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▎WuXi AppTec Content Team Editor On February 8, 2022, Eureka Therapeutics announced that the U.
S.
Food and Drug Administration (FDA) has granted orphan drug designation to the investigational T-cell therapies ET140203 and ECT204 for the treatment of hepatocellular carcinoma (HCC)
.
Both T cell product candidates are developed based on its proprietary ARTEMIS technology platform, targeting specific liver cancer antigens
.
Eurek is currently enrolling patients in three Phase 1/2 clinical trials to evaluate their safety and potential efficacy, respectively
.
Liver cancer is one of the leading causes of cancer-related deaths worldwide
.
It is estimated that in 2020, there will be more than 905,000 new cases of liver cancer worldwide, and more than 830,000 people will die from the disease
.
HCC is the most common type of liver cancer, accounting for about 75% to 90% of primary liver cancer cases
.
Worldwide, the main factors that increase the risk of HCC are chronic hepatitis B and C, alcohol consumption and metabolic syndrome
.
The ARTEMIS platform has two core functional components: an antibody-based antigen binding domain and an effector domain
.
The receptor design of ARTEMIS allows it to take advantage of the activation and regulation pathways normally employed by endogenous T cell receptors (TCRs)
.
Because this strategy does not directly link the intracellular signaling domain to the co-stimulatory domain, it is expected to eliminate cytokine release syndrome (CRS) caused by T cell hyperactivation
.
▲The product pipeline of Uricco Bio (picture source: Uric Bio's official website) The treatment process of ET140203 collects the patient's T cells, engineer them to express Uric Bio's proprietary ARTEMIS cell receptor, and reinfused into the patient
.
The receptor expressed by the modified ET140203 T cells targets the alpha-fetoprotein (AFP)-peptide/HLA-A2 complex expressed on hepatoma cells
.
In addition, ET140203 T cells also incorporate Urico's proprietary tumor infiltration technology, which has been shown in animal models to enhance the drug's ability to infiltrate solid tumors, which is expected to improve patient outcomes
.
The therapy is currently being evaluated in two open-label, dose-escalation, multicenter Phase 1/2 clinical trials, one in adults with AFP-positive HCC and one in AFP-positive patients with relapsed/refractory disease in pediatric subjects with hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS), and HCC
.
ECT204 targets GPC3 expressed on liver cancer cells, a promising HCC antigen present in more than 70% of HCC cells
.
ECT204 T cells also incorporate Urico's proprietary tumor infiltration technology
.
It is currently being evaluated in a Phase 1/2 clinical trial for the treatment of adult patients with GPC3-positive HCC
.
▲Dr.
Liu Cheng, CEO of Urica BioRelated reading: US$60 million in Series D financing, T cell therapy clinical data unveiled at ASCO: Interview with Urico CEO Liu Cheng "We are very pleased to receive FDA approval for the treatment of hepatoma Orphan drug designation for ET140203 and ECT204 came months after Fast Track designation (FTD) for pediatric patients with hepatoblastoma and HCC, and Rare Pediatric Disease Designation (RPDD) for the treatment of hepatoblastoma
.
"This underscores the significant unmet medical need in the medical community for more effective liver cancer treatment options," said
Dr.
We are committed to working closely with regulatory agencies, clinical investigators, patients and their families to advance the clinical development of these programs
.
"Reference: [1] Eureka Therapeutics Receives Orphan Drug Designations for Treatment of Hepatocellular Carcinoma (HCC) With ARTEMIS® T Cells.
Retrieved February 8, 2022, from https:// enDisclaimer: The WuXi AppTec content team focuses on introducing the progress of global biomedical health research
.
This article is for information exchange purposes only, and the opinions in this article do not represent WuXi AppTec's position, nor do they support or oppose the views in the article
.
This article is not Recommended treatment plan
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
S.
Food and Drug Administration (FDA) has granted orphan drug designation to the investigational T-cell therapies ET140203 and ECT204 for the treatment of hepatocellular carcinoma (HCC)
.
Both T cell product candidates are developed based on its proprietary ARTEMIS technology platform, targeting specific liver cancer antigens
.
Eurek is currently enrolling patients in three Phase 1/2 clinical trials to evaluate their safety and potential efficacy, respectively
.
Liver cancer is one of the leading causes of cancer-related deaths worldwide
.
It is estimated that in 2020, there will be more than 905,000 new cases of liver cancer worldwide, and more than 830,000 people will die from the disease
.
HCC is the most common type of liver cancer, accounting for about 75% to 90% of primary liver cancer cases
.
Worldwide, the main factors that increase the risk of HCC are chronic hepatitis B and C, alcohol consumption and metabolic syndrome
.
The ARTEMIS platform has two core functional components: an antibody-based antigen binding domain and an effector domain
.
The receptor design of ARTEMIS allows it to take advantage of the activation and regulation pathways normally employed by endogenous T cell receptors (TCRs)
.
Because this strategy does not directly link the intracellular signaling domain to the co-stimulatory domain, it is expected to eliminate cytokine release syndrome (CRS) caused by T cell hyperactivation
.
▲The product pipeline of Uricco Bio (picture source: Uric Bio's official website) The treatment process of ET140203 collects the patient's T cells, engineer them to express Uric Bio's proprietary ARTEMIS cell receptor, and reinfused into the patient
.
The receptor expressed by the modified ET140203 T cells targets the alpha-fetoprotein (AFP)-peptide/HLA-A2 complex expressed on hepatoma cells
.
In addition, ET140203 T cells also incorporate Urico's proprietary tumor infiltration technology, which has been shown in animal models to enhance the drug's ability to infiltrate solid tumors, which is expected to improve patient outcomes
.
The therapy is currently being evaluated in two open-label, dose-escalation, multicenter Phase 1/2 clinical trials, one in adults with AFP-positive HCC and one in AFP-positive patients with relapsed/refractory disease in pediatric subjects with hepatoblastoma (HB), hepatocellular neoplasm not otherwise specified (HCN-NOS), and HCC
.
ECT204 targets GPC3 expressed on liver cancer cells, a promising HCC antigen present in more than 70% of HCC cells
.
ECT204 T cells also incorporate Urico's proprietary tumor infiltration technology
.
It is currently being evaluated in a Phase 1/2 clinical trial for the treatment of adult patients with GPC3-positive HCC
.
▲Dr.
Liu Cheng, CEO of Urica BioRelated reading: US$60 million in Series D financing, T cell therapy clinical data unveiled at ASCO: Interview with Urico CEO Liu Cheng "We are very pleased to receive FDA approval for the treatment of hepatoma Orphan drug designation for ET140203 and ECT204 came months after Fast Track designation (FTD) for pediatric patients with hepatoblastoma and HCC, and Rare Pediatric Disease Designation (RPDD) for the treatment of hepatoblastoma
.
"This underscores the significant unmet medical need in the medical community for more effective liver cancer treatment options," said
Dr.
We are committed to working closely with regulatory agencies, clinical investigators, patients and their families to advance the clinical development of these programs
.
"Reference: [1] Eureka Therapeutics Receives Orphan Drug Designations for Treatment of Hepatocellular Carcinoma (HCC) With ARTEMIS® T Cells.
Retrieved February 8, 2022, from https:// enDisclaimer: The WuXi AppTec content team focuses on introducing the progress of global biomedical health research
.
This article is for information exchange purposes only, and the opinions in this article do not represent WuXi AppTec's position, nor do they support or oppose the views in the article
.
This article is not Recommended treatment plan
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
