Satricabtagene autoleucel

SHANGHAI, June 4, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the final follow-up results of the investigator-initiated trial CT041-CG4006 (NCT03874897) of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against Claudin18.2) have been published in Nature Medicine on June 3, 2024. Data were presented as an oral presentation at the 2024 American Society of Clinical Oncology ("ASCO") Annual Meeting on June 3, 2024, 12:30 pm-3:30 pm, Eastern Daylight Time. Further details have been posted on the corporate website . The article in Nature Medicine was titled "Claudin18.2-specific CAR T Cells in gastrointestinal cancers: phase 1 trial final results".[1] The 2024 ASCO Annual Meeting abstract was titled "Claudin18.2-Targeted Chimeric Antigen Receptor T Cell Therapy for Patients with Gastrointestinal Cancers: Final Results of CT041-CG4006 Phase 1 Trial".[2] The leading PI of this study, Professor Lin Shen of Beijing Cancer Hospital, said, "Satri-cel has shown promising efficacy and manageable safety profiles in patients with Claudin18.2-positive advanced gastrointestinal cancers, particularly those with gastric cancer or gastroesophageal junction cancer. This study marks a significant advancement in the field of CAR T-cell therapy for solid tumors. It suggests that CAR T-cell therapy has the potential to transform existing treatment paradigms and provides important reference points for further innovative research. In the future, we anticipate that more clinical trials and studies will further validate and refine this innovative therapy, enabling it to benefit a broader patient population as soon as possible." Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are delighted to announce that the final results of the CT041-CG4006 study have been simultaneously published in the prestigious journal Nature Medicine and reported as an oral presentation at the 2024 ASCO Annual Meeting. This study represents a significant milestone in the field of CAR T-cell therapy for solid tumors, demonstrating the encouraging safety and efficacy of satri-cel. We extend our heartfelt thanks to the investigators for their years of dedicated efforts, and to the patients and their families for their trust and support. It is our shared goal to provide better treatment options for patients, and we will continue to advance the global clinical development of satri-cel, ensuring this innovative CAR T-cell therapy benefits more patients with gastric, pancreatic, and other gastrointestinal cancers." About Satri-cel Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that can potentially be the first-in-class globally. Satri-cel has been developed for the treatment of Claudin18.2 positive solid tumors with a primary focus on gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). Ongoing trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced GC/GEJ in China (CT041-ST-01, NCT04581473), a Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA for the treatment of advanced GC/GEJ with Claudin18.2-positive tumors in January 2022 and was granted PRIME eligibility by the EMA for the treatment of advanced gastric cancer in November 2021. Satri-cel received an Orphan Drug designation from the U.S. FDA in 2020 for the treatment of GC/GEJ and an Orphan Medicinal Product designation from the EMA in 2021 for the treatment of advanced gastric cancer. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform, encompassing target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's mission is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, . No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Reference [1] Qi, C., Liu, C., Gong, J. et al. Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial final results. Nat Med (2024). [2] Qi C, et al. ASCO 2024. Abstract 2501 Company Codes: HongKong:2171

CHICAGO, June 1, 2024 /PRNewswire/ -- On June 1st, 2024, Immunofoco Biotech, a company dedicated to developing cell therapy products for solid tumors, announced that the clinical research data for two of its products have been accepted for presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The company will showcase the latest clinical trial findings for IMC001 in a poster presentation and for IMC002 in an online presentation during the ASCO event, scheduled from May 31 to June 4, 2024. Outstanding safety and efficacy data of IMC002, an autologous CLDN18.2-targeting CAR-T, in CLDN18.2+ advanced solid tumors (e16012) Claudin 18.2 (CLDN18.2) is a promising therapeutic target for treating advanced solid tumors. IMC002 is an autologous CLDN18.2-targeting CAR-T cell directed by a high specific anti-CLDN18.2 VHH, the specificity of which was confirmed by a membrane proteome array assay. Preclinical studies showed that IMC002 exhibited high tumor specificity, potent anti-tumor efficacy, and excellent safety profile in both cellular and animal models. As of January 17, 2024, three patients with advanced unresectable gastric cancer received IMC002 infusion. There was no dose-limiting toxicity (DLT) or serious adverse events (SAE) reported. All three patients experienced manageable cytokine release syndrome (CRS) at grade 1. In addition, all adverse events recovered quickly. Preliminary efficacy data showed that all three patients exhibited stable disease as their best overall response, as evaluated by RECIST 1.1 criteria. Among the two patients who received a dosage of 3 million CAR-T cells/kg, successful radical surgeries were performed at week (W) 11 and 44 post-IMC002 infusion respectively when CAR-T treatment reduced the tumor burden. Notably, pathological complete response (pCR) was achieved in one patient with surgery at W44. Noteworthy expansion of CAR-T cells in peripheral blood was observed in all three patients, with peak CAR+cell counts recorded between day 7-11 in the peripheral blood post-infusion. Moreover, CAR-T cell infiltration in the tumor tissues was detected in the surgical samples obtained at weeks 11 and 44. Significant increases of serum levels of IFN-y, IL-10, IP-10, IL-2 and IL-6 were observed in all three patients. The trial remains ongoing. IMC002 demonstrated a promising safety profile, along with encouraging anti-tumor effects, including observed pCR and sustained expansion within tumor tissues, even at the low dosage levels among patients with advanced CLDN18.2+ gastric cancer. In addition, our trial has successfully facilitated a surgical treatment intervention following CAR-T therapy, enabling the downstaging of previously deemed unresectable gastric cancers. Efficacy of EpCAM CAR-T IMC001 in advanced gastric cancers (Poster #4043) 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. Led by a collaborative team of physicians and scientists from Shanghai Changhai Hospital, The First Affiliated Hospital of Zhejiang University, and Suzhou Immunofoco Biotechnology Co., Ltd, the trial demonstrated promising safety and preliminary efficacy findings for IMC001. 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. One patient in the middle-dose group achieved a confirmed PR by Week 24, leading to a radical gastrectomy at Week 27, and the patient had survived for more than 22 months by the cutoff date. Analysis of tumor immune microenvironment suggested that an inflamed tumor environment may favor the anti-tumor effects of IMC001. In this phase I dose-escalation trial, IMC001 exhibited a favorable safety profile and encouraging efficacy in patients with advanced, pre-treated gastric cancer (GC). Further investigation is needed to further evaluate the potential of IMC001 for patients with advanced GC. Dr. Tianhang Luo, a distinguished chief physician from Shanghai Changhai Hospital and principal investigator for the IMC001 and IMC002 trials, commented, "We have witnessed remarkable cases at our institution where patients, after receiving infusion with IMC001 or IMC002 CAR-T cell products, became eligible for surgical treatment by downstaging previously unresectable gastric cancers. Notably, there was a case where a patient treated with IMC002 underwent surgery about 10 months after CAR-T infusion, and the pathological examination of the resected tumor tissues showed only fibrous and adipose tissues without any tumor cells. This indicates successful infiltration of CAR-T cells into the solid tumor, effectively eliminating the tumor cells. A single infusion of CAR-T cells achieved disease control for over a year, with the tumor shrinking to complete remission, greatly reducing the need of other medication for the patient. This demonstrates the tremendous potential of CAR-T cell therapy in treating solid tumors." Dr. Minmin Sun, Founder, Chairman, and CEO of Immunofoco Biotech, stated in an interview: "IMC002 and IMC001 have shown good safety and significant anti-tumor effects in treating patients with advanced gastric cancer. CAR-T cells have shown ongoing expansion within tumor tissues, with one patient achieving complete remission upon pathological examination. These encouraging results have greatly strengthened our commitment to expanding the scope of clinical trials and quickly advance to registrational phase II clinical trials. We firmly believe that IMC002 & IMC001 will offer more innovative treatment options to cancer patients worldwide." 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 ODD from the U.S. FDA in July 2022, 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 . SOURCE Immunofoco