The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting has commenced today (local time).May 31) officially opened in Chicago, USA. According to the abstract information on the ASCO official website, more than 5,800 studies have been selected for this year's conference, among whichA total of 426 studies were selected for the "Oral Abstract Session.""And"Rapid Oral Abstract"Session") Link"。

Reviewing these oral presentation studies, we found that nearly 20 cell therapy-related research projects were selected, includingCAR-T Cell Therapy, TCR-T Cell Therapy, TIL Therapy, Off-the-Shelf Cell-Based ImmunotherapyWait. Among these, cell therapies from multiple Chinese companies have also been selected for oral presentation at the ASCO conference, such asCARsgen TherapeuticsClaudin18.2-targeted CAR-T,Yimiao ZhongshenCAR-T Targeting GUCY2C,Bosin GeneCD7-targeted CAR-T products, etc.

We noticed that among the cell therapies selected for oral presentation at this year's ASCO conference, at least six studies targeted solid tumors, coveringGastrointestinal tumors, synovial sarcoma, liver cancer, breast cancer, melanomaetc. In the field of cell therapy, solid tumors were once an insurmountable peak, but in recent years, more and more new therapies and technologies are addressing this challenge and achieving clinical breakthroughs. In this article, we will take a look at cell therapies for solid tumor indications and see how they perform clinically.

Note: This table is compiled by "MedView" based on the abstract from the ASCO official website. If there are any omissions, please feel free to add.

CBMG/AstraZeneca: C-CAR031

Mechanism of Action: Autologous Anti-GPC3 CAR-T Therapy

Indications: Hepatocellular Carcinoma

C-CAR031 is an autologous anti-GPC3 CAR-T therapy targeting hepatocellular carcinoma. The oral presentation selected this time features the Phase 1 study results of this product in treating patients with advanced hepatocellular carcinoma (HCC). GPC3 is a surface antigen overexpressed in HCC and is almost absent in healthy tissues.

As of January 5, 2024, a total of 24 patients have received C-CAR031 infusions at four dose levels (DLs). All patients are evaluable for safety. No dose-limiting toxicity or immune effector cell-associated neurotoxicity syndrome (ICANS) has been observed. Efficacy is evaluable in 22 patients.90.9% of patients experienced tumor shrinkage, with a median tumor reduction rate of 44.0% (ranging from 3.4% to 94.4%) for both intrahepatic and extrahepatic lesions.。The disease control rate (DCR) for all patients was 90.9%, the objective response rate (ORR) was 50.0%, and the ORR for DL4 was 57.1%.The study showed that C-CAR031 had controllable safety and enhanced antitumor activity in heavily pretreated advanced HCC patients.

Yimiao Zhongshen: IM96

Mechanism of Action: CAR-T Therapy Targeting GUCY2C

Indications: Colorectal Cancer

IM96 is aCAR-T Therapy Targeting Guanylate Cyclase 2C (GUCY2C), this timeSelected for Oral PresentationPhase 1 Study Results of the Product in Treating Patients with Metastatic Colorectal Cancer. GUCY2C is ectopically expressed in all stages of colorectal cancer.

As of December 2023, 20 patients were enrolled and administered IM96, with all patients followed up for 7 to 19 months. Safety data showed that only 5% of patients exhibited neurotoxicity and grade 3 cytokine release syndrome (CRS). The study did not reach dose-limiting toxicity or the maximum tolerated dose. Among 19 evaluable patients,DCR was 73.7%, ORR was 26.3%。DL3 Group (12×10⁸）Patients' ORRFor40.0%, regardless of whether there is liver metastasis. The median progression-free survival in the DL3 group was 7 months, and the median duration of response was 10 months. In all patients, tumor response was associated with a significant decrease in carcinoembryonic antigen levels. This study demonstrates,IM96 Demonstrates Durable Efficacy and Acceptable Safety in Mismatch Repair Proficient (pMMR) mCRC Patients, Showing High Treatment Potential Particularly in Liver Metastasis Patients.

CARsgen Pharma: CT041

Mechanism of Action: Claudin18.2-targeted Autologous CAR-T Cell Candidate Product

Indications: Gastrointestinal Tumors

CT041 is an autologous CAR-T cell candidate product targeting the Claudin18.2 protein, currently in a confirmatory Phase 2 clinical trial for advanced gastric cancer/esophagogastric junction adenocarcinoma.Selected for Oral Presentation:OnePhase 1 Clinical Study Data for the Treatment of Gastrointestinal Tumor Patients。

Efficacy data show，The ORR and DCR of all patients reached 37.8% and 75.5%, respectively.The median progression-free survival (PFS) and median overall survival (OS) for all patients were 4.4 months and 8.4 months, respectively.In evaluable gastric cancer patients receiving CT041 monotherapy, the ORR and DCR for those with measurable disease (n=47) reached 57.4% and 83.0%, respectively., all evaluable gastric cancer patients (n=55)The median PFS and median OS were 5.8 months and 9.7 months, respectively.。Researchers believe that CT041 in heavily pretreatedClaudin18.2Promising safety and highly encouraging efficacy were demonstrated in patients with positive advanced GI cancer.

Adaptimmune：letetresgene autoleucel（lete-cel）

Mechanism of Action: TCR-T Therapy Targeting NY-ESO-1 Antigen

Indications: Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Lete-cel is aEngineered T-cell receptor (TCR)-T cell therapy targeting NY-ESO-1 solid tumor antigenNY-ESO-1 is highly expressed in HLA-A*02 in synovial sarcoma and myxoid/round cell liposarcoma (MRCLS).This timeSelected for Oral Presentation:Results from a Phase 2 clinical study. The study enrolled 98 patients with synovial sarcoma and MRCLS, and 45 patients were evaluable for efficacy.

The results showed,The overall ORR was 40% (including 2 cases of CR and 16 cases of PR), with ORRs of 39% and 41% for patients with synovial sarcoma and MRCLS, respectively.The median duration of response was 10.6 months. In the study, adverse events were consistent with previous observations. The researchers believe that the study further supportsThe Potential of Lete-cel as a Therapy for Advanced Synovial Sarcoma and MRCLS。

Obsidian Therapeutics：OBX-115

Mechanism of Action: TIL Therapy Targeting IL-15

Indications: Melanoma

OBX-115 is aEngineered Tumor-Infiltrating Lymphocyte (TIL) Therapy Retaining Interleukin-2 (IL-2), the product uses the FDA-approved small molecule drug acetazolamide (ACZ) to modulate the expression of membrane-bound IL15, providing cytokine support for the expansion and survival of TILs, thusPatients do not need to receive high-dose IL2 simultaneously while undergoing this therapy.. The product is currently in the phase 1/2 multi-center research stage.Selected for Oral Presentation:Results from a Phase 1 study evaluating the efficacy and safety of the OBX-115 regimen in patients with ICI-resistant, unresectable/metastatic melanoma.

As of January 2, 2024, nine melanoma patients received OBX-115 infusions, with a median of three prior treatment lines. Among the patients with at least 12 weeks of follow-up (n=6), calculated per RECIST v1.1,ORR was 50% (2 CR, 1 PR, 3 SD); All reactions occurred between weeks 6 and 18, with the longest reaction duration lasting >12 months.Researchers believe that OBX-115 treatment is well-tolerated, producing sustained and deepening responses, indicating its potential to mediate complete remission and durable clinical benefits in ICI-resistant metastatic melanoma without high-dose IL2.

BriaCell Corporation: Bria-IMT (SV-BR-1-GM)

Mechanism of Action: Cell-Based Targeted Immunotherapy

Indications: Breast Cancer

The Bria-IMT regimen is aBased on Allogeneic Whole-cell Immunotherapy，Can stimulate the patient's immune system to induce targeted killing of cancer cellsAccording to the introduction on the ASCO official website, brachytherapyBria-IMTBreast cancer cells secrete GM-CSF and present tumor-associated antigens (TAAs) on HLA-I and II molecules, directly stimulating anti-tumor immunity. PD-1 immune checkpoint inhibitors（CPI）Further stimulate T cells and synergize with SV-BR-1-GM.Selected for oral presentation isEvaluate the efficacy and safety of this product in combination with CPI for the treatment of advanced/metastatic breast cancer that has been previously treated multiple times (including failure of ADC and CPI treatments).

A total of 54 patients received treatment, and the results showed that the Bria-IMT regimen was well tolerated, with only 9% discontinuing due to adverse events (AE). Among the patients treated with the SV-BR-1-GM Phase III formulation (n=23, evaluable results),ORR was 13%, DCR was 61%, and the median PFS and OS were 4.1 months and 13.3 months, respectively.The research results show that BRIA-IMT has demonstrated good safety while providing benefits for heavily treated patients with advanced/metastatic breast cancer. This Phase 2 study also provides the basis for the ongoing Phase 3 clinical trial.

Notably, in January this year, BriaCell companyAnnouncementBria-IMTAchieved a 71% intracranial objective response rate (iORR) in patients with advanced breast cancer accompanied by central nervous system (CNS) metastases. Currently, the therapy'sThe pivotal Phase 3 trial is currently underway.

In addition to the aforementioned products, several other cell therapies have been selected for oral presentation at this year's ASCO conference, targeting various types of hematological malignancies (see table below). Due to space limitations, they will not be individually introduced here.

For those who wish to obtain the oral presentation of this year's ASCO conferenceCell Therapy Pipeline and Clinical Trial Data, please scan belowQR CodeDownload the form to view.

Related Reading:

• Overview of ADC R&D Pipeline from the 2024 ASCO Oral Presentation

References:
[1]ASCO Conference Official Website. From https://conferences.asco.org/am/abstracts

[2] Public information and official press releases from various companies