second-line chemotherapy. However, disease progression was observed in June 2024, with multiple metastases to the pancreas, liver, lungs, peritoneum, and the presence of ascites. After thorough communication and assessment, Professor Jianming Xu, Chief Physician of the Oncology Department at Beijing 301 Hospital, deemed the patient eligible for the IMC002 CAR-T cell therapy clinical trial. The patient underwent leukapheresis in July 2024 and received the infusion in August.
On September 28, six weeks post-infusion, the first tumor assessment revealed a significant reduction in pancreatic lesions, with a 30.3% decrease from the baseline, achieving a partial response (PR). A second tumor assessment on November 2 confirmed further tumor shrinkage, with a 39.4% reduction from the baseline at 12 weeks, confirming the partial response (PR) and sustained remission for over 3 months.
Professor Jianming Xu remarked, "Pancreatic cancer is among the most aggressive gastrointestinal malignancies, with gemcitabine-based chemotherapy being the standard first-line treatment. Yet, for those whose disease progresses post-initial therapy, second-line treatments are not only limited but also frequently fall short of expectations. CAR-T cell therapy, as an emerging immunotherapy approach, offers a new direction for pancreatic cancer patients. This patient has shown continuous tumor reduction and improved disease control following IMC002 CAR-T cell therapy, providing a new treatment option and hope for pancreatic cancer patients."
"IMC002, an autologous CAR-T product targeting CLDN18.2, utilizes a highly specific VHH nanobody, enhancing its safety and allowing for a broader clinical dose range, which may facilitate its use in earlier-line, combination, or sequential treatments. 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 received clinical approval from the U.S. FDA in March 2023 and implicit approval from China's CDE in April 2023. Additionally, IMC002 has been granted orphan drug designation for gastric and pancreatic cancer by the FDA. Recently, IMC002 has completed the registered clinical dose-escalation phase in China, showing promising safety and efficacy in late-stage gastric and pancreatic cancer patients who have failed standard treatments.
The clinical trial of IMC002, initiated across several renowned hospital research centers such as the First Medical Center of the General Hospital of the Chinese People's Liberation Army (Beijing 301 Hospital), Fujian Provincial Cancer Hospital, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Zhejiang University School of Medicine in Hangzhou, Shandong Cancer Hospital, West China Hospital of Sichuan University, The Second Affiliated Hospital of Nanchang University, and The First Affiliated Hospital of the Naval Medical University (Changhai Hospital in Shanghai). These centers are currently enrolling patients with advanced gastric cancer.
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.