▎WuXi AppTec Content Team Report

The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting will be held in Chicago, USA, from May 31 to June 4 (US local time).According to the ASCO Annual Meeting official website,More than 5,000 abstracts have been selected this year.。Recently, many Chinese companies have also issued press releases announcing their new drug studies selected for this year's ASCO conference, including several oral presentations. This article will combine the press releases from various companies,Share Some Oral Reports of Chinese New Drugs Selected for This Year's ASCO Conference, for readers' reference only (this article is an incomplete statistics, sorted by the initial letters of the company names).

Avistone: Beretinib Enteric-Coated Capsules

Mechanism of Action: MET Inhibitor

Indications:Glioblastoma

According to the news release from Avistone, two clinical studies of the enteric-coated capsule Boritini, developed by its wholly-owned subsidiary Puluo Bio, have been selected for this year's ASCO Annual Meeting, one of which was awarded an oral presentation. The study receiving the oral presentation is a phase 2/3 clinical trial evaluating Boritini for the treatment ofTreated, CarryPTPRZ1-METFusion Gene (FUGEN) Secondary Glioblastoma/IDHMutant GlioblastomaThe efficacy and safety of patients. Just a few days ago (April 23), Berotinib in ChinaApprovedNew Indication for Patients with Previous Treatment FailurePTPRZ1-METFusion GeneIDHAdult patients with mutant astrocytoma (WHO Grade 4) or glioblastoma with a history of low-grade lesions.

Bo sheng ji: PA3-17 Injection

Mechanism of Action: Autologous CD7-CAR-T Product

Indications: T-lymphoblastic leukemia/lymphoma

According to the press release from Bo sheng ji medicine science and technology (suzhou) co., LTD, the company has developedAutologous CD7-CAR-T ProductPA3-17 Injection TreatmentRelapsed/Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL)The Phase 1 clinical study was selected for the rapid oral presentation at this year's ASCO conference.T-ALL/LBL is a highly aggressive malignant hematological tumor, and the prognosis for relapsed/refractory patients has always been poor.CD7 is overexpressed in up to 100% of relapsed/refractory T-ALL/LBL, making it an attractive therapeutic target.。PA3-17 is a CAR-T cell injection based on CD7 nanobody, which has demonstrated good safety and encouraging efficacy in patients with relapsed/refractory T-ALL/LBL.

Antengene Corporation: ATG-008

Mechanism of Action: mTORC1/2 Inhibitor

Indications: Cervical Cancer

According to the news release from Antengene Corporation, the company has four studies selected for this year's ASCO Annual Meeting, including an mTORC1/2 inhibitor.ATG-008Combination with anti-PD-1 monoclonal antibody Toripalimab inCervical CancerPhase 2 Clinical Study Data in Patients Selected for Oral Presentation.ATG-008 (onatasertib) can target and inhibit the activity of mTOR, thereby inducing apoptosis in tumor cells and reducing tumor cell proliferation.Antengene Corporation previously reported the clinical results of this product for the treatment of advanced solid tumors at the 2023 ASCO Conference, and this time will present an oral report fromCervical Cancer CohortData.

Dizhe Pharmaceuticals: Sunvozertinib

Mechanism of Action: EGFR-TKI

Indications: Non-Small Cell Lung Cancer (NSCLC)

Dizhe Pharmaceuticals announced that it will present its highly selective EGFR tyrosine kinase inhibitor (TKI) Sunvozertinib at the upcoming ASCO Annual Meeting.EGFR20Exon Insertion (exon20ins) Two latest research achievements on mutant advanced NSCLC. Among them,Sunvozertinib for Previously TreatedEGFR exon20insGlobal Registration Clinical Study "WU-KONG1 Part B" for Mutant NSCLC to Premiere Worldwide as Oral Presentation。It is reported that this is an open-label, international multi-center phase 2 clinical study aimed at evaluating Sunvozertinib in patients who have failed or are intolerant to platinum-based chemotherapy.EGFR exon20insEfficacy and safety in patients with mutant NSCLC are currently being studied in 10 countries and regions worldwide, including the United States, Europe, and China.

Jacobio: glecirasib, JAB-3312

Mechanism of Action: KRAS G12C inhibitor, SHP2 inhibitor

Indications: Non-Small Cell Lung Cancer

According to the JACOBIO press release, the company will present at this ASCO conference in the form of an oral report.Glecirasib (KRAS G12C inhibitor) and JAB-3312 (SHP2 inhibitor) combinationFirst-line treatment for non-small cell lung cancer patientsUpdates on the safety and efficacy data. Jacobi previously released preliminary data from this trial at the 2023 European Society for Medical Oncology (ESMO) Congress, and this update will provide long-term follow-up data. Additionally, glecirasib targetsKRAS G12CMutatedNon-Small Cell Lung CancerThe phase 2 single-arm registrational clinical study conducted by the patient will also be featured at the ASCO Plenary Series meeting held on May 1st.Online Oral Presentation SessionDisplay.

Precision Biologics: C-13-60 Cell Preparation

Mechanism of Action: CEA-Targeted CAR-T Cell Product

Indications: CEA-positive advanced solid tumors

According to the news release from Avistone, the company willAt this year's ASCO conferencePresent it in the form of an oral report.Independently DevelopedCEA-Targeted CAR-T Cells (C-13-60 Cell Formulation)Clinical trial data for the treatment of CEA-positive advanced solid tumors. This is aPhase 1 Trial of Hypoxia-Reactive CEA CAR-T Cells Administered via Intraperitoneal or Intravenous Infusion for Heavily Pretreated Solid Tumor PatientsAccording to the press release from Precision Biologics, the unique intraperitoneal administration method of the C-13-60 cell preparation can overcome the limitations of traditional intravenous infusion, establish long-lasting immunity, enhance the killing effect on solid tumors and prevent recurrence, while potentially reducing the risks associated with off-target effects.

Akeso: Ivonescimab, Cadonilimab

Mechanism of Action: PD-1/VEGF Bispecific Antibody,PD-1/CTLA-4 Bispecific Antibody

Indications: Non-small cell lung cancer, gastric or gastroesophageal junction adenocarcinoma

Akeso announced that the company will attend this year's ASCO Annual Meeting.Presented for the first time in an oral report the Phase 3 registrational clinical trial data of its PD-1/VEGF bispecific antibody drug, Yivoki.. This is a randomized, double-blind, multi-center Phase 3 clinical study aimed at evaluating the efficacy of Ivonescib in combination with chemotherapy compared to placebo in combination with chemotherapy for patients who have progressed after EGFR-TKI treatment.EGFRLocally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer with MutationsThe effect. Currently, Akeso's new drug application for this indication has been accepted by the Chinese NMPA and granted priority review.

In addition, Akeso will also announce one in the form of a rapid oral reportPD-1/CTLA-4 Bispecific Antibody CadonilimabThe results of a multicenter, randomized, double-blind trial, which aimed to evaluate the efficacy of Cadonilimab combined with Proxilumab and Paclitaxel as a second-line treatment for patients who failed previous immunotherapy combined with chemotherapy.Advanced Gastric or Gastroesophageal Junction (G/GEJ) AdenocarcinomaEfficacy and safety of patients.

CARsgen Therapeutics: CT041

Mechanism of Action: CAR-T Targeting Claudin18.2

Indications: Gastrointestinal Tumors

According to the press release from CARsgen Therapeutics, the companyAutologous CAR-T Cell Candidate Targeting Claudin18.2CT041The abstract has been selected for oral presentation at this year's ASCO Annual Meeting, which presents the final results of the Phase 1 CT041-CG4006 study for the treatment of patients with gastrointestinal tumors. CT041 is being developed to treat Claudin18.2-positive solid tumors. The product has been granted Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation by the U.S. FDA for the treatment of advanced gastric cancer/esophagogastric junction adenocarcinoma positive for Claudin18.2, as well as for the treatment of gastric cancer/esophagogastric junction adenocarcinoma.

Lepu Biopharma: MRG004A, MRG003, Prolgolimab

Mechanism of Action: Anti-Tissue Factor ADC, EGFR-Targeted ADC, Anti-PD-1 Monoclonal Antibody

Indications: Solid Tumors

Lepu Biotech Announces Three Latest Clinical Trial Advancements to Be Presented at This Year's ASCO Annual MeetingIncluding 2 Oral Presentations, respectively: EvaluationMRG004A in Patients with Solid TumorsResults of a Phase 1/2 clinical study on safety and efficacy; andPurtilizumab in Combination with MRG003 for the Treatment of Patients with EGFR-Positive Solid TumorsPreliminary results of a phase 1/2 study on safety and efficacy.

Among them,MRG004A is an antibody-drug conjugate (ADC) targeting tissue factor (TF)., which was granted Fast Track designation by the FDA for the treatment of pancreatic cancer in March this year.MRG003 is an ADC targeting EGFR., whose application for recurrent/metastatic nasopharyngeal carcinoma has been included in the NMPA's breakthrough therapy designation and has been granted orphan drug status by the FDA for the treatment of advanced nasopharyngeal carcinoma.Putelimab is an anti-PD-1 monoclonal antibody., has been approved in China for the treatment of patients with unresectable or metastatic MSI-H or dMMR advanced solid tumors.

Mabwell: 9MW2821

Mechanism of Action: ADC Targeting Nectin-4

Indications: Advanced Solid Tumors

Mechanism of Action: CLDN18.2/CD3 bispecific antibody, anti-PD-1 antibody, ROS1 inhibitor, etc.

Indications: Gastric cancer, pancreatic ductal adenocarcinoma, cervical cancer, etc.

According to a press release from Innovent Bio, the company will present approximately 20 latest clinical research data at this year's ASCO Annual Meeting, including a series of monoclonal antibodies, bispecific antibodies, and ADC pipelines under development, as well as innovative oncology drugs such as Olverembatinib and Taremetinib (ROS1 inhibitor).

Among them, eight studies will be presented in oral or rapid oral report formats, respectively:

1）EvaluationAnti-CLDN18.2/CD3 Bispecific AntibodySafety and Preliminary Efficacy of IBI389 in Patients with Solid Tumors and Gastric or Gastroesophageal TumorsA Phase 1 Dose-Escalation and Expansion Study；
2) EvaluationAnti-CLDN18.2/CD3 Bispecific AntibodyPreliminary Results of a Phase 1 Study on the Safety and Efficacy of IBI389 in Patients with Advanced Pancreatic Ductal Adenocarcinoma;
3) EvaluationAnti-CTLA-4 AntibodyIBI310UnitedAnti-PD-1 AntibodyResults of a Randomized, Open-Label Phase 1b Study of Sintilimab as Neoadjuvant Therapy for Patients with Microsatellite Instability-High (MSI-H)/Mismatch Repair Deficient (dMMR) Colorectal Cancer;
4) EvaluationROS1 InhibitorTaladegibIn advanced or metastaticROS1-Positive Non-Small Cell Lung CancerPhase 2 TRUST-I Study on Efficacy and Safety in Patients;
5) EvaluationAnti-PD-1 monoclonal antibodySintilimabNeoadjuvant therapy with paclitaxel and cisplatin for locally advancedCervical CancerA Phase 2 Study on the Efficacy and Safety;
6) Evaluation of NeoadjuvantSintilimabTransoral Robotic Surgery Following Combined Platinum-based Doublet ChemotherapyHPV-Related Resectable OropharynxCancerA single-arm, Phase 2 clinical study;
7) EvaluationSintilimabEfficacy and Safety of Combined Doxorubicin and Ifosfamide as First-Line Treatment for Advanced Undifferentiated Pleomorphic Sarcoma, Synovial Sarcoma, Myxoid Liposarcoma, and Dedifferentiated LiposarcomaSingle-arm Phase 2 Study；
8）OlverembatinibLatest efficacy data for the treatment of succinate dehydrogenase-deficient (SDH-) gastrointestinal stromal tumors (GIST) and paragangliomas in patients resistant to tyrosine kinase inhibitors (TKI).

Ascentage Pharma: OrelabrutinibNi

Mechanism of Action: Third-Generation BCR-ABL Inhibitor

Indications: Gastrointestinal Stromal Tumor and Paraganglioma

Ascentage Pharma announced that four clinical studies of three new drugs from the company have been selected for the 2024 ASCO Annual Meeting, one of which will be presented orally. These three drugs are the third-generation BCR-ABL inhibitor Olverembatinib (HQP1351), the Bcl-2 selective inhibitor APG-2575, and the FAK/ALK/ROS1 triple inhibitor APG-2449. Among them,Orelabrutinib TreatmentTyrosine Kinase Inhibitor (TKI) Resistance in Succinate Dehydrogenase-Deficient (SDH-)Gastrointestinal Stromal Tumor (GIST)AndPatients with paragangliomaThe latest efficacy dataSelected for Oral Presentation。

Immunotech: IMM01 (timdarpacept)

Mechanism of Action: A New Generation of CD47-Targeting Molecules

Indications: Classical Hodgkin Lymphoma, Myelodysplastic Syndromes

Immunotech announced that a total of five innovative drug research results from the company will be presented at the ASCO conference this year.Among themTwo Studies on the New Generation CD47-Targeting Molecule IMM01 Selected for Oral Presentation, respectively: an open-label, multicenter, phase 2 study named IMM01-04, aimed at evaluatingIMM01 Combined with Tislelizumab for the Treatment of Classical Hodgkin Lymphoma After Failure of Prior Anti-PD-1 Therapysafety and preliminary anti-tumor activity; another one isIMM01 in combination with azacitidine for adult patients with high-risk myelodysplastic syndromesLatest Results of Phase 2 Study in First-Line Treatment.

Notably, on April 17, Yimeng Mingke announced that IMM01 in combination with the anti-PD-1 monoclonal antibody tislelizumab (Tislelizumab) has been approved for a Phase 3 clinical trial in China. The trial aims to develop the combination therapy for patients with classic Hodgkin's lymphoma who are refractory to anti-PD-(L)1 monoclonal antibodies.

Chia Tai Tian Qing: Anlotinib

Mechanism of Action: Tyrosine Kinase Inhibitor

Indications: Alveolar Soft Part Sarcoma

China Biologic Products Holdings announced that the company will present 51 latest clinical and basic research data at this year's ASCO conference, including Anlotinib (a small-molecule multi-target receptor tyrosine kinase inhibitor), Ebagstim-alpha (third-generation dual-molecule G-CSF), Penpulimab (PD-1 inhibitor), as well as innovative pipeline projects such as Bemarituzumab (TQB2450, PD-L1 inhibitor), TQB3617, TQB3728, TQB2930, and other innovative oncology drugs. Among them,A Study of AnlotinibPhase 2 StudySelected for Rapid Oral PresentationThis study aims to evaluate the efficacy of Anlotinib combined with anti-PD-L1 antibody in the treatment of alveolar soft part sarcoma, and the results of the expanded cohort of this study will be announced this time.

The annual ASCO meeting is one of the major academic exchange events in the global oncology field, showcasing cutting-edge clinical oncology research achievements and cancer treatment technologies worldwide. In addition to the aforementioned studies, many other Chinese new drug research projects have also been selected for this year’s ASCO conference. Due to space limitations, they will not be individually introduced here. We will continue to track information from this ASCO meeting and share more frontier developments in the field of cancer research.

[1] 2024 ASCO Annual Meeting Official Website. From https://conferences.asco.org/am/attend
[2] Press releases from various companies