simridarlimab (IBI-322) / Innovent Biologics - LARVOL DELTA

A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy (clinicaltrials.gov) - P1 | N=70 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Completed | N=230 ➔ 70

Enrollment change • Trial completion • Hematological Disorders • Hematological Malignancies • Oncology

Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P=N/A | N=160 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Not yet recruiting ➔ Recruiting

Biomarker • Combination therapy • Enrollment open • Real-world • Real-world evidence • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and Biomarker Explanation of IBI-322 Plus Lenvatinib on Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=83 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Dec 2025

Biomarker • Enrollment open • Trial completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Phase 1a Study Evaluating the Safety, Tolerability, and Efficacy of IBI322 in Subjects With Advanced Cancers (clinicaltrials.gov) - P1a | N=22 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Completed | N=51 ➔ 22 | Trial completion date: Jul 2023 ➔ Feb 2023

Enrollment change • Metastases • Trial completion • Trial completion date • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - P1a/1b | N=94 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | N=218 ➔ 94 | Trial completion date: Dec 2023 ➔ Aug 2023

Enrollment change • Metastases • Trial completion • Trial completion date • Oncology • Solid Tumor

A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor (clinicaltrials.gov) - P1a/1b | N=1 | Terminated | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | N=124 ➔ 1 | Trial completion date: May 2024 ➔ Aug 2023 | Not yet recruiting ➔ Terminated; Due to the company's development strategy adjustment]

Enrollment change • Trial completion date • Trial termination • Acute Myelogenous Leukemia • Essential Thrombocythemia • Myelodysplastic Syndrome • Oncology • ABL1 • BCR

IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors. (clinicaltrials.gov) - P1a/1b | N=61 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | N=36 ➔ 61 | Trial primary completion date: Mar 2023 ➔ Dec 2022

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion • Trial primary completion date • Oncology • Solid Tumor

Efficacy and Biomarker Explanation of IBI-322 +Lenvatinib Plus Platinum Based Chemotherapy on ALK-Rearranged NSCLC (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Hunan Province Tumor Hospital | Trial completion date: Apr 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Biomarker • Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Efficacy and Biomarker Explanation of IBI-322 Plus Lenvatinib on Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=83 | Not yet recruiting | Sponsor: Hunan Province Tumor Hospital | N=40 ➔ 83 | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Oct 2023 ➔ Oct 2024

Biomarker • Enrollment change • Trial completion date • Trial primary completion date • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

CD47/PD-L1 BISPECIFIC ANTIBODY (IBI322) IN ANTI-PD-1 OR PD-L1 TREATMENT-RESISTANT CLASSICAL HODGKIN LYMPHOMA: A PHASE I STUDY (EHA 2023) - P1 | "Despite the excellent efficacy of PD-1 or PD-L1 inhibitors and brentuximab vedotin (BV) in relapsed or refractory classical Hodgkin lymphoma (cHL), some patients (pts) still have disease progression. IBI322 monotherapy showed a promising anti-tumor effectivity with a manageable safety profile in anti-PD-1 or PD-L1 treatment-resistant classical Hodgkin Lymphoma patients. Clinical trial information: NCT04795128 Hodgkin's lymphoma, Resistance, Immune therapy"

P1 data • Anemia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • SIRPA

Innovent Announces Phase 1 Clinical Data of IBI322 (CD47/PD-L1 Bispecific Antibody) in the Treatment of Anti-PD-(L)1-resistant Classic Hodgkin Lymphoma Patients at the EHA 2023 Annual Meeting (PRNewswire) - P1 | N=230 | NCT04795128 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...announced that Phase 1 clinical data of the globally first anti-CD47/PD-L1 bispecific antibody IBI322 for the treatment of anti-PD-(L)1-resistant patients with classic Hodgkin lymphoma was presented in oral presentation at the 28th Annual Meeting of the European Society of Hematology....Among the 23 patients, the objective response rate (ORR) and disease control rate (DCR) were 47.8% (95% CI: 26.8-69.4) and 91.3% (95% CI: 72.0-98.9), respectively. Among the 7 patients with primary resistance, the ORR was as high as 57.1% (95% CI: 18.4-90.1), and 3 patients achieved complete response (CR). In terms of safety, the incidence of treatment-related adverse reactions (TRAE) was 91.7%, and the most common TRAE were decreased lymphocyte count (62.5%), anemia (62.5%), decreased white blood cell count (20.8%), and decreased platelet count (20.8%)."

P1 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Efficacy and Biomarker Explanation of IBI-322 +Lenvatinib Plus Platinum Based Chemotherapy on ALK-Rearranged NSCLC (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Hunan Province Tumor Hospital | Initiation date: Jul 2022 ➔ Mar 2023 | Trial primary completion date: Apr 2023 ➔ Dec 2023

Biomarker • Trial initiation date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Efficacy and Biomarker Explanation of IBI-322 Plus Lenvatinib on Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Hunan Province Tumor Hospital | Trial completion date: Sep 2023 ➔ Dec 2023 | Trial primary completion date: Jan 2023 ➔ Oct 2023

Biomarker • Trial completion date • Trial primary completion date • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and Biomarker Explanation of IBI-322 Plus Lenvatinib on Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Hunan Province Tumor Hospital | Trial completion date: Mar 2023 ➔ Sep 2023 | Initiation date: Jul 2022 ➔ Jan 2023

Biomarker • Trial completion date • Trial initiation date • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Phase I study of IBI322 (anti-CD47/PD-L1 bispecific antibody) monotherapy therapy in patients with advanced solid tumors in China (AACR 2022) - P1a/1b | "IBI322 monotherapy showed a manageable safety profile with a promising anti-tumor activity in heavily treated patients with advanced malignancies. Study is ongoing to further evaluate IBI322 monotherapy and in combination with other regimen in various types of solid tumor."

Clinical • Monotherapy • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • SIRPA

IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors. (clinicaltrials.gov) - P1a/1b | N=36 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Jun 2023 ➔ Sep 2023 | Trial primary completion date: Jun 2022 ➔ Mar 2023

Combination therapy • Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - P1a/1b | N=218 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy (clinicaltrials.gov) - P1 | N=230 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Trial completion date: Nov 2023 ➔ Apr 2024 | Trial primary completion date: Feb 2023 ➔ Oct 2023

Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology

A Phase 1a Study Evaluating the Safety, Tolerability, and Efficacy of IBI322 in Subjects With Advanced Cancers (clinicaltrials.gov) - P1a | N=51 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2022 ➔ Jul 2023

Enrollment open • Trial completion date • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Innovent Release Phase 1 Results of IBI322 (anti-PD-L1/CD47 bispecific antibody) in patients with advanced solid tumors at AACR Annual Meeting 2022 (PRNewswire) - P1 | N=218 | NCT04328831 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...announced that the results of the Phase I study for IBI322 (anti-CD47 /PD-L1 bispecific antibody) in patients with advanced solid tumors were presented today at the American Association for Cancer Research (AACR) Annual Meeting 2022....58 subjects were enrolled in the study, 16 of which (27.6%) had previously received PD-1/L1 treatment....20 patients with various advanced solid tumors at active doses of IBI310 ≥10 mg/kg group were evaluable per RECISTv1.1, 4 achieved PR, with investigator assessed ORR 20%. Among 9 patients with NSCLC treated at active doses of IBI310 ≥10 mg/kg group, 3 achieved PR, with investigator assessed ORR 33.3% and the DCR 88.9%."

P1 data • Oncology • Solid Tumor

A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor (clinicaltrials.gov) - P1a/1b; N=124; Not yet recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Clinical • New P1 trial • Oncology

IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors. (clinicaltrials.gov) - P1a/1b; N=36; Not yet recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Clinical • Combination therapy • Monotherapy • New P1 trial • Oncology • Solid Tumor

A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy (clinicaltrials.gov) - P1; N=182; Recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Disorders • Hematological Malignancies • Oncology

Innovent Announced Financial Results for Full Year Ended December 31, 2020 and Corporate Progress (PRNewswire) - “The Company plans to enter phase III or pivotal clinical trial this year for 1L MDS for IBI-188…The Company plans to obtain proof-of-concept (PoC) data for IBI-322 in 2021…The Company has completed phase 1b enrollment for IBI-110 and will obtain PoC data in 2021. The potential first-in-class PD- L1/LAG-3 bispecific antibody has also received IND approval recently, and the Company will start Phase 1 study in 2021…In TIGIT area: the TIGIT monoclonal antibody IBI-939 has entered Phase 1b study, with plan to obtain PoC data in 2021. The Company also submitted the IND application for its PD-1/TIGIT bispecific antibody IBI-321 recently, and plans to start clinical study in 2021.”

New P1 trial • New P3 trial • P1 data • Myelodysplastic Syndrome • Oncology • Solid Tumor

A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy (clinicaltrials.gov) - P1; N=182; Not yet recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Clinical • New P1 trial • Hematological Disorders • Hematological Malignancies • Oncology