This week, GeneQuantum Healthcare, a Suzhou, China-based developer of bioconjugate drugs, confirmed that the company has received an Investigational New Drug (IND) approval for GQ1001, the world’s first site-specific ADC being developed using a proprietary, highly efficient, ‘intelligent Ligase Dependent Conjugation‘ (iLDC) technology platform.

GQ1001 is a novel, next-generation, antibody-drug conjugate (ADC) candidate for the treatment of HER2-positive tumors. A validation of GQ1001 (PK/PD, Toxicology, etc.) has demonstrated superiority in drug stability and safety profile.

Novel platform technology
Leveraging the company’s innovative technology platform and a newly designed linker chemistry, GeneQuantum developed this novel ADC with high homogeneity and stability, increases drug tolerability, broadening the therapeutic window the investigational drug.

MabPlex
 

Prior to the IND filing in the United States, in 2019 GQ1001 had been approved for the first-in-human clinical study in Australia.

GeneQuantum Healthcare has developed the intelligent ligase-dependent conjugation (iLDC) system based on the independently developed ligase-dependent conjugation (LDC) technology. This platform technology uses an enzyme-catalyzed intelligent continuous conjugation process, a systematic solution toward manufacturing next-generation ADC.

“This is another milestone achievement for GeneQuantum Healthcare. This helps us get closer to our vision that ‘to proactively implement a global multi-center clinical strategy to address a critical unmet clinical need and to benefit global oncology patients.'” noted Gang Qin, Ph.D., the Chairperson and Chief Executive Officer of GeneQuantum Healthcare after receiving the IND approval.

“Based on a large amount of desired safety data and efficacy preclinical evidence, we are confident that GQ1001 will prominently improve the therapeutic outcome of HER2-positive solid tumor patients,” Gang Qin added.

“[This] approval is also a recognition of [our] dedication towards differentiated technology innovation over the past years. Considering the various limitations of current ADC technologies such as high heterogeneity, manufacturing complexity, poor stability, and toxicity profile, we have modified and optimized these technologies. [Based on our] expertise in the field of enzyme evolution, protein engineering, and chemical biology, we have advanced the existing chemical conjugation based production mode and developed an innovative integrated immobilized enzymatic conjugation technology platform called ‘intelligent Ligase Dependent Conjugation‘ (iLDC),” Gang Qin explained.

GeneQuantum Healthcare combines the iLDC technology with IP protected automatic on-line monitoring conjugation system and linker screening and optimization platform to provide a novel solution for the development and manufacturing of high-quality next-generation ADCs.

“The technology can be widely applied to the automated manufacturing of various ADCs,” Gang Qin said.

Groundbreaking
Gang Qin further explained that the iLDC platform employs a unique immobilized enzymatic conjugation process that allows GeneQuantum Healthcare to produce high-quality ADCs within any standard monoclonal antibody manufacturing facility at a speed and yield comparable to mAb equivalents, at a greatly reduced cost. Qin compared the introduction of the company’s novel technology to “the transition from 3G to 5G in the telecommunications industry”.

“We’re thrilled to develop an innovative pipeline of proprietary and co-developed drug candidates to continuously provide safer, more efficacious, and more cost-effective treatment options,” Gang Qin noted.

Investment
GeneQuantum Healthcare believes that GQ1001 as a potential best-in-class candidate, noting that the company’s enzymatic continuous conjugation process is truly groundbreaking, allowing the precise conjugation of a cytotoxin to an antibody, increasing the drug’s tolerability and broadening the therapeutic window, compared with comparable therapies.

GeneQuantum was established in 2013, and has collaborations for ADC drug candidate development with Nanjing- (China) based MITRO Biotech and Beijing-headquartered Biocytogen. Pre-Series B funding in May 2019 yielded GeneQuantum Healthcare RMB 100 million (US $ 14 million). The financing round was led by Huagai Capital, joined by Hofon Capital and Changjinboya, Oriza Seed, and TF Capital.

The company intends to use the funds to promote the global clinical development of the next generation of ADCs, as well as the rapid development and layout of a series of differentiated innovative technologies and products.

“GeneQuantum Healthcare welcomes global established investors and visionary collaborators to discuss co-development and partnership opportunities,” Gan Qin concluded.