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.

芝加哥，2024年6月1日/PRNewswire/--2024年6月1日，致力于开发实体瘤细胞治疗产品的Immunofoco Biotech公司宣布，其两种产品的临床研究数据已被接受在2024年美国临床肿瘤学会（ASCO）年会上发表。

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..

该公司将在2024年5月31日至6月4日的ASCO活动期间，在海报展示中展示IMC001的最新临床试验结果，并在在线展示中展示IMC002的最新临床试验结果。。

Outstanding safety and efficacy data of IMC002, an autologous CLDN18.2-targeting CAR-T, in CLDN18.2+ advanced solid tumors (e16012)

IMC002（一种靶向CLDN18.2的自体CAR-T）在CLDN18.2+晚期实体瘤（e16012）中的出色安全性和有效性数据

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..

Claudin 18.2（CLDN18.2）是治疗晚期实体瘤的有希望的治疗靶点。IMC002是由高特异性抗CLDN18.2 VHH指导的自体CLDN18.2靶向CAR-T细胞，其特异性已通过膜蛋白质组阵列测定法证实。临床前研究表明，IMC002在细胞和动物模型中均表现出高肿瘤特异性，有效的抗肿瘤功效和优异的安全性。。

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.

截至2024年1月17日，三名晚期不可切除胃癌患者接受了IMC002输注。没有报道剂量限制性毒性（DLT）或严重不良事件（SAE）。所有三名患者均在1级经历了可控的细胞因子释放综合征（CRS）。此外，所有不良事件迅速恢复。

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.

初步疗效数据显示，根据RECIST 1.1标准评估，所有三名患者均表现出稳定的疾病作为其最佳总体反应。在接受300万CAR-T细胞/kg剂量的两名患者中，当CAR-T治疗减轻肿瘤负荷时，分别在IMC002输注后第11周和第44周进行了成功的根治性手术。

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.

值得注意的是，在W44手术的一名患者中实现了病理完全缓解（pCR）。在所有三名患者中均观察到外周血中CAR-T细胞的显着扩增，输注后第7-11天外周血中记录到峰值CAR+细胞计数。此外，在第11周和第44周获得的手术样品中检测到肿瘤组织中的CAR-T细胞浸润。

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..

在所有三名患者中均观察到血清IFN-y，IL-10，IP-10，IL-2和IL-6水平显着升高。审判仍在进行中。。

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..

IMC002表现出有希望的安全性，以及令人鼓舞的抗肿瘤作用，包括观察到的pCR和肿瘤组织内的持续扩增，即使在晚期CLDN18.2+胃癌患者的低剂量水平下也是如此。此外，我们的试验成功地促进了CAR-T治疗后的外科治疗干预，从而可以降低先前认为无法切除的胃癌的分期。。

Efficacy of EpCAM CAR-T IMC001 in advanced gastric cancers (Poster #4043)

EpCAM CAR-T IMC001在晚期胃癌中的疗效（海报#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..

介绍了一项令人兴奋的I期临床试验，展示了针对EpCAM的CAR-T细胞疗法在治疗晚期胃肠道（GI）癌症中的创新应用。该试验由上海长海医院、浙江大学第一附属医院和苏州Immunofoco生物技术有限公司的医生和科学家组成的合作团队领导，证明IMC001具有良好的安全性和初步疗效。。

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).

在2021年8月18日至2023年5月8日期间，共有11名患者接受了IMC001 CAR-T细胞输注。截至截止日期（2024年3月31日），低剂量和中剂量IMC001的输注显示出良好的安全性。在10例可评估患者中，疾病控制率为90%，低剂量组1例（1/3，33.3%），中剂量组2例（2/5，40%）达到部分缓解（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.

中剂量被确定为推荐剂量，中位无进展生存期（PFS）为18.1周（95%CI 7.97，--），中位总生存期（OS）为55.1周（95%CI 23.78，--）；在中剂量组中，3/5患者存活超过10个月。中剂量组中的一名患者在第24周达到确诊的PR，导致在第27周进行根治性胃切除术，并且该患者在截止日期存活了22个月以上。

Analysis of tumor immune microenvironment suggested that an inflamed tumor environment may favor the anti-tumor effects of IMC001..

对肿瘤免疫微环境的分析表明，发炎的肿瘤环境可能有利于IMC001的抗肿瘤作用。。

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.

在这项I期剂量递增试验中，IMC001在晚期预处理胃癌（GC）患者中表现出良好的安全性和令人鼓舞的疗效。需要进一步研究以进一步评估IMC001对晚期GC患者的潜力。

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.

上海长海医院特聘主任医师兼IMC001和IMC002试验的首席研究员罗天行博士评论道，“我们在我们的机构中看到了显着的病例，患者在接受IMC001或IMC002 CAR-T细胞产品输注后，通过降低先前不可切除的胃癌分期，有资格接受手术治疗。

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.

值得注意的是，有一例接受IMC002治疗的患者在CAR-T输注后约10个月接受了手术，切除的肿瘤组织的病理检查仅显示纤维和脂肪组织，没有任何肿瘤细胞。这表明CAR-T细胞成功浸润到实体瘤中，有效地消除了肿瘤细胞。

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.'.

单次输注CAR-T细胞可以控制疾病一年多，肿瘤缩小到完全缓解，大大减少了患者对其他药物的需求。这证明了CAR-T细胞疗法在治疗实体瘤方面的巨大潜力。”。

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.

Immunofoco Biotech创始人、董事长兼首席执行官孙敏敏博士在接受采访时表示：“IMC002和IMC001在治疗晚期胃癌患者方面显示出良好的安全性和显着的抗肿瘤作用。CAR-T细胞在肿瘤组织内持续扩张，一名患者在病理检查后完全缓解。

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.'.

这些令人鼓舞的结果大大加强了我们扩大临床试验范围的承诺，并迅速推进到注册II期临床试验。我们坚信IMC002和IMC001将为全球癌症患者提供更多创新的治疗选择。”。

About Immunofoco

关于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.

Immunofoco开创了一项临床策略，重点是“通过将实体瘤视为血液系统恶性肿瘤来治疗实体瘤”，解决实体瘤治疗中的挑战以及治疗血液系统恶性肿瘤的临床优势。为了提高CAR-T产品的安全性，抵消肿瘤异质性，并提高其在肿瘤扩增和浸润中的有效性，我们开发了创新平台，如Peri Cruiser®，SNR和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.

在临床结果的推动下，我们公司保持了广泛的产品线。值得注意的是，我们的IMC002（CLDN18.2 CAR-T）产品于2022年7月从美国FDA获得ODD，其IND申请已于2023年4月在美国和中国获得批准。同样，我们的IMC001（EpCAM CAR-T）产品从美国获得ODD。

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.

FDA于2023年8月批准了其IND申请，并于2024年2月在美国和中国获得批准。IMC008（SNR CAR-T）产品已迅速进入IIT阶段，并获得了美国的两项批准。S、 FDA于2023年8月分别用于治疗胃癌和胰腺癌。

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..

我们公司秉承“合作、渴望和奉献以获得最佳临床效果”的精神，汇集行业人才和专家，开发创新的细胞疗法，为实体瘤患者提供持久的生存益处。有关Immunofoco的更多详细信息，请访问我们的网站www.Immunofoco.com。。

SOURCE Immunofoco

SOURCE免疫恐惧症