Antengene Corporation Limited, a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced ATG-101, a novel PD-L1/4-1BB bispecific antibody being developed by the company, has completed its quantitative and systems pharmacology (QSP) modeling that will provide data guiding the first-in-human study of ATG-101. Antengene plans to submit a clinical trial application for the first-in-human (FIH) study of ATG-101 in Australia starting in mid-2021, to be followed by submissions in US and China.

QSP is a highly innovative methodology that has been used recently in drug discovery and development. QSP supports the pharmacological research of drugs through modeling and simulations, and quantitatively determines drug pharmacology and dynamical properties through integrated pharmacokinetics (PK), pharmacodynamics (PD), and statistical modeling, in providing evidential support to the design, decision-making, and dose selection in clinical trials1. In December 2020, Antengene entered into a strategic collaboration with Applied BioMath, LLC to initiate the pharmacology modeling of ATG-101 to determine the starting and efficacious doses for the first-in-human study of the drug candidate. Completing this QSP modeling will deepen our understanding of ATG-101's antitumor mechanism and provide us with the quality data that will enhance the first-in-human study of ATG-101.

"We collaborated with Applied BioMath to best prepare our team for predicting accurate starting and efficacious doses for our first-in-human studies of ATG-101," said Dirk Hoenemann, M.D., VP, Head of Medical Affairs for Asia Pacific Region (APAC) and Early Clinical Development. "The Applied BioMath models provided us with a thorough understanding of ATG-101's antitumor mechanism which enabled us to better design clinical trials moving forward, including our first-in-human trials."

"Systems pharmacology modeling is uniquely suited for the translation of antibody therapies from in vivo experiments to first-in-human studies," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath.  "Complicated mechanism of actions, as is common in modern antibody therapy designs, requires more sophisticated translational approaches than traditional methods and systems pharmacology has a proven track record of providing accurate translation for such therapies."

To date, Antengene has achieved multiple progress with the development of ATG-101, and is actively preparing to initiate clinical trials of ATG-101 in multiple countries and regions, including China, Australia, and the U.S. In China, Antengene has previously entered into a partnership with Wuxi Biologics for the chemistry, manufacturing, and control (CMC) manufacturing of ATG-101 to further optimize and accelerate the development of ATG-101.

About ATG-101

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of cancer. ATG-101 can activate anti-tumor immune effectors by simultaneously blocking PD-L1/PD-1 binding and 4-1BB stimulation. In the presence of PD-L1 over-expressed cancer cells, ATG-101 showed a significant and PD-L1 crosslinking-dependent 4-1BB agonist activity, thus enhancing therapeutic efficacy, and mitigating hepatoxicity simultaneously. ATG-101 demonstrated potent activity in preclinical animal models, including strong tumor-suppressing effect in models of PD-1/PD-L1 inhibitor-resistant or -relapsed tumors. Meanwhile, the GLP toxicology study has produced results highlighting a favorable safety profile.

At present, Antengene has already completed the preclinical study of ATG-101, and is actively preparing to initiate clinical trials of ATG-101 in multiple countries and regions, including China, Australia, and the U.S. Antengene plans to submit a clinical trial application for the first-in-human (FIH) study of ATG-101 in Australia starting in mid-2021, to be followed by submissions in U.S. and China.

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life threatening diseases. Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since its establishment in 2017, Antengene has built a broad and expanding pipeline of clinical and pre-clinical stage assets through partnerships as well as in-house drug discovery, and obtained 15 investigational new drug (IND) approvals and submitted 5 new drug applications (NDA) in multiple markets in Asia Pacific. Antengene's vision is to "Treat Patients Beyond Borders". Antengene is focused on and committed to addressing significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics. 

About Applied BioMath

Founded in 2013, Applied BioMath's mission is to revolutionize drug invention. Applied BioMath uses mathematical modeling and simulation to provide quantitative and predictive guidance to biotechnology and pharmaceutical companies to help accelerate and de-risk drug research and development. Their approach employs proprietary algorithms and software to support groups worldwide in decision-making from early research through clinical trials. The Applied BioMath team leverages their decades of expertise in biology, mathematical modeling and analysis, high-performance computing, and industry experience to help groups better understand their candidate, its best-in-class parameters, competitive advantages, patients, and the best path forward into and in the clinic.