July 13, 2020 – SAN DIEGO, California
GeneQuantum Healthcare (Suzhou) Co., Ltd. announced on July 7, 2020 that the first patient has been dosed at their Australia site in a global phase 1 first-in-human clinical trial of GQ1001. GQ1001 is a next generation anti-HER2 antibody drug conjugate for the treatment of HER2-positive advanced solid tumors.
Dr. Qin Gang, founder and CEO of GeneQuantum, said “With the current global state of the COVID-19 pandemic, it is a lot more challenging to efficiently implement a global clinical trial. Happily and proudly, after several months of close collaboration and dedication by all relevant parties, we could finally bring our potentially revolutionary medicine to patients. I am really appreciative of the great efforts each party has made and I hope to witness the clinical benefits that GQ1001 could introduce to our patients.”
Dr. Qinhua Cindy Ru, managing director of CRC Oncology, said “We are excited that the GQ1001 program has reached this clinical milestone and has begun patient enrollment in Australia. We look forward to our future collaborations with GeneQuantum Healthcare on the GQ1001 program.”
GQ1001 is a next generation, anti-HER2 antibody-drug conjugate (ADC) designed for specific delivery of highly potent cytotoxin to malignant cells. GQ1001 leverages GeneQuantum’s leading integrated immobilized enzymatic conjugation technology namely intelligent Ligase Dependent Conjugation (iLDC). GQ1001 displays optimal drug homogeneity and stability and significantly expanded therapeutic window from non-clinical studies, in comparison to other existing ADC products.
A phase I, first-in-human, multicenter global trial has been designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of GQ1001. More information can be found on ANZCTR.org.au, using identifier ACTRN12620000592943. Information on the US site for this phase I study can be found on ClinicalTrials.gov using identifier NCT04450732.
About GeneQuantum Healthcare
GeneQuantum Healthcare (Suzhou) Co., Ltd. is a high-tech biopharmaceutical company dedicated to the development of innovative biotherapeutics. The company is focused on the development of a new generation of bioconjugate therapeutics to meet the unmet medical needs of cancer patients globally. For more information, visit www.genequantum.com.
About CRC Oncology
CRC Oncology is a contract research organization (CRO) focused on reshaping the global landscape of innovative drugs and therapies for cancer treatment. CRC Oncology provides high quality development and research services by strategically driving global regulatory submissions, authoring quality eCTD dossiers, leading US clinical development, advancing quality management expertise, building and maintaining a 24/7 audit trail, providing full GxP compliance master quality management systems, and bridging global business development needs. For more information, visit www.crconc.com.