GQ1001 / GeneQuantum Healthcare - LARVOL DELTA

Ligand-binding assays validated for quantitative bioanalysis of a novel antibody-drug conjugate in monkey serum and related application in a nonclinical study. (PubMed, J Pharmacol Toxicol Methods) - "All tested performance parameters of the assays met the validation acceptance criteria, which supported the application of the two assays in the nonclinical PK study and allowed the evaluation of the related PK parameters for GQ1001."

Journal • Preclinical • Hematological Disorders

Qide Pharmaceutical Technology (Suzhou) Co., Ltd.'s application for implied clinical trial approval has been accepted [Google translation] (new.qq.com) - "On January 24, according to the official website of CDE, QiDe Pharmaceutical Technology (Suzhou) Co., Ltd. jointly applied for the drug 'GQ1001 Lyophilized Powder Injection for Injection' and obtained implicit approval for clinical trials, acceptance number CXSB2400142....Public information shows that the drug 'GQ1001 Lyophilized Powder Injection' is indicated for HER2-positive solid tumors in adults."

New trial • Solid Tumor • HER-2

A phase Ia study of a novel anti-HER2 antibody-drug conjugate GQ1001 in patients with previously treated HER2 positive advanced solid tumors. (PubMed, J Transl Med) - P1 | "GQ1001 is well tolerated and shows promising efficacy in previously treated HER2-positive advanced solid tumors. DRDE was determined as 8.4 mg/kg for following trials. Trial registration NCT, NCT04450732, Registered 23 June 2020, https://clinicaltrials.gov/study/NCT04450732."

Journal • P1 data • Oncology • Salivary Gland Cancer • Solid Tumor

SABCS China Voice丨Professor Wang Biyun: Pharmacokinetic characteristics and preliminary efficacy of GQ1001 combined with pyrotinib in the treatment of previously treated HER2+MBC [Google translation] (Sohu.com) - P1b/2 | N=75 | GRACE (NCT05575804) | "A total of 15 patients with HER2-positive metastatic breast cancer were treated with GQ1001 and pyrotinib. All patients (15/15) had previously received trastuzumab (or its biosimilars). 33.3% of patients (5/15) had previously received pertuzumab. The dose escalation phase of this study has been completed and no DLTs have been reported...Pharmacokinetic data from 15 patients showed that, compared with previously reported single-agent Phase Ia pharmacokinetic data, GQ1001 combined with pyrotinib (320 mg, qd) had no significant effect on the blood concentrations of GQ1001 and free DM1. In addition, no significant accumulation of GQ1001 was observed after multiple combined administrations....The 12-month progression-free survival (PFS) rate for all enrolled patients was 73.5%, and the ORR was 80% (12/15). At the 6.0 mg/kg, 7.2 mg/kg, and 8.4 mg/kg dose levels, the ORR was 75% (3/4), 100% (5/5), and 66.7% (4/6), respectively."

P1/2 data • HER2 Positive Breast Cancer

Pharmacokinetic profile and preliminary efficacy of GQ1001, a next generation HER2-targeting ADC, combined with pyrotinib in pretreated patients with HER2-positive metastatic breast cancer: A phase 1b clinical trial (SABCS 2024) - P1, P1/2 | "A total of 15 HER2-positive metastatic breast cancer patients received GQ1001 and pyrotinib treatment. All patients (15/15) had failed on previous trastuzumab (or its biosimilars) containing therapy. And 33.3% of the patients (5/15) had been treated with pertuzumab."

Clinical • Metastases • P1 data • PK/PD data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Safety and preliminary efficacy of GQ1001, a next generation HER2-targeting ADC, combined with pyrotinib in pretreated patients with HER2-positive metastatic breast cancer: A phase 1b clinical trial. (ASCO 2024) - P1, P1/2 | "3% of the patients (5/15) had been treated with pertuzumab. GQ1001 in combination with pyrotinib demonstrated manageable safety profile and promising preliminary antitumor activity among pretreated patients with HER2-positive metastatic breast cancer. [1] HUANG L, et al. Cancer Research, 2023, 83(7_Supplement): 2702-."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Dermatology • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Immunology • Oncology • Solid Tumor • Thrombocytopenia • Urticaria • HER-2

GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=75 | Recruiting | Sponsor: Fudan University | Active, not recruiting ➔ Recruiting | Trial completion date: Jan 2024 ➔ Jan 2025 | Trial primary completion date: Jan 2024 ➔ Jan 2025

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

GQ1001: A next generation HER2-targeting ADC that exhibits promising early clinical efficacy with excellent tolerance in a multi-center, Phase Ia study (AACR 2023) - P1 | "GQ1001 demonstrates an excellent tolerability and promising antitumor activity in heavily pretreated HER2-positive advanced solid tumors, supporting further evaluation of the safety and efficacy of GQ1001 at DRDE of 8.4 mg/kg in the following phase Ib trial."

Clinical • P1 data • Oncology • Solid Tumor • HER-2

GQ1001 is a next generation HER2-targeting ADC with excellent druggability, safety and potency (AACR 2023) - "GQ1001 demonstrated similar in vitro anti-cancer activities to T-DM1 in HER2+ tumor cells. GQ1001 is a unique HER2-targeting ADC that exhibits markedly-enhanced linker stability and safety profiles. Judging from preclinical data, GQ1001 demonstrates the potential to treat HER2-positive cancer patients, alone or in combination, who have progressed on previous HER2-targeting therapeutics with reduced toxicity."

Clinical • Oncology • Solid Tumor • HER-2

Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd. | Trial primary completion date: Dec 2022 ➔ Mar 2024

Metastases • Trial primary completion date • Biliary Cancer • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Salivary Gland Cancer • Solid Tumor • HER-2

Development, Validation and Application of a Bridging ELISA for Detection of Antibodies against GQ1001 in Cynomolgus Monkey Serum. (PubMed, Molecules) - "The validated assay was, thereafter, successfully applied to a single-dose toxicity study of GQ1001. Anti-drug antibody positive rates among dosing animals and testing samples were reported, and no significant impact was found on toxicokinetic outcomes."

Journal • Preclinical

GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer (clinicaltrials.gov) - P1/2 | N=75 | Active, not recruiting | Sponsor: Fudan University

New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd. | N=27 ➔ 96 | Trial completion date: Dec 2021 ➔ May 2024 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Enrollment change • Trial completion date • Trial primary completion date • Biliary Cancer • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Salivary Gland Cancer • Solid Tumor • HER-2

Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers. (PubMed, Front Mol Biosci) - "A third HER2-directed ADC, disitamab vedotin (RC48), has been approved for locally advanced or metastatic gastric or gastroesophageal junction cancer by the NMPA (National Medical Products Administration) of China in 2021. In this review article, we summarize the three approved ADCs (T-DM1, DS-8201a and RC48), together with the investigational EGFR-directed ADCs (ABT-414, MRG003 and M1231), HER2-directed ADCs (SYD985, ARX-788, A166, MRG002, ALT-P7, GQ1001 and SBT6050) and HER3-directed ADC (U3-1402). Lastly, we discuss the major challenges associated with the development of ADCs, and highlight the possible future directions to tackle these challenges."

Journal • Review • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ERBB3 • ERBB4 • HER-2

Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors (clinicaltrials.gov) - P1; N=27; Recruiting; Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd.; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • MRI

Samsung Bio aims for China entry via GeneQuantum ADC partnership (GBI Health) - "South Korea-based biopharma Samsung Biologics (KS.207940) formed a strategic partnership with China-based biotech GeneQuantum Healthcare designed to accelerate Samsung’s entry into the China market. Under the deal, the Korean firm will provide development support for one of GeneQuantum’s pipeline antibody drug conjugates (ADCs), under development for non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and other solid tumors. Deal specifics were not disclosed."

Licensing / partnership • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors (clinicaltrials.gov) - P1; N=27; Recruiting; Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd.; Not yet recruiting ➔ Recruiting; Trial primary completion date: Feb 2021 ➔ Jun 2021

Clinical • Enrollment open • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors (clinicaltrials.gov) - P1; N=27; Not yet recruiting; Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd.

Clinical • New P1 trial • Breast Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor