January 4, 2025 Source: drugdu 121
On the morning of December 30, Keji Pharmaceutical (02171.HK) announced that China’s pivotal Phase II clinical trial of Serigene Oronza Injection for the treatment of advanced gastric/esophagogastric junction adenocarcinoma has obtained preliminary positive results.
▍About Sulgid Oronza Injection
According to the announcement, this trial is a randomized controlled, multi-center clinical trial conducted in China, aiming to evaluate the treatment of Shuruiji Olense Injection (CT041) in the treatment of advanced patients with positive Claudin18.2 expression who have failed at least 2 lines of treatment in the past. Efficacy and safety in gastric/esophagogastric junction adenocarcinoma. The trial achieved its primary endpoint of progression-free survival (PFS) as assessed by an independent review committee (IRC).
There was a statistically significant improvement in progression-free survival among subjects in the Serigen-Olenza injection group compared with the investigator's choice treatment group. Previous test data shows that the safety of this product is controllable. Shuregen Orenza Injection is a potentially first-of-its-kind autologous CAR-T therapy targeting Claudin18.2 protein in the world. It is used to treat Claudin18.2-positive solid tumors. It mainly treats gastric cancer/esophagogastric junction adenocarcinoma and pancreatic cancer. cancer, clinical trials are currently underway in China and North America. In January 2022, Serigenase Injection was awarded the "Advanced Therapy of Regenerative Medicine" by the FDA (U.S. Food and Drug Administration) and was recognized for the treatment of Claudin18.2-positive advanced gastric cancer/esophagogastric junction adenocarcinoma. In 2020, Shuregen Oronza Injection was granted "Orphan Drug" designation by the US FDA for the treatment of gastric cancer/esophagogastric junction adenocarcinoma.
▍Current research and development status of CAR-T therapy for solid tumors
As a revolutionary therapy in the treatment of hematological tumors, CAR-T cell therapy has attracted public attention in recent years. Since the approval of China's first CAR-T therapy, Akilenza Injection, in June 2021, China has approved 6 CAR-T therapies, including Keji Pharmaceutical's Zevogilenza Injection. .
However, unlike hematological malignancies, CAR-T therapy has progressed relatively slowly in the field of solid tumors compared with hematological malignancies. As of now, no CAR-T cell therapy for solid tumors has been approved for marketing in the world.
Non-viral vector CAR-T therapy is effective in treating prostate cancer. On February 17, 2022, Poseida Therapeutics announced the interim results of its Phase 1 clinical trial of autologous CAR-T therapy P-PSMA-101 for the treatment of metastatic castration-resistant prostate cancer at the ASCO GU Symposium. P-PSMA-101 targets prostate-specific membrane antigen (PSMA) and is developed using Poseida's piggyBac DNA modification system. It can produce a high proportion of stem cell memory T cells (Tscm) and effectively eliminate tumor cells. As of the end of 2021, a total of 17 patients have been included, 14 of whom are evaluable. These patients had received an average of seven lines of therapy, and the median disease duration was 6.4 years. The results showed that 71% of patients had a significant decrease in prostate-specific antigen (PSA) levels, 36% of patients had a PSA decrease of more than 50%, and 1 patient had a complete tumor disappearance and maintained remission for more than 10 months. P-PSMA-101 demonstrated good safety and tolerability.
Reaching the top of AACR: mRNA technology combined with CAR-T therapy has made a breakthrough in the treatment of solid tumors, with a disease control rate exceeding 40%. From April 8 to 13, 2022, the AACR General Meeting was held grandly, and the results of the first Phase 1/2 clinical trial that combined mRNA technology to improve the activity of CAR-T cells were announced.
This trial selected CLDN6 as the target of CAR-T cell therapy because it is not expressed in normal adult tissues but is highly expressed in various cancers such as ovarian cancer and testicular cancer. A total of 16 patients with solid tumors from 6 different cancer types participated in the trial, including 8 cases of testicular cancer and 4 cases of ovarian cancer. Efficacy evaluation started from the 6th week after patients received treatment. The results showed that 6 of the 14 evaluable patients (including 4 testicular cancer and 2 ovarian cancer patients) experienced partial response, with an objective response rate of nearly 43 %. Four of the patients had durable responses, and one patient achieved complete remission 18 weeks after treatment, indicating that this therapy may bring hope for long-term survival in patients with solid tumors.
CAR-T therapy for liver cancer is emerging, with a disease control rate as high as 78%. At the 2021 ASCO Annual Meeting, Chinese researchers announced the clinical data of the GPC3-targeted CAR-T drug Ori-CAR-001 in the treatment of relapsed/refractory hepatocellular carcinoma. Of the 11 patients with advanced hepatocellular carcinoma included, 9 were evaluable. The results showed that 4 patients achieved partial response, 3 patients had stable disease, the objective response rate was 44%, and the disease control rate was as high as 78%. In addition, the "Journal of Hematology & Oncology" reported another study, in which a patient with advanced liver cancer received CAR-T treatment and his liver lesions basically disappeared; after a patient with advanced pancreatic cancer received treatment, the metabolic activity of systemic lesions basically disappeared .
▍Keji Pharmaceutical rose sharply during the session
Surigen Oronza Injection is one of the core pipelines of Keji Pharmaceutical. In addition to the third-line and above treatment of gastric cancer, it is also exploring postoperative adjuvant treatment for pancreatic cancer or gastric cancer. According to the official website of Keji Pharmaceutical, in addition to the commercialized Zevogeolense, four autologous CAR-T and four universal CAR-T candidate products targeting different targets are already in the clinical stage. After the news was announced, Keji Pharmaceutical's stock price rose by more than 20% during the day, closing at HK$9.03 per share, an increase of 7.63%. In terms of performance, the semi-annual report data shows that Keji Pharmaceutical’s revenue is approximately 6 million yuan, mainly from Xikaize (Zewoji Olense Injection); the net loss is 352 million yuan, compared with 4.04 in the same period in 2023 billion has narrowed.
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