2017 was an important node in the development of CAR T-cell immunotherapy, where the two cell immunotherapies of Novartis and Gilead were successively approved by FDA. The CAR-T development in China has received attention since Nanjing Legend Biotechnology stunned in 2017 ASCO annual meeting. There have been 7 companies including Nanjing Legend Biotechnology filing clinical trial applications to CDE, wherein, Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd. (Unicar) is different from the rest, with indication and CAR-T product design being the bright spots.
I. Unicar different from the rest: the indication is central nervous system (CNS) leukemia
According to the public data, 2 CAR T-cell immunotherapies of Shanghai Unicar were accepted by CDE on January 31, 2018, with the information as follows: 1. CXSL1800005, IL-6 secretion function knocking down, CD19-targeted autologous gene editing T-cell injection; 2. CXSL1800006, IL-6 secretion function knocking down, CD19-targeted autologous gene editing T-cell injection, with indications of CNS leukemia (CD19+) and acute B-lymphoblastic leukemia (CD19+). The CNS leukemia is included in the indications applied for by Unicar this time, which is a quite noteworthy point.
We know that the CNS leukemia often occurs in the remission of the acute lymphoblastic leukemia, leading to the CNS reactions of patients, which is considered as an important reason for the disease recurrence of patients. The conventional CAR-T has three safety issues: 1. CRS (cytokine release syndrome), how to solve this issue has been a subject of concern; 2. Product central neurotoxicity; 3. Off-target effect. Given the CNS safety concerns of the conventional CAR-T, CNS leukemia patients often cannot be enrolled, and there is rarely the CAR-T product for this indication at present.
Unicar is different: the company has designed the new-generation CAR T-cell product with much improved safety based on the unique OCTS-CAR-T technology. According to part of the clinical data made public by the company, the products’ severe CRS (above class III) is 15.5%, and severe central neurotoxicity is 5.4%, which are lower than similar products. A part of the data is as follows:
|
Disease |
Refractory and relapsed acute B-lymphoblastic leukemia |
|||||
|
Company |
Juno |
Kite |
Novartis |
Unicar |
||
|
Number of cases |
24 |
11 |
55 |
29 |
68 |
129 |
|
Product |
JCAR-014 |
Yescarta |
Tisagenlecleucel |
SssUCA-019 |
||
|
Complete response (CR) |
88% |
82% |
94.5% |
69% |
82.5% |
85.5% |
|
Severe CRS (above class III) |
35.6% |
46% |
N/A |
N/A |
63.20% |
15.5%<...
xiaobin
December 20, 2024
financialexpress
January 24, 2017
financialexpress
January 24, 2017
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