Suzhou- (China) based GeneQuantum Healthcare, a high-tech biopharmaceutical company dedicated to the development of innovative biotherapeutics through differentiated innovation platforms, and BrighGene Biomedical signed an agreement for the development GQ1007, an antibody immune agonist conjugate or AIAC.

GQ1007 is a new type of antibody-drug conjugate linking an antibody to a potent immune agonist.

Immunotherapeutic antibody drugs targeting PD-1 and PD-L1 (representing immune checkpoint inhibitors) have revolutionized cancer therapy. However, even though the superior efficacy of immune checkpoint inhibitor treatment has shown great benefit, many cancer patients do not respond to treatment. These non-responsive tumors are referred to as “cold” tumors.

Compared with other immunotherapies, such as anti-PD1 / PD-L1 and anti-CD40 etc., GQ1007 not only can precisely reach the tumor site but also enhance innate and adaptive immune responses.  It activates dendritic cells and macrophages and increases T-cell infiltration into tumor tissue through immune agonists, thus “cold” tumors become “hot” tumors and the immune system is mobilized to suppress tumors. Ultimately, GQ 1007 achieves a strong and lasting anti-tumor effect, overcomes the low response rate of PD-1 antibody in immunotherapy, and has great clinical value and market potential.

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Antibody-drug Conjugates
“Since the establishment of GeneQuantum we have focused on the development of innovative bioconjugate drugs represented by Antibody-drug-Conjugate. We’ve developed highly differentiated ADC technology platforms, including enzyme-catalyzed site-specific conjugation technology, innovative linker technology, integrated manufacturing process, are collectively called intelligent continuous ligase-dependent conjugation (iLDC) platform,” Gang Qin, founder and Chief Executive Officer of GeneQuantum Healthcare, said.

“These platforms effectively address the current limitations of ADC industry, such as high heterogeneity, narrow therapeutic window, and high manufacturing cost. GeneQuantum’s pipeline portfolio includes not only potential blockbuster ADCs with validated targets, but also drug candidates with novel mechanisms of action,” Qin further noted.

“Our R&D capabilities and iLDC technologies will enter the important harvest period in the near future. We are confident that our’s innovative products will go through global clinical development to commercialization in the next few years. Together with our partners, we will develop a pipeline of novel agents and bring them to the commercialization stage to help benefit patients around the world,” Qin added.

Extensive experience
“BrighGene has extensive experience in small molecule drug development, they hold a unique and competitive advantage in TLR7/8 agonists. We are incredibly pleased to work with R&D team led by Dr. Jiandong Yuan, the Chief Executive Officer of BrightGene,” Paul Song, Ph.D, Chief Scientific Officer of GeneQuantum said.

“By working together, we expect to achieve IND filing for GQ 1007 soon,” Song added.

“I expect that the Seamless integration of small molecule platform of BrighGene and our iLDC technology platform of will enhance our R&D capability for world competitive innovation conjugates, this collaboration fully demonstrate high effectivity of resource and expertise integration among China biomedical companies, which significantly improve new drug development,” noted Qin.

“Based on our in-house iLDC technology, GeneQuantum continues to establish in-depth collaborations with domestic and international biopharmaceutical companies to develop more innovative drugs,” Qin added.

“GeneQuantum’s enzymatic site-specific conjugation technology and unique linker technology effectively improve current issues of chemical conjugation, such as high heterogeneity, low stability, narrow treatment window, and difficult manufacturing challenges for ADC drug products,”  Jiandong Yuan, Ph.D, Chief Executive Officer of BrightGene explained.

“Linker stability is extremely important in the field of antibody immune agonist conjugates. GeneQuantum’s unique stable linker technology can decrease or even avoid random shedding of immune agonists in circulation and significantly reduce the likelihood of general (non-specific) immune activation, it ensures this AIAC molecule with best-in-class potential,” Yuan said.

“BrighGene and GeneQuantum will keep close collaboration relationship, fully leverage our individual core strengths to develop more globally competitive first-in-class or best-in-class drugs in near future,” he added.

Investigational New Drug Application
Earlier this year the China National Medical Products Administration (NMPA) approved GeneQuantum Healthcare’s Investigational New Drug (IND) application for GQ1001, an in-house developed, site-specific, ADC produced using GeneQuantum Healthcare’s intelligent ligase-dependent conjugation (iLDC) technology platform.

GQ1001 is an antibody drug conjugate (ADC) that is currently in global multi-center clinical trial development for treatment of HER2+ solid tumor. GQ1001 was synthesized by site-specific conjugation of DM1 [N2’-deacetyl-N2’-(3-mercapto-1-oxopropyl)-maytansine], a synthetic derivative of the microtubule-targeted agent maytansine, to trastuzumab, based on GeneQuantum exclusive ligase-dependent conjugation and patented ring-opened linker technology. Using GeneQuantum technologies, the linker stability and homogeneity of GQ1001 were significantly improved, expanding the therapeutic window of GQ1001.

GQ1001 has already received Clinical Trial approval from the Therapeutic Goods Administration (TGA) in Australia and IND from U.S. Food and Drug Administration.

“GQ1001 is a project specially funded by National Science and Technology Major Project of the Ministry of Science and Technology of China. The patients have been enrolled into a multi-center Phase I, dose-escalation trial in the United States and Australia. The NMPA’s IND approval is not only an important leap forward in GQ’s global development plans for GQ1001, but also a demonstration of acceptance that GQ’s iLDC platform has been accepted by multi-country drug authorities. GQ successfully developed this technology to address the challenges during process and manufacturing of ADC industry. It demonstrates that China is leading in this area.” GeneQuantum Healthcare’s Qin said.

Maturing in China
“ADC drug development in China is maturing, and opening up a new chapter of tumor-targeted therapy and broadens therapeutic applications. GeneQuantum has focused on developing next-generation ADCs and bioconjugates for years and provides innovative solutions that address the limitation of conventional ADC technology by its iLDC technologies,” said Ms. Leidi Zhang, managing director of China Life Private Equity Investment.

“GeneQuantum’s drug candidates have also demonstrated excellent safety profile in clinic with a larger therapeutic window. China Life Health Foundation hopes to support GeneQuantum for its continuing innovation in bioconjugate drug, promoting new bioconjugate development, and expanding the indications of clinical bioconjugates, as well as accelerating the commercialization of drugs. In the end, we are confident GeneQuantum will provide safer and more effective drug and treatment options for patients worldwide,” Zhang concluded.

Featured image: Suzhou, china (苏州,中国). Suzhou is a major city along the Yangtze River Delta and is known for its gardens and silk trade. It’s been a big player in the Chinese economy for years, and is now considered a UNESCO Heritage Site. GeneQuantum Healthcare is headquartered here. Photo courtesy: © Cattan 2011.

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