Stock prices soar by 220%! CGT, once “unsellable,” is back in the spotlight
Jinsong Guo (Founder of DrugTimes)
Founder of DrugTimes（药时代）, Co-President and Secretary General of China Alliance of New Drug Development for Liver Diseases
On August 12, 2024, the anti-cancer drug sector in the A-share market saw a surge. By the close, Guangzhou Xiangxue Pharmaceutical Co., Ltd and Fujian Cosunter pharmaceutical Co.,Ltd. both hit the 20% limit, ABA Chemical Corporation surged by more than 13%, and Si Huan Biotech, Yiling Pharmaceutical, Berry Genomics, Da An Gene, and Shuangcheng Pharmaceutical all reached the up limits.
It is worth noting that the 20% rise on the closing of August 12 was the fourth one Xiangyxue Pharmaceutical has achieved in the nine trading days since July 30, with the stock price soaring by 220.54%, and its market value also significantly increased from the low point in February this year.
Table of Contents
TCR-T, a new hot spot
One of the reasons behind the resurgence of Xiangxue Pharmaceutical’s market value is related to the progress of the approval of its research on TCR-T therapy.
On July 30, 2024, Xiangxue announced that its subsidiary, Guangdong Xiangxue Life Sciences, has had its TAEST16001 injection included in the list of breakthrough therapies by the Center for Drug Evaluation (CDE) under NMPA of China.
(Image source: Official website of CDE)
TAEST16001 injection is the first TCR-T cell therapy product developed by Xiangxue Pharma. It is based on the genetic engineering of a patient’s T cells ex vivo, transduced with a lentivirus carrying the TCR gene specific to the NY-ESO-1 tumor antigen, followed by ex vivo expansion, and then reinfused into the patient to achieve effective tumor treatment (the general process is very similar to CAR-T therapy). The primary indication for this TCR-T therapy is advanced soft tissue sarcoma that is HLA-A*02:01 positive and expresses the NY-ESO-1 antigen.
Currently, TAEST16001 has completed Phase I clinical trials and the first stage of Phase II clinical trials. At the ASCO conference in June 2024, the interim summary data of the Phase II clinical trials of TAEST16001 were first publicly presented in the form of a poster. The data showed that the best response rate assessed by the Independent Review Committee (IRC) was 50%, and the median progression-free survival (mPFS) assessed by both the IRC and the researchers was 5.9 months, demonstrating significant clinical efficacy and controllable safety.
Like CAR-T therapy, TCR-T therapy belongs to the “T cell receptor retargeting” technology, but there are differences in the specific mechanisms of action.
In CAR-T therapy, artificial single-chain antibody fragments are used, which can only recognize antigens on the surface of tumors, transmit signals through intracellular co-stimulatory molecules, and then activate T cells.
TCR-T therapy is more similar to natural T cells, identifying antigens presented by tumor MHC molecules through affinity-optimized or purely natural TCRs. It can not only accurately recognize antigens on the surface of tumors but also deeply recognize hundreds to thousands of antigens inside the tumor. This difference determines that compared to CAR-T therapy, TCR-T is more suitable for the treatment of solid tumors (compared to hematological tumors, solid tumors have fewer specific antigens expressed on the cell surface).
Currently, there are several CAR-T therapy products on the market (a total of 5 have been marketed in China). The first product of TCR-T therapy has only recently been approved (not yet in China), and the global research and development/approval progress is still in the early stages.
On August 2, 2024, the FDA granted accelerated approval for the first TCR-T therapy for the treatment of adult patients with unresectable or metastatic synovial sarcoma who have previously received chemotherapy.
According to the product instructions, patients eligible to receive this product must meet the following conditions:
In comparison, the TCR-T product that Xiangxue Pharma’s product TAEST16001 targets and attacks tumor cells that express the NY-ESO-1 antigen. Both of these antigens have been confirmed to be expressed in various solid tumors, but the frequency of expression varies in different types of cancer.
Xiangxue Pharma’s TAEST16001 is the first TCR-T therapy to obtain an IND approval and start clinical research in China. After being included in the list of breakthrough therapies by the CDE, and assuming the clinical trial progresses smoothly, it is very likely to be the first TCR-T therapy to be marketed in China.
In addition to Xiangxue Pharma, other companies that have recently attracted attention due to transactions in the CGT field include East China Pharmaceutical and Northeast Pharmaceutical (click for details).
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Unsellable CGT Products
Whether it’s CAR-T therapy or TCR-T therapy, “unsellable” is a label that is temporarily stuck on these types of CGT products and cannot be peeled off.
Recently, it is the Q2 2024 earnings season, and the author will simply list the quarterly revenue of some popular CGT products that have been announced in the financial reports of MNCs in terms of R&D/cooperation:
Cell Therapies:
Others:
It can be seen that although the therapeutic effects of the products themselves are indeed prominent, their commercial performance is relatively average.
CGT Field: It’s Still Early
In recent years, the CGT field has been developing rapidly, but compared to the already more mature fields of small molecule drugs and antibodies, it is still immature and in a stage with great potential for development. Earlier in 2024, a report from IQVIA pointed out that transactions in the field of cell and gene therapy have increased by 48% compared to 10 years ago. Now is the time for this field to flourish.
Currently, the breakthrough directions in the CGT field are mainly:
1. CAR-T Therapy: Moving from personalized to universal, from hematological tumors to solid tumors.
Recent domestic good news: On July 16, 2024, BRL Med announced that its self-developed allogenic universal CAR-T has been successful in treating autoimmune diseases. The research was published for the first time in the top journal Cell, and this is also the first time Cell has published research results on CAR-T treatment for autoimmune diseases.
2. Gene Editing Therapy: From rare diseases to common diseases, more precise gene editing technology.
At the end of 2023, the FDA approved two CRISPR gene editing therapies – Casgevy (Vertex) and Lyfgenia (Bluebird bio), both products are used for sickle cell disease (SCD), a rare disease. Currently, gene editing therapy is still commonly used for rare genetic diseases.
3. Breakthroughs in More Therapies: The approval and expansion of diseases for related products such as CAR-NK therapy, TIL therapy, TCR-T therapy, etc.
4. Cost Reduction
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