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October 12, 2022 / eMedClub News / -- On October 10, Immatics announced the results of its latest clinical trial of
IMA203, a TCR-T therapy targeting the PRAME antigen 。 Overall, IMA203 is well tolerated and has achieved confirmed objective remission
in a variety of solid tumors such as melanoma, ovarian cancer, head and neck cancer, uveal melanoma, and synovial sarcoma.
IMA203 is an autologous TCR-T therapy based on Immatics' ACTengine platform, which genetically modifies the patient's own T cells to express TCR
for the target.
In addition, Immatics combines its proprietary cell therapy manufacturing platform with the ability to genetically engineer and produce
T cells in 6-10 days.
The data released this time covers 27 patients who have completed phase 1a dose escalation and the top 5 patients
who are undergoing phase 1b dose expansion.
From Phase 1a to Phase 1b, Immatics employed a variety of strategies to improve the clinical outcomes of IMA203, including (1) increasing doses, (2) optimizing the IMA203 manufacturing process, and (3) working with disease experts for more rational patient screening
.
Combining data from phase 1a and phase 1b clinical trials, an objective response rate (cORR) of 50% was confirmed in 12 patients treated with doses of more than 1 billion TCR-T cell therapy; For period 1b alone, the ORR is 80% (4/5).
In addition, early signs of improved efficacy durability were observed with high-dose therapy, with all four patients treated with a Phase 1b trial cohort who received treatment and achieved an initial response lasting more than 12 weeks and still in remission
.
This result also shows the potential of
IMA203 as a monotherapy for a variety of solid tumors.
Conquer solid tumors, a variety of cell therapies have shown their own magic
The ORR rate of up to 80% in stage 1b preliminarily validates the potential of TCR-T therapy for the treatment of
solid tumors.
At present, there are still a large number of unmet clinical needs for solid tumors, which are also the key directions
for R&D personnel and innovative pharmaceutical companies to overcome.
It is worth mentioning that many progress
has been made in the field of solid tumor cell therapy in China.
NO.
1
TCR-T therapy
TAEST16001 is a NY-ESO-1 specific TCR-T therapy independently developed by Xiangxue, and is the first TCR-T therapy
in China to obtain IND approval.
At the American Society of Clinical Oncology (ASCO) in 2022, Xiangxue accurately announced the phase 1 clinical data of TAEST16001 for the treatment of soft tissue sarcoma: the ORR was 41.
7%, and the overall safety was good
.
Currently, the product candidate is undergoing Phase 2 clinical trials
.
LioCyx-M004 is a first in class TCR-T therapy candidate independently developed by Laien Biologics, which uses mRNA electroporation technology to target hepatitis B surface antigen for the treatment of hepatitis B-associated hepatocellular carcinoma (HCC).
。 At the European Liver Association (EASL) Digital Liver Cancer Summit held in February 2021, Laien Biologics announced the Phase 1 clinical data of LioCyx-M004: ORR of 16.
7%, median overall survival of 33.
57 months (the median overall survival of the current FDA-approved first-line drug sorafenib is 10.
7 months); no cytokine release syndrome (CRS), neurotoxicity or other systemic immune system-related adverse reactions
were observed.
In September 2021, LioCyx-M004 was approved by the FDA to carry out a phase 1b/2 international multicenter clinical study, which is also the world's first clinical study
using HBV-specific TCR-T cell therapy for the treatment of hepatitis B-associated HCC.
In addition, Hengrui Pharmaceutical, Euric Biologics, Beijing Catty, Innoimmunity, Kerui Biologics, Binder Biologics, Baiji Biologics, Fosun Kite, Huaxia Yintai (for cytomegalovirus infection) and other enterprises have deployed TCR-T therapy
.
NO.
2
CAR-T therapy
CAR-T therapy has 8 products for hematological tumors approved for marketing, but the field of solid tumors is still blank.
There are many companies deploying CAR-T therapy in China, and solid tumors have become a hot spot
in the research and development of enterprises.
Image source: Bing
Among them, the fastest progress is Keji Pharmaceutical, whose self-developed world's first Claudin18.
2 CAR-T candidate CT041 has entered the phase 2/3 clinical trial stage, mainly used for the treatment of gastric cancer/esophageal and gastric junction adenocarcinoma and pancreatic cancer
。 The CT041 data presented at the 2022 ASCO annual meeting showed that: (1) In the group of patients with gastric cancer/esophageal gastric junction adenocarcinoma in the multicenter phase 1b trial, the ORR was 60%, and 1 patient achieved CR; (2) Of the 14 patients with advanced gastric cancer/esophageal gastric junction adenocarcinoma in the phase 1b/2 trial, 8 (57.
1%) achieved partial response in the first tumor evaluation after the first infusion of CT041, based on the investigator's assessment of ORR and DCR of 57.
1% and 78.
6%,
respectively.
In addition, companies such as Stansel, Boshengji, Legend Biotechnology, Chongqing Precision Biotechnology, Innovent Biotechnology, Baiji Genetics, and Eurek have also laid out this direction
.
Recommended reading: Analysis of the three major innovation directions of CAR-T therapy companies
NO.
3
CAR-NK therapy
NK cells are widely sourced, have a natural broad-spectrum killing mechanism, do not require antigen presentation, are not limited to the major histocompatibility complex (MHC) on the cell surface, and rarely cause graft-versus-host disease (GvHD).
It has unique advantages
in becoming a universal cell therapy for the treatment of solid tumors.
▲Layout of CAR-NK enterprises
(In no particular order, if there is any omission, please add it)
CAR-NK therapy is a relatively new field, and most domestic companies are still in the early stage of development, covering hematological tumors and solid tumors
.
Among them, Guojian Chengnuo's clinical trial application for "Mesothelin, MSLN) chimeric antigen receptor NK cell (CAR-NK) injection for the treatment of advanced epithelial ovarian cancer" was approved by CDE in November 2021, which is the first "off-the-shel" allogeneic CAR-NK product
approved for IND in China.
At present, more clinical data of domestic CAR-NK therapy have yet to be announced
by companies.
Recommended reading: National Day Special Planning: CAR-NK Universal Cell Therapy Global Progress Ultracomplete Review
NO.
4
TIL therapy
TIL therapy is widely used in clinical research
in the treatment of solid tumors due to its advantages of low toxicity, recognition of a range of tumor antigens, and ability to deal with tumor heterogeneity.
At present, foreign product candidates have entered clinical phase 3, and China is still in the early stage
.
In April 2022, GT101 injection (acceptance number: CXSL2200061) independently developed by Sha Bo Biotech was officially approved by the National Medical Products Administration (NMPA) for clinical trials, becoming the first TIL therapy approved for clinical trial in China.
On May 23, Sand Gravel Bio announced the completion of the GT101 clinical trial in
China's first patient enrollment.
In April 2022, Junsai's self-developed "Autologous Natural Tumor Infiltrating Lymphocyte Injection (GC101 TIL)" (acceptance number: CXSL2200070) was officially approved by NMPA for clinical trials
.
At the same time, this is the world's first natural TIL cell drug
that does not require drenching and IL-2 injection.
In the clinical study (IIT) initiated by the previous investigator, 2 subjects achieved complete remission (CR) efficacy, 3 subjects achieved partial remission (PR) efficacy, and 2 CR patients have maintained tumor-free state for 12 months and 9 months, respectively, which initially demonstrated the good safety and efficacy
of GC101.
In addition, companies such as Jinfeng Biotechnology, Reincarnation Medicine, Zhilin Biotechnology, Sibiman Biotechnology, Huasaiberman, Yuanqi Biotechnology, and Ranma Medical have also deployed TIL therapy
.
summary
Overall, different cell immunotherapies have their own characteristics in the treatment of solid tumors, but at present, cell therapies in this field are still in a blank state, as far as the published data is concerned, each therapy has the potential to overcome solid tumors, as for which therapy is the first to come out, we will wait
and see.
In addition, Treg cell therapy also has many studies in the treatment of solid tumors, but at present, China is still in a state of "vacancy", I believe that with the development of technology and the deepening of research, Treg cell therapy can also provide more choices
for the treatment of solid tumors.
Recommended reading: Global clinical progress of Treg cell therapy: domestic companies are waiting for vacancies
Resources:
1.
https://immatics.
com/
2.
Official website of each enterprise
——List of recent popular events——
▼October 13, Sino-US Double Report Cell Bank Verification Strategy Seminar
▼October 18, the application and development trend of biopharmaceutical safety detection technology
