The clinical progress of TCR-T therapy is gratifying!

In the field of cancer cell immunotherapy, CAR-T and TCR-T occupies half of the country
.
Compared with CAR-T, which has achieved outstanding results in the treatment of hematoma, for solid tumors, the industry generally believes that TCR-T cell therapy that can specifically recognize tumor antigens has more therapeutic potential

TCR-T cell therapy has recently become increasingly popular
.
In terms of financing, in September and October, domestic Cardi Medical, Zhenzhi Medical, China Inteck, and Xinjing Zhiyuan completed early financing of more than 100 million yuan

Adaptimmune: New data supports the first market application for TCR-T therapy for solid tumors next year

On November 11, Adaptimmune, a leader in the field of TCR-T therapy, announced at the 2021 Connective Tissue Oncology Society (CTOS) annual meeting that its TCR-T cell therapy afamitresgene autoleucel (afami-cel) is in the treatment of advanced synovial sarcoma or mucoid Positive results were obtained in the pivotal SPEARHEAD-1 trial (Phase II) for round cell liposarcoma (MRCLS)
.
These data will be used to support the submission of afami-cel's biological product licensing application (BLA) next year

afami-cel is a specific peptide-enhancing affinity receptor (SPEAR) T cell targeting MAGE-A4+ tumors.
This phase II open-label trial aims to evaluate the effectiveness of afami-cel in the treatment of advanced synovial sarcoma or MRCLS Efficacy, safety and tolerability
.

MAGE-A4 is highly expressed in a variety of solid tumors including synovial sarcoma and MRCLS
.
SPEAR is Adaptimmune's unique TCR-T cell therapy platform

In this trial, 50 patients (42 cases of synovial sarcoma, 8 cases of MRCLS) received afami-cel treatment, with a median age of 41 years (range: 19 to 73 years)
.
Among the 47 evaluable patients who had undergone various pre-treatments, the overall response rate (ORR) was 34% (36% in patients with synovial sarcoma and 25% in patients with MRCLS), and the disease control rate was 85%

The risk assessment showed that the main adverse reactions were low-grade cytokine release syndrome (CRS) and tolerable/reversible hematological toxicity
.
The transformation data confirmed that afami-cel is active against MAGE-A4 expression targets in vitro and in vivo, and maintains a high level of persistence in most patients who are followed up for at least 6 months after infusion

Immatics: The first low-dose TCR-T with anti-tumor activity appears in phase I clinical data

Just two days before Adaptimmune announced key data (November 9), Immatics, a clinical-stage biopharmaceutical company actively deploying the TCR-T pipeline, also announced its promising phase Ia clinical trial of its PRAME-targeted autologous TCR-T therapy IMA203 Data, it has shown considerable curative effect in a variety of solid tumors
.

The ongoing dose-escalation phase I trial included patients with HLA-A*02:01 and PRAME-positive relapsed/refractory solid tumors who did not respond to available standard treatments
.
The test mainly evaluates the safety and tolerability of IMA203

As of October 5, 2021, 18 patients have received ACTengine® IMA203 T cell therapy from dose level 1 (DL1) to dose level 4 (DL4)
.
According to RECIST 1.

In terms of efficacy, among the 16 cancer patients who had previously received a median of 4 systemic treatments, half (8/16) of the patients showed an objective response, including synovial sarcoma, malignant melanoma, and uveal melanoma A variety of solid tumors such as head and neck cancer have responded
.
Among patients receiving DL2 and DL3 doses, the response rate was 62% (8/13)
.
Among the patients who did not respond, 3 received the lowest dose of IMA203, which is almost impossible to have an effect
.

Source: Immatics official website

In addition, 15 of the 16 patients (94%) achieved disease control, and 14 patients (88%) saw tumor shrinkage
.
The researchers also observed that all patients had robust T cell implantation, and that TCR-T cells also had tumor infiltration in evaluable patients undergoing biopsy during treatment
.

In terms of safety, IMA203 seems to be well tolerated, with only short-term and controllable treatment emergent adverse events (AE)
.
Adverse events included grade 1–4 cytopenia, grade 1 and 2 cytokine release syndrome (CRS), immune effector cell-related neurotoxicity syndrome (ICANS), and 1 dose limiting toxicity at the second dose level (DL2)
.

"Our next goal is to maximize the use of (1) ACTengine®IMA203 target-dose monotherapy, (2) combined checkpoint inhibitors, and (3) our next-generation TCR-T therapy ACTengine®IMA203CD8.
It brings benefits to PRAME-positive patients,
” said Dr.
Cedrik Britten, Chief Medical Officer of Immatics
.

Note: The original text has been deleted

Reference materials:

1# Adaptimmune Reports Positive Results from its Pivotal SPEARHEAD-1 Trial in Patients with Synovial Sarcoma and MRCLS at CTOS (Source: Adaptimmune official website)

2# Immatics Reports Clinical Responses across Multiple Solid Tumor Types in Ongoing ACTengine® IMA203 Phase 1a Trial Targeting PRAME (Source: Immatics official website)