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Due to the serious homogenization of PD-1 monoclonal antibodies and fierce competition on the track, the "next PD-1" has become the focus of
Based on this, TIGIT, LAG-3, TIM-3, B7-H3, Claudin 18.
Among them, the Claudin 18.
Claudin 18.
Claudin 18.
Under the background of PD-1 monoclonal antibody being deeply involved in internal volume, the diversification of targets and indications has become the key consideration for
In the case of Claudin 18.
Up to $650 million $1.
Since the beginning of this year, Claudin 18.
$350 million is worth $1 billion and is over $900 million
2021-present CLDN18.
From: Insight Database Web (http://db.
The reason for this is that Claudin 18.
Claudin 18.
It is precisely because of the high specificity of Claudin 18.
From the perspective of market prospects, due to the high expression rate of Claudin 18.
From the perspective of market prospects, the number of patients benefiting from Claudin 18.
In 2020, China's gastric cancer drug market reached $4.
3 billion and is expected to increase to $7.
9 billion in 2025, with a compound annual growth rate of 12.
8%; The Chinese market is expected to grow at a compound annual growth rate of 10.
2% from 2025 to 2030 and reach $
12.
8 billion by 2030.
3 billion in 2020 and is expected to grow to $7.
9 billion by 2025, with a CAGR of 12.
8%
In addition, according to Frost & Sullivan's statistics and forecasts, the number of pancreatic cancer cases worldwide reached about 472,000 in 2019, with a compound annual growth rate of about 2.
7%-2.
8% between 2016 and 2030, rising to 639,000 in
2030.
The number of pancreatic cancer cases in China reached 108,000 in 2019 and is expected to reach 152,000 by 2030
.
CLDN18.
2 Target Nearly 100 new drugs in the world are in research! Astellas is ahead of the curve
2 Target Nearly 100 new drugs in the world are in research! CLDN18.
2 target Astellas is ahead of the curve
As mentioned earlier, drugs developed with Claudin 18.
2 as the target involve monoclonal antibodies, di-antibodies, ADCs, CAR-T cell therapies, etc.
, covering the main product forms
at present.
According to the Insight database, at least 112 CLDN18.
2 projects are advancing worldwide, with more than 20 monoclonal antibody, di-antibody and CAR-T therapies, and more than 17 ADC drugs
.
CLDN18.
2 Target Component Category Distribution
From: Insight Database Web (http://db.
dxy.
cn/v5/home/)
Due to the high expression rate of Claudin 18.
2 in gastric cancer and pancreatic cancer, the indications currently under study are mainly concentrated in the fields of gastric cancer, pancreatic cancer, and gastroesophageal junction cancer, but the clinical progress is mostly in the early stage
.
CLDN18.
2 target indication distribution
From: Insight Database Web (http://db.
dxy.
cn/v5/home/)
Overall, the fastest progress is Zolbetuximab (IMAB362) developed by Astellas, the only Target Claudin 18.
2 monoclonal antibody currently entering Phase III clinical studies
.
CLDN18.
2 target new drug development phase distribution
From: Insight Database Web (http://db.
dxy.
cn/v5/home/)
According to data from previous studies presented by Astellas at asco 2021, patients with locally advanced or metastatic gastric cancer treated with zolbetuximab + CAPOX (capecitabine + oxaliplatin) chemotherapy regimen had a median progression-free survival of 7.
9 months and a median overall survival of 13.
2 months; Patients treated with ONLY THE CAPOX chemotherapy regimen had a median progression-free survival of 4.
8 months and a median overall survival of 8.
4 months
.
This means that with Zolbetuximab, the patient's progression-free and overall survival is extended by nearly half
.
The results of another clinical trial, FAST, showed that in 70% of patients with ≥ of Claudin 18.
2 expression, patients with Adenocarcinoma at the gastric and gastroesophageal junction who were treated in the first-line treatment of the Zolbetuximab +EOX regimen (epirubicin + oxaliplatin + capecitabine) had a median progression-free survival of 9 months vs 5.
7 months and a median overall survival of 16.
5 months vs 8.
9 months
.
In China, there are many pharmaceutical companies that lay out Claudin 18.
2 targeted drugs, including Keji Pharmaceutical, Junshi Biological, Innovent Biologics, Aosacon, Chuangsheng Group, etc.
, and the products under development are mainly concentrated in the fields of monoclonal antibodies and ADCs, followed by dual antibodies and CAR-T therapy
.
2 targeted drugs, including Keji Pharmaceutical, Junshi Biological, Cinda Biological, Aosaikang, and Chuangsheng Group
Among them, Cinda has the most comprehensive layout, with 4 products under development that target Claudin 18.
2: monoclonal antibody IBI360, dual antibody IBI389, CAR-T therapy IBI345 and ADC drug IBI343
.
2 products under development
Innovent Bio CLDN18.
2 pipeline
From: Insight Database Web (http://db.
dxy.
cn/v5/home/)
O'Sai Kang, Koji, Rong Chang.
.
.
Compete for the Claudin 18.
2 Targeted Drug Track
.
.
Compete for the Claudin 18.
2 Targeted Drug Track
At present, claudin 18.
2 monoclonal antibody and ADC track have become a must for domestic pharmaceutical companies
.
According to the statistics of the Insight database, there are 14 new drugs under development in the domestic clinical stage of Claudin 18.
2 monoclonal antibodies
.
2 monoclonal antibody and ADC track have become a must for domestic pharmaceutical companies
.
From the pipeline point of view, Aosaikang's ASKB589, Lixin Pharmaceutical's LM-102, Zaiding Pharmaceutical's ZL-1211, Chuangsheng Group's TST001, etc.
are leading
the research and development progress of Claudin 18.
2 monoclonal antibody new drugs.
are leading
the research and development progress of Claudin 18.
2 monoclonal antibody new drugs.
The TST001 developed by Chuangsheng Group for research indications includes monotherapy for gastric cancer, pancreatic cancer, and first-line unresectable locally advanced or metastatic gastric cancer or gastroesophageal conjugate cancer (G/GEJ) with combination chemotherapy, and is currently undergoing several phase II trials worldwide and is expected to enter Phase III clinical trials
in the first half of 2023.
In the global Claudin 18.
2 monoclonal antibody research and development progress, it ranks second
only to Astellas Zolbetuximab.
From: Chuangsheng Group official website according to
According to the 2022 interim report, in February this year, the First Phase IIa study of TST001 combined with cisplatin and gemcitabine for first-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) successfully completed the first patient administration; In March, Chuangsheng partnered with BMS to conduct a global clinical trial
evaluating TST001 and Odivo ® (navuliyumab) for first-line gastric/gastroesophageal junction cancer.
In June 2022, Chuangsheng Group presented clinical data from the dose-escalating portion of the Phase I clinical study of TST001 combined with CAPOX as the first-line treatment for advanced or metastatic G/GEJ cancer at the ASCO Annual Meeting, and observed well-tolerated and encouraging initial anti-tumor activity
.
Of the 9 assessable dosing patients, 5 achieved partial remission and 3 others achieved stability
.
From: Insight Database Web
Aosaikang's self-developed monoclonal ANTIBODy ASKB589, which uses defulose technology in molecular design and cell line components, further enhances its ADCC and CDC functions, and is currently conducting phase I and II clinical trials for the treatment of gastric and pancreatic cancers, and preliminary data show good tolerance
.
ASKB589 Indications develop gantt chart
From: Insight Database Web
In addition to monoclonal antibodies, domestic pharmaceutical companies also concentrate on the layout of ADC drugs
.
According to the Insight database, there are 13 new ADC drugs targeting Claudin 18.
2 in research, of which 8 are in clinical stages
.
Listed pharmaceutical companies such as Cinda Biology, Junshi Biologics, Kelun Pharmaceutical, CSPC Pharmaceutical Group, and Connoa have layouts
.
.
13 Cinda Biologics, Junshi Biologics, Kelun Pharmaceutical, CSPC Pharmaceutical Group, Connoa
Among them, Rongchang's RC118 and Lixin Pharma's TPX-4589 are currently undergoing Phase I/II clinical studies
.
Domestic enterprises are in the clinical stage of ADC new drugs
From: Insight Database Web
Rongchang Bio's RC118 is made of anti-human Claudin 18.
2 antibody coupled with the microtubule inhibitor monomethyl oriostatin E (MMAE), using the company's proprietary bridging technology, through the coupling process control so that the average coupling rate (DAR) between the antibody and cytotoxin is 4.
0±0.
5, the product uniformity is better
.
Currently, RC118 has conducted a phase I clinical trial in Australia for locally advanced unresectable or metastatic malignant solid tumors in patients with positive Claudin 18.
2 expression, and has also conducted a phase I clinical trial in China, enrolling 5 patients
as of June 30, 2022.
RC118 Indications developed gantt chart
From: Insight Database Web
The claudin 18.
2 ADC drug SYSA1801 developed by CSPC for the treatment of pancreatic cancer and the Claudin 18.
2 monoclonal antibody NBL-015 for the treatment of gastric cancer(including gastroesophageal conjugate cancer) were both granted orphan drug qualification by the FDA in 2021, and both drugs have been authorized externally, and both drugs are currently in the clinical phase I stage
.
In addition, CSPC has an ADC drug CPO102 under study
.
2 ADC drug SYSA1801Claudin 18.
2 monoclonal antibody drug NBL-015
CSPC CLDN18.
2 pipeline
From: Insight Database Web
In the field of CAR-T therapy, Keji Pharmaceutical is in a leading position
.
Eye-catching data
was previously disclosed at as 2021 ASCO.
.
Coji Pharmaceuticals' CT041 is a potentially first-of-its-kind autohythropolytic CAR-T cell candidate that targets Claudin 18.
2 and is the world's first and only CAR-T cell candidate for the treatment of solid tumors in confirmatory Phase II clinical trials for the treatment of CLDN18.
2-positive solid tumors
.
Currently, ongoing CT041 trials include a Phase 1b/2 clinical trial (CT041-ST-02, NCT04404595) in North America for advanced gastric/esophageal gastric-conjugate adenocarcinoma (GC/GEJ) and pancreatic cancer (PC), a Phase Ib clinical trial in China for advanced GC/GEJ and PC, and a confirmatory Phase II clinical trial for advanced GC/GEJ (CT041-ST-01, NCT04581473) and trials initiated by researchers
.
CT041 Indications develop gantt chart
From: Insight Database Web
In the 2022 ASCO, Cozi published the results
of two clinical trials.
The latest Phase Ib study (NCT04581473) for advanced gastric/esophageal-gastric-conjugated adenocarcinoma shows that as of December 22, 2021, 8 out of 14 patients (57.
1%) achieved partial remission in the first tumor assessment after the first infusion of CT041, based on investigator assessments of ORR and DCR of 57.
1% and 78.
6%,
respectively 。 The median follow-up was 8.
8 months, and the mPFS and median overall survival (mOS) were 5.
6 months and 10.
8 months
, respectively.
By the data deadline, 7 patients were still alive
.
Based on this, Cozi will advance further Phase II trials
.
Cozi said it plans to submit NDA to the State Food and Drug Administration in the first half of 2024; Overseas, it plans to launch a Phase 2 clinical trial in North America in the second half of 2022 and submit a BLA
to the US FDA in 2024.
epilogue
epilogue To sum up, although there is no new drug targeting Claudin 18.
2 in the world, the competition is undoubtedly quite fierce
from the existing pipeline.
This can be seen
from the domestic Claudin 18.
2 new drug layout.
Whether it is the Claudin 18.
2 monoclonal antibody or the Claudin 18.
2-ADC track, each track has more than 10 pharmaceutical companies participating in the layout, and the research and development progress is almost
the same.
Before the commercial listing has been realized, fierce market competition
has been staged in advance.
the same.
Before the commercial listing has been realized, fierce market competition
has been staged in advance.
It is foreseeable that the future Claudin 18.
2 targeted drug track will be like the PD-1 monoclonal antibody
.
It depends on which pharmaceutical company can take the lead in rushing the line and seize the market first-mover advantage
.
2 targeted drug track will be like the PD-1 monoclonal antibody
.
It depends on which pharmaceutical company can take the lead in rushing the line and seize the market first-mover advantage
.
