ZL-1201 / ZAI Lab - LARVOL DELTA

After the failure of Gilead and AbbVie, can domestic innovative pharmaceutical companies support CD47 research and development? [Google translation] (Yicai Global) - "An industry insider told China Business News: 'CD47 drug research and development is generally in trouble. In the past year, CD47 has indeed ceased to be the highest priority project for many pharmaceutical companies.' For example, Zai Lab last year also Due to the 'competitive landscape', the internal development priority of CD47 antibody ZL-1201 was canceled."

Clinical • Oncology

A Trial of ZL-1201 in Subjects With Advanced Cancer (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: Zai Lab (Shanghai) Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Jan 2024 ➔ Jan 2023

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

CD47-blocking Antibody ZL-1201 Promotes Tumor-associated Macrophage Phagocytic Activity and Enhances the Efficacy of the Therapeutic Antibodies and Chemotherapy. (PubMed, Cancer Res Commun) - "Moreover, tumor-infiltrating immune cells and cytokine analysis showed that ZL-1201 and chemotherapies remodel the tumor microenvironment, which increases antitumor immunity, leading to augmented antitumor efficacy when combined with mAbs. ZL-1201 is a novel anti-CD47 antibody that has improved hematologic safety profiles and combines with SoC, including mAbs and chemotherapies, to potently facilitate phagocytosis and antitumor efficacy."

Journal • Hematological Disorders • Oncology • SIRPA

The CD47-targeting antibody ZL-1201 enhances anti-tumor activity of standard of care therapeutic antibodies by promoting phagocytosis in hematologic and solid tumor models (AACR 2022) - P1 | "These include rituximab for CD20-expressing lymphomas, trastuzumab for HER2-amplified cancers, and cetuximab for EGFR-driven solid tumors. This study indicates that ZL-1201 may combine with a broad range of SoC mAbs to enhance their clinical benefit across a variety of hematologic and solid tumor indications. ZL-1201 is under Ph1 clinical investigation (NCT04257617)."

IO biomarker • Preclinical • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • CD20 • CD47 • EGFR • FCGR2A • FCGR2B • HER-2 • PD-L1 • SIRPA

A Trial of ZL-1201 in Subjects With Advanced Cancer (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd. | Recruiting ➔ Active, not recruiting | N=66 ➔ 37 | Trial primary completion date: Jan 2024 ➔ May 2022

Enrollment change • Enrollment closed • Trial primary completion date • Hematological Malignancies • Oncology • Solid Tumor

Zai Lab to shop around CD47 after deciding to ‘deprioritize’ internal development (FierceBiotech) - "Zai Lab has determined “due to the competitive landscape,” that internal development of monoclonal antibody ZL-1201 will be deprioritized...Zai’s asset was in development for multiple hematological and solid tumor types." "

Pipeline update • Hematological Malignancies • Oncology • Solid Tumor

Zai Lab Announces First Quarter 2022 Financial Results and Corporate Updates (PRNewswire-Asia) - "ZL-1201 (CD47 Inhibitor, Global Rights) - Anticipated 2022 Zai Milestone: Determine a recommended Phase 2 dose in the ongoing Phase 1 trial in mid-2022."

Trial status • Oncology

Zai Lab to Present New Oncology Research at 2022 AACR Annual Meeting (GlobeNewswire) - "Three poster presentations will highlight additional key programs in Zai Lab’s internal oncology pipeline....Preclinical data will measure the enhanced antitumor effect by combining ZL-1201 with the current standard of care antibody treatments in hematologic and solid tumor models. Data from ZL-1211, a CLDN18.2-specific monoclonal antibody will be presented with preclinical results supporting effective targeting of CLDN18.2+ gastric cancer, including CLDN18.2-low expressing malignancies....Another presentation will feature the discovery and development of ZL-2201, a novel, orally bioavailable, selective DNA-PK inhibitor."

Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Zai Lab Announces Financial Results and Corporate Updates for Twelve Months Ended December 31, 2021 (GlobeNewswire) - "Anticipated 2022 Zai Milestone: Simurosertib: Initiate a Phase 2 biomarker-driven proof-of-concept study in the second quarter of 2022; ZL-1201: Determine a recommended Phase 2 dose in the ongoing Phase 1 trial in mid-2022; Present preclinical data of ZL-1201 in combination with standard of care therapeutic antibodies in hematologic and solid tumor models at the 2022 AACR annual meeting; ZL-1211: Present preclinical data of ZL-1211 (Claudin18.2), ZL-2201 (DNA-PK), and ZL-1218 (CCR8) at the 2022 AACR annual meeting."

Clinical • New P2 trial • Preclinical • Hematological Malignancies • Oncology • Solid Tumor

Zai Lab Announces Third Quarter 2021 Financial Results and Corporate Updates (GlobeNewswire) - "[For Tebotelimab] Provide an update regarding ongoing studies and plans for the next stage of development; Present preclinical data supporting combination of BLU-945 and BLU-701 in EGFR-driven NSCLC at a medical conference; Initiate Phase 1 trial of BLU-701 in EGFR-driven NSCLC in the fourth quarter of 2021; [for ZL-1201] Determine a recommended Phase 2 dose in the ongoing Phase 1 trial; [For Simurosertib] Initiate a Phase 2 biomarker-driven proof-of-concept study."

New P2 trial • Preclinical • Trial status • Lung Cancer • Non Small Cell Lung Cancer

[VIRTUAL] ZL-1201, a differentiated CD47 therapeutic antibody with improved hematological safety profile (AACR 2021) - "Thus, ZL-1201 treatment represents an effective CD47-targeting therapy with improved hematological safety consequences. A Ph1 dose escalation study to assess the safety of ZL-1201 is currently ongoing in patients with solid tumors, and future combination studies are planned for both hematologic and solid tumor indications."

Clinical • Oncology • Solid Tumor • CD47

A Trial of ZL-1201 in Subjects With Advanced Cancer (clinicaltrials.gov) - P1; N=65; Recruiting; Sponsor: Zai Lab (Shanghai) Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

A Trial of ZL-1201 in Subjects With Advanced Cancer (clinicaltrials.gov) - P1; N=65; Not yet recruiting; Sponsor: Zai Lab (Shanghai) Co., Ltd.

Clinical • New P1 trial