In 2021 ESMO domestic pharmaceutical companies were selected for oral reports with more than ten Cinda and 2 cornerstones each

The 2021 European Society of Medical Oncology (ESMO) annual meeting officially opened on September 16, local time

According to incomplete statistics, domestic pharmaceutical companies were selected for more than 10 oral reports of this ESMO annual meeting, and nearly 50 were selected for electronic poster presentations

In addition, most of the innovative therapies involved in the research are PD-1 monoclonal antibodies, reaching 6 drugs (5 domestically developed and one is Merck’s pembrolizumab), and 7 studies (including Xinda Biotech’s Xindi Lizumab accounted for two studies)

This article will select some of the research results of domestic enterprises based on the oral report items in this conference, and combine the information disclosed by the conference and the press releases of various companies to organize and share with readers

01 Cinda Bio

Cinda Bio: Sintilimab (sintilimab)

Study 1: Interim analysis results of a Phase 3 clinical study of Sintilimab combined with chemotherapy versus chemotherapy for first-line treatment of advanced or metastatic esophageal squamous cell carcinoma (ORIENT-15)

Study 2: Sintilimab combined with chemotherapy compared to placebo combined with chemotherapy for the first-line treatment of unresectable or metastatic gastroesophageal junction adenocarcinoma in the phase 3 randomized controlled study (ORIENT-16)

Innovent will announce a number of clinical data at this conference, including PD-1 inhibitor Sintilimab, anti-CTLA-4 mAb IBI310, FGFR 1/2/3 inhibitor pemigatinib (IBI375) Clinical data

Sintilimab is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to PD-1 molecules on the surface of T cells, thereby blocking PD-1/programmed death receptors that cause tumor immune tolerance.

The ORIENT-15 study is a randomized, randomized study comparing Sintilimab combined with chemotherapy (cisplatin + paclitaxel/5-fluorouracil) and placebo combined with chemotherapy for the first-line treatment of patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.

The ORIENT-16 study is a comparison of sintilimab combined with chemotherapy (oxaliplatin + capecitabine) and placebo combined with chemotherapy for the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junctions A randomized, double-blind, multi-center phase III clinical study of adenocarcinoma

02 CStone Pharmaceuticals

CStone Pharmaceuticals: Sugemalimab, Ivosidenib

Study 1: GEMSTONE-301-a randomized, double-blind, placebo-controlled, stage Ⅲ unresectable stage Ⅲ non-small cell lung cancer (NSCLC) without progression after concurrent or sequential radiotherapy and chemotherapy (CRT) Research

Study 2: The results of a bridging study of Avonib in Chinese patients with relapsed/refractory acute myeloid leukemia (R/R AML) who are susceptible to isocitrate dehydrogenase-1 (IDH1) mutations

Also included in the two oral reports was CStone Pharmaceuticals, which were aimed at suglizumab and avonib, respectively

Suglizumab is an anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals based on the OmniRat® transgenic animal platform

The GEMSTONE-301 study is a multi-center, randomized, double-blind phase III clinical trial designed to evaluate sugarizumab as a consolidation treatment without disease progression, locally advanced/unresectable disease after concurrent or sequential radiotherapy and chemotherapy Efficacy and safety in patients with stage III NSCLC

Avnib is an IDH1 inhibitor, which can promote the differentiation of AML cells by blocking the activity of IDH1 mutant enzymes, thereby exerting an anti-tumor effect

The CS3010-101 China Bridging Study is a phase I, multi-center, single-arm study being conducted in China

03 Junshi Bio

Junshi Bio: Toripalimab (Treplimumab)

Study: JUPITER-06 Study: A randomized, double-blind, phase III study of teriprizumab versus placebo combined with chemotherapy in the first-line treatment of primary, advanced, or metastatic esophageal squamous cell carcinoma (ESCC)

Junshi Biotech's Teriplimumab is a recombinant humanized anti-PD-1 monoclonal antibody injection with a unique dual mechanism of action

JUPITER-06 is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical study, which aims to compare teriprizumab combined with paclitaxel/cisplatin and placebo combined with paclitaxel/cisplatin in advanced or metastatic Efficacy and safety of first-line treatment of esophageal squamous cell carcinoma

Based on the results of the interim analysis, the Independent Data Monitoring Committee (IDMC) determined that the two main research endpoints of the study had reached the pre-specified superiority cut-off value for both the progression-free survival and overall survival.

04 Keji Pharmaceutical

Keji Pharmaceutical: CLDN18.
2 CAR-T

Research: CLDN 18.
2 targets CAR-T cells to treat digestive system tumors

The CAR-T therapy research at this ESMO annual meeting also received much attention
.
The CT041 autologous CAR T cell injection independently developed by Keji Pharmaceutical is a chimeric antigen receptor (CAR) modified T cell targeting Claudin 18.
2 (CLDN 18.
2) with a humanized antibody.
The main target indications are Advanced gastric adenocarcinoma/esophagogastric junction adenocarcinoma and pancreatic cancer with positive expression of CLDN18.
2, and progression or recurrence after previous systemic treatment
.

CLDN 18.
2 is a gastric-specific isoform of Claudin-18, which is highly expressed in gastric adenocarcinoma and pancreatic adenocarcinoma.
Keji Biosciences and Shanghai Cancer Institute jointly developed the world’s first CAR- for Claudin 18.
2.
T cells, and proved in mouse models that CAR-T cells targeted by CLDN18.
2 can efficiently eliminate gastric adenocarcinoma in mice, and have good safety, and are expected to become a new treatment method for gastric adenocarcinoma and other tumors
.

In the first half of the year, Keji Bio announced that humanized anti-Claudin 18.
2 (CLDN18.
2) autologous CAR T cell injection (CT041) is used to treat advanced gastric glands that have positive expression of CLDN18.
2 and have progressed or recurred after previous systemic treatment.
Cancer/Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer New Drug Clinical Trial (IND) application was approved by the U.
S.
Food and Drug Administration (FDA), becoming the first CAR- for CLDN 18.
2 to obtain clinical trial approval in the world.
Candidate T cell drugs
.

At present, Keji Pharmaceutical has initiated a phase 1b/2 clinical trial for advanced gastric cancer/gastric junction cancer and pancreatic cancer in China, and a phase 1b clinical trial for advanced gastric cancer or pancreatic cancer in the United States.
Experiment
.
In ongoing clinical trials, CT041 has shown good therapeutic effects and good safety
.

You can find a number of blockbuster research results selected at this conference, covering many innovative therapies such as monoclonal antibodies, CAR-T products, and small molecule inhibitors.
Domestic pharmaceutical companies will bring these studies to shine on the international stage
.
Of course, in addition to the research mentioned above, other domestic and foreign research that could not be sorted out at this conference should not be underestimated
.
In the next few days, Sina Pharmaceuticals (sinayiyao) will continue to pay attention!

Reference source: Cinda Bio, CStone Pharmaceutical, Junshi Bio, Keji Pharmaceutical official website and announcement