World's first iLDC enabling ADC drug receives IND clearance by the US FDA

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Jun 11, 2020, 05:10 ET

SUZHOU, China, June 11, 2020 /PRNewswire/ -- GeneQuantum Healthcare (GQ) has recently received the US IND approval for its in-house developed next generation antibody drug conjugate (ADC) asset, GQ1001. This is the world's first site-specific ADC produced using the intelligent ligase-dependent conjugation (iLDC) technology platform.

GQ1001 is a novel ADC drug candidate for the treatment of HER2-positive tumors, developed by using GQ's differentiated and innovative iLDC platform. Leveraging the patented breakthrough iLDC technology and uniquely designed linker, GQ has demonstrated its world class development capability to precisely conjugate a given small molecule, such as a cytotoxin, to an antibody at the specific site, producing GQ1001 with high homogeneity and stability. Such advancement significantly increases the drug tolerability and broadens the therapeutic window of GQ1001, when comparing with therapies in the same class. This makes GQ1001 a superior candidate that has a great potential to become the global best-in-class for treating HER2-positive solid tumour. Prior to the US IND filing, GQ1001 has alreadybeen approved for the first-in-human study in Australia last year.

"This is another milestone achievement for GQ and a leapfrog towards our vision that is 'to proactively implementing a global multi-center clinical strategy to address a critical unmet clinical need and to benefit global oncology patients.' 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," commented by Dr. Gang Qin, CEO of GQ after receiving the IND approval. "Moreover, such approval is also a recognition of GQ's dedication towards differentiated technology innovation over the past years. Considering the various limitations of current industrial standard ADC technology such as high heterogeneity, manufacturing complexity, poor stability and toxicity profile, GQ team has made all round modifications and optimizations. In combination with expertise in the field of enzyme evolution, protein engineering and chemical biology, GQ team has developed innovative integrated immobilized enzymatic conjugation technology platform iLDC, providing a holistic solution for the development and manufacturing of high quality next generation BioConjugation Drugs (BCDs). We believe the invention of such a unique enzymatic continuous conjugation process is truly groundbreaking. With our new technology, we are able to produce high quality ADC within any standard monoclonal antibody (mAb) manufacture facility at a speed and yield that are comparable to mAb equivalents to the transition from 3G to 5G in the tele-communication industry. We are 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. GQ welcomes global established investors and visionary collaborators to discuss co-development and partnership opportunities. "

About GeneQuantum Healthcare

GeneQuantum Healthcare (Suzhou) Co., Ltd. is a privately held, innovative high-tech company dedicated to the development of First-in-Class and Best-in-Class novel biotherapeutics. Our vision is to become a biopharmaceutical industry leader in China with international competitiveness through differentiated multi-discipline integrated innovation.

GeneQuantum has the world-leading, intelligent Ligase-Dependent Conjugation (iLDC) technology platform with global intellectual property rights. This game-changing technology will be the cornerstone for the development of a new generation site-specific BioConjugation Drugs to meet the vast number of unmet clinical needs around the world.

Forward-looking Statement

Any forward-looking statements in this announcement are based upon information available to GQ and/or their respective board of directors at the time, as the case may be, as of the date of this announcement and, while believed to be true when made, may ultimately prove to be incorrect. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Subject to any obligations under applicable law, none of GQ or any member of their respective board of directors undertakes any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations.

SOURCE GeneQuantum Healthcare